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________________________________________________________________ Subject: BLOODBORNE PATHOGEN EXPOSURE CONTROL PLAN Effective Date: 03/13 Supersedes: 9/11 Approved By: Infection Control Committee 03/13 Responsibility: All Category I and II personnel Author: D. Rich, RN, BSN MM J. Ricca, MSN/CI, FNP-BC M. Boyer, UML Intern _______________________________ Marlene Durand, MD Hospital Epidemiologist 0

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________________________________________________________________

Subject: BLOODBORNE PATHOGEN EXPOSURE CONTROL PLAN

Effective Date: 03/13 Supersedes: 9/11

Approved By: Infection Control Committee 03/13

Responsibility: All Category I and II personnel

Author: D. Rich, RN, BSN MM J. Ricca, MSN/CI, FNP-BC M. Boyer, UML Intern

_______________________________

Marlene Durand, MD Hospital Epidemiologist

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MASSACHUSETTS EYE AND EAR INFIRMARYBLOODBORNE PATHOGENEXPOSURE CONTROL PLAN

I. INTRODUCTION...…………………………………………………. 2

II. RESPONSIBILITIES…………………………………………………… 2

III. TASKS, PROCEDURES, POSITIONS INVOLVING POTENTIAL EXPOSURES………………………………………………………… 3

IV. STANDARD PRECAUTIONS ……………………………………… 4

V. SHARPS SAFETY DEVICES………………………………………… 4

VI. WORK PRACTICE CONTROLS…………………………………….

VII. PERSONAL PROTECTIVE EQUIPQUIPMENT.........

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VIII. HOUSEKEEPING, CLEANING, AND DISINFECTION… 7

IX. MEDICAL SURVEILLANCE …………………………….. 7

X. EMERGENCY MEDICAL RESPONSE IN THE EVENT OF EXPOSURE …………………………………………………….

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XI.TRAINING……......................................................... 10

XII. RECORD KEEPING AND DOCUMENTATION ………… 11

XIII. PLAN REVIEW ………………………………………………. 12

COMPLIANCE MONITORING..................................... 12

XIV. EMPLOYEE CLASSIFICATION/TRAINING BY RISK CATEGORY..................………………………………………. 12

ATTACHMENTS A. Exposure Determination Form B. Exposure Determination by Tasks and Procedures C. Unit Specific Exposure Control Plan D. Exemption From Use Of Devices With Sharps Injury Prevention Technology

Federal Register- http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051

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MASSACHUSETTS EYE AND EARBLOODBORNE PATHOGENEXPOSURE CONTROL PLAN

Purpose of Plan:One of the major goals of the Occupational Safety and Health Administration (OSHA) is to promote safe work practices in an effort to minimize illness and injury experienced by employees in the workplace. OSHA enacted the Bloodborne Pathogens Standard, codified as 29 CFR 1910.1030, in 1991. The purpose of the Bloodborne Pathogens Standard is to “reduce occupational exposure to hepatitis B virus (HBV), human immunodeficiency virus (HIV), hepatitis C virus (HCV), and other Bloodborne pathogens that employees may encounter in their workplace.

I. Introduction

All personnel working with blood, body fluids and Other Potentially Infectious Materials (OPIM) must be knowledgeable in procedures to minimize exposures to staff, patients, visitors, and the environment. This Exposure Control Plan has been designed to minimize or eliminate potential exposures.

To meet these responsibilities, the Exposure Control Plan addresses:A. Employer and Employee ResponsibilitiesB. Tasks, Procedures, and Job Categories that have the potential for

exposureC. Work Practice and Engineering ControlsD. Personal Protection RequirementsE. Housekeeping, Cleaning, and DisinfectionF. Medical SurveillanceG. Emergency Medical ResponseH. TrainingI. Record Keeping and Documentation

II. Responsibilities

A. Employer, Managers and Supervisors:

1. Oversee proper work practices and safety devices. Identify and document all tasks and procedures where occupational exposures to bloodborne pathogens may take place.2. Identify and document all job categories that may have associated

occupational exposures.3. Provide all necessary personal protective equipment to employees whose tasks, procedures, or job categories may lead to an occupational, bloodborne pathogens exposure.4. Provide necessary and required information and training to minimize or eliminate exposure to potentially infectious materials.5. Provide post-exposure counseling, prophylaxis and follow-up as indicated.6. Fulfill other responsibilities as delineated in the Exposure Control Plan.7. Annually:

Complete an inventory list of safety sharp products Complete an exemption form for the use of any device in use that does not

incorporate safety technology which will be reviewed by the Sharp Reduction Task Force**.

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B. Employees:

1. Report any percutaneous or mucous membrane (eyes, nose, mouth) broken skin etc. exposure to blood or body fluid. 2. Notify supervisor and Employee Health nurse practitioner (or designee) of any open

wounds or abrasions that might allow disease transmission before initiating work activities involving potential exposure to blood or body fluids.

3. Properly wear all personal protective equipment prescribed in this plan and as prescribed by Departmental Infection Prevention and Control Guidelines.

4. Complete the Hepatitis B Virus vaccination series if work activities involve bloodborne pathogens.

5. If the hepatitis B vaccine is refused, a declination statement is signed.6. Receive proper training before initiating work activities involving

bloodborne pathogens or other biologicals.7. Report any situation that has the potential for causing injury or

exposure to bloodborne pathogens or other biologicals.8. Report all accidents or near occurrences to manager. Employee Health or Nursing Supervisor.9. Fulfill other responsibilities as delineated in the Exposure Control Plan, Environment of

Care Manual and Departmental Infection Control Guidelines. 10. Lack of compliance with safe work practices, including proper/appropriate use of PPE,

could lead to disciplinary action, up to and including termination.

