POCT:

1

• POCT
• Building and Managing
• a Top-Notch Program

SHARON S. EHRMEYER, Ph.D. MEDICAL
SCHOOL Department of Pathology and Laboratory
Medicine UNIVERSITY OF WISCONSIN MADISON, WI
2
POCT -- Where are we now?

• Two US hospital surveys, one in 1999 (510) and
  one in 2001 (584)
• Tracked POCT in hospitals
• Provided information to manufacturers, healthcare
  providers, and testing sites
• - US Hospitals POCT Survey, Enterprise
  Analysis Corp (EAC), Stamford, Connecticut

3
POCT -- Where are we now?

• Instrument category (584) hospitals using
  POCT
• Blood glucose meters 100
• Coagulation 62
• Blood gas/electrolytes 50
• Chemistry (other) 36
• Hematology 28
• Urine chemistry 15
• Cardiac markers 4
• - US Hospitals POCT Survey, Enterprise
  Analysis Corp (EAC), Stamford, Connecticut

4
POCT Growth

• Predicted - growth rate will double in next 5
  years
• Now 1 in 4 tests performed at POC
• May represent 40 of laboratory tests in future
• Current POCT market is estimated at 4.9 billion
• Expected to double within next 5 10 years
• 414 of 584 hospitals anticipate purchasing POCT
  instruments before June 2002
• - US Hospitals POCT Survey, Enterprise

5
POCT Benefits

• Improved turn around times (TAT)
• Quicker intervention
• Better treatment
• Improved patient outcomes
• Convenience
• Patient
• Physician
• Potential for decreased costs
• Reduced cost for episode of care

6
POCT -- What about cost?

• Be careful with any POCT comparisons

7
POCT Concerns

• Oversight and Quality
• Each addressed through
• Structure, Leadership and Managing the Process

8
POCT Structure

• Provides
• Authority, responsibility,
• and accountability for POCT

9
Administrative Structure

• Situational-specific
• Design for local needs
• Should be reality driven, not perception driven
• Includes players/parties involved in POCT
• Hospital and laboratory administration
• Medical staff
• Nursing
• Pharmacy
• Purchasing
• Information Services
• Risk management
• etc., etc.

10
Administrative Oversight

• Determines appropriateness of POCT
• For a given site, test, and patient
• cost vs benefits
• influence on length of stay (LOS)
• Assures appropriate selection of testing
  procedure / instrument
• Assists in evaluation of technology
• Assures training of testing personnel
• Makes recommendations on who will test
• Advises senior management of status/changes
• Builds bridges with all involved

11
Administrative Oversight

• Assures regulations are met
• Determines needed policies and procedures
• Documentation
• QC/QA
• Provides oversight for getting the job done
  right
• Advise senior management of status/changes
• Build bridges with all involved

12
Administrative Oversight

• Authority
• Make and enforce policy
• Assign responsibility
• Make decisions
• Problem solve
• Provide administrative support

13
POCT Oversight

• Authority assures a team effort
• Clinicians define the medical situations where
  POCT is appropriate
• Laboratory focuses on good POCT results
• Nursing and other health professionals strive for
  good patient care

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Oversight - Leadership

• Leadership
• Pick the right coordinator

15
POCT Oversight

• Final Outcome
• Right test
• Right result
• Right patient
• Right time
• Right record

16
POCT Concerns

• Quality

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Quality of Health Care in U.S.

• Institute of Medicine
• Medical errors cause 44,000 to 98,000 deaths each
  year
• Equivalent to 200 deaths each day in airline
  crashes
• Fifth leading cause of death in U.S.
• Ahead of diabetes, breast cancer, HIV
• Lab testing certainly contributes to deaths
• Lab is looking for built-in safeguards to prevent
  errors

To Err is Human Building a Safer Health
System. Washington, DC, National Academy Press
2000
18
Errors in perspective (per 106)
Airline passenger fatalities 0.2 Deaths due to
general anesthesia 2-5 Viral transmissions from
blood transfusions 29 Deaths/accidents due to
defective Firestone tires 300 Lost bags of
airplane passengers 5000 Lab errors
10000-30000
Arch Pathol Lab Med 123761, 1999
19
Quality POCT Results - a major concern!

• Must focus on reducing medical errors
• Patients deserve quality
• POC needs to generate quality results
• Yet, non-laboratorians often do the testing

20
IOM - Why Testing Fails

• Human error
• Lack of documentation
• Lack of test management

21
Error Reduction

• Prevention of human error will fuel the next wave
  of significant change in medical care
• Data management and QC processes are key to
  error prevention
• Error prevention will result in both better
  patient safety and decreased costs
• Goals of regulations are to reduce/eliminate
  errors
• Error prevention cannot be achieved without
  participation from industry (manufacturers)

22
In U.S. CLIA sets minimum testing standards

• Intent of Regulations is reduce/eliminate errors
• Quality Control
• Personnel
• Proficiency testing (external assessment)
• Quality Assurance
• Inspection

23
POCT Concerns

• Regulatory compliance
• Will POCT meet regulatory requirement?
• Will POCT be acceptable to the central
  laboratory?

