Interim Upstate University Hospital Downtown Campus Ebola ... · 1/3/2017 · ii) Evenings, weekends, holidays: 1-866-881-2809 iii) Follow and implement any additional recommendations

1

The information contained in this document was compiled and/or created as part of Quality assurance/Quality Improvement activities and/or peer review, and/or is patients safety work product, therefore, it is afforded all

available legal protections under State and Federal law, including, but not limited to, NYS Ed. Law § 6527 & Public Health Law § 2805-m, and the Patient Safety Quality Improvement Act. No redisclosure of the information is

allowed.

Interim Upstate University Hospital Downtown Campus

Ebola (EVD) Guidance

Revised: 1/3/2017

The goal of this document is to offer information during an encounter with a suspected EVD patient. It is not intended as an

all encompassing document but a collection of current guidance from other sources as well as existing policies and

procedures at Upstate.

Contents Background ................................................................................................................................................... 4 Transmission ................................................................................................................................................. 4 Case Definition ............................................................................................................................................. 4 Upstate EVD Notifications Listing: Downtown Campus ............................................................................. 4 Risk of Exposure (cdc.gov) ........................................................................................................................... 5 Personal Protective Equipment (PPE) ........................................................................................................... 6 Trained Observer Role Definition & Initial Training Guidance ...................................................................... 7

A Trained Observer primarily responsible for: .......................................................................................... 7 Use of a Trained Observer ........................................................................................................................ 7 Role Clarity ................................................................................................................................................ 7 S.T.E.P. practice ......................................................................................................................................... 8 Principles of PPE during an EVD Patient: .................................................................................................. 8 Donning: The Trained Observers Role in Donning .................................................................................... 9 Donning: Pre-Donning Briefing ................................................................................................................. 9 Donning: Error Catching and Pro-active Assistance ................................................................................ 10 Doffing: the Trained Observer’s Role in Doffing ..................................................................................... 10 Doffing: Role Clarity for Suit Buddy ........................................................................................................ 10 EVD PPE Roles & Training Matrix ........................................................................................................ 15 EVD PPE “on-hand” Matrix ................................................................................................................... 17 EVD PPE DONNING AND DOFFING CHECKLIST .......................................................................... 19 LEVEL 1 ................................................................................................................................................... 19 EVD PPE DONNING AND DOFFING CHECKLIST .......................................................................... 23 LEVEL 2 (N95) .......................................................................................................................................... 23

EVD PPE DONNING AND DOFFING CHECKLIST ............................................................................................ 26 LEVEL 3 (BUDDY) ............................................................................................................................... 26 Safety & Awareness Posters for 8M ....................................................................................................... 28 Rapid Extrication Incapacitated Staff in PPE (8m) ................................................................................. 32

Downtown Emergency Dept. EVD Operations .......................................................................................... 36 8M Unit EVD Operations ........................................................................................................................... 38

8M Opening Process: .............................................................................................................................. 38

Upstate Hospital EVD Guidance Downtown Campus Page 2 of 250

8M Staff Primary Evaluation and Feedback Process: ...................................................................................... 43 8M Clinical Staffing Process ....................................................................................................................... 44 Protecting Patient information ................................................................................................................ 44 Daily Clinical Meetings .......................................................................................................................... 44 Property Management for a diagnosed EVD Patient .............................................................................. 45 8m Security Coordination ........................................................................................................................... 45 8M unit access ......................................................................................................................................... 45 Visitors .................................................................................................................................................... 46 Upstate 8m Consultation & Intercom Use .............................................................................................. 46 EVD Equipment Log ................................................................................................................................. 47 Nursing Specimen Collection /ISTAT 8m ................................................................................................. 48 EVD Patient Discharge Process ................................................................................................................ 51

Exposure Management ................................................................................................................................ 52 Employee Monitoring Process .................................................................................................................... 54 Special Populations: Pediatrics/OBGYN .................................................................................................... 56 Upstate HCW EVD Health Monitoring Log ............................................................................................... 58 Patient Transfer Protocol (Internal & External) .......................................................................................... 59

UH Downtown to another EVD Center ................................................................................................... 59 Other Hospitals & Upstate Community Campus to Downtown Campus................................................ 59 Communications during Transfer............................................................................................................ 60 UH Outpatient Clinics to UH Downtown ................................................................................................. 60 Transport of EVD Patients from Downtown ED to Inpatient Room ........................................................ 60 EVD Direct Admit/EMS Integration for 8M ............................................................................................. 62

Environmental Infection Control/Waste ..................................................................................................... 68 Disposal of Body Fluids (Toilet & Shower) .............................................................................................. 70 Fluid Disposal Procedure (SOLIDIFICATION). .......................................................................................... 70 Patient Flush Procedure .......................................................................................................................... 71 Patient Shower Procedure ...................................................................................................................... 71 Bed Pan Solidification Procedure ............................................................................................................ 71 Category A Waste Removal EVD ............................................................................................................. 71

Spill Cleanup ................................................................................................................................................ 72 Category A Waste Handlin/ Packaging .................................................................................................... 74 EVS WASTE REMOVAL – Cold zone to Waste Staging Rm 8216.............................................................. 75 Class A Waste Travel Routes ................................................................................................................... 77 from ED................................................................................................................................................... 77 from 8M (Patient Care Area & POC Lab) ............................................................................................. 77 from 4 South (Designated EVD Entrance for EMS) ................................................................................. 78 Patient Room Cleaning Procedure 8M/ EVD ........................................................................................... 79 Anteroom Cleaning Procedure 8M/ EVD ................................................................................................ 80 EVD Sharps Container Removal .............................................................................................................. 82 Discharge EVD Warm/Hot Zone Cleaning ............................................................................................... 83

Dietary......................................................................................................................................................... 84 Support Services Employees & Family ...................................................................................................... 85 Communications/Public Relations .............................................................................................................. 87 Post Mortem Preparations ........................................................................................................................... 88 Restraints for a Diagnosed EVD Patient ..................................................................................................... 90 Pharmacy..................................................................................................................................................... 91 Aerosol Generating Procedures (AGPS) ..................................................................................................... 97 Central Line Placement for EVD Patients .................................................................................................. 98


Chest X-Ray ................................................................................................................................................ 99 Highly Infectious Phlebotomy Protocol .................................................................................................... 102 Adult Continuous Renal Replacement Therapy (CRRT) .......................................................................... 104 Galileo Mechanical Ventilator .................................................................................................................. 111 Microbiology Procedure ........................................................................................................................... 113 POC 8M Laboratory ................................................................................................................................. 177

Hemochron Signature Elite ................................................................................................................... 189 Citrate Activated Partial Thromboplastin Lime Testing ........................................................................ 189 Hemochron Signature Elite ................................................................................................................... 198 Citrate Prothrombin Time ..................................................................................................................... 198 Hemochron Signature Elite ................................................................................................................... 207 Preventive Maintenance ....................................................................................................................... 207 Hemochrom Signature Elite .................................................................................................................. 213 Training Checklist .................................................................................................................................. 213 Hemochron Signature Elite ................................................................................................................... 214 General Operating Procedure ............................................................................................................... 214 Horiba ABX Micros 60 Analyzer ............................................................................................................ 222 General Operating Procedure ............................................................................................................... 222 Horiba ABX Micros 60 Analyzer ............................................................................................................ 231 Preventive Maintenance ....................................................................................................................... 231 Horiba Training Checklist ...................................................................................................................... 236 Piccolo Xpress ........................................................................................................................................ 237 General Operating Procedure ............................................................................................................... 237 Piccolo Xpress ........................................................................................................................................ 255 Preventive Maintenance ....................................................................................................................... 255 Piccolo Training Checklist ...................................................................................................................... 259

Upstate Outpatient & Ambulatory EVD Guidance: .................................................................................. 260 Appendix A: EVD Decontamination Zone Room Diagrams .................................................................... 265 Appendix B: Level 1 PPE: PAPR Initial Training Curriculum ............................................................... 269 Appendix C: Upstate EVD Steering Committee Improvement Process/Drill Planning .......................... 273 Appendix D : Upstate Departmental Disaster Plan 8M ........................................................................... 276 Appendix E : Upstate EVD Training Tracker Codes ............................................................................... 280 Appendix E: Rural Metro EMS EVD Policies ........................................................................................ 282 Appendix F : User guide CDESS for Employee Monitoring ................................................................... 291 Appendix F : 8m Video Monitoring User Guide ....................................................................................... 306


Background

Ebola Viral Disease (EVD) is one of numerous Viral Hemorrhagic Fevers. It is a severe, often fatal disease

caused by infection with a virus of the family Filoviridae, genus Ebola virus.

Transmission

Direct contact (through broken skin or mucous membranes) with bodily fluids such as, but not limited to, blood,

urine, feces, sweat, semen, and breast milk of an infected person. Exposure to objects that have been

contaminated with infected secretions (such as needles) Direct handling of bats, rodents or primates from

disease endemic areas. EVD is not spread by an airborne route: Incubation period: 8–10 days (ranges from 2–21

days)

Case Definition

1) All Triage and Registration personnel must ask the following questions per NYSDOH Commissioners

Order of 10/16/14

a) Suspected Case

i) Clinical criteria: including:

(1) A international travel history within the last 21 days or any other country that CDC designates as

having a widespread EVD outbreak; and (2) any symptoms of EVD including fever, headache,

muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhage. AND

(2) Epidemiologic risk factors within the past 21 day before the onset of symptoms as well as

contact with a patient known to have or suspected to have EVD;

ii) Questions asked by Registration/Clinical Staff to all patients presenting for care at all Upstate

facilities.

(1) Identify if patient is possible case:

(a) A suspected case is considered a confirmed case until proven otherwise

In the past 21 days has the patient been outside the United States?

(b) Has the patinet been near other people who have been diagnosed with Ebola?

(c) Does the patient have the symptoms of Ebola?

(i) Temprature: Greater than 38.6 C or 101.6 F

(ii) Severe Headache, Muscle Pain, Weakness, Diarrhea, Vommiting, Abdominal pain

Unexplained hemorrhage (bleeding or brusing)

(2) IF QUESTIONS (#Aand #C ) OR questions (#B and #C) are answered positive please follow

main EVD Guidance on ipage.

2) Confirmed Case

(1) A suspected case with laboratory-confirmed diagnostic evidence of EVD.

Upstate EVD Notifications Listing: Downtown Campus

1) Contact Administrative Supervisor

a) Notify them of event for the immediate activation of Incident Command.

(a) see DIS C-00

(2) Administrative Supervisor Downtown can utilize EVD Red Alert Messaging for activation of 8m

staff.

2) Notify University Police/Security ASAP


3) Contact Hospital Epidemiologist: If one is unavailable call the other physician

a) Downtown Campus: W. Javaid Pager: 467-4529 Cell 315-447-3222

b) Community Campus: M. Brodey Cell only 315-382-3740

4) Administrative Supervisor will notify the following as soon as possible

a) Environmental Health and Safety

b) Laboratory Services: Laboratory Manager 315-882-5063, Microbiology Director 315-373-3074

c) Environmental Services Supervisor- At UH Via VOCERA 464-1400

d) Nursing staff manager for 8m

e) Onondaga County Health Department

i) Business hours: 315- 435-3252

ii) Evening: 315-435-3236

f) NYS Bureau of Communicable Disease Control if unable to reach OCHD

i) Business hours: 518-473-4439

ii) Evenings, weekends, holidays: 1-866-881-2809

iii) Follow and implement any additional recommendations

Risk of Exposure (cdc.gov)

“High Risk” Exposure Examples

1) direct contact with body fluids, from a person sick with Ebola and showing symptoms, through:

a) a needle stick

b) splashes to eyes, nose, or mouth

c) getting body fluids directly on skin

2) touching a dead body while in a country with a large Ebola outbreak without wearing recommended

personal protective equipment (PPE) or not wearing PPE correctly both living with and taking care of a

person sick with Ebola

3) If testing is believed to be required by Upstate contact the local or state health department immediately to

receive direction from them regarding EVD testing

“Some Risk” Exposure Examples

1) close contact (within 3 feet) of a person sick with Ebola for a long time

2) Direct contact with a person sick with Ebola (such as in a hospital) in a country with a large Ebola outbreak

even while wearing PPE correctly

“Low (but not zero) Risk” Exposure Examples

1) having been in a country with a large Ebola outbreak within the past 21 days with no known exposure (such

as NO direct contact with body fluids from a person sick with Ebola)

2) being in the same room for a brief period of time with a person sick with Ebola

3) brief direct contact, like shaking hands, with someone sick with Ebola

4) direct contact with a person sick with Ebola in the United States while wearing PPE correctly

5) traveling on an airplane with a person sick with Ebola

“No Risk” Exposure Examples

1) having contact with a healthy person who had contact with a person sick with Ebola

2) having contact with a person sick with Ebola before he or she had any symptoms

a) someone who left a country with a large Ebola outbreak more than 21 days ago and has not been sick

with Ebola since leaving that country


b) having been in a country where there have been Ebola cases, but no large Ebola outbreak (for example,

Spain)

Personal Protective Equipment (PPE)

1) All hospital personnel involved in patient care will use PPE provided by Upstate.

2) NO SKIN EXPOSURE WHEN PPE IS WORN

3) Each Upstate employee must be monitored for proper donning and doffing and for fatigue while wearing

PPE.

4) If the normal supply chain is interrupted Upstate will seek additional PPE from other local hospitals not

impacted by the EVD patient and coordinate such supplies with NYSDOH/Onondaga County Department

of Emergency Management

5) Hospital has provided disposable shoes (crocs) are optional PPE intended only to those staff who do not

want to wear their own personal footwear. It is recommended that staff members utilize this footwear.


Trained Observer Role Definition & Initial Training Guidance

**** Taken from current CDC recommendations regarding Ebola Treatment and PPE usage.

http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/guidance.html

A Trained Observer primarily responsible for:

Monitoring compliance with PPE protocols for EVD

Guiding, correcting PPE during donning and doffing.

Protecting Themselves

Anticipating and planning for risks or situations that may demand a higher level of safe operations or

urgent situations in which highly trained personnel on site may assist clinical providers engaged in the

care of an EVD patient.

Ensure that the entry and exit Log of all healthcare workers who enter the unit is completed per

NYSDOH guidelines. Ensure that this contact log is communicated to Incident Command or Employee

Health at the end of each shift.

Use of a Trained Observer

1. Because the sequence and actions involved in each donning and doffing step are critical to avoid

exposure, a trained observer should read aloud to the healthcare worker each step in the procedure

checklist and visually confirm and document that the step has been completed correctly.

a. Remember to use verbal and explicit closed-loop communication for each step in the process.

b. Ideally, as the Trained Observer, you tell the health care provider what step to perform, they

verbalize back the task to ensure they understood, and you as the observer verbalize completion.

2. The trained observer has the sole responsibility of ensuring that donning and doffing processes are

adhered to.

3. The trained observer must be knowledgeable about all PPE recommended in the facility’s protocol and

the correct donning and doffing procedures, including how to dispose of used PPE, and must be

qualified to provide guidance and recommendations to the healthcare worker.

4. The trained observer will coach, monitor all donning and doffing procedures, and provide immediate

corrective instruction if the healthcare worker is not following the recommended steps.

5. However, the trained observer should NOT provide physical assistance during doffing, which would

require direct contact with potentially contaminated PPE.

6. The trained observer should know the exposure management plan in the event of an unintentional break

in procedure.

Role Clarity

1. Safety demands active communication by the Trained Observer and the healthcare worker it is up to the

Trained Observer to lead the process and not be a casual observer.

2. The safety of the healthcare worker should be the top priority.

a. Help them by establishing clear roles. Let them know you are here to help and guide them

through the process.

http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/guidance.html


3. Anticipate any challenges you might face by practicing and identifying steps that may have require extra

diligence or verbal explanations for the healthcare worker.

a. It is your job to put them at ease and keep them at a slow and methodical pace. By asserting

your leadership, you can keep them calm and in the proper frame of mind as they are donning

and doffing equipment, and preparing to attend to the patient.

4. Before beginning either the donning or doffing process, it may help to establish proper communication

protocols.

a. Work with the providers to establish ‘red flag’ words so that any situations can be handled by all

parties involved. Use closed-loop communication for clarity. For example, whenever you need to

give a command, have the healthcare worker repeat the command back, so there are no

misunderstandings.

5. Your role as the Trained Observer goes beyond reading the checklist.

a. You should proactively sensitize the health care provider to risks at different steps of the process.

For example, when a health care provider removes their protective head gear, they may be likely

to inadvertently wipe their brow or push their hair back. When providing directions for these

steps, you can offer supportive comments and reminders to be careful not to make those slips.

S.T.E.P. practice

1. Use the STEP practice to make sure the physical surroundings promote safety.

2. Situation –

a. What is my situation? Do we have correct PPE in the needed sizes? Is the equipment functioning

properly?

b. Is the process set up to ensure safety for you and the healthcare providers before and after

attending to the patient?

3. Team members –

a. Be familiar with the protocols for donning and doffing PPE.

b. Are the proper people involved?

c. Are they fatigued or feeling anxiety? Are you making them feel safe?

d. Are they wearing and using the proper PPE? Has everyone been trained on the process properly?

4. Environment –

a. Anticipate any contamination of areas, surfaces or equipment. Is the room set up for donning or

doffing properly?

b. Are the required waste receptacles available? Do you have properly marked clean and dirty

chairs?

c. Is the proper signage posted where it needs to be?

5. Progress toward goal –

a. Be prepared with the latest procedures, and know them to the point you feel comfortable leading

others through them. Do you have the latest checklist? Are you maintaining a connection with

the healthcare worker you are assisting? Are you getting verbal confirmation as you complete

each step?

Principles of PPE during an EVD Patient:

1. Healthcare workers must follow the basic principles below to ensure that no infectious material reaches

unprotected skin or mucous membranes while providing patient care.


2. Donning

a. PPE must be donned correctly in proper order before entry into the patient care area; PPE should

not be later modified while in the patient care area. The donning activities must be directly

observed by a trained observer.

3. During Patient Care

a. PPE must remain in place and be worn correctly for the duration of work in potentially

contaminated areas.

b. PPE should not be adjusted during patient care. In the event of a significant splash, the healthcare

worker should immediately move to the doffing area to remove PPE.

c. Healthcare workers should perform frequent disinfection of gloved hands particularly after

contact with body fluids.

d. If during patient care any breach in PPE occurs (e.g., a tear develops in an outer glove, a

needlestick occurs, a glove separates from the sleeve), the healthcare worker must move

immediately to the doffing area to assess the exposure.

e. The SUNY Upstate exposure management plan should be implemented; including correct

supervised doffing and appropriate employee health follow-up

4. Doffing

a. Removing used PPE is a high-risk process that requires a structured procedure, a trained

observer, a “suit buddy” all operate in the designated area for PPE removal to ensure protection.

b. PPE must be removed slowly and deliberately in the correct sequence to reduce the possibility of

self-contamination or other exposure to Ebola.

Donning: The Trained Observers Role in Donning

1. The Trained Observer’s role in the donning process has three major components.

a. Guide the healthcare provider through donning according to the checklist.

i. All instructions from the checklist need to be verbally confirmed – closing the

communications loop – before they are acted on.

ii. Assuring successful completion of each donning step is one of your major roles.

b. As you are both in a clean area, you may, if needed, assist the health care provider in donning

their PPE as necessary.

c. To ensure safety, continually scan your colleagues’ PPE and the environment for possible

contamination risks during donning.

d. The checklist is a memory aid that structures the donning process.

e. Remember to use verbal and explicit closed-loop communication for each step in the process.

i. Ideally, as the Trained Observer, you tell the health care provider what step to perform,

they verbalize back the task to ensure they understood, and you as the observer verbalize

completion.

f. Completion also means a thorough check to ensure no part of the PPE is ripped, torn or

otherwise vulnerable to contamination.

Donning: Pre-Donning Briefing

1. The donning process begins when you and the health care provider engage one another and verbally

review the protocol.

2. This timeout or Pre-Briefing will involve several important parts.


a. Both of you should first confirm that all PPE and other necessary supplies are available,

conveniently located, correctly sized, and in good working order, free of any rips or tears.

b. Together, you should run through the order of activities on the checklist, setting expectations

about the timeline and agreeing on a slow, steady and deliberate pace for completing the donning

process. In addition to establishing closed loop communication, make sure there is a common

understanding of what you will do if something unexpected happens.

Donning: Error Catching and Pro-active Assistance

1. Acting as a guide and protector means you are proactive about identifying breaches of protocol and

possible points of contamination.

a. As examples, when you and your colleague begin the donning process you may notice that they

are still wearing jewelry, or ID badges.

b. Be sure those are removed prior to donning any equipment as they can cause rips or tears to the

PPE.

2. Draw items like cell phones and ID badges to your colleague’s attention well before they don any PPE.

3. These are items which can be easily forgotten about as we have them on our person every day. A good

time to do a final check may be when they first change into their fresh surgical scrubs.

4. Other examples of proactive risk monitoring during doffing might include identifying issues with

equipment, identifying placement and fit issues with PPE and maintaining control of the pace of the

donning process.

5. These are only a few examples. Your role is to protect by using common sense. Don’t simply depend on

what is on the checklist, proactively monitor for any contamination risks.

Doffing: the Trained Observer’s Role in Doffing

1. The Trained Observer’s role in the doffing process is to guide the healthcare provider, and in some cases

the Suit Buddy, through the doffing process using the checklist provided.

2. As with donning, you must ensure doffing proceeds at a slow, deliberate and methodical pace.

3. Continually scan your colleagues’ PPE and the environment for possible contamination risks during

doffing.

4. Always engage in confirmatory, closed-loop communications with the health care providers and doffing

assistants you are guiding.

5. You should assure successful completion of each doffing step, remembering that completion means a

removed item is intact and has not touched ‘clean’ areas and has been disposed of properly in the

available waste container and has not contaminated any staff members.

Doffing: Role Clarity for Suit Buddy

1. In cases where you will be assisting a colleague wearing a PAPR, or an N95 Respirator combined with a

coverall, a third person will be needed. It is your role, as the Trained Observer, to ensure this person -

called a Suit Buddy - is available and also wearing appropriate PPE. The Suit Buddy should be well-

trained on the protocols as well.

2. Remaining outside the doffing area, you will observe and guide as a Suit Buddy inspects the health care

provider for any signs of contamination.

3. Any areas that are identified as contaminated should be disinfected using approved wipes.


4. The Suit Buddy is to provide a minimum of direct assistance to the health care provider.

5. If they do assist the healthcare provider directly, it is your job to ensure they immediately perform hand

hygiene.

6. You will remain outside the doffing area, guiding and pacing without coming into contact with your

colleague.


8 and



15

EVD PPE Roles & Training Matrix

Primary Staff

member/ Health

Care Worker

(HCW)

Suit Buddy Trained Observer

(aka- CDC Site Manager)

POC

Laborator

y

Personnel

Environmen

tal Services

University

Police/ Public

Safety

Registration

Staff

Outpatient/Ambul

atory Clinical

Staff

Physical

Plant

PPE Level 1 (PAPR) or

Level 2 (N95) Level 3 NONE Level 3

Level 2 or 3

depending on task

surgical mask &

double glove surgical mask

surgical mask &

double glove

Level 1 or

Level 2

Role Upstate Employee

directly engaged in the care of a patient

with EVD (Nurse,

Physician)

Tasked with actively

monitoring and

assisting the HCW/Staff member

with correctly

donning and doffing PPE, observing staff

members for

increased fatigue or possibility of injury,

breaks in PPE.

Measuring vitals of the primary staff

member prior to

donning and after doffing.

To provide direct onsite

management and oversight for

the overall safe operation of all

staff members engaged in the care of an EVD patient. The

Trained observer must

implement both administrative and environmental controls by

continuous safety checks through

direct observation. They must be able to take immediate corrective

action once a breach in PPE or

unsafe environment has been identified. In addition they must

ensure the completion of the

EVD exposure log and that information is communicated to

Employee Health at the end of

every shift. Ensure completion of the employee monitoring form

once HCW/Staff member is out

of the PPE. Ensures proper measuring and recording vital

signs and looking for signs of

fatigue both during donning and doffing. Also ensure appropriate

personnel are on standby to

assist if someone who is currently wearing PPE becomes

injured.

Process and analyze

clinically

required specimens

in the POC

lab on 8m for an EVD

patient

Waste

removal and cleaning for

an EVD

patient

Law Enforcement

and area

security as it relates to an

EVD patient.

Asks all

presenting

patients Initial EVD Screening

questions as

indicated in Upstate's

guidance and

communicates any suspect

cases to clinical

staff members/ Triage Nurses.

Coordinates the

isolation and

communications per Upstate EVD

guidance to ensure

a minimum amount of patient contact.

Must be able to

integrate with local EMS as needed.

Repairs as

needed to

physical space

impacted by

an EVD patient.


Qualifications

Job specific and/or

PPE specific training as

designated by

Upstate Hospital for

the role expected to

be engaged in

surrounding the care, transport or

waste management

of an EVD patient.

The Suit Buddy will

be knowledgeable

about all PPE in Upstate's EVD

Guidance.

Specifically they

should be well

versed in the correct

donning and doffing procedures, disposal

of used PPE and

their role in the EVD exposure plan

The trained observer will be very

knowledgeable about all the PPE components in Upstate's EVD

response. Specifically they

should be well versed in the correct donning and doffing

procedures, waste disposal and

qualified to provide on the spot

guidance as needed. In addition,

The trained observer should be

able to implement the EVD exposure management plan in

the event of an unintentional

break in procedure by possessing an above average awareness of

the resources available to them

in such a situation.

Job specific and/or PPE specific training as

designated by Upstate Hospital for the role

expected to be engaged in surrounding the care,

transport or waste management of an EVD

patient.

As indicated by Upstate's

department of

Human Resources and

Supervisors

within the Department for

the screening of

all patients presenting for

care at Upstate.

Job specific and/or

PPE specific training as

designated by

Upstate for the role expected to be

engaged in

surrounding the care, transport or

waste management

of an EVD patient as it occurs in an

outpatient or

ambulatory setting

Job specific and/or PPE

specific

training as designated

by Upstate

Hospital for the role

expected to

be engaged in

surrounding

the care, transport or

waste

management of an EVD

patient.

Reports to: Direct Supervisor or

trained observer

when in PPE

Direct Supervisor or

trained observer

when in PPE

Direct Supervisor or Safety

Officer if Incident Command has

been activated

Direct Supervisor or others as indicated by Incident Command

PPE Level 1 (PAPR) or

Level 2 (N95) Level 3 NONE Level 3

Level 2 or 3 depending on

task

surgical mask &

double glove surgical mask

surgical mask &

double glove

Level 1 or

Level 2

Training Required

Monthly verified PPE donning/doffing training sessions per NYSDOH Commissioners order (10/16/14) in the

presence of Upstate Super-User. Also drills and exercises as determined by EVD Steering Committee. Each

employee needs to complete the appropriate respirator fit-testing program per Upstate policy in Employee Health

in addition to a current and acceptable medical evaluation on file per normal policy.

Blackboard

Class on

identification

and isolation of

a suspected

EVD patient

Monthly EVD

identification and isolation

Drills per

NYSDOH Commissioners

order (10/16/14)

Monthly EVD

identification and

isolation Drills per

NYSDOH

Commissioners

order (10/16/14)

Training will

occur only if

a critical need for one

of these staff

members to enter the

warm or hot

zone arises.

17

EVD PPE “on-hand” Matrix

Upstate PPE USAGE ESTIMATION FOR 1 EVD patient (CDC Minimum Days on Hand =7 days)

Assumptions: Location Title Estimated #

staff per shift

Shifts per Day

Suits per Day

Total # of People who

need PPE per day (Level 1,2 &

3)

level 1 or 2 PPE

8m Shifts are 12 hrs long (2 shifts per day); ED EVD

"shift" would be less than 12hrs as they would be

transported to 8m ASAP on the first day.

8m Physician 1 2 2

52

8m RN 4 2 8

ED Physician 2 1 2

ED RN 4 1 4

ED/8m Enviro Services 3 3 9

Level 3 PPE (Buddy)

ED EVD "shift" would be less than 12hrs as they would be transported to 8m ASAP on

the first day.

8m Physician & Rn 2 2 4

ED Physician & Rn 2 2 4

POC Lab Lab 5 2 10

ED/8m Enviro Services 3 3 9

# on Hand right now # est. used in 7

days Est. Use per day

Overage/ shortage

Days on Hand

Minimum PPE

Allowed Vendor Mfg.

PAPR Hoods 275 112 16 163 17.19 125 Grainger LC DOVER

PAPR filters 500 112 16 388 31.25 125 Grainger LC DOVER

TYCHEM Suits 601 175 25 426 24.04 175 MDS DuPont

Face Shields 451 364 52 87 8.67 400 Medline Medline

Cowls 940 364 52 576 18.08 400 Fisher DuPont

Gown 495 364 52 131 9.52 400 MMS MMS

Outer Glove (Nitrile) 400 364 52 36 7.69 400 Fisher sol-vex

Boot Covers 600 364 52 236 11.54 400 Medline Medline

N95 masks 103125 364 52 102761 1983.17 400 MMS Kimberly Clark

In the event of a diagnosis of EVD in a suspected patient a pre-set PPE order would be initiated

by incident command through our normal supply chain for the following items in order to

increase our inventory of essential PPE.

# on Hand right now Days on Hand

Pre- determined

order (if EVD confirmed)

Days on Hand w/

order (if EVD confirmed)

PAPR Hoods 275 17.19 400 42.19

PAPR filters 500 31.25 400 56.25

TYCHEM Suits 601 24.04 600 48.04

Face Shields 451 8.67 1200 31.75

Cowls 940 18.08 1200 41.15

Gown 495 9.52 1200 32.60

Outer Glove (Nitrile)

400 7.69 1200 30.77

Boot Covers) 600 11.54 1200 34.62

N95 masks 103125 1983.17 0 1983.17

EVD PPE DONNING AND DOFFING CHECKLIST

LEVEL 1 Equipment needed: washable clogs, suit, PAPR, HEPA cartridges, hood, trauma gown, outer gloves (green), inner gloves (Nitrile) and Chem Tape. ***for the purpose of this document “Bleach wipe” refers to Clorox Healthcare Bleach Germicidal Wipes *** Dwell time: three minutes

TOPIC Completed?

Have the 3rd person (Trained Observer) calling out each step, wait for (trained observer)

DO NOT RUSH THIS PROCESS

Pre Donning Instructions: The COLD ZONE (Clean Area):

1. Before donning with PPE

receive Safety Briefing

make sure to take bathroom break

drink fluids

secure belongings including jewelry, cell phone, watch, Vocera, etc. in staff locker

For staff with long hair, pull back with hair tie.

2. Change out of clothes into hospital scrubs.

3. Tuck shirt into waist band and tuck scrub pant legs into socks or tape.

4. Change into washable shoes (Hospital provided clogs).

5. Checking vitals: make sure to check vitals of both the person going in the room and the buddy. Document on staff tracking form.

PAPR ASSEMBLY

1. Both the Care Provider and Suit Buddy:

Inspect breathing tube, connections, and body

Look for gaskets,

Look for any breaks in the tube,

Obtain 2 new (sealed in foil) PAPR filters

Inspect for expiration date

Pull tabs on filters to allow for airflow

Check threading of filters and PAPR

Secure filters “hand tight” do not over tighten

Make sure the battery is fully charged.

2. Air Flow

Insert the air flow indicator into the blower opening on the top of the PAPR

Turn the blower on

The plastic cone should rise above the minimum flow mark

If the indicator fails to rise to this level, check the battery, and make sure the caps are removed from the filters/cartridges

If still fails to rise to this level or PAPR alarms, do not use PAPR

TOPIC Completed?

3. PAPR hood assembly

Check that the breathing hose thread has the black rubber gasket seal

Check the threads in the blower unit is in good condition and clear of foreign matter

Screw the end of the breathing hose into the blower unit until it is hand tight

Do not over tighten!

Connect the tube to the head piece, screw the end of the breathing hose until it is hand tight

Do not over tighten!

PPE & Supplies Check 1. Inspect ALL personal protective equipment for any rips or tears and signs of wear.

2. Position a cleanable table with a blue wrap available in the COLD ZONE for the doffing process.

3. Suit Buddy will rip (3) 12” pieces of ChemTape.

4. Suit Buddy will attach zipper tab to suit.

Donning: The COLD ZONE (Clean Area):

1. Put washable clogs on.

2. While sitting place feet into personal protective suit.

3. Stand and Pull suit up to waist.

4. Put first set of inner gloves on (Nitrile).

5. Put arms into suit and bring suit up to shoulders.

6. Ensure the sleeve of the suit completely covers the inner glove to the wrist.

7. Buddy assists with donning the green outer gloves

Place the green outer gloves over first set of gloves and arms of suit

Ensure that inner gloves are tucked under sleeve of the suit

8. Tape green outer gloves to outside of suit and make tabs on end of Chem Tape for ease in removal.

Marry glove to suit and be sure to check for any exposure or gaps.

9. Zip suit above waste.

10. Partially close flap of suit

11. Buddy holds the PAPR blower unit and assists the Care Provider in securing the belt

Ensuring the belt holders are secured in place.

Adjust belt as needed for a snug fit.

12. Buddy turns the PAPR blower unit button ON.

13. Put PAPR hood over head, pulling chin strap securely under chin.

14. Tuck inner bib of the PAPR hood into the suit

15. Zip suit up completely up

16. Seal the flap of suit. Use Chem tape as needed.

17. Put Trauma gown over suit

Tie in back at neck and waist.

Ensure the trauma gown does not obstruct the PAPR blower motor by securing the trauma gown waist tie underneath the blower motor.

TOPIC Completed?

18. Buddy conducts visual inspection of Care Provider to ensure PPE is properly donned.

Once the Care Provider is fully donned, the Buddy should put on the Buddy Suit: Level 3 PPE

Note: When in Hot Zone, if any breech in PPE or Contamination occurs, the Care Provider must stop, disinfect with bleach wipe, come into Warm Zone, doff PPE and follow the Exposure Procedure.

Doffing Instructions: Have a 3rd person (Trained Observer) calling out each step, DO NOT RUSH THIS PROCESS.

While Care Provider is the Hot Zone (Patient Room)

If grossly contaminated, wipe down as much contaminates using Bleach wipes as possible while still in the Hot Zone (patient room). (3 minute dwell time)

1. Carefully remove trauma gown by criss crossing arms and carefully pull gown at shoulders to breaking top attachment point

2. Turn sleeves and gown inside out while rolling gown away from your body 3. Once detached and completely rolled up place gown in rigid waste container. 4. Pause to inspect your PPE again for any gross contamination

1. Wipe hands with Bleach wipe (discard wipe) and wait Dwell time: 3 minutes 2. Wipe door knob with second Bleach wipe (do not need to wait dwell time) 3. While using the Bleach wipe to open door step into Warm Zone. 4. Discard wipe in warm zone ridged waste container.

HOT TO WARM ZONE TRANSISTION 1. The Buddy stays in the Cold Zone at all times. 2. The Care Provider is in the Warm Zone.

If the Buddy steps into Warm Zone, the Buddy must stay in the Warm Zone and follow decontamination doffing process.

If the Care Provider becomes contaminated at any point of this process, STOP, clean with Bleach wipes, document exposure and follow Exposure Procedure.

1. Care Provider in suit should stand on the blue wrap inside the Warm Zone at all times.

2. Buddy ensures the table (adjust height related to Care Provider) with blue wrap is set up in the COLD ZONE on the edge of the warm zone for placement of PAPR blower.

3. Bleach Wiping procedure:

Buddy hands Care Provider a new Bleach wipe to wipe gloves between select doffing steps or when a breach in protocol occurs.

Wait appropriate Dwell time: 3 minutes.

Discard wipe immediately after each step.

DOFFING PROCESS in Warm ZONE 1. Buddy verbally assists Care Provider with backing up to the table.

2. Buddy will grasp the PAPR and instruct the Care Provider to unbuckle the PAPR belt

3. Buddy tells Care Provider they will be disconnecting the air.

4. Buddy disconnects the PAPR hose attached to the hood and places it on the table.

5. Buddy Turns PAPR off. Buddy wipes gloved hands. (3 minute dwell time)

6. Care Provider in suit leans head forward then pulls the PAPR hood off and places in rigid waste container used for bio-hazardous waste. Care Provider wipes gloved hands. (3 minute dwell time)

7. Care Provider in suit will open flap and completely unzip suit.

TOPIC Completed?

8. The Care Provider reaches behind and pulls suit off shoulders and down to waist.

9. With arms behind back grab outer glove from behind to free inner gloved hand.

10. Use clean hand with inner glove inside of suit to free other hand from sleeve and outer glove.

11. Carefully roll suit inside out down to knees being sure not to touch outside of suit.

12. The Buddy will position a clean chair on edge of Cold and Warm Zones so that the Care Provider will face the Warm Zone with feet and suit in Warm Zone.

The chair must always remain in the cold zone

13. Care provider pulls legs out of suit one leg at a time and carefully keeps feet in suit or stand in suit until both legs are out of PPE Suit.

Care providers feet CANNOT touch warm zone area including the blue wrap.

14. While still sitting in chair the Care Provider pivots and steps out into the Cold Zone.

15. Care Provider wipes gloved hands. (3 minute dwell time)

16. Care provider takes inner gloves off, discarding them in ridged waste container.

17. Wash hands with hand sanitizer or soap and water for at least 30 seconds.

18. Care Provider showers and changes into clean scrubs.

19. Document vitals on medical evaluation form when finished.

Cleaning up the Warm Zone (Suit Buddy) 1. Trained Observer will guide Buddy on cleaning of PAPR and warm zone

2. The Buddy should watch to make sure the chair used during donning/doffing does not become contaminated if a breach in suit, visual contamination, or the suit accidently touched the legs of the chair during the doffing process. If the chair becomes contaminated, the Buddy should wash with Bleach wipes.

3. Buddy wipes the PAPR blower unit and waist strap down with Bleach wipes and leaves on table. Buddy disinfects gloved hands with bleach wipe allowing for appropriate dwell time: 3 minutes.

4. The buddy will remove the HEPA filters from the PAPR then place in waste bin.

5. Buddy will disconnect PAPR hose from PAPR then wipe hose with disinfectant wipe. After wiping with bleach wipe place clean hose on clean surface in cold zone.

6. Buddy will disconnect the belt from the PAPR then wipe belt with disinfectant wipe and place in the cold zone.

7. Buddy will wipe PAPR with disinfectant wipe then place on clean surface in cold zone.

8. The Buddy will gather up blue wrap carefully rolling dirty surface inward, and place in rigid container. Buddy will wipe gloved hands. (dwell time 3 minutes)

9. The washable shoes worn by the Care Provider are clean and should be wiped with Bleach wipe and returned to the PPE equipment area. (dwell time 3 minutes)

10. Buddy will follow waste procedure to bag up waste in the warm zone.

11. Buddy will follow buddy doffing procedure.

12. Wash up /Shower per Protocol and change into clean clothes.

13. Document vitals of the Buddy on medical evaluation form when finished.


LEVEL 2 (N95) PPE ATTIRE NEEDED: washable clogs, suit, N95, face shield, cowl (hood), trauma gown,

outer gloves (green), and inner gloves (Nitrile) and Chem Tape.

***for the purpose of this document “Bleach wipe” refers to Clorox Healthcare Bleach Germicidal Wipes *** Dwell time: considered at least three minutes at a minimum.

TOPIC Completed?







drink fluids




3. Tuck shirt into waist band and tuck scrub pant legs into socks or tape.


5. Checking vitals: make sure to check vitals of both the person going in the room and the buddy. Document on staff tracking form.

PPE & Supplies Check 1. Inspect ALL personal protective equipment for any rips or tears and signs of wear.

2. Have a cleanable table with a blue wrap available in the COLD ZONE for the doffing process.

3. Suit Buddy will rip (3) 12” pieces of Chem Tape. 4. Suit Buddy will attach zipper tab to suit.


1. Put washable clogs on.

3. While sitting place feet into personal protective suit.

4. Stand and Pull suit up to waist.

2. Put first set of inner gloves on (Nitrile).

5. Put arms into suit and bring suit up to shoulders, ensuring that the sleeve of the suit completely covers the inner glove to the wrist.

6. Trained Observer will review the proper way to put on N-95 and Employee will

then put on N-95.

5. Buddy assists with donning the green outer gloves:

Place the green outer gloves over first set of gloves and arms of suit

Ensure that inner gloves are tucked under sleeve of the suit

6. Tape green outer gloves to outside of suit and make tabs on end of Chemtape for ease in removal.

Marry glove to suit and be sure to check for any exposure or gaps.

7. Place Cowl/hood over head and N 95 mask.

8. Tuck hood inside suit.

9. Zip suit up.

10. Seal the flap of suit with Chem Tape

11. Place a 4” piece of Chem tape from the front of cowl to chest.

12. Put Trauma gown over suit and tie in back at neck and waist.

13. Put face shield on and secure shield in place with tabbed Chem Tape on each side of head.

Note: No exposed skin or hair of the employee in the suit should be visible at the conclusion of the donning process.

HOT TO WARM ZONE TRANSISTION Have a 3rd person (Trained Observer) calling out each step, wait for caller do not rush this process

The Buddy stays in the Cold Zone at all times.

The Care Provider is in the Warm Zone.


If the Care Provider becomes contaminated at any point of this process, STOP, clean with Bleach wipes, document exposure and follow Exposure Procedure.

Doffing Instructions: Before leaving the Hot Zone (Patient Room) to go into the Warm Zone:

If grossly contaminated, wipe down as much contaminates using Bleach wipes as possible while still in the Hot Zone (patient room) (Dwell time 3 minutes)

Carefully remove trauma gown by criss crossing arms and carefully pulling gown at shoulders, rolling gown inside out and place in rigid waste container

Place all materials in the rigid waste container in the patient room

Wipe hands with Bleach wipe

Discard wipe

Wait Dwell time: 3 minutes

Wipe door knob with Bleach wipe and while using wipe open the door (No need to wait dwell time)

Step into Warm Zone

Discard wipe

1. Care Provider in PPE should be standing on the blue wrap inside the Warm Zone.

2. Bleach Wiping procedure:

Buddy hands person in suit a new Bleach wipe to wipe gloves between select doffing steps or when a breach in protocol occurs

Wait appropriate Dwell time: 3 minutes after each step

Discard wipe immediately after each step

3. Care Provider in suit leans head forward near rigid waste container designated for bio-hazardous waste.

4. With two hands the care provider pulls shield and cowl off by placing hands on straps on side of shield (pulling off both the face shield and cowl over head at the same time).

Care Provider wipes hands with Bleach wipe (Dwell time 3 minutes)

5. Care Provider will open flap and completely unzip suit.

6. The Care Provider reaches behind and pulls suit off shoulders and down to waist.

7. With arms behind back grab outer glove from behind to free inner gloved hand.

8. Use clean hand with inner glove inside of suit to free other hand from sleeve and outer glove.

9. Carefully roll suit inside out down to knees being sure not to touch outside of suit.

10. The Buddy will position a clean chair on edge of Cold and Warm Zones so that the Care Provider will face the Warm Zone with feet and suit in Warm Zone.

The chair must always remain in the cold zone

11. Care provider pulls legs out of suit one leg at a time and carefully keeps feet in suit or stand in suit until both legs are out of PPE Suit.

12. While still sitting in chair the Care Provider pivots and steps out into the Cold Zone.

13. Care Provider wipes gloved hands. (3 minute dwell time)

Care providers feet CANNOT touch warm zone area including the blue wrap.

14. Lean head forward and grasp front of N-95 mask:

pull outward until elastic straps come off head

drop N 95 mask onto blue wrap in warm zone

15. Care provider takes inner gloves off, discarding them in ridged waste container.

16. Wash hands with hand sanitizer or soap and water for at least 30 seconds.

17. Care Provider showers and changes into clean scrubs.

18. Document vitals on medical evaluation form when finished.

Cleaning up the Warm Zone (Buddy) 1. The Buddy will gather up blue wrap carefully rolling dirty surface inward, and place

in rigid container. Buddy will wipe gloved hands. (dwell time 3 minutes)

2. The washable shoes worn by the Care Provider are clean and should be wiped with Bleach wipe and returned to the PPE equipment area. (dwell time 3 minutes)

3. Buddy will follow waste procedure to bag up waste in the warm zone.

4. Buddy will follow buddy doffing procedure.


6. Document vitals of the Buddy on medical evaluation form when finished.


LEVEL 3 (BUDDY) PPE ATTIRE: Equipment needed: N95, face shield, cowl/hood, trauma gown, (2) pair of gloves (Nitrile), knee high boot covers. ***for the purpose of this document “Bleach wipe” refers to Clorox Healthcare Bleach Germicidal Wipes *** Dwell time: considered at least three minutes at a minimum.

TOPIC Completed?







drink fluids




3. Tuck shirt into waist band and tuck scrub pant legs into socks


5. Document vitals on medical evaluation form


Have a 3rd person (Trained Observer) calling out each step, DO NOT RUSH THIS PROCESS.

1. Put on boot covers over disposable shoes.

2. Put on inner nitrile gloves.

3. Put on outer nitrile gloves.

4. Put on N95.

5. Put on hood/Cowl.

6. Put on gown - Note: sleeves should cover inner gloves.

7. Put on face shield.

8. Place two small pieces of Chem Tape around face shield band to secure it to the hood.

9. Place a 4” piece of Chem Tape from the front of cowl to chest.

The Buddy is now ready to work in the Cold Zone

The Buddy stays in the Cold Zone at all times.


Doffing Instructions: Have a 3rd person (Trained Observer) calling out each step, DO NOT RUSH THIS PROCESS.

TOPIC Completed?

1. Decontaminate hands using Bleach wipe.

Wait appropriate Dwell time: 3 minutes

Discard wipe when done.

