Tubing Misconnections Self Assessment for Healthcare ... (Urinary) Irrigation 16—Vascular ... coupled with TJC on ways to prevent these types of errors. Photographs show

Tubing Misconnections Self Assessment for Healthcare Facilities

DELIVERING FULL CIRCLE CLINICAL SOLUTIONS

Program Overview ................................................ 1

Process Flow ........................................................ 7

Getting Started ..................................................... 8

Data Collection ....................................................10

Analysis ..............................................................11

Action Plan ..........................................................13

Appendix A: Data Collection Tool ........................ 21

Appendix B: Data Collection Spreadsheet .......... 25

Appendix C: Action Plan Templates .................... 26

Appendix D: References ..................................... 34

Table of ContentsTubing Misconnections Self Assessment for Healthcare Facilities

Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432A 11/11

Program OverviewTubing Misconnections Self Assessment for Healthcare Facilities

W

IntroductionThe Ease of Inadvertent Tubing Misconnections Inadvertent tubing misconnections are frequent and preventable errors that

pose a significant risk to patient safety and can result in devastating outcomes.21

Tubing misconnections occur most often when Luer-activated tubing is mistakenly

connected to another type of tubing into which it can be fit, but for which it was not

designed. Healthcare providers use a variety of catheters, tubing, connectors, and

syringes to deliver medications and other substances to patients through various

delivery routes, including topical, vascular, enteral, respiratory, and neuraxial

(epidural and intrathecal). Luer connectors easily link various delivery system

equipment across multiple applications using the male and female components of

the connectors to create a secure yet detachable connection. Because of human

factors, the clinical environment, and the interconnectivity of Luer connectors,

healthcare professionals may mistakenly connect the wrong devices and deliver

substances through the wrong route.

Due to potential harm to patients, tubing misconnections have garnered the

attention of safety focused organizations including the FDA (Food and Drug

Administration), A.S.P.E.N (American Society for Parenteral and Enteral Nutrition),

ISMP (Institute for Safe Medication Practices), the ECRI Institute, TJC (The Joint

Commission), and USP (United States Pharmacopeia), as well as other patient

advocacy organizations and federal agencies.

Patient Injuries and DeathTubing misconnections have led to serious patient injuries and deaths. In 2006, TJC

published in its Sentinel Event Alert that nine cases involving tubing misconnections

reported to the organization’s Sentinel Event Database had resulted in eight deaths

and one instance of permanent loss of function.21 A study published in Critical

Care Medicine (CCM) in 2005 found that 56 percent of 114 intensive care patients

involved in a “line, tube, or drain” incident sustained physical injury; 23 percent had

an increased hospital stay; and one patient died.11 ISMP, ECRI, and the FDA have

also reported serious injuries and deaths associated with tubing misconnections.1, 4, 8, 16, 19

Welcome to the Tubing Misconnections Self Assessment for Healthcare Facilities presented by the Baxter Clinical Center of Excellence and in collaboration with the Institute for Safe Medication Practices (ISMP). This multi-tiered self assessment tool is designed to help you identify the potential causes of inadvertent tubing misconnections and to help prevent misconnections.

By successfully completing this self assessment, your institution will identify potential tubing misconnection risks in major patient care areas and develop an action plan to mitigate risks through established processes, device selection, and education.

1


Factors associated with tubing misconnections include:

1) Unsecured or loose line connections1

2) Use of unintended adapters that permit incorrect connections38

3) The positioning of functionally dissimilar tubes/tubing in close proximity to each

other (often called the “spaghetti syndrome”)2

4) The use of tubes, catheters, syringes, and connectors for unintended purposes

(such as using IV tubing and an IV infusion pump to administer breast milk

to infants, or using IV tubing and an infusion pump to connect solution to a

nebulizer cup in order to administer a constant flow of nebulized solutions of

respiratory medications)6-7

5) Movement of the patient from one setting or service to another8

6) Look-alike and unlabeled connectors/jacks1, 9

California Legislation Effective in 2014California legislators signed into law a bill prohibiting the use of intravenous, epidural,

or enteral feeding connections that fit into connection ports other than the type

for which it was intended, unless an emergency or urgent situation exists and the

prohibition impairs delivering healthcare.23 The law takes effect no later than January

1, 2014. The World Health Organization’s (WHO) World Alliance for Patient Safety

and the Collaborating Centre include catheter and tubing misconnection avoidance

among nine effective solutions to reduce the toll of healthcare related harm that affect

millions of patients worldwide.24

International StandardsThe Association for the Advancement of Medical Instrumentation (AAMI),

the International Organization for Standardization (ISO) and the International

Electrotechnical Commission (IEC) contributed to the international standard to

assess non-interconnectability characteristics of small-bore connections used in the

development of intravascular, breathing systems, enteral/gastric, urethral/urinary, limb

cuff inflation and neuraxial devices.15, 26-28 Entitled “Small-bore connectors for liquids

and gases in healthcare applications” (ANSI/AAMI/ISO 80369-1:2010), the standard

would establish engineering “forcing functions” that would strive to eliminate the

possibility of misconnections. If the FDA recognizes the standard, the Agency will

provide guidance to manufacturers regarding issues such as whether there will be

a set period of time for currently marketed devices to come into compliance and the

effect of the standard on new devices.15

It is becoming

increasingly important

for healthcare facilities

to proactively address

inadvertent tubing

misconnections and

prepare for device

changes that will

eventually reach

clinical settings.

2


With both the healthcare manufacturers and advocacy groups focused on this

issue, it is becoming increasingly important for healthcare facilities to proactively

address inadvertent tubing misconnections and prepare for device changes that will

eventually reach clinical settings.

