Preventing Catheter and Tubing Misconnections

Transcription

Preventing Catheter and Tubing Misconnections: Risk Assessment and Interventions that Work ‐ October 24, 2013
Preventing Catheter and Tubing Misconnections:
Risk Assessment and Interventions that Work
Michael R. Cohen, RPh, MS, ScD (hon), DPS (hon)
President
Institute for Safe Medication Practices
2013
Sponsored by an educational grant from Baxter
4
© ISMP 2013
Objectives
• Part I
– Explore the issues surrounding tubing and catheter
misconnections
– Present a FREE tool that guides users through a
modified risk assessment of potential misconnections
– Provide an update on standards for incompatibility of
unrelated delivery systems
• Part II
– Describe interventions including differentiation of infusion
pumps, task lighting, line labeling, and behavioral
expectations
– Explain I-TRACE, which provides procedural guidance
5
Tubing misconnections: The issues
• Typical patient connected via tubes and catheters to several
delivery systems
• Small-bore connectors used to connect medical devices to
tubing/catheters
• Misconnections happen when a tube from one delivery system
is connected to another delivery system that serves a different
function, often with fatal outcomes
• Misconnections attributed in part to universal design of Luer
connector systems common to catheters, tubes, administration
sets, syringes, other connectors
Luer slip
Luer lock
6
1
Other factors associated with misconnections
• Unsecured or loose line connections
• Use of unintended adapters that permit incorrect connections
• Positioning of functionally dissimilar tubes/tubing in close
proximity to each other (spaghetti syndrome)
• Use of tubes, catheters, syringes, and connectors for
unintended purposes
• Movement of the patient from one setting/service to another
• Look-alike and unlabeled connectors
• Allowing unlicensed, untrained staff to connect/disconnect
tubes, connectors
• Environmental distractions/clutter/dim lighting
7
Enteral/Oral—Medical Device
Feeding tube erroneously connected to trach tube
 Infant in NICU had feeding tube
and tracheostomy
 Feeding tube accidentally placed in
trach tube
 Milk delivered to infant’s lungs
 Infant died
WARNING: Photographs depict
feeding tube erroneously
connected to trach tube.
DO NOT DO THIS!
Potential for Harm: High
Pictures: FDA case studies at Look. Check. Connect.
http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM134873.pdf
8
Neuraxial—Vascular
Epidural infusion erroneously connected to IV tubing
epidural tubing erroneously
connected to IV tubing.
DO NOT DO THIS!
 Nurse accidentally spiked a bag of
bupivacaine and fentanyl intended for
epidural during labor and delivery
 Nurse connected the tubing to the
patient’s IV tubing
 The epidural medication was delivered
IV
 Mother had seizures and
cardiorespiratory arrest
 Infant delivered by emergency Csection
 Mother died from bupivacaine toxicity
9
2
Vascular—Medical Device
IV tubing erroneously connected to trach cuff
 Nurse not familiar with
tracheostomy tube
components
 Triple lumen catheter
unsecured
 Nurse mistakenly
attached IV line to trach
cuff pilot line instead of
IV catheter
 Patient died from
asphyxiation
WARNING:
Photographs depict
IV tubing erroneously
connected to trach
cuff.
DO NOT DO THIS!
10
Medical Device—Vascular
Oxygen tubing erroneously connected to IV port
 Child receiving medication via nebulizer
 Oxygen tubing became disconnected from
nebulizer fluid chamber
 Hospital staff accidentally attached oxygen tubing
to needleless injection port on IV line
 Oxygen tubing disconnected in
seconds, but not before air entered
tubing
 Child died instantly
IV port
nebulizer
WARNING: Photographs
depict oxygen tubing
erroneously connected to a
needleless IV port.
DO NOT DO THIS!
Oxygen tubing
Oxygen tubing
11
Medical Device—Vascular
Blood pressure tubing erroneously connected to IV catheter
BP monitor (L)
attached to IV port
(bottom) instead of