2. Remove boot covers. (Use chair as needed to maintain balance)



Discard wipe when done

4. Remove outer gloves being careful not to contaminate inner gloves.




6. Remove hood and face shield together.




8. Remove gown rolling it inside out.




10. Remove N95




12. Remove gloves.

13. Wash hands with soap and water for at least 30 seconds.

14. Put on new pair of gloves to bag up buddy PPE waste.

Follow waste bagging procedures



Discard wipe when done

16. Discard gloves in red waste bin.

17. Wash hands with soap and water for at least 30 seconds.


19. Document vitals of the staff monitoring form when finished.

Safety & Awareness Posters for 8M

The following are posters created to promote an increased awareness for certain actions such as donning

and doffing. These posters do not take the place of the checklists created as a step by step guide for the

trained observer to read.

EVD Procedure

Procedure Issue Date: 2/16/15 Applies to: Downtown

Last Revision Date: 2/16/15

Last Review Date: 2/16/15

Rapid Extrication Incapacitated Staff in PPE (8m)

Number of Staff Needed: 1 buddy RN, 1 standby Rn, Trained Observer, Code Response

team (if needed), Trained ED EVD personnel,

Equipment: Backboard, Trauma Scissors, Mega Mover, C- Collar, stretcher or bed from

ED.

Purpose: The primary focus of this procedure is to clinically stabilize life threatening injuries or

conditions while minimizing exposure to EVD when a staff member is located in the patient’s

room on 8m while wearing level 1 PPE.

Assumptions:

1) Primary Care Staff Member (or the injured person while located inside the hot zone)

becomes injured or incapacitated in such a way to jeopardize the physical safety of that

person or impair their ability to doff safely under the normal established process. Additional

personnel must be sent in to the hot zone in order to assist them maintain a safe working

environment.

2) The Trained Observer & Suit Buddy will observe the Primary Care Staff Member for signs

of heat stress or other potential opportunities for injury in order to prevent this from ever

happening.

3) A 3rd

fully trained RN, not actively engaged in other duties, will be placed on “stand-by” in

case the need for additional resources becomes apparent. That 3rd

“stand by” RN will not

leave 8m without suitable replacement being found and integrated in to the process.

4) At no time does the Trained Observer enter the room during this process.

5) Every effort should be made to minimize additional injury to the staff member during this

extrication process. Balancing the urgent need to remove them from the hot zone & PPE

quickly with reducing the possibility of exposure to EVD as the process evolves.

Process

1) Immediately following the initial donning process:

a) Once that Primary Clinical Staff Member is donned and about to enter patient room, the

Suit Buddy and 3rd

“stand by” staff member must “lay out” or prepare a full level 1 or

level 2 PPE for each of them in a location that enables quick access.

i) This location should be coordinated with the Trained Observer.

b) Suit Buddy and Trained Observer will verify the presence of a Backboard and trauma

scissors in the anteroom/hallway.

2) If Rapid Extrication is needed:

a) The Trained Observer (or designee) will immediately notify Incident Command/ Code

Team Activation

i) All arriving staff members must remain in the clean zone and the patient will be

brought to them “clean” before initiating patient care.

ii) A determination should be made if more than two staff members are needed in this

situation based on presentation of the scene, suspected injury and body type/ weight

of the injured staff member

iii) Call the ED for more trained personnel who can don PPE.

iv) Call for other trained 8m staff if located nearby.

v) The Trained Observer will notify the 3rd

“stand-by” RN to begin donning Level 1

PPE with the help of the Suit Buddy already in Level 3 PPE.

3) Once the 3rd “stand-by” RN staff member is donned and in the patient room.

a) This person would bring the “mega mover” transport sheet as needed.

b) Perform an initial assessment of the Injured Person.

c) Communicate any needs to the Trained Observer.

d) (if needed) Instruct patient to not participate in this process. Have them stay on the bed.

e) No clinical interventions should be performed on the Injured Person while inside the hot

zone. Even life saving procedures must be performed outside the patient room.

f) Tear away or cut the Trauma Gown from the Injured Person and dispose of it inside

patient room per normal process.

4) While the 3rd “stand-by” RN staff is assessing the situation/just entered the room:

a) The Suit buddy will then begin doffing the level 3 PPE

b) Once doffed that individual must immediately begin donning the level 1 PPE with the

assistance of the Trained Observer (or available trained designee)

c) Once in Level 1 PPE they should enter the patient room and prop open the outer door to

the anteroom as well as patient’s room door to increase ease of extrication.

5) Once an initial assessment has been made and doors are open:

a) Both the 3rd “stand-by” RN Staff member and the Suit Buddy (both in level 1 PPE) will

determine the best method to move the Primary Clinical Staff Member/Injured Person

and communicate that to the Trained Observer using the “mega mover” transport sheet if

possible.

i) If the Primary Clinical Staff Member /Injured Person can walk with assistance have

them assume a supine position once out of the patient room and in the warm

zone/anteroom.

ii) If unable to ambulate

(1) Remove trauma gown: rolling it slowly away from injured person.

(2) Use a log roll to position injured person on to “mega mover” transport sheet

(3) Identify and wipe any gross contamination prior to moving.

b) The patient’s room door in between warm/hot zone will be closed once staff have moved

injured person in to the anteroom.

i) Leave door to clean zone open to facilitate passing of equipment such as the

backboard, collar.

c) If the Injured Person is medically compromised where immediate removal of PPE is

recommend in the safest manner possible

i) The injured person’s Level 1 PPE will be completely wiped with Clorox wipes if any

gross contamination noticed

ii) If at any point in this process a need arises to wipe down the outer gloves both the

Suit Buddy and the 3rd “stand-by” RN will do so per normal procedures.

iii) Use trauma scissors to cut the level 1 PPE off taking care not to create a higher risk

of exposure for the Injured Person.

(1) Slowly roll the suit away from the injured person as it is cut.

(2) Once cutting is completed place trauma scissors in safe location in order to avoid

puncturing anyone’s PPE

d) Once out of PPE the Injured Person should be placed on a backboard with C-collar as

needed

e) The code team/ED personnel or 8m staff will pull the head backboard from the warm

area to the clean area once the injured person has been secured.

i) Staff in PPE will place the backboard at the edge of the warm/clean zone in order to

help this process.

ii) Under no circumstances would anyone in not in appropriate PPE enter the warm zone

f) The injured person would be transferred to ED for further evaluation as needed using

standard contact precautions per hospital policy.

6) Once injured the Injured Person has been removed from 8m:

a) Doffing will occur for the 3rd “stand-by” RN and Suit buddy utilizing additional

personnel to assist them.

b) The anteroom is to be no longer considered the warm zone; instead it should be treated as

a hot zone until a risk assessment can be completed by Environmental Health and Safety

and/or Infection Control.

c) Primary coordination and reporting of this unusual circumstance will be the responsibility

of the Trained Observer working with Employee Health, the ED and Incident Command.

d) An employee injury report should be completed and the EVD log should be noted as soon

as practical but before the end of the Trained Observers’ shift.

7) Rapid Extrication/ Emergent Move Concepts for Safe Operations:

a) Body Mechanics/Lifting Techniques

i) Safety precautions

(1) Use legs, not back, to lift.

(2) Keep weight as close to body as possible.

(3) Guidelines for lifting

(4) Consider weight of patient and the need for help.

(5) Know your physical ability and limitations.

(6) Lift without twisting.

(7) Have feet positioned properly.

(8) Communicate clearly and frequently with partner

ii) The greatest danger in moving a patient quickly is the possibility of aggravating a

spine injury.

iii) Every effort should be made to pull the patient in the direction of the long axis of the

body to provide as much protection to the spine as possible.

“ Mega Mover”

Log Roll *** Pictures do not represent acceptable PPE during this process

EVD Procedure




Downtown Emergency Dept. EVD Operations

Procedure:

1) Identify if patient is possible case using triage questions per NYSDOH order 10/16/14:

2) Patient Placement:

a) Have patient don a surgical mask immediately

b) Place patient in room A2 if available. (If occupied, place patient in triage 3 and make A2

available immediately for this patient.) Negative Pressure Required

c) Notify Charge Nurse, ED attending and Administrative Supervisor

d) ED Attending will confirm patient meets PUI status, involving Hospital Epidemiologist

as needed. (See EVD Notifications listing section above).

e) Incident Command will be activated by Administrative Supervisor

f) Retrieve EBOLA PPE from side room in Trauma 1

g) Designate PPE “suit buddy” and Trained Observer from trained staff to assist in the

donning and doffing

h) EVS Set up CAT A waste barrel in room 2261

i) Ensure that only trained EVD PPE personnel are engaged in the care surrounding this

patient. If needed contact Administrative Supervisor for additional trained staff.

3) If suspected patient is transported by local EMS

a) ED clinical or registration staff (whoever makes initial contact) will question the patient

presenting for care even if the transporting EMS agency has asked the questions indicated

in the NSDOH Commissioners order of 10/16/2014.

b) If the patient is incapacitated or presents with altered mental status -the transporting EMS

agency will be questioned in order gain the most amount of information if possible.

4) Care of this patient:

i) All Health Care Workers will use LEVEL 1 or LEVEL 2 PPE without exception.

(1) Suit Buddies would use Level 3

ii) A1 will be identified as room for donning and doffing PPE

iii) Security will secure area surrounding A1/A2/radio room allowing no foot traffic.

iv) If possible place privacy screens around A1/A2 area to increase privacy for staff

donning and doffing as well as the patient.

v) Maintain log of those entering A1/A2 area (see ipage for EVD contact log)

vi) NO VISITORS ARE ALLOWED TO ENTER THE PATIENT ROOM

5) SEE APPENDIX for Decontamination Zone Diagrams for A1/A2

6) A1/A2 Preparations

a) A1:

i) Remove stretcher and any other items not needed for donning and doffing.

ii) Place a bedside table in room for removal of PAPR

iii) Assure large bleach wipes are in room.

iv) Place blue mat on floor.

v) Place chair with arms in room.

vi) Bring dynamap into room.

vii) Assure red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear

resistance and 165 grams of impact resistance.) s are in cans and extra are in room.

viii) Obtain waste drum from EVS and place in room.

ix) Call HVAC to lower temperature in both rooms if clinically acceptable to do so.

b) A2:

i) Assure red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear

resistance and 165 grams of impact resistance.) are in room.

ii) Assure large bleach wipes are in room.

iii) Scan room for patient care items needed.

iv) Assure phone is in working order.

7) Management of Equipment & Bodily Fluids in and out of room:

a) ISTAT and all other equipment (i.e. disposable thermometer) used in room will remain in

room A1 or A2 as needed until a full decontamination is completed.

b) Labs: (See Highly Infectious Phlebotomy Protocol section below).

i) Limited to essential labs

c) Specimens transported in secure container by Microbiology personnel

d) Xray only when critical. If used, portable x-ray will remain in restricted area and not

return to general use.

e) EVS will manage the process for disposal of waste

f) All equipment and waste/trash must stay in room until appropriate EVS support is

available to assist in removing the waste in approved containers in PPE. (see waste

transport procedure)

g) Cleaning of ED waiting room begins ASAP, EVS staff will don Level 1 PPE.

8) Plan for Admission:

i) Transfer to 8M to be coordinated by Incident Command (See: Transfer Procedure)

EVD Procedure




8M Unit EVD Operations

Procedure: 8m, the designated EVD unit, has developed a functional team from nursing,

physicians and specialty services in order to provide the highest quality patient care under

this type of dynamic environment. Only trained and identified Upstate personnel will be

allowed to care for an EVD patient on 8m in order to minimize the number of staff

potentially exposed.

8M Opening Process:

Purpose: to identify specific action steps for staff in order to make ready the unit ready to accept

a patient.

1. Administrative supervisor is notified a patient is being sent to the Emergency dept. or

directly admitted to 8M.

2. Administrative supervisor calls the Hospital Administrator or Nursing Director on

call, security, and housekeeping.

3. *Incident Command is activated*

4. Administrative Supervisor will trigger the Everbridge Alert system to notify RN/MD

volunteers and other personnel (Emergency Preparedness, 8M manager, and

Environmental Health and Safety).

5. Administrative Supervisor will identify 4 RNs to send to 8M to open unit. (Check for

any current in house Ebola trained RNs).

6. Obtain key from key box on 8M to unlock equipment cart.

7. Remove training equipment from room 1 (8132).

8. Call environmental services to clean room. Environmental services will also set up

barrels, supply red bags, twist ties, and bleach wipes for unit.

9. Call pharmacy for stock medications (Narcotics and override meds).

10. Obtain Istat machine and supplies from 6th

floor (If not in use with patient in ED).

11. Bring swat monitor to 8M.

12. Confirm eye wash station is functional

8m Activation Checklist

Purpose: to identify specific action steps for staff in order to make ready the unit ready to accept a

patient.

1) Identify Staff Roles for those who are present:

a) Team leader to coordinate all efforts pre arrival

b) 2 (Level 1) PPE trained 8m clinical staff members to participate in EMS hand off on the 4th floor

c) 2 (Level 3) PPE Trained 8m staff members to assist as suit buddies

d) 2 (Level 1) PPE trained 8m clinical staff members to wait on the unit to assume patient care after

the patient has arrived on the unit

e) One Trained Observer (EHS, IC)

f) Request Environmental services personnel report to 8m to assist in general cleaning

g) Nursing Supervisor or 8M Manager to unlock supply carts in unit and Linen Room on 8B

2) START EMPLOYEE MONITORING PAPERWORK FOR ALL STAFF WHO DON PPE.

a) Work with incident command on the proper reporting of those documents after patient has

arrived.

b)

3) Verify the notification of the following thru the Admin Super

a) UPD

b) Environmental Services

c) Lab

d) Physicians who are trained on 8m PPE

e) OTD personnel to begin just in time training of other identified clinical staff (physicians, etc.)

that may not be current.

f) Pharmacy

g) Nurse Manger of 8M unit

4) Patient Room Area

a) Remove

i) mannequin to ergonomics room (or off unit)

ii) Throw out IV training supplies currently connected to pump

iii) Empty Sharps containers of training items/Obtain new sharps containers

iv) Empty Trash Cans of training waste (ensure training waste in clear NOT red bags and off the

unit prior to patient arrival)

b) Change bed linen and pillow

c) Turn all Lights on

d) Verify operational status and location:

i) IV pump

ii) O2

iii) Monitor

iv) Monitor cables

v) containers of bleach wipes are in holders

vi) Mulltiple zip ties next to door

vii) Lab specimen container

viii) Suction unit

ix) Ambu bag

x) Verify clean up/spill kit is near room

xi) Verify TV works (do not leave on)

xii) Call bell

xiii) Bedside Table

e) Obtain

i) Portable blood pressure cuff- Float Office

ii) digital stethoscope

iii) Med Box

iv) Istat

v) central line kit, foley, barrier cart, ultra sound machine

vi) Thermometer

vii) Several bed pans /urine jug

viii) Commode (to be placed in supply room)

ix) Obtain liquid bleach for bathroom in pt room

x) Fill latex glove rack in pt room

xi) Egg timer for dwell time.

5) 2ndary patient room

a) Remove ventilator unless clinically needed

b) Decide placement of crash cart (in hall or in 2ndary patient room) based on clinical needs

c) Verify presence of swiffer sweeper

d) Verify operation of pass thru to lab

6) Ante Room/ Doffing area

a) Verify the following are in good supply in the cabinets located in the anteroom

i) Egg timer

ii) Multiple Blue sheets

iii) Red bags

iv) Bleach wipes

v) Gloves (all sizes)

vi) Extra bottles of solidifier

b) Ensure the following are in the room or obtain.

i) Folding chair

ii) Bedside Table

iii) Garbage can (remove training waste similar to patient room)

iv) Hand soap in dispenser

v) Trauma scissors are on wall

7) Nurses Station

a) Remove

i) Training PAPR Hoods & Filters from unit (throw away)

ii) All training or unit trash (non medical waste) prior to patient arrival

b) Verify operational status and location:

i) Audio and video system

(1) Sign in to camera system (use AV binder for instructions)

ii) Desktop computer/EPIC system

(1) Sign in as needed

iii) code cart is present

iv) Zoll operational

v) Phillips Intellevue MP 50

vi) Scale for clinical staff use pre and post donning and doffing near RN station

c) Obtain

i) Ensure new PAPR hoods and filters are placed on the donning table

ii) Ensure new Tychem level 1 suits are placed on the donning table

iii) key for Pharmacy box

iv) portable blood pressure cuff for donning pre-checks of clinical staff

v) Linen key

vi) Supply closet door code is (*****)

vii) patient chart as needed

viii) Create patient bracelet, labels, welcome folder/booklet.

d) Contact pharmacy

i) order antiemetic, anti diharria as well as pain meds per clinical needs

ii) order electrolytes fluids on standby

iii) Order rehydration fluids for patient to drink if able.

8) Other items

a) Order additional linen for unit as well as a schedule of fresh linen for regular delivery

b) Open Family Room

c) Contact Incident Command

i) Obtain cell phone for patient use if needed

ii) Laptop for patient use if needed

d) Verfiy Eyewash is operational

e) Personnel on 8m need to be kept to a minimum. Utilize UPD for help controlling this

f) When patient is approaching 8m during EMS transfer ALL personnel not in LEVEL 1 PPE MUST BE

OFF THE UNIT until deemed safe and the patient is in the designated room on 8m

g) Obtain

i) Portable blood pressure cuff- Float Office

ii) digital stethoscope

iii) Med Box

iv) Istat

v) central line kit, foley, barrier cart, ultra sound machine

vi) Thermometer

vii) Several bed pans /urine jug

viii) Commode (to be placed in supply room)

ix) Obtain liquid bleach for bathroom in pt room

x) Fill latex glove rack in pt room

xi) Egg timer for dwell time.

9) 2ndary patient room

a) Remove ventilator unless clinically needed

b) Decide placement of crash cart (in hall or in 2ndary patient room) based on clinical

needs

c) Verify presence of swiffer sweeper

d) Verify operation of pass thru to lab

10) Ante Room/ Doffing area

a) Verify the following are in good supply in the cabinets located in the anteroom

i) Egg timer

ii) Multiple Blue sheets

iii) Red bags

iv) Bleach wipes

v) Gloves (all sizes)

vi) Extra bottles of solidifier

b) Ensure the following are in the room or obtain.

i) Folding chair

ii) Bedside Table

iii) Garbage can (remove training waste similar to patient room)

iv) Hand soap in dispenser

v) Trauma scissors are on wall

43

11) Nurses Station

a) Remove

i) Training PAPR Hoods & Filters from unit (throw away)

ii) All training or unit trash (non medical waste) prior to patient arrival

b) Verify operational status and location:

i) Audio and video system

(1) Sign in to camera system (use AV binder for instructions)

ii) Desktop computer/EPIC system

(1) Sign in as needed

iii) code cart is present

iv) Zoll operational

v) Phillips Intellevue MP 50

vi) Scale for clinical staff use pre and post donning and doffing near RN station

c) Obtain

i) Ensure new PAPR hoods and filters are placed on the donning table

ii) Ensure new Tychem level 1 suits are placed on the donning table

iii) key for Pharmacy box

iv) portable blood pressure cuff for donning pre-checks of clinical staff

v) Linen key

vi) Supply closet door code is (*****)

vii) patient chart as needed

viii) Create patient bracelet, labels, welcome folder/booklet.

d) Contact pharmacy

i) order antiemetic, anti diharria as well as pain meds per clinical needs

ii) order electrolytes fluids on standby

iii) Order rehydration fluids for patient to drink if able.

12) Other items

a) Order additional linen for unit as well as a schedule of fresh linen for regular delivery

b) Open Family Room

c) Contact Incident Command

i) Obtain cell phone for patient use if needed

ii) Laptop for patient use if needed

d) Verfiy Eyewash is operational

e) Personnel on 8m need to be kept to a minimum. Utilize UPD for help controlling this

f) When patient is approaching 8m during EMS transfer ALL personnel not in LEVEL 1 PPE MUST BE

OFF THE UNIT until deemed safe and the patient is in the designated room on 8m

8M Staff Primary Evaluation and Feedback Process: 1) Evaluation of team members is achieved through direct observation during full scale exercises and various drills

conducted every month.

2) Topics for these exercises includes clinical skills while in PPE and staff must demonstrate competency on infection

control practices, policies, and procedures while for caring for a patient with Ebola

3) Any remediation of procedures or PPE usage is done immediately with continued performance improvements corrected

as the nursing manager, safety officer or drill coordinator as they see fit at the time of the drill.

4) At the conclusion of each drill or exercise feedback is requested from those staff members participating as a

methodology for process improvement in Upstate’s EVD preparedness globally.

a) Feedback items are tracked by Emergency Management and/or Infection Control using the normal reporting process

to the Upstate Safety Committee.

5) Representatives from Employee health and/or Human Resources will be made available to speak with all

Upstate personnel who directly care for or support the care of an EVD patient in order to answer any

questions they may have.

8M Clinical Staffing Process 1) All volunteer clinical staff members who participate in the care of a diagnosed EVD patient will be

reassigned from their areas to 8m for the duration of the patient’s stay at Upstate.

2) The 8m Unit Director and Administrative Supervisor shall ensure 24/7 coverage across all shifts for appropriate on-site

available staff members to immediately report to 8m if a possible EVD patient is sent to Upstate.

a) Staffing numbers will be validated monthly using existing schedules and identifying trained staff members

availability.

3) If an EVD patient arrives

4) The 8m Unit Director and/or Administrative Supervisor shall initiate a “RED ALERT” call to all designated and trained

staff members to report to 8m immediately.

5) 8m will operate on either 8 hour or 12 hour shifts with a minimum of 4 nurses and 1 physician in the department at all

times.

6) Daily Clinical Meetings will be held twice a day in order to coordinate care in 8m as well as to ensure that a minimum

number of staff is needed in the warm zone. (see section below)

7) Maximum duration that staff will be allowed in PPE will be determined in these meetings based on clinical needs as

well as the number of staff available. Every effort shall be made to keep the amount of time in PPE to a minimum

amount.

8) Staff will be instructed to rest/recover in the staff lounge in between durations of time spent in PPE or supporting those

in PPE. Minimum timeframe for rest will be determined by the staff member involved and the Trained Observer on site

at the time.

Protecting Patient information 1) All Upstate suspected of diagnosed EVD patients will be made a “Private Encounter or Alias” per policy A-

12 as soon as possible.

2) The patient must be informed that 8m unit closed circuit cameras/intercom will be used to monitor and

record actions of clinical staff in addition assisting clinical assessments for specialists who cannot enter the

room. All saved tapes will become part of the medical record.

Daily Clinical Meetings 1) At least twice a day with Physicians, Nursing, Environmental Services, and Safety/Trained Observers &

Laboratory personnel will meet on 8m to discuss the clinical goals, logistics and any safety related issues

regarding the current care of the EVD patient.

a) The goal of this meeting is to

i) Coordinate all clinical care and testing to ensure the smallest number of procedures and staff

required to enter the patient room.

ii) Coordinate waste management and transfer.

b) These meeting will be a method to communicate any information received from the CDC and NYSDOH

regarding this EVD patient

i) Other items that should be discussed

(1) Special equipment needed

(a) Staging, use and process needed to use the equipment (example: X-ray) and

decontamination/storage in patient room if required ( completing equipment log)

(b) Specifically identify how something is to be cleaned and by whom if necessary

(2) Clinical Consultations required

(3) Staffing needs

(4) Patient needs

(5) Other safety topics as needed.

Property Management for a diagnosed EVD Patient 1) All property that a suspected EVD patient brings with him/her into the facility will go into room with

patient or in room #2 (in the warm zone) located on 8m.

2) All property will be checked in using form #f83584 by RN on 8m.

3) Subsequent to treating a confirmed EVD Patient, all property in the room will be treated as waste and will

be discarded in accordance with Upstate’s waste disposal procedure.

8m Security Coordination 1) 8m will be considered a restricted access space within Upstate Hospital

2) The north door to 8m will remain on key card access throughout the patient’s stay

3) The south door to 8m will remain an emergency exit only door.

4) Access to the space on 8m will be coordinated between Incident Command, University Police and 8m Unit Director on

an as needed basis.

5) Most consulting clinicians will need to be escorted in to the 8m clean zone and would not need continuous key card

access.

6) Ensuring the general public and news media remain away from that space will remain a top priority. Any changes in

securing that area should be communicated to other departments located on the 8th

floor as well as 8m staff by UPD or

Incident Command as needed.

8M unit access 1) The 8M “Ebola” Unit is a secured unit from the outside to prevent unauthorized access. There are both

North and South exit doors leading from the unit that are fully accessible from the inside at all times in the

event of an emergency.

2) The North exit door is labeled “Authorized Personnel Only” and is accessible to authorized personnel via ID

card swipe. The ID card swipe is maintained by the 8M Unit Director or designees.

3) The South exit door is labeled “This is not an entrance. “Emergency Exit Only”.

4) Both exit doors are off of the hospital master key with the following personnel as key holders: 8M Unit

Director, Environmental Health and Safety Department, University Police and Administrative Supervisor.

5) Room 8133, designated a patient ant-room, is fitted with a key lock located on the corridor side of the door.

6) The intent of the lock is to provide the ability to secure access to and from the patient room when the room

is actively being used during treatment of a suspected or known Ebola patient.

7) The use of the key is strictly controlled and is intended to be used only as conditions warrant while a patient

is actively being treated on 8M. The key will be secured in a key lock box operated by a key code located

adjacent to the nurses’ station at all other times.

8) The key shall only be used at the direction of Hospital Incident Command, as necessary, to mitigate

unauthorized entry or exit to the patient room. (i.e. wandering patient, visitor control) The following

procedures shall be followed while the patient room key is in use:

a) One nurse shall be present outside of room 8133 at all times and in possession of the key for room 8133

while the patient room door is locked.

b) A spare key for room 8133 shall be maintained in the key lock box adjacent to the nurses’ station.

c) When the lock is in use and access to the patient room is required the nurse shall unlock the door and

place all keys back in the key lock box to prevent accidental re-locking of the door.

Visitors 1) Visitors who have been in contact with EVD patients before and during hospitalization are possible source

of EVD for others.

2) Visitors cannot enter into a patient’s room.

3) Evaluate exceptions on a case-by-case basis with Incident Command and take in to consideration pediatric

patients need to stay near parents.

4) Consult Onondaga County/ NYSDOH for management of visitors on premises

5) Assist with Onondaga County/ NYSDOH as they begin a patient history investigation to identify other

people the patient may have had extended contact with.

Upstate 8m Consultation & Intercom Use

1) Use of the 8m intercom and video monitoring system will be used in conjunction with phones to minimize

the number of clinical providers and support staff members who would need to enter the warm zone.

2) The non-inclusive list below are some of the team members who would use the intercom systems on 8m to

communicate with the patient or primary care staff members in Level 1 or 2 PPE.

a) Infectious Diseases physician

b) Nephrologist

c) Nutritionist(s)

d) Physical/occupational therapist(s)

e) Family Support Staff

f) Mental Health Specialists

g) Pallaitive Care

h) Chaplain

i) Interpretive Services

j) Other Ancillary services providers as needed.

EVD Procedure




EVD Equipment Log

Procedure: This log must be completed by the Trained Observer (or designee) every time piece of clinical

equipment is used in the care of an EVD patient. (Printed Copies of this log are located at the 8M nursing

station) This log must be kept on file in 8m with copies sent to Incident Command as requested.

Equipment log 8m EVD

Date

used

Equipment

Name/type

ID # or

serial

number

Did

equipment

enter the

warm

zone?

(circle

one)

Can

equipment

be cleaned

for reuse

by EVD

patient?

(circle

one)

Cleaning/Decon

process

identified &

reviewed with

Trained

observer?

Cleaning/Decon

completed?

(circle one only

if it can be

cleaned for

reuse for EVD

patient)

Date

Cleaned

Name

of

cleaner

Notes:

1 Y / N Y / N Y / N Y / N

2 Y / N Y / N Y / N Y / N

3 Y / N Y / N Y / N Y / N

4 Y / N Y / N Y / N Y / N

5 Y / N Y / N Y / N Y / N

** equipment log only need for types of equipment normally not designed as "single use" or "disposable" but attempt to record as much as possible during the care

of an EVD patient

*** all equipment used in the care of an EVD patient must not be returned to normal circulation in the hospital even after a cleaning has been

performed

EVD Procedure




Nursing Specimen Collection /ISTAT 8m

1) General Points and Safety

a) iSTAT should only be used if POC lab on 8m Pass thru portal is non operational.

b) Limit testing to those tests performed using the iSTAT device

c) iSTAT machine should be placed in the Anteroom in between use

i) The iSTAT machine will remain in the anteroom and cannot be used for any other patient.

ii) If laboratory-based testing is required, every effort will be made to coordinate submission of

specimens during the Day Shift.

iii) All personnel involved in specimen handling will use required PPE provided in the EVD kit.

d) Limit testing to only essential labs.

i) If possible, fix a time table for collection of specimens

ii) Limit the use of needles and other sharps as much as possible

iii) Phlebotomy and laboratory testing should be limited to the minimum necessary for essential

diagnostic evaluation and medical care

iv) For patients with suspected EVD, collect the following samples via a single venipuncture using a

butterfly/vacutainer set. Fill out down-time requisition pre-completed for Ebola PCR, malaria PCR,

and malaria antigen. Fill out NYS Infectious Disease requisition.

v) 3 EDTA (lavender top) tubes

e) Needles and sharps should be handled with extreme care and disposed in properly labeled puncture-

proof, sealed containers

2) 8m iSTAT quick tips

b) Below are a basic list of tests available on each POC or Lab device:

c) All EVD patient testing will be coordinated and reduced to an absolute minimum

d) iSTATs:

i) blood gas, lactate, hgb/hct, Chem 8 (Na, K, CL, CO2, Bun, Creat, Ca, Glucose), troponin I

e) Piccolo:

i) Albumin, ALP, ALT, Amylase, AST, Total Bilirubin, Bun, Calcium, Creat, Glucose, GGT, Total

Protein, Uric Acid , Na, K, CL, Co2, Mg, Phos

EVD Procedure




EVD Patient Discharge Process

Procedure:

1) Prior to the Patient’s discharge

i. Family member/friend will be asked to bring clean clothing to the hospital

ii. These clothes will be placed in a clean shower room on 8B

2) On the day of discharge

i. Nursing staff will explain this procedure to patient. Reviewing the use of trained observers and suit

buddies.

3) In the Patient Room

i. Clean scrubs and sock/slippers will be placed in sealed bag in patient’s room

ii. Patient will be reminded that they may take nothing with them out of the room. (example: personnel cell

phone)

iii. Patient takes a shower inside their room.

iv. After shower, patient will stand on clean towel in bathroom and after drying puts on clean scrubs &

socks/slippers

v. Patient dons Level 3 boot covers over sock/slippers

vi. Patient dons 1 pair of gloves

vii. Patient will step to their room door and open it using bleach wipe.

viii. Patient will then begin doffing procedures as read by Trained Observer with help from Buddy.

4) In the Warm Zone

i. Patient will use a bleach wipe to clean gloves – allow for dwell time then remove gloves. Patient will then

put on another pair of clean gloves

ii. Patient will sit on stool and carefully remove one boot cover and sock and discarding them into

regulated medical waste container

iii. Patient will then don clean sock and without placing their foot in the warm zone puts clean foot into the

cold zone

iv. Patient will carefully remove second boot cover and sock and repeat process for second foot.

5) While standing in the Cold Zone

i. Patient will carefully stand in cold zone, doffs gloves and cleans hands with alcohol

ii. Patient walks to the room designated in 8B to dress in personal clothes after showering a second time.

B. Coordinate with Incident Command and Environmental Services regarding the terminal cleaning of

patient areas on 8m.

EVD Procedure




Exposure Management

Procedure:

1) Known or suspected percutaneous or mucus membrane exposures to blood, body fluids, secretions, or

excretions from a patient with suspected EVD.

2) Each and every employee who donns PPE during the care/treatment or support of an EVD patient will

complete the Upstate EVD Contact Log and Upstate Employee Medical Monitoring sheet prior to wearing

any level of PPE.

3) Employees are encouraged to report illnesses prior to donning and after doffing each shift by the suit buddy

and the trained observer. All employees are reminded to report illness or injury to supervisors or employee

health per normal policy.

4) Once created this log will be entered in the HCS (Health Commerce System) after each shift

5) Employee health working with Upstate’s Infection Control & Onondaga Dept of Health, will initiate a

system of health checks while providing care and support to an EVD patient at Upstate. These checks will

continue for an additional 21 days after the last exposure to an EVD patient.

6) IMMEDIATELY

a) Wash contacted skin surfaces with soap and water

b) Irrigate mucus membranes (e.g., conjunctiva) with copious amounts of water or eye wash solution

c) Complete an Injury Report Form

d) Reporting Exposure proceed without delay

e) Downtown Campus: Call Employee Student Health (ESH) at 464-4260 on weekdays between 7:30 AM

- 5 PM.

f) Both campuses: After hours, weekends and holidays, notify supervisor and request to leave work.

Report to ED per policy for evaluation for Blood and Body Fluid Exposures. For questions regarding

EVD: ED physician will contact Hospital Epidemiologist. Notify EH of exposure by leaving message at

above numbers.

7) EH informs Infection Control upon notification of exposure

8) Monitoring asymptomatic HCP for illness

9) Documentation of current health status (complete medical questionnaire)

10) Monitor and record body temperature twice daily for 21 days after exposure

11) Twice Daily communication with EH to report:

a) See Employee/Student Health Appendix C

12) Asymptomatic HCP may continue to work with twice daily fever checks and symptom monitoring

depending on NYSDOH and CDC recommendations as interpreted by the Hospital Epidemiologist.

13) If an Upstate Employee is quarantined by a public health officer (such as the County Health Dept., NYS

Health Dept., CDC etc.), the New York State Time & Attendance Rules provide a means for State

employees to remain in a full-pay status during the quarantine period. If there is an on-the-job high risk

exposure, or if an employee exposed at work becomes symptomatic with a confirmed Ebola diagnosis, a

workers’ comp claim will be initiated to provide income replacement and payment of eligible related

medical expenses.

14) Symptomatic Employee

a) Do not report to work – communicate medical status to employee health

b) If currently at work immediately notify your supervisor after isolating yourself as much as possible.

c) Comply with work exclusion per Public Health Officials until deemed no longer infectious to others

EVD Procedure




Employee Monitoring Process

Number of Staff Needed: Infection Control and Employee Health personnel working with the trained

observer on 8m

Equipment: CDESS Access for IC and Employee Health

1) Definition:

A. Healthcare workers providing care to Ebola patients in U.S. facilities while wearing appropriate PPE and

with no known breaches in infection control are considered to have low (but not zero) risk of exposure

considering unrecognized breaches PPE

B. All Upstate employees who wear PPE for the care or support of an EVD patient will be monitored as

indicated in this document

2) Procedure

1. Each identified employee will do twice daily temperature checks and symptom evaluation

i. While actively engaged in Ebola patient care and related cleaning duties and for an additional 21

days after the last date of contact

ii. Temperature monitoring will be completed by body temperature measurement using an oral

thermometer , which will be provided

2. EVD patient contact documentation

a. Employees with EVD patient contact must complete the EVD Contact Log (on the Upstate Ipage)

ii. Safety Officer monitors for proper completion each shift

iii. Safety officer (or designee) enters all EVD Contact Log data HCS (Health Commerce System)

CDESS for future tracking (requires HCS & CDESS access)

iv. EVD Contact Log will be provided to Employee Health or Infection Control by 10 AM daily (may

be coordinated by Incident Command)

3. Daily Active Health Monitoring

A. Completed daily by every employee listed on the EVD Contact Log

B. Begins with the first contact and continues until 21 days after the last contact

1) Employee must call Employee Health (464-4260) before 9 AM and again before 7 PM

a. Choose the phone menu option specific to EVD monitoring.

b. Required information.

1) Time of call

2) Name

3) Employee ID number

4) Contact phone number

5) Body temperature (oral)

6) State any other symptoms associated with EVD such as vomiting, diarrhea or unexplained

bleeding or bruising

7) Express related health concerns or questions

ii. Employee Health or Infection Control will document employee self monitoring calls twice daily

iii. Changes in health prior to normal telephone reporting time

a. Immediately contact Employee Health and speak directly with clinical staff member between

8AM – 5 PM weekdays (do not leave a message)

b. During Employee Health off-hours, call the Upstate operator and ask to speak with the on-call

Infectious Disease attending

c. Do not report to work or travel

d. Isolate yourself in a separate room with its own bathroom if possible while using a cell phone to

communicate

e. Further direction will be provided by the Hospital Epidemiologist

iv. Failure to report

1) Employee Health will notify Onondaga County Department of Health within 24 hours of the last

missed call.

4. Employee Health Active Monitoring Process:

A. Ensure the EVD Contact Log is being properly completed every shift

1) Documentation includes name, date of birth, contact information, location of work, time in and

out of care area or lab, specific tasks and type of exposure, infection control breach (if any), type

of PPE worn, donning/doffing and patient care observation, etc. (See attached EVD Personnel

log.)

ii. EVD Contact Log shall be provided to Department of Health at agreed upon intervals. (should be

coordinated through Upstate Incident Command)

iii. Upstate Incident Command will request CDESS Trainers from NYSDOH to assist in the set up

and initial phases of the employee monitoring process.

iv. Additional administrative help can be coordinated by Upstate Incident Command.

i. HCS & CDESS access must be granted by NYSDOH. ( 1 day turn around)

v. Employee Health or Infection Control will review CDESS data daily for any indication of a

higher level of exposure. EVD exposure protocol will be initiated by the Director of Employee

Health.

EVD Procedure




Special Populations: Pediatrics/OBGYN

Procedure:

1) All patients will be screened per NYSDOH Commissioners order of 10/16/14 every time they present for

care.

a) Coordination and Communication with the care of these types of patients is critical.

b) Contact NYSDOH and Onondaga County Dept of Health immediately.

2) Pregnant Patients:

a) Any suspect EVD patient that presents for care and answer the screening questions with a high degree of

suspicion necessary clinical specialists would be moved from the Upstate Community Campus to the

Downtown Campus immediately in order to provide the appropriate level of care.

b) If a pregnant patient with suspected EVD and concern for imminent delivery presents to the ED, the

patient will be assessed by the ED physician and appropriate measures for emergent delivery will be

undertaken while maintaining established EVD precautions, If a pregnant patient presents without

obstetrical complaints but meets concern for EVD, standard ED EVD care will be followed.

c) This should be the last option.

3) Pediatrics

a) Pediatric EVD patients will not be cared for in the Ebola unit

b) ED physicians and pediatric ED nurses will provide immediate care in the Emergency Department

c) NYSDOH should be contacted immediately in order to assess another pediatrics facility with more

resources and plan for transfer of patient

4) Parents/Caregivers

a) A safety briefing will be given by identified clinical care staff to review the following with the parents

i) Parents/caregiver should wear appropriate PPE when in the patient care room at all times (Training

will be provided as soon as possible)

ii) Consult with legal department/NYSDOH if Parent/Caregiver refuses such PPE

iii) Such a refusal must be documented and witnessed per Legal Department standards

It must be made clear to Parent/Caregiver that refusal to wear PPE would remove their ability to leave

the patient room at any time and could pose a threat to their own safety.

Ebola Medical Monitoring Worksheet

1. Filled out by all Upstate personnel who don PPE at any time during the course of an EVD patient’s care.

This form is to be used in conjunction with the EVD HCW contact log as both of these documents will be

given to Infection Control/Employee health at the end of each shift.

(This form does not replace the need to fill out EVD Monitoring Spreadsheet) Employee Name: ___________________________________________ Date: __________

Trained Observer: ______________________ Buddy: ______________________

Donning of personal protective equipment may be denied to any person with the following vitals

o Temperature > 37.3,

o Respiration > 24,

o Pulse >110,

o Blood Pressure >150/90

You must monitor your own physical condition while in protective clothing. If you develop chest pain, shortness of breath, dizziness,

light-headedness, change in gait or behavior, you must leave the patient area immediately using good doffing procedures.

*****Early identification of any potential medical or physical issues is essential in maintaining your safety. Discuss any concerns

you may have with your suit buddy or trained observer prior to donning.

Pre-entry Data P

o

s

t

-

e

n

t

r

y

D

a

t

a

Time:_______________________

Vitals:

Temperature: ________

Pulse: ______________

Respirations: ________

BP: _____/____

Weight: ______

Vitals taken by:

_____________________________

Time:_______________________

Vitals:

Temperature: ________

Pulse: ______________

Respirations: ________

BP: _____/____

Weight: ______

Reassessment is needed write in below:

Vitals taken by:

_____________________________

Original to Employee/Student Health Services with Daily EVD Contact Log ---- Copy to be kept on 8M

Suit Sizing Information: N95:____

Gloves (outer):_____ Gloves (inner):_____ Tyvek Suit Size:_______

Cowel:_____ Clogs:____

58

Upstate HCW EVD Health Monitoring Log

59

EVD Procedure




Patient Transfer Protocol (Internal & External)

UH Downtown to another EVD Center

A. UH has been designated the region’s hospital for the care of EVD patients.

B. As such it would be a rare circumstance that UH would be transferring a patient to another

facility. Possible exceptions to this may be patient/family request or need for specialty care

not available at UH, e.g., Pediatrics or OBGYN

C. This circumstance would be so unusual as to render a prior transfer protocol with another

receiving hospital extremely difficult to arrange.

D. Upstate would seek NYSDOH guidance on determining receiving hospital.

E. These cases would follow standard EMTALA & UH policies.

NYSDOH EVD Center Distance

from SYR Est.

time

University of Rochester Medical Center in Rochester 89 miles 1.5

hours

Women and Children’s Hospital of Buffalo 150 miles 2 hours

Erie County Medical Center 146 miles 2hours

Bellevue in Manhattan 250 miles 4 hours

Montefiore in the Bronx 253 miles 4 hours

Mt. Sinai in Manhattan 254 Miles 4 hours

New York Presbyterian in Manhattan 250 miles 4 hours

North Shore Health System in Nassau County 267 Miled 4 hours

Stony Brook University Hospital on Long Island 300 miles 5 hours

** Estimated time assumes good weather. Taken from Google maps

Other Hospitals & Upstate Community Campus to Downtown Campus

1) Patients meeting threshold for EVD testing or optional testing as defined by NYSDOH

Commissioners order of 10/16/14 should be considered for transfer to UH-Downtown for

evaluation and/or care. (Patients that present to UH-CC ED will follow similar steps as the as

that Campus is not considered an EVD Treatment Hospital)

2) These patients will be transferred by Rural Metro with coordination with NYSDOH (See

Direct Admit Process/ EMS Integration)


3) Pts must be transferred in biohazard coveralls (if patient is able to don this without

assistance) or an impervious sheet.

(1) The patient must wear a surgical mask unless clinical condition precludes.

(2) Paramedic personnel will follow their own agency’s EVD protocol otherwise.

4) Patients being transferred from other Hospitals will go directly to 8M and bypass the Upstate

ED.

Communications during Transfer

1) Transferring hospitals make a request for transfer via the UH Transfer Center (315 464

5449).

2) Per NYS directive the transferring hospital must have notified and discussed the case with

their local health department official.

3) The Transfer Center will contact UH Epidemiologist on call to discuss the case with the

transferring hospital physician.

4) UH will accept patients that meet threshold for EVD testing or optional testing as defined by

NYSDOH Decision Guide for Consultation and Ebola Virus Disease (EVD) Testing.

5) The Transfer Center will contact the UH Nursing Administrator on call and the ICU EVD

Attending on call to confirm bed placement and formalize patient acceptance, respectively.

6) These patients will be accepted directly 8M

7) Transporting EMS agency will be coordinated with Syracuse Rural Metro, Upstate and

NYSDOH

8) Patient must be transferred in biohazard coveralls (if patient is able to don this without

assistance) or an impervious sheet.

9) The patient must wear a surgical mask/ PPE “coverall” provided by EMS which is water

impervious unless clinical condition precludes.

10) Paramedic personnel will follow their own agency’s EVD protocol otherwise.

UH Outpatient Clinics to UH Downtown

1) Clinics will follow UH EVD Guidance Document.

2) Once identified, if able, clinic physician will contact appropriate campus epidemiologist to

discuss case and need for further evaluation.

3) Transport of the EVD pt will occur with cooperation of the Onondaga County 911 Center as

well as Rural Metro

Transport of EVD Patients from Downtown ED to Inpatient Room

1) Coordination should occur between the following prior to any movement

i. UPD

ii. 8m staff

iii. ED staff

iv. Environmental Services

v. Incident Command

2) Patient must be transferred in biohazard coveralls (if patient is able to don this without

assistance) or an impervious sheet. The patient must wear a surgical mask unless clinical

condition precludes


3) Use of the Room 1 bed from 8M is preferred.

4) All equipment used in the transportation of an EVD patient must stay in the warm zone on

8m until decontaminated.

5) Nursing and ancillary transport staff will wear EVD PPE Level 1 or Level 2

6) Only Trained EVD PPE Staff are allowed to move the patient.

7) UH Security will secure hallways and reserve elevator.

i. Terminal cleaning of hallways will be coordinated through Environmental Services and

Incident Command.

ii. Any gross contamination will follow Waste Spill Protocol with consultation from

Environmental Health and Safety.

iii. All Environmental services personnel would don Level 2 PPE for this process.