Types of MisconnectionsThe following are examples of the types of tubes and catheters in misconnections

based on reports of actual events or near misses by the USP, ISMP, TJC, ECRI,

and FDA:

1. Neuraxial — Vascular12

• Epidural infusion administration set connected to injection port of IV

infusion administration set or IV catheter

• IV administration set used for epidural infusion connected to IV catheter or

injection port of IV infusion administration set

• Syringe containing neuraxial medication (e.g. analgesics and anesthetics)

connected to IV catheter or injection port of IV infusion administration set

2. Topical — Vascular9

• IV administration set used with an infusion device for wound management

to deliver a topical wound irrigation solution connected to injection port of

IV infusion administration set

• IV administration set connected to port of topical wound irrigation set

3. Bladder (Urinary) Irrigation — Vascular16

• IV administration set used for bladder irrigation connected to IV catheter

or injection port of IV infusion administration set

• IV infusion administration set connected to an indwelling Foley catheter

inflation port

4. Medical Device — Vascular14, 16

• Sequential compression device hose connected to injection port of IV

infusion administration set or IV catheter

• Pneumatic blood pressure cuff tubing connected to injection port of IV

infusion administration set

• Oxygen tubing connected to injection port of an IV infusion

administration set

• Syringe containing air for indwelling Foley catheter inflation port connected

to injection port of IV infusion administration set

3


5. Respiratory — Vascular4

• IV administration set connected to injection port of administration set

attached to a respiratory therapy (RT) nebulizer

• IV administration set connected to RT nebulizer

• Syringe containing parenteral medication connected to injection port of

administration set attached to RT nebulizer.

6. Hemodialysis/Peritoneal Dialysis — Vascular8

• Peritoneal dialysis solution administration set connected to IV injection port of

IV infusion administration set or IV catheter

• IV infusion administration set connected to external hemodialysis catheter

7. Enteral/Oral — Vascular6, 13

• Enteral feeding tubing connected to IV catheter or injection port of IV

administration set

• Enteral feeding tubing connected to IV catheter or injection port of IV infusion

administration set

• Syringe containing parenteral medication connected to Y-connector port of

enteral administration set

• IV infusion administration set connected to Y-connector port of enteral

administration set

• IV infusion administration set connected to enteral feeding tubing,

percutaneous feeding tube, and/or nasogastric tube

8. Enteral/Oral — Medical Device8, 16, 20

•Enteral feeding tubing connected to a tracheostomy tube

•Enteral feeding tubing connected to ventilator in-line suction catheter

•Foley catheter connected to nasogastric tube

9. Enteral/Oral — Hemodialysis/Peritoneal Dialysis8

•Enteral feeding tubing connected to peritoneal dialysis catheter

•Enteral feeding tubing connected to a port on a hemodialysis line

10. Intravenous — Arterial8, 16

• IV infusion administration set connected to injection port of arterial infusion

administration set

• Syringe of IV medication connected to injection port of arterial infusion

administration set

• Arterial infusion administration set connected to IV catheter or injection port

of IV administration set

4


Other medical tubing, catheters, and connectors with the potential for

misconnections include:

•Abdominal catheter (e.g. t-tube, wound drainage tube)

•Blakemore tube

•Cantor tube

•Chest tube

•Cranial catheter

• In-line or detachable suction tubing/connector

• Intra-aortic balloon pump (IABP) tubing

•Nephrostomy tube

•Amnioinfusion catheter (intrauterine pressure)

•Ventriculostomy catheter

•Drain

Graphic depictions of misconnection cases have been compiled by the FDA and

coupled with TJC on ways to prevent these types of errors. Photographs show

simulated “erroneous misconnections” to illustrate the reported error. Photographs

have warning labels, where appropriate, to indicate that they are erroneous

connections. These may be found at http://www.fda.gov/downloads/MedicalDevices/

Safety/AlertsandNotices/UCM134869.pdf16

www.fda.gov/cdrh/luer

eveNT

Case sTUDy

The jOINT COmmIssION safeTy TIp

U.S. Food and Drug Administration

feeding tube erroneously connected to trach tube

pOTeNTIaL fOR haRm

high

An infant in the pediatric intensive •care unit had both a feeding tube and a trach tube

The feeding tube was inadvertently •placed in the trach tube and milk was delivered into the infant’s lungs

The infant died•

Always trace a tube or catheter from the patient to the point of origin before connecting any new device or infusion

WARnInG: Photographs depict feeding tube erroneously connected to trach tube. DO nOT DO THIS!


eveNT

Case sTUDy

The jOINT COmmIssION safeTy TIp

U.S. Food and Drug Administration

An anesthetist and a midwife •mistakenly connected an epidural set to the patient’s IV tubing

The epidural medication •was delivered to the IV

The patient died•

epidural tubing erroneously connected to Iv tubing

pOTeNTIaL fOR haRm

high

For certain high-risk catheters (e.g., epidural, intrathecal, arterial), label the catheter and do not use catheters that have injection ports

WARnInG: Photographs depict epidural tubing erroneously connected to IV tubing. DO nOT DO THIS!

Medical Device Safety Calendar 2009


5


Self Assessment RationaleThe Tubing Misconnections Self Assessment for Healthcare Facilities will help you

identify devices and practices that pose a risk of inadvertent tubing misconnections

and help prioritize your efforts to mitigate those risks. The self-paced and self-

directed risk analysis can be tailored to your healthcare facility, specific at risk patient

populations, and the catheters, tubing, connectors, and syringes used in your facility.

ObjectivesUpon completion of this self assessment, you will be able to:

• Identify and prioritize devices and practices vulnerable to tubing

misconnections.

• Establish processes and device selection guidelines to help safeguard

against misconnections.