BP cuff (top R)
blood pressure tubing
erroneously connected to IV
catheter
DO NOT DO THIS!
 Patient in ED had saline lock
but no fluids
 Patient also had noninvasive
blood pressure cuff placed for
continuous monitoring
 BP cuff disconnected when
patient went to bathroom
 When patient returned, her
spouse mistakenly connected
the BP cuff tubing to the IV
catheter
 Air delivered to IV catheter
when equipment recycled and
trying to inflate cuff
 Patient died from air embolus
12
3
Enteral/Oral—Vascular
Enteral feeding tubing connected to IV tubing
 An infant with an NG tube
was supposed to receive
30 mL breast milk over 2
hours
 Had IV syringe pump for
IV fluids and another IV
syringe pump to deliver
breast milk via NG tube
 Nurse connected breast
milk to IV syringe pump
 Baby developed
respiratory distress but
survived
enteral feeding tubing
erroneously connected to an
infant’s UVC line.
DO NOT DO THIS!
13
Vascular—Neuraxial
IV saline flush erroneously given via peripheral nerve block
 Patient had ON-Q C-bloc catheter draped near
central venous line catheter (red, green yellow
arrows)
 Connector used to attach yellow tubing to On-Q
system (purple arrow)
 Same connector often used with central lines (not
(under patient’s gown)
 ON-Q C-bloc continuous peripheral nerve block
system (red, green, yellow, and purple arrows)
was confused with the central venous catheter
(blue and orange arrows)
 Saline flush intended for central venous catheter
administered via ON-Q C-bloc line
feeding tube erroneously
connected to trach tube.
DO NOT DO THIS!
14
Other types of misconnections
• Topical—Vascular
– Topical wound irrigation connected to IV tubing
• Bladder Irrigation—Vascular
– Bladder irrigation connected to IV tubing
• Hemodialysis/Peritoneal Dialysis—Vascular
– Peritoneal dialysis solution connected to IV tubing
• Intravenous—Arterial
– Syringe of IV medication administered via arterial line
• Unusual but True
– Syringe of air for Foley catheter balloon connected to IV port
– IV tubing connected to nasal cannula
– Foley catheter connected to NG tube
15
4
Tubing Misconnections Self Assessment
• Modified risk assessment to
evaluate current delivery
systems/mating devices
• Assesses tubes, catheters,
connectors including some you
may not think of…
• T-tube, cranial
catheter, amnioinfusion catheter,
ventriculostomy
catheter, Ommaya
reservoir
http://www.baxter.com/healthcare_professionals/clinical_center_of_excellence/
toolkit_download.html?token=68.80.75.156
16
Tubing Misconnections Self Assessment
• Objectives
– Prioritize list of at-risk devices
and practices
– Identify strategies/action plan
– Establish processes and device
selection guidelines to help
safeguard against future
misconnections
• CMS focusing on how
organizations prevent
misconnections
• E-tutorial
http://www.baxter.com/healthcare_professionals/clinical_center_of_excellence/
toolkit_download.html?token=68.80.75.156
17
Risk-assessment process
Planning
Data
Collection
Analysis
Action
• Establish team
• Identify devices for evaluation
• Test connections
• Assign ease of connection/potential harm score
• Enter data into the Data Collection Spreadsheet
• Review graph and summary reports to prioritize risk
• Use findings to develop action plan
• Refer to recommended strategies in assessment tool
18
5
Ease of connection X potential harm = RPN
1
Ease of Connection Scale
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
2
Extremely difficult
to connect
Connection made with extreme
manipulation, force, and/or
damage or modification to
device
3
Moderately difficult
Connection made with
moderate manipulation, force,
and/or modification to device
Connection made with no
equipment damage
4
Moderately easy
5
Very easy
Connection made with minimal
manipulation and/or force
Connection made with no
device modification or damage
Seemingly correct fit
Perfect 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
4
Moderate
harm
Injury of limited extent or