EVD Procedure




EVD Direct Admit/EMS Integration for 8M

Staff needed: 2 Rural Metro staff members, 4 8m RNs, 3 ED RN’s, Trained Observer, 3

Environmental Services, and 5 University Police/Security

Equipment Needed: 8m Bed, PPE Level 1, 2 & 3. Blue Mats,

Procedure:

1) 911 Center calls ED via radio or phone to notify EMS dispatch to a highly suspect EVD

patient.

a) ED attending or ED Charge would notify Administrative Supervisor immediately

2) The Administrative Supervisor would

a) trigger Red Alert: 8M General Alert and 8M Staffing Need Alert

b) Ensure all clinical staff report to 8m for initial briefing

c) Admin Supervisor should also report to 8m

d) Send someone from UPD or EVS to open up room 4760

e) Determine if ED or room 4760 is the best point of entrance for this highly suspect patient.


i) Consider factors such as

ii) Patient clinical needs

iii) ED patient load

iv) Availability of staff to fulfill PPE roles

v) Activation time and current state of readiness for 8m

f) Immediately move nursing resources to support the ED

g) Contact manager of Surgical Specialties and other 4th

floor departments to warn them of

incoming patient as needed and if time allows. (UPD/Security can assist with this

h) Activate Incident Command/ Contact the Administrator on Call

i) Contact EHS person on call

j) Contact Environmental Services Supervisor on duty

k) University Police Dispatch

l) If facility to facility transfer coordinated with the assistance of NYSDOH the transporting

EMS agency would be directed to alternate entrance (room 4760) and avoid using the ED

all together.

m) Once on 8m all staff need to sign in to the EVD contact log.

3) 8M Preparations

a) Administrative Supervisor will identify 4 RNs to send to 8M

i) Check Kronos for any Ebola RN on call staff

ii) 2 staff members must change in to scrubs/shoe, grab their own appropriate sizes

for PPE out of the 8m stock and take the primary patient bed to transport patient from

room 4760.

b) Obtain keys from Administrative Supervisor (or 8m Nursing Director) to unlock

equipment carts

c) Call Environmental Services to clean room; make bed and place barrels, red bag (meeting

ASTM 1922 and ASTM1709 standards for 480 grams tear resistance and 165 grams of

impact resistance.) s, twist ties, bleach wipes as needed.

d) Call for any specialized equipment as needed.

e) Call Pharmacy for stock meds (narcotics and override meds)

f) Obtain iSTAT from 6th

floor room 6414 and supplies

g) Call 12F for U/S machine

h) Turn on video and intercom systems.

i) Once 8m staff has arrived

i) Initiate briefing for staff to review plan, assign roles.

ii) Immediately don PPE

LEVEL 1 or 2 PPE: Tychem full body suit with booties, N95/PAPR, Face Shield,

Cowl (hood), Outer Glove, 2 pair of Inner Gloves (Blue Nitrile), trauma gown.

iii) The other 2 staff member should stay in 8m to prep room

(1) LEVEL 1 or 2 PPE: Tychem full body suit with booties, N95/PAPR, Face Shield,

Cowl (hood), Outer Glove, 2 pair of Inner Gloves (Blue Nitrile), trauma gown.

iv) Bring patient bed and PPE to 4760 for donning as well as an emisis bucket.

4) Initial ED responsibilities

a) Immediately designate 3 trained staff members to report to room 4760 to operate as Suit

Buddies for 8m staff as well as assistants for EMS crew doffing and waste disposal.


(1) LEVEL 3 PPE: N95, face shield, trauma gown, (1) pair of inner gloves (Blue

Nitrile), knee high boot covers, hood

(2) One pre-identified staff member would operate as a trained “observer” role for

whole donning/doffing operation. (No PPE needed)

5) Initial Environmental Health and Safety (EHS) responsibilities

a) Report to 8m for briefing. Ensure that there are two Trained Observers (one for

8m and one for 4760)

b) Report to Rm 4760 as soon as possible to assume the role of Safety Officer/observer.

c) Begin communications process with Administrative Supervisor or Incident Command as

needed.

6) Initial UPD/Security Responsibilities

a) Ensure all UPD/Securitas officers have (and are wearing) appropriate PPE

b) Open room 4760 for clinical staff.

c) Block vehicle traffic to access road between Upstate and Crouse

d) Stop all outside pedestrian traffic around 4th floor entrance until EVS has cleaned the

area.

e) Verbally warn all impacted departments on 4th

and 8th

floor (surgical specialties, EPIC

training, etc.) of pending restriction of movement if time allows.

f) Stop all pedestrian traffic around gold elevator lobby on the 4th

floor

g) Stop and hold one of the larger gold elevators on the 4th

floor once the bed/staff from 8m

has moved down.

h) Stop all pedestrian traffic on the 8th

floor until EVS has cleaned the area.

i) Advise Safety officer or Administrative Supervisor that this has been done and area is

clear.

j) Public Safety will capture the elevator and hold it on the 4th floor using a key to put it

into independent service.

i) UPD/Public Safety will take the elevator to the 4th floor, leaving the key in the

elevator, and vacate it.

ii) Once nursing staff gets on the elevator, with the patient, they need to press and hold

the 8th floor button until the door closes.

iii) Once they arrive on the 8th floor, nursing staff will exit the elevator and continue the

patient transport.

iv) UPD/Public Safety will have an Office stationed in the 8th floor elevator lobby who

will make sure that no one takes the elevator until housekeeping has cleaned the

elevator.

v) Once that is complete, we will place the elevator back in service and remove the key

7) Initial Environmental Services Responsibilities

a) Ensure personnel have and are wearing appropriate levels of PPE

b) Ensure clinical staff inside room 4760 have needed supplies for doffing/cleaning

c) Stage all needed equipment and personnel outside room 4760 in the hallway once EMS

arrives at Upstate.

d) Communicate with Administrative Supervisor or Safety Officer once EVS is ready.

e) EVS will clean, starting in room 4760 and moving outward to the hallway/elevator, once

EMS has completely decontaminated their vehicle and everyone has doffed all PPE.

8) Once in Rm 4760 the Trained Observer must:


a) Verify all personnel are wearing appropriate levels of PPE

i) That there are at least two staff members from 8m are present and 3 staff members

from the ED.

ii) Verify the following teams are staged and ready

b) University Police/Security in position

c) Environmental Services in position wearing appropriate PPE

d) 8m room is ready.

e) 4760 is prepared also 2 rigid waste containers & blue mats are kept outside doors for

Ambulance

f) Verify Supplies

(1) Task EVS with providing more as needed.

(2) 4 red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear

resistance and 165 grams of impact resistance.)(large)

(3) 1 rigid outer container to hold red bag (meeting ASTM 1922 and ASTM1709

standards for 480 grams tear resistance and 165 grams of impact resistance.) .

(4) container of bleach wipes for the EMS crew member to remove any gross

decontamination

(5) 10 absorbent pads.

(6) large blue floor pad (for doffing PPE)

(7) One small blue pad (for under rigid container) to be located next to hot zone.

(8) impermeable sheet/coverall is ready for patient

(9) Emisis bucket on 8m bed.

g) Verify all staff are donned appropriately.

9) Once Ambulance Arrives

a) EMS should be instructed to remain in ambulance until Upstate staff are ready to allow

entrance by staff in PPE.

i) This should be communicated by 8m staff in PPE speaking to driver or opening rear

of ambulance

b) UPD/Security officer must be stationed near EMS vehicle but far enough away to prevent

accidental contact with the vehicle itself or any personnel.

c) Place yellow ramp on curb so that the EMS stretcher may be moved inside the 4760rm

vestibule to enable patient transfer. (see room diagram)

d) If the patient is ambulatory instruct EMS crew to assist the patient to walk up the ramp

and sit on the 8M bed waiting inside 4760

e) All “suit Buddies” should remain at least 6 feet away from the patient at all times

(regardless if wearing PPE)

f) Place a blue disposable sheet on the ground at the rear of the EMS ambulance to allow

for a collection point for waste materials accidentally brought out of the ambulance.

g) The EMS stretcher can be placed back into the rig and the disposal sheet can be carefully

gathered and placed in a waste receptacle once transfer is complete

h) Advise the EMS Crew to roll stretcher out of vehicle

i) Disconnect all equipment not needed for the transfer or other clinical needs and place it

on the blue mat at the rear of the ambulance.

j) All personal patient items should be transferred with the patient.


k) Ensure patient is covered in an impermeable coverall or sheet if not already placed

therein by the transporting EMS crew.

l) Once patient transfer from EMS stretcher to 8m bed is complete inside Room 4760

m) Move the patient to 8m as safely and quickly as possible placing the hand-rails of the bed

in the lowered or “down” position as needed to move bed through doors.

n) 8m personnel should utilize designated path of travel (see diagrams at end of this sheet)

i) Once nursing staff gets on the elevator, with the patient, they need to press and hold

the 8th floor button until the door closes.

ii) Once they arrive on the 8th floor, nursing staff will exit the elevator and continue the

patient transport.

o) If there are any spills or possible body fluid dispersal during the time moving 8m staff

should alert (by voice) the nearest UPD/Security officer or EVS team member.

Environmental Services will utilize appropriate spill protocols once this area has been

identified.

i) Transport of the patient should not be stopped or slowed for any reason.

p) Once Patient has arrived in 8m

q) Every effort should be made to doff those 8m transport personnel as they would have

expended a lot of energy during the moving process.

r) Monitor vitals per guidance.

10) Once transport of the patient has been initiated to 8m

a) Ems personnel should begin decontaminating their vehicle.

b) Upstate Suit Buddies should

i) Move Class A waste bins and cleaning supplies toward the transport vehicle.

ii) Upstate personnel should not decontaminate the transport vehicle. Instead they should

serve as runners/assistants to the EMS crew.

c) EMS personnel will then doff all PPE in room 4760 vestibule or outside if weather

permits.

d) Ask EMS personnel if they have a set of instruction or training sheets for properly

doffing their agencies specific PPE. If possible this sheet should be utilized by the Safety

Officer or Observer role.

e) EMS/Fire agencies may have internal procedures which enable their own trained “PPE

Observer/suit buddy” to be present in order to assist their crew with doffing. If there are

designated EMS/FD supervisors or trained buddies to fill this role than Upstate personnel

should continue to serve as assistants.

f) Every effort should be made to integrate Upstate’s waste disposal process with their

agency specific doffing procedures.

g) EMS personnel will be considered free to leave per their agencies guidelines &

NYSDOH protocols once they have doffed safely.

h) Showers and scrubs should be made available to EMS personnel as needed,

i) Once EMS has successfully doffed their PPE the 3 Upstate Suit Buddies would then

begin doffing PPE as appropriate once all blue sheets, discarded PPE and other waste is

properly disposed of in (meeting ASTM 1922 and ASTM1709 standards for 480 grams

tear resistance and 165 grams of impact resistance.) red bags

j) Rural Metro will provide personnel to clean their equipment outside 4760 as well as a

trained observer/supervisor


11) Terminal Cleaning of space and returning to normal operations:

a) Environmental services would then clean any spills or gross contamination as needed

i) Room 4760 from red/yellow line out to hallway.

ii) The hallway leading from room 4760 to the gold elevators

iii) Ride another elevator to the 8th

floor (clean the one they rode in)

iv) The hallway from the goal elevator to the entrance of 8m

v) Any gross contamination ES should follow spill policy

vi) Expect at least a 45min to 1 hour cleaning turn around for hallways and elevators

vii) Notify Nursing Administrative Supervisor when completed.

viii) Restock waste/ cleaning supplies in 4760 as needed.

ix) Once Environmental Services cleans UPD/Security would then release that area to

normal pedestrian traffic and verbally advise those impacted area managers that

operations have concluded.

EMS

4th floor path of travel


EVD Procedure




Environmental Infection Control/Waste

Environmental Infection Control- this process will be monitored by the Trained Observer on

site working in close consultation with Environmental Services and Environmental Health and

Safety.

1 ) Below is a list describing several types of waste that would be generated during the care of

a suspected or confirmed EVD patient

a) Patient specimens collected for laboratory testing

b) Waste generated from the testing of patient specimens in the laboratory

c) Waste generated from any invasive procedure

d) Personal protective equipment (PPE)

e) Single use devices (Recycling of SUDs that may normally be done is

unacceptable)

f) Disposable commodes, bed pans and/or urinals

g) Items used for environmental cleaning and disinfection

h) Sheets, food items, feces, urine, cubicle curtain, supplies, any other disposable items

i) Stained ceiling tiles

j) Mattress covers

k) Mattresses with cracks/ tears/ penetrations

l) Feces, urine and vomit, and liquid waste from washing m) Sharp objects (e.g. needles, syringes, glass articles) and tubing that has been in contact

with the bloodstream

n) All items in contact with the patient

o) Furniture that has become compromised

p) Disposable food trays, dishes, and cutlery

q) Disposable dedicated medical equipment

r) Materials used to clean up spills of body fluids 2) Any procedure performed in the patient room will be done in PPE level 1 or level 2, while

most procedures done in the anteroom will be done in Level 3 PPE. See PPE Roles Matrix

and corresponding PPE donning and doffing check sheet at the beginning of this document.

3) Use only hospital EPA approved disinfectant for cleaning (single use only)

4) Stericycle is the designated waste contractor

a) Maureen Guile 518-365-0046

b) Selin Hobry VP legislative and regulatory affairs 847-943-6685


5) All equipment used for the treatment of a suspect case must be kept separate and not used by

any other patient.

6) Category A Waste from a highly suspect (but not clinically diagnosed EVD patient will be

sequestered in Room 8216

7) Rm 8216 Class A waste storage room is negative to the corridor and exceed the 6 air

exchange/ hour requirements (has 12 air exchanges/ hour)

8) Use only a mattress and pillow with plastic or other covering that fluids cannot get through

9) Should there be waste that is larger than the containers available, EVS will contact the

vendor immediately referring to US DOT Special permit 16279

a) For 8M

i) 8132 and 8134 place into room 8216

ii) Terminally clean 8132 and 8134.

iii) Leave large trash can (no lid) with red bag (meeting ASTM 1922 and ASTM1709

standards for 480 grams tear resistance and 165 grams of impact resistance.) for

waste in patient room.

10) Discard all linens, pillows, mattresses, privacy curtains, sharps container as Category A

waste.

11) Any reusable equipment must be cleaned and disinfected according to manufacturer’s

instructions.

a) See equipment specific cleaning items listed in each clinical procedure as needed in this

document.

CLEAN UTILITY EVD- ROOM 8228 CLEAN SUPPLY EVD- ROOM 8218

Item Volume Item Volume

1.5 ML regulated

medical waste bags

meeting ASTM 1922

and ASTM1709

standards for 480

grams tear resistance

and 165 grams of

impact resistance.

6 DOZ

CAT A GREEN

Poly WASTE

BARRELS

6 EACH

12" twist ties 500 Each 36" Bungee Cords 12 Each

Liqui-loc @ 3.2 ounces

which solidifies 3000cc 120 3.2 oz bottles Instazorb 12 @ 1 gallon

Clorox bleach germicidal

cleaner 20 Gallon bottles 18# Zip Ties 200 Each

Clorox wipes - containing

110 wipes 12' x 12' per

bucket

3 Buckets

Clorox wipes - containing

110 wipes 12' x 12' per

bucket

5 Refills @ 110 sheets

per

1 metal transport dolly 1

4 solid waste cans 4


Disposable needle bucket-

wall mounted 5, 1 gallon disposable

Disposable needle bucket-

floor unit 1 floor unit disposable

Disposable Swifter mop 1 Each

Soiled Utility Biohazard Waste - Authorized Personnel Only- Room 8216

Area designated as CAT A WASTE holding- sequestered as required. Transport time will be 3 am to

5 am as required

Disposal of Body Fluids (Toilet & Shower)

1) Liquid wastes may be disposed of in the sanitary sewer as prescribed below.

2) Bleach was selected as the best choice disinfectant for waste water treatment plant

purposes.

3) Clorox® Bleach – off the shelf (Clorox

® is a registered trademark of The Clorox

Company.)

4) Equipment Needed

a) PPE (Level 1) for Clinical staff in Patient Room (hot zone)

b) A straight bleach solution in a container for use directly in the toilet

c) Receptacle for waste

d) Disposable commode bucket liners as necessary

e) Bedside commode as necessary

f) Disposable patient under pad or other absorbent covering

g) Trash cans lined with red bag (meeting ASTM 1922 and ASTM1709 standards for 480

grams tear resistance and 165 grams of impact resistance.)

h) Disinfectant bleach wipes—approved for use in EVD patient care areas

Fluid Disposal Procedure (SOLIDIFICATION).

1) This procedure is for waste not collected directly into the toilet by the patient.

2) It should be applied in any location where an EVD patient excretes liquid wastes into a

collection vessel other than a fixed toilet.

3) Proceed to designated area and don PPE according to hospital procedure for PPE in

isolation rooms for EVD patients.

4) Inside room Don 3rd

pair of nitrile gloves

5) Stage small blue wrap, solidifier, bleach solution and liquid collection container near area

of collection

6) Lay blue wrap out and place waste collection container in the center of the blue wrap

7) Liquid bleach may be added to the collection container at the direction of the trained

observer

8) Empty Foley bag into liquid container

9) Slowly add solidifier from the edge of the container

10) Allow container to stand for 2 minutes

11) Once liquid is completely solidified surround and wrap the container in the blue wrap.

Place the entire wrapped container into the red bag (meeting ASTM 1922 and ASTM1709


standards for 480 grams tear resistance and 165 grams of impact resistance.) waste

receptacle

12) Remove outer gloves and decontaminate hands with a disinfectant bleach wipe.

Patient Flush Procedure

1) This procedure is for waste excreted directly into the toilet by the patient.

2) It should be applied in any location where an EVD patient excretes liquid wastes into

toilet. Auto-flush toilet valves must be disabled to ensure manual flushing only.

3) Place two containers of bleach in the restroom—one to clean the bowl (straight bleach)

and bleach wipes

4) Instruct the patient not to flush the toilet after use

5) Before patient use, staff in appropriate PPE will apply bleach solution around the bowl in

the same manner as liquid/gel toilet bowl cleaner. Use one cup of bleach

6) Allow 10 minutes of contact time after patient use then flush toilet.

7) Wipe the surfaces with bleach wipe to ensure complete surface contact.

Patient Shower Procedure

1) Immediately after the shower, apply to shower floor drain one cup bleach (sodium

hypochorite)

2) After shower, apply bleach solution wipe to ensure contact with all areas of surface, and

allow to air dry.

Bed Pan Solidification Procedure

1) Don additional outer gloves.

2) Place bed pan under patient

3) Prep small area on floor with blue wrap

4) When patient finished move bed pan to blue wrap on the floor

5) Clean patient. Place wipes into red waste bin.

6) Add bleach to bed pan as directed by trained observer

7) Carefully pour full container of solidifier into the bed pan

8) Let stand for kill time

9) Wrap up bed pan with blue wrap then place into red waste bin

10) Disinfect gloved hands then remove outer gloves.

Category A Waste Removal EVD

1) Nursing

a. To be Performed in the Hot or Warm Zone

b. Use proper PPE per Upstate EVD Guidelines

c. Line a rigid container (with Bio- hazard sticker) with two red rmw bags meeting ASTM

1922 and ASTM1709 standards for 480 grams tear resistance and 165 grams of impact

resistance.


d. Once the bag is half full, carefully remove the bag from the rigid container. The

individual bag can weigh no more than 22 pounds when filled.

e. Pour bleach in the bag to saturate the contents of the bag with approximately 8 OZ (1

cup).

f. Grasp the bag just above the filled portion of the bag. Carefully gather the slack of the

bag in one hand until the entire width is gathered in one hand.

g. Carefully twist the neck of the bag until wound tightly.

h. Fold the neck of the bag in half.

i. Use zip tie to tightly secure the neck of the bag.

j. Wipe the outside of the bag with bleach wipes and allow for proper dwell time (2

minutes).

k. Place the bag and bleach wipe(s) in a second red rmw bag (meeting ASTM 1922 and

ASTM1709 standards for 480 grams tear resistance and 165 grams of impact resistance.)

l. Red biohazard trash cans should be visually inspected after every waste removal process

and decontaminated with bleach wipes as needed

m. Repeat steps E through I.

2) Environmental Services

A. EVS will don LEVEL 3 PPE and locate themselves in the clean zone outside the

designated patient care area. (see decontamination zone maps in Appendix A)

B. Open the CATEGORY A WASTE drum. Remove the zip tie and 6 mil plastic liners. Set

the zip tie aside where it will be available at a later time. Line the 55 gallon CATEGORY

A WASTE drum with a 6 mil plastic liner.

C. Pour 2 gallons of Instazorb in the bottom of the 6 mil plastic liner.

D. Place double bagged red rmw bags in CATEGORY A WASTE drum until full or weight

capacity is reached. CATEGORY A WASTE drum may not exceed 500 pounds.

E. Once the CATEGORY A WASTE drum is full, properly secure the liner. Gather the liner

in the same manner as the red bag as stated in step E above. Once complete, follow

repeat steps F and G on the 6 mil liner.

F. Place the lid on the CATEGORY A WASTE drum and properly secure the metal band.

Pay attention to the markings on the lid that indicate the proper positioning of the band.

G. Wipe down the exterior of the CATEGORY A WASTE drum with bleach wipes and

ensure the proper dwell time of 2 minutes.

A. Once proper dwell time (2 mins) has occurred, the CATEGORY A WASTE drum can be

relocated to 8216 via the appropriate route

Spill Cleanup

1. Alert team.

2. Need to have at least 2 people in PPE full

3. Employee entering area to assist with clean up sanitize gloved hands then don an

additional pair of gloves on the outside. (3 total)

4. Obtain the spill kit [absorbent pad, bleach wipes, red bag ,(sharps container, dust pan/

tongs as directed)]

5. Assist Patient first by cleaning gross contaminants.

6. Establish a spill perimeter.


7. Position clean up supplies including the red bag waste container outside the spill

perimeter to ensure easy access.

8. Visually check PPE of both people in the area/room and clean any visible contamination

9. Sanitize gloves

10. Cover spill from the outside working in with bleach wipes until entire spill areas is

covered.

11. Place absorbent pad over the bleach wipes.

12. Pick up any broken glass, plastic or sharp materials with dust pan, tongs or some other

mechanical device as directed by the trained observer. Do not use your hands. Place

material in approved sharps container.

13. If no potentially sharp items are present in spill area, obtain an additional spill pad. Fold

pad over and lightly press clean pad down on covered spill to ensure complete bleach

contact. Disposed pad when complete

14. Allow for appropriate contact time (5 minutes)

15. Clean- up spill material from outside-in

16. Sanitize gloves

17. Perform a final wipe of the spill area with bleach wipes/ swiffer with bleach wipes as

directed by the Trained Observer.

18. Re-inspect area and PPE for gross contamination clean as needed

19. Remove outer gloves

20. Follow waste management for Category A Waste Removal protocol

STOP If:

At any time there is a question or concern.

At Any time there is contact with blood or bodily fluids.

o Remove gross contamination before proceeding with spill clean-up process

Directed to do so by the trained observer or other members of the team


Category A Waste Handlin/ Packaging

This procedure is identical regardless of location inside the hot or warm zone. (patient rooms,

ED, POC Lab, EVD designated entrance on the 4th

floor) to be performed by clinical staff

members in Level 1 or Level 2 PPE. Please reference EVD Decontamination Room diagrams

(Appendix A) for more information.


EVD Procedure




EVS WASTE REMOVAL – Cold zone to Waste Staging Rm 8216

Room 8216 shall remain locked at all times. The room has a dedicated key assigned only to the EVD unit

to ensure no unauthorized access.

Step 1. CAT A WASTE- Poly Drum ready for waste holding.

Step 2. Open barrel and 6 mil.liner (clear lining). Add absorbent material to the bag, 2

gallons.

Step 3. Place double bagged waste directly into the Poly Drum.


Step 4. Twist clear 6 mil liner carefully

Step 5. Place zip tie over the clear 6 mil liner secure

Step 6. Place cover on Green poly barrel- secure with metal binder- wipe with bleach

cloths dwell time is 2 minute. Stage in room 8216


Class A Waste Travel Routes

a) The section below delineates the exact route EVS will travel in order to transport clean

55 gallon drum from various possible points of waste generation during the care of an

EVD patient. Since the plan accounts for the avoidance of the ED in all but the most

extreme circumstance (see EVD Direct Admit section) typically only one of these

pathways would be used at any one time.

b) Transportation of clean 55 gallon drum would be coordinated with security, EVS, EHS

and Incident Command as needed.

c) Once transported to the dock area each 55 gallon drum would be placed in to designated

95 gallon overpack containers for storage and shipment by Stericycle.

d) EVS staff will don Level 3 PPE for transport of clean 55 Cat A drums to secured trailer.

from ED

1) Travel the 2 East hall to #3 Gold Elevator. Take this elevator to the basement. Follow

basement west corridor to the ROC. Take the freight elevator to the first floor. Turn left

towards the receiving dock. Using swipe access enter dock area.

2) 55 gallon CAT A Waste drum will be placed into the 95 gallon overpack CAT A

WASTE.

A. The 95 gallon overpack should not be stored or packed in the Category A Waste

storage area. It will be kept near the secure trailer area

B. the outer category A waste drum must remain in the cold zone

C. Remove the 55 Gallon special Category A DOT Waste Green Drum/Poly Drum

from the Category A Waste storage area (containers should have been wiped

down prior to movement).

D. Overpack the 55 Gallon special Category A DOT Waste into the plastic 95 gallon

overpack drum. The 95 gallon overpack shall be closed in accordance with the

manufacturer’s instructions and the lid shall have duct style tape applied at the

interface of the lid and the body of the drum in a manner to secure the lid in the

closed position and also to provide additional security and prevent tampering.

E. Wipe down the outer 95 gallon overpack with bleach wipes

F. Only Label the outermost 95 gallon overpack with the Category A labels.

G. Load the 95 gallon overpack onto the Stericycle trailer. Secure trailer gate

immediately upon exiting

H. Stage CATEGORY A WASTE drum in designated CATEGORY A WASTE

trailer separated from other regulated medical waste in secure trailer.

I. EVD Drum cart will be visually inspected and cleaned with bleach wipes after

each use.

from 8M (Patient Care Area & POC Lab)

1) Take Gold elevator #3 to the basement. Follow basement west corridor to the ROC. Take the

freight elevator to the first floor. Turn left towards the receiving dock. Using swipe access

enter dock area. Overpack 55 gallon CAT A Waste green drum into the 95 gallon CAT A

WASTE overpack. Stage CATEGORY A WASTE drum in designated CATEGORY A

WASTE trailer


2) 55 gallon CAT A Waste drum will be placed into the 95 gallon overpack CAT A WASTE.

a) The 95 gallon overpack should not be stored or packed in the Category A Waste storage

area. It will be kept near the secure trailer area

b) the outer category A waste drum must remain in the cold zone

c) Remove the 55 Gallon special Category A DOT Waste Green Drum/Poly Drum from the

Category A Waste storage area (containers should have been wiped down prior to

movement).

d) Overpack the 55 Gallon special Category A DOT Waste into the plastic 95 gallon


manufacturer’s instructions and the lid shall have duct style tape applied at the interface

of the lid and the body of the drum in a manner to secure the lid in the closed position and

also to provide additional security and prevent tampering.

e) Wipe down the outer 95 gallon overpack with bleach wipes

f) Only Label the outermost 95 gallon overpack with the Category A labels.

g) Load the 95 gallon overpack onto the Stericycle trailer. Secure trailer gate immediately

upon exiting

h) Stage CATEGORY A WASTE drum in designated CATEGORY A WASTE trailer

separated from other regulated medical waste in secure trailer.

i) EVD Drum cart will be visually inspected and cleaned with bleach wipes after each use.

from 4 South (Designated EVD Entrance for EMS)

1) Turn right down 4 south hall way to Gold elevator #3 to the basement. Follow basement west

corridor to the ROC. Take the freight elevator to the first floor. Turn left towards the

receiving dock. Using swipe access enters dock area. . Overpack 55 gallon CAT A Waste

green drum into the 95 gallon CAT A WASTE overpack as defined in step 12 b. Stage

CATEGORY A WASTE drum in designated CATEGORY A WASTE trailer

2) 55 gallon CAT A Waste drum will be placed into the 95 gallon overpack CAT A WASTE.

a) The 95 gallon overpack should not be stored or packed in the Category A Waste storage

area. It will be kept near the secure trailer area

b) the outer category A waste drum must remain in the cold zone

c) Remove the 55 Gallon special Category A DOT Waste Green Drum/Poly Drum from the

Category A Waste storage area (containers should have been wiped down prior to

movement).

d) Overpack the 55 Gallon special Category A DOT Waste into the plastic 95 gallon


manufacturer’s instructions and the lid shall have duct style tape applied at the interface

of the lid and the body of the drum in a manner to secure the lid in the closed position and

also to provide additional security and prevent tampering.

e) Wipe down the outer 95 gallon overpack with bleach wipes

f) Only Label the outermost 95 gallon overpack with the Category A labels.

g) Load the 95 gallon overpack onto the Stericycle trailer. Secure trailer gate immediately

upon exiting

h) Stage CATEGORY A WASTE drum in designated CATEGORY A WASTE trailer

separated from other regulated medical waste in secure trailer.

i) EVD Drum cart will be visually inspected and cleaned with bleach wipes after each use.


EVD Procedure




Personnel Needed: 1 8m Nurse

Equipment Needed: EPA approved disinfectant, disposable cloths, disposable mop heads,

mop handle.

Patient Room Cleaning Procedure 8M/ EVD

1) Cleaning should occur at least daily or more if possible.

2) While wearing Level 1 or Level 2 PPE in Hot /Warm zone

3) Use EPA approved disinfectant, disposable cloths, disposable mop with disposable mop

heads

4) Empty all waste/linen/debris dispose of per CATEGORY A waste handling procedures.

5) Use caution and avoid agitation or unnecessary movement of linens to prevent additional

contamination of surfaces or personnel.

6) Proceed to restroom – Use one EPA approved disinfectant wipe for each fixture/ piece

equipment. Dispose of each wipe as CATEGORY A WASTE. Wipe each: faucets, sink,

toilet handle, toilet seat, and outer bowl, grab rails, dispensers and mirrors. Spot wash walls

as needed.

7) Proceed to patient room- Use EPA approved disinfectant wipes for each fixture with one

wipe. Dispose of each wipe as CATEGORY A WASTE.

a) Wipe each: over the bed table, night stand, IV pole, bedrails, monitors, cables, call bell,

door knobs, wall dispensers, chair, TV remote, all horizontal surfaces. Spot wash walls as

needed.

8) Repeat process two times for each fixture/surface or piece of equipment

9) Refill all supplies as needed.

10) Mop bathroom floor, beginning at the far corner working toward the door.

a) remove mop head. Dispose of as CATEGORY A WASTE. Replace mop head, mop

patient room beginning at the far corner working toward the door. Dispose of as

CATEGORY A WASTE.

11) Clean mop handle place in bathroom shower. Dispose of wipe AS CATEGORY A WASTE

12) Class A waste storage containers in Hot/Warm zone will be visually inspected and cleaned

with bleach wipes once a day.

13) Self inspect area for visible contamination.


EVD Procedure




Anteroom Cleaning Procedure 8M/ EVD

1) With Level 1or Level 2 PPE’s (Personal Protective Equipment), put on protective clothing as

required.

2) Use EPA approved disinfectant, disposable cloths, disposable mop with disposable mop

heads

3) Empty all waste/linen/debris dispose of per CATEGORY A waste handling procedures.

4) Use EPA approved disinfectant wipes. Use one wipe for each fixture/horizontal surface. Re-

wipe all fixtures and horizontal surfaces.

5) Dispose of each wipe as CATEGORY A WASTE. Spot wash walls as needed.

a) Remove outer gloves; sanitize inner gloves, re glove.

6) Refill all supplies as needed.

7) Replace mop head, mop anteroom beginning at the far corner working toward the door.

8) Dispose of as CATEGORY A WASTE. Clean mop handle hang in defined area.

9) Dispose of wipes as CATEGORY A WASTE

10) Self inspect area.

81


EVD Procedure




EVD Sharps Container Removal

1) With PPE level 1. When sharps container is ¾ full

2) All sharps waste must be packaged in pre –staged FDA cleared sharps disposal

containers that are securely closed in accordance with the manufactures

instructions.

3) Close lid

4) Open wall mounted cabinet.

5) Remove plastic sharps container.

6) Place container inside a red bag (meeting ASTM 1922 and ASTM1709 standards

for 480 grams tear resistance and 165 grams of impact resistance.)

7) For both floor unit and wall mounted unit add approximately 1 cup bleach to

sufficiently cover surface of contents as required by the DOT Special Permit-16279.

8) Close red bag by carefully gathering the slack of the bag in one hand until the

entire width is gathered in one hand.

9) Carefully twist the neck of the bag until wound tightly

10) Bend the twisted top over

11) Carefully place a twist tie around the twisted bag. Pull the twist tie closed

securing the contents in the bag.

12) While holding the bag wipe the outside of the bag with a bleach wipe with 2 min

dwell time.

13) Place secure, disinfected bag into another bag. Repeat steps 6 thru 10


EVD Procedure




Discharge EVD Warm/Hot Zone Cleaning

Personnel Needs: 1 EVS Cleaner

Equipment Needed: Clorox disposable wipes, disposable mop heads. Procedure: 1. Level 1 PPE. All waste, linens, bodily fluids, gross contaminants should be

removed and disposed of by nursing prior to EVS Cleaning Clean and disinfect

all surfaces listed

2. Proceed to restroom – clean all fixtures-, including light, mirror, sink fixtures

and toilet. Remove and discard supplies, mop floor, dispose of mop handle as

CAT A waste.

3. Clean the entire over bed light with a bleach cloth. Use friction to help reduce

the bio-load when cleaning.

4. Clean all with bleach wipes, window sill, window frame, pull cord/chain or rod

and patient contact furniture.

5. Clean exterior of radiator/heater enclosure, ensure vents are clean.

6. Clean the closet interior & exterior.

7. Clean wall dispensers *Pay special attention to pump when cleaning units.

8. Clean the entire over bed table, top to bottom.

9. Clean the pillow(s).

10. Clean bed as required in bed cleaning procedure.

11. Clean head boards (both front and back), phone and monitor. Clean remaining

patient contact items in room: chairs, cushions, all furniture, door handles, call

bell, TV remote, channel changer equipment and c-locker/isolation cart (inside

& out).

12. Detail clean walls- replacing bleach wipe after four wipes of the wall.

13. Mop bathroom floor- mop room floor

14. Proceed to Ante room. Clean sink, counter, doors, knobs, lights, vents, mirrors,

detail clean mirrors, walls, all horizontal surfaces, mop floor.

15. Remove outer gloves, purell, reglove. Re-enter patient bathroom perform steps 2

through 13 again.

16. EVS personnel will don Level 1 or Level 2 PPE

17. Repeat step 14.

18. UV bathroom/patient room/ante room

19. Self-inspect area.

Works Cited

CDC. (2015, Feb 19). CDC Center forDisease Control and prevention. Retrieved Feb 20, 2015, from CDC.gov:

http://www.cdc.gov/vhf/ebola/healthcare-us/cleaning/hospitals.html


EVD Procedure




Dietary

Procedure:

1. Meals will be served on 100% disposable service (dishware, trays and eating utensils). Tray

ticket will be marked "All Disposables and Not to be Returned to Food and Nutrition"

2. Under no circumstance is the tray or any utensils to be returned to Food and Nutrition

Services once it has been placed in the warm or hot zones and must be treated as Class A

medical waste. Food/trays/utensils that stay in the cold zone can be disposed of in regular

waste by nursing staff on 8m.

3. Nursing will interpret orders for isolation based on the disease type and communicate this to

Food and Nutrition according to standard procedures. Off menu requests by the patient will

be determined clinically acceptable on a case by case basis at the time.

4. The entire 8m unit space will not be entered by Food and Nutrition Associates.

5. Food and Nutrition will deliver the tray/nourishment to the cart outside of locked unit doors

to 8m and then they will notify nursing staff via VOCERA or phone that it is available for

them to move in to the unit.

6. Menu selection will be obtained via phones/VOCERA from patient room by nursing staff

twice a day or as needed

7. The patient may utilize a phone and call 464-4305 to the Food and Nutrition office

Supervisor to place a meal order if clinically appropriate.


EVD Procedure




Support Services Employees & Family

1) Family Support

a) UH will have a designated room on the 8th

floor near the Ebola unit where families of

Ebola patient(s) and/or their significant others (extended families) can meet and gather

for comfort and support.

A. Family Emotional Support/Spiritual Support: UH will support the families using skilled

social workers and chaplains who will provide direct support services to the families

including emotional counseling, crisis intervention and bereavement counseling as

needed. Social workers will be available to help with findings resources for the families

as needed including temporary shelter and transportation They will facilitate

communication with the physicians and nursing staff so that the families’ questions can

be answered promptly. Social work will coordinate appropriate referrals to community

agencies that can help support the families as needed. Chaplains can provide religious

services as needed and will support and coordinate for the family religious contacts in the

community for their support as needed. Chaplains can provide religious rituals for

spiritual support when needed. Social work and the chaplains will conduct individual

assessments of families and they will identify specific family care plans for each family.

B. Family education on Ebola: Nursing and medical staff will provide “just in time”

education to the patient and their extended families on relevant EBOLA education to

alleviate fears and provide factual information to the family as they cope with the stress

of having a family member diagnosed and treated with Ebola. Nursing will develop in

EPIC care plans for the Ebola patient that identifies how care will be coordinated with the

families and describe the education that family will receive on Ebola.

C. Family Communication: All are providers as well as the social workers and chaplains

working in the family support area will use available communication tools such as

VOCERA/ ipads and telephone computers Skype technology to allow for frequent verbal

communication between the patient and their families as desired. When needed,

translation services will be provided using existing protocols so optimum communication

can be supported.

D. Family Comfort Services: Social Work will coordinate for the families’ meals and

snacks as needed in the family using the hospital food services. UH will support being

sure the family have access to TV and phone services as well as access to internet

services if needed and overnight accommodations as needed.

E. Games and entertainment resources, assessed as needed by the social worker, will be

provided for the family. (Examples: music, games, Electronic gaming: Wii, exercise

equipment, reading materials)


2) Staff Support

A. UH will have a designated room on the 8th

floor near the Ebola unit for staff involved

with Ebola patient(s) can decompress and receive needed rest and support. Services able

to be offered:

B. Emotional Support/Spiritual Support: UH will support the staff using skilled social

workers and chaplains who will provide direct support services to the staff including

emotional counseling, crisis intervention and bereavement counseling as needed. Social

workers will be available to help with findings resources for the staff as needed including

on campus housing and transportation. Social work will coordinate for the staff any

appropriate referrals to community agencies that can help with staff’s family at home in

their absence. Chaplains can provide religious services as needed and will support and

coordinate for the staff contacts in the community for their support as needed. Chaplains

can provide religious rituals for spiritual support when needed. Social work and the

chaplains will conduct individual assessments of staff to identify specific employee care

plans that can determine how we can best sustain the employee in their active Ebola duty.

C. Staff education on Ebola: Nursing and medical staff will continually be provided as

needed with “just in time” education on Ebola care directed by the NYSDOH and CDC

to alleviate fears and provide factual information to help them cope with the stress of

providing care to an Ebola patient.

D. Family Communication: Social workers and chaplains working in the staff support area

will use available communication tools such as VOCERA/ ipads and telephone

computers Skype technology to allow for frequent verbal/visual communication

between the staff and their families as desired. When needed, translation services will be

provided using existing protocols so optimum communication can be supported.

E. Staff Comfort Services: Food Service will coordinate for the staff meals and snacks as

needed using the hospital food services. UH will support being sure the staff employed

have access to TV and phone services as well as access to internet services if needed and

overnight accommodations as needed in Clark Hall.

F. Games and entertainment resources, assessed as needed by the social workers, will be

provided for the staff. (Examples: music, games, Electronic gaming: Wii, exercise

equipment, reading materials)


EVD Procedure




Communications/Public Relations

Procedure:

1) Upstate University Hospital’s Public and Media Relations Department, in conjunction with

Emergency Management and Hospital Administration, works together with local, state and

federal agencies to assess, update and communicate information regarding Ebola training and

care to Upstate Medical University staff through targeted and campus-wide communications.

2) A primary point of contact from Public and Media Relations is available 24 hours a day,

seven days a week, through the hospital's on-call system. A public information officer is

designated and available at all times to assist the team in external and internal

communications.

3) Public and Media Relations serves as the liaison for all media inquiries regarding Ebola and

the care of an Ebola patient at Upstate University Hospital and will make experts available to

media when appropriate. Upstate University Hospital protocol regarding release of private

patient information will be followed.


EVD Procedure




Post Mortem Preparations

Equipment: 1 trained observer, 2 clinical personnel in Level 3 PPE, 4 clinical personnel in

Level 1 PPE, 2 mortuary or hospital personnel in double gloves, 1 cremation casket, 3

approved body bags, PPE doffing supplies as needed.

Procedure:

1) ONLY PERSONNEL TRAINED IN THE HANDLING OF INFECTED REMAINS, AND

WEARING PPE, SHOULD TOUCH, OR MOVE, ANY EBOLA-INFECTED REMAINS.

2) Preparation of the body: At the site of death, only nurses who have been trained in the

handling of infected remains will prepare the body.

a) Level 1 (PPE) must be worn while performing these tasks.

3) Notify Technical Director of Hospital Autopsy Service of the death of an Ebola patient.

Request appropriate body bags (3) and cremation casket.

4) For identification purposes, use video monitoring system to take a photograph of the

decedent's face. (see 8m Video Users Guide for more information)

5) Staff wearing Level 1 PPE will enter patient room with necessary supplies.

6) Pull bed sheet(s) up around body.

7) Do not wash or clean body.

8) Do not remove any inserted medical equipment from body.

9) Gently roll body wrapped in sheets while sliding first bag under body.

10) Complete transfer of body to first bag.

11) Zip up bag, minimizing any air in bag – do not push or compress air in bag.

12) Disinfect outside of bag with bleach wipes.

13) Disinfect gloved hands using EPA registered hospital disinfectant (bleach wipes).

14) Fold second bag around first bag and close bag, minimizing any air in bag.

15) Disinfect outside of second bag with EPA registered hospital disinfectant (Bleach wipes).


17) Work the mega mover under the second bag.


19) Decontaminate surface of body bag with EPA registered hospital disinfectant.

20) Notify trained observers that body is ready to be transferred to cremation container.


21) Open anteroom door

22) Wheel cremation casket into clean side of ante room.

23) Open 3rd (heavy duty) body bag inside of cremation casket.


25) Open Patient door.

26) Place double bagged body into the 3rd open body bag in wooden cremation container then

close bag .

27) Zip 3rd bag closed and place a purple lock seal on zipper and lock.

28) Place a toe tag on zipper with patient identification, including patient name, date of birth and

medical record #. Close cover on cremation casket.

29) Disinfect outside of cremation container with EPA registered hospital disinfectant (bleach

wipes).

30) Push/lift cremation container into cold zone. All personnel who placed the body in the

bags or sealed the container will remain in the anteroom.

31) A new set of workers will receive the body for transport to morgue

32) All personnel in the anteroom will proceed to doff PPE. Disinfect gloved hands using EPA

registered hospital disinfectant (bleach wipes).

33) Burgess & Tedesco Funeral Home/Crematory will load the cremation container into their

service vehicle and transport directly to their crematory for cremation.

a) Burgess & Tedesco Funeral Home will be responsible for obtaining the necessary

information for the death certificate, filing the death certificate with the local registrar,

obtaining the burial transit permit for cremation, and for supplying the necessary

cremation container.

34) All transportation, including local transport, should be coordinated with relevant local and

state authorities in advance. Interstate transport should be coordinated with CDC by calling

the Emergency Operations Center at 770-488-7100.


35) EVD Procedure




Restraints for a Diagnosed EVD Patient

Procedure:

1. A patient will only be restrained if a determination is made that the patient is at risk of

harming him/herself or others

2. The treating clinician will determine the need for involuntary and/or physical restraints.

a) Where possible, involuntary or chemical restraint should be utilized since PPE may tear/rip

with the application of physical restraints.

3. Rationale for use of restraints will be documented in EPIC and must include duration of the

restraint.

4. Use of restraints will follow Upstate policy CMR-17 as much as practical ensuring the

utmost safety to 8m staff and the patient.


EVD Procedure




Pharmacy

Procedure:

1. Non-Controlled Medications

a) Delivery

i) All medications will be labeled with required patient identifiers, medication name,

strength, quantity, route, and frequency as well as barcode.

ii) Scheduled unit-dose, bulk, and intermittent intravenous (IV) infusion medications

that will be administered between the times of 1600 the same day to 1600 the

following day will be delivered with the 1500 refill that takes place that same day.

iii) New medications orders and STAT orders that are not already available in the unit

will be delivered from the central pharmacy on the hourly runs by the pharmacy

runner.

iv) Unit-dose/Bulk Scheduled and “As Needed (PRN)” Medications

(a) Unit-dose medications will be delivered and stored in sealed, plastic bags

v) Continuous IV infusions (CIVI)

(a) CIVI not stocked by distribution will be delivered from central pharmacy

(b) 2 hour notification request via an intervention in Epic will be needed for

production and delivery

2) Intermittent IV medications

a) Intermittent IV medications will be delivered as lyophilized powder either in vials or

vials “pig-tailed” to compatible diluents bags dependent upon the medication.

b) Storage

i) Scheduled medications will be delivered into the large, teal, patient-room specific

medication bin

ii) PRN medications will be delivered to the small, purple, patient-room specific

medication bin

c) Destruction

i) All medications will be destroyed within the unit and not returned to central

pharmacy

3) Controlled Medications

a) Stock

i) Initial supplies of midazolam, fentanyl and morphine injection will be provided to 8M

when/if Ebola Isolation Unit receives a patient

ii) Additional supplies of other controlled substances will be provided when/if

prescribed

b) Delivery


i) Controlled medications will be delivered the same as non-controlled medications with

the following additions

a. Delivery Sheet (Attachment A)

b. The pharmacist checking the medication will sign the delivery sheet for release

from the pharmacy

c. The delivering pharmacy technician will sign the sheet for delivery

d. The nurse receiving the medication will sign the sheet upon delivery

c) Storage

i) Controlled medications will be stored in a double locked cabinet in the unit (see

Attachment B)

d) Tracking (administration and waste)

i) CIVI

ii) Nursing will continue using the “Controlled Substance and Analgesic Administration

Record” for documentation of administration and waste. (Attachment C)

e) Unit-dose

i) Nursing will continue to document administration via the MAR in Epic

ii) Additionally, accountability and/or wastage of each dose will be managed using the

pharmacy generated Controlled Drug Administration Record (Attachment D)

f) Destruction

i) All controlled medications will be destroyed in the unit and not returned to central

pharmacy.

ii) Documentation of wastage/destruction will be performed using the “Controlled

Substance and Analgesic Administration Record” for CIVI or Controlled Drug

Administration Record for unit dose controlled substances.

iii) Controlled substance documentation forms will be returned to the pharmacy upon

completion.