MethodologyThe self assessment guides users through a modified risk assessment. To complete the

analysis, users evaluate current delivery systems and mating devices, rate the ease of

connection and potential for patient harm, and assign risk priority scores.

OutcomesFacilities using this self assessment and the available resources and recommendations

can expect to:

•Prioritize a list of at risk devices and processes.

• Identify strategies to minimize the risk of inadvertent tubing misconnections.

• Develop an action plan to implement strategies to help minimize the risk of

tubing misconnections.

For questions about this self assessment, please contact:

Center for One Baxter

(8 a.m. – 5 p.m., CST, Monday - Friday)

at 800-422-9837

or

e-mail [email protected].

6Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432B 11/11

Pre-implementation

Implementation

Use the findings from your risk assessment and analysis to develop an action plan. Use the Action Plan Templates (found in Appendix C) to help document and organize your institution’s risk of tubing misconnections.

Implementation

PlanningDetermine awareness level of tubing misconnections risk.

Establish a multi-disciplinary committee.

Determine the scope of the assessment.

Use the Examples of Misconnection Types in the Program Overview Section to help identify the devices for evaluation.

Process FlowTubing Misconnections Self Assessment for Healthcare Facilities

Analysis & InterpretationEnter the data from Ease of Connection and Potential Harm scores recorded in the Data Collection Tool into the Data Collection Spreadsheet.

Review the Risk Rating Graph and Data Collection Spreadsheet Summary, prioritizing the risk, with consideration of the factors identified in the Interpreting Findings section of this assessment.

Test connections among the targeted devices.

Assign an Ease of Connection score.

Data Collection

Calculate a Risk Priority Number (RPN).

Assign a Potential Harm score.

7Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432C 11/11

TFirst StepsAchieving a successful outcome depends on participation and support from

all levels of hospital leadership, management, and staff. Gaining commitment

from your institution’s leadership early in the process, may help achieve

institutional support.

1. Meet with key members of your institution (including administrators, clinical

managers, patient care providers, risk managers, educators, and materials

management) to determine the level of awareness of tubing misconnections risk

in their respective departments.

2. Establish an interdisciplinary team to help assess misconnections in your

institution. Include representatives from the following areas/departments: Quality,

Risk Management, Patient Care Units, Anesthesia, Radiology, Pharmacy, Clinical

Education, IV Therapy Team, Respiratory Therapy, Biomedical/Clinical Engineers,

and Materials Management. Be sure to include frontline staff who routinely use

medical devices. Assign the organization’s patient safety officer, medication

safety officer, or other qualified professional to lead the team.

3. Determine the scope of the assessment based on your organization’s desired

objectives. While a system-wide assessment should be the aspired goal, resource

limitations may require several small scale assessments in targeted areas,

such as:

• Unit-specific (e.g. neonatal intensive care unit, emergency department,

medical-surgical, critical care, labor and delivery, oncology)

• Therapy-specific (e.g. enteral feedings, pain management)

• Facility-wide (for health systems with multiple facilities)

4. Based on the scope of the assessment, review the Types of Misconnections in

the Program Overview section to help determine which are available or potentially

available in the selected area(s) under evaluation. Additionally, consider any other

disposables and devices that are specific to your institution that are not included

on the list.

Thoughtful preparation and attention to the process help yield both relevant results and an attainable action plan. Following these suggestions and meeting the key milestones outlined in the Process Flow will help you successfully use this tool and adapt it to the needs of your institution.

Getting StartedTubing Misconnections Self Assessment for Healthcare Facilities

8

EASE OF CONNECTION x POTENTIAL HARM = RISK PRIORITY NUMBER

Ease of Connection Scale

1 Unable to connect

Unable to make connection even with extreme manipulation, force, and/or damage or modification to device; Easy to see that devices not intended to be connected

2Extremely difficult

to connectConnection made with extreme manipulation, force, and/or damage or modification to device

3 Moderately difficultConnection made with moderate manipulation, force, and/or modification to device; Connection made with no equipment damage

4 Moderately easy

Connection made with minimal manipulation and/or forceConnection made with no device modification or damage; Seemingly correct fit

5 Very easyPerfect fit with no manipulation, force, or device modification or damage;Hard to detect misconnection

Potential Harm Severity Scale

1 No harm No harm to patient

2 Minor harm Minor harm to patient;No intervention anticipated

3 Low harm Injury of limited extent or duration;Minimal or no intervention anticipated

4 Moderate harm

Injury significant and/or enduring Intervention anticipated;Injury not expected to impact quality of life and life expectancy

5 High Harm

Injury serious, may be life-threatening or deadly; Intervention anticipated;Injury expected to diminish quality of life and life expectancy

Next Steps 1. Confirm you have downloaded the Tubing Misconnections Self Assessment for

Healthcare Facilities Data Collection Spreadsheet – Appendix B, from

www.baxter.com.

2. Identify participating units.

3. Review the Ease of Connection and Potential Harm Severity Scales (below and in

Appendix A) with the assessment team.

4. Review the devices (e.g. tubing, syringes, catheters, connectors) that will be

included in the assessment.

5. Identify locations where the devices to be assessed are stored.

6. Gather targeted disposable devices for the team to assess.

7. Plan how the team will assess connections with devices that are not disposable,

equipment that is not easily gathered, or devices that may be costly to open

and manipulate.

8. Perform the assessment as described in the Data Collection section.

Quick Tip:

When determining the

scores associated with Ease

of Connection and Potential

Harm, consider variables

that may influence these

scores, such as the types

of medications/solutions,

the patient population, and

the typical infusion rates.

Getting StartedTubing Misconnections Self Assessment for Healthcare Facilities

9Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432D 11/11

Instructions

1. Gather the Tubing Misconnections Data Collection Tool (Appendix A), which includes the Ease of Connection Scale and the Potential Harm Severity Scale, and the targeted devices (as possible). It is suggested that potential connections be grouped by the Connection Type.