24
POCT Users Major Compliance Concerns

• QC
• Performance remedial actionsdocumentation
• Operator certification
• Authorized operators recertification when
  required
• Lack of identification
• Operator patient
• Appropriate documentation in patient records
• Patient results in a timely manner
• Audit trail to link patient result with analyst,
  instrument, QC, time, date
• Documentation
• Method verification, reagent validation,
  proficiency testing, etc.
• http//www.advanceforal.com/asp/spotanswer.asp

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Top POCT Deficiencies 5 Cincinnati Hospitals

• Following manufacturers instructions
• Documentation of patient results in patient
  record
• Patient identification
• Operator identification
• Failure to do QC
• Failure to respond to out-of-control situations
• Unauthorized tester
• Using outdated/expired reagents
• Failure to observe safety requirements
• Barbara Goldsmith, 2001

26
POCT Oversight

• Centralize decisions allows for
• Appropriate POCT instrument selection
• Built-in safeguards
• Quality assured results
• Documentation

27
POCT 2003 Beyond

• Consider the environment
• Select the appropriate instruments/methods
• Proactively manage the process

28
POCT versus Central Lab Testing
Central Lab POCT
Testing personnel Pathologists,, PhDs, Med. Lab Technologists Nurses, other care givers
Primary duties Laboratory testing Patient care
Knows laboratory testing Extensive Minimal
Understands instruments quality checks Extensive Minimal
Can interpret QC data Yes Probably not
Skills to resolve problems, troubleshooting Yes No
Recognizes quality testing Yes Not necessarily
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POCT Environment

• Nurses are patient caregivers
• Nurses are very competent
• Nurses are very busy
• Nurses perspective must be considered when
  selecting POCT instruments
• Quality POCT to better treat patients
• Easy and trouble free POCT

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POCT instrument selection criteria

• Testing needs (menu)
• Many instruments or just one
• Space limitations / portability needs
• Reagents and storage requirements
• Test volume Sample volume
• Accuracy and precision
• Measurement range
• Costs
• Reliability
• Manufacturer support

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POCT instrument selection criteria

• To prevent human errors, need
• Embed operating rules
• Impossible not to follow manufacturers testing
  instructions
• Patient ID
• No sample preparation
• Easy sample application

Kost, GJ, Arch Pathol Lab Med. (2001)
12513071315
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POCT instrument selection criteria

• To prevent human errors, need
• Operator ID required
• Trained and competent operators only
• Operator lockout
• Preventative maintenance done automatically
• No expired/deteriorated reagents allowed
• Automatic assured calibration

Kost, GJ, Arch Pathol Lab Med. (2001)
12513071315
33
POCT instrument selection criteria

• To prevent human errors, need
• Assured quality of test results
• Automatic QC and data evaluation
• Result withheld when QC fails
• Automatic monitoring of instrument functions
• Automatic error detection and correction
• Instrument shutdown when correction is not
  possible
• Tracking of errors

Kost, GJ, Arch Pathol Lab Med. (2001)
12513071315
34
POCT instrument selection criteria

• To prevent human errors, need
• Automatic data capture (documentation)
• Patient results in patient record
• Instrument checks
• Regulatory / legal information

Kost, GJ, Arch Pathol Lab Med. (2001)
12513071315
35
Instrumentation 2003

• 2003 instrument philosophy
• Coca Cola anyone?
• Put sample in get quality result
• Quality control/quality assurance
• Not my problem dont bother me just do it
• Documentation/Connectivity
• Automatic dont bother me just do it

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Instrumentation 2003

• Accurate and precise
• Easy to operate foolproof
• Built-in safeguards
• Minimum (no) maintenance
• 24/7 availability instant results
• Readily accessible to all care providers
• Quality control dont bother me just do it
• Quality assurance not my problem
• Data capture automatic
• Result in patient record -- automatic

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Instrumentation 2003 Beyond

• Automatic self-calibration
• On-board calibrator materials
• Automatic QC
• On-board QC materials
• Automatic QC interpretation
• Guaranteed quality results
• Withhold bad results
• Connectivity
• Paperless system
• From order to report to billing
• Regulations are no problem
• Requirements met data assessed documentation
  inspector-ready

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Connectivity Solves many POCT problems
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Benefits of connectivity

• Increased surveillance
• Patient results, QC, QA, analyst
• Alerts supervisor to problems
• Reduced data handling
• Less chance for transcription errors
• Full data record for traceability
• Links patient result, instrument, analyst, QC
• Patient results in patient record
• Cost savings
• Fewer repeats
• Only authorized testing

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Where are we now?