Availability of the Exposure Control Plan to Employees: The Bloodborne Pathogen Exposure Control Plan can be found in the Mass Eye and Ear Infection Control Precaution Manual and on Mass Eye and Ear Intranet: The Source. The OSHA Blood Born pathogen Standard is available at: http://www.osha.gov/SLTC/bloodbornepathogens/index.html.

III. Tasks, Procedures, Positions Involving Potential Exposures

A. Exposure Determination1. Each job title is classified as either having or not having potential exposure to Bloodborne pathogens by Employee Health Service based, on information provided at the time of new hire screening by Human Resources or manger regarding the employee’s work responsibilities.

2. A list of tasks (see attachment A) and procedures during which occupational exposure may occur is included at the end of this plan. These tasks maybe performed by several different job titles.

3. The list also identifies required Personal Protective Equipment (PPE) that must be worn, based on the risk of exposure associated with the task. This list was approved by the Infection Control Committee.

B. Methods of Reduction of Risks of ExposureThe following methods of exposure risk reduction are intended to eliminate or minimize exposure to Bloodborne pathogens:

Using Standard Precautions Establishing appropriate engineering controls including use of sharps safety devices. Implementing appropriate work practice controls. Using required PPE and additional protection as indicated. Implementing appropriate housekeeping procedures. Providing hepatitis B vaccination and post-exposure management.

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Using appropriate labels and signs.Information on these methods is included in the employee training materials and should be covered during their Bloodborne pathogen-related training as part of Healthstream and orientation in their work place.

C. Tasks procedures (Attachment A)

Positions (All Category I & II Employees)1. Nurses 2. Physicians3. Nursing assistants/Patient Care Assistants/Patient Operations Assistants 4. Therapists: Occupational, Physical, Speech, Respiratory 5. Social Service direct care personnel 6. Environmental Services Staff7. Maintenance personnel8. Phlebotomists/Lab Technologist9. Surgical Technicians10. Radiology Technicians11. Researchers working with human (or primate) blood, body fluids, or

unfixed tissue.12. Security Staff 13. Any position not listed that performs tasks that involve planned or unplanned exposure to blood, body fluids or tissue. [Category I or II employees see page 10]

IV. Standard PrecautionsStandard Precautions are observed to prevent contact with blood and other potentially infectious materials. As a result, all human blood and body fluids are treated as if they are known to be infectious for HBV, HIV, HCV, and other bloodborne pathogens. (Standard Precautions, Isolation Precautions/Infection Control Precaution Manual – Section 3 Transmission Based Precautions.)

Body fluids known to be associated with transmission of Bloodborne pathogens include: Blood, Semen, Vaginal secretions, Cerebrospinal fluid, Synovial fluid, Pleural fluid,

Pericardial fluid, Peritoneal fluid, Amniotic fluid, Saliva.

V. Sharps Safety Devices One of the key aspects of the Exposure Control Plan is the use of engineering controls to eliminate or minimize employee exposure to bloodborne pathogens. Examples include the following sharps safety devices: syringes with a sheath that shields the attached needle after use, needles that retract into a syringe after use, shielded or retracting catheters for intravenous use, lancets with retractable blades, sheathing butterfly needles, and needleless intravenous systems that use a port or connector site for access without using a needle.  

A. Sharps injury prevention technology, when it exists in the marketplace and is not clinically contraindicated#, will be used to isolate or to remove sharps hazards. When clinically contraindicated an exemption form will be completed and forwarded to the Sharps Reduction Task Force.

B. All employees will follow Infectious Waste and Sharps Disposal Policies. (See Precaution Manual Chapter 6)

C. Employees involved in direct patient care will be involved in the selection and evaluation of sharps safety devices.

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D. A Sharps/Needle Stick Reduction Task Force is multidisciplinary and includes representatives from Employee Health, Infection Control, Operating Room, physicians and direct patient care givers. This committee is responsible to:

Assess sharps usage throughout the Infirmary and satellite locations. Review exemptions for the use of any device that does not incorporate safety technology

which must be submitted in accordance with 105 CMR 130.1003 and 105 CMR 130.0050. Coordinate the evaluation, introduction and ongoing review of new safety products. Facilitate the transition to sharps safety products including education and training. Critical analysis of sharps incidents to determine cause and address the need for

corrective action. Increase sharps safety awareness throughout the organization

E. The following additional engineering controls are used throughout the facility: Hand washing facilities that are readily accessible to all employees. Alcohol-based hand rub is available for hand disinfection. Sharp disposal containers that are:

o Puncture-resistanto Color-coded or labeled with a biohazard warning labelo Leak-proof on the sides and bottomo Replaced when ¾ full

VI. Work Practice ControlsThe facility has adopted the following work practice controls as part of the Bloodborne Pathogens Exposure Control Plan.

A. All employees shall follow Standard Precautions with all patients and non human primates.1. Standard Precautions:

All blood and body fluid should be considered as potentially infectious. When contact with blood or body fluid is anticipated personal protective equipment

(PPE) will be used.

2. PPE includes: Gloves- use when you anticipate direct contact with blood, body fluid, mucous

membrane or non-intact skin. Gowns or Aprons- use when soiling or splashing of clothing is likely to occur. Mask and goggles use when eyes or mucous membrane (nose, mouth) may be

splashed with blood or body fluid substances. 3. Hand hygiene is the single most important procedure for preventing transmission of infection. All personnel will perform hand hygiene with alcohol hand rub or soap and water:

Before and after direct contact with patients or patient care items. Before and after eating, drinking, and smoking. After using the toilet or covering a sneeze or cough. Before and after removing gloves. After contacting contaminated equipment and materials.

4. Personnel whose hands are visibly dirty or soiled with blood or body fluids must wash hands with soap and water for approximately 15 to 20 seconds.

B. All employees shall remove gloves or other personal protective equipment immediately after use or as soon as possible when contaminated.

C. All used or contaminated personal protective equipment shall be placed in a designated container for storage, washing, decontamination, or disposal immediately after use.

D. Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses is prohibited in the waste handling and storage areas, laboratory, dirty utility rooms and patient care areas.