2. Test connections among the targeted devices (e.g. tubing, syringes, connectors, catheters). Be sure to assess connectivity if devices can be connected in unintended ways or by means of jury-rigging or significant device manipulation.

3. Using the Ease of Connection Scale, rate the extent of force, manipulation, and/or device modification or damage required to make the connection.

4. Using the Potential Harm Severity Scale, rate the severity of potential patient harm that would result if the connection is made. Please note: Only device connections that were assessed a score of “2” or above for Ease of Connection should be given a Potential Harm Severity score. Device connections that scored “1” on Ease of Connection — meaning the connection cannot be made despite extreme force or manipulation — do not require a Potential Harm score.

5. Document the results using the Data Collection Tool.

6. Calculate the Risk Priority Number (RPN) by multiplying the Ease of Connection and Potential Harm Scores. Add pertinent comments regarding frequency of use and current unit-specific or organization-wide safety practices associated with the devices. (See the following examples.)

Examples

Connection Type: IV Tubing

Mating Device: Respiratory Nebulizer

Patient Care Area: ICU

Ease of Connection Potential Harm Risk Priority Number

3 x 4 = 12

Frequency of Use: Daily on post-op orthopedic surgeriesComments:A 2 RN check is required before connection.

Connection Type: Blood pressure/Tube

Mating Device: Venous Injection Port

Patient Care Area: All nursing units that administer IV solutions


4 x 5 = 20

Frequency of Use: DailyComments:There is variability in the blood pressure equipment (NIBP). Only model #124 mates with the valve on IV tubing.

Data CollectionTubing Misconnections Self Assessment for Healthcare Facilities

10Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432E 11/11

Instructions

1. Open the Data Collection Spreadsheet (Appendix B) and enable the macros in Excel per the instructions on the first worksheet.*

2. Enter the data you’ve recorded from the Data Collection Tool (Appendix A) into the spreadsheet.

3. After entering the data, the spreadsheet will:

■ Calculate the Risk Priority Number (RPN) Ease of Connection x Potential Harm = RPN

■ Generate a Risk Rating Graph ■ Provide a Data Collection Summary

4. Review the graphs and Summary rankings to prioritize risk.

* Note: The System Requirements to run the Data Collection Summary Spreadsheet are a WINDOWS PC with Office 2003 or Office 2007. This application is not compatible with MACINTOSH systems.

Interpreting Findings1. The Risk Rating Graph provides a visual expression of the connection types

posing risk in your institution. Pay close attention to:

• Circles in the upper right, which represent connection types that are

easy to make and pose a risk to patients (RPN 15 to 25).

• Circles in the upper left, which represent connection types that are

not easy to make but still pose a risk to patients (RPN less than 15).

2. The Data Collection Summary ranks the Risk Priority Numbers from highest to

lowest. Note which connection types have received higher rankings. This may

help in prioritizing risk and developing your action plan.

3. After reviewing the findings, consider the following when prioritizing the risk within

your institution:

• Frequency of using the devices

• Reported events or near misses within your institution

• Reports of events or near misses in the literature8

• Detection and prevention strategies already in place to reduce the risk of

misconnections, and the anticipated effectiveness of those strategies

AnalysisTubing Misconnections Self Assessment for Healthcare Facilities

11

•Unique institutional variables, including:

■ High staff turnover ■ Significant number of per diem/traveling nurses ■ Presence of students in a teaching facility ■ Staff shared between units/floating nurses ■ Use of rental equipment ■ Experience with device shortages ■ Absence of dedicated in house transport team

AnalysisTubing Misconnections Self Assessment for Healthcare Facilities

12Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432F 11/11

Action Plan

Risk Reduction StrategiesTJC30, ISMP13, USP30, ECRI1, FDA16, WHO25, A.S.P.E.N.30 and other patient safety-

focused organizations33 and researchers29 offer the following strategies to help

mitigate the risk of tubing misconnections. Organizations are encouraged to review

the following recommended risk reduction strategies during the development of an

action plan to address tubing misconnections:

Use Forcing Functions (designs that strive to eliminate the possibility of misconnections)

• Use only oral syringes for oral liquid medications. Never use a standard

Luer syringe for oral medications or enteric feedings.30

• Use only oral syringes for enteral medications or solutions.30

• Use only administration sets without injection ports for epidural infusions.1

• Purchase non-intravenous devices (e.g. nebulizers, NIBP) that are

equipped with connectors that cannot physically mate with a female Luer

IV line connector.1

• Purchase enteral feeding sets and gastrointestinal tubes that do not

mate with female Luer connectors (e.g. compliant with American

National Standards Institute/Association for the Advancement of Medical

Instrumentation [ANSI/AAMI] standard ID54).1, 13, 30

Tubing Misconnections Self Assessment for Healthcare Facilities

Use the findings from the risk assessment and analysis to develop an action plan to increase staff awareness

and help reduce the risks of tubing misconnections. The action plan could include:

•Barriers that prevent tubing misconnections

• Implementation of redundancies to help prevent misconnections before they lead to patient harm

•Recovery strategies to help reduce harm caused by tubing misconnections

•Equipment maintenance plans

•An educational campaign to increase awareness

•Product selection guidelines

•Development of a tubing misconnections prevention policy for the institution

•Process to further review current devices and future device acquisitions

Provide the risk assessment findings and action plan to hospital administration for support in promoting

activities presented in the action plan.

Use the Action Plan Template (Appendix C) to help document and organize your institution’s risk of tubing

misconnections.