EVD Procedure




Aerosol Generating Procedures (AGPS)

Procedure:

1. Avoid AGPs for EVD patients.

2. AGPS include Bi-level Positive Airway Pressure (BiPAP), bronchoscopy, sputum

induction, intubation and extubation, and open suctioning of airways.

3. If performing AGPs, use a combination of measures to reduce exposures:

4. HCP should wear PPE as described above

5. Limit the number of HCP present during the procedure to only those essential for patient-

care and support.

6. Entry and exit should be minimized during and shortly after the procedure.

7. Visitors should not be present during aerosol-generating procedures under any

circumstances.

8. Conduct environmental surface cleaning following procedures


EVD Procedure




Central Line Placement for EVD Patients

Procedure:

1. The steps below are considered to be an addendum to policy “CM C-34 Central Lines”

written specifically for a patient with Ebola. These steps are to be considered “helpful hints”

that should be discussed in detail with the clinical team prior to beginning the process.

A. Prep in the hallway of 8M. (Need counter and bedside table)

B. Pull out all equipment needed for procedure. (Drape, cvc kit, etc…)

C. Don sterile gloves

D. prep the bedside table with the max barrier kit

E. Take off gloves.

F. Don PPE

G. Make sure 3 claves are ready in the room.

H. Have 3 sterile saline flushes or a bowl with sterile saline to flush

I. Wait until in the room to open Central line container.

J. Bring Ultrasound sheath

K. Bring Sterile dressing

L. Bring into room the following: bedside table with max barrier kit, line kit, extra chloro

preps, sterile flushes, U/S machine with sheath cover and gel, 2 extra pair of sterile

gloves.

M. RN: Turn on u/s. Adjust contrast as needed.

N. At this point the Central Line Insertion and Removal procedure should be followed


EVD Procedure




Chest X-Ray

Procedure:

1) The X-Ray Technologist will prepare the x-ray plate for use in the patient room: to be

performed in the cold zone.

a. The X-ray plate will be placed in three separate x-ray bags.

i. The first two bags will be rolled and sealed at the open end of the bag. The third,

outer bag will be rolled and sealed with a tabbed piece of duct tape positioned in the

center of the rolled/ sealed end of the bag.

ii. Once complete, the x-ray tech will provide the bagged x-ray plate to the Buddy while

standing in the cold zone.

iii. Radiology staff will ensure the tape and all folds of the bag will be placed on the side

of the x-ray plate that faces toward the bed. Nursing staff review with radiology

which side faces patient and which side faces the bed prior to entering the room.

2) The Buddy then hands the sealed plate to the Nurse in the patient room while standing

in the cold zone.

3) The Nurse in the patient room will(prep the bedside table with a blue wrap) accept the

x-ray plate, close the patient room door, place the plate on the bedside table and await

further instruction.

4) The Buddy will prepare the warm zone by providing a clean path of travel (clean zone)

for the x-ray machine and the x-ray technologist.

a. Wipe the warm zone floor from the clean zone with an approved disinfectant wipe on a

swiffer. Allow Disinfectant to dwell as directed by the trained observer. (2 mins)

i. Once complete, remove the disinfectant wipe and dispose of in the red bag (meeting

ASTM 1922 and ASTM1709 standards for 480 grams tear resistance and 165

grams of impact resistance.) waste container.

ii. Wipe swiffer with a separate disinfectant wipe.

iii. Wash hands with a separate disinfectant wipe.

b. While in the cold zone place a large blue wrap on the floor in the warm zone up to the

patient room door.

c. A second small blue wrap will be placed on the floor overlapping the large blue wrap up

to the corridor door. Use a third small blue wrap if necessary.

d. Once complete open the corridor door.


5) The X-Ray Technologist will don a pair of nitrile gloves and roll the x-ray machine on

the blue wrap up to the patient room door. (the patient room door will remain closed at

all times until the x-ray unit and technologist have been removed from the area)

6) The Nurse will prepare the patient for the X-ray:

7) Don a 3rd

pair of nitrile gloves.

8) Raise the patient on the bed to a minimum 45% angle.

9) Move the patient bed away from the wall far enough to unplug the bed.

10) Unplug the bed and position the cord safely to prevent damage from the wheels or other

moving parts of the bed.

11) Clear the bed path of travel leading to the patient room door.

12) Move the patient bed directly in front of the patient room door.

13) Place the x-ray plate (black side to patient) with technologist guidance for proper

alignment.(side with the duct tape will face the bed)

14) Once aligned the Nurse will proceed to the patient room bathroom during x-ray.

a. In the event the patient is unstable and the nurse must remain with the patient

during the x-ray, the nurse will don a lead apron under the direction of the

Technologist.

15) When directed by the X-ray Technologist the Nurse will remove the x-ray plate and place

the bagged and sealed plate on the bed side table.

16) Return the patient to their original location keeping the bed out from the wall until the

bed has been plugged in. Once the bed is plugged in, push the bed back against the wall

and lower the patient on the bed.

17) The X-Ray Technologist removes the x-ray unit from the room.

18) X-ray plate hand off:

a. Buddy closes the corridor and Nurse open the patient room door

b. Nurse stands the x-ray plate up on the bedside table and wipes the outer plate bag

with the approved disinfectant. Allow for dwell time as directed by the trained

observer (2 mins)

c. Nurse carries the x-ray plate to the patient room door staying in the patient room.

d. Nurse lifts the tabbed duct tape from the bag, grabs the bagged plate in the middle on

both sides and slides the outer bag down exposing the two inner bags.

e. Buddy receives the x-ray plate from the nurse while standing in the cold zone careful

to grab the x-ray plate at the end touching the inner two bags only.

f. Nurse pulls the 3rd

outer bag away, places bag in the red bag (meeting ASTM 1922

and ASTM1709 standards for 480 grams tear resistance and 165 grams of impact

resistance.) waste container and wipes hands. Nurse closes patient room door. If 3rd

pair of outer gloves used remove the gloves at this point.

g. Once the patient room door is closed the X-ray Technologist donns a pair of nitrile

gloves and opens the corridor door.

h. Buddy grabs the bagged plate in the middle on both sides and slides the two inner

bags down exposing the plate. X-ray Technologist retrieves the plate careful not to

touch the x-ray bag and processes the x-ray panel to ensure the image is diagnostic.

i. Buddy disposes of the x-ray bag in the red bag (meeting ASTM 1922 and

ASTM1709 standards for 480 grams tear resistance and 165 grams of impact


resistance.) waste container and wipes hands with approved disinfectant wipe. Allow

for dwell time as directed by the trained observer (2 mins). Buddy closes corridor

door.


EVD Procedure




Highly Infectious Phlebotomy Protocol

Procedure: In-house patients identified as highly infectious will have phlebotomy performed by the in-house

care team.

1. Patient care personnel will perform the following actions prior to specimen collection:

a. Notify Security (4-4000) to report to patient room to provide escort for

Microbiology specimen transport personnel.

b. Confirm tests to be drawn then complete testing request paper work. (There are

downtime requisitions pre-completed for Ebola PCR, malaria PCR, and malaria

antigen tests for initial screening).

c. Obtain necessary specimen collection tubes.

d. If sending to Wadsworth complete NYSDOH Infectious Disease Requisition.

2. Microbiology/Core Lab personnel will report to the patient room with appropriate PPE

and specimen transport container once Incident Command has been activated.

(The following steps shall be read by Trained Observer)

3. Patient care personnel will proceed with specimen collection:

a. Don PPE in accordance with PPE Guidelines and enter patient room.

b. Retrieve specimen collection items stored in patient room, e.g. needle collection

device, alcohol pads, tourniquet, bleach wipes, labeling pen, and plastic transport

container (contains 3 EDTA tubes, 2 biohazard bags, and an absorbent pad), other

specimen collection tubes as needed.

c. Prep bedside table for blood draw. Place large bleach wipe on table. Open

specimen collection container. Open both biohazard bags and prop one of them

open inside of the collection container

d. Label the specimen tubes using permanent marker with patient name and DOB.

e. Follow routine phlebotomy patient identification procedure.

f. Collect specimens.

g. Discard phlebotomy materials.

h. Clean gloves with bleach wipe.

i. Decontaminate the shaft and rubber stopper of each specimen tube using a fresh

bleach wipe.

NOTE: there should be no visible contamination on the outside of the tube.

j. Place tubes into biohazard bag and seal.

k. Wipe outside of bag with bleach wipe.


l. Place bagged tubes into second biohazard bag and seal. Wipe secondary bag with

bleach wipe.

m. Place the double-bagged specimen into the plastic transport container and

securely seal lid. The pass thru portal on 8m Room #2. Close door in room #2.

i. POC Lab door cannot be opened to remove specimen until door is closed.

n. Thoroughly clean outer surface of plastic container with a bleach wipe.

o. Place container on bleach wipe on table.

p. Clean gloves with bleach wipe then open door into warm zone by gripping door

handle with a bleach wipe.

q. Grip bottom of container and hand it to the buddy, positioning hand below

buddy’s hand.

4. Microbiology/ Core Lab will open anteroom door (note that only one door may be open

at a time, wait for door to room to be closed before opening the door from the hallway)

then buddy will place container into open cooler held by Microbiology personnel,

ensuring that no part of his/her body comes into contact with the cooler.

5. Nurse at the desk will provide all necessary paperwork as described above to

Microbiology/Core Lab personnel.

6. Specimens will then be transported to the lab on 8M.

7. If specimen is coming from a location other then 8M security will escort

Microbiology/Core Lab personnel to the laboratory on 8M following designated transport

route.


EVD Procedure




Adult Continuous Renal Replacement Therapy (CRRT)

Number of Staff Needed: 2

Equipment: Alaris Pump for Heparin or Argatroban (per order)

Procedure:

1) Initiation of CRRT

2) 8M ICU Nurse Responsibilities a) Secure Equipment

i) 1- intravenous pump for Heparin or Argatroban (if ordered)

b) Obtain labs as indicated in the orders.

c) Weigh the patient, prior to starting the CRRT.

d) Send for Replacement Therapy Fluids and Heparin or Argatroban drips as ordered.

e) Establish baseline hemodynamic parameters prior to initiating and monitor the following for

stability:

i) EKG monitoring-continuous

ii) Arterial line-continuous or non-invasive BP (NIBP) at least q 15 minute readings during

initiation.

f) Secure documentation materials from CRRT chart/resource on unit (i.e. Troubleshooting

guidelines, Sample flow sheet, Dialysis flow sheet, and Physician’s orders).

3) Dialysis RN Responsibilities a) Dialysis RN will secure NxStage Dialysis Machine, set up and prime the system in Cold

Zone, including Replacement Therapy Fluids as ordered.

b) 8M RN will start the patient on the system. Dialysis RN will act as a resource to the ICU RN

in establishing the flow chart, maintaining the system, and in developing troubleshooting

skills from the Cold Zone.

4) Monitoring: Patient Care and Maintenance a) Responsibilities of the Dialysis RN

b) The set up for flushing the system should be labeled with the appropriate steps in a manner

(i.e.: 1-2-3, etc.) that clearly defines the process while in the Cold Zone.


5) To deliver a fluid bolus: a) Note the fluid volume in the saline bag, then unclamp the saline “T” (red clamp) and the

saline line (white clamp).

b) When the desired saline volume is delivered, re-clamp the saline “T” (red clamp) and the

saline line (white clamp). During bolus a transient low venous pressure caution (20, 21) may

occur and should resolve after the bolus is delivered.

c) This additional saline must be considered when calculating fluid balance and ultra filtration

target. A bolus for hypotension should not be considered when calculating fluid balance and

ultra filtration target.

6) Daily assessment of CRRT system. a) The normal saline flush used by the dialysis RN is recorded as intake on ICU flow sheet by

8M ICU RN, NOT as a bolus. Document system change in EMR.

b) Responsibilities of the 8M ICU RN i) Monitor vital signs per orders. Observe the patient for signs of bleeding. Assess dialysis

catheter/site for bleeding, kinks. Change central line dressing as needed if wet or soiled.

ii) Establish baseline for pressures and vital signs for patient.

iii) Monitor treatment using the “Home” display screen on the One-View Monitor of the

NxStage CRRT machine.

iv) Address red alarms and yellow cautions immediately. See Troubleshooting.

v) Every hour ensure that there is enough Replacement Therapy Fluids available for the next

hour and that the bags are draining evenly. Check for air build up at top of filter/dialyzer

and remove air via post-filter cap port to reduce clot formation. Check therapy fluid

levels are topped off in “warmer bag”; purge excess air as needed. (See Troubleshooting).

vi) Call and communicate when Replacement Therapy Fluids order has changed to the

Pharmacy.

vii) If Replacement Therapy Fluid needs to be replaced, remove the used concentration fluid

and replace per order. Requires two (2) RNs to verify the Replacement Therapy fluid

with the physician's order.

viii) Document hourly in EMR. See Documentation section.

ix) Monitor and Document the following on an hourly basis:

(1) Total intake.

(2) Total output (NG drainage, urine output, CT drainage, JP drainage, or other drain

output.

(3) Therapy Fluid Flow, verify machine setting is consistent with physician order.

(4) Pressures - effluent and venous pressure.

(5) Blood pump speed.

(6) Heparin or Argatroban infusion rate.

(7) Circuit check. Filter/dialyzer and blood circuit clotting should be evaluated routinely

to identify early stages of clotting and plan interventions as needed to prevent further

clotting, potential blood loss or hemolysis. Evaluation of filter clotting may be done

by performing a fluid bolus. For the best visualization of the filter/dialyzer, occlude

the arterial (access) patient line (red clamp) just


(8) before the saline “T” (red clamp) while saline is infusing. When flushing is complete,

release the arterial (access) patient line (red clamp) and re-clamp the saline line

(white clamp) and the saline “T” (red clamp). Record this fluid bolus as intake on

ICU flow sheet.

(9) In addition to RED ALARM 33.34 (Check filter: High TMP), and YELLOW

CAUTION 31, (Clotting Suspected: Check filter Clotting), Alarms and Cautions

indicating low venous (20and 21) or effluent pressure (22) may signal clotting of the

filter or blood circuit. One or more of these Alarms and Cautions indicate the need to

evaluate the blood circuit and filter for clotting.

c) Set/Change ml/hr (the amount drawn off each hour) i) Increase/Decrease UF rate volume by touching keypad, using adjustment arrows (up or

down) in Middle Window – yellow arrows) to modify the Ultrafiltration Rate

d) Set/Clear L/hr i) Touch green L/hr button adjustment arrows (up or down) in Upper Window, and set rate.

L/hr of Therapy Fluid is only changed by nephrologist order.

e) Flush the filter prn with 100 to 200 ml normal saline to assess for clotting as described

in step 9h above. Observe the filter for yellowing or darkening of the fibers. Document

filter appearance.

f) Monitor PTT and electrolytes per Heparin protocol and CRRT orders.

g) Weigh the patient BID. Weight should be at approximately the same times daily.

h) Notify the Nephrologists for the following: i) Systemic bleeding.

ii) System shut-down

iii) Hypotensive episode

i) For Acute Hypotensive Episode: i) Reduce ultra filtration rate down by either using the YELLOW ARROW or

ii) Press and hold red “STOP “button for 2 seconds to immediately reduce Therapy and

Ultrafiltration rates to “0” (after hypotension is treated, to return to previous rates), press

TREATMENT (green kidney shaped button).

iii) Give fluid bolus as ordered.

iv) Note fluid volume in saline bag, then unclamp the saline “T” (red clamp) and the saline

line (white clamp).

v) When the desired/ordered saline volume is delivered, reclamp the saline “T” (red clamp)

and the saline line (white clamp) NOTE: During the bolus, a transient LOW VENOUS

PRESSURE YELLOW CAUTION may occur and should resolve after the bolus is

delivered.

(1) Do not turn off the blood pump or disconnect the patient from hemofiltration unless

there is a blood leak in the system itself or a clot that is impeding flow, or patient

remains hypotensive after three- 200 ml boluses.

(2) Notify the Nephrologist.

7) Discontinuation and Returning Patient’s Blood a) Supplies:

i) NxStage System One’s User’s Guide

ii) Prep Pads

iii) 2 Multilumen dialysis catheter caps or red caps

iv) 2 vials-sterile normal saline 10 ml for injection or 2 10cc normal saline pre-filled

syringes.


b) Sufficient volume of saline for rinseback

c) Heparin 1,000 units/ml, draw up volume of catheter ports plus 0.1 ml. (ex. If catheter port

volume is 2.1 ml, using 1,000 units/ml heparin, draw up 2.2 ml (2,200 units)) or Alteplase

(TPA) if ordered – 2 vials Alteplase (TPA), 1 vial sterile H20-reconstitute each TPA vial

with 2.2 ml sterile H20. Draw up port volume and instill briskly.

i) 2 -10 ml syringes

ii) 2 -3 ml syringes

d) One chux or other type barrier

8) Rinseback Procedure: a) Scrub the connection of the multilumen dialysis catheter and the arterial/venous lines with

prep pads using moderate friction. Allow the area to air dry at least 30 seconds

b) Clamp arterial /access monitor line (Label line #1) with blue clamp or booted hemostat.

c) Open normal saline line, both red and white clamps (Label line #2). Make sure there is a

minimum of at least 300ml in flush bag.

d) If blood pump is off, press “Stop” key, then the green kidney shaped “treatment” key to

restart pump (Label line #3).

e) Turn on the blood pump at a low blood flow rate (150 ml/min).

f) When all of the patient’s blood has been returned, turn off the blood pump by pressing the

“Stop” key.

g) Clamp the venous port of the multilumen dialysis catheter and the venous CRRT bloodline.

h) With the blood pump off, unclamp arterial blood line, letting normal saline flush back to the

arterial side blood by gravity.

i) Clamp the arterial CRRT blood line and arterial side of multilumen dialysis catheter.

j) Place mask on you and patient if non-ventilated. Disconnect the arterial blood tubing from

the arterial port of the catheter. Place 10 ml syringe of normal saline flush on dialysis catheter

which was just cleaned.

k) Unclamp the multilumen dialysis catheter on the arterial side and briskly flush with 10 ml

normal saline. Clamp the catheter. Attach 3 ml syringe with Heparin to arterial port of

dialysis catheter. Unclamp the catheter and briskly fill the arterial side lumen with the

appropriate volume of Heparin or TPA solution as ordered. Check CRRT orders for catheter

block orders. Re-clamp the catheter, remove the syringe, and cap the port aseptically.


l) Repeat Steps 10 & 11 above for the venous blood tubing and the venous port of the catheter.

Note and document the time and reason for disconnection. Ensure the Nephrologist and

Dialysis Nurse are aware of the disconnection.

m) Once values are recorded from the One-View Monitor power off the machine by turning the

power switches to both the Cycler and Fluid Warmer OFF. Shut down the One View Monitor

by touching upper right corner of screen and then select “POWER OFF”.

n) Lift the front door handle of the Cycler up completely (until it clicks) and pull to open the

door.

o) Remove the disposables:

i) Disconnect the access pressure pod from the Cycler.

ii) Clamp and disconnect the Cartridge from the warmer disposable outlet.

iii) Clamp and disconnect the waste line from the waste line extension.

iv) Remove the saline bag and Cartridge and discard per hospital protocol.

v) Open the Fluid Warmer door and remove the warmer disposable/therapy MLA and

discard appropriately.

vi) Call Dialysis Nurse to discard the blood lines and filter in contaminated trash bag.

9) Alternative Rinseback Method: a) Press and hold STOP for 2 seconds. “000” will appear in the YELLOW Caution Window.

The Therapy Fluid and Ultrafiltration rates go to “0” and the Blood Pump continues.

b) Press STOP to stop the blood pump.

c) Verify rinseback display.

d) Clamp and disconnect the arterial (access) patient line (red clamp), reconnect it to the

priming spike (red port), then unclamp.

e) Press ADD FLUID to begin returning the blood (observe “210” in the top window, counting

down to “0”).

f) When rinseback is complete, clamp and disconnect the venous (return) patient line (blue

clamp) from the patient’s vascular access.

g) Turn the power switches to both the Cycler and the Fluid Warmer OFF.

h) Lift the front door handle of the Cycler up completely (until it clicks) and pull to open the

door.

i) Remove the disposables:




iv) Remove the saline bag and Cartridge and discard per hospital protocol.

v) Open the Fluid Warmer door and remove the warmer disposable/therapy MLA and

discard appropriately.

10) Manual Rinseback a) Termination of the treatment in the event of a power failure or unrecoverable alarm.

i) Make sure enough saline is available to rinse back the blood.

ii) Turn the power switches to both the Cycler and Fluid Warmer OFF.

iii) Clamp the waste line (yellow clamp) and therapy fluid inlet (green clamp).

iv) Clamp and disconnect the arterial (access) patient line (red clamp), reconnect to the

priming spike (red port), then unclamp.


b) Lift the front door handle of the Cycler up completely ( until it clicks) and pull toward you to

open cycler door.

c) Squeeze the saline bag until patient lines have rinsed clear. If pressure/ resistance exists, or

air is present in the venous (return) patient line (blue clamp). DO NOT attempt to rinseback.

d) Clamp and disconnect the venous (return) patient line (blue clamp) from the patient’s

vascular access.

e) Remove the disposables:




iv) Remove the saline bag and Cartridge and discard appropriately.

v) Open the fluid warmer disposable/therapy MLA and discard appropriately.

11) Temporary Disconnection a) The following procedure can be used to recirculate the extracorporeal circuit after returning

blood to the patient for periods when the patient needs to be off CRRT for testing such as CT

Scans, MRI, etc. The system can recirculate for a period up to two hours.

b) To Temporarily Disconnect Patient

i) Complete rinseback of blood to patient as per Section IV above. (NOTE: If clotting is

present, discard the cartridge/filter and call Dialysis Nurse to set up new CRRT system.)

ii) Attach the arterial (access) patient line (red clamp) to the priming spike (red port/clamp).

Unclamp both clamps.

iii) Attach the venous (return) patient line (blue clamp) to the priming spike (blue

port/clamp). Unclamp both clamps.

iv) Press green TREATMENT key to recirculate the blood circuit with saline.

v) Immediately set the rates using the ADJUSTMENT ARROWS on cycler.

vi) Dialysate Rate: green arrows (Top Window) – set to 0.1

vii) Ultrafiltration Rate: yellow arrows (Middle Window) – set to 0

viii) Blood Flow Rate: red arrows (Bottom Window) – set to 300 – 350

(1) When patient is to be reconnected, clean catheter access ports using prep pads or

similar hospital approved item. Press STOP key, clamp and disconnect the patient

lines from the priming spike, then reconnect to patients vascular access and unclamp.

(2) Press TREATMENT key and re-enter the ordered therapy parameters to resume

therapy.

12) Resetting the access pressure pod a) Procedure

i) Detach the access monitoring line from the Cycler, and observe the access pressure pod

deflate (bottom out).

ii) Press STOP.

iii) Clamp the arterial (access) patient line (red clamp).


iv) Unclamp the saline line (white clamp) and the saline “T” (red clamp) and observe the

diaphragm filling with blood. When it is full, clamp the saline line (white clamp), saline

“T’ (red clamp) and the access pressure pod monitoring line (red clamp).

v) Unclamp the arterial (access) patient line (red clamp).

vi) Press TREATMENT.

vii) Attach the access pressure pod monitoring line, by holding the line behind the locking

collar and inserting the tip into the connection point until it stops. While maintaining firm

pressure, twist the tip ¼ turn counterclockwise (to properly seal the connection), then

tighten the locking collar.

viii) Unclamp the access pressure pod monitoring line (red clamp).

ix) Confirm that the arterial (access) pressures are within range.

x) Check Blood Circuit: Pressure Alarms

xi) Red Alarm “20, 21, 22, 23, 24, 30, 31, 33, 34, 35”

b) In electronic medical record (EMR) documentation flow sheet Continuous Renal

Replacement Therapy Flow sheet (CRRT)

i) A new flow sheet is initiated and dated for each 24-hour period. Flow sheets must include

patient identification information from stamped patient nameplate or printed forms.

ii) The CRRT flow sheet should be placed in the patient’s chart.

iii) The desired net fluid loss is an ordered amount by the nephrologist on the order sheet.

This is documented in the appropriate column at the start of each hour.

iv) The CRRT Flow sheet intake and output section will reflect all fluids administered to the

patient, except IVF bolus received for hypotension and all output removed from the

patient. It will also reflect the calculated output, labeled CRRT real fluid loss/UF

Removed.

v) Document the following in an hourly basis:

(1) Total Intake and Output

(2) Pressures effluent, and venous

(3) Therapy Fluid Rate (ordered)

(4) Blood pump speed/rate

(5) Heparin or Argatroban infusion rate, when ordered.

c) Circuit check - Air Trap/Warmer i) In EMR

(1) Record VS/Temperature as ordered/indicated.

(2) Weight and time are recorded prior to treatment then every 12 hours at set times,

unless ordered otherwise.

(3) Rate of Heparin or Argatroban is recorded in the Drip section.

(4) The ICU Flow sheet intake and output section will reflect all fluids administered to

the patient, and all output removed from the patient. It will also reflect the calculated

output, labeled CRRT real fluid loss UF Removed.

(5) See CRRT/ Flow sheet: Guidelines for completion.

(6) Trouble shooting, Yellow and Red alarms put into tables Appendix A, B, C Refer to

Procedure C-28A


Procedure




Galileo Mechanical Ventilator

Procedure:

1) Ebola Procedure: The Respiratory Therapist will communicate with the Doctor/Nurse

working in the –patient room to perform the necessary steps below to use the Galileo

Ventilator to make the following settings. The Respiratory Therapist will communicate while

monitoring outside via the video to assure that each step is performed correctly

2) Mechanical Ventilation Mode and Tidal Volume

a) Patients will be ventilated using Volume cycled assist control at a tidal volume of 6-ml/kg

ideal body weight (IBW).

3) Ventilator Rate

a) Initial ventilator rate will be set to match the expected minute ventilation based upon

(a) normal needs of rate times tidal volume. Typical rate would be set at 10-14.

b) Adjustments to ventilator rate and tidal volume will be adjusted to achieve Arterial pH

goal of 7.20 pH<= 7.45.

c) Plateau Pressure goals <=30 cm H2O.

4) Inspiratory Flow and I:E Ratio

a) Inspiratory flowrate will be adjusted to maintain the I:E ratio = 1:1.0 – 1:3.0

5) Oxygenation

a) The oxygenation target range is 55 mm Hg <= PaO2 <= 80 mm Hg or 88% <= SpO2- sat

<= 95%. When both PaO2 and SpO2 are available simultaneously, the PaO2 criterion will

take precedence.

b) Levels of PEEP may be used to keep airways open as needed.



Microbiology Procedure

Section 110 : Select Agents Number: 110.5.9

Part 5 : Identification

No. 9 : Viral Hemorrhagic Fever (VHF) 8/20/14 DLK

_____________________________________________________________________________

Revised Date: Change Description:

8/19/16 SWR Modified donning/doffing using PAPR; updated bleach kill

times; updated Appendix 13

I. Principle:

The following guidance is for Microbiology-specific processing

and testing of specimens from patients with suspected viral

hemorrhagic fever (VHF). Specifically, this document provides

guidance for packaging and shipping of blood specimens to NYSDOH

and for malaria antigen performed in-house.

II. Background:

A. VHF is caused by members of four different viral families,

including Arenaviridae, Filoviridae, Bunyaviridae, and

Flaviviridae (see table). Person-to-person transmission

occurs through direct contact (through broken skin, mucus

membranes) with infected blood or body fluids or objects

contaminated with infected fluids.

Ebola Chapare Nanjianyin Nairovirus

Marburg Guanarito Omsk Hantavirus

Lassa Sabia Crimean Congo Yellow Fever

Junin Whitewater Arroyo Rift Valley Kyasanur Forest

Machupo Phlebovirus Dengue Alkhumra


III. VHF-specific Testing:

A. Providers must contact the Onondaga County Health

Department (OCHD) to discuss the case and to seek approval

for testing at (315)435-3256 (after hours, 315-682-7068

Quoc Nguyen, M.D.).

1. If unable to reach OCDC, providers can contact the

NYSDOH Bureau of Communicable Disease Control at

(518)473-4439 during business hours or the NYSDOH

Public Health Duty Officer at 1-866-881-2809

evenings, weekends, and holidays.

B. If approval for testing is given, public health officials

will provide guidance for specimen collection, handling,

and transport. The laboratory will be notified (S.R. and

S.L.) once Incident Command has been activated.

C. Tests Available for Ebola virus at CDC (similar testing

available for other VHF agents):

TIMELINE OF INFECTION DIAGNOSTIC TESTS AVAILABLE

Within a few days after

symptoms begin

Antigen-capture enzyme-linked

immunosorbent assay (ELISA)

testing

IgM ELISA

Polymerase Chain Reaction (PCR)

Virus isolation

Later in disease course or

after recovery

IgM and IgG antibodies

Retrospectively in deceased

patients

Immunohistochemistry testing

PCR

Virus isolation

D. Tests available for Ebola virus at NYSDOH: Real-time RT-PCR

1. Performed 24/7 for approved cases.

2. Samples will be transported 24/7 using DOH resources

according to NYSDOH Critical Specimen Transport

Program (Appendix 2). OCHD will initiate the CST

process.

a. OCHD will provide the Incident Command phone

number (315-464-4888) to the CST dispatcher and

courier.


b. The courier will park in the traffic circle at

the front entrance of the hospital, stay in

their vehicle, call the number, and provide

their name and a description of their vehicle.

c. Incident Command will notify University Policy

of their presence.

d. All specimens will be packaged as Category A

Infectious Substances according to DOT

regulations.

e. Microbiology trained personnel will deliver the

packaged specimen to the courier and will

verify the courier's NYSDOH identification.

3. Expected turnaround time (specimen pickup to report):

6-12 hours.

4. Malaria PCR automatically performed immediately after

a. Negative Ebola PCR.

b. Results available 3-5 hours after the Ebola

report.

E. Specimen Collection:

1. For patients with suspected VHF, the following

samples will be collected.

a. 3 completely filled EDTA (lavender top) tubes

b. Ebola PCR, malaria PCR, and malaria antigen

will be requested using a downtime requisition.

c. A completed NYS Infectious Disease Requisition

will accompany the specimens.

2. For patients with confirmed VHF and suspected

bacteremia, blood specimens for culture will be

collected according to institutional guidelines based

on patient weight (Policy CM B-08).

a. Only plastic blood culture bottles will be

used.

b. For patients weighing less than 13 kg, a single

adult aerobic bottle will be used.

http://www.upstate.edu/policies/documents/intra/CM_B-08.pdf


IV. Definitions:

A. Work Zones:

1. Hot Zone (laboratory):

a. Defined by red tape.

b. Contains Ebola (or suspected) infectious waste.

2. Warm Zone:

a. Defined by yellow tape.

b. Designated area between hot and cold zones used

for doffing.

3. Cold Zone (anteroom):

a. Defined by green tape.

b. Clean area with no infectious waste.

B. Personnel:

1. Care Provider:

a. Physician or nurse who cares for patient.

2. Buddy:

a. Clinical staff who observes and assists with

donning and doffing process as necessary.

3. Trained Observer:

a. Person calling out each step in the donning and

doffing process.

4. Assistant:

a. Laboratorian who assists processor and packages

specimen.

5. Processor:

a. Laboratorian who prepares specimen for shipping

and performs malaria antigen testing.

V. Personal Protective Equipment (PPE):


A. Only properly trained individuals will be permitted to

handle specimens from suspected or confirmed VHF patients.

B. Laboratory personnel will receive initial and biannual

refresher training regarding PPE donning and doffing.

C. Packs containing necessary PPE are pre-positioned and

include the following:

1. Full gown (Thumbs Up Isolation gown)

2. Knee-length boot covers

3. Outer pair of gloves (purple nitrile extended cuff)

4. Inner pair of gloves (blue nitrile)

5. Scrubs

6. Crocs

NOTE: Additional stocks of these items are available on 8M.

D. Powered Air Purifying Respirator (PAPR) – all components

are pre-positioned in the 8M laboratory.

E. PPE donning and doffing will be observed and documented

using a buddy and trained observer.

VI. Specimen Transport:

A. Microbiology personnel will be notified by Incident Command

when specimen collection/testing is required.

1. Emergency Room:

a. Microbiology trained personnel will bring the

VHF specimen transport cooler to the ER. PPE

for transport will consist of hospital scrubs,

crocs, a disposable blue lab coat and gloves.

b. Microbiology trained personnel, with a security

escort, will transport the specimens, completed

downtime requisition, and completed NYS

Infectious Disease Requisition from the ER to


the 8M laboratory anteroom. The lab coat and

gloves will be discarded in red trash can.

c. The specimen transport cooler and paperwork

will remain in the anteroom while the transport

person dons full PPE (VII).

d. The transport person (in full PPE) will open

the cooler in the anteroom, remove the specimen

container, close the cooler, and proceed into

the laboratory with the specimen container.

NOTE: If the specimen spilled/leaked while in

transport, immediately close the cooler and

proceed into the laboratory with the cooler.

See Appendix 3 for cooler cleaning protocol.

2. 8M Unit:

a. Microbiology trained personnel wearing full PPE

(VII) will report to the 8M laboratory.

b. Specimen will be received in pass through

portal.

VII. Donning PPE - Processor and Assistant (Private area/Room 8138):

A. Pre-Donning Procedure:

1. Remove all personal clothing and jewelry.

2. Put on hospital scrubs and clogs and proceed to 8M –

see also VI and VIII.

3. Remove ID badge.

3. Tuck pant legs into socks and shirt into pants.

4. Verify PAPR unit assembly

a. Inspect breathing tube, connections, and body

(look for gaskets, check for breaks in tube,

check threading of filters and PAPR).


b. Inspect filters/cartridges for correct

installation

c. Ensure battery is fully charged.

5. Verify PAPR air flow

a. Check that the correct filter is used.

b. Insert air flow indicator into blower opening

on top of PAPR.

c. Turn on blower.

d. Plastic cone of air flow indicator should rise

above the minimum flow mark.

e. If indicator does not reach minimum flow mark,

check battery and ensure that filter and

cartridge caps have been removed.

6. Inspect PAPR hood assembly

a. Check that breathing hose thread gasket seal is

present.

b. Check that thread in blower unit is in good

condition and is clear of foreign matter.

c. Screw end of breathing hose onto blower unit

until hand tight. Do not over-tighten.

d. Connect tube to headpiece, screw on end of

breathing hose until it is hand tight.

7. Check vials of Processor, Assistant, and Buddy.

8. Inspect PPE for rips or tears.

B. Donning Procedure

1. Put on knee-length boot covers.

2. Put on first pair of nitrile gloves (blue).

3. Put on Thumbs Up Isolation gown and tie.

4. PAPR unit


a. Buddy holds the blower unit and helps secure

belt, ensuring the belt holders are secured in

place. Adjust belt as needed.

b. Buddy turns on the blower motor.

c. Place hood over the head and pull chin strap to

snug under chin.

5. Put on second pair of nitrile gloves (purple extended

cuff).

6. No exposed skin or hair should be visible.

NOTE: once Hot Zone door is closed, Buddy will don

appropriate PPE and place blue wrap on counter in warm

zone.

VIII. Preparatory Steps:

A. Assistant:

1. Retrieve the following items and proceed to 8M.

a. Cold pack from freezer in 3818C.

b. Malaria antigen kit in walk-in refrigerator

(Room 3719).

c. PPE pack for transport person.

d. PPE pack for yourself.

2. Don full PPE (VII) and enter 8M laboratory anteroom.

3. Open shipping box and remove shipping container.

Remove blue foam square and insert cold pack.

4. Line red trash can in anteroom with 2 red biohazard

bags.

5. Bring shipping container, 2 malaria antigen test

cards and Reagent A into laboratory.

6. Cover top of cart with a blue absorbent pad and place

the following items on pad:

a. pipettor


b. pipette tips

c. timer (in zip-lock bag, pre-set to 15 minutes)

d. BinaxNOW card

e. gauze

f. Binax Reagent A

g. purple gloves

h. shipping container

7. Place a blue absorbent pad, small bleach wipes,

gauze, alcohol bottle, and rack in BSC.

8. Pour 500 mL of Chlorox Healthcare bleach in measuring

cup, and then into urine container. Place container

under BSC.

9. Position white plastic bucket near BSC and line with

a red biohazard bag.

10. Line the large red trash can with 2 red biohazard

bags.

IX. Packaging:

A. Processor - 8M Specimens:

1. Place specimen bag in BSC on blue absorbent pad.

2. Wipe surface of outer bag using a small bleach wipe.

a. Discard wipe into urine container.

b. Wait 1 minute for bleach kill time.

3. Open both bags carefully and inspect contents for

leakage or contamination.

NOTE: If this has occurred, close the bags and do not

process. Discard entire contents into lined white

bucket. Request repeat sample collection.


4. Remove one tube from inner bag and place in rack for

malaria antigen.

5. Re-seal bags, minimizing trapped air.

a. Wipe surface of outer bag using a small bleach

wipe.

b. Place bag on metal surface of BSC.

6. Discard wipe into urine container.

7. Remove outer gloves and discard into urine container.

8. Put on a clean pair of extended cuff gloves.

9. Insert specimen bag into shipping container.

a. Close the lid tightly.

b. Wipe outer surface of shipping container using

a small bleach wipe.

c. Discard wipe into urine container.

d. Wait 1 minute for bleach kill time.

10. Give shipping container to assistant.

a. Assistant will place shipping container on

table near door.

11. Proceed with malaria antigen test.

a. Assistant will read Malaria Antigen Procedure

steps to processor.

B. Processor - Emergency Room Specimens:

1. Place specimen container in BSC on blue absorbent

pad.

2. Wipe outer surface of specimen container using a

small bleach wipe.

a. Discard wipe into urine container.

b. Wait 1 minute for bleach kill time.


3. Open specimen container carefully and inspect

contents for leakage or contamination.

NOTE: If this has occurred, close the container and

do not process. Discard entire contents into lined

white bucket. Request repeat sample collection.

4. Remove double biohazard bag containing the specimens.

5. Remove one tube from inner bag and place in rack for

malaria antigen.

6. Re-seal bags, minimizing trapped air.

a. Wipe surface of outer bag using a small bleach

wipe.

b. Place bag on metal surface of BSC.

7. Discard wipe into urine container.

8. Seal specimen container and discard into lined white

bucket.

9. Remove outer gloves and discard into urine container.

10. Put on a clean pair of extended cuff gloves.

11. Insert specimen bag into shipping container.

a. Close the lid tightly.

b. Wipe outer surface of shipping container using

a small bleach wipe.

c. Discard wipe into urine container.

d. Wait 1 minute for bleach kill time.

12. Give shipping container to assistant.

a. Assistant will place shipping container on

table near door.

13. Proceed with malaria antigen test.

a. Assistant will read Malaria Antigen Procedure

steps to processor.


X. BinaxNOW Malaria Antigen (Processor):

A. Place pipettor, pipette tips, one BinaxNOW card, and

BinaxNOW Reagent A in BSC.

B. Wipe outside of blood tube with a small bleach wipe.

Discard wipe in urine container. Wait 1 minute for bleach

kill time.

C. Mix sample by gently inverting the tube several times.

D. Remove stopper using gauze.

1. Lay stopper face up on top of gauze on blue absorbent

pad.

2. Place tube in specimen rack and clean gloves with a

small bleach wipe.

3. Discard wipe in urine container.

4. Wait 1 minute for bleach kill time.

E. Open Binax card and lay flat.

F. Pre-rinse the pipette tip and then slowly add 15 µL of

blood to the bottom half of the PURPLE sample pad. Eject

pipette tip into urine container.

IMPORTANT: Incorrect addition of sample may lead to an invalid or

uninterpretable test.


G. There is a white pad immediately below the purple sample

pad.

1. Hold the Reagent A bottle vertically 1/2 inch above

this pad and add three (3) free-falling drops.

2. Allow the first drop to absorb into the pad before

adding the second drop.

3. Do NOT add Reagent A directly to the purple pad.

4. Re-cap tube with stopper.

a. Discard gauze in urine container.

b. Wipe tube with a small bleach wipe and place in

rack until test is complete.

c. Discard wipe in urine container.

H. Allow the blood sample to run up the full length of the

test strip.

1. Do not allow the blood to run into or under the

absorbent pad at the top of the strip, as doing so

will hinder optimal washing (clearance) of the test

strip.


I. Just before the blood sample reaches the base of the white

absorbent pad located at the top of the test strip, SLOWLY

add four (4) free-falling drops of Reagent A to the wash

pad on the top left-hand side of the test device, allowing

each drop to absorb into the pad before adding the next.

NOTE: The third and fourth drops may not completely absorb

into the pad.

J. When the sample just reaches the base of the white

absorbent pad at the top of the test strip, remove the

adhesive liner from the right edge of the device, and close

the device.

1. This allows the Reagent A to wash (clear) the blood

sample off the test strip.

2. To ensure good device closure and test flow, press

very firmly along the entire edge to the right of the

result window.

K. Set timer for 15 minutes.

L. Read the test result through the viewing window 15 minutes

after closing the test device.


1. Results read before 15 minutes may be incorrect.

2. Tilting the device may reduce glare and facilitate

interpretation.

M. Valid Test Results:

1. The Control (C) line will appear on all valid tests

and, when it is present, test results are interpreted

as follows:

a. Note that the appearance of any Test (T) line,

even when very faint, indicates a positive

result.

b. See table on next page for interpretation. See

108.8.4 for reporting.

TEST RESULTS DESCRIPTION/INTERPRETATION

T1 (HRPII)

Positive

Positive result for P. falciparum

T2 (aldolase)

Positive

Positive result for P. vivax or P.

malariae or P. ovale. In some

cases the appearance of only T2

Line may indicate a mixed infection

with two or more of these species.

T1 & T2

Positive

Positive result for P. falciparum.

In some cases the appearance of

both T1 and T2 Lines may indicate a

mixed infection of P. falciparum

with another species.

No T1 or T2

Lines

Negative result (no malaria

antigens were detected)

Invalid and/or

Uninterpretable

The test is invalid if the Control

(C) Line does not appear, whether a


Test Results

Test (T) Line(s) is present or not.

The test is uninterpretable if the

background color hinders reading of

the test result at 15 minutes.

Invalid or uninterpretable tests

can occur due to improper sample or

Reagent A addition. Consult the

Test Procedure Section and

Precaution #5 before repeating

testing with a new device. Call

Technical Service if the problem

persists.

N. Discard blood tube in urine container.

O. Roll up Binax card in blue absorbent pad and discard in

lined white bucket.

P. Decontaminate outer surface of pipettor, pipette tip box,

rack, and Reagent A bottle with small bleach wipes.

1. Discard wipes in urine container.


Q. Remove residual bleach using alcohol-soaked gauze.

1. Place items on cart as they are cleaned and discard

gauze into urine container.

R. Decontaminate BSC work surface with a small bleach wipe and

discard wipe in urine container.

S. Remove residual bleach using alcohol-soaked gauze. Discard

gauze in urine container.


T. Decontaminate outer surface of wipe container and alcohol

bottle with small bleach wipes.

1. Discard wipes in urine container.

2. Leave wipes and alcohol under hood.

U. Seal urine container tightly, wipe with a small bleach

wipe, and discard both in lined white bucket.

V. Decontaminate outer pair of gloves with a small bleach

wipe.


2. Remove outer gloves and discard along with wipe into

lined white bucket.

W. Put on a clean pair of extended cuff gloves.

X. Place items back into cart and discard blue absorbent pad

into lined white bucket.

Y. Proceed with waste handling and doffing as in XI.

Z. Assistant:

1. When malaria antigen is completed, proceed with

doffing (first out) (X1).

2. Wash hands with soap and water.

3. In anteroom, put on a clean pair of gloves.

4. Insert shipping container into box.

5. Place the foam lid over the top of the slotted foam

block.

6. Fold the top of the plastic liner into place.


7. Insert NYS Infectious Diseases Requisition into a zip

lock bag and place inside shipping container on top

of plastic liner.

8. Close the box, folding the front flap in first.

9. Complete the Shipper's Declaration of Dangerous Goods

Form per example (Appendix 1).

10. Insert Dangerous Goods Form into FedEx pouch.

Reserve one copy of form.

11. Secure lid with packing tape.

12. Attach pouch to box.

13. When laboratory door is closed, step into hallway

with shipping box and Specimen Log (Appendix 4).

14. Place box and log on counter.

15. Change into a clean pair of scrubs.

16. Take box and Specimen Log to front entrance of

hospital.

17. Give box to CST courier and complete Specimen Log.

XI. Doffing PPE:

A. First Out:

1. Wave at ceiling camera to alert buddy/trained

observer.

2. Open folding chair and position near warm zone.

3. Wipe gloves with a large bleach wipe and discard wipe

in red trash can. Wait 1 minute for bleach kill

time.

4. When buddy arrives, signal intention to exit the lab

with the "thumbs up" sign.

5. Sit in chair.


a. Remove boot cover from left foot without

touching gloves to pants.

b. Place left foot on floor in warm zone and

discard boot cover in red trash can.

c. Repeat process for right foot.

6. Stand up (assistant should steady chair if needed).

7. Wipe gloves with a large bleach wipe and discard.

Wait 1 minute for bleach kill time. Discard outer

gloves.

a. Pinch glove near cuff.

b. Roll the glove inside out and discard in trash

can.

c. Insert finger inside the cuff of the remaining

outer glove, pull inside out, and discard in

trash can.