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E. Food and drink shall not be eaten or stored in any area where there is potential for contamination from blood or body fluids. Eating and drinking shall be within designated lunchroom areas.

F. All procedures involving medical waste transfer, handling, and disposal shall be conducted in a manner to minimize splashing, spraying, and aerosolization.

G. Personal protective equipment used during work operations shall remain at the facility and shall not be permitted to be worn home or to be decontaminated, cleaned, or washed at home.

VII. Personal Protective Equipment (PPE)

A. General Procedures1. The Infirmary shall provide, clean, and maintain all personal protective equipment required by the employee to minimize or eliminate occupational exposures to blood, body fluid or OPIM.

2. The Infirmary shall make all personal protective equipment readily accessible and available in the appropriate sizes.

3. The Infirmary shall provide for the cleaning, laundering, or disposal of personal protective equipment.

4. The Infirmary shall repair or replace required personal protective equipment as needed to maintain effectiveness.

5. The employee shall properly wear all personal protective equipment as described in this plan and as prescribed by the Exposure Determination Form located in the departmental Infection Control Guidelines. (See Attachment A Exposure Determination)

6. All personal protective equipment shall be removed immediately after completing tasks for which it was worn and prior to leaving work area.

B. Gloves1. Gloves shall be worn when the employee has the potential for the hands to have direct skin contact with blood and other potentially infectious materials. Latex-free and powder free gloves are available.

2. Disposable gloves shall be replaced as soon as possible when their ability to function as a barrier has been compromised.

3. Disposable gloves shall not be washed or disinfected for reuse.

4. Utility gloves may be disinfected for reuse if the integrity of the glove has not been compromised. If the gloves are cracked, peeling, discolored, torn, punctured, or show signs of deterioration, they must be discarded.

5. Sterile gloves shall be worn for sterile procedures.

C. Masks, Eye Protection (protective goggles), and Face Shields Masks and eye protection shall be worn whenever splashes, spray, splatter, droplets, or

aerosols of blood or other potentially infectious materials may be generated. Personal eyeglasses are not acceptable as PPE.

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D. Gowns, Aprons, and Other Protective Body Clothing Appropriate, fluid resistant, protective clothing shall be worn when;

An employee has a potential for an occupational exposure to blood or other potentially infectious materials.

Selection of the appropriate protective clothing will be made based on Standard Precaution principles.

E. Closed toe shoes must be worn to protect feet from sharps injury and blood body fluid contact. These are not provided by the employer but are included in the OSHA general requirements for PPE

VIII. Housekeeping, Cleaning, and Disinfection

A. The facility will be maintained in a clean and sanitary condition as prescribed in procedures described in the Environmental Services Infection Control Policies.

B. All equipment and environmental and working surfaces that come in contact with blood, body fluids secretions or excretions shall be properly cleaned and disinfected with hospital approved disinfectant after:

Completion of procedures that may result in contamination When surfaces are overtly contaminated Immediately after any spill of blood or other potentially infectious material (OPIM). At the end of the work shift.

C. All bins, pails, cans, and similar receptacles intended for reuse which have the potential for becoming contaminated with blood or other potentially infectious materials will be inspected daily for visible contamination. When visibly contaminated or when notified of contamination, bins pails and cans will be cleaned and disinfected by Environmental Service department. All waste containers are cleaned thoroughly every 3 months.

D. Any broken glassware that may be contaminated shall not be picked up directly with the hands. This material shall be cleaned up using a brush,

dust pan or tongs.

E. Any reusable items contaminated with other potentially infectious materials or blood shall be washed and decontaminated prior to reprocessing.

F. Any infectious waste generated will be packaged to prevent leakage and spills. All labeling and packaging will be done as outlined in the Infectious Waste Disposal Policies (see Precaution Manual chapter 6).

E. Contaminated laundry will be placed and transported in designated bags and laundered at thecontracted laundry service. Laundry service personnel will wear gloves and any other protective equipment to sort and handle laundry as outlined in the service Exposure Control Plan. All detergent and water temperatures will be maintained according to the contract service plan.

IX. Medical Surveillance

A. Hepatitis B Vaccination To protect employees as much as possible from the possibility of hepatitis B infection, the

Employee Health Services offers the Hepatitis B vaccination series available to all employees who have the potential for occupational exposures, after those employees have received appropriate training and within ten working days of initial assignment at no cost to the

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employee. A copy of their vaccination status will be provided to the employee upon written request.

If an employee declines to accept the offered Hepatitis B Vaccination, the employee shall sign the “Hepatitis B Vaccination Declination Statement”

(Attachment B).

B. Post-Exposure Evalution and Follow-Up If an employee is involved in an incident in which exposure to Bloodborne pathogens may

have occurred, the employee will report to Employee Health (or designee) for immediate medical consultation and post-exposure prophylaxis (if required) as expeditiously as possible.

Post-exposure follow up is available through Employee Health (or designee) in accordance to the guidelines provided by the Center for Disease Control (CDC) for all employees who sustain an occupational exposure, at no cost to the employee.

C. All medical evaluations and procedures will be performed by or under the supervision of a licensed physician or nurse practitioner at no cost to the employee.

D. All laboratory tests will be conducted by an accredited laboratory at no cost to the employee

E. The evaluating health care professional has access to the following:1. A copy of the OSHA Bloodborne Standard (29 CFR 1910.1030) and its appendices.2. A description of the affected employee’s duties as they relate to the

occupational exposure.

X. Emergency Medical Response in the Event of an Exposure

A. Immediately following a needle stick or other exposure, the health care worker should do the following to decontaminate the exposed area:

1. Skin wounds or splashes Wash skin well with soap and large amounts of water for approximately 15 to 20

minutes. After using soap and water, may use an alcohol-based hand rub on skin. Note: Squeezing of the wound, bleeding the wound, or washing with an antiseptic are

no more effective at decontaminating than soap and water.