Instructions

13

• If possible, use enteral pumps that feature an automatic flush mode

so manually flushing lines is not required (which makes it less likely for

staff to use an adapter that links the enteral administration set with a

Luer connector).1

• Avoid buying pre-filled enteral feeding containers, except for those with

design technology labeled non–IV compatible. This technology, just

recently introduced in the United States, uses a screw-top design that

reduces compatibility with IV equipment.30

• When appropriate, purchase devices with connectors that have locking

mechanisms to keep the connection secure.1

Use Differentiation • Dispense intrathecal medications in overwraps that help differentiate these

syringes and bags from other medications intended for IV administration.12

• Dispense IV vincristine in a small volume bag to differentiate it from

syringes used for intrathecal medications.12

• Use only tubing without injection ports for epidural infusions to distinguish

it from typical IV tubing.1, 8, 12 Yellow striped tubing must only be used for

epidural infusions.

• Use distinctly different pumps for IV delivery and epidural delivery of

medications/solutions.12, 14

Provide Reminders• Purchase products with warning labels or deliberate differentiating

markings when possible (e.g. oral syringes that are tinted and labeled

“For Oral Use Only”).1, 30

• Place labels (indicating what the port/line is being used for) on distal ports

and tubing of certain high risk access lines, such as epidural, intrathecal,

and arterial lines.8, 13, 14 (A neon sticker stating “Epidural” is often included

in special epidural administration sets.)

• Label pumps and bags used to deliver epidural medications as

“EPIDURAL ONLY.”8, 12, 14

• Label enteral pumps as “ENTERAL ONLY.”30

Improve Access to Information and Tools• Always hang infusion bags with labels facing out so they can be read.

Make sure labels are on the same side of the infusion that includes any

other important preprinted information.12, 14

• Supply all clinical areas with oral syringes, and ensure staff is thoroughly

familiar with the design and purpose of all syringes and their important

safety features, particularly their inability to be connected to IV or other

male Luer ports.13

Action PlanTubing Misconnections Self Assessment for Healthcare Facilities

14

• Report all misconnections in accordance with your institution’s

guidelines—even those that are caught before harm occurs—to clinical

engineering, the patient safety officer, risk management, the device

manufacturer, ISMP (https://www.ismp.org/orderForms/reporterrortoISMP.

asp) and ECRI (www.ecri.org/problemreport). (ISMP shares all reports with

the FDA, anonymously, if desired.)1, 12, 14, 16-18

• Ensure that the appropriate administration set is packaged with

medication infusions and enteral feeding bags before they are sent

to/stocked in patient care units.1, 3, 6

• Purchase adequate numbers of enteral pumps so that IV pumps are not

needed for delivery of enteral products.30, 35-36

Improve Environmental Performance Shaping Factors• Turn on the light in a darkened room or use a flashlight before connecting

or reconnecting tubes or other devices. 8, 14

• Place infusion pumps on opposite sides of the bed when administering

infusions via different routes of administration. When possible, do not keep

them next to each other or place them on the same pole.8, 12, 14

• Route tubes and catheters that have different purposes in different

standardized directions (e.g. IV lines routed toward the patient’s head,

enteral lines routed toward the patient’s feet).1, 30

Verify During Connection• When connecting any new device or product, always trace the

connection port on the tube or catheter to the point of origin or entry

into the patient.1, 3-14, 16-19, 22, 24, 25, 30-34

• Ensure that all device connections are secure when making a connection

or reconnection.1

Implement Redundancies to Help Prevent Misconnections• Require an independent double check at the bedside of all epidural

medications and selected high alert IV medications (e.g. IV opioids)

to verify correct line attachment before administration.12, 14

• Upon arrival at a new setting or as part of a handoff process, develop a

standardized “line reconciliation” process to recheck all connections and

trace all patient tubes and catheters to their source. If not already done,

label all tubes and catheters at the point(s) of connection.1, 8, 30

Recovery Strategies to Help Reduce Harm• Develop resuscitation protocols to treat toxicity associated with

administration of drugs by the wrong route.12, 14

• Establish a policy that states the course of action to follow if a line

disconnects in an area without a qualified licensed practitioner present

to reconnect the line.34


15

Equipment Maintenance Plans1

• Ensure that all clinical engineering staff performing equipment repairs

are aware of tubing misconnection issues, and that they avoid modifying

devices in ways that might facilitate misconnections.

• During testing of new equipment, require clinical engineering staff to look

for conditions that might invite misconnections with medical devices, and

to report these conditions to risk management so they can be addressed.

• During inspection and preventive maintenance procedures, require clinical

engineering to assess all fittings and replace worn connectors to ensure

that safety mechanisms are functional.

Education and Awareness• Implement an ongoing campaign designed to educate all clinical and non-

clinical staff about the dangers of tubing misconnections. The educational

campaign should be initiated during orientation and reinforced periodically

in training curricula for all staff, including per diem and temporary staff.

Include education regarding:

Types of medical devices used in your facility and their

intended purposes1

Causes of tubing misconnections12, 14

Potential serious consequences that could result from tubing

misconnections1, 8, 12, 14

Examples of actual tubing misconnections that have occurred

in the organization and in other organizations, as reported in

the literature1, 8, 16, 30

Personnel that is authorized to connect, reconnect, and

disconnect medical devices1, 5, 8

Instruction for non-authorized staff, patients, and their families to

call for assistance from the clinical staff in the case of accidental

disconnections or if other concerns regarding a patient’s device or

infusion connections arise.1, 5, 8, 34

Refusals of requests to connect or disconnect medical tubing

when it is not in a staff member’s scope of practice5, 34

Prohibition of device modification (e.g. cutting off tip of tubing),

adaptation, use of force, jury rigging, or manipulations that could

compromise device safety features in order to create a makeshift

connection between devices1, 6-8, 12, 14, 34, 35


FOR PATIENT SAFETY

Please contact staff member

for assistance with connecting

or disconnecting any tubing,

wires, equipment or devices .