8. Use a clean wipe to open door with left hand

a. Pass shipping container to buddy in anteroom.

b. Enter anteroom and discard wipe in anteroom

trash can.

c. Buddy will place shipping container on blue

wrap on counter in anteroom and wipe gloves

with a bleach wipe.

9. Turn around so that PAPR is facing Buddy.

a. Buddy grasps blower unit and staff unbuckles

belt.

b. Buddy disconnects air hose connected to the

hood, places unit on blue wrap on counter, and

turns power off.

c. Buddy wipes down PAPR with a large bleach wipe

and leaves unit on blue wrap on counter.

10 Lean forward and remove hood into red trash can.

11. Wipe gloves with a large bleach wipe. Discard wipe

in trash can. Wait 1 minute for bleach kill time.

11. Pull gown at waist to break tie.

12. Cross arms to shoulders, pinch gown and pull outward.

Turn gown inside out, roll it up, and place in trash

can.

13. Wipe blue gloves with a large bleach wipe. Discard

wipe. Wait 1 minute for bleach kill time.

14. Remove blue pair of gloves.




can.



trash can.


16. Put on a clean pair of gloves and place shipping

container into box.

a. Remove gloves.

b. Wash hands with soap and water and complete

packaging process.

c. Remain in anteroom until laboratory door is

closed.

B. Last Out and Waste Removal:

1. Add ~1 cup of Chlorox Healthcare bleach to red

biohazard bag in white plastic bucket to saturate

items.

2. Lift bag away from your body, taking care not to

touch the inside of the bag.

3. Grab the bag just above the level of the waste and

twist the top section. Try to minimize the amount of

incorporated air.

4. Bend the twisted top over.


5. Carefully place the zip tie around the twisted bag

and pull to close.

6. While holding the bag, wipe the outside of the bag

with a large bleach wipe. Discard wipe in red trash

can.

7. Place bag into red trash can.

8. Add ~1 cup of Chlorox Healthcare bleach to red trash

can waste to saturate items

9. Wipe gloves with a large bleach wipe and discard in

red trash can. Wait 1 minute for bleach kill time.

10. Signal buddy and trained observer intention to exit

the lab with the "thumbs up" sign.

11. Sit in chair.

a. Remove boot cover from left foot without

touching gloves to pants.


b. Place left foot on floor in warm zone and

discard boot cover in red trash can.


12. Stand up.

13. Lift inner bag of red trash can away from your body,

taking care not to touch the inside of the bag.

14. Grab the bag just above the level of the waste and


incorporated air.



and pull to close.


with a large bleach wipe. Discard wipe in red trash

can.

18. Place bag back into red trash can.

19. Use a clean wipe to open door with left hand until

door stays in open position. Discard wipe in red

trash can.

20. Lift the outer red bag of red trash can, holding it

away from your body.

21. Grab the red bag just above the level of the waste

and twist the top section. Try to minimize the

amount of incorporated air.



and pull to close.


with a large bleach wipe.

25. Hand bag to buddy for disposal in RMW container, then

discard wipe in red trash can in anteroom.



in red trash can in anteroom. Wait 1 minute for

bleach kill time.

27. Close laboratory door by pushing on laboratory side

of door.

a. Do not touch outer (anteroom) side.

b. Keep door closed until RMW waste is removed

from anteroom.

NOTE: Packager should leave the anteroom at

this time.

28. Use a clean wipe to open door with left hand and walk

into anteroom. Discard wipe in anteroom trash can.

29. Turn around so that PAPR is facing Buddy.

a. Buddy grasps blower unit and staff unbuckles

belt.

b. Buddy disconnects air hose connected to the

hood, places unit on blue wrap on counter, and

turns power off.

c. Buddy wipes down PAPR with a large bleach wipe

and leaves unit on blue wrap on counter.



in trash can. Wait 1 minute for bleach kill time.



Turn gown inside out, roll it up, and place in trash

can.

34. Wipe blue gloves with a large bleach wipe. Discard

wipe. Wait 1 minute for bleach kill time.

35. Remove blue pair of gloves.




can.



trash can.


37. Put on clean glove and transport specimen cooler to

Microbiology Laboratory for cleaning (Appendix 3).

XII. Blood Cultures:

NOTE: The following procedure is used for patients with proven

VHF. For those patients who test negative for VHF, use routine

blood culture protocol (see Section 105).

A. BACTEC Instrument Loading:

1. Specimens will be received via pass-through portal.

2. Specimens will be processed using the buddy system.

3. ASSISTANT:

a. Line red trash can in anteroom with 2 red

biohazard bags.

b. Place a blue absorbent pad, small bleach wipes,

gauze, and alcohol bottle in BSC.

c. Pour 500 mL of Chlorox Healthcare bleach into

measuring cup and then into urine container.

Place urine container under BSC.

d. Position white plastic bucket near BSC and line

with a red biohazard bag.

e. Line the large red trash can with 2 red

biohazard bags.

f. Cover cart with blue absorbent pad.

4. PROCESSOR:


a. Place bagged bottles in BSC on blue absorbent

pad.

b. Wipe surface of outer bag using a small bleach

wipe.

(1) Discard wipe into urine container.

(2) Wait 1 minute for bleach kill time.

c. Open inner bag carefully and inspect contents

for leakage or contamination.

NOTE: If this has occurred, close the bags and

do not process. Discard entire contents into

lined white bucket. Request repeat sample

collection.

d. Remove bottles from bags and discard bags in

urine container.

e. Wipe outer surface of bottles with a small

bleach wipe and place bottles on metal surface

of BSC.

(1) Discard wipe in urine container.


f. Remove residual bleach using alcohol-soaked

gauze and place bottles in rack on cart.

Discard gauze into urine container.

(1) ASSISTANT: Load bottles into

instrument(see 110.11.2).

g. Roll up blue absorbent pad and discard into

lined white bucket.

h. Decontaminate BSC work surface with a small

bleach wipe and discard wipe in urine

container.


i. Remove residual bleach using alcohol-soaked

gauze. Discard gauze in urine container.


j. Decontaminate outer surface of wipe container,

and alcohol bottle.

(1) Discard wipes into urine container.


k. Remove residual bleach using alcohol-soaked

gauze.

l. Seal urine container tightly, wipe with a small

bleach wipe, and discard both in lined white

bucket.

m. Discard blue pad from cart into lined white

bucket.

n. Decontaminate outer pair of gloves with a small

bleach wipe.

(1) Discard wipe into lined white bucket.


o. Remove outer gloves and discard into lined

white bucket.

p. Put on a clean pair of extended cuff gloves.

q. Proceed with waste handling and doffing as in

XI.

B. BACTEC Instrument Positives:

1. When the BACTEC audible alarm sounds, the individual

responsible for monitoring 8M audio/video will

contact the Microbiology Supervisor.


3. Retrieve the following items and proceed to 8M

laboratory.

a. One sleeve of each agar media (BAP, CHOC, MAC,

SAB)

b. Two 50 mL conical tubes filled with methanol to

30 mL line

c. Anaerobic bags/generator/redox indicator


d. PPE pack

4. Don full PPE (VII) and enter laboratory anteroom with

supplies.

5. ASSISTANT:

a. Line red trash can in anteroom with 2 red

biohazard bags.

b. Bring supplies into laboratory.

c. Place the following items in BSC:

(1) blue absorbent pad

(2) venting devices

(3) loops

(4) 50 mL conical tubes filled with methanol

in rack

(5) bleach wipes (small)

(6) gauze

(7) alcohol bottle

(8) plastic forceps

d. Cover cart with a blue absorbent pad and place

the following items on cart:

(1) media

(2) glass slides

(3) Blenderm

(4) alcohol pads

(5) metal bottle rack

(6) plastic slide carriers

e. Pour 500 mL of Chlorox Healthcare bleach into

measuring cup and then into urine container.

Place container under BSC.


f. Position white plastic bucket near BSC and line

with a red biohazard bag.

g. Line the large red trash can with 2 red

biohazard bags.

6. PROCESSOR:

a. Place correct number of plates and slides in

BSC.

(1) 2 slides per bottle

(2) 6 plates per bottle - BAP, CHOC, MAC,

SAB, BAP ANA, CHOC ANA

b. Clean rubber septum of each bottle with an

alcohol pad. Allow to dry.

c. Insert venting device into rubber septum of

each bottle.

d. Remove venting device cap, invert bottle, and

inoculate 1 drop to each slide and 2-3 drops to

each agar plate.

(1) Using a loop, carefully spread inoculum

on slide and streak plates for isolation

and allow inoculum to dry. Discard loops

into urine container.

(2) Seal plates with Blenderm.

(3) Insert anaerobic plates into one or more

anaerobic bags. Place bag(s) and aerobic

plates into incubator.

e. Allow slides to air dry and then fix in

methanol for 30 minutes. Place 2 slides back-

to-back with uninoculated sides together. Make

sure the slides are completely submerged in the

methanol. Do not remove smears from BSC until

they have been dried and fixed.

(1) Remove slides from methanol using forceps

and place slides on gauze to dry.

(2) Close lid of methanol tube tightly and

discard in urine container.


(3) Place dried slides in plastic slide

carrier and take to Microbiology

Laboratory for Gram stain.

(4) Apply permount and coverslip before

reading.

f. While slides are methanol fixing, cover venting

devices with gauze, remove, and discard into

urine container.

g. Remove outer gloves and discard into urine

container.

h. Put on a clean pair of extended cuff gloves.

i. Wipe outer surface of bottles with a small

bleach wipe. Discard wipe in urine container.

Wait 1 minute for bleach kill time.

j. Remove residual bleach using alcohol-soaked

gauze.

k. Place bottles in rack on cart as they are

cleaned and discard gauze into urine container.

(1) ASSISTANT:

(a) Place blood bottles in lined

plastic bucket under blood culture

instrument.

(b) Blood bottles will be discarded

after final organism

identification.

l. Decontaminate outer surface of plates, loop

bag, rack, and forceps with small bleach wipes.


m. Remove residual bleach using alcohol-soaked

gauze.

(1) Place items on cart as they are cleaned

and discard gauze into urine container.

n. Discard blue absorbent pad into urine

container.


o. Decontaminate BSC work surface with a large

bleach wipe and discard wipe in urine

container.


o. Remove residual bleach using alcohol-soaked


p. Decontaminate outer surface of wipe container

and alcohol bottle with small bleach wipe.

(1) Discard wipe in urine container.


(3) Leave wipes and alcohol under hood.

q. Remove residual bleach using alcohol-soaked


r. Seal urine container tightly, wipe with a small

bleach wipe, and discard both in lined white

bucket.

s. Discard blue pad from cart into lined bucket.

t. Decontaminate outer pair of gloves with a large

bleach wipe.


(2) Remove outer gloves and discard along

with wipe into lined white bucket.

u. Put on a clean pair of extended cuff gloves.

v. Proceed with waste handling and doffing as in

XI.

C. BACTEC Instrument Negatives:


2. Don full PPE (VII) and enter laboratory anteroom.

3. Line red trash can in anteroom with 2 red biohazard

bags. Proceed into laboratory.

4. Line white plastic bucket with a red biohazard bag.


5. Line the large red trash can with 2 red biohazard

bags.

6. Unload negative blood bottles from instrument and

place inside a urine container.

7. Seal urine container tightly and discard in lined

white bucket.

8. Proceed with waste handling and doffing as in XI.

XIII. References:

A. Interim Guidance for Specimen Collection, Transport,

Testing, and Submission for Patients with Suspected

Infection with Ebola Virus Disease. August 6, 2014.

http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-

collection-submission-patients-suspected-infection-

ebola.html

B. Interim NYS/NYC Laboratory Guidelines for Handling

Specimens from Cases or Suspected Cases of Ebola Virus

Disease. August 11, 2014.

https://apps.health.ny.gov/pub/ctridocs/alrtview/postings/

Notification_17105.pdf

C. Interim Laboratory Guidelines for Handling/Testing

Specimens from Cases or Suspected Cases of Hemorrhagic

Fever Virus (HFV). August 21, 2014. American Society for

Microbiology.

D. Tightened Guidance for U.S. Healthcare Workers on Personal

Protective Equipment for Ebola. October 20, 2014.

http://www.cdc.gov/media/releases/2014/fs1020-ebola-

personal-protective-equipment.html

http://www.cdc.gov/media/releases/2014/fs1020-ebola-personal-protective-equipment.html

http://www.cdc.gov/media/releases/2014/fs1020-ebola-personal-protective-equipment.html


Appendix 1: Dangerous Goods Form

1. Shipper Information:

a. Name of individual packaging the specimen

b. SUNY Upstate/Clinical Pathology

c. 750 East Adams Street

d. Syracuse, NY 13210

2. Consignee Information:

a. NYS Department of Health/Wadsworth Center

b. Virus Isolation Lab

c. 120 Scotland Avenue

d. Albany, NY 12208

e. (518)473-6153

3. Transport Details:

a. Cross out both "Passenger and Cargo Aircraft" and

"Cargo Aircraft only".

b. Mark NA in airport or departure.

4. Shipment Type: Cross out "Radioactive"

5. Nature and Quantity of Dangerous Goods:

a. Proper shipping name: Infectious substance, affecting

humans (possible Ebola virus)

b. Class or Division: 6.2

c. UN or ID No.: UN 2814

6. Packing Group: <leave blank>

7. Subsidiary Risk: <leave blank>

8. Quantity and Type of Packaging: 8.0 mL EDTA whole blood all

packaged in one fiberboard box.


9. Packing intr: 620

10. Authorization: <leave blank>

11. Additional Handing Information: <leave blank>

12. Emergency Telephone Number: (315)373-3074

13. Fill out Name/Title of Signatory and Place and Date of

Shipment.

14. Sign the form with name of the preparer.


Appendix 1 - Dangerous Goods Form - Continued

_________________


Appendix 2 - NYSDOH Fact Sheet


Appendix 3: Specimen Transport Cooler Cleaning Protocol

A. Specimen did not spill/leak during transport:

1. Transport cooler to Room 3818B, wearing a disposable blue

lab coat and gloves.

2. Wearing gloves, use large bleach wipes to thoroughly clean

the interior and exterior of cooler. Discard wipes in

trash can.

3. Allow cooler to sit for 5 minutes and then wipe interior

and exterior surfaces with alcohol-soaked gauze.

B. Specimen spilled/leaked during transport:

1. Proceed into 8M Laboratory.

2. Using a large bleach wipe, remove plastic transport

container from cooler and discard it, along with the wipe,

in lined white plastic bucket.

3. Remove absorbent material from cooler, being careful not to

touch soiled area, and discard in white plastic bucket.

4. Wipe gloves with a large bleach wipe. Discard wipe in

white bucket. Wait 1 minute for bleach kill time.

5. Using a large bleach wipe, thoroughly clean interior of

cooler. Discard wipe in white bucket.



7. Using a large bleach wipe, thoroughly clean exterior of

cooler. Discard wipe in white bucket.



9. Allow cooler to sit for 5 minutes and then wipe interior

and exterior surfaces with alcohol-soaked gauze. Discard

gauze in white bucket.

10. Pass cooler to buddy in anteroom.



Appendix 4

VHF SPECIMEN LOG

DATE PATIENT LABEL TECH DATE/TIME

TO NYSDOH

COURIER

NAME

VHF RESULT

TRANSPORT PROCESS SHIP




________________

Appendix 5: Donning PPE Checklist

Pre-donning procedure (private area/room 8138)

1 Remove ID badge and jewelry.

2 Tuck pant legs into socks and tuck shirt into pants.

3

Verify PAPR unit assembly

Inspect breathing tube, connections, and body

(look for gaskets, check for breaks in tube, check

threading of filters and PAPR).

Inspect filters/cartridges for correct

installation

Ensure battery is fully charged.

4

Verify PAPR air flow

Check that the correct filter is used.

Insert air flow indicator into blower opening on

top of PAPR.

Turn on blower.

Plastic cone of air flow indicator should rise

above the minimum flow mark.

If indicator does not reach minimum flow mark,

check battery and ensure that filter and cartridge

caps have been removed.

5

Inspect PAPR hood assembly

Check that breathing hose thread gasket seal is

present.

Check that thread in blower unit is in good

condition and is clear of foreign matter.

Screw end of breathing hose onto blower unit until

hand tight. Do not over-tighten.

Connect tube to headpiece, screw on end of

breathing hose until it is hand tight.

6 Check vitals of Processor, Assistant, and Buddy.

7 Inspect PPE for rips or tears.


Appendix 5: Donning PPE Checklist - continued

Donning procedure (private area/room 8138)

1 Put on knee-length boot covers.

2 Put on first pair of nitrile gloves (blue standard

length).

3 Put on Thumbs Up Isolation gown and tie.

4

PAPR unit

Buddy holds the blower unit and helps secure

belt, ensuring the belt holders are secured in

place. Adjust belt as needed for a snug fit.

Buddy turns on the blower motor.

Place hood over the head and pull chin strap to

snug under chin.

5 Put on second pair of nitrile gloves (purple extended

cuff).

6 No exposed skin or hair should be visible.

Buddy - once Hot Zone door is closed, Buddy will:

Don appropriate PPE.

Place blue wrap on counter in warm zone.


Appendix 6: Doffing PPE (First Out) Checklist

Pre-doffing procedure (Hot Zone)

1 Open folding chair and position near warm zone.

2 Wipe gloves with a large bleach wipe and discard wipe

in red trash can.

3 Wait 1 minute for bleach kill time.

4 Signal buddy for intention to exit the lab with the

"thumbs up" sign.

5 Sit in chair.

6 Remove boot cover from left foot without touching

gloves to pants.

7 Place left foot on floor in warm zone and discard boot

cover in red trash can.

8 Remove boot cover from right foot without touching

gloves to pants.

9 Place right foot on floor in warm zone and discard boot


10 Stand up.

11 Wipe gloves with a large bleach wipe and discard wipe.


13 Discard outer gloves.

14

Use a clean wipe to open door with left hand

Pass shipping container to buddy in anteroom.

Enter anteroom and discard wipe in anteroom trash

can.

Buddy will place shipping container on blue wrap on


counter in anteroom and wipe gloves with a bleach wipe.

PAPR removal (Warm Zone)

1 Turn around so that PAPR is facing Buddy.

2 Buddy grasps blower unit and staff unbuckles belt.

3

Buddy disconnects air hose connected to the hood,

places unit on blue wrap on counter, and turns power

off.




Appendix 6: Doffing PPE (First Out) Checklist - Continued

6


Buddy wipes down PAPR with large bleach wipe and leaves

unit on counter. Buddy wipes gloves with bleach wipe.

7 Pull gown at waist to break tie.

8 Cross arms to shoulders, pinch gown and pull outward.

9 Turn gown inside out, roll it up, and place in trash

can.

10 Wipe blue gloves with a large bleach wipe and discard

wipe.


12

Remove blue pair of gloves:

Pinch glove near cuff. Roll the glove inside out

and discard in trash can.

Insert finger inside the cuff of the remaining outer

glove, pull inside out, and discard in trash can.

13 Wash hands with soap and water.

Packaging

1

Put on a clean pair of gloves and place shipping

container into box.

Remove gloves.

Wash hands with soap and water and complete

packaging process.


Appendix 7: Doffing PPE (Last Out) and Waste Removal Checklist

Pre-doffing procedure (Hot Zone)

1

Add ~1 cup of Chlorox Healthcare bleach to red

biohazard bag in white plastic bucket to saturate

items.

2 Lift bag away from your body, taking care not to touch

the inside of the bag.

3

Grab the bag just above the level of the waste and


incorporated air.

4 Bend the twisted top over.

5 Carefully place the zip tie around the twisted bag and

pull to close.

6 While holding the bag, wipe the outside of the bag with

a large bleach wipe. Discard wipe in red trash can.

7 Place bag into red trash can.

8 Add ~1 cup of Chlorox Healthcare bleach to red trash

can waste to saturate items.

9 Wipe gloves with a large bleach wipe and discard in red

trash can.


11 Signal buddy and trained observer intention to exit the

lab with the "thumbs up" sign.

12 Sit in chair.

13 Remove boot cover from left foot without touching

gloves to pants.

14 Place left foot on floor in warm zone and discard boot


15 Remove boot cover from right foot without touching

gloves to pants.


16 Place right foot on floor in warm zone and discard boot


17 Stand up.

18 Lift inner bag of red trash can away from your body,

taking care not to touch the inside of the bag.

19

Grab the bag just above the level of the waste and


incorporated air.



pull to close.


a large bleach wipe. Discard wipe in red trash can.


Appendix 7: Doffing PPE (Last Out) and Waste Removal Checklist - Continued

23 Place bag back into red trash can.

24 Use a clean wipe to open door with left hand until door

stays in open position. Discard wipe in red trash can.

25 Lift the outer red bag of red trash can, holding it

away from your body.

26

Grab the red bag just above the level of the waste and


incorporated air.



pull to close.


a large bleach wipe.

30 Hand bag to buddy for disposal in RMW container and

discard wipe in red trash can in anteroom.

31 Wipe gloves with a large bleach wipe. Discard wipe in

red trash can in anteroom.


33 Close laboratory door by pushing on laboratory side of

door. Do not touch outer (anteroom) side.

34 Keep door closed until RMW waste is removed from

anteroom.

35 Packager may leave the anteroom at this time.

36 Use a clean wipe to open door with left hand and walk

into anteroom. Discard wipe in anteroom trash can.

PAPR removal (Warm Zone)


1 Turn around so that PAPR is facing Buddy.

2 Buddy grasps blower unit and staff unbuckles belt.

3

Buddy disconnects air hose connected to the hood,

places unit on blue wrap on counter, and turns power

off.



6


Buddy wipes down PAPR with large bleach wipe and leaves

unit on counter. Buddy wipes gloves with bleach wipe.

7 Pull gown at waist to break tie.

8 Cross arms to shoulders, pinch gown and pull outward.

9 Turn gown inside out, roll it up, and place in trash

can.


Appendix 7: Doffing PPE (Last Out) and Waste Removal Checklist -

Continued

10 Wipe blue gloves with a large bleach wipe and discard

wipe.


12

Remove blue pair of gloves:

Pinch glove near cuff. Roll the glove inside out

and discard in trash can.

Insert finger inside the cuff of the remaining outer

glove, pull inside out, and discard in trash can.


14 Put on clean glove and transport specimen cooler to

Microbiology Laboratory for cleaning (Appendix 3).


Appendix 8: BinaxNOW Malaria Antigen Checklist

1 Place pipettor, pipette tips, one BinaxNOW card, and

BinaxNOW Reagent A in BSC.

2 Wipe outside of blood tube with a small bleach wipe.

Discard wipe in urine container.


4 Mix sample by gently inverting the tube several times.

5 Remove stopper using gauze.

6 Lay stopper face up on top of gauze on blue absorbent

pad.

7 Place tube in specimen rack and clean gloves with a

small bleach wipe.

8 Discard wipe in urine container.


10 Open BinaxNOW card and lay flat.

11 Pre-rinse the pipette tip and then slowly add 15 µL of

blood to the bottom half of the PURPLE sample pad.

12 Eject pipette tip into urine container.

13

There is a WHITE pad immediately below the purple

sample pad. Hold the Reagent A bottle vertically 1/2

inch above this pad and add three (3) free-falling

drops.

14

Allow the first drop to absorb into the pad before

adding the second drop. Do NOT add Reagent A directly

to the purple pad.

15 Re-cap tube with stopper.

16 Discard gauze in urine container.

17 Wipe tube with a small bleach wipe and place in rack


until test is complete.

18 Discard wipe in urine container.

19 Allow the blood sample to run up the full length of the

test strip.

20

Do not allow the blood to run into or under the

absorbent pad at the top of the strip, as doing so will

hinder optimal washing (clearance) of the test strip.

21

Just before the blood sample reaches the base of the

white absorbent pad located at the top of the test

strip, SLOWLY add four (4) free-falling drops of

Reagent A to the wash pad on the top left-hand side of

the test device, allowing each drop to absorb into the

pad before adding the next.


Appendix 8: BinaxNOW Malaria Antigen Checklist - Continued

22 NOTE: The third and fourth drops may not completely

absorb into the pad.

23

When the sample just reaches the base of the white

absorbent pad at the top of the test strip, remove the

adhesive liner from the right edge of the device, and

close the device.

24 Press very firmly along the entire edge to the right of

the result window.

25 Set timer for 15 minutes.

26 Read the test result through the viewing window 15

minutes after closing the test device.

27 Results read before 15 minutes may be incorrect.

28 Tilting the device may reduce glare and facilitate

interpretation.

29 Interpretation

30 The Control (C) line will appear on all valid tests.

31 Note that the appearance of any Test (T) line, even

when very faint, indicates a positive result.

32 Refer to Table for band pattern interpretation.

33 Discard blood tube in urine container.

34 Roll up Binax card in blue absorbent pad and discard in

lined white bucket.

35

Decontaminate outer surface of pipettor, pipette tip

box, rack, and Reagent A bottle with small bleach

wipes.

36 Discard wipes in urine container.



38 Remove residual bleach using alcohol-soaked gauze.

39 Place items on cart as they are cleaned and discard

gauze into urine container.

40 Decontaminate BSC work surface with a small bleach wipe

and discard wipe in urine container.

41 Remove residual bleach using alcohol-soaked gauze.

Discard gauze in urine container.

42 Decontaminate outer surface of wipe container and

alcohol bottle with small bleach wipes.

43 Discard wipes in urine container.

44 Leave wipes and alcohol under hood.


Appendix 8: BinaxNOW Malaria Antigen Checklist - Continued

45 Seal urine container tightly, wipe with a small bleach

wipe, and discard both in lined white bucket.

46 Decontaminate outer pair of gloves with a small bleach

wipe.


48 Remove outer gloves and discard along with wipe into

lined white bucket.

49 Put on a clean pair of extended cuff gloves.

50 Place items back into cart and discard blue absorbent

pad into lined white bucket.

51 Proceed with waste handling and doffing as in XI.


Appendix 9: BinaxNOW Malaria Antigen Table

TEST RESULTS DESCRIPTION/INTERPRETATION

T1 (HRPII)

Positive

Positive result for P.

falciparum

T2 (aldolase)

Positive

Positive result for P. vivax

or P. malariae or P. ovale.

In some cases the appearance

of only T2 Line may indicate

a mixed infection with two

or more of these species.

T1 & T2

Positive

Positive result for P.

falciparum. In some cases

the appearance of both T1

and T2 Lines may indicate a

mixed infection of P.

falciparum with another

species.

No T1 or T2

Lines

Negative result (no malaria

antigens were detected)

Invalid and/or

Uninterpretable

Test Results

The test is invalid if the

Control (C) Line does not

appear, whether a Test (T)

Line(s) is present or not.

The test is uninterpretable

if the background color

hinders reading of the test

result at 15 minutes.

Invalid or uninterpretable

tests can occur due to

improper sample or Reagent A

addition. Consult the Test

Procedure Section and


Precaution #5 before

repeating testing with a new

device. Call Technical

Service if the problem

persists.


Appendix 10: Packaging 8M Specimens - Processor (Hot Zone):

1 Place specimen bag in BSC on blue absorbent pad.

2

Wipe surface of outer specimen bag using a small bleach

wipe.

3 Discard wipe into urine container.


5 Open bags carefully and inspect contents for leakage or

contamination.

6




7 Remove one tube from bags and place in rack for malaria

antigen.

8 Reseal bags, minimizing trapped air.

9 Wipe surface of outer bag using a small bleach wipe.

10 Place bag on metal surface of BSC.


12 Remove outer gloves and discard into urine container.

13 Put on clean pair of extended cuff gloves.

14 Insert specimen bag into shipping container.

15 Close the lid tightly.

16 Wipe outer surface of shipping container using a small

bleach wipe.




19 Give shipping container to assistant.

20 Assistant will place shipping container on table near

door.

21 Proceed with Malaria Antigen Test.

22 Assistant will read Malaria Antigen Procedure steps to

processor.


Appendix 11: Packaging Emergency Room Specimens - Processor (Hot Zone):

1 Place specimen container in BSC on blue absorbent pad.

2

Wipe outer surface of specimen container using a small

bleach wipe.



5 Open specimen container carefully and inspect contents

for leakage or contamination.

6




7

Remove double biohazard bag containing the specimen.

8 Remove one tube from bags and place in rack for malaria

antigen.

9 Reseal bags, minimizing trapped air.

10 Wipe surface of outer bag using a small bleach wipe.

11 Place bag on metal surface of BSC.


13 Seal specimen container and discard into lined white

bucket.

14 Remove outer gloves and discard into urine container.

15 Put on clean pair of extended cuff gloves.

16 Insert specimen bag into shipping container.

17 Close the lid tightly.


18 Wipe outer surface of shipping container using a small

bleach wipe.



21 Give shipping container to assistant.

22 Assistant will place shipping container on table near

door.

23 Proceed with Malaria Antigen Test.

24 Assistant will read Malaria Antigen Procedure steps to

processor.


Appendix 12: Packaging - Assistant (Cold Zone):

1 When Malaria Antigen is completed, proceed with doffing

(first out) (XI).


3 In anteroom, put on a clean pair of gloves.

4 Insert shipping container into box.

5 Place the foam lid over the top of the slotted foam

block.

6 Fold the top of the plastic liner into place.

7

Insert NYS Infectious Diseases Requisition into a zip

lock bag and place inside shipping container on top of

plastic liner.

8 Close the box, folding the front flap in first.

9 Remove gloves and wash hands with soap and water.

10 Complete the Shipper's Declaration of Dangerous Goods

Form per example (Appendix 1).

11 Insert Dangerous Goods Form into FedEx pouch. Reserve

one copy of form.

12 Secure lid with packing tape.

13 Attach pouch to box.

14 Take shipping box and Specimen Log (Appendix 4) to

front entrance of hospital.

15 Give box to CST courier.

16 Complete Specimen Log.


Appendix 13: Floor Plan


EVD Procedure




POC 8M Laboratory

Principle:

The following guidance is for Core Laboratory specific testing of specimens from

patients with suspected viral hemorrhagic fever (VHF). Specifically this document

provides guidance for the transport and testing of specimens by the POC Lab. This

testing includes the Piccolo xpress, Horiba ABX Micros 60, and the Hemochron

Signature Elite.

II. Background:

A. VHF is caused by members of four different viral families, including Arenaviridae,

Filoviridae, Bunyaviridae, and Flaviviridae. Person-to-person transmission occurs

through direct contact (through broken skin, mucus membranes) with infected blood or

body fluids or objects contaminated with infected fluids.

III. VHF-Specific Testing:

A. When approval for testing is given, the Core Laboratory will be notified at extension 4-

6832 or 4-6834 to schedule time that testing is needed.

B. Tests available for testing on Ebola patients or suspected patients:

1. Piccolo® xpressTM

:

a. Chemistry analyzer:

Pack 1: MG

Pack 2: ALB, ALP, ALT, AMY, AST, BILT, BUN, CA, CRE, GGT, GLUC, TP, UA

2. Horiba ABX Micros 60 Analyzer:

a. Hematology analyzer:

CBC and 3 part diff

3. Hemochron Signature Elite®:

a. Coagulation analyzer:

PT, PTT

4. Siemens Multistix 9:

a. Urine chemistries:

LEU, NIT, PRO, PH, BIO, KET, BIL, GIU

(See 103.40)

IV. Definitions:

A. Work Zone:

1. Hot Zone (laboratory):

a. defined by red tape

b. contains Ebola (or suspected) infectious waste

2. Warm Zone:


a. defined by yellow tape

b. designated area between hot and cold zones for doffing

3. Cold Zone (anteroom):

a. defined by green tape

b. clean area with no infectious waste

V. Specimen Transport:

A. Personnel will be notified when specimen collection/testing is required.

1. 8M Unit:

a. Trained personnel wearing full PPE (VI.C) will bring the VHF specimen transport cooler

to the patient's room.

b. Trained personnel will transport the specimens, completed downtime requisition from the

patient's room to the 8M laboratory anteroom.

c. The transport person will open the cooler in the anteroom, remove the specimen

container, close the cooler, and proceed into the laboratory with the specimen container.

B. Specimens must be processed by trained personnel using the buddy system.

1. All processing and manipulation steps, as described below, must be performed in a

biological safety cabinet (BSC) while wearing full PPE (VI.C).

VI. Personal Protective Equipment (PPE):

A. Only properly trained individuals will be permitted to handle specimens from suspected

or confirmed VHF patients.

B. Laboratory personnel will receive initial and monthly refresher training regarding PPE

donning and doffing.

C. Packs containing necessary PPE are pre-positioned and include the following:

1. Full gown

2. Knee-length boot covers

3. Cowl

4. Outer pair of gloves (purple nitrile extended cuff)

5. Inner pair of gloves (blue nitrile)

6. Face shield

7. N95 mask

8. Scrubs

9. Crocs

10. Surgical cap

NOTE: Additional stocks of these items are available on 8M.

D. PPE donning and doffing will be observed and documented using an assistant and trained

observer.

E. Donning PPE (Private area/Room 8138):

1. Remove all personal clothing and jewelry.

2. Put on hospital scrubs and clogs and proceed to 8M.

3. Tuck pant legs into socks and tuck shirt into pants.

4. Put on surgical cap and tuck hair underneath.

5. Put on knee-length boot covers.

6. Put on N95 respirator.

7. Put on first pair of nitrile gloves (blue).

8. Put on full gown and tie tightly.


9. Put on cowl and tuck hair underneath.

10. Put on face shield.

11. Put on second pair of nitrile gloves (purple extended cuff).

12. No exposed skin or hair should be visible.

F. Doffing PPE (first out):

1. Wave at ceiling camera to alert buddy/trainer.

2. Open folding chair and position near warm zone.

3. Wipe gloves with a large bleach wipe and discard in red trash can. Wait 2 minutes for

bleach kill time.

4. When buddy arrives, signal intention to exit lab with the "thumbs up" sign.

5. Sit in chair.

a. Remove boot cover from left foot without touching gloves to pants.

b. Place left foot on floor in warm zone and discard boot cover in red trash can.


6. Stand up (assistant should steady chair if needed).

7. Wipe gloves with a large bleach wipe and discard. Wait 2 minutes for bleach kill time.

8. Use a clean wipe to open door with left hand until door stays in the open position.

Discard wipe in trash can.

9. Facing red trash can, remove cowl and face shield by grasping face shield straps and

cowl, lean forward over trash can, and drop into bag.

10. Wipe outer pair of gloves with a large bleach wipe. Discard wipe in trash can. Wait 2

minutes for bleach kill time.



a. Turn inside out, roll it up, and place in trash can.

b. Do not touch gown to trash can.

NOTE: It is OK if outer gloves roll off into gown - proceed to step 13c or 14.

13. Take off outer pair of nitrile gloves.

a. Pinch glove near cuff (or near palm if glove is partially removed from previous step).

b. Roll the glove inside out and discard in trash can.


c. Insert finger inside the cuff of the remaining outer glove, pull inside out, and discard in

trash can.

14. Wipe gloves with a large bleach wipe. Discard wipe. Wait 2 minutes for bleach kill

time.

15. Pass shipping container to buddy in anteroom. Buddy will place shipping container on

counter in anteroom and wipe gloves with a bleach wipe.

16. With two hands grasp the outer edges of the N95 mask (along beak). Lean forward and

pull the mask off and drop into trash can.

17. Wipe gloves with a large bleach wipe. Discard wipe. Wait 2 minutes for bleach kill time.

18. Remove surgical cap and discard in trash can.

19. Remove last pair of gloves.




trash can.

21. Step into anteroom.


22. Put on a clean pair of gloves and place shipping container into box.

a. Remove gloves.

b. Wash hands with soap and water and complete packaging process.

c. Remain in anteroom until laboratory door is closed.

G. Doffing PPE (last out) and Waste Removal:

1. Add ~1 cup of Chlorox Healthcare bleach to red biohazard bag in white plastic bucket to

saturate items.

2. Lift bag away from your body, taking care not to touch the inside of the bag.

3. Grab the bag just above the level of the waste and twist the top section. Try to minimize

the amount of incorporated air.



5. Carefully place the twist tie around the twisted bag and pull to close.

6. While holding the bag, wipe the outside of the bag with a large bleach wipe. Discard

wipe in red trash can.

7. Place bag into red trash can.

8. Wipe gloves with a large bleach wipe and discard in red trash can. Wait 2 minutes for

bleach kill time.

9. Signal buddy and trained observer intention to exit the lab with the "thumbs up" sign.

10. Sit in chair.


a. Remove boot cover from left foot without touching gloves to pants.

b. Place left foot on floor in warm zone and discard boot cover in red trash can.


11. Stand up.

12. Add ~1 cup of Chlorox Healthcare bleach to red trash can waste to saturate items.

13. Lift inner bag away from your body, taking care not to touch the inside of the bag.

14. Grab the bag just above the level of the waste and twist the top section. Try to minimize

the amount of incorporated air.




wipe in red trash can.

18. Place bag back into the red trash can.

19. Lift the outer red bag, holding it away from your body.

20. Grab the red bag just above the level of the waste and twist the top section. Try to

minimize the amount of incorporated air.




wipe in red trash can in anteroom.

24. Hand bag to buddy for disposal in RMW container.

25. Wipe gloves with a large bleach wipe. Discard wipe in red trash can in anteroom. Wait 2

minutes for bleach kill time.

26. Close laboratory door by pushing on laboratory side of door.

a. Do not touch outer (anteroom) side.

b. Keep door closed until RMW waste is removed from anteroom.

NOTE: Packager may leave the anteroom at this time.

27. Use a clean wipe to open door with left hand until door stays in the open position.

Discard wipe in red trash can in anteroom.

28. Facing red trash can, remove cowl and face shield by grasping face shield straps and

cowl, lean forward over trash can, and drop into bag.

29. Wipe outer pair of gloves with a large bleach wipe (from buddy). Discard wipe in trash

can. Wait 2 minutes for bleach kill time.



a. Turn inside out, roll it up, and place in trash can.

b. Do not touch gown to trash can.

NOTE: It is OK if outer gown roll off into gown - proceed to step 32c or 33.

32. Take off outer pair of nitrile gloves:

a. Pinch glove near cuff (or near palm if glove is partially removed from previous step).



trash can.

33. Wipe gloves with a large bleach wipe. Discard wipe. Wait 2 minutes for bleach kill

time.


34. With two hands grasp the outer edges of the N95 mask (along beak). Lean forward and

pull the mask off and drop into trash can.

35. Wipe gloves with a large bleach wipe. Discard wipe in trash can. Wait 2 minutes for

bleach kill time.

36. Remove surgical cap and discard in trash can.

37. Remove last pair of gloves.




trash can.

38. Don fresh glove and pull lab door closed while stepping into anteroom. Discard glove in

trash can in anteroom.


40. Put on a clean glove and transport specimen cooler to Core Laboratory for cleaning

(Form A).

H. See chart below for PPE handling of specimens.

PROCEDURE POTENTIAL

HAZARD(S)

CONTROL/PROTECTION ADDITIONAL

INFORMATION

Package receipt

and transfer of

packages to testing

area

Leaking package Place leaking package in

plastic bag and transfer to a

Biological Safety Cabinet

(BSC).

Wear approved PPE

Contact Infectious

Control Officer

immediately

Disinfect exterior of

sealed plastic bag prior

to transfer to testing

area.

Unexpected

delivery to main

lab

Place specimen in plastic

white container while

wearing appropriate PPE.

Notify Infectious

Control Officer

immediately of

expected package

delivery.

Transport of

specimens

between testing

areas

Breakage of the

specimen

container

Specimens should be

transported in a clearly

labeled, durable, leak-proof

transport container directly to

the POC Lab.

Decontaminate all

surfaces of transport

container prior to

placing in cooler.

Preparation of

specimens for

testing

Aerosolization/

Splash/Splatter Minimize the number of

workers handling the

specimens

Work inside a certified class

II BSC with the sash at the

appropriate level.

Minimize unnecessary

movements while working in

No exposed skin inside

the BSC.

Bring all necessary

material into the BSC

before starting to work.

No sharps will be used.

Dispose of all pipette

tips in dedicated


the BSC. Follow acceptable

BSC practices.

Use BSL-3 practices that

include the following PPE:

fluid resistant back-closing

gown, double gloves, N95

respirator and full face shield

(eyes and mucous membranes

covered).

Limit the traffic around the

BSC.

Use only pipette tips (no

needles).

Have a dedicated rigid waste

container in the BSC.

Do not aliquot - obtain

sample directly from primary

tube.

container in the BSC.

Specimens, equipment,

and all materials must

be decontaminated

before removing from

BSC.

PROCEDURE POTENTIAL

HAZARD(S)

CONTROL/PROTECTION ADDITIONAL

INFORMATION

Bleach disinfectant Accidental

exposure Perform in BSC.

Use BSL-3 practices that

include the following PPE:

fluid resistant back-closing

gown, double gloves, N95

respirator, and full face shield

(eyes and mucous membranes

covered).

Do not vortex specimen.

Prevent contact with

skin, eyes and clothing.

Wash exposed skin

with soap and water

immediately or in the

case of a conjunctional

exposure with water.

Remove all

contaminated clothing

or shoes.

Report exposure

immediately to

Supervisor/Infection

Control.

Vortexing and

centrifuging

Aerosolizing Do not centrifuge specimen.

Do not vortex specimen.

Use whole blood for

testing.

After specimen

inactivation

completed and

before removal of

specimen from the

BSC

Accidental

transfer of

contaminated

material from the

BSC.

Wipe all tubes with

disinfectant before removing

from BSC.

Place remaining specimen in

Ziploc plastic bag. Disinfect

exterior of bag before

removing from BSC.

Disinfectants for

containers and work

surfaces.

Dedicated waste bag

for gloves and other

waste.


Change gloves.

Store specimen(s) in

refrigerator inside BSL-3

suite.

Post extraction

BSC

decontamination

Contamination of

BSC surfaces. Wipe the inside of the BSC

with disinfectant.

Remove all PPE and discard

into medical waste stream.

Chlorox bleach wipe is

used: followed by

wiping down all

surfaces in the BSC and

allow to air dry.

Waste autoclaving External

contamination of

waste containers

Disinfect outside of waste

containers before removal

from BSC and BLS-3.

Chlorox bleach wipe

Dispose of PPE used in

specimen handling

waste and testing in

RMW container.

VII. Specimen Receipt and Processing:

A. Specimens must be processed by trained personnel.

1. All processing and manipulation steps, as described below, must be performed in a

biological safety cabinet (BSC) while wearing specified PPE.

a. Li-heparinized tube for Chemistry testing

b. Citrate tube for Pt, PH

c. Lavender top tube for CBC

d. Leak proof urine cap - for urinalysis

B. Turn ON BSC and ensure hood door is 3/4 down.

C. Collect all supplies needed under BSC hood.

a. Blue absorbant pad

b. Gauze

c. Pipette and pipette tips

d. Urine container - uncap

e. Piccolo xpress and/or Hemochron

f. Cartridges

g. Biohazard bag

D. Processor:

1. Place specimen container in BSC on blue absorbant pad (on one side of hood).

2. Wipe outer surface of specimen container using a small bleach wipe. Discard wipe into

urine container.

3. Open specimen container carefully and inspect contents for leakage or contamination.

NOTE: If this has occurred, close container and do not process. Discard entire contents.

Notify care provider.

4. Remove double biohazard bag containing the specimens and place on blue absorbant

pad. (Throw out plastic container.)

5. Remove samples from inner bag and discard outer bag in plastic bucket. Place in rack

for testing.


7. Decontaminate outer pair of gloves with a Chlorox bleach wipe, and discard wipe into

urine container.

8. Proceed to Specimen Testing.

VIII. Specimen Testing:

A. Follow the steps below for specimen testing:

1. Perform Chemistry, Coagulation, and Urine Chemistry testing under the BSC.

2. For Chemistry and Coagulation testing remove stopper using gauze. Perform CBC

testing on analyzer without opening sample tube. (Do not remove waste when container

is 1/2 full. Contact Infectious Disease for removal.)

3. Follow manufacturer's protocol and test specific standard operating procedures for

testing.

4. When samples are obtained from tube:

a. Load disc/cartridge for testing.

b. Recap tubes and wipe tube and cap with bleach wipe.

c. Discard wipe in urine container.

d. Place samples in a clean biohazard bag.

e. Save samples in refrigerator for 3 days.

5. Place all disposables (gauze, pipette tips) in urine container. Discard cartridge/reagent

disc in the lined plastic bucket.

6. Clean outer gloves with bleach wipe, remove outer pair of extended cuff gloves, and

discard gloves and wipe into lined plastic bucket.

7. Decontaminate surface of analyzers with Chlorox wipe (wait 2 minutes). Follow

manufacturer's protocol and specific laboratory preventive maintenance procedures for

cleaning each analyzer.

8. Clean specimen rack, pipetter, and tip container with Chlorox wipes. Place on analyzer

bench.

9. Cap urine container and place in lined white bucket.

10. Roll up and discard the blue absorbent pad into the lined plastic bucket.

11. Decontaminate outer pair of gloves with a small bleach wipe, and discard wipe into

lined plastic bucket.

12. Decontaminate BSC with large bleach wipe. Discard wipe into urine container.

13. Proceed with Reporting of Results.

IX. Specimen Documentation and Reporting:

A. Report appropriate information on Form A, Specimen Log.

B. Enter results into computer.

C. Proceed with Doffing and Waste Handling as per this procedure.

X. Instrumentation Failure:

A. Techs will follow manufacturer's troubleshooting guide to repair analyzer.

B. Call Tech Support for Piccolo xpress Analyzer at (516)443-2745 (Glen Rizzardi) or 1-

800-366-8020. Abbott will replace ASAP. For ABX see sticker on front of analyzer.

C. In the event that the POC instrument fails or testing cannot be performed, the Supervisor

will be notified and another area hospital will be contacted for use of equipment.