2. Splash to nose or mouth Rinse mouth or nose several times with large amounts of clean water.

3. Splash to eye Rinse eye immediately several times with clean water, saline or sterile irrigant. If

you are wearing contact lens, remove them before rinsing eyes. Follow manufacturer’s recommendations for disinfecting before using lenses again.

B. Reporting the incident and obtaining HIV post-exposure prophylaxis.

Prompt reporting is essential so the patient source can be consented for HIV testing (testing for hepatitis B and C does not require a consent form). Post-exposure treatment (i.e. HIV antiviral medications) should be started as soon as possible when indicated.

1. The employee should immediately report an incident which occurs by calling the operator ( ext. 0 or ext. 33333) and informing they have a sharp/splash incident. The operator will page the Employee Health Nurse Practitioner (beeper 1232)) and the Nursing Supervisor (beeper 1164). The Employee Health Nurse Practitioner will provide counseling and post-exposure prophylaxis per protocols outlined by the CDC. When the Employee Health Nurse Practitioner is not available, and post-exposure prophylaxis is needed, the

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Nursing Supervisor or designee will send the employee immediately to the MGH Emergency Department for evaluation and prescription per Post-Exposure Prophylaxis Protocol outlined by the CDC.

2. Rotations at MEEI satellites. To report an incident which occurs at an off-site facility of the Infirmary (e.g. ambulatory off- site facilities), the individual is to immediately call Mass. Eye and Ear operator at 617-523-7900. Notify operator of sharps splash incidents at specific satellite location. The operator will page the Employee Health Nurse Practitioner (beeper 1232) or the Nursing Supervisor on-call (1164). If this is a potential Bloodborne pathogen exposure the employee will be advised to immediately come to the Infirmary or go to a local Emergency Dept. for initial prophylaxis, whichever is closer.

3. Rotations at other Harvard teaching hospitals. To report an incident while the MEEI health care worker is on rotation at another Harvard teaching hospital(e.g. MGH, Brigham and Women’s Hospital), the individual is to immediately call or page the Occupational Health Department at that hospital . Please also page the Employee Health Nurse Practitioner (beeper 1232) or the Nursing Supervisor on-call (1164). Initial counseling and prophylaxis will be provided at the outside hospital. The employee should report the incident to the MEEI Employee Health Nurse Practitioner for coordination of follow-up care.

C. Post-Exposure Medical Response and Documentation

1. The affected individual and/or attending supervisor will recount the incident to the Employee Health Nurse Practitioner/designee responsible for post-exposure follow-up.

2. The Post-Exposure Prophylaxis Protocol per CDC guidelines will be followed.

3. A Sharp/ Splash Body Fluid Incident Report Form (Attachment E) will be completed by the employee or person conducting the immediate post-exposure follow-up.

4. All required information must be obtained, including but not limited to:

The name of the exposed employee and their employer Occupation of exposed employee The name, date of birth, and unit number of the patient source, if known The date and time of the incident The time started working for the day Work being performed at the time of the incident Type of exposure (i.e. percutaneous, mucous membrane, skin) Location and severity of the injury If sharp involved type, model, brand and manufacturer of device and if it was part of a

pre-packaged kit. A brief, factual description of how the exposure occurred If exposed by inappropriately discarded waste-document the source of waste, if known

(OR, ED, patient room#) Any mitigating circumstances surrounding the incident Recommendations for prevention of similar injuries in the future.

5. A critical analysis of each incident will be confidentially conducted by the Employee Health nurse practitioner, the manager, and others (e.g. the OR educator) to identify risk factors for the injury. This analysis, the plan of action and the follow up action will be reported to the Sharps/Needlestick Reduction Task Force and the Safety Committee.

6. The following information will be documented in the Employee Health medical record.a. Results from testing of patient sources and employee’s blood or serum sample

(sample to be collected as soon after the exposure as possible).

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b. Counseling, illness reported, and post-exposure prophylaxis recommendations. Treatment or first aid given.

c. Follow-up results of the testing, counseling, illness reported, and post-exposure prophylaxis.

d. All employees’ documentation will be available to the employee per confidentiality guidelines (HIPAA).

7. Exposure data will be reported yearly to the Massachusetts Department of Public Health. Records which comply with OSHA and federal requirements will be maintained.

XI. Training

A. General1. The Infirmary shall provide a training program to each of its employees through an on- line computer course via HealthStream, and through nursing education for employees with direct patient care responsibilities. This education is at the time of initial employment and annually thereafter for category I and II employees (those listed in the Department Exposure Control Plan).2. Additional training will be provided when there is modification in

tasks or new procedures develop. 3. Materials appropriate in content and vocabulary to educational level,

literacy and language of employees shall be used when possible.

B. The training program will contain the following elements:1. An accessible copy of the regulatory text of 29 CFR 1910, 1030 and

an explanation of all applicable regulations regarding exposure to occupational bloodborne disease.

2. A general explanation of the epidemiology and symptoms of bloodborne disease.

3. An explanation of the mode of transmission of bloodborne pathogens and other common microbial pathogens.

4. An explanation of the employer’s Exposure Control Program and a means by which employees can obtain a copy of the written plan.

5. An explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially

infectious materials.

6. An explanation of the use and limitations of methods that will prevent or reduce exposure, including appropriate engineering controls, work practices, and personal equipment.

7. Information on the types, proper use, location, removal, handling, decontamination and/or disposal of personal protective equipment.

8. An explanation of the basis for selection of personal protective equipment.

9. An explanation of the signs and labels and/or color coding that is required by applicable regulation.

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10. Information on the appropriate actions to take and the persons to contact in the event of an exposure.

11. An explanation of the types and action of the disinfectants used for spill decontamination.

12. A detailed explanation of the spill containment and spill decontamination procedures.

13. An explanation of the personal decontamination methods.14. Information on the hepatitis B vaccine, including information on its’ efficacy, safety, and the benefits of being vaccinated.