M I S C O N N E C T I O N S

” C H E C K B E F O R E Y O U C O N N E C T ”

M I S C O N N E C T I O N S

16

Enforcement of key risk prevention strategies, including a firm

policy on tracing tubes and catheters to point of origin before

connections are made, and labeling of intravenous, PCA, epidural,

intrathecal, and arterial lines.1, 6-14, 34, 35

Assumption that two pieces of tubing connect because of

matching adapters or “standard/familiar” tubing types34

• Use tubing misconnections simulation training during orientation and

annual safety competencies.14, 16, 18, 19

• Inform patients and their families that they must notify clinical staff

whenever there is a real or perceived need to connect or disconnect

tubing or other devices.8, 34

• Explain the purpose of each piece of tubing, line, or other device to the

patient and family so they can also monitor for unintended variation.34

• Provide staff and patients with posters, brochures, or other informational

pieces that communicate the dangers of potential tubing misconnections

and strategies for preventing them.34 (Free posters are available at: http://

www.americannursestrainingassociation.com/tubing%20misconnections.

html#q4)

• Provide education to staff before using new syringes, tubes, catheters,

or connectors. Include discussion about possible sources of errors

uncovered during an initial risk assessment and steps to avoid

these errors.14

• Ensure that staff receives training from the manufacturer before using

new equipment so they know how to use it correctly and understand

its safeguards.1

Product Review and Selection Guidelines• Establish a device selection policy to ensure that, whenever possible, only

devices with effective design solutions are purchased and used in patient

care areas.1 Formalize an internal review process for all new acquisitions

of devices with connectors to identify the potential for misconnections with

existing syringes, catheters, tubes, and connectors.1, 8, 30 Do not permit

“special order” items to bypass the internal review process.

• Conduct pre-purchase evaluations in which device users can “play” with

the device to uncover misconnection hazards before purchasing and

using the devices. (Refusal to purchase unsafe equipment will also drive

manufacturers to create better designed devices.)1

• In general, avoid buying devices with connectors for functions that are

interchangeable or look like other connectors that serve different functions.1

• Limit and standardize the number and types or brands of the same

devices when possible.8


FRONT BACK

INSIDE

4. Inform non-clinical staff,patient and their families that theymust get help from clinical staffwhenever there is a real orperceived need to connect ordisconnect devices or infusions.

5. Whenever possible, route tubes& catheters having differentpurposes in different standardizeddirections.

a. IV lines routed toward the headb. Enteric lines toward the feet

6. Use oral medication syringes todeliver medication; do not use astandard luer syringe for oralmedications or enteric feedings.

- ܀ -

Nursing InterventionsTo Prevent

Misconnections:

1. Always trace a tube or catheterfrom the patient to the point oforigin before connecting any newdevice or infusion.

2. Line reconciliation: Recheckconnection & trace all patienttubes & catheters to their sourcesupon the patient’s arrival to anew setting or service as part ofthe hand-off process.

3. Label epidural, intratheral andarterial catheters.

- ܀ -

DON’T BE A MISFIT;CHECK BEFORE YOU CONNECT!

TUBING MISCONNECTIONS:A persistent and

potentially deadly occurrence

The above Tubing MisconnectionsSentinel Event Alert was issued by theJoint Commission on Accreditation ofHealthcare Organizations in April 2006.

In a tertiary healthcare setting medicaldevices are connected to patients for thepurposes of delivering medications, gases& enternal feedings.

These devices frequently have similar &often identical connectors. The multitudeof similar connectors in a clinicalenvironment may lead a patient careprovider to connect two devices whichhave different intended purpose, thusleading to a “misconnection.”

[email protected] ܀ -

MISCONNECTIONS

17

Additional Risk Reduction Strategies• Staff members who are allowed to connect, disconnect, or reconnect

medical tubing should be limited to those who have received institution

approved healthcare training and education on safety measures regarding

the serious risks associated with misconnections.5

• In each staff member’s job description, define whether the task of

performing connections and disconnections of tubing falls within a safe

and acceptable scope of practice. Be specific regarding technicians who

work in diagnostic areas, transport staff, nursing assistants, and students,

who might routinely encounter this situation.34

• Avoid using dual channel pumps for infusions via different routes

of administration.12

• Limit the frequency of disconnecting and reconnecting tubing (particularly

IV tubing) to reduce the risk of misconnections and infections.14

• Remove adapters and connectors from care areas where they are not

essential to reduce the likelihood of work arounds, jury rigging, and

improper connections. Remind staff that the need for an adapter could

signal that the connection should not be made.1, 30

• When possible, use connector designs (e.g. locking connectors) that

reduce the risk of disconnections.1

• Store medications for different routes of administration in different

locations.12, 30

• Deliver and administer one time doses of intrathecal medications in an

area separate from any other medications, particularly IV medications. In

low volume use areas, dispense epidural medication immediately before

use and hand it to an authorized clinician. In high volume areas, place the

medication immediately in the appropriate storage locations.12

• Dispense oral liquid medications from the pharmacy when possible in unit-

of-use oral syringes.13

• Nasogastric tubes should be connected only to oral syringes via

enteral syringe extension sets (non-Luer syringe extension sets for

enteral feeding).6

Quick Tip:

To keep pace with the

changes at your institution,

make the self assessment

for tubing misconnections

an ongoing process.


18


19

Monitoring and Revising the Self Assessment• Minimizing tubing misconnections requires monitoring of established

procedures and protocols.

• Establish a procedure for reviewing the results of the self assessment and

established action plan.