D. CDC and NYS Department of Health will be contacted for assistance.

XI. References:


A. Guidance for Specimen Collection, Transport, Testing, and Submission for Patients with

Suspected Infection with Ebola Virus Disease. August 6, 2014.

http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-collection-submission-

patients-suspected-infection-ebola.html

B. NYS/NYC Laboratory Guidelines for Handling Specimens from Cases or Suspected

Cases of Ebola Virus Disease. August 11, 2014.

https://apps.health.ny.gov/pub/ctridocs/alrtview/postings/ Notification_17105.pdf

C. Laboratory Guidelines for Handling/Testing Specimens from Cases or Suspected Cases

of Hemorrhagic Fever Virus (HFV). August 21, 2014. American Society for Microbiology

D. Tightened Guidance for U.S. Healthcare Workers on Personal Protective Equipment for

Ebola. October 20, 2014. http://www.cdc.gov/media/releases/2014/fs1020-ebola-

personal-protective-equiment.html

188

Core Laboratory

__________________

Number: 107.4.1

Page: 14 of 14

FORM A

1/27/15 SL

__________________

SPECIMEN LOG

DATE PATIENT LABEL OR

PATIENT INFORMATION

TESTS

ORDERED

TESTING PERSONNEL

Upstate Hospital EVD Guidance Downtown Campus

Page 189 of 250

EVD Procedure




Hemochron Signature Elite Citrate Activated Partial Thromboplastin Lime Testing

Procedure:

I. Principle:

The Hemochron® Jr. Citrate Partial Thromboplastin Time (APTT) Test is a quantitative assay

intended for diagnostic testing. The Hemochron Jr. APTT is a measure of the intrinsic

coagulation pathway, which involves all coagulation factors except Factors VII and III (tissue

factor). The APTT is a modification of the Partial Thromboplastin Time (PTT) test that uses a

phospholipid derived from either brain or lung tissue to mimic the role of platelets in the

coagulation process and does not employ a contact activator. The APTT contains a contact

activating substance to standardize the activation of Factor XII such as glass, kaolin or

diatomaceous earth.

The Citrate APTT test is performed on the Hemochron Jr. Signature Elite instrument using a

citrated venous whole blood sample. The instrument is portable and the use of citrated

specimens allow testing to be conducted at the satellite laboratory.

The Hemochron Microcoagulation Systems utilize a mechanical endpoint clotting mechanism

in which testing occurs within the cuvette. Following whole blood sample introduction, the

instrument measures 15 microliters (µL) of blood and automatically moves the sample into the

test channel within the cuvette. The remainder of the blood sample, not needed for testing, is

automatically drawn into the waste channel of the cuvette. Sample/reagent mixing and test

initiation are performed automatically, requiring no operator interaction. After mixing with

the reagent, the sample is moved back and forth within the test channel and monitored by the

analyzer for clot formation. The clot detection mechanism consists of several LED optical

detectors aligned with the test channel of the cuvette. The speed at which the blood sample

moves between the two detectors is measured. As clot formation begins, blood flow is

impeded and the movement slows. The instrument recognizes that a clot endpoint has been

achieved when the movement decreases below a predetermined rate. Electronic optical

detection of a fibrin clot in the blood sample automatically terminates the test. Assay

resolution is achieved through the use of Platelet Factor 3 (PF3) substitute and a kaolin

activator, and does not require an incubation step. The instrument reports plasma-equivalent

(P-E) values mathematically converted from fresh whole blood. Both results (P-E and whole


Page 190 of 250

blood) are displayed on-screen. The Analytic Measurement Range (AMR) for this test:

Whole Blood seconds - 90-286; Plasma-equivalent seconds - 20.0-396.9

II. Specimen:

A. 3.2% sodium citrate blue top tube

B. Sample Storage:

1. For optimal performance, testing should be done within one (1) hour of

collection.

2. The sample should be stored at room temperature (15-30°C) prior to

testing.

C. Unacceptable Sample Types:

1. Samples with any of the following characteristics should be discarded

immediately, and a fresh whole blood sample must be collected prior to

performing any test on any model Hemochron instrument.

a. Sample collected into a pre-heparinized syringe.

b. Sample contaminated with tissue thromboplastin.

c. Sample contaminated with indwelling intravenous (I.V.) solutions.

d. Sample contaminated with alcohol cleansing solution.

e. Samples with visible clotting or debris accumulation.

III. Equipment - Materials and Reagents:

A. Equipment:

1. Hemochron Signature Elite® Instrument

2. AC/DC 12 volt Power Module (for use when charging the device)

B. Materials:

1. 3.2% Citrate whole blood sample

2. Biohazard disposal receptacle

3 Sharps disposal receptacle

C. Reagents:

1. The APTT test cuvette is a self-contained disposable test chamber

preloaded with a dried preparation of kaolin, phospholipid, calcium salts,

stabilizers and buffers.

a. Each test cuvette is individually packaged in a foil pouch with a

desiccant.

(1) Each box contains 45 individually pouched cuvettes.

(2) Cuvette pouches are stamped with a lot-specific expiration

date.

PRECAUTION: All used cuvettes should be considered as

potentially infectious, handled with care and disposed of by

following standard waste facility disposal policy.

b. Preparation:

a. Hemochron Jr. cuvettes must be at room temperature

before opening the pouch.

c. Storage Requirements:


Page 191 of 250

(1) While refrigerated (2-8°C), the unopened foil-pouched test

cuvette is stable until the marked expiration date.

(2) Room temperature storage (15-30°C) is optional for sealed-

pouched cuvettes:

(a) Room temperature cuvettes are good for a

maximum of twelve weeks.

(b) Re-dating is necessary if stored at room

temperature. A re-dating label is included on the

side panel of each box of cuvettes and should be

completed.

(c) Re-dating must never exceed the marked expiration

date.

(3) Hemochron Jr. cuvettes should not be exposed to

temperatures in excess of 37°C.

2. Liquid QC Material, Level 1 and Level 2:

a. Each box of directCHECK® Whole Blood Quality Control

contains fifteen (15) dropper vials and each vial contains dried

whole blood (0.5 mL) and diluent (0.7 mL).

b. There are also four (4) reusable protective sleeves for use in

processing the control material.

c. Should be stored in refrigerator.

d. Stable until expiration date stated.

e. Complete instructions and acceptable performance ranges are

included on each package insert.

f. directCHECK Whole Blood Quality Control Manufacturer Catalog

numbers:

(1) Level 1 - DCJCPT-N

(2) Level 2 - DCJCAPPT-A

IV. Calibration:

A. There is no calibration of the instrument as calibration is completed by the

manufacturer.

V. Quality Control Procedure:

A. System Self-Checks:

1. When a test is initiated by inserting a cuvette, system checks are

automatically performed and include:

a. Verification of adequate battery power to complete a full test.

b. Verification of the test-type on the screen display to insure that the

LEDs used for identifying the tests are functioning properly.

c. Verification that the cuvette temperature is warmed to 37°C±1°C.

If this temperature is not achieved or is exceeded, an appropriate

error message will be displayed and testing is prohibited.

2. After the sample is added and the "Start" key is pressed, the system

continues a self checking process:


Page 192 of 250

a. Verification that the sample is present and is of sufficient size to

run the test.

(1) This ensures that the pumps and sample-sensing LEDs are

functioning properly and that the cuvette is adequately

sealed.

(2) If these instrument and sample parameters are not

appropriate, the test is terminated and an error message is

displayed.

b. Verification that the internal timers function correctly for each test.

(1) If the system timer and assay timer disagree, a real-time

clock error message is displayed and the test result is not

reported.

B. Electronic Quality Control (EQC):

1. EQC is used to provide a two-level electronic verification of instrument

performance.

a. This testing does not use any external device.

b. The time interval to perform EQC is recommended by the

manufacturer to occur every eight (8) hours of each patient-testing

day.

c. The internal EQC will check a Normal level (30 seconds), and an

Abnormal level of QC (300 seconds or 500 seconds) plus the

internal temperature, and will store each result.

(1) If one test fails to meet specifications, the EQC test will

stop and record all results as failed.

(2) If the user aborts the EQC, the test is not saved to the

database or printed.

(3) If a cuvette is inserted in the instrument, EQC will be

aborted and recorded as a failed test.

2. EQC can be programmed to be performed automatically at

prescribed intervals by the instrument through the Configuration

Manager or can be performed manually by the Operator.

a. Manual Performance of EQC:

(1) If the instrument is turned off, hold in the "Start" key 2-3

seconds to turn it on.

(2) When "Connecting to network" is displayed, select

"Cancel".

(3) Display the QC status menu by pressing the "QC" key

before a cuvette is inserted.

(4) Press "1-EQC". The test chamber warms to temperature

and the EQC test begins. The results are displayed while

the test is progressing.

(5) When the test is completed, the results are displayed on the

screen and written to the QC database.


Page 193 of 250

b. Automatic Performance of EQC:

(1) If enabled by designating in the Configuration Manager

programming, Electronic Quality Control (EQC) tests will

be performed automatically at present intervals if the Elite

instrument is "On" and connected to a DC source by the

AC/DC power module.

(2) If the instrument is not in use, the EQC will automatically

initiate when the instrument is activated.

NOTE: If the electronic QC procedure yields an on-screen

ERROR message, discontinue use of the instrument and

contact the manufacturer.

C. Liquid Quality Control (LQC):

1. Frequency of Liquid QC:

a. Each lot of the Hemochron Jr. cuvettes should be validated for

performance using 2 levels of LQC:

(1) When a new shipment is received.

(2) Once per 30 calendar days thereafter.

2. Procedure for Performing LQC Tests:

a. Remove the direct CHECK vials, one each Level 1 and Level 2,

from the refrigerator and allow them to come to room temperature

prior to testing.

b. Remove two test cuvettes from the refrigerator and allow them to

come to room temperature. The foil pouch must be at room

temperature before opening.

c. Visually inspect each vial to insure that the glass ampule inside the

plastic vial is intact.

d. After the reagents have reached room temperature, open the

cuvette pouch and insert into the cuvette slot on the side of the

instrument.

(1) The instrument will prompt to scan barcode on cuvette.

(2) Press the "Scan" key and hold barcode in front of barcode

reader.

e. The instrument will prompt to enter Operator ID (OID).

(1) Enter employee ID number and hold in "Enter" key for 1-2

seconds to store.

f. Press "QC" key and select QC level (1-Normal or 2-Abnormal) to

tag the sample.

(1) The instrument will prompt to scan barcode of QC located

on package insert.

(2) Press the "Scan" key and hold appropriate barcode in front

of barcode reader.

g. The instrument will signal when ready with an audible beep, and

display alternating messages: "Add sample" and "Press Start".


Page 194 of 250

(1) The instrument will remain in the ready mode for five (5)

minutes.

(2) If the testing has not been started within five (5) minutes, a

"Start timeout" will occur indicating that the current cuvette

must be discarded and a new cuvette placed in the

instrument.

h. Remove the top of the plastic seal from the directCHECK vial.

i. Insert the directCHECK vial into the white protective sleeve.

j. Holding the vial upright, tap the directCHECK vial on the table top

to settle the inner glass ampule to the bottom of the plastic vial.

k. Crush the inner glass ampule by bending the vial over the edge of

the table top.

l. Immediately repeat this crushing action one to two more times at

different locations of the vial to ensure complete breakage of the

glass ampoule.

m. Quickly invert the dropper vial (dropper tip down) end-to-end 10

times and use a downward snapping motion of the wrist to ensure

the control material flows to dropper tip.

n. Remove the vial cap.

o. Squeeze the vial to discard the first drop of control material onto a

gauze.

p. Immediately dispense as many drops of control material as needed

to fill the cuvette sample well flush to the top. Should a large

dome extend over the top of the center sample well, push it over

into the outer sample well.

q. Press the "START" key.

r. Dispose of the vial and vial cap according to institutional policy

and retain the protective sleeve for reuse.

s. Wait for a single beep signaling the conclusion of the test.

t. Results are displayed as Plasma-equivalent (P-E) seconds or

Whole Blood seconds.

u. Record result on control log.

v. The instrument will display if QC passed or failed. These ranges

are Lot number-specific so there is a slight variation from lot to lot.

w. Remove the cuvette from the instrument and dispose according to

institutional policy.

3. Out-of-Range LQC Recommendations:

a. In cases where LQC results are outside of an acceptable range, the

cause may be one of the following categories:

(1) Improper Test or Mixing Technique

(2) Expired or improperly stored QC material

(3) Expired or improperly stored test cuvettes


Page 195 of 250

(4) Instrument temperature

b. If none of the above parameters are suspect, repeat the test using

LQC material with the same lot number.

c. If this repeat does not fall within the expected range, address the

above parameters again.

d. Obtain a cuvette from a different lot number and repeat the test

using LQC of the same lot number.

e. If this repeat test still does not fall within the expected range,


VI. Test Procedure:

A. Follow the steps below to run the test:

1. Remove the test cuvette from the refrigerator and allow to reach room

temperature.

2. Insert the cuvette into the cuvette opening.

3. The instrument will prompt the user to scan the barcode on the cuvette

wrapper.

a. Press the "Scan" key and place barcode in front of barcode reader.

4. This initiates the pre-warm/self-check mode.

5. During the pre-warm stage, observe the display for any fault messages.

6. The instrument will prompt you to enter operator ID (OID).

a. Enter employee ID and press "Enter".

7. The instrument will prompt to enter patient ID (PID).

a. Press the "Scan" key and place patient accession number barcode

in front of barcode reader.

8. The instrument will signal when "Ready" with an audible tone.

9. The screen will display the messages "Add Sample" and "Press Start".

a. The instrument will remain in the ready mode for five (5) minutes.

b. If the testing has not been started within five (5) minutes, a "Start

timeout" will occur.

c. Discard cuvette and obtain a fresh cuvette.

10. Immediately dispense one large drop of blood into the sample well of the

test cuvette.

11. Fill the sample well from the bottom up with fresh whole blood.

12. A sufficient quantity of blood must be added directly to the center sample

well to fill it flush to the top.

13. Should a large drop of blood extend above the top of the center sample

well, creating a "dome-like" appearance, push it over into the outer ring

with the tip of the dispensing device.

14. When transferring blood into the sample well, do not force blood into the

pin located on the center of the sample well.

15. Avoid generating air bubbles in the sample well when applying the

sample.

16. Press the "START" key.


Page 196 of 250

17. Test completion will be indicated by a single beep and test results will be

displayed.

18. The instrument reports whole blood numbers mathematically converted to

an International Normalized Ratio (INR) and a plasma equivalent value.

19. Record results in log.

20. Remove the cuvette from the instrument and dispose in accordance with


VII. Reporting Results:

A. Report Whole Blood (WB) results in seconds.

B. Reference Interval: 92-114 seconds

C. "Out of Range - Lo" results may indicate excessive blood coagulation activation,

possibly due to specimen contamination upon collection or processing, and should

be repeated.

1. Repeat on original specimen.

2. If results still show "Out of Range-Lo", report as "QRN (questionable

result, new specimen requested)".

3. If new sample still shows "Out of Range-Lo", use the English Text Code

"ECOAG" to report "Shortened below measuring range in repeated tests.

Shortened time is not associated with a disease state."

D. "Out of Range - Hi" results should be considered beyond clinical significance and

the test should be repeated.


2. If results still show "Out of Range-Hi", report as "QRN (questionable


3. If new sample still shows "Out of Range-Hi", use English Text Code

"EPTTC" to report "Prolonged >400 sec."

VIII. Limitations:

A. As with all diagnostic tests, results should be scrutinized in light of a specific

patient's condition and anticoagulant therapy. Any results exhibiting

inconsistency with the patient's clinical status should be repeated or supplemented

with additional test data. Samples with a hematocrit of less than 20% or greater

than 55% are not recommended due to optical densities outside of the instrument

levels of detection.

B. Tests may be affected by any of the following conditions:

1. Foaming of the sample (air bubbles)

2. Hemolysis

3. Clotted or partially clotted blood

4. Presence of the lupus anticoagulant or anti-phospholipid antibodies

(APLAs)

5. unsuspected anticoagulation with high concentrations of heparin or Low

Molecular Weight Heparins (LMWH).

IX. References:


Page 197 of 250

A. Bull, BS; Korpman, RA; Huse, WM; Briggs, BD; Heparin Therapy during

Extracorporeal Circulation: I. Problems Inherent in Existing Protocols. J Thorac

Cardiovasc Surg 1975; 69:674-684.

B. Clinical Laboratory Standards Institute (CLSI) Document GP02 - Laboratory

Documents: Development and Control; approved Guideline.

C. Clinical Laboratory Standards Institute (CLSI) Document GP17 - Clinical

Laboratory Safety; Approved Guideline.

D. Clinical Laboratory Standards Institute (CLSI) Document H03 - Procedures for

the Collection of Diagnostic Blood Specimens by Venipuncture; Approved

Standard.

E. Clinical Laboratory Standards Institute (CLSI) Document H12 - Collection,

Transport, and Preparation of Blood Specimens for Testing Plasma-Based

Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline.

F. Clinical Laboratory Standards Institute (CLSI) Document H47 - One-Stage

Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT)

Test; Approved Guideline.

G. Clinical Laboratory Standards Institute (CLSI) Document M29 - Protection of

Laboratory Workers from Occupationally Acquired Infections; Approved

Guideline.

H. Doty, DB; Knott, HW; Hoyt, JL; Koepke, JA: Heparin dose for accurate

anticoagulation in cardiac surgery. J Cardiovasc Surg 20:597-604, 1979.

I. Gambino, R: Monitoring heparin therapy. Lab Report for Physicians 4:17-20,

1982.

J. Hattersley, P: Activated Coagulation Time of Whole Blood. JAMA 1966:136-

436.

K. ITC Operators Manual Hemochron Signature Elite, March 2007.

L. Ogilby, JD; Kopelman, HA; Klein, LW; Agarwal, JB: Adequate heparinization

during PTCA: Assessment using Activated Clotting Times. Cath and Cardiovasc

Diag. 18:206-209, 1989.

M. Pan, CM; Jobes, D; Van Riper, D; Ogilby, JD; Lin, CY; Horrow, J; Blumenthal,

R; Mendoza, M; LaDuca, F: A Modified microsample ACT test for heparin

monitoring. J Extra-corporeal Technology, 28(1):16-20, 1996.

N. Wang, J-S; Lin-CY; Hung, W-T; Thisted, RA; Karp, RB: In vitro effects of

aprotinin on Activated Clotting Time measured with different activators. J Thorac

Cardiovasc Surg 14, 4:1135-1140, 1992.

O. Young, Donald S: Effects of Drugs on Clinical Laboratory Tests, Fourth Edition,

AACC Press, Washington, D.C., 1995.


Page 198 of 250

EVD Procedure




Hemochron Signature Elite Citrate Prothrombin Time

I. Principle:

The Hemochron® Jr. Citrate Prothrombin Time (PT) Test is a quantitative assay intended

for in vitro diagnostic use in performing a quantitative, one-stage assay for monitoring

oral anticoagulation effects by hemostasis assessment. The Prothrombin Time Test

monitors the extrinsic coagulation pathway, using a citrated whole blood sample on any

model Hemochron Whole Blood Microcoagulation System.

It is intended for use during procedures and therapeutic interventions that require

monitoring of oral anticoagulants and for hemostasis assessment before or after blood

transfusions. The Hemochron Jr. PT test is performed using fresh whole blood to ensure

accurate assessment of patient homeostasis.

The Hemochron Microcoagulation Systems utilize a mechanical endpoint clotting

mechanism in which testing occurs within the cuvette. Following whole blood sample

introduction, the instrument precisely measures 15 microliters of blood and automatically

moves it into the test channel within the cuvette. The remainder of the blood sample, not

needed for testing, is automatically drawn into the waste channel of the cuvette.

Sample/reagent mixing and test initiation are performed automatically, requiring no

operator interaction. After mixing with the reagent, the sample is moved back and forth

within the test channel and monitored by the analyzer for clot formation. The clot

detection mechanism consists of two LED optical detectors aligned with the test channel

of the cuvette. The speed at which the blood sample moves between the two detectors is

measured. The clot formation begins, blood flow is impeded and the movement slows.

The instrument recognizes that a clot endpoint has been achieved when the movement

decreases below a predetermined rate. Electronic optical detection of a fibrin clot in the

blood sample automatically terminates the test.

The instrument reports the whole blood result after a mathematical conversion to

International Normalized Ratio (INR) and plasma-equivalent (P-E) value in seconds in

order to provide a familiar clinical format and thus facilitate accurate clinical test result

interpretation. Both results (P-E and whole blood seconds) are displayed on-screen. The

International Normalized Index (ISI) for the reagent has been determined to be equal to

1.0. The Analytic Measurement Range (AMR) for INR: 0.8 to 7.0

II. Specimen:


Page 199 of 250


B. Sample Storage:


collection.


testing.



immediately, and a fresh whole blood sample must be collected prior to

performing any test on any model Hemochron instrument.







A. Equipment:



B. Materials:



3 Sharps disposal receptacle

C. Reagents:

1. The PT test cuvette is a self-contained disposable test chamber preloaded

with a dried preparation of thromboplastin, calcium salts, stabilizers and

buffers.

a. Each test cuvette is individually packaged in a foil pouch with a

desiccant.



date.




b. Preparation:

a. The test cuvettes must be at room temperature (15-30°C)






Page 200 of 250


pouched cuvettes:






completed.


date.

(3) The test cuvettes should not be exposed to temperatures in

excess of 37°C.

2. Liquid QC Material, Level 1 and Level 2:








e. Complete instructions and acceptable performance ranges are


f. directCHECK Whole Blood Quality Control Manufacturer Catalog

numbers:

(1) Level 1 - DCJCPT-N

(2) Level 2 - DCJCPT-A

IV. Calibration:


manufacturer.














Page 201 of 250


run the test.



sealed.



displayed.




reported.



performance.




day.










2. EQC can be programmed to be performed automatically at prescribed

intervals by the instrument through the Configuration Manager or can be

performed manually by the Operator.





"Cancel.






(5) When the test is completed, the results are displayed

on the screen and written to the QC database.


Page 202 of 250






AC/DC power module.



NOTE: If the electronic QC procedure yields an on-screen

ERROR message, discontinue use of the instrument and




a. Each lot of the Hemochron cuvettes should be validated for




b. Complete instructions and acceptable performance ranges are



a. Remove the directCHECK vials, one each Level 1 and Level 2,


prior to testing.








instrument.



reader.



seconds to store.


tag the sample.


on package insert.


of barcode reader.


Page 203 of 250




minutes.

(2) If the testing has not been started within five (5) minutes, a "Start

timeout" will occur indicating that the current cuvette must be

discarded and a new cuvette placed in the instrument.






the table top.



glass ampoule.






gauze.









t. The instrument reports whole blood numbers mathematically

converted to an International Normalized Ratio (INR) and a

plasma equivalent value.












Page 204 of 250











VI. Test Procedure:



temperature.



wrapper.












b. If the testing has not been started within five (5) minutes, a "Start

timeout" will occur.


10. Immediately dispense one large drop of blood into the sample well of the

test cuvette.










sample.


Page 205 of 250



displayed.

18. The instrument reports whole blood numbers mathematically converted to

an International Normalized Ratio (INR) and a plasma equivalent value.

19. Record WB results in log.




A. Report Whole Blood (WB) result in seconds.

B. Reference Interval: 20-26 seconds

C. "Out of Range - Lo" results may indicate excessive blood coagulation activation

possibly due to specimen contamination upon collection or processing, and should

be repeated.


2. If results still show "Out of Range-Lo", report as "QRN (questionable


3. If new sample still shows "Out of Range-Lo", use the English Text Code

"ECOAG" to report "Shortened below measuring range in repeated tests.

Shortened time is not associated with a disease state".

D. "Out of Range - Hi" results should be repeated.


2. If results still show "Out of Range-Hi", report as "QRN (questionable

result, new specimen requested)"

3. If new sample still shows "Out of Range-Hi", use English Text Code

"EPTC" to report "Prolonged >170 sec."

VIII. Limitations:









2. Hemolysis


4. Unsuspected anticoagulation


(APLAs)

C. Interfering Substances:

1. Many concomitant medications can also affect results.


Page 206 of 250

2. Other than the hematocrit range as outlined in "Limitations", substances

that interfere with whole blood assays but not plasma-based tests have not

been identified.

IX. References:










Standard.









Guideline.




1982.


436.

K. ITC Operator Manual Hemochron Signature Elite, March 2007.



Diag. 18:206-209, 1989.






Cardiovasc Surg 14, 4:1135-1140, 1992.




Page 207 of 250

EVD Procedure




Hemochron Signature Elite Preventive Maintenance

Procedure: I. Principle:

A. The analyzer must be functional and operate within the limits specified by the

manufacturer. These standards are monitored by quality control procedures.

B. This procedure outlines preventative maintenance and function verification

performed on a regular basis to ensure that the analyzer meets set standards. II. Reagents and Equipment:

A. Reagents:

1. Cuvette:

a. Appropriate test cuvette for QC running.

(1) Each test cuvette is individually packaged in a foil pouch

with a desiccant.



date.




b. Preparation:

(1) The test cuvettes must be at room temperature (15-30°C)






pouched cuvettes:






completed.


date.


Page 208 of 250


excess of 37°C.

2. Liquid QC Material:

a. Each box of directCheck® Whole Blood Quality Control contains

fifteen (15) dropper vials and each vial contains dried whole blood

(0.5 mL) and diluent (0.7 mL).





B. Supplies:

1. Kim wipes

2. bleach

3. Distilled water

C. Equipment:

1. Hemochron Signature Elite®

2. AC/DC 12 volt Power Module (for use when charging the device) III. Maintenance:

A. When In Use:

1. System Self-Checks:

a. When test is initiated by inserting a cuvette, system checks are


(1) Verification of adequate battery power to complete a full

test.

(2) Verification of the test-type on the screen display to insure

that the LEDs used for identifying the tests are functioning

properly.

(3) Verification that the cuvette temperature is warmed to

37°C±1°C. If this temperature is not achieved or is

exceeded, an appropriate error message will be displayed

and testing is prohibited.

b. After the sample is added and the "Start" key is pressed, the

system continues a self-checking process:

(1) Verification that the sample is present and is of

sufficient size to run the test.

(a) This ensures that the pumps and sample-sensing

LEDs are functioning properly and that the cuvette

is adequately sealed.

(b) If the instrument and sample parameters are not

appropriate, the test is terminated and an error

message is displayed.

(2) Verification that the internal timers function correctly for

each test.


Page 209 of 250

(a) If the system timer and assay timer disagree, a real-

time clock error message is displayed and the test

result is not reported.

2. Electronic Quality Control (EQC):

a. EQC is used to provide a two-level electronic verification of

instrument performance.

(1) This testing does not use an external device.

(2) The time interval to perform EQC is recommended by the

manufacturer to occur every eight (8) hours of each patient-

testing day.

(3) The internal EQC will check a Normal Level (30 seconds),

and an Abnormal Level of QC (300 seconds or 500

seconds) plus the internal temperature, and will store each

result.

(a) If one test fails to meet specification, the EQC test

will stop and record all results as failed.

(b) If the user aborts the EQC, the test is not saved to

the database or printed.

(c) If a cuvette is inserted in the instrument, EQC will

be aborted and recorded as a failed test.

b. EQC can be programmed to be performed automatically at

prescribed intervals by the instrument through the Configuration

Manager or can be performed manually by the Operator.

(1) Manual Performance of EQC:

(a) If the instrument is turned off, then hold in "Start"

key 2-3 seconds to turn it on.

(b) When "Connecting to network is displayed" then

select "Cancel".

(c) Display the QC status menu by pressing the "QC"

key before a cuvette is inserted.

(d) Press "1-EQC". The test chamber warms to

temperature and the EQC test begins. The results

are displayed while the test is progressing.

(e) When the test is completed, the results are displayed

on the screen and written to the QC database.

(2) Automatic Performance of EQC:

(a) If enabled by designating in the Configuration Manager




AC/DC power module.


Page 210 of 250

(b) If the instrument is not in use, the EQC will

automatically initiate when the instrument is

activated.

NOTE: If the electronic QC procedure yields an

on-screen ERROR message, discontinue use of the

instrument and contact the manufacturer.

3. Disinfecting Instrument:

a. Disinfect outer parts of instrument after each patient as needed.

(1) Wipe outside of analyzer using bleach (Clorox wipes)

after each patient.

(2) Re-wipe outside of analyzer with water-dampened gauze to

remove any residual bleach from plastic surfaces.

(3) Inspect and clean cuvette opening as needed by removing

residual blood with a water dampened gauze or cotton swab

only.

(4) DO NOT use solvents or strong cleaning solutions as they

may damage instrument components.

4. Battery Care:

a. The life of the internal Lithium battery is optimized when the

battery is exercised by using it on a regular basis; (i.e.; run battery

life during the day and charge it at night by plugging it into an AC

outlet).

b. "Charge Battery" will display if batteries are drained to the point

that valid testing cannot be performed. Plug into AC outlet to

continue testing.

B. Monthly:

1. Liquid Quality Control (LQC):

a. Frequency of Liquid QC:

(1) Each lot of the Hemochron cuvettes should be validated for


(a) When a new shipment is received.

(b) Once per 30 calendar days thereafter.

(2) Complete instructions and acceptable performance ranges

are included on each package insert.

b. Procedure for Performing LQC Tests:

(1) Remove the directCheck vials, one each, Level 1 and Level

2, from the refrigerator and allow them to come to room

temperature prior to testing.

(2) Remove two test cuvettes from the refrigerator and allow

them to come to room temperature. The foil pouch must be

at room temperature before opening.


Page 211 of 250

(3) Visually inspect each vial to insure that the glass ampule

inside the plastic vial is intact.

(4) After the reagents have reached room temperature, open the

cuvette pouch and insert into the cuvette slot on the side of

the instrument.

(a) The instrument will prompt to scan barcode on

cuvette.

(b) Press the "Scan" key and hold barcode in front of

the barcode reader.

(5) The instrument will prompt to enter Operator ID (OID).

(a) Enter employee ID number and hold in "Enter" key

for 1-2 seconds to store.

(6) Press "QC" key and select QC Level (1-Normal or 2-

Abnormal) to tag the sample.

(a) The instrument will prompt to scan barcode of QC

located on package insert.

(b) Press the "Scan" key and hold appropriate barcode


(7) The instrument will signal when ready with an audible beep

and display alternating messages: "Add Sample" and "Press

Start".

(a) The instrument will remain in the ready mode for

five (5) minutes.

(b) If the testing has not been started within five (5)

minutes, a "Start Timeout" will occur indicating that

the current cuvette must be discarded and a new

cuvette placed in the instrument.

(8) Remove the top of the plastic seal from the directCHECK

vial.

(9) Insert the directCHECK vial into the white protective

sleeve.

(10) Holding the vial upright, tap the directCHECK vial on the

table top to settle the inner glass ampule to the bottom of

the plastic vial.

(11) Crush the inner glass ampule by bending the vial over the

edge of the table top.

(12) Immediately repeat this crushing action one to two more

times at different locations of the vial to ensure complete

breakage of the glass ampule.

(13) Quickly invert the dropper vial (dropper tip down) end-to-

end 10 times and use a downward snapping motion of the

wrist to ensure the control material flows to dropper tip.

(14) Remove the vial cap.


Page 212 of 250

(15) Squeeze the vial to discard the first drop of control material

onto a gauze.

(16) Immediately dispense as many drops of control material as

needed to fill the cuvette sample well flush to the top.

Should a large dome extend over the top of the center

sample well, push it over into the outer sample well.

(17) Push the "START" key.

(18) Dispose of the vial and vial cap according to institutional

policy and retain the protective sleeve for reuse.

(19) Wait for a single beep signaling the conclusion of the test.

(20) The instrument displays the result.

(21) Record result on control log.

(22) The instrument will display if QC passed or failed. These

ranges are Lot Number-specific so there is a slight variation

from lot to lot.

(23) Remove the cuvette from the instrument and dispose

according to institutional policy.

c. Out-of-Range LQC Recommendations:

(1) In cases where LQC results are outside of an acceptable

range, the cause may be one of the following categories:

(a) Improper Test or Mixing Technique

(b) Expired or Improperly Stored QC Material

(c) Expired or Improperly Stored Test Cuvettes

(d) Instrument Temperature

(2) If none of the above parameters are suspect, repeat the test

using LQC material with the same lot number.

(3) If this repeat does not fall within the expected range,

address the above parameters again.

(4) Obtain a cuvette from a different lot number and repeat the

test using LQC of the same lot number.

(5) If this repeat test still does not fall within the expected

range, contact the manufacturer.

IV. References:

A. ITC Operator's Manual, Hemochron Signature Elite, March 2007.


Page 213 of 250

EVD Procedure




Hemochrom Signature Elite Training Checklist

EMPLOYEE: ___________________________OBSERVED BY: ______________________

ASSESSMENT FOR THE TIME PERIOD: _______________ TO _____________________

□ COMPETENCY □ TRAINING

ITEM V W DO ACCEPTABLE

COMPETENCE

DATE

INITIAL

YES NO*

1 Able to name and locate all components on the Hemochron

Signature Elite: display panel, keypad, test chamber, and

barcode scanner.

2 Properly performs and documents the when in use and

monthly Preventive Maintenance procedures as detailed in

the Procedure Manual.

3 Understands the location, storage, and stability of test

cartridges and liquid control materials.

4 Demonstrates knowledge on how to perform and record

Quality Control Protocol: EQC, LQC.

5 Understands Specimen and Processing Requirements.

6 Understands Loading Requirements.

7 Understands test results and familiar with Data Entry

Procedure.

8 Acceptable performance of an unknown and/or control

analysis (attach results).

9 Practices Universal Precautions and exhibits compliance

with all safety protocols.

10 Acceptable performance on written exercise (80%).

11 Review of written procedure (employee initials). Assessment Method: V = verbal; W = written; DO = direct observation

*If unacceptable performance noted, please detail corrective action and achievement of acceptable competency.

Item #: _______________________ Date: _________________________

Corrective Action: __________________________________________________________

Employee: _______________________________________________ Date: ___________

Competency Officer: _____________________________________ Date: ___________


Page 214 of 250

EVD Procedure




Hemochron Signature Elite General Operating Procedure

I. Principle:

The Hemochron Microcoagulation Systems utilize a mechanical endpoint clotting

mechanism in which testing occurs within the cuvette. Following whole blood sample

introduction, the instrument precisely measures 15 microliters of blood and automatically

moves it into the test channel within the cuvette. The remainder of the blood sample, not

needed for testing, is automatically drawn into the waste channel of the cuvette.

Sample/reagent mixing and test initiation are performed automatically, requiring no

operator interaction. After mixing with the reagent, the sample is moved back and forth

within the test channel and monitored by the analyzer for clot formation. The clot

detection mechanism consists of two LED optical detectors aligned with the test channel

of the cuvette. The speed at which the blood sample moves between the two detectors is

measured. As clot formation begins, blood flow is impeded and the movement slows.

The instrument recognizes that a clot endpoint has been achieved when the movement

decreases below a predetermined rate. Electronic optical detection of a fibrin clot in the

blood sample automatically terminates the test.

II. Specimen:


B. Sample Storage:


collection.


testing.



immediately, and a fresh whole blood sample must be collected.







A. Equipment:



B. Materials:


Page 215 of 250



3 Sharps dsposal receptacle

C. Reagents:

1. Cuvette:

a. Appropriate test cuvette for test ordered.

(1) Each test cuvette is individually packaged in a foil pouch

with a desiccant.



date.




b. Preparation:

(1) The test cuvettes must be at room temperature (15-30°C)






pouched cuvettes:






completed.


date.


excess of 37°C.

2. Liquid QC Material:








IV. Calibration:


manufacturer.


Page 216 of 250














run the test.



sealed.



displayed.




reported.



performance.




day.










2. EQC can be programmed to be performed automatically at prescribed

intervals by the instrument through the Configuration Manager or can be

performed manually by the Operator.


Page 217 of 250





"Cancel".






(5) When the test is completed, the results are displayed on the

screen and written to the QC database.






AC/DC power module.



NOTE: If the electronic QC procedure yields an on-screen ERROR

message, discontinue use of the instrument and contact the manufacturer.



a. Each lot of the Hemochron cuvettes should be validated for




b. Complete instructions and acceptable performance ranges are



a. Remove the directCHECK vials, one each Level 1 and Level 2,


prior to testing.








instrument.



Page 218 of 250


reader.



seconds to store.


tag the sample.


on package insert.


of barcode reader.




minutes.

(2) If the testing has not been started within five (5) minutes, a

"Start timeout" will occur indicating that the current cuvette

must be discarded and a new cuvette placed in the

instrument.






the table top.



glass ampule.






gauze.









t. The instrument displays the result.


Page 219 of 250





















VI. Test Procedure:



temperature.



wrapper.












b. If the testing has not been started within five (5) minutes, a

"Start timeout" will occur.


10. Immediately dispense one large drop of citrated blood into the

sample well of the test cuvette.


Page 220 of 250










sample.



displayed.

18. Record results in log.




A. Refer to Individual Assay Procedures:

1. Hemochron Signature Elite® Citrate Prothrombin Time with INR.

2. Hemochron Signature Elite® Citrate Activated Partial Thromboplastin

Time Testing.

VIII. Limitations:









2. Hemolysis


4. Unsuspected anticoagulation


(APLAs)

C. Interfering Substances:

1. Many concomitant medications can also affect results.

2. Other than the hematocrit range as outlined in "Limitations", substances

that interfere with whole blood assays but not plasma-based tests have not

been identified

References:


Page 221 of 250










Standard.









Guideline.




1982.


436.

K. ITC Operators Manual Hemochron Signature Elite, March 2007.



Diag. 18:206-209, 1989.






Cardiovasc Surg 14, 4:1135-1140, 1992.




Page 222 of 250

EVD Procedure




Horiba ABX Micros 60 Analyzer General Operating Procedure

Equipment:

I. Principle: The Horiba ABX Micros 60 Hematology Analyzer is a quantitative,

automated hematology analyzer and leukocyte differential counter for in vitro diagnostic

use in clinical laboratories.

A. CBC Analysis:

1. An Electronic Impedance Method counts the size cells by detecting and

measuring changes in electrical resistance when a particle (such as a cell)

in a conductive liquid goes through a small aperture.

2. Blood cells suspended in a conductive liquid (diluent) act as electrical

insulators.

3. The cell suspension is pulled through the aperture by a gentle vacuum.

4. A flow of electrical current is established between two submerged

electrodes, one within the aperture housing (internal electrode) and one

suspended in the cell dilution in the aperture bath (external electrode).

5. As each cell passes through the aperture, it momentarily increases the

resistance of the electrical path between the two submerged electrodes.

6. This causes an electrical pulse that can be counted and sized.

7. While the number of pulses indicates particle count, the size of the

electrical pulse is proportional to the cell volume.

8. The WBC and RBC are directly measured parameters, the MCV is derived

from the RBC histogram, and the platelet count is derived from the

platelet histogram.

9. The MCH, MCHC, HCT and RDW are computed parameters.

B. Differential Analysis:

1. WBC differential analysis is done after a lysing action is complete.

2. The instrument analyses the height of each electronic pulse as the WBC's

pass through the Micro-aperture.

3. The pulses are then channeled, thresholded, and grouped according to their

size and calculated mathematically to create the WBC distribution curve

which in turn is known as the WBC Histogram.

C. Hemoglobinometry:


Page 223 of 250

1. The lytic reagent used for the complete blood count (CBC) parameters

prepares the blood so the system can count leukocytes and measure the

amount of hemoglobin.

2. The lytic reagent rapidly and simultaneously destroys the erythrocytes and

converts a substantial proportion of the hemoglobin to a stable pigment

while it leaves leukocyte nuclei intact.

3. The absorbance of the pigment is directly proportional to the hemoglobin

concentration of the sample.

D. Hematocrit:

1. The Hematocrit is a combination measurement of electronic pulses and

mathematical calculations.

2. All the RBC pulses are grouped into various sizes.

3. Each group pulse height is then averaged.

4. All the pulse height averages are then averaged one final time for a Mean

average of all the RBC pulse heights.

5. This is a function of the numeric integration of the MCV.

6. Results are given as a percentage of this integration.

II. Specimen Requirements:

A. Whole blood collected in an EDTA anticoagulated (lavender cap) Vacutainer

tube. Horiba ABX recommends the use of dipotassium (K2) or tripotassium (K3)

salt of EDTA.

1. 1.0 mL of blood is required for the sample to be processed in the

automatic mode.

a. 10 µL of blood is aspirated in the automatic mode.

B. The specimen must be mixed immediately prior to processing on the analyzer.

C. Specimen Stability:

1. For CBC and Differential:

a. Run within 8 hours after collection if stored at 21.2 - 25.6°C (70-

78°F).

D. Specimens that are mislabeled, unlabeled, clotted, collected in the wrong tube,

grossly hemolyzed, contaminated with IV fluids, or the quantity of the sample is

not sufficient for the ordered test, must be rejected. These samples are to be

credited and the appropriate individual notified that the test cannot be performed.

III. Reagents - Special Supplies and Equipment:

A. Reagents:

1. ABX Minipack LMG (REF #0602050):

a. Reagent 1 (5L):

(1) Enzymatic solution with proteolytic action for the cleaning

of Horiba ABX blood cell counters.

b. Reagent 2 (3L):

(1) Erythrocyte lysing agent for white blood cell counting, and

differentiation and hemoglobin determination on Horiba

ABX blood cell counters.


Page 224 of 250

c. Reagent 3 (4L):

(1) Buffer isotonic solution for the determination and the

differentiation of blood cells, and the measurement of the

hematocrit on Horiba ABX blood cell counters.

2. Replacing Reagents:

a. Reagents are stored at ambient room temperature and discarded at

the expiration date.

b. Reagent pack includes the entire set of reagents in the "Pack" and

is able to receive the waste liquids.

(1) The three soft pockets contain the 3 reagents and are closed

by means of the valve connectors located at the bottom of

the pack.

(2) The fourth pocket is empty and is intended for receiving

waste liquids.

c. To change the reagent pack, remove the reagent output protections,

as well as the waste input protection.

(1) Install the pack directly into the compartment of the

instrument.

(2) Push the pack down in order to plug correctly the pack on

the male connectors.

(3) The free male connector must be plugged on the pack upper

valve in order to receive the waste liquids.

B. Supplies:

1. ABX Minoclair

2. ABX Minipack LMG

3. Minotrol 16 controls - 3 levels

4. Distilled H2O

5. Clorox bleach (for troubleshooting)

6. Gauze or tissue

7. Printer paper

C. Equipment:

1. Horiba ABX Micros 60 Analyzer

2. Power supply

3. Printer

IV. Calibration - ABX Minocal:

A. Calibration of the Micros and Minocal is performed:

1. Upon installation

2. On a semi-annual basis

3. Following the replacement of a major component or a repair effecting

calibration

4. As a result of a drift or problem with the quality control

5. Per ABX service.

B. The Micros Calibration Procedure:


Page 225 of 250

1. Auto Calibration:

a. From the Calibration Menu Select "1" "Autocalibration".

b. Select one of the (4) Operators (O.P.) which may be entered in the

"System Set-up" menu.

c. Press the "Enter" key.

d. The LCD will display a message saying "Error: No Smart Card".

e. Press the "ESC" key which will allow entry into the "Calibration"

menu to edit all the calibration information manually.

f. Press the "Enter" key to enter the new lot number of the calibrator

material.

g. Enter the new "Lot Number" of the current calibrator from the

Assay sheet that comes with the calibration material.

(1) Use the "Up" and "Down" arrow keys to enter the numbers.

(2) Press the "Enter" key to save the new lot number and move

to the next entry.

h. The next screen will indicate changing the expiration date of the

new calibrator.

(1) Press the "Enter" key and enter the new expiration date

from the Calibration Assay sheet.

(2) Use the "Period" key after the day.

(3) Press the "Enter" key to save the new expiration date.

(4) Move to the next entry.

i. The next screen will indicate changing the WBC Target Value.

(1) Press the "Enter" key and enter the new target value for the

WBC from the Calibration Assay sheet.

(2) Press the "Enter" key to save the new target value.


j. Repeat steps I (1) through (3) for the RBC, HGB, HCT, PLT, and

MPV.

k. The next screen will appear and ask if there is a change to the

number of samples to be run for the calibration a-i. Then press

"Enter".

l. The LCD will now state "RUN CAL?".

m. Press the "Enter" key to start the calibration process.

n. Once a prime cycle is done a message of "Start Calibration"

appears.

(1) Select the tube holder position for the calibrator vial and

rotate it to the 12 0'clock position.

(2) Now gently and thoroughly mix the Calibrator material as

indicated on the instruction sheet that comes with the

calibrator.

o. Place the calibrator into the tube holder and press the "Start"

key on the front panel to initiate the cycle of first sample.


Page 226 of 250

(1) The LCD display will indicate "Close the tube holder

door".

(2) When the cycle is done, the door will open so that the vial

can be removed for the next cycle.

p. Mix the material for the next calibration run.

(1) When the first sample is complete the results will display

on the screen.

(2) Press "Enter" to continue.

q. The next LCD will ask to "Accept" or "Reject" the results.

(1) Press "ESC" key to reject and start all over.

(2) Press "Enter" to accept the result and validate the results.

r. The display will then ask for the next calibration sample

until the calibration is complete.

s. Once the calibration is complete and has passed, press the

"ESC" key until the "Main" menu is displayed.

t. Run the QC for the instrument.

2. RDW Calibration:

a. The RDW calibration is a separate calibration outside the

"Autocalibration" menu.

b. The RDW will be calibrated using ABX Minotrol.

c. Run the Normal Level control 6 times, as a regular patient.

d. When the cycles are completed calculate the mean value of RDW.

e. Calculate the new calibration factor using the mean in the control

package insert.

f. Enter the new value.

g. Run QC.