15. An explanation of the medical and notification procedures to follow if an exposure event occurs, including:

A) the method of reporting the incidentB) The medical follow-up that will be made available.C) Information on the medical counseling that the employer is providing for the

exposed individual.

16. An opportunity for questions and feedback from a knowledgeable Instructor.

XII. Record Keeping and Documentation

A. Medical Records1. The facility will establish and maintain an accurate Employee Health medical record for each employee to include:

The name and date of birth of each employee. All records relative to the employee’s ability to receive the Hepatitis B

vaccination. A copy of each covered employee’s Hepatitis B vaccination or Hepatitis B titer or refusal-to-receive HBV vaccination record.

All records detailing the circumstances of an exposure incident A copy of all results of physical examinations, medical testing, and follow-up

procedures as they relate to post exposure evaluation. Documentation of the risk assessment of the exposure and treatment

recommendations. Documentation of counseling regarding the exposure and associated risks. Documentation of any work limitations that may result from the exposure

incident.

2. The hospital shall keep all medical records confidential as required by OSHA.

3. These records will be maintained for at least the duration of employment plus thirty years.

B. Training Records1. Training records will include the following information:

The dates of the training sessions The contents or summary of the training sessions The names of all the persons conducting the training and/or the computer program

used for training The names of all persons attending the training sessions

2. The training records will be maintained by the Infirmary for at least three years.

C. Record Availability

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1. All records will be made available upon request to the Assistant Secretary and Director of OSHA for examination and copying.

2. Employee training records will be provided upon request for examination to employees, employee representatives, and the Assistant Secretary of OSHA.

3. Employee medical records and training records will be provided upon request for examination and copying to the subject employee, to anyone having written consent of the subject employee and to the Assistant Secretary of OSHA. All medical record releases must have the written consent of the employee.

D. Transfer of Records1. The Infirmary will comply with the requirements set forth under CFR 1910.20(h) involving the transfer of records.

2. If the Infirmary ceases to do business and there is no successor, the Infirmary will notify the Director of OSHA at least three months prior of ceasing business to transmit records required by the Director of OSHA and to do so during that three month period.

XIII. Plan Review

This plan will be reviewed once per year or more often if changes are required, by the Infection Control Committee.

XIV. Compliance Monitoring to Standard Precautions is mandatory. Each manager is responsible for monitoring and ensuring employee compliance to Standard Precautions and documentation of compliance on individual employee performance appraisals annually. Failure to comply with Standard Precautions will lead to disciplinary action according to the Infirmary policy up to and including termination of employment.

XV. Employee Classification by Risks of Exposure

Each department will maintain a list of job classifications by risk categories (see Unit Specific Exposure Control Plan). These categories are defined as followed:

Employee Exposure Risk/Task Categories

Category I: Employees who perform tasks that involve exposure to blood, body fluids, or tissueAll procedures or other job related tasks that involve an inherent potential for mucous membrane or skin contact with blood, body fluids or tissues, or a potential for spills or splashes from them, are Category I tasks. Use of appropriate protective measures will be utilized when applicable.

Category II: Employees who perform tasks that involve NO planned exposure to blood, body fluids, or

tissue. All procedures or other job related tasks that involve NO exposure to blood, body fluids, or tissue but employment may require unplanned tasks that involve exposure to blood, body fluids, or body tissue are Category II tasks. Use of appropriate protective measures will be utilized when applicable.

Training Requirements by Risk Category

Category I Employees: Must receive Standard Precaution/Bloodborne Pathogen training on hire and annually thereafter.

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Category II Employees: Will receive Standard Precaution/Bloodborne Pathogen training on hire and annually thereafter.

**Sharps Reduction Task Force

The Sharps Reduction Task Force meets quarterly to solicit input from employees on identification, selection of safe sharp devices, pilot testing, and collecting data to evaluate these devices. This committee consists of members from the following departments: Employee Health Services; Infection Prevention and Control; Operating Room; ENT physician, Ophthalmology physician, Anesthesiologist, Clinical Laboratory, Nursing Education, and Purchasing. The committee reviews sharps incidents to determine if equipment issues contributed to the injuries and to analyze injuries that have occurred to improve work practices. Sharp incident summary and analysis are reported to the Infection Control Committee and to the Safety Committee.

Reference

Occupational Safety and Health Administration. Occupational Exposure to Bloodborne Pathogens; Final Rule. Federal Register 1991; 56:64003-182.http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGISTER&p_id=16265http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010&p_text_version=FALSE

Occupational Safety and Health Administration. Occupational Exposure to Bloodborne Pathogens; Needlestick and Other Sharps Injuries; Final rule, Federal Register 2001; 66:5318-25. http://www.osha.gov/SLTC/bloodbornepathogens/index.html

OSHA 29 CFR 1910.132 Personal Protective Equipment- General Requirements. http//www.OSHA.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARS&p_id=9777

Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxishttp://www.cdc.gov/mmwr/preview/mmwrhtml/rr5409a1.htm

MDPH Use of Sharp Safety Devices June 2004http://www.mass.gov/Elwd/docs/dos/mwshp/hib411.pdf

NIOSH Publication No. 2007-158: Sept 2007:Protect Your Employees with an Exposure Control Planhttp://www.cdc.gov/niosh/docs/2007-158/pdfs/2007-158.pdf

NIOSH Publication No. 2007-159: Sept 2007: Encourage Your Workers to Report Bloodborne Pathogen Exposureshttp://www.cdc.gov/niosh/docs/2007-159/pdfs/2007-159.pdf

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ATTACHMENT A

EXPOSURE DETERMINATION FORM

TASKS INVOLVING RISKS OF CONTACT WITH BLOOD, BODY FLUID AND BODY TISSUE AND RECOMMENDED STANDARD PRECAUTIONS, PERSONAL PROTECTION EQUIPMENT (PPE), ENGINEERING AND WORK PRACTICE CONTROLS.