Note: It is the responsibility of the healthcare providers to report any adverse events/

complaints to the FDA and manufacturers.

The Action Plan is a dynamic document that should reflect changes in regulatory

guidance and new product acquisitions, as well as educational requirements of

clinical staff to maintain a high level of awareness. The self assessment should be

conducted at appropriate intervals in keeping with changing hospital dynamics.

For questions about this self assessment, please contact:

Center for One Baxter

(8 a.m. – 5 p.m., CST, Monday - Friday)

at 800-422-9837

or

e-mail [email protected].

Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432G 11/11

Legal DisclaimersTubing Misconnections Self Assessment for Healthcare Facilities

• The information published in this Self Assessment is for general and educational

purposes only. This information is not meant to be construed as medical advice,

diagnosis or treatment. No action or inaction should be taken based solely on

the information provided in this Self Assessment. Baxter, in collaboration with the

Institute for Safe Medication Practices (ISMP), has made all reasonable efforts to

ensure that all of the information provided through this Self Assessment is accurate

at the time of the inclusion; however Baxter and ISMP make no assurances as

to the accuracy, currency or completeness of the content provided in this Self

Assessment.

• THIS SELF ASSESSMENT IS PROVIDED “AS IS.” BAXTER AND ISMP MAKE NO

REPRESENTATIONS OR WARRANTIES AS TO THE INFORMATION OR MATERIALS

PROVIDED IN THIS SELF ASSESSMENT. YOU EXPRESSLY AGREE THAT YOUR

USE OF THIS SELF ASSESSMENT IS AT YOUR SOLE RISK. BAXTER AND ISMP

DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT

LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A

PARTICULAR PURPOSE.

• Neither Baxter nor ISMP shall be liable for any indirect, special, incidental,

consequential or punitive damages, arising out of the use of this Self Assessment.

By using this Self Assessment you agree to the exclusions and limitations of liability

stated above and accept them as reasonable.

20

Appendix A

Data Collection Tool Tubing Misconnections Self Assessment for Healthcare Facilities

Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432H 11/11

21

Appendix A


Ease of Connection Scale

1 Unable to connectUnable to make connection even with extreme manipulation, force, and/or damage or modification to device;

Easy to see that devices not intended to be connected

2Extremely difficult

to connectConnection made with extreme manipulation, force, and/or damage or modification to device

3 Moderately difficultConnection made with moderate manipulation, force, and/or modification to device;

Connection made with no equipment damage

4 Moderately easy

Connection made with minimal manipulation and/or force

Connection made with no device modification or damage;

Seemingly correct fit

5 Very easyPerfect fit with no manipulation, force, or device modification or damage;

Hard to detect misconnection

EASE OF CONNECTION x POTENTIAL HARM = RISK PRIORITY NUMBER

22

Potential Harm Severity Scale

1 No harm No harm to patient

2 Minor harmMinor harm to patient;

No intervention anticipated

3 Low harm

Injury of limited extent or duration;

Minimal or no intervention anticipated

4 Moderate harm

Injury significant and/or enduring

Intervention anticipated;

Injury not expected to impact quality of life and life expectancy

5 High harm

Injury serious, may be life-threatening or deadly;

Intervention anticipated;

Injury expected to diminish quality of life and life expectancy

Appendix A


Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

P O T E N T I A L C O N N E C T I O N S

Appendix A


Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

Connection Type:

Mating Device:

Patient Care Area:


x =

Frequency of Use:

Comments:

P O T E N T I A L C O N N E C T I O N S

Appendix B

Data Collection Spreadsheet Tubing Misconnections Self Assessment for Healthcare Facilities

Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432I 11/11

25

Please refer to the downloaded Excel spreadsheet.

(See page 9, step 1, of this assessment.)

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Appendix D

ReferencesTubing Misconnections Self Assessment for Healthcare Facilities

1) ECRI. Preventing misconnections of lines and cables. Health Devices.

2006;35(3):81-95. https://www.ecri.org/Documents/Patient_Safety_Center/

Preventing_Misconnections_of_Lines_and_Cables.pdf

2) Clark D. (1994). Untangling the “spaghetti syndrome” — inspiration for a

business. Revolution; 4(4): 55-56.

3) Cook TM, Seavell CR. (1996). Patient transfer; what to do about the “spaghetti”.

Anaesthesia; 51(1): 90-91.

4) ISMP. Problem persists with life-threatening tubing misconnections. ISMP

Medication Safety Alert! 2004;9(12):1-2. http://www.ismp.org/newsletters/

acutecare/articles/20040617.asp

5) ISMP. Worth repeating…IV tubing misconnected to tracheostomy collar. ISMP

Medication Safety Alert! 2007;12(12):1-2

6) ISMP. Preventing accidental IV infusion of breast milk in neonates. ISMP

Medication Safety Alert! 2006;11(12):1-2.

7) ISMP. Questionable safety with continuous inhalation albuterol infusion set-up.

ISMP Medication Safety Alert! 2010;15(11):1-2.

8) The Joint Commission. Tubing misconnections — a persistent and potentially

deadly occurrence. Sentinel Event Alert. 2006;36:1-4. http://www.premierinc.

com/quality-safety/tools-services/safety/topics/tubing-misconnections/

downloads/jcaho-sentinel-event-issue-36.pdf

9) ISMP. Dakin’s solution accidentally given IV. ISMP Medication Safety Alert!

2010;15(21):1-2.

10) ISMP. Blood pressure monitor tubing may connect to IV ports. ISMP Medication

Safety Alert! 2003;8(12):1-2.

11) Needham DM, Sinopoli DJ, Thompson DA et al. (2005). A system factors

analysis of “line, tube and drain” incidents in the intensive care unit. Crit Care

Med; 33(8): 1701-1707.