duration
Minimal or no intervention
anticipated
Injury significant and/or
enduring
Intervention anticipated
Injury not expected to impact
long-term quality of
life/expectancy
5
High harm
Injury serious, may be lifethreatening or deadly
Intervention anticipated
Injury expected to diminish longterm quality of life/expectancy
19
Analysis
• Spreadsheet will:
– Calculate RPN
– Generate Risk Rating Graph
• Circles in upper right: priority
– Provide Data Collection Summary
• After review reports, consider:
– Frequency of using devices
– Reported events or near misses in facility and literature
– Detection and prevention strategies already in place
– Variables unique to organization
• Prioritize: connection types that need action
20
Develop action plan
• Verify
• Forcing functions
– Trace lines
– Oral syringes
• Reminders
• Differentiate
– “For oral use only”
– Vincristine in minibag
• Redundancies
• Environment/job aids
– Recheck connections
during handoffs
– Administration set
dispensed with product
• Recovery
• Education/awareness
– Bupivacaine toxicity
protocols
– Personnel authorized to
connect/disconnect
• Equipment maintenance
• Product review guidelines
21
6
International Standards Organization (ISO)
80369 Standards
Requirements
• Not connectable with others in a series
• Not connectable with Luer/needleless ports
• Addresses shape and size of connectors
• No color coding by delivery system
Breathing
systems
80369-2
Enteral
80369-3
Limb Cuff
80369-5
Neuraxial
80369-6
Luer
Vascular
80369-7
Urology
80369-4
(planned)
Completed: ISO 80369-1: General requirements for small-bore
connectors for liquids and gases in healthcare applications; also
provides a framework for testing connectors
All Luer connectors for intravascular/hypodermic use only.
22
Color can present problems in patient safety
Standards development timeline (approximate)
2013
Q4
2014
Q1
Q2
2015
Q3
Q4
Q1
April
Gases
Enteral
Limb
Cuff
Neuraxial
Luer
Test
Methods
Key
Draft Standards
ISO Publication
Provisional AAMI Standards
AAMI Publication
Final Draft of Standards
24
7
Adoption of standards
• Adoption
– Currently voluntary-no federal mandate
– California law (HB 1867) regarding enteral connectors
– FDA consider recognizing ISO standards
– Expected that all device manufacturers/suppliers will comply
• Transition period
– Introduction plan is under development for each delivery
system
– Transition in stages, communicated well in advance
– Changes rolled out by delivery system (enteral first)
– Identify each unique connector with a common name to be
used by all suppliers
25
Preparing for change
• Aware
– Generate awareness of impending changes
– Identify leader to stay informed
– Recognize only one human error away from
misconnection
• Prepare
– Don’t wait; assess existing systems, processes, protocols
– Train for impending change
• Adopt
– Introduce new connectors into work stream according to
introduction plan
26
Other alerts and guidance documents
• ISMP (http://www.ismp.org/newsletters/acutecare/articles/CatheterMisconnections.asp)
• The Joint Commission (http://www.jointcommission.org/
assets/1/18/SEA_36.PDF)
• FDA (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
TubingandLuerMisconnections/default.htm)
• AAMI (http://www.aami.org/publications/BIT/2011/2011ND.cover.pdf;
http://www.aami.org/hottopics/connectors/index.html)
• A.S.P.E.N (http://www.aami.org/hottopics/connectors/TJC/S5-JQPS-0508-guenter.pdf)
• CMS (http://www.aami.org/hottopics/connectors/Other/Survey-and-CertLetter-13-14_03082013.pdf)
• Premier (https://www.premierinc.com/safety/topics/tubingmisconnections/resources.jsp)
27
8
Tubing and Line
Safety Initiative
A Multi-System Organization’s Journey Toward
Safest Practice
Jane Englebright, PhD, RN
Chief Nursing and Patient Safety Officer
Vice-President
Dahna Wright, BSN RN
Women’s and Children’s Clinical Services
Director
HCA
Southwest Group
Anchorage
International
Central Group
Central London
National Group