TASK

REQUIRED PPE, ENGINEERING OR WORK PRACTICE

CONTROLS

EXAMPLES OF ADDITIONAL PPE

AVAILABLE1 JOB TITLE

1 Additional PPE is available. Use your judgment to determine use of PPE necessary to prevent a direct body fluid exposure. IF YOU DON’T KNOW, ASK!

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ATTACHMENT B

EXPOSURE DETERMINATION BY TASKS AND PROCEDURES

PROCEDURE REQUIRED ADDITIONAL JOB PROTECTION PROTECTION TITLE

Direct Patient Care not involving contact with blood or body fluids

Good Hand Hygiene Access to gloves, goggles, masks/face shields, gowns

MD including Residents and Fellows, Nursing, RN, Manager, Supervisor, Clinical leader, Nurse practitioner, CRNA, LPN, Surgical technologist, Nursing Assistant, Student, Ophthalmic assistant, Ophthalmic technician, Ophthalmic photographer, Medical assistant, Patient service coordinator, Patient operations asst., Child life specialist, Respiratory Therapist, Radiology Technologist –MRI, CAT scan, Social worker, Discharge planning nurses, Audiologist, Nerve monitoring technician, Anesthesia technicians, Research personnel

Physical exam Gloves Gown, goggles, masks/face shields, as necessary

Handling secretions and objects or materials soiled with secretions, excretions (e.g., linen, Chux. drainage tubes)

Gloves Gown, goggles, masks/face shields AND Unit coordinator, Patient Operations Assistant, Data entry coordinator, Diet Aide, Receptionist, Security Officer,Patient Care Aide, Clinic Personnel, Pharmacy, Admitting personnel

Administration Fluorescein ICG dye

Gloves Gown, goggles, masks/face shields, as necessary

Transport Specimens Biohazard specimen bags or a hard plastic specimen containers

Gloves as necessary

Dressing changes, wound care, wound irrigation

Gloves Gown, goggles, masks/face shields, as necessary

Complex dressing changes involving large amounts of drainage or irrigation

Gloves, Gown Goggles, masks/face shields

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Central line insertion Sterile gloves, Sterile gown, masks/face shields

PROCEDURE

Central line dressing including Hickman, broviac

REQUIRED PROTECTION

Sterile gloves, sterile gown

ADDITIONALPROTECTION

Masks/face shields

JOB TITLE

Care of nonintact skin lesions, rashes, mucous membrane

Gloves Gown, goggles, masks/face shields, as necessary

Administration of IV therapy blood, blood products,

GlovesNeedleless IV system

Goggles, masks/face shields as necessary

Injection of IM, SC medication

Gloves

Secondary IV medication administration

Gloves

Injecting contrast material Gloves Gown, goggles, masks/face shields, as necessary

Endotracheal, tracheal, oral nasopharyngeal suctioning & Assisting with suctioning

Gloves, mask, goggles, or face shields

Gown

Changing suction canister Gloves Gown, goggles, masks/face shields, as necessary

Emptying drains Gloves, goggles/faceshield

Gown, as necessary

Changing needle box Gloves

Tube feeding Gloves Gown, goggles, mask/face shields if splashing likely to occur

Chest physical therapy with coughing handling of raised secretions

Gloves, goggles, masks Gown

Handling or disposing of equipment which is likely to be soiled with blood or body fluids

Gloves

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Disposing of excretions, secretions, e.g., sputum, urine, feces, emesis, blood, bile, nasogastric, pleural synovial, etc

Gloves Gown, goggles, mask/face shields if splashing likely to occur

Mouth Care Gloves Gown, goggles, mask/face shields if splashing likely to occur

Perineal Care Gloves Gown, goggles, mask/face shields if splashing likely to occur

Tubing, drainage care, e.g., Foley, Salem sump

Gloves Gown, goggles, mask/face shields if splashing likely to occur

PROCEDURE

Emptying collection systems, Foley bag, etc

REQUIRED PROTECTION

Gloves

ADDITIONAL PROTECTION

Gown, goggles, mask/face shields if splashing likely to occur

JOB TITLE

Gastric lavage Gloves Gown, goggles, mask/face shields if splashing likely to occur

Tube feeding Gloves Gown, goggles, mask/face shields if splashing likely to occur

Enema Gloves Gown, goggles, mask/face shields if splashing likely to occur

Incontinent care, colostomy care

Gloves Gown, goggles, mask/face shields if splashing likely to occur

Peritoneal dialysis Gloves Gown

PhlebotomyInitiation, tubing change, or discontinuation of IV

Gloves Gown, goggles, masks/face shields if splashing is anticipated.

Application of pressure to control minor bleeding (e.g., IV removal)

Gloves Gown, goggles, masks/face shields if splashing is anticipated.

Application of pressure to control moderate to large amounts of bleeding

Nitrile GlovesGown, goggles, masks/face shields

Blood drawing/injecting medication via implanted device

Gloves Gown, goggles, masks/face shields if splashing is anticipated

Obtaining blood specimens from arteries or arterial lines

Gloves Gown, goggles, masks/face shields if splashing is anticipated.

Obtaining Glucometer Specimen

Gloves

Restraint of Patients Gloves Gown, goggles, masks/face shields if splashing is anticipated.

AND Security Officer

Assisting with Bronchoscopy, Endotracheal intubation

Gloves, gown, goggles/masks or face shield

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Assisting with invasive procedures, e.g., Chest tube insertion, lumbar puncture etc

Gloves Gown, goggles, masks/face shields

Code-Participation in resuscitation efforts at bedside

Gloves, goggles, masks or face shields

Gowns if soiling of clothing is likely AND All responders at patient bedside

Assisting with surgical procedure

Gowns, sterile gloves, goggles/face shield, mask

AND OR Personnel

PROCEDURE

Cleaning, disinfecting equipment surfaces, items visibly contaminated with blood and body substances

REQUIRED PROTECTIOM

Gloves

ADDITIONAL PROTECTION

Gown, goggles, mask/face shields if splashing is likely

JOB TITLE

AND Environmental Services Lab Personnel

Cleaning, disinfecting equipment surfaces, items visibly contaminated with blood and body substances

Masks, goggles, face shields, plastic aprons, gowns, head cover

Booties

Transport of blood or other body fluids in plastic containers

Biohazard Specimen bag: Zip lock securely closed to prevent leaking.