V. Quality Control:

A. Quality Control for the ABX Micros 60 includes:

1. Commercial controls

2. Calibration

3. Linearity verification

B. Refer to the procedure for Quality Control Monitoring and Proficiency

Testing of Clinical Tests, 101.2.

C. Running Quality Control:

1. For Minotrol (Follow the control package insert for mixing and handling

instructions.)

2. Place the Quality Control Smart Card in the reader.

3. From the "Main" menu select "2" "QC" then "1" "Automatic" if reader is

present.

4. Confirm the OP, Lot Number, Expiration Date, and Level of Control.

5. Mix the Control level selected, place it into the tube holder and close the

tube holder door.

6. The Quality Control cycle will automatically begin.


Page 227 of 250

7. The results are compared to the ranges on the Smart Card.

a. If the results are acceptable, press the "Enter" key twice to accept

the level result.

b. If the results are not acceptable, rerun that level.

8. Continue to the next level of Minotrol until all 3 levels have been run.

9. When all 3 levels of controls have been run, the display will indicate

"Valid QC?".

a. Press the "Enter" key to store the accepted QC data onto the card.

10. If any level of control fails twice, when repeated, perform a

Concentrated Cleaning and re-run the control.

11. If controls fail again after the concentrated cleaning, call Service.

VI. Instrument to Instrument Comparisons:

A. At six month intervals, 10 specimens are run on each individual instrument that

reports a CBC and Differential.

B. The average percent and absolute difference between the instruments are

calculated for all measured parameters.

C. Acceptable limits for the comparisons are:

1. WBC = ± 0.4 or 5%

2. RBC = ± 0.2 or 2%

3. Hgb = ± 0.3 or 2%

4. PLT = ± 20 or 7%

D. Unacceptable values may indicate an instrument problem or the need for

recalibration of one of the modes.

VII. Linearity Verification:

A. Linearity limits of the Horiba ABX are performed once every 6 months.

1. Use the linearity standards for each assay.

2. The materials used for validation must be matrix appropriate material with

accurate target values that are specific for the method.

3. Follow the guidelines/instructions in the package insert for the material

used.

4. Compare the results obtained with the specific target values for the

parameters.

a. All levels are expected to be in the acceptable range given for the

standard.

b. The percent bias should not exceed the CLIA limits for that

parameter.

5. The test specimen must have analyte values which at a minimum are near

the low, midpoint, and high values of the analytic measurement range

(AMR). A minimum of five points should be used to cover the AMR.

6. Compare the results using linear regression analysis.

7. Refer to the Linearity Validation section of the Quality Assurance

Procedure, 104.1.


Page 228 of 250

8. Successful verification certifies that the calibration is still valid.

Unsuccessful verification requires remedial action. Verify calibration.

9. Technical limits: Posted on analyzer.

VIII. Procedure - Patient Samples:

A. Processing Patient Samples:

1. Automatic Mode:

a. Press the "ID" key and enter either the "Sample Identification"

using the "Number" keys or the "UP" and "DOWN" arrow keys for

alphabetical characters or "Run Number" using the number keys

only.

b. Press the "Enter" key to accept the entry.

c. Mix the sample gently and thoroughly before placing it into the

tube holder.

d. Place the sample into the tube holder and close the tube holder

door. The analysis cycle will start automatically.

e. The LED on the front panel will turn "Green" when the cycle is

complete.

f. Results will automatically print out.

g. If the sample has flags, repeat the sample.

h. If the sample still has flags, perform a Concentrated Cleaning and

Re-run the sample.

i. If the sample still has flags contact Horiba ABX Technical

Support.

IX. Result Reporting:

A. Reference Intervals:

CBC MALE FEMALE

AGE RANGE AGE RANGE

WBC x 109/L 21 4-10 21 4-10

6 4.5-13 6 4.5-13

4 5-15 4 5-15

6M 6-17 6M 6-17

0 5-10 0 5-20

RBC x 1012

/L 12 4.6-6.1 12 4.1-5.3

2 4.0-5.1 2 4.0-5.2

6M 3.7-5.3 6M 3.7-5.3

3M 3.1-4.5 3M 3.1-4.5

2M 2.7-4.9 2M 2.7-4.9

1M 3.0-5.4 1M 3.0-5.4

0 3.8-6.3 0 3.8-6.3

HGB g/dL 18 13.5-18 6 11.5-15.5

12 13-17 2 11.5-13.5


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6 11.5-15.5 6M 10.5-13.5

2 11.5-13.5 3M 9.5-13.5

6M 10.5-13.5 2M 9-14

3M 9.5-13.5 1M 10-18

2M 9-14 14D 12.5-20.5

1M 10-18 0 13.5-21.5

14D 12.5-20.5

7D 13.5-21.5

0 13.5-21.5

HCT % 18 41-53 12 36-45

12 37-49 6 35-45

6 35-45 2 34-40

2 34-40 6M 33-39

6M 33-39 2M 28-42

2M 28-42 1M 31-55

1M 31-55 14D 39-63

14D 39-63 0 42-66

0 42-66

MCV fl 18 80-96 18 80-96

6 77-96 6 77-96

2 75-87 2 75-87

6M 70-86 6M 70-86

3M 74-108 3M 74-108

2M 77-115 2M 77-115

1M 85-123 1M 85-123

14D 86-123 14D 86-123

0 88-126 0 88-126

MCH pg 18 27-33 18 27-33

12 25-32 12 25-32

6 25-31 6 25-31

2 24-30 2 24-30

6M 23-30 6M 23-30

3M 25-32 3M 25-32

2M 26-32 2M 26-32

0 28-40 0 28-40

MCHC % 2 32-36 2 32-36

6M 31-36 6M 31-36

1M 30-36 1M 30-36

0 29-36 0 29-36

PLAT x 109/L 0 150-400 0 150-400

RDW 0 11.5-14.5 0 11.5-14.5

Retic % (automated) 0.6-2.8 0.6-2.8


Page 230 of 250

Absolute Retic Automated

(K/µL

0 26-122 0 26-122

WBC Differential MALE FEMALE

AGE RANGE AGE RANGE

Neutrophil (BAND) 0 0-7 0 0-0.6

Neutrophil (NEUT) 21 33-73 10 1.8-7.0

10 28-68 6 1.5-8.0

4 21-63 2 1.5-8.5

1 16-48 6M 1.0-8.5

14D 21-63 1M 1.0-9.0

0 26-48 14D 1.0-9.5

0 1.5-10.0

Eosinophil (EOS) 0 0-5 0 0-0.45

Basophil (BASO) 0 0-2 0 0-0.2

Lymphocyte (LYMP) 16 13-52 16 1.2-4.0

10 17-56 10 1.5-6.5

6 21-60 6 1.5-7.0

4 30-70 4 2.0-8.0

6M 42-80 2 3.0-9.5

1M 37-75 1 4.0-10.5

14D 28-68 6M 4.0-13.5

0 20-62 1M 2.5-16.5

0 2.0-17.0

Monocyte (MONO) 6M 0-10 21 0-0.9

1M 0-14 6 0-0.8

0 0-18 2 0-1.0

6M 0-1.2

1M 0-1.4

14D 0-2.0

0 0-2.2

XI. References:

A. ABX Micros 60 CS/CT - User Manual, Horiba ABX, Montpellier, France,

9/2005.

B. Nathan and Oski's Hematology of Infancy and Childhood, 6th Edition. Normal

Hematologic Values in Children, p. 1841, 2003.


Page 231 of 250

EVD Procedure




Horiba ABX Micros 60 Analyzer Preventive Maintenance

I. Principle:

A. The instrument must be functional and operate within the limits specified by the

manufacturer.

B. Maintenance procedures are aimed at keeping the analytical systems operating

optimally. Periodic preventive maintenance will ensure proper instrument

function and accurate patient results.

II. Reagents - Special Supplies and Equipment:

A. Reagents:

1. ABX Minipack LMG (Ref. #0602050)

B. Supplies:

1. ABX Minoclair

2. ABX Minipack LMG

3. Minotrol 16 controls - 3 levels

4. Distilled H2O

5. bleach

6. Gauze or tissue

7. Printer paper

C. Equipment:

1. Horiba ABX Micros 60 Analyzer

III. Preventive Maintenance - Day of Use:

A. Startup and Standby Cycles:

1. At the beginning of each day of use perform a Startup Cycle.

2. Press the "Startup" key on the front of the instrument panel.

3. At the end of the day, perform a Standby Cycle.

4. Press the "Standby" key on the front of the instrument. This cycle takes

about one minute.

B. Quality Control (with QC Smart Card):

1. For Minotrol, refer to the Control Package insert for mixing and handling

instructions.

2. Place the "Quality Control Smart Card" in the reader.

3. From the Main Menu, select <2> QC, then <1> AUTOMATIC, if reader

is present.

4. Confirm the OP, Lot Number, Expiration Date, and Level of Control

5. Mix the control level selected, REMOVE CAP, place it into the tube

holder and close the tube holder door.


Page 232 of 250

6. The Quality Control Cycle will automatically begin.

7. The results are compared to the ranges on the Smart Card.

a. If the results are acceptable (NO flags), press the "Enter" key twice

to accept the level result.

b. If the results are unacceptable with flags (*,$,!,H,L), repeat the

analysis of that level.

8. Continue with the next level of MINOTROL until all 3 levels have been

run.

9. When all 3 levels of controls have been run, the display will indicate

"Valid QC?".

a. Press the "Enter" key to store the accepted QC data onto the card.

10. If any level of control fails twice, when repeated, perform a Concentrated

Cleaning and re-run the control.

11. If controls fail again after the concentrated cleaning, call the Horiba ABX

Technical Support Representative.

C. General Cleaning of the Instrument:

1. Clean the outside surface of the instrument each day of use for dried blood

deposits with 10% bleach solution.

IV. Preventive Maintenance - Weekly (when in use):

A. Concentrated Cleaning (This service function allows the operator to perform a

very strong cleaning of the WBC and RBC counting chambers and apertures.

1. From the Service Menu, use the "Down" arrow and select "4 -

Concentrated Cleaning".

2. Press the "Enter" key to access this function and follow the steps that

appear on the display indicated: "Close the tube holder door, press a key to

continue...."

3. Open the main cover door of the ABX Micros 60 as indicated: "Please

open cover door, press a key to continue..."

4. Dispense the ABX Minoclair into the RBC chamber and into the hole on

the top of the WBC chamber cover so that it goes into the chamber.

5. The display states: "Pour 3 mL of cleaner in the WBC chamber, press a

key to continue." Use a disposable pipette to perform this step

6. Then the display states: "Pour 3 mL of cleaner in the RBC chamber, press

a key to continue." Use a disposable pipette to perform this step.

7. After the solution has been added to both chambers, press any key to

continue. The cleaning cycle will begin and a cleaning time will be

displayed.

8. After this procedure is complete, perform a "Startup" cycle to verify that

the background parameters are within their limits.

9. Once the Startup Cycle has passed, QC should be performed.

V. Calibration - Every 6 months:

A. Calibration Procedure:

1. Auto Calibration:


Page 233 of 250

a. From the Calibration Menu, select "1 - Autocalibration".

b. Select one of the (4) Operators (O.P.) which may be entered in the

"System Set-up" menu.

c. Press the "Enter" key.

d. The LCD will display a message saying "Error: No Smart Card".

e. Press the "ESC" key which will allow entry into the "Calibration"

menu to edit all the calibration information manually.

f. Press the "Enter" key to enter the new lot number of the calibrator

material.

g. Enter the new "Lot Number" of the current calibrator from the

Assay Sheet that comes with the calibrator material.

(1) Use the "Up" and "Down" arrow keys to enter the numbers.

(2) Press the "Enter" key to save the new lot number and move

to the next entry.

h. The next screen will indicate changing the expiration date of the

new calibrator.

(1) Press the "Enter" key and enter the new expiration date

from the Calibration Assay Sheet.

(2) Use the "Period" key after the day.

(3) Press the "Enter" key to save the new expiration date.


i. The next screen will indicate changing the WBC Target Value.

(1) Press the "Enter" key and enter the new target value for the

WBC from the Calibration Assay Sheet.

(2) Press the "Enter" key to save the new target value.


j. Repeat steps 9a through c for the RBC, HGB, HCT, PLT, and

MPV.

k. The next screen will appear and ask if there is change to the

number of samples to be run for calibration 1-9. Then press

"Enter".

l. The LCD will now state "RUN CAL?".

m. Press the "Enter" key to start the calibration process.

n. Once a prime cycle is done a message of "Start Calibration"

appears.

(1) Select the tube holder position for the calibrator vial and

rotate it to the 12 o'clock position.

(2) Now gently and thoroughly mix the calibrator material as

indicated on the instruction sheet that comes with the

calibrator.

o. Place the calibrator into the tube holder and press the "Start" key

on the front panel to initiate the cycle of the first sample.


Page 234 of 250

(1) The LCD display will indicate "Close the tube holder

door".

(2) When the cycle is done, the door will open so that the vial

can be removed for the next cycle.

p. Mix the material for the next calibration run.

(1) When the first sample is complete the results will display

on the screen.

(2) Press "Enter" to continue.

q. The next LCD will ask to "Accept" or "Reject" the results.

(1) Press "ESC" key to reject and start all over.

(2) Press "Enter" to accept the result and validate the results.

r. The display will then ask for the next calibration sample until the

calibration is complete.

s. Once the calibration is complete and has passed, press the "ESC"

key until the Main Menu is displayed.

t. Run the QC for the instrument.

2. RDW Calibration:

a. The RDW calibration is a separate calibration outside the

"Autocalibration" menu.

b. The RDW will be calibrated using ABX Minotrol.

c. Run the Normal Level Control 6 times, as a regular patient.

d. When the cycles are completed, calculate the mean value of RDW.

e. Calculate the new calibration factor using the mean in the control

package insert.

f. Enter the new value.

g. Run QC.

B. Linearity Verification (Linearity limits of the Horiba ABX are performed once

every 6 months):

1. Use the linearity standards for each assay.

2. The materials used for validation must be matrix appropriate material with

accurate target values that are specific for the method.

3. Follow the guidelines/instructions in the package insert for the material

used.

4. Compare the results obtained with the specific target values for the

parameters.

a. All levels are expected to be in the acceptable range given for the

standard.

b. The percent bias should not exceed the CLIA limits for that

parameter.

5. The test specimen must have analyte values which at a minimum are near

the low, midpoint, and high values of the analytic measurement range

(AMR). A minimum of five points should be used to cover the AMR.

6. Compare the results using linear regression analysis.


Page 235 of 250

7. Refer to the Linearity Validation Section of the Quality Assurance

Procedure, 104.1.

8. Successful verification certifies that the calibration is still valid.

Unsuccessful verification requires remedial action. Verify calibration.

9. Technical limits are posted on the instrument.

VI. References:

A. ABX Micros 60 CS/CT - User Manual, Horiba ABX, Montpellier, France,

9/2005.

236




Horiba Training Checklist EMPLOYEE: __________________________OBSERVED BY: ______________________




COMPETENCE

DATE INITIAL

YES NO*

1 Able to identify and explain function of analyzer components.

2 Identifies and explains overview of screens.

3 Understands the Uses of Resources: Instrument Manual and Laboratory Protocol.

4 Properly performs and documents the day of use and weekly (When in use) Preventive Maintenance procedure as

detailed in the procedure manual.

5 Knows the location, storage, and handling of reagents and consumable supplies.

6 Manages reagents and consumables and knows how to replace reagent container/consumables.

7 Demonstrates the location, storage, stability, and how to perform the result Quality Control and takes corrective action

when required.

8 Understands QA/QC Procedures:

Knows how to setup new lot numbers for controls.

Demonstrates proper handling of controls.

Understands how to run control.

Reviews QC results per laboratory protocol.

9 Processes Quality Control materials and patient samples:

Knows how to run control/sample using Single-tube Presentation with barcode ID and without.

Reviews sample results for flags, codes, or messages.

10 Understands specimen and processing requirements.

11 Recognizes abnormal results and confirms, phones, and documents critical values.

12 Identifies potential hazards and safety features, reviews MSDS, and recognizes hazard symbols.

13 Acceptable performance of an unknown and/or control analysis (attach results).

14 Practices Universal Precautions and exhibits compliance with all safety protocols.


16 Review of written procedure (employee initials).

Assessment Method: V = verbal; W = written; DO = direct observation

*If unacceptable performance noted, please detail corrective action and achievement of acceptable competency.

Item #: _______________________ Date: _________________________


_____________________________________________________________________________

Employee: _______________________________________________ Date: ___________


237

EVD Procedure




Piccolo Xpress General Operating Procedure

I. Principle:

a. The piccolo xpressTM

chemistry analyzer provides quantitative in vitro determinations

of clinical chemistry analytes in lithium-heparinized whole blood, heparinized

plasma, or serum.

b. The piccolo chemistry system consists of a portable analyzer and disposable single-

use reagent discs. Each reagent disc contains all the reagents needed to perform a

panel of tests on a single sample.

c. The piccolo xpressTM

analyzer uses centrifugal and capillary forces to process

heparinized whole blood samples and distribute diluted plasma to the reaction

chambers (cuvettes) in the reagent disc. Serum and heparinized plasma samples are

processed in a similar manner. The analyzer optically measures the chemical

reactions and calculates analyte concentrations from these measurements and from

encoded calibration data contained on the barcode ring on the reagent disc.

d. Results are stored in memory, and can be printed using the built-in thermal printer or

downloaded to an external personal computer for data management.

e. The touchscreen display provides easy communication with the analyzer. The

touchscreen shows procedural instructions, indicates the status of the analyzer, and

presents any error messages.

f. The reagent disc drawer slides out from the front of the analyzer, and transports the

reagent disc into the analyzer and automatically positions it for analysis.

g. The analyzer prints results on adhesive-backed thermal paper tape, through its

internal printer.

II. Specimen:

A. The piccolo xpressTM

chemistry analyzer accepts lithium-heparinized

whole blood, plasma, or serum samples.

1. Lithium heparin is the only anticoagulant recommended for use with the

piccolo xpressTM

.

2. Sample size: 90-120 µL

NOTE: When collecting the sample in lithium heparin collection tubes, fill the

tube at least half-way so the anticoagulant does not become too concentrated in

the sample.

B. Sample Storage:

1. Whole blood must be analyzed within 60 minutes of collection, or

separated into plasma or serum.


Page 238 of 250

2. To prevent hemolysis, do not refrigerate or shake whole blood.

3. If not analyzed immediately, plasma or serum can be stored at room

temperature for no longer than 5 hours after centrifugation.

4. If storage for more than 5 hours is required, refrigerate the sample in the

stoppered tube at 2-8°C (36-46°F) for no longer than 48 hours, or store it

at -10°C for up to 5 weeks in a freezer with no self-defrost cycle. Under

these conditions, there will be no clinically important changes in most

analyte concentrations.

C. WARNING: Operator health and safety regulations require Universal

Precautions be observed at all time while handling human blood samples or

working with the piccolo xpressTM

chemistry analyzer in any way.

III. Equipment - Special Supplies and Reagents:

A. Reagent Discs:

1. Disc Structure and Function:

a. In the piccolo® system, all chemistry reactions are performed

inside clear plastic reagent discs, 8 cm in diameter and 2 cm thick,

specially designed to perform all the steps required to convert a

few drops of whole blood, plasma, or serum into a panel of test

results.

b. Each disc contains all the components and reagents needed to

perform one or more tests on a single sample.

c. A total of 30 cuvettes are located around the periphery:

(1) Four system cuvettes contain QC reagent beads for

instrument and chemistry quality control.

(2) A minimum and maximum absorbance cuvette are used to

calibrate the spectrophotometer.

(3) A specially designed cuvette detects whether sample

volume was sufficient.

(4) A cuvette verifies that sufficient diluted sample was

delivered to the reaction cuvettes.

(5) An empty cuvette captures excess fluids.

(6) 21 cuvettes contain test-specific lyophilized reagent beads.

(a) The Bar Code Ring:


Page 239 of 250

i. That is attached to the top of the reagent disc

contains calibration data for the specific

chemistries in the disc.

ii. It also contains the disc identification code,

lot number, and expiration date.

iii. The analyzer automatically checks the code

and rejects any expired disc.

iv. The bar code ring also protects the optical

surfaces of the cuvette from fingerprints and

debris, and helps minimize contamination of

the analyzer by capturing small drops of

blood that may be on the disc surface.

(b) The Sample Port:

i. Is marked by an arrow pointing to a molded

circle on the disc's upper surface, and

provides access to the sample chamber.

ii. When sufficient sample has been loaded into

the sample chamber, the sample fill line

forms between two molded arrows on the

disc surface.

(c) Sample Diluent:

i. Is sealed in a container inside the center of

the disc.

ii. At the beginning of the reaction cycle, the

analyzer opens this container and releases

the diluent.

(d) Mixing Chamber:

i. The analyzer separates a lithium-heparinized

whole blood sample by centrifugation inside

the disc.

ii. Plasma and serum samples are unaffected.

iii. Precisely measured quantities of sample and

diluent are delivered to the mixing chamber.

iv. Centrifugal and capillary forces then deliver

the diluted sample to the cuvettes, where it

dissolves the reagent beads and initiates the

chemical reactions.

v. Reaction products in the cuvettes are then

measured photometrically.

2. Disc Storage and Handling:

CAUTION: Discs are fragile. Always handle with care. Do not tap discs

on the table or work bench to empty the sample port. Do not use a disc


Page 240 of 250

that has been dropped. Inspect every reagent disc for damage before use.

Never use a damaged disc.

a. Store each reagent disc as described on its label.

(1) This keeps the disc's reagents stable until the expiration

date printed on the disc's foil pouch and encoded in its bar

code ring.

(2) The analyzer automatically rejects any expired disc.

b. Discs can be used directly from the refrigerator (stored at 2-8°C)

without warming.

c. A disc can remain in its sealed pouch at room temperature for a

cumulative period of 48 hours. Longer time at room temperature

can cause suppression of chemistries and disc cancellations.

d. Do not expose discs, in or out of their foil pouches, to direct

sunlight or to temperatures above 32°C (90°F).

e. Inspect the unopened foil pouch for tears and punctures. A torn or

damaged pouch can allow moisture to reach the disc and reduce

reagent performance.

f. Open the disc pouch at the notch on the top right edge of the

package.

NOTE: The disc must be used within 20 minutes of opening its

pouch.

g. Once the pouch is opened, do not place the disc back in the

refrigerator for later use.

h. Keep discs clean.

(1) Handle them only by their edges to avoid smudges on the

optical surfaces.

(2) Use a lint-free tissue to remove any spilled blood from disc

surfaces.

i. Hold reagent discs flat after introducing the sample or control to

avoid spillage.

WARNING: BIOHAZARD: Used reagent discs contain body

fluids. Follow good laboratory working practices and universal

precautions.

B. Supplies:

1. Powder-free gloves

2. Micropipette

3. Kimwipes

4. 100 µL MLA pipette

5. MLA tips

C. Equipment:

1. piccolo® xpressTM

IV. Procedure:


Page 241 of 250

A. Analyzer Operation (The analyzer has a touchscreen display to operate the

analyzer.):

1. Use the ten numbers on the touchscreen to input patient information.

2. The left and right arrow touchscreen keys move the display cursor

forward or backward to change a number on the display.

a. The right arrow key functions as a dash(-) when entering a patient

identification number.

b. The left arrow key functions as a backspace.

3. Use the up and down arrow keys to scroll through a displayed list

of items, or to increase or decrease a displayed value.

4. Operating functions are available through various icons on the

touchscreen, as well as specific keys that appear on the touchscreen

according to the actions performed.

5. Press "Back" on the touchscreen to cancel a choice and return to the

previous screen, or to move backward through a series of screens.

6. Turn the analyzer's power on and off by pressing the power button on the

front of the instrument. (This button can only turn the power off if the

drawer is closed and there is no disc in the analyzer.)

7. The drawer opens or closes by pressing "Analyze" or "Close" on the

touchscreen. Closing a drawer containing a reagent disc initiates an

analysis.

8. Results for previously analyzed samples can be accessed using the

"Recall" function.

9. Information Icons:


Page 242 of 250

a. A number of the piccolo xpressTM

touchscreen displays include an

information icon that gives additional information about the

procedure being performed.

b. For example, in the screen that appears when a disc is loaded, press

the "Information" icon to view a screen outlining the basic analysis

procedure.

c. Press "Next" or "Back" to move through the information screens,

and "Exit" to close them.

B. Preparing the Reagent Disc:

NOTE: Analysis must begin immediately (no more than 10 minutes) after

dispensing the sample into the reagent disc.

CAUTION: Discs are fragile, always handle with care. Do not tap discs on the

table or work bench to empty the sample port. Do not use a disc that has been

dropped. Inspect every reagent disc for damage before use. Never use a damaged

disc.

1. Dispense the Sample:

a. Use a 100 µL MLA pipette and tip to dispense approximately 100

µL of sample into the disc via the sample chamber.

b. CAUTION: Wear powder-free gloves while handling reagent discs

or operating the analyzer. Powder can disrupt the analyzer's

optical component.

c. Fill the Sample Chamber:

(1) Place the pipette tip into the disc's sample chamber, and tilt

the disc to 45° with the sample port above the fill line, so


Page 243 of 250

that the entire sample flows into the sample chamber. The

tip should touch the sample chamber, as shown below.

(2) Dispense the sample from the tip with a slow, continuous

motion.

(a) Take care not to overfill the sample chamber.

(b) A 90 µL sample will fill the sample chamber and

form a line between the two arrows molded on the

disc.

(c) More than 120 µL of sample will overfill the

chamber.

(3) Discard the pipette tip into a biohazard container.

(4) Clean the reagent disc.

(a) Use a Kimwipe to remove any sample spilled on the

outside of the disc, taking care that the tissue does

not withdraw any sample from the sample port.

(b) Dispose of the tissue in a biohazard container.

CAUTION: Do not remove the sample and try to

reintroduce it into the disc.


Page 244 of 250

d. Place the prepared disc in the analyzer.

(1) Hold the disc by its edges in a flat position.

V. Calibration:

A. The piccolo xpressTM chemistry analyze is self-calibrating.

1. The bar code on the reagent disc contains the required information to

perform its calibration whenever a reagent disc is run.

2. Each reagent bead used in the disc is calibrated to a reference method

and/or reference material.

3. If the recommended procedures in the procedure manual are followed, the

analyte concentrations produced by the analyzer will be accurate.

VI. Quality Control Features:

A. Internal Quality Control Checks:

1. The piccolo xpressTM

includes quality control features such as optical

sensing and electronic feedback systems, to ensure that accurate results are

reported.

a. The analyzer performs tests on both internal components and the

reagent discs whenever the power is turned on and/or a reagent

disc is inserted.

b. Additionally, the analyzer continues to perform tests during

analysis.

c. Messages on the display or on the result printout warn of analyzer

malfunctions and possible errors or explain why no results are

reported.

2. Intelligent Quality Control (iQC):

a. The piccolo xpressTM

hardware performs an iQC test whenever

power is turned ON.

b. iQC ensures that all optics, flash, and circuit board components are

functioning properly and verifies the memory functions.

c. The analyzer performs this analysis only when the iQC confirms

that all components are functional.

d. A hardware malfunction message appears on the display if any

component malfunctions.

e. Statistical methods are incorporated into the analyzer software to

ensure the accuracy of the results.

f. The lamp flashes up to 13 time points for rate chemistries and

typically three time points for endpoint chemistries.

g. The distribution of flashes at each time point is analyzed and the

standard deviation is compared to a pre-determined limit to ensure

the analyzer is functioning properly.

3. Quality Control During Analysis:

a. During an analysis, the analyzer's internal components and the

reagent disc are checked to ensure the accuracy of the results.


Page 245 of 250

(1) piccolo xpressTM

Analyzer:

(a) The analyzer's photometer takes readings with the

light path obstructed and unobstructed to determine

the appropriate light intensity range, and then

checks that the range is within specification, before

analysis begins.

(b) It also continually checks the performance of the

motor, flash, and optics during analysis as well.

(2) Reagent Disc:

(a) The analyzer performs several tests on the reagent

disc during the analysis.

(b) These checks confirm:

i. Calibration factors

ii. Expiration date

iii. All reagent beads are present

iv. Timing of fluid movement through the disc

v. Diluent and sample mixing

vi. Sufficient sample has been applied to the

disc

vii. Reagent beads dissolve when mixed with

diluted sample

(c) Each reagent disc contains reagents to detect

exposure to extreme conditions such as temperature

and humidity.

i. The message "QC OK" is printed on the

result printout when results from these

reagents are within the expected ranges.

ii. Otherwise, no results are printed, and a "run

canceled" message is shown on the display.

(d) The analyzer monitors the performance of the

reactions.

i. For rate chemistries, the analyzer confirms

that the reactions are linear with time, that

the slope is within range, and whether the

substrate has been depleted.

ii. In endpoint chemistries, the analyzer verifies

the flatness (completeness) of the endpoints.

(3) Sample:

(a) Samples are checked for physical interference.

(b) The analyzer estimates the sample indices,

hemolysis, lipemia, and icterus using absorbance

readings for the sample at 340 nm, 405 nm, and 467

nm.


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(c) This information is then compared to the pre-

established limits for hemolysis, lipemia, and

icterus for each method.

(d) When all three indices are below these limits for the

method, the result for that method is printed on the

result card.

(e) When even one index exceeds the limit, the result

for the method is suppressed and the error condition

displayed as HEM, LIP, or ICT.

B. External Quality Control:

1. Refer to Quality Control and Proficiency Testing procedure 101.2.

a. The composition of the matrix must be such that the solution

closely matches that of the biological specimen for characteristics

of importance to the analyzer.

b. Control materials need to be stable and available in sufficient

volumes in multiple portions and over an extended period.

c. Assayed controls come with expected values of the analytes.

2. Handle the control as described in the control package insert. Call Abaxis

Technical Support for assistance in interpreting control results.

NOTE: Before a control can be run, a control level must be enabled in the

reference ranges.

3. Abaxis recommends control testing as follows:

a. at least every 30 days

b. whenever laboratory conditions have changed significantly

c. when training or retaining of personnel indicate

d. when test results do not match patient symptoms or clinical

findings

e. with each new lot (CLIA waived tests in waived status labs)

4. Samples and controls are run identically by the analyzer.

a. However, using the "Run Controls" option in the "Menu" function

stores control results separately from patient results in the analyzer

memory.

(1) The Recall function can be used to search for specific

control results without searching through all patient results

stored in memory.

b. Control results can be printed on a result card immediately after

the conclusion of the control run, or whenever the control run

results are

5. Controls can be run whenever the analyzer displays the Home Screen.

VII. Procedure:

A. Running Patient Samples:

1. Turn on the analyzer by pressing the "Power" button on the front of the

analyzer. Do this before removing reagent discs from the refrigerator.


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a. The analyzer starts up, then performs a self test.

b. If the analyzer needs time to warm the disc chamber to operating

temperature, the display shows "Warming Up".

c. When the analyzer reaches operating temperature, it displays

"Analyze" on the Home screen.

2. Press "Analyze" on the touchscreen to open the disc drawer.

a. The following messages are then displayed:


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3. After inoculating the sample disc place the disc in the recessed area in the

drawer.

4. Press "Close" on the touchscreen. The analyzer then closes the drawer.

5. Select the sample type from those shown in the display.

a. The figure below shows the default selections: "Patient" and

"Control".

NOTE: The correct sample type is necessary for results to be

interpreted correctly.


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6. Enter the patient MR number for the sample (up to 14 characters), then

press "Done".

7. The analyzer then checks the disc type, and begins processing the sample.

NOTE: If the disc is found to be of an incorrect type or expired, an error

message appears. Repeat the analysis with another disc of the correct

type.

8. When the sample is finished processing, the analyzer stores the results and

displays that the analysis is complete.


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9. By default, the analyzer automatically prints the results of the analysis.

a. If the results do not print automatically, they can be recalled from

memory and printed.

NOTE: Be sure to review the results printout for any suppressed

results, which are marked with these symbols: "~~~"

10. Press "Open" to open the disc drawer.

11. Remove the reagent disc from the drawer.

CAUTION: Dispose of the disc according to the lab's standard procedures

for human patient samples.

12. To analyze another sample, insert the new reagent disc and repeat the

above procedure.

13. When finished, press "Close" to close the drawer and return the analyzer

to standby mode.


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B. Canceling Analysis (Occasionally there may be a need to cancel an analysis in

progress):

1. Press "Cancel" on the touchscreen. The display asks for confirmation.

2. Press "Cancel" again to confirm. The analysis is then canceled.

a. The disc drawer then opens.


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3. Remove the disc from the drawer.

a. The analyzer is now ready to perform another analysis.

b. Press "Close" to close the drawer.

VIII. Reporting Results:

A. The results calculated by the analyzer are stored in memory and printed

automatically, and can also be recalled and printed later as needed.

B. The heading of the results printout includes information such as the reagent disc

type, test date and time, sample type, sample ID number, alternate ID number,

gender, age, operator ID number, disc lot number, and analyzer serial number.

The tests results section of the card is printed in four columns:

1. Chemistry Name

2. Analyte Concentration

3. Reference Range

4. Specified Units


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C. Each reagent disc contains reagents to detect exposure to extreme conditions such

as temperature and humidity. The Message "QC OK" is printed on the results

when results from these reagents are within the expected ranges. Otherwise, no

results are printed, and the analyzer opens the disc drawer.

1. Results outside the reference range are indicated in the results by an

asterisk (*) printed next to the analyte concentration.

2. Results outside the dynamic range are indicted in the results by a "less

than" symbol (<) printed next to the lowest value of the dynamic range, or

a "greater than" symbol (>) printed next to the highest value of the

dynamic range.

a. For example, the dynamic range of glucose is 10-700 mg/dL.

(1) A sample concentration of glucose below this range would be

printed as <10 mg/dL, and a concentration above this range would

be printed as >700 mg/dL.

(2) Results outside the dynamic range should be reported as being

below or above the value indicated.

3. The symbols "~~~" are printed in place of numbers when a result cannot

be determined - that is the result is suppressed.

a. A result may be suppressed:

(1) Due to improper mixing of a reagent bead with diluted

sample.


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(2) A nonlinear reaction, an endpoint of a particular reaction

not reached.

(3) A concentration outside the analyzer's capabilities.

b. When a chemistry is suppressed (~~~), the analyzer prompts the

operator to print an error report.

4. For the Lactate Dehydrogenase (LD) Assay Only:

a. Blood cells contain significant levels of LD, and therefore all LD

assays are sensitive to hemolysis caused by release of LD from red

blood cells.

b. In the following circumstances, the results are annotated to help

interpret LD activity in the presence of small amounts of

hemolysis.

(1) If HEM is greater than 50 and less than or equal to 100

mg/dL, the printed LD value is followed by an "H"

indicating additional influence from hemolysis.

(2) If HEM is greater than 100 and less than or equal to 150

mg/dL, the LD value is preceded by "<" and followed by

"H", indicating that the true LD recovery is less than

reported.

(3) If HEM is greater than 150, no result will be indicated and

only "HEM" will be printed.

5. HEM, LIP, or ICT is printed in place of the

analyte concentration if hemolysis, lipemia, or icterus,

respectively, has adversely affected the results.

a. HEM is also printed if hemolysis and icterus, hemolysis and

lipemia, or hemolysis, lipemia, and icterus have affected a

particular analyte.

b. Examine the sample indices to determine if more than one

interferent is affecting a particular result.

6. The sample indices are included at the bottom of the results printout.

a. These indices indicate the degree of hemolysis, icterus, and

lipemia found in the sample.

b. Hemolysis, icterus, and lipemia are measured on a scale of 0

(clear), 1+ (slight), 2+ (Moderate), and 3+ (gross).

D. If the sample is identified as hemolytic, a new sample can be collected and

another reagent disc run.

E. High Lipemia may be due to diet.

1. Ensure the patient has fasted for at least 12 hours before collecting another

sample.

IX. References:

Piccolo® xpressTM

Chemistry Analyzer, ABAXIS, 3240 Whipple Road, Union City, CA.

2007.


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EVD Procedure




Piccolo Xpress Preventive Maintenance

I. Principle:

The piccolo xpressTM

chemistry analyzer requires minimal maintenance. Regular

maintenance of the analyzer will assure reliable operation.

CAUTION: Abaxis recommends only the cleaning methods described in this procedure.

If for some reason another method is needed, contact Abaxis Technical Support

beforehand at 800-822-2947 to verify that the proposed method will not damage the

analyzer. Abaxis is not responsible for damage caused by non-recommended cleaning

methods.

II. Reagents - Supplies and Equipment:

A. Supplies:

1. Gauze

2. bleach

B. Equipment:

1. piccolo xpressTM

Chemistry Analyzer:

a. Check that the electrical outlet utilized for the analyzer is

grounded.

b. Check that the ambient temperature where the analyzer is located

is 15-32°C (59-90°F).

c. Do not disconnect the power to the analyzer while running a

sample.

d. Keep the analyzer drawer closed when not in use.

e. Do not attempt to repair the analyzer. This may void the warranty.

Refer to Troubleshooting Section of package insert for regular

maintenance.

III. Maintenance Procedure:

A. After every use:

1. Cleaning the Case:

a. Clean the analyzer with a gauze, dampened with a 10% bleach

solution.

b. Do not spray or pour any detergents, solutions or other liquids

directly onto the analyzer.

c. Always dampen the gauze, then apply to the analyzer.

2. Cleaning the Display:


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a. Clean the analyzer screen with a gauze dampened with 10%

bleach.

CAUTION: Do not use any cleaner containing alcohol. Do not

spray cleaner directly onto the display. Dampen the cloth instead.

3. Cleaning Spills:

a. Observe universal precautions when cleaning spills on the

analyzer.

b. Use bleach to clean spills, following the standard cleaning

guidelines.

B. Bi-Annually:

1. Cleaning the Air Filter (The air filter in the back of the analyzer should be

cleaned at least twice per year. Check the air filter more often than twice

per year if the analyzer is located in an environment with excessive dust or

dirt.):

a. Unplug the analyzer and remove the power cord from the back of

the analyzer.

b. Grasp the black mesh filter in the circular opening and remove it.

c. Wash the filter in warm soapy water and dry completely.

d. Place the clean, dry filter flat in the circular opening and push the

sides of the filter behind the edges of the circular opening.

e. Plug the power cord into the back of the analyzer.

f. Plug the power cord into the power source, and press the "Power"

button on the front of the analyzer.

(1) The analyzer will perform a diagnostic self test.

(2) It may take up to another four minutes for the heaters to

bring the analyzer disc chamber to operating temperature.

g. If the analyzer does not successfully pass the self test see "Run

Samples" in 107.3.1.

2. Updating the Analyzer Software: Refer to the Operators Manual, S 9.4.

3. Instrument Comparison:

a. Between instrument comparisons are performed every six months.

b. A combination of patient samples, controls, and calibrators can be

sued for each assay.

(1) The samples should include a low, normal, and high value

for each analyte to be compared. A total of five points

should be used to cover the technical range.

c. Run the samples on the Piccolo and with the main chemistry

analyzer.

d. Compare the two instruments using linear regression analysis.

Refer to the Method/Instrument Correlation Procedure, 104.6.

IV. References:

Piccolo® xpressTM

Chemistry Analyzer, ABAXIS, 3240 Whipple Road, Union City, CA.

2007.


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Instrument: Piccolo® xpressTM

Location:_______ Serial #: ______________ Date: _____________________

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

WEEKLY:

Clean the

Case

Clean the

Display

Clean

Spills

TECH

INITIALS


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Pathology-Core Laboratory

Number: 107.3.2

Page: 5 of 5

2/2/15 SG

Location: ____________ Year: _________________

MAINTENANCE LOG FOR ADVANCED Piccolo® xpressTM

OPERATI

ON

JA

N FE

B

MA

R AP

R

MA

Y

JUN

E

JUL

Y

AU

G

SEP

T

OC

T

NO

V

DE

C

BI-ANNUAL

Clean Air

Filter

Update

Analyzer

Software

Instrument

Compariso

n

TECH

INITIALS


259

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EVD Procedure




Piccolo Training Checklist

EMPLOYEE: __________________________OBSERVED BY: ______________________




COMPETENCE

DATE

INITIAL

YES NO*

1 Able to name and locate all components on the Piccolo

xpress: display panel, keypad, reagent disc, and printer.

2 Properly performs and documents the daily Preventive

Maintenance procedures as detailed in the Procedure

Manual.

3 Understands the location, storage, and stability of reagent

disc and liquid control materials.

4 Demonstrates knowledge on how to perform and record

Quality Control Protocol.

5 Understands Specimen and Processing Requirements.

6 Understands Loading Requirements.

7 Understands test results and familiar with Data Entry

Procedure.

8 Acceptable performance of an unknown and/or control

analysis (attach results).

9 Practices Universal Precautions and exhibits compliance

with all safety protocols.


11 Review of written procedure (employee initials).

Assessment Method: V = verbal; W = written; DO = direct observation

*If unacceptable performance noted, please detail corrective action and achievement of acceptable

competency.

Item #: _______________________ Date: _________________________


Employee: _______________________________________________ Date: ___________



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EVD Procedure




Upstate Outpatient & Ambulatory EVD Guidance:

Quick Reference, Ambulatory/Outpatient Rn Mgr. Checklist

a) Identify if patient is possible case (A suspected case is considered a confirmed case until

proven otherwise)

i) In the past 21 days has the patient been outside the United States?

ii) Has the patient been near other people who have been diagnosed with Ebola?

iii) Does the patient have the symptoms of Ebola?

(1) Temperature: Greater than 38.6 C or 101.6 F

(2) Severe Headache, Muscle Pain, Weakness, Diarrhea, Vomiting, Abdominal pain

Unexplained hemorrhage (bleeding or bruising)

b) IF QUESTIONS (#1 and #3 ) OR questions (#2 and #3) are answered positive please

contact supervisor and follow main EVD Guidance on ipage. (Utilize language line (464-

1454), on the speaker phone, if non-English speaking patient.)

i) Isolate: If positive for questions (#1 and #3 ) OR questions (#2 and #3) Isolate

Patient:

ii) Employee/clerk should don a blue procedural mask (Lawson #72043).

iii) Employee/clerk has patient don a procedural mask immediately

iv) Employee/clerk immediately notify Charge Nurse/Nurse Manager/Provider

v) Charge Nurse/Nurse Manager dons surgical mask and double gloves and reasks Ebola

Screening Questions

c) IF QUESTIONS (#1 and #3 ) OR questions (#2 and #3) are answered positive place

patient in designated isolation exam room with bed pan (or commode or urinal) and

telephone

d) In accordance with CDC Guidelines for Ambulatory areas there should be NO patient

contact after patient is placed in the designated isolation exam room.

i) Charge Nurse and/or Nurse Manager should place Ambulatory Services Stop sign

(F8890) outside exam room where patient is isolated

ii) A staff member will be assigned to sit outside the room where the patient is isolated.

Responsibilities:


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iii) The designated staff member assigned outside of the isolation exam room will be

responsible for maintaining Ambulatory or Outpatient EVD Suspected/Confirmed

Exposure Isolation Room Log, of all person(s) who enter the room where the patient

is isolated. Every effort should be made to NOT ALLOW ANYONE to enter the

room.

iv) Anyone who enters the designated isolation patient room MUST stay in the room

with the patient. If necessary Upstate University Police may be called for assistance

(464-4000).

e) Charge Nurse and/or Nurse Manager will contact/inform the following people, in the

order specified, and specific to the campus or site of the program:

i) For the Downtown and private clinics:

(1) Contact Dr. Waleed Javaid (pager: 467-4529 or cell: 447-3222)

(2) If Dr. Javaid is not available, contact Dr. Mitchell Brodey (cell: 382-3740).

(3) If not available, the Hospital Operator should be called and request the Infectious

Disease Consult Attending be contacted.

(4) The hospital Administrative Supervisor should be called at 464-1400 to institute

Incident Command.

ii) For the Community campus:

(1) Contact Dr. Mitchell Brody (cell: 382-3740).

(2) If Dr. Brody not available, contact Dr. Waleed Javaid (pager: 467-4529 or cell:

447-3222)

(3) If not available call the hospital operator to contact the Infectious Disease Consult

Attending.

(4) Call the Administrative supervisor to institute incident command office (492-

5480) pager (441-0108)

f) Infectious Disease physician will provide further direction.

i) If patient needs ADMISSION, Drs. Waleed Javaid, Mitchell Brody or Infectious

Disease Consult Attending will instruct the Charge Nurse and/or Nurse Manager to

contact the local health department (LHD, contact telephone numbers below), the

Administrative Supervisor (DT 464-1400 or CC 441-0108 ) and EMS (911) to

arrange patient transport.

ii) If the patient requires Quarantine: Once confirmation has been made related to

monitoring and/or quarantine, (Dr. Waleed Javaid, Dr. Mitchell Brody or the

Infectious Disease Consult Attending) will instruct the Charge Nurse and/or Nurse

Manager to contact the Local Health Department regarding the patient. Please

indicate when contacting the local health department that you are reporting a

“suspected case for monitoring and quarantine.”

g) If Plan is for Transport and Hospital Admission:

i) Infectious Disease physician will instruct the Charge Nurse and/or Nurse Manager to

call for transport (call 911).

ii) Please indicate when calling Department of Health and 911/EMS that there is a

“suspected Ebola patient that requires transport.”


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h) Notification – Contact Numbers – Local Health Department

i) Onondaga County Health Department (OCHD)

ii) Business Hours: 315-435-3252

iii) Evening Hours: 315-435-3236

i) (If unable to reach OCHD) NYS Bureau of Communicable Disease Control

i) Business Hours: 518-473-4439

ii) Evenings, weekends, holidays: 1-866-881-2809

iii) Follow and implement any additional recommendations

j) Presence and Disposition of Visitors and/or family:

i) If patient is a minor child, parent must stay with child.

ii) If spouse, partner or significant other is present with patient and asymptomatic, they

may be allowed to stay in the waiting room.

iii) If spouse, partner or significant other is present with patient and SYMPTOMATIC,

they should be masked and isolated in the same room with the patient.