Western
Western
W
Idaho
Idaho
W
Utah
Utah
W
San Jose
San Jose

Kansas City
Denver
W
W
C Northeast
Idaho Falls
W Idaho Falls
Wichita
Kansas City
WichitaW
Las Vegas
Southern
California
El Paso
Terre Haute
C
Terre
No. VA
C C Richmond
C
SW VA
Frankfort SW VA
Frankfort
Nashville C
W
Chattanooga
Oklahoma City
Augusta
Grand Strand
Okl ahoma City
NW GA
NW GA
Central
Trident/Charleston
AtlantaAtl anta
Louisiana
E
Col umbus
Middle GA
Columbus
Palmyra
E
Jacksonville
Panhandl e**
North Central Florida
Panhandle
Treasure Coast
Tallahassee
Lafayette
Palm Beach
W Corpus Christi
Tampa
Broward
New Orleans
Brownsville
Dade
Dallas/FtW
Dal las/FW
W
Austin
Austin
San Antonio
WHouston
Houston
San Antonio
W
W
W

Haute


166 hospitals in 27 states &
England
110 free-standing surgery
centers
191,000 employees
Approx. 35,000 affiliated
physicians
40,000+ licensed beds
14 million patient
encounters annually
Safe Medication Practices
9
Presented by CPSG Clinical Excellence
The Journey…
“An opportunity to prevent harm is much better than trying to correct it.” ‐ Dr. Jonathan Perlin President, Clinical and Physician Services and Chief Medical Officer
Hospital Corporation of America, Inc. Emphasis on Misconnection Errors
•
•
•
Intravenous infusions connected to epidural lines, and epidural solutions (intended for epidural administration) connected to peripheral or central IV catheters. •
Bladder irrigation solutions using primary intravenous tubing connected as secondary infusions to peripheral or central IV catheters. • Infusions intended for IV administration connected to nasogastric (NG) tubes. Infant formula infused IV over 3 hours resulting in brain damage, • Intravenous solutions administered blindness and loss of hearing
with blood administration sets, and blood products transfused with Pureed carrots infused IV to an primary intravenous tubing. infant resulting in respiratory arrest and death
•
Infant formula infused IV over 9 hours resulting in seizures , hypoglycemia and e‐coli sepsis.
10
“Take-Aways” from the Sentinel Event Alert
• Tubing labeling and color‐coding approaches to reducing the risk of misconnections “have significant potential for unintended consequences” (TJC , 2006)
• #1 practice solution revisited at the point of care: Trace all lines back to the point of origin prior to connection or disconnection of any devices or infusions.
Unique Risks for a Unique Population
Chronic Conditions
Complex Environment
“Spaghetti‐Syndrome”
Nurse Fatigue
Mitigating Risks for a Vulnerable Population
• Phase 1
– Focus Group Engagement
• Review risks
• Redefine practice
• Alert Executive Leaders
– Unit‐Level Implementation
• Evidence‐based resources
• Job aids
• Population‐specific needs addressed
11
Mitigating Risks for a Vulnerable Population
• Phase 2
– Gap Analysis
• Best Practice Expectations: equipment, management of environmental factors, team communication, staff knowledge and point‐of‐care procedures
– Risk Reduction Strategies
• Low – education, policy
• Mid – checklists, redundancies in work processes
• High ‐ device constraints, i.e. oral syringes, enteral/IV tubing, connection hubs and ports
Re-Shaping Practice Norms, Molding Behaviors
MULTIDISCIPLINARY TEAM
DIAGNOSTICS
UNIT DESIGN POLICIES&PROCEDURES
EQUIPMENT STANDARDIZATION
EVIDENCE BASED PRACTICE
PARENT INVOLVEMENT
VLBW STRICT HANDWASHING
DEVELOPMENTAL SUPPORT
REDUCE INFECTION
DISCHARGE PLANNING
PATIENT SAFETY
CIRCULATION PAIN MANAGEMENT
I-TRACE
• I
• T
• R
• A
• C
• E
Illuminate Turn on the light in the infant care area. Ensure full view of infant and medical equipment.
Touch Perform hand hygiene. Trace the tubing with your fingers from the patient to point of origin.
Review Review the orders to assure right patient, right solution, right route, and right rate. Also assure right tube and right connection.
Act immediately if wrong patient, wrong solution, wrong route, wrong rate, wrong tube or wrong connection!
Correct Make any needed corrections. Recheck and continue the process. Start the pump.
Expect to perform ITRACE with transfer of care or during shift or formal report. A second nurse should be involved when enteral and parenteral tubing changes may occur simultaneously.
12
Enteral Nutrition Tubing Safety
• Implementation Plan
– Introduction of ITRACE mnemonic
– Implementation of Risk Assessment, Education and Competency Guide for Staff
– Incorporation of Enteral Nutrition and Tubing Safety Policy into Current Facility Policies and Procedures
– Monitoring for Use of ITRACE Line‐reconciliation and Hand‐off Communication Tool
Product Standardization
VENDOR CRITERIA Features that promote patient safety, comfort and improved outcomes:
1……3…….5
Score
Decreases risk of tubing misconnection*
Latex free