Gloves if outside of specimen bag contaminated.

Transport of blood or other body fluids in containers which may puncture specimen bags, e.g., glass tubes, etc.

Specimen bag: Zip lock securely closed to prevent leaking AND hard sided container, e.g., plastic coolers.

Gloves if outside of specimen bag contaminated.

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Drawing blood Arterial

Venous

Gown, gloves, goggles, mask/face shield.

Gloves

Gown, goggles, masks/face shields, if splashing is anticipated

Administration of blood products

Gloves Gowns, goggles, masks/face shields, if splashing is anticipated

Dressing Change Gloves Gowns, goggles, masks/face shields if splashing is anticipated

Plumbing: unclogging toilets, drains

Gloves, Cover plunger with plastic bag for transport to and from job.

Goggles, mask/face shields, if splashing is anticipated

AND Maintenance plumber, HVAC tech, Maintenance tech.

Soiled laundry collection, bags for collection and transport to laundry

Gloves when touching soiled linen and wet laundry bags. Gloves, if outside of bag is wet or soiled.

Gown as needed. AND Environmental Service Aide

PROCEDURE

Removing, packaging waste

REQUIRED PROTECTION

Gloves

ADDITIONAL PROTECTION

Gown, goggles, mask/face shields, booties if soiling/splashing is anticipated

JOB TITLE

Deliver trays Gloves AND Food service aide,Diet aide, diet tech, dietary function coordinator, cook, dietary cashier

Collecting, washing soiled dishes

Gloves

Collect, review menus Gloves if contact with soiled items AND Dietician

Processing central sterile supply equipment

Gloves Gown, goggles, mask/face shields, if splashing anticipated

AND Central supply aide

Processing endoscopic/ bronchoscopic equipment

Gloves, Gown, goggles, mask/face shields, if splashing anticipated

Handling/caring for non-human primates with exposure to blood, body tissue or body fluids

Ultra thick gloves or Kevlar Gloves

Gown, goggles, mask/face shields, if splashing anticipated

Research personnel

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Cleaning up of blood, body fluid spills.

Utility Gloves Gown, goggles, mask/face shields, if splashing anticipated

Research personnel

CDC Pamphlet information for EmployeesExposure to Blood: What Healthcare Personnel Need to Know: Updated July 2003http://www.cdc.gov/ncidod/dhqp/pdf/bbp/Exp_to_Blood.pdf

Attatchment C

UNIT SPECIFIC EXPOSURE CONTROL PLAN

UNIT : _____________________________ DATE REVIEWED_________________

The MEEI is committed to providing a safe and healthful work environment for our entire staff. The following Unit Specific Exposure Control Plan (ECP) is an addendum to the Hospital Exposure Control Plan and outlines Unit Specific responsibilities and mechanisms for compliance to the OSHA standard 29 CFR 1910.1030, “Occupational Exposure to Bloodborne Pathogens.”

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Unit Specific Responsibilities

__________________is (are) responsible for the implementation of the Unit Specific ECP. _________________ will ensure that supplies of all necessary Personal Protective Equipment (PPE, ie.

gowns, gloves-in appropriate sizes, face shields etc.), Sharps containers and biohazardous waste bags are available.

_________________ will maintain, review, and update the Unit Specific ECP at least annually, and whenever necessary to include new or modified tasks and procedures. _________________ will be responsible for ensuring that Employee Health and Incident Review follow-

up* is conducted after an employee exposure to blood or body fluids. _________________ will be responsible for ensuring that Category I and II employee training and

documentation is completed. All employees who have occupational exposure to blood or other potentially infectious materials (OPIM)

must comply with the procedures and work practices outlined in this Unit Specific and the Hospital Exposure Control Plans. (OPIM= semen, vaginal secretions, cerebrospinal fluid, pleural fluid, pericardial fluid, pertioneal fluid, amniotic fluid, saliva in dental procedures, and fluid visibly contaminated with blood.)

Additional responsibilities for specific tasks will be noted where appropriate throughout this plan.

Exposure Determination

The following is a list of all job classifications for this unit in which employees have (or may have) occupational exposure (Cat. I&II employees) ________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ ____________________________________

METHODS OF IMPLEMENTATION AND CONTROL

All employees will follow Standard Universal Precautions as described in the Precaution Manual, Section II.

Personal Protective Equipment (PPE)Personal protective equipment is used whenever there is anticipation of exposure to blood or body fluids, including splashes and aerosols. (See attached departmental “Exposure Determination Form” for mandatory PPE requirements.)

PPEused in this department.

location

latex gloves Y N/Alatex free alternatives Y N/A nitrile gloves Y N/Autility gloves Y N/Aface masks with shields Y N/Aface masks Y N/AGoggles/ Side Shields Y N/Abarrier gowns Y N/AOther/Full face barriers Y N/A

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Engineering Controls

Safety DevicesPrevention of exposure to blood and body fluids is a priority. The use of commercially available and effective safer medical devices, designed to minimize exposure, is mandatory (exceptions below). The following devices have been evaluated and are in use on this unit: (list all products designed to decrease potential exposure to blood ie. BD Saf-T- Intima IV Catheter, Abbot needleless IV tubing etc.)_____________________ __________________ _____________________________________________ __________________ _____________________________________________ __________________ _____________________________________________ __________________ ________________________The following non-safety device(s) is (are) used for reasons indicated._____________________ __________________ _____________________________________________ __________________ ________________________

NCA= safety alternative not commercially available NCI= safety alternative clinically contraindicated (ie. interferes with medical procedure)*NCS= safety alternative does not decrease risk of exposure*

*supporting documentation required

Sharps Containers Sharps container selection and location should be based on functionality, accessibility, visibility, and accommodation to the needs of the area. (See Sharp’s Disposal Policies, Precaution Manual Section 6-any questions call Infection Control @ext. 3724) List types of containers used in each area of unit (ie. wall mounted-patient rooms, floor model in rolling stand-OR, table top-lab benches etc.)