Ambulatory or Outpatient Nurse Manager EVD Incident Checklist

Date

Completed

Task Notes

Registration/Reception

Employee/clerk dials language line for non-

English speaking patient, using speaker phone.

Employee/clerk asks patient ALL 3 questions

noted in the EVD Quick Reference Guide, in the

order noted. Patient replies to all questions. If

the answers create a high degree of suspicion do

the following.

Employee/clerk should don a mask.

Employee/clerk advises patient to don a mask.

Employee/clerk should contact Nursing

designee IMMEDIATELY to assess patient for

isolation.

Nursing designee must don a mask and double

glove and go to the registration/reception desk.

Nursing designee must re-ask the patient the

questions in Step 1 prior to leaving the

registration/reception desk. If non-English

speaking patient, please use language line and

speaker phone at the registration/reception desk.

If response to the prescribed EVD questions are

verified as a YES, the nursing designee must


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Date

Completed

Task Notes

place the patient in the designated isolated exam

room.

Patient Placement

Nursing designee should place Ambulatory

Services STOP sign (F8890) on exam room

door where patient is isolated.

Nursing designee will be assigned to be the

patient’s primary nurse.

Nursing designee will be assigned to sit outside

the room where the patient is isolated.

Nursing designee will be responsible for

maintaining a log, EVD Suspected/Confirmed

Exposure Contact Log (see ipage) , of all

person(s) who may have had accidental contact

with the patient or come within three feet of the

patient.

Notification:

If the answers create a high degree of

suspicion

Employee/clerk should contact area Supervising

Nurse as directed by nurse designee.

Supervising Nurse will call their onsite Consult

Provider and review and confirm responses to

the same three (3) questions in Step 1: EVD

Quick Reference Guide. They should go over

the questions asked with the employee/clerk and

nursing designee to make sure the questions

were appropriately asked and answered (i.e., not

just travel, but travel to at risk countries, etc.).

Once confirmation has been made by the

Consult Provider and Supervising Nurse

regarding the isolated patient, following

contacts will be made, dependent upon site:

For DOWNTOWN AND PRIVATE CLINICS,

Dr. Waleed Javaid (pager: 467-4529 or cell:

447-3222) should be contacted first. If he is not

available, Dr. Mitchell Brodey (cell: 382-3740)

should be contacted. If he is not available, the

Hospital Operator should be called and

Supervising Nurse should request the Infectious


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Date

Completed

Task Notes

Disease Consult Attending be contacted.

For COMMUNITY CAMPUS, Dr. Mitchell

Brodey (cell: 382-3740) should be contacted

first. If he is not available, Dr. Waleed Javaid

(pager: 467-4529 or cell: 447-3222) should be

contacted. If he is not available, the Hospital

Operator should be called and Supervising

Nurse should request the Infectious Disease

Consult Attending be contacted.

Infectious Disease physician (Dr. Waleed

Javaid, Dr. Mitchell Brodey or the Infectious

Disease Consult Attending) will instruct the

Supervising Nurse to contact the local health

department (LHD) and EMS, based on the

situation.

Contain and Isolate

A restricted entry sign (Ambulatory Services

STOP sign) indicating that a suspected Ebola

patient is isolated will be placed on the door of

the room in which a suspected Ebola patient is

located.

Nurse will be posted at the door to the patient’s

room to ensure the patient does not leave the

room. Under no circumstances should nurse

stop, impede or prohibit someone who is

determined to leave. Maintain a space with

suspected patient to ensure no physical contact.

Plan for Transport and Admission

Infectious Disease physician will instruct the

Supervising Nurse to call for transport and

notify the local and state health dept.


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Appendix A: EVD Decontamination Zone Room Diagrams


266

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267

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4th floor direct admission entrance for EVD


268

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POC Lab on 8M


CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.

Appendix B: Level 1 PPE: PAPR Initial Training Curriculum

1) Purpose

a) Upstate University Hospital establishes uniform procedures, in accordance with the Occupational

Safety and Health Administration (OSHA) Standards, 29 CFR Part 1910.134, Respiratory

Protection, for the appropriate selection, use, and care of respiratory protective equipment for

employees.

2) Employee’s use of PAPR for Ebola requires participation in the Upstate Respiratory Protection

Program. Employee clearance for the use of PAPR’s requires:

a) Completion of the Medical Evaluation Questionnaire for Respirator Use: Initial Clearance,

administered by Employee Health.

b) Completion of respiratory protection training.

c) At least specific Annual re-fresher training.

d) Training Objectives

e) Upon completion of training, employees shall be able to demonstrate a working knowledge of the

potential respiratory hazards and respirator requirements for their work areas. Employees shall

demonstrate proficiency in the proper use, inspection, maintenance, and storage of a respirator.

Employees shall understand the respirator’s limitations and capabilities, as well as any physical or

medical conditions that may limit or prevent the effective use of a respirator.

f) Respirator users will be trained in basic respirator practices by personal instruction as outlined in

Powered Air-Purifying Respirator Training Outline. Examinations shall be administered at the

end of each training session. Employees are expected to correctly answer eighty percent (100%)

of the questions correctly, and all missed questions are reviewed with the employee. A copy of

the exam shall be kept with the employee’s records. Training shall be conducted for employees

covered under the Respiratory Protection Program on an annual basis.

3) POWERED AIR-PURIFYING RESPIRATOR TRAINING OUTLINE

a) Purpose and Objectives i) This training outline will demonstrate the uses, capabilities, limitations, care, and

maintenance for powered air-purifying respirators used at Upstate (Sentinel XL HP )

ii) Upon completion of instruction, employees will be able to:

(1) Define the working principle of a PAPR and its components.

(2) Describe the operational limitations of PAPRs.

(3) Use, remove, and replace filters and battery packs.

(4) Conduct a pre and post operational inspections.

(5) Show proficiency with system assembly and PAPR donning.

b) Introduction i) Ambient air is drawn thru the belt-mounted filters/cartridges and passes through the breathing

tube connected to the hood or helmet. The filtered air passes over the user’s face and

maintains a positive pressure inside the hood/helmet at all times. The Sentinel XL HP is

designed to work with two external HEPA filter which only protects the user from dusts,

fumes, and mists. It has an internal battery that can be recharged

c) Operational Limitations i) Not for use in atmospheres that are Immediately Dangerous to Life or Health (IDLH).

ii) Not for use where oxygen concentrations are below 19.5% or above 21.5%.

iii) Not for use in working atmospheres that contain toxic gases or vapors when fitted with HEPA

filters.

iv) Never open the motor/blower unit of the PAPR.

d) PAPR System i) System equipped with:



(1) Hood

(2) Breathing Tube

(3) HEPA filters

(4) Motor/Blower

(5) Belt

(6) Replacement parts demonstration

ii) Remove and insert the battery.

(1) Replace the HEPA filters ensure that a filter gasket is located in each recess.

(2) Check hose for gaskets

(3) Snap the back cover into place.

e) Pre-Operational Inspection i) Prior to the beginning of each work shift, an inspection of the PAPR should include:

(1) Inspection of breathing tube, connections, and body.

(2) Inspection of filter(s)/cartridge(s) to make sure they are/it is correctly installed and the

battery is fully charged.

ii) Air flow

(1) Remove the air tube and insert the air flow indicator into the blower opening.

(2) Turn the blower on.

(3) The plastic cone should rise above the minimum flow mark.

(4) If the indicator fails to rise to this level, check the breathing tube, battery, and make sure

the caps are removed from the filters/cartridges.

f) System Assembly and Donning

i) Assemble in non-contaminated environment.

ii) Check that the breathing hose thread has the black rubber gasket seal present

iii) Check that the thread in the blower unit is in good condition and clear of foreign matter

iv) Screw the end of the breathing hose into the blower unit until it is hand tight Do not over

tighten!

v) To connect the tube to the head piece, screw the end of the breathing hose until it is hand

tight

vi) Properly donning the PAPR:

vii) Place the unit against your lower back and along your spinal column.

viii) Holding it in place, fasten the belt buckle and ensure the unit rests comfortable against

your back and turn the unit on.

ix) Turn unit on.

x) Pull the hood or helmet over your head and adjust it so the sweatband is on your forehead and

the elasticized edge of the face seal fits under your chin. The face seal is pulled as far as

possible under your chin and snug around your face.

xi) Tuck the inner bib inside the suit.

xii) WARNING: (1) Protection against airborne contaminants is not provided unless the hood/helmet is

correctly positioned over your head and the visor and face seal are correctly positioned in

front of your face. An adequate supply of filtered air must be maintained at all times.

(2) If the airflow ceases, decreases, or suddenly increases, leave the work area immediately

and check the hood, breathing tube, and motor/blower unit.

g) Filter/Cartridge Replacement for PAPR

i) Change the filter:

ii) When an airflow check of the unit reveals that the airflow indicator does not rise above the 6

CFM level.

iii) When the filter is physically damaged.



iv) When water has entered the filter or cartridge.

v) Filter/Cartridge Replacement

vi) Make sure you line up the threads properly and screw on slowly.

vii) Do not over tighten.

viii) Remove caps.

ix) WARNING: (1) If the equipment is not properly assembled and used in strict conformance with the

manufactures specifications, contaminated air may be drawn into the system resulting in

exposure that may lead to serious health impairment or death. (MISUSE MAY RESULT

IN SICKNESS OR DEATH.)

(2) HEPA filters are only approved for protection against dust, fumes and mists.

h) Air Hepa Mate Battery Pack Use, Removal, and Replacement i) Completely exhausted battery should be charged for 4-6 hours.

ii) Repeated charging for more than 16 hours may reduce battery pack life.

iii) When fully charged, the battery should last at least ?? hours.

iv) Replace battery every three years.

v) Removal of battery pack:

(1) Remove the back cover..

(2) Slide the battery clip out of the locking slot.

(3) Lift the battery out.

i) Post Operational Maintenance 4) Wipe the outside of the unit using a bleach wipe.

5) ABRASIVE CLEANERS MUST NOT BE USED.

6) Properly discard cartridges/filter(s).

7) Disassemble the breathing tube from the headpiece.

8) Separate the tube from the unit.

9) Hang breathing tube to dry.

10) After all components have been cleaned, inspect all parts for damage or wear, and replace

worn parts.

11) Dry all parts completely, keeping them away from sunlight and direct heat.

POWERED AIR-PURIFYING RESPIRATORS TEST

Name: _________________________ID#: _______________________Date: _______________

1. The airborne hazards must be known before wearing a PAPR.

A) True

B) False

2. What does a PAPR fitted with High Efficiency (HE) filters provide protection from?

A) Gases and Vapors

B) Atmospheres below 19.5% oxygen

C) Atmospheres Immediately Dangerous to Life or Health (IDLH)

D) Particles

3. Which of the following statements is incorrect?

A) PAPRs may only be used in ambient air atmospheres where the oxygen concentration falls

between 19.5% and 21%

B) PAPRs are not for use in atmospheres which are Immediately Dangerous to Life or Health

(IDLH)

C) Any manufacturer can be used for replacement parts on any PAPR

D) You must know the contaminant you could potentially be exposed to before wearing a PAPR

4. Prior to wearing your PAPR, you should:

A) Inspect the breathing tube, body, and unit casing



B) Check the airflow by using the airflow indicator (bullet)

C) Wash the entire HEPA unit in the sink with mild detergent

D) A and B

5. After you finish wearing your PAPR, you should:

A) Wipe it down with an abrasive cleaner

B) Follow the appropriate decontamination procedures as instructed

C) Use dust spray and a cloth to wipe it down

D) Use acetone to wipe it down

6. The PAPR airflow is adequate if:

A) The plastic cone floats above the lowest raised line

B) The battery has not been placed on the charger for several days

C) The plastic cone does not float

D) Air is coming out of the tube

7. If the airflow ceases while wearing the PAPR, you should:

A) Check the power by turning the ON/OFF button on the battery

B) Leave the work area immediately

C) Wait until you finish your job

D) Ask a fellow employee to check the PAPR

8. Change the filter when:

A) An airflow check of the unit reveals that the airflow indicator does not rise to the specified

level, yet the battery is fully charged

B) The filter or cartridge is physically damaged

C) Water has entered the any of the filters or cartridges

D) All of the above

9. A completely exhausted battery pack should be charged for the following time period:

A) One hour

B) 4-6 hours, or the period noted in the operating manual

C) 48 hours

D) Never – battery packs don’t get exhausted

10. Care should be taken when handling PAPR components, including the batteries (e.g. do not drop on

the ground, etc.).

A) True

B) False



Appendix C: Upstate EVD Steering Committee Improvement

Process/Drill Planning

Drill Implementation & Design Process

1) Upstate EVD process/guidance approval and testing

a) Identify needed process/issue or equipment that staff needs to practice to improve

familiarity and performance.

b) Emergency Management will identify stakeholders and “owner” of the process (if one is

not apparent guidance will be provided by EVD steering)

c) A meeting will be help by Emergency Management with all available stakeholders in

order to

2) Define process.

a) Write an initial draft procedure

b) Identify necessary personnel for testing the procedure prior to offering the drill to other

staff members.

c) Emergency Management will schedule and perform draft procedure with stakeholders in

space where procedure will occur

d) Emergency Management will adjust any identified concerns after initial “walk thru”

e) Retest as needed

f) Emergency Management will present draft to Clinical Advisory group for approval.

g) Final draft will be presented EVD Steering for approval.

h) Drills will be scheduled for rollout to all required staff members as soon as practical

i) Any revisions or improvements identified during additional drills will be updated in the

policy once approved by EVD steering

3) Goal: This document is intended to define a set process in which clinical, support and other

staff members can test various components of Upstate Hospitals Ebola response plan. With

the ever increasing complexity of personal protective equipment coupled with a dynamic

clinical environment the need for clear and concise drills becomes paramount.

4) Definitions:

a) Tabletop Exercise – A tabletop exercise involves key personnel discussing simulated

scenarios in an informal setting can be used to assess plans, policies, and procedures.

b) Drill – A drill is a coordinated, supervised activity usually employed to test a single,

specific operation or function within a single entity (e.g., donning and doffing PPE)

c) Full-Scale Exercise – multi-agency and/or multidiscipline exercise involving "boots on

the ground" response (e.g., nursing decontaminating mock victims).

d) After Action Report (AAR) - is the final product of an exercise which captures

observations and recommendations based on the exercise objectives as associated with

the tasks identified

e) Improvement Items- a question, process and/or performance concern that is identified

during the physical act of the drill. A root analysis of each must be identified in order to

improve overall performance or ensure process success under “real world” conditions.

5) Process:



a) A specific group or individual has identified a particular problem, question or issue that

requires some level of physical testing or equipment usage in order for that specific

process to become more efficient or safer.

b) That group or individual that has identified a particular testing opportunity must then

c) Write down specific steps of that process as they see it happening.

d) Create a checklist of movements or actions in order using existing materials or

experiences from other EVD/ID centers to assist in writing a task list.

e) Send an email to EVD Drill Coordinator indicating the following with as much detail

as possible. (SEE SAMLE EMAIL FORMAT BELOW)

f) The specific goal of the drill. Is the goal to see if something can be done in a specific way

or in a set amount of time?

g) What is the desired level of staff/equipment performance or expected outcome?

h) A copy of the written standard or process to be tested that the group has developed.

i) Date in which drill needs to be completed.

j) Identify specific groups/departments that would perform the skill and any personnel that

would be involved in processing or assisting.

k) The specific area in which this skill/process is to occur. (8m, GEM Care, ED, etc.)

l) What equipment is needed for staff to perform the drill?

m) What factors would make the environment as realistic as possible? Are there any

environmental factors that cannot be replicated during the drill?

n) Who would need to be present at the drill in order to audit or facilitate the exercise?

o) Once the request for a EVD Drill has been received the Drill Coordinator will

p) Identify or clarify any issues with drill request

q) Recruit staff/designate roles for drilling. Coordinating with Training and Clinical Staff

managers to reduce duplication of training and ensure a minimal impact on normal

operations.

r) Prepare equipment or ensure needed equipment is available

s) Reserve designated drilling space ensuring minimal impact to Upstate’s “day to day”

operations.

t) Designate additional facilitators or evaluators as the requirements of the drill determine.

u) Ensure the role of safety officer is been identified prior to the start of every drill.

6) During Drill

a) The Drill Coordinator will brief participants on Goals, expectations, environmental

factors and overall safety before beginning.

b) The Drill Coordinator will also record any issues or new questions as they are mentioned

by staff participating during the drill.

7) After the Drill

a) Evaluations or discussion points will be collected by the Drill Coordinator immediately

after the session has completed. A brief after action report will be created and kept on

file with the Department of Emergency Management.

b) Once all the improvement items have been compiled

c) The Drill Coordinator will list a summary reporting to the EVD Steering Committee.

d) A recommendation will be made to the committee from the EVD Drill Coordinator as to

whom each item should be assigned in order to reach a resolution or level of completion.

e) A copy of all improvement items identified will be sent to the drill requesting/originating

individual or group along with a copy of the AAR.



f) Once at the EVD steering committee level all improvement items will be reviewed

weekly.

g) Completion progress will be monitored for those individuals assigned.

h) Additional resources will be assigned by the EVD steering committee as needed in order

to complete outstanding improvement items.

8) EMAIL FORMAT TO BE SENT TO EVD DRILL COORDINATOR:

a) GOAL OF DRILL:

i) What is the desired level of performance or expected outcome:

ii) Date in which drill needs to be completed:

iii) List Departments that need to participate:

iv) The specific area drill should be held: (8m, GEM Care, ED, etc.)

v) What equipment is needed for the drill?

vi) What additional factors would need to be changed to make the environment as

realistic?

vii) Are there environmental factors that cannot be replicated?

viii) Are there specific supervisors who need to be present in order to audit or

facilitate?

ix) Attach a copy of the written standard or process to be tested

9) All process improvements, once approved by the EVD Steering Committee, will be

communicated to all Upstate staff members via the EVD button on the ipage.



Appendix D : Upstate Departmental Disaster Plan 8M

EMERGENCY RESPONSE PLAN

COMPREHENSIVE EMERGENCY

MANAGEMENT PLAN

POLICY: a. The 8m Infectious disease unit will follow the recommended guidelines in the

event that Incident Command is initiated at University Hospital at the

Downtown Campus as detailed in policies DIS C-00 and DIS J-12.

1. DISASTER DEFINITIONS:

a. Level I- Pending Disaster situations can be effectively handled by personnel

currently on duty.

b. Level II- Pending Disaster situations cannot be effectively handled by

personnel presently on duty at the time of the crisis.

c. Disasters are also categorized by the source of the situation.

i. External: Response to something that has happened in the

community.

ii. Internal: Response to something that has happened within the

hospital that requires a coordinated response.

2. NOTIFICATIONS:

a. When Incident Command has been activated, personnel will be notified by

email, fax, phone, overhead page and/or by person. Personnel will be

expected to return to their work area. (See DIS J-12 for more information).

b. At the conclusion of the incident, “Code CLEAR” will be given via email, fax,

phone overhead page, and/or by person. Personnel will be expected to

resume normal activities after that announcement.

4. EXPECTED RESPONSE:

a. These steps should be taken when Incident Command is activated:

i. Assess your current operational status.

ii. Report any operational problems through your chain of command or

Incident Command.

iii. If your unit/department is the scene of a fire or disaster perform an

immediate headcount of staff (and patients) to give to University

Police and Community First responders (Fire Department, Bomb

Squad, etc.) upon their arrival.

iv. Inform your staff that shifts have been extended to 12 hours until

further notice. Do not release the end of shift staff until told to do so

by the incident commander.

v. Continue normal operations unless instructed (or unable) to do

otherwise.

vi. If you are away from your work area, return to it and report in.



vii. Do not send staff to the Labor Pool, Hospital Administration or scene

until directed to do so.

viii. Ensure someone at the department level is assigned to monitor their

own e-mail and the department fax machine for disaster related

communications.

b. Maintain a heightened sense of awareness to:

i. Changes in the environment.

ii. Overhead announcements, faxes or e-mails.

iii. Operational problems.

iv. Reaction of staff, patients, families.

v. Observe staff for signs of stress.

5. STAFFING:

a. Staffing information can be accessed via Self Serve through the University

Hospital webpage.

b. If staff needs to be recalled in response to a Level II Disaster, remind them to

report to the Labor Pool upon arrival at the hospital (the specific site will be

determined at the time of the incident).

c. Notify 8m Supervisor or Administrative Supervisor as soon as possible to

ensure appropriate staffing

6. EMERGENCY/DISASTER OPERATIONS:

a. Continue normal operations unless instructed or unable to do otherwise by

Incident Command or Fire Department Personnel.

b. Assess current operational staffing status requirements and report

operational issues/concerns to Administrator or the Incident Command

Center.

c. Fire or Disaster:

i. Use nearest pull alarm box if you are able.

ii. Call 4-5555 in the hospital and 9-911 external….Do not hang

up…..Give specific location of fire.

iii. For Disaster call 4-8888 if Incident Command has been activated.

iv. Examine Environment.

v. Evaluate if oxygen needs to be shut off.

vi. Turn off all unnecessary electrical equipment.

vii. Clear corridors of all equipment and obstacles.

viii. Close all windows and doors.

ix. Shelter in place and monitor through overhead page and IC.

x. In the event of a fire or other event on 8m move the patient two smoke

compartments with staff in full ppe.

xi. All staff- not directly involved in the patient move should evacuate

through the south 8m exit.

xii. If the patient is to be moved from 8m – if possible move the patient to

the ED Room A1/A2 EVD designated areas.

xiii. Coordination of this movement with Incident Command is critical

d. Evacuation Plan: (See Policy DIS M-40 for more information)



NEVER hesitate to relocate because of imminent

danger e. DO NOT USE ELEVATORS, (unless specifically instructed to do so by the

Fire Department).

h. During an evacuation of patient areas, patients should be prioritized for

evacuation in the following manner:

i. Patients and Visitors in Immediate Danger

ii. Ambulatory Patients

iii. Wheelchairs, Isolettes, Cribs

iv. Bed Bound Patients

i. Total Facility Evacuation: Evacuation of the entire hospital would be

coordinated and directed through Incident Command.

7. EDUCATION:

a. All Staff will complete Safety at Work (SAW) and review the Departmental

Disaster Plan annually. (See M04 Mandatory and Staff Education for more

information on required Incident Command Training for all staff.)

8. Emergency Code Names:

9. DEPARTMENT SPECIFIC PLANS AND PROCEDURES:

a. Minimal Staffing in a Disaster:

i. Follow the directions issued by the Administrative Administrative

Supervisor or Incident Commander concerning preparation of

patients for transfer or discharge.



ii. The 8m Supervisor will determine what staffing is needed to continue

to operate.

iii. If the nature of the disaster is such that 8m needs additional staff, the

Supervisor will notify Incident Command immediately.

Originating Department: 8m EVD Steering Committee

Contributing Department(s): Emergency Management

References: none



Appendix E : Upstate EVD Training Tracker Codes

Compiled by: Org. Training and Development

Training Intended Audience Tracker Code

DRILLS

8M Drill Assisting Staff Member

in Emergency EBOLAASSIST

8M Drill Spills EBOLASPILLS

8M Drill Waste EBOLAWASTE

8M Drill X-ray EBOLAXRAY

8M Drills (Instructor Sign Up) Ebola PPE SuperUsers sign up to

support 8M Drill EBOLA8M

8M Drill PAPR EBOLAPAPR

8M Drill Phlebotomy EBOLAPHLEB

Ebola Drill EBOLADRILL

1/2015 tracking all 8M drills under

this code for consistency and

monthly report to Dave Anthony EDUCATION

Blackboard web-based related to

screening of patients

Registration and UPD staff EBOLAREG

1/21/2015 – Blackboard course

turned off

Ebola Fast Facts - November

2014 (Both Campuses) EBOLAFF

Full Ebola PPE Staff requiring PPE training EBOLAPPE

EDUCATION CHANGES EFFECTIVE 3/1/2015

Level 1 PPE: includes PAPR An Upstate employee directly

engaged in the care or support of

a patient with EVD (Nurse,

Physician)

EBOLAPPE1

Level 2: includes N95 An Upstate employee directly

engaged in the care or support of

a patient with EVD (Nurse,

Physician)

Some Environmental

Services

EBOLAPPE2

Level 3: Suit Buddy Primarily tasked with actively

monitoring and assisting the

HCW/Staff member with

correctly donning and doffing

PPE, observing staff members for

increased fatigue or possibility of

injury, breaks in PPE and

measuring vitals of the primary

staff member prior to donning

and after doffing.

EBOLAPPE3

https://selfserve.upstate.edu/ais/applications/tracker/admin/course_code_details.cfm?id=87236









Training Intended Audience Tracker Code

Laboratory

Some Environmental

Services

Trained Observer To provide direct onsite

management and oversight for

the overall safe operation of all

staff members engaged in the

care of an EVD patient.

EBOLAOBSERVER



Appendix E: Rural Metro EMS EVD Policies

EBOLA VIRUS DISEASE (EVD) PROTOCOL

The enclosed policy is developed from CDC’s Oct. 1, 2014 Interim Guidance for EMS Systems & 911 PSAP’s,

NYS DOH planning considerations, SUNY Upstate collaboration agreement and CNY Regional Emergency

Medical Advisory Committee’s Dec. 4, 2014 Ebola advisory. Further updates will be issued, reviewed and amended

as they become available.

Ebola Virus Disease (EVD) – is one of numerous Viral Hemorrhage Fevers. It is a rare, severe, often deadly illness

caused by infection with a virus of the family Filoviridae, genus Ebolavirus. Early recognition of Ebola is critical for

infection control. EMS providers should be alert for and evaluate any patients suspected of having EVD.

Background (World Health Organization, 2014)

The current outbreak in West Africa (first cases notified in March 2014) is the largest and most complex Ebola

outbreak since the Ebola virus was first discovered in 1976. There have been more cases and deaths in this outbreak

than all others combined. It has also spread between countries starting in Guinea then spreading across land borders

to Sierra Leone.

EVD may spread to other countries before the outbreak is contained. Patients are not contagious prior to the

development of symptoms. Patients can transmit the virus from onset of fever and through later stages of the

disease, as well as post mortem. Recovery from Ebola depends on good supportive clinical care and the patient’s

immune response. People who recover from Ebola infection develop antibodies that last for at least 10 years.

Current Situation:

NYS Department of Health has designated SUNY Upstate (Downtown) Medical Center as an Ebola care hospital for

the 14 upstate counties. SUNY Upstate is one of 10 designated Ebola hospitals in NYS. SUNY Upstate has selected

R/M of CNY to be its lead EMS agency to support a Regional Response Team approach for emergency medical

response and inter-facility transportation.

Travelers are routed to five United States airports in which their passports are scanned. At JFK Airport, if positive

travel from one of the three countries stated above, they will be screened by CDC, and then screened again by NYS

DOH where a risk level will be determined (i.e. low, moderate, or high risk). The NYS DOH will notify the

respective county/local health department(s) of a traveler within their region. SUNY Upstate and R/M are then

contacted and provided a brief on these travelers in the region.

Transmission (CDC and Prevention, 2014)

Ebola is spread through direct contact (through broken skin or mucous membranes i.e. eyes, nose or mouth) with:



Blood or body fluids (including but not limited to: urine, saliva, sweat, blood, vomit, semen, feces and

breast milk) of an infected person.

Objects (i.e. needle and syringes) that have been contaminated with the virus

Infected animals, in Africa, EVD may be spread as a result of handling bush meat (wild animals hunted for

food) and contact with infected bats. There is no evidence that mosquitos or other insects can transmit

Ebola virus. Only mammals (i.e. humans, bats, monkeys & apes) have shown the ability to become

infected with and spread Ebola virus.

Ebola is not spread through the air or by water, or in general, by food. However, airborne transmission of

the virus may occur during aerosol-generating procedures. Signs & Symptoms of EVD

Fever (100.4 degrees F) Severe headache

Muscle pain Weakness

Diarrhea Vomiting

Abdominal (stomach) pain Unexplained hemorrhage (bleeding or bruising)

EVD symptoms can appear from 2 to 21 days after exposure, but the average is with 8 to 10 days.

Person Under Investigation (PUI)

A person who has both consistent signs or symptoms and risk factors as follows:

1. Elevated body temperature or subjective fever or symptoms, including severe headache, fatigue, muscle

pain, vomiting, diarrhea, abdominal pain or unexplained hemorrhage; AND

2. An epidemiologic risk (i.e. positive travel to an EVD country or contact with a person with EVD) factor

within the 21 days before the onset of symptoms

Dispatch Screening:

To keep EMS providers safe, the Onondaga County’s Emergency Communications 911 Center and R/M’s Dispatch

Center will use modified caller queries to screen for EVD. Call takers should ask:

1. Has the patient traveled out of the country in the last month (specifically to West Africa [ Sierra Leone] or

another area where EVD has been reported) or has the patient come in contact with a sick patient who has been

out of the country in the last month.

2. Does the patient have any of the following symptoms:

Fever of greater than 100.4 degrees F (38 degrees C)

Severe headache

Unexplained muscle pain

Vomiting, diarrhea, abdominal pain

Unexplained medical hemorrhage

If Question 1 & 2 is answered yes, the patient is: ‘High Risk Illness with Travel’

If Question 1 is answered yes only, the patient is: ‘Moderate Risk Illness with Travel’.

If Question 1 is yes to positive travel, but no to EVD contact; the patient is: ‘Low Risk Illness’.

Notification:

County 911 will notify R/M via phone and in their Emergency Medical Dispatch (EMD) case entry notes that the

Emerging Infection Disease Syndrome (EIDS) tool is being utilized on this call. The EIDS tool is being used by all

call takers for documenting potential concerns as related to EVD. R/M will then dispatch a suspected Ebola call as

an illness over the air, but write in on the crew’s pagers potential EVD call. The EMS crew will be instructed to call

dispatch before arrival on scene to advice of the potential for a patient with possible exposure/signs & symptoms of

Ebola. Do Not use ‘Ebola’ word over an open radio channel and EMS should call Resource via phone patch.

SUNY Upstate has stated they would prefer a phone patch to communicate.

R/M Dispatch will ask County 911 for the Syracuse Fire Department’s Haz-Mat is dispatched to the scene within the

City of Syracuse suspected EVD calls. R/M will notify Onondaga County Health Department that R/M is

responding to a potential EVD patient with positive travel and positive symptoms. R/M Dispatch will call SUNY



ED to notify Upstate of Highly suspected case. For suspected EVD 911 calls and inter-facility EVD transports,

R/M Support Service’s Manager and SUNY Upstate’s Director of Emergency Management will communicate so

SUNY’s staff is allowed sufficient time to coordinate their internal preparation of receiving an EVD patient.

Regional Plan for R/M as the Ebola EMS Agency

As stated in the introduction, SUNY has selected R/M to be the lead EMS Agency to support the regional approach

to emergency medical response and provide inter-facility transportation for EVD patients within the 14 upstate

counties.

The Core Mission of this Regional approach program is to:

1. To protect the health and safety of our EMS providers.

2. To provide persons under investigation (PUI) or patients with diagnosed EVD, with appropriate care

while limiting the possibility of further contagion.

R/M has developed a team of Bio-Techs to perform these regional responses. They have received proper education

on the current Ebola monitoring process in NYS, reviewed CNY’s Ebola field care, understand the direct admit

process at SUNY Upstate, successfully donned & doffed R/M’s full protection PPE and exercised with SUNY. R/M

has also participated in an informative Ebola update and exercise with NYS Department of Health – Central Region.

In this WebEx, the 14 counties within the Central NY region were represented and know that SUNY is the dedicated

CNY Ebola hospital and that R/M is the lead EMS Ebola transport agency.

EMS – Prior To Arrival at Patient

Considerations for Infection Control and PPE

If 911 or R/M dispatch advises the patient is suspected to have Ebola, the EMS crew should put on

appropriate PPE (personal protection kit: double gloves, impermeable gown, eye protection and N-95

mask. Avoid direct contact with a patient who may have Ebola without wearing appropriate PPE.

PPE should be put on before entering a scene to attend to a suspected EVD patient and continued to be

worn until providers are no longer in contact with the patient. PPE should be put on and off under the

supervision of a trained monitor. The Shift/Assistant Commanders and the Support Services Manager can

be a trained monitor. See Attachment: Donning & Doffing

Limit the number of EMS providers to essential personnel only who provide care for a patient with

suspected EVD. Again,

Keep the patient separated from other persons as much as possible.

One EMS crew member should approach the patient and perform the initial screening from at least 3 feet

away from the patient.

Use caution when approaching a patient with possible EVD. On rare occasions, illness can cause delirium,

with erratic behavior (i.e. flailing or staggering) that can place EMS personnel at additional risk of

exposure.

There may be situations where a patient must be carried and multiple providers are required to put on PPE.

Any provider (EMS and/or Fire) wearing PPE who have cared for the patient must remain in the back of

the ambulance (patient compartment) and should not serve as the driver.

Occupational Exposure

If blood, body fluids, secretions, or excretions from a patient with suspected EVD come into direct contact

with an EMS provider’s unprotected skin or mucous membranes, then the EMS provider should

immediately stop working and:

- immediately wash the affected skin surfaces with a cleansing or antiseptic solution. Mucous

membranes should be irrigated with a large amount of water or eyewash solution.

All wipes should be red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear resistance

and 165 grams of impact resistance.) ged. The solution run off should be left on the 6 mil plastic and when

at SUNY Upstate, carefully remove the plastic from the patient compartment and place within one of



SUNY’s 55 gallon bio-waste drums. Note: the patient stretcher is to be decontaminated including the

wheels.

Place all waste in a red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear resistance

and 165 grams of impact resistance.) .

Notify the Shift Commander of the exposure and report the exposure to the receiving hospital (SUNY).

Follow agency policy for medical evaluation and follow-up care and monitoring. Note: Onondaga County

will be involved with the monitoring.

EMS Arrival at Scene & Field Care

STEP 1. No EVD suspected from 911 or R/M Dispatch and no risk factors, proceed with normal EMS care.

a. Minimum Basic PPE: gloves and mask for ALL respiratory complaints

b. Perform EMS screening from >3 feet from all patients

See Attachment: Field Personnel Ebola Screening Questionnaire

i. If patient screens Moderate Risk Illness with Travel:

Follow CNY protocols, maintain basic PPE, brief Resource on patient history/symptoms

and ETA, this will allow SUNY Upstate staff to prepare to receive.

ii. If patient screens High Risk Illness with Travel:

Remove EMS crew from environment, contact Resource & advise on history/symptoms

and ETA

GO TO STEP 3 BELOW

STEP 2. EVD suspected Pre-notification (Positive Dispatch EMD Screen)

a. Dispatch notification of responding EMS ‘patient is High or Moderate Risk Illness with Travel’

b. On arrival, EMS must don PPE Kits: gown, N95, face protection, double glove, shoe protection

c. Perform EMS screening from 6 feet away from patient

i. If patient screens Low Risk Illness, doff to basic PPE level (gloves & masks), and contact

Resource and advise reasons for downgrading of risk level

ii. If patient screens Moderate Risk Illness with Travel:

1. Follow regional protocols

2. Maintain present PPE

3. Ask patient to apply mask, gown & gloves themselves

4. Contact Resource to advise of history/symptoms and ETA

iii. If patient screens High Risk Illness with Travel:

1. Contact Resource to advise of history/symptoms and ETA

2. GO TO STEP 3 BELOW

STEP 3. If patient is identified as High Risk Illness with Travel:

a. If PPE not already applied, remove EMS crew from environment and allow for SFD Haz-Mat to don

their full protection PPE (hooded coverall suits, double gloved, and NIOSH filtered masks) to

make entry to render direct patient care.

Note: if a tympanic membrane temperature is taken, take two temperatures, one from each ear and

take the highest figure. Red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear

resistance and 165 grams of impact resistance.) the ear probe caps & gauge and leave the red bag (meeting ASTM

1922 and ASTM1709 standards for 480 grams tear resistance and 165 grams of impact resistance.) in the patient

compartment of the transporting ambulance for disposal at SUNY.

b. SFD will use two HM personnel to render direct patient care. An R/M personnel will drive the

ambulance. Any person that has made patient contact should not enter the cab of the ambulance (Unit 137)

or other apparatus under any circumstances.

c. Ask the patient to apply the following (if their condition allows): surgical mask, gloves & gown

d. If the patient cannot ambulate, apply an impermeable (bariatric stretcher sheet) by wrapping the patient

‘burrito’ style with access to the head. Place a surgical mask on face.



e. Patient care

i. Only bring disposable equipment to the patient (limit to absolutely necessary equipment only).

ii. Do not perform ANY invasive procedures unless absolutely necessary.

iii. No IV access unless for life-saving interventions.

iv. No IN or aerosolized medications.

v. IM Benzodiazepine should be used for delirium or agitation if necessary.

vi. NO PROCEDURES SHOULD BE PERFORMED IN A MOVING AMBULANCE.

EMS Field Care: Special Circumstances

a. If the patient screens Moderate or High Risk and is refusing transport, contact Resource and have R/M

Dispatch contact OCHD.

b. If the patient is found to be presumably deceased:

i. If PPE not already applied, remove crew from environment and preferably one EMS provider

don standard PPE, then make re-entry.

ii. Only one provider should make patient contact to assess and confirm death.

iii. No resuscitative effort should be performed.

iv. Maintain a 3-6 foot distance from the deceased at all times.

v. Contact Resource, OCHD, and law enforcement.

Note: if R/M responds to a PUI who is being monitored for 21 days and is NOT symptomatic, but injuries

themselves, EMS should treat this call as like any other and use minimum (basic) PPE: gloves and mask.

EMS providers should always take standard precautions when caring for patients, regardless of their presumed

diagnosis. This includes basic hand hygiene, respiratory hygiene, appropriate PPE (to block splashes or other

contact with infected materials) and safe injection practices.

Unit 137 - Special Transport Vehicle

Unit 137 is the designated transport vehicle to be used for suspected EVD patients and for regional inter-

facility EVD patient transports.

Unit 137’s patient compartment is completely stripped and gowned with 6 mil clear plastic secured with

duct tape to the walls, floor and back doors. This separation of the ambulance cab and patient compartment

will allow for two PPE EMS providers to be in the rear and for a non-PPE driver in the cab. **If SFD

HazMat is requested to don and provide patient care, R/M will provide Unit 137 and the R/M driver will

NOT be required to don PPE protection.

The patient stretcher mattress will be covered with a bariatric sheet (grey, impermeable), disposable

blankets with no available pillows. Disposable stretcher straps will be in place.

The patient compartment will have vomit bags, red bag (meeting ASTM 1922 and ASTM1709 standards

for 480 grams tear resistance and 165 grams of impact resistance.) s, B/P cuff, stethoscope, clavicide

(disinfectant) wipes and gloves.

On regional inter-facility transports, OCHD will provide R/M with a patient brief.

Appropriate medical supplies/equipment will be provided prior to transport for any anticipated patient

treatment.

The ambulance cab will have an EVD ‘Go Bag’ to include: N-95s, disposable sheets & blankets, red bag

(meeting ASTM 1922 and ASTM1709 standards for 480 grams tear resistance and 165 grams of impact

resistance.) s, gloves, duct tape, clavicide wipes, 2 personal protection kits, a large & an extra-large full

coverall suits for patient donning along with copies of R/M’s full coverall PPE don & doff procedures to be

surrendered to SUNY Upstate’s Suit Buddies to assist with R/M’s doffing of full coverall PPE at SUNY.

Transport

Separate the non-doffed driver from the patient compartment.

Prior to leaving the scene, the R/M driver will notify Resource when leaving and provide an ETA.



Prior to arrival, SUNY will provide instructions to which hospital entrance will be used.

Primary entrance – Room 4730, behind Crouse Hospital

See attached SUNY Upstate Direct Admit Process for EVD Patients: EMS & 8m

R/M Support Manager will contact the SUNY Upstate’s Director of Emergency Management with an ETA

for the transporting R/M ambulance arrival time.

Patient and crew shall remain in the ambulance until advised by hospital staff.

1. No one other than the patient should be transported in the ambulance unless the patient is a minor.

2. Family or persons in direct contact with a suspected patient should be advised to remain at their current

location until notified otherwise.

At Hospital

Upon arrival at SUNY, contact Resource of arrival and remain in the ambulance until instructed by SUNY

staff to unload.

Keep stretcher on blue impermeable sheet on ground, follow thru double doors of Room 4730. This is as

far the stretcher will enter the hospital.

EMS personnel will not enter the hospital while still wearing PPE at any time

After patient transfer, keep the patient stretcher outside of the ambulance on the blue sheet and carefully

peel the 6 mil plastic wrap in the patient compartment off of walls, floors and back doors. Dispose of the

potentially contaminated plastic and any other materials used in the rear patient compartment as waste into

SUNY’s 55 gallon waste drums.

Any body fluid contamination on stretcher wheels will be disinfected with Clavicide wipes (kills non-

enveloped viruses) as a wet decontamination; goes on wet and allowed to dry for 10 minutes

R/M’s doffing of PPE will take place inside Room 4730. The doffing will be supervised by our Trained

Monitor to adhere to established procedures and a buddy system will be instituted to prevent self-

contamination or other exposure to EVD.

SUNY’s Suit Buddies will also assist EMS/Fire in their doffing procedures. See attached SUNY Upstate

Direct Admit Process for EVD Patients: EMS & 8m

An area to change into clean clothes will be available.

Decontamination

A R/M Supply Tech will be prepositioned as a trained person wearing appropriate PPE to perform decontamination.

This will allow the transfer EMS crew to doff, cleanse, and complete their documentation. The R/M Supply Tech

will conduct a wet decontamination of the patient compartment and gurney.

If no body fluids are present, then a gown, N95, face protection and double glove PPE should be worn.

Utilize the blue impermeable sheet on the ground at the back of the ambulance to collect all cleaning

materials.

R/M is using Clavicide wipes which meet the EPA label for non-enveloped virus to disinfect environmental

surfaces of vehicle and equipment used with suspected or confirmed Ebola virus infection.

A bulk wipe will be conducted on all surfaces of the patient compartment including the ceiling, gurney

antlers and the gurney.

If there was body fluids were spilled, then full protection PPE must be worn.

The Trained Monitor will provide careful attention to the vehicle decontamination process to ensure the

safety of the Supply Tech during the cleaning and decontamination process.

Double bag all disposable materials/equipment on blue sheet.

Double bag (red biohazard bags) all contaminated wipes/rags into properly labeled Red Biohazard Bags.

Clean and disinfect patient-care surfaces and equipment, and other areas that are likely to become

contaminated after each transport. Avoid contamination of reusable porous surfaces that are not designated

as single use.



Place contaminated reusable patient care equipment (i.e. B/P cuff) in biohazard bags and label for cleaning

and disinfection. R/M has Supply Tech’s that are trained personnel who are familiar with our agency’s

protocol and the manufacturer’s instructions on how to clean and disinfect.

Discard any bodily secretions (i.e. vomit, urine) as directed by SUNY staff.

Leave vehicle to dry as normal.

Once cleaning and disinfecting is complete, doff PPE using the same procedures and with a Trained

Monitor.

Vehicle is to be returned to Station One and the outside is to be washed out in normal fashion using PPE.

R/M will work with SUNY and OCHD to obtain directions on managing the vehicle.

No individual should reenter the vehicle for any reason without prior medical clearance to do so.

Follow-up

1. EMS personnel with exposure to blood, bodily fluids, secretions or excretions from a patient with suspected

or confirmed Ebola should immediately:

i. Stop working and wash the affected skin surfaces with soap and water. Mucous membranes (i.e.

eyes) should be irrigated with a large amount of water or eyewash solution.

2. Notify R/M on-duty Shift Commander as soon as practical after exposure to a suspected Ebola patient.

3. R/M management will notify R/M’s Medical Director and OCHD for deciding the employees risk level,

guidance on care and the monitoring process.

4. R/M will make sure that each employee receives medical evaluation and follow-up care in accordance with

public health and CDC guidelines.

5. Any employee required being in isolation/quarantine and unable to work as a result of exposure to Ebola

will be placed on paid medical leave until cleared to return to duty.

R/M personnel who develop sudden onset of fever, intense weakness or muscle pains, vomiting, diarrhea, or any

signs of hemorrhage after exposure to a suspected or confirmed Ebola patient should:

Not report to work or immediately stop working and isolate themselves;

Notify R/M management, who should notify OCHD & NYS DOH;

From direction of OCHD/NYS DOH, post exposure management will begin; and

Comply with work exclusions until they are deemed no longer infectious to others.

Contacts:

SUNY Upstate - Phone

Chris Dunham, Emergency Management Director [email protected] cell 289-7354

Joe Tschoop, Emergency Management [email protected] cell 383-2581

Onondaga County Health Department (OCHD) – phone 435-3252

Dr. Quoc Nguyen, Medical Director [email protected]

Michelle Mignano, Deputy Commissioner [email protected] 435-3665

Indu Gupta, Public Health Commissioner [email protected]

NYS DOH Central New York Regional Office – Phone 477-8100

Amy O’Brien, Office of Health Emergency Preparedness [email protected] cell 480-5094

Dan Casler, Communicable Disease Program Director [email protected] 477-8177

Dr. David Brittain, Director Center NY Regional Office [email protected] 477-8522

mailto:[email protected]













Appendix F : User guide CDESS for Employee Monitoring

Login to your HCS account: https://commerce.health.state.ny.us/public/hcs_login.html

1. Click on the ‘My Content’ button on the top right corner of the screen

2. Select ‘All Applications’ from the dropdown list

https://commerce.health.state.ny.us/public/hcs_login.html



3. Select the C tab at the top of the page

4. Select ‘Communicable Disease Electronic Surveillance ’ from the list of applications

5. You can also add this application to your favorites by selecting ‘Add/Remove’; this will make the

‘Communicable Disease Electronic Surveillance’ application show up on your HCS homepage.





























Appendix F : 8m Video Monitoring User Guide