DEHP free
Feeding tube designed to prevent migration
Tube positioning verification
Integrated medication port
Low profile tube offering
Specialty product line with sizes available to meet the needs of preterm or low birth weight
13
Targeted Education
• Direct Care Members
– Unit or Primary Nursing Staff, Nurse Practitioners, Clinical Specialists, and Nursing Students
– Respiratory Therapy
– Physicians, Residents and Medical Students
– Speech Therapy, PT/OT
– Lactation Consultants
– Float Staff, Shared staff, Travelers, Agency
• Parents
• Indirect Care Members
– Equipment Techs/Aides – Unit Clerks
– Volunteers, including “Rockers/Cuddlers”
“Teachable Moments” Emerge
Behind the “Secret Squares”
Color‐Coding
Anti‐IV
Tethered Tags
Oral‐Only Syringes
14
Safety Enhancements
• Compliance with JC Patient Safety Requirement – Identify potential misconnection through risk assessment of unit equipment, workflow and staff awareness
– Develop a standardized line‐reconciliation process as part of the hand‐off communication
– Educate all clinical and non‐clinical staff about the hazard of misconnecting tubing devices
Change That Sticks: Hierarchy of Reliability
Forcing functions & Constraints
Automation & Computerization
Standardization & Protocols
Checklists & Double check systems
Rules & Policies
Education & Information
Leape, L. Error in medicine. JAMA 1994; 272: 1851-1857.
Institute for Safe Medication Practices. Medication Error Prevention Toolbox. ISMP
Medication Safety Alert. 1999. Available at:
http://www.ismp.org/newsletters/acutecare/articles/19990602.asp. Accessed June 6, 2008.
Strength of the NICU Safety Project
I‐TRACE changed care norms in more than 80 special and intermediate care nurseries across the enterprise. Forcing functions & Constraints
Rules & Policies
More than 3,000 neonatal care team members were educated by Q3 2010
6 national neonatal enteral supply vendors were evaluated against the new patient safety product criteria for this high‐risk care area‐3 vendors selected
15
Improving Safety Across the Enterprise
• Phase 1 Assessment
– Standard gap assessment tool to document current practice norms across all care areas
• Phase 2 Action
– Implementation of standard, evidence‐based resources and job aids in a common tool kit
– Results of the gap analysis shared at service line and administrative levels
• Phase 3 Evaluation
– Facility re‐surveyed using the original gap assessment to document relative reductions in risk
– Executive sponsor was responsible for certifying interventions and practice changes and submitting results.
A Multidimensional Approach to Patient Safety
Ongoing Efforts to Sustain Safety Gains
• 58% increase in adoption of engineered device constraints, i.e. routinely stocking oral syringes
• Adoption of standard practice guidance (I‐TRACE)
• 48% increase in the incorporation of tubing and line reconciliation as a standard safety check during hand‐off
• More than 68, 000 individuals completed online education
80,675
16
Shared Learnings
•
New events and learnings from reports of close calls and actual events are shared with facilities
•
Actual internal and external events are shared as Patient Safety Improvement Process or PSIP scenarios in webcasts, articles across the enterprise and briefings provided to clinical leaders
•
Results from NICU and enterprise‐wide tubing and line safety initiatives were shared in poster presentations at the National Patient Safety Foundation Annual Congress in May 2011
•
Connectors for small‐bore medical devices are changing to prevent misconnections!
Retrieved from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/T
ubingandLuerMisconnections/ucm313322.htm
Barriers to Implementation
• Implementation of a “best practice norm” across a multi‐
hospital healthcare organization
• Optional source agreements for tubing and lines and related equipment
• Fail‐safe processes imposed by manufactured connectivity constraints not yet attainable (highest level risk reduction)
• Provider/Clinician preference for tubes and lines
• Ongoing safety culture improvement projects
Lucian Leape, MD
Reliable
Performance
System
Reliance
Individual
Error in Medicine,
The Journal of the American Medical Association,
December 21, 1994.
Reliance
17
Change That Sticks: Hierarchy of Reliability
Forcing functions & Constraints
Rules & Policies
Leape, L. Error in medicine. JAMA 1994; 272: 1851-1857.
Institute for Safe Medication Practices. Medication Error Prevention Toolbox. ISMP
Medication Safety Alert. 1999. Available at:
http://www.ismp.org/newsletters/acutecare/articles/19990602.asp. Accessed June 6, 2008.
18

Preventing Catheter and Tubing Misconnections

Transcription

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