_____________________ __________________ ________________________ Sharps containers will be monitored and replaced when ¾ full by __________________________ on the following schedule. (call EVS at x3095 for pick up of full containers) Daily Weekly Circle day M T W T F Monthly All MEEI staff members are responsible for monitoring the Sharp’s containers in their areas on an ongoing basis and ensuring that containers are replaced when ¾ full. Replacement container location______________________________ The following staff members are trained to replace Sharps containers.

(list job title: RN, LPN, NA, POA). _____________________________ __________________ Biohazardous Waste Disposal Biohazardous waste trash containers are located in the following locations (list areas ie. treatment rooms, utility rooms etc.)______________________________________________________________ ________________________________________________________________________________

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Red biowaste bags are located in the following locations (note specific locations_______________________________________________________________

Biohazardous waste is removed by ____________________________________________ Biohazardous waste is removed on the following schedule- daily , weekly , monthly , whenever

necessary x Call ext. 3095 for removal.

_______ ____________________________

SIGNATURE OF REVIEWER

*Incident Review follow-up to include the following: -Assessment of factors contributing to incident-Recommendations for changes in work practices/engineering controls and training as indicatedunitecpblank

Attachment D

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTHGuidelines Regarding

EXEMPTION FROM USE OF DEVICES WITH SHARPS INJURY PREVENTION TECHNOLOGY

Pursuant to 105 CMR 130.1005 and 105 CMR 130.0050, a hospital may evaluate particular devices and determine those that qualify for exemption from the requirement to use devices with Sharps Injury Prevention Technology in the delivery of patient care.

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The Massachusetts Department of Public Health (MDPH) has outlined the procedure for hospitals to follow as well as the documentation required. The following device questionnaire, supporting documentation, and determination shall be maintained at the hospital and made available to DHCQ health care surveyors upon request. The necessary documentation should not be sent to the Department unless requested.

The following process must be followed for each device that is evaluated for exemption:

- The attached device questionnaire must be completed.

- Supporting documentation, including device evaluations from healthcare workers and information from the manufacturer or relevant studies, must be included.

- The device, device questionnaire and other documentation must be reviewed by the Infection Control Committee, Sharps Committee, or other appropriate committee as identified by hospital management or medical staff.

- Points to consider and review in the evaluation include:

o Existence / availability of alternative technology on the marketo Potential interference of sharps injury prevention technology with medical procedures and

patient safety o Degree of effectiveness in preventing exposures to healthcare workers as compared with

devices without sharps injury prevention technology

- If the exemption is approved by the hospital, then the hospital must state the measures to be taken to minimize risk of sharps injuries with the device currently in use. This may include work-practice controls such as making sharps containers available at the point of use, as well as engineering controls such as add-on devices to reduce risk of injury.

- Hospitals must maintain a list of devices for which alternative devices with sharps injury prevention technology will not be used. (See attached template.)

The hospital must review and update devices and their respective exemptions annually. As required by state (105 CMR 130.1003-1004) and federal (29 CFR 1910.1030) regulations, facilities shall document annually the consideration and implementation of commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure to bloodborne pathogens. As both technology and the marketplace change, it should be recognized in the hospital’s review that new, medically appropriate devices with safety features enter the commercial market on a regular basis.

Device Questionnaire

Type of Device: _______________________________________Date: _____________________

Prepared by:____________________________________ Reviewed by: _________________

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1) Please list the specific device or technology that is being evaluated for exemption from the use of devices with Sharps Injury Prevention Technology. Please provide any specific manufacturer information regarding the device or technology.

2) Please provide information regarding the following operational practices:

a. Procedures for which the device or technology is generally used.

b. Patient populations for which the device or technology is typically used.

c. Frequency with which the device or technology is typically used, and by which staff.

3) Please indicate whether the facility has evaluated and considered alternative devices with Sharps Injury Prevention Technology. Provide specific information related to the review that identifies the facility’s determination to exclude the device with Sharps Injury Prevention Technology. Hospitals may also include any meeting minutes that include discussion about this device versus alternative devices with safety features, and quality and safety reviews.

a. Please list the alternative devices considered.

b. Please describe the circumstances in which devices with sharps injury prevention technology interfere with medical procedures under the hospital’s standards of practice.

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c. Please describe the circumstances in which sharps injury prevention technology is not more effective than the current measures used to prevent exposures to healthcare workers.

d. Please provide the final determination and rationale regarding the request to use a device without engineered sharps injury prevention features.

4) What actions will be taken to minimize risk of injury while using the conventional device?

5) How many sharps injuries have occurred with this device since the last review or within the previous 12 months?

6) Was this exemption from the use of devices with sharps injury prevention technology reviewed by any hospital committee? If so, please explain.

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The following table is designed to be a template for maintaining an inventory of devices, their respective manufacturers and the presence of safety features, as well as tracking dates of device review.

HOSPITAL: ____________________________________ DATE: _____________________

CONTACT: ________________________________________________________________________________________

Device Manufacturer Brand Model(size / gauge)

Is this device part of a commercially available pre-packaged kit? (Y/N)

Number of injuries from this device in the previous 12 months

Date of previous review

Date of most recent review (and exemption, if applicable)

Does this device qualify for exemption from use of devices with sharps injury prevention technology? (Y/N)

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