• Documentation
• Estimated that only 15 of POCT results get into
  patient record (US)
• - US Hospitals POCT Survey, Enterprise Analysis
  Corp (EAC)

41
POCT oversight

• Pick the right instrument

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Selecting right instrument eliminates problems

• Following manufacturers instructions
• Documentation of patient results in patient
  record
• Patient identification
• Operator identification
• Failure to do QC
• Failure to respond to out-of-control situations
• Unauthorized tester
• Using outdated/expired reagents
• Failure to observe safety requirements
• Barbara Goldsmith, 2000

43
Management

• It is all about management, only management
• Features and benefits exist only in the context
  of customers situations
• Take a quality systems approach

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Total Analytical Error Distribution
 
Error Source
Ross and Boone1
Plebani et al.2  
Pre-analytical
46
68
Analytical
7
13  
47
Post-analytical
19
1 Ross and Boone, Inst. of Critical Issues in
Health Lab Practices, DuPont Press, 1991 2 -
Plebani and Carraro. Clin Chem 431348, 1997
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Error managementQuality system
NCCLS Document EP18 Quality Management
(System) for Unit-use Testing
46
Error managementQuality system
EP18

• Quality systems approach to identify potential
  error sources
• pre-analytical, analytical and post analytical 
• Identify strategies to eliminate/reduce errors
• Differs for different test systems
• Design a quality system for all of POCT, not just
  analytical phase

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Sources of errorPOCT

• Pre-analytical
• patient identification
• specimen collection
• arterial versus venous
• fasting versus non-fasting
• wrong anticoagulant
• contamination from intravenous fluids, cleansing
  agents
• inadequate amount collected
• hemolysis
• delay in sample analysis
• etc., etc., etc.

48
Sources of errorPOCT

• Analytical
• sample inadequately mixed
• introduction of air bubbles
• adverse reaction conditions
• temperature, humidity, power, barometric
  pressure, altitude
• outdated reagents
• deterioration of reagents
• instrument failure
• QC out of acceptable limits
• inadequate maintenance
• etc., etc., etc.

49
Sources of errorPOCT

• Post-analytical
• incorrect reading of results
• outlier, nonsense result
• result does not correlate with patients
  condition
• result outside of linear limits
• non-recognition of interferences
• no result recorded
• result recorded in wrong patient chart
• etc., etc., etc.

50
EP18PBasic premise

• Errors impacting results vary with the test
  device
• a single quality regimen cannot cover all devices
  
• Partnership between users and manufacturers
• devices design should eliminate/minimize sources
  of error
• manufacturer identifies what device does in terms
  of detecting / preventing these errors
• manufacturer discloses errors NOT detected
• POCT incorporates manufacturers approaches and
  develops additional practices to detect/minimize
  errors that remain

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EP18 (quality tool) error matrixPre-analytical
Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks Training/ Policies/ Maintenance
Patient ID
Collection technique
Hemolysis
Time of collection
Interfering substances
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EP18 (quality tool) error matrixAnalytical
Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks Training/ Policies/ Maintenance
Reaction temperature
Sample volume
Reagent storage
Reagent failure
Poor precision
53
EP18 (quality tool) error matrixPost-analytical
Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks Training/ Policies/ Maintenance
Nonsense result
Result outside of reportable range
No result recorded
Incorrect information recorded
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A real-world example for using EP18
The Biosite Triage Cardiac System
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Triage Cardiac SystemPre-analytical
Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks Training/ Policies/ Maintenance
Patient ID X Each patient X
Patient info X
Specimen collection X
Wrong sample X
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Triage Cardiac SystemAnalytical
Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks Training/ Policies/ Maintenance
Cartridge integrity X M X
Authorized operator X
Sample application X X M X
Precision X X M
Inaccuracy X X M
Meter status X M X
M with each measurement
57
Triage Cardiac SystemPost-analytical
Potential source of error (critical points) Device capabilities (function checks, EQC, etc.) Liquid QC Frequency of checks Training/ Policies/ Maintenance
Interpretation of QC X M X
Outlier recognized and marked X M X
Critical value recognized X M X
Result in patient chart X (connectivity) X
Results uploaded to data management system X X
M with each measurement
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Error management Quality System EP18

• Users must
• identify relevant sources of error
• develop strategies to ensure quality test results
• Tools
• manufacturers approaches
• additional protocols (QC and QA practices)
• training
• protocolspolicies and procedures

59
What Defines Quality for Patient Testing?

• Right test
• Right time
• Right patient
• Right specimen
• Right (accurate) result
• Leading to the right therapeutic action