12) ISMP. Epidural-IV route mix-ups: reducing the risk of deadly errors. ISMP

Medication Safety Alert! 2008;13(13):1-3.

13) ISMP. Oral syringes: a crucial and economical risk-reduction strategy that has

not been fully utilized. ISMP Medication Safety Alert! 2009;1(21):1-3.

14) ISMP. Preventing catheter/tubing misconnections: much needed help is on the

way! ISMP Nurse Advise-ERR. 2010;8(12):1-2.

34

15) FDA. Letter to manufacturers of enteral feeding tubes. July 9, 2010.

http://www.premierinc.com/quality-safety/tools-services/safety/topics/tubing-

misconnections/downloads/FDA-Enteral-Feeding-Tube-Letter.pdf

16) FDA. Look. Check. Connect. Medical device safety calendar 2009. Available

at: http://www.premierinc.com/quality-safety/tools-services/safety/topics/tubing-

misconnections/downloads/FDA-Medical-Device-Calendar-2009.pdf

17) FDA. Luer misconnections. Medical Devices. Available at: http://www.fda.gov/

MedicalDevices/Safety/AlertsandNotices/ucm134863.htm

18) FDA. Luer lock misconnections can be deadly. Patient Safety News. December

2005. http://www.premierinc.com/quality-safety/tools-services/safety/topics/

tubing-misconnections/downloads/fda-luer-lock-misconnections.pdf

19) FDA. More patient deaths from Luer misconnections. Patient Safety News.

October 2007. http://www.accessdata.fda.gov/psn/transcript.cfm?show=68#5

20) Hicks R, Provan LN. Preventing tubing misconnections: a practical view.

Safe Practices in Patient Care. 2009;3(2):2-8. http://www.safe-practices.org/

SafePractice8.pdf

21) The Joint Commission. Summary data of sentinel events reviewed by The Joint

Commission. December 2010. http://www.jointcommission.org/assets/1/18/

SE_Data_Summary_4Q_2010_(v2).pdf

22) FDA. Luer connector misconnections: under-recognized but

potentially dangerous events. Webcast. FDA and Beaumont Hospital.

November 19, 2008. http://www.fda.gov/MedicalDevices/Safety/

MedSunMedicalProductSafetyNetwork/ucm127745.htm

23) California Assembly Bill (AB) 818 (Hernandez, Chapter 476, Statutes of 2009).

http://www.cdph.ca.gov/certlic/facilities/Documents/LNC-AFL-09-41.pdf

24) World Health Organization (WHO). WHO launches ‘nine patient safety solutions.’

May 2, 2007.

http://www.who.int/mediacentre/news/releases/2007/pr22/en/index.html

25) World Health Organization, The Joint Commission, Joint Commission

International. Avoiding catheter and tubing mis-connections. WHO

Collaborating Center for Patient Safety Solutions. May 7; 1(7): 1-3. http://www.

ccforpatientsafety.org/common/pdfs/fpdf/presskit/PS-Solution7.pdf

26) Association for the Advancement of Medical Instrumentation (AAMI). ISO/IEC

small bore connector new work proposal package including contact information.

August 2006. http://www.aami.org/Applications/CommitteeCentral-app/

Documents/SBC_PA.pdf

Appendix D


35

27) International Organization for Standardization (ISO). ISO/CD 80369-1. Updated

2008. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.

htm?csnumber=45976

28) Standards to focus on tubing misconnections. Healthcare Purchasing

News. October 2008. http://www.hpnonline.com/inside/2008-10/0810-or-

gowns&drapes.html

29) Lovell MA, Mudaliar MY, Klineberg PL. (2001). Intra-hospital transport of

critically ill patients: complications and difficulties. Anaesth Intensive Care; 4:

400-405.

30) Guenter P, Hicks RW, Simmons D, Crowley J, et al. Enteral feeding

misconnections: a consortium position statement. J Com J on Qual and Patient

Safety. 2008;34(5);285-292. http://www.premierinc.com/quality-safety/tools-

services/safety/topics/tubing-misconnections/downloads/S5-JQPS-05-08-

guenter.pdf

31) Hicks R, Pratt N, Simmons D. Panel discussion: tubing misconnections: where

are we today? Safe Practices in Patient Care. 2010;4(2):2-3. http://www.safe-

practices.org/SafePractice11.pdf

32) National Patient Safety Agency. Neuraxial update. February 2001;2:1-5.

http://www.nrls.npsa.nhs.uk/resources/patient-safety-topics/medical-device-

equipment/?entryid45=94529

33) Gallauresi B, Eakle M, Morrison A. Misconnections between medical devices

with Luer connectors: under-recognized but potentially fatal events in clinical

practice. Safe Practices in Patient Care. 2009;3:1,4-8. http://www.safe-practices.

org/SafePractice8.pdf

34) American Nurses Training Association. Tubing misconnections. 2007.

http://www.americannursestrainingassociation.com/tubing%20misconnections.

html#q4

35) ISMP. Improvised drug delivery: a cause for concern. ISMP Medication Safety

Alert! 2004;9(8):1-2.

36) ISMP. Worth repeating. ISMP Medication Safety Alert! 2003;8(6):2.

37) Jones S.A., Guenter P.: Automatic flush feeding pumps: A move forward in

enteral nutrition. Nursing 27:56–58, Feb. 1997.

38) Pennsylvania Patient Safety Authority. Tubing Misconnections: Making the

Connection to Patient Safety. Vol. 7, No 2-June 2010; 41:45.

Appendix D


Baxter and Connections Portfolio and Design are trademarks of Baxter International Inc.All other trademarks, brands or product images appearing herein are the property of their respective owners.Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073, www.baxter.com 750432K 11/11

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