Transcript Multi-Helath Systems

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
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
POCT -- Where are we now?

Instrument category
using POCT
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Blood glucose meters
Coagulation
Blood gas/electrolytes
Chemistry (other)
Hematology
Urine chemistry
Cardiac markers
% (584) hospitals
100%
62%
50%
36%
28%
15%
4%
* - US Hospitals POCT Survey, Enterprise Analysis
Corp (EAC), Stamford, Connecticut
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
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
POCT -- What about cost?
Be careful with any POCT comparisons
POCT Concerns
Oversight and Quality
Each addressed through:
Structure, Leadership and
Managing the Process
POCT: Structure
Provides:
Authority, responsibility,
and accountability for POCT
Administrative Structure

Situational-specific
– Design for local needs
Should be reality driven, not “perception”
driven
 Includes “players/parties” involved in POCT

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–
–
–
–
–
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Hospital and laboratory administration
Medical staff
Nursing
Pharmacy
Purchasing
Information Services
Risk management
etc., etc.
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
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
Administrative Oversight
Authority
–
–
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–
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Make and enforce policy
Assign responsibility
Make decisions
Problem solve
Provide administrative support
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

Oversight - Leadership
Leadership
Pick the right coordinator
POCT Oversight
Final Outcome
Right test
Right result
Right patient
Right time
Right record
POCT Concerns
Quality
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
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
Lost bags of airplane passengers
Lab errors
300
5000
10000-30000
Arch Pathol Lab Med 123:761, 1999
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
IOM - Why Testing Fails
 Human
error
 Lack of documentation
 Lack of test management
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)
In U.S.: CLIA sets minimum testing standards
Intent of Regulations is reduce/eliminate
errors
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Quality Control
Personnel
Proficiency testing (external assessment)
Quality Assurance
Inspection
POCT Concerns
 Regulatory
compliance
– Will POCT meet regulatory requirement?
– Will POCT be acceptable to the central
laboratory?
POCT – Users’ Major Compliance Concerns

QC
– Performance; remedial actions;documentation

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
Top POCT Deficiencies – 5 Cincinnati Hospitals
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Following manufacturer’s 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
POCT: Oversight
 Centralize
decisions allows for:
– Appropriate POCT instrument
selection
Built-in
safeguards
Quality assured results
Documentation
POCT 2003 & Beyond
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Consider the environment
Select the appropriate instruments/methods
Proactively manage the process
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 instrument’s
quality checks
Extensive
Minimal
Can interpret QC data
Yes
Probably not
Skills to resolve problems,
troubleshooting
Yes
No
Recognizes quality testing
Yes
Not necessarily
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
POCT instrument selection criteria
 Testing
–
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–
–
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
POCT instrument selection criteria
To prevent human errors, need:
 Embed
operating rules
– Impossible not to follow manufacturer’s
testing instructions
 Patient
ID
 No sample preparation
– Easy sample application
Kost, GJ, Arch Pathol Lab Med. (2001) 125:1307–1315
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) 125:1307–1315
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) 125:1307–1315
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) 125:1307–1315
Instrumentation 2003
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2003 instrument philosophy
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Coca Cola anyone?
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Quality control/quality assurance
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Put sample in; get quality result
Not my problem; don’t bother me; just do it
Documentation/Connectivity
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Automatic; don’t bother me; just do it
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 – don’t bother me; just do it
 Quality assurance – not my problem
 Data capture – automatic
 Result in patient record -- automatic

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 inspectorready
Connectivity – Solves many POCT problems
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
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)
POCT oversight
Pick the right instrument
Selecting “right” instrument eliminates
problems
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Following manufacturer’s 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
Management
 It
is all about management, only
management
 Features and benefits exist only in the
context of customers’ situations
 Take a quality systems approach
Total Analytical Error Distribution
Error
Source
Ross and Boone1
Plebani et al.2
Pre-analytical
46%
68%
Analytical
7%
13%
Post-analytical
47%
19%
1 – Ross and Boone, Inst. of Critical Issues in Health Lab Practices, DuPont Press, 1991
2 - Plebani and Carraro. Clin Chem 43:1348, 1997
Error management
Quality system
NCCLS Document EP18
“Quality Management (System*) for Unit-use Testing”
Error management
Quality 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
Sources of error
POCT

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.
Sources of error
POCT

Analytical
– sample inadequately mixed
– introduction of air bubbles
– adverse reaction conditions

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–
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temperature, humidity, power, barometric pressure,
altitude
outdated reagents
deterioration of reagents
instrument failure
QC out of acceptable limits
inadequate maintenance
etc., etc., etc.
Sources of error
POCT
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Post-analytical
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incorrect reading of results
outlier, nonsense result
result does not correlate with patient’s condition
result outside of linear limits
non-recognition of interferences
no result recorded
result recorded in wrong patient chart
etc., etc., etc.
EP18P
Basic premise

Errors impacting results vary with the test
device
– a single quality regimen cannot cover all devices

Partnership between users and manufacturers
– device’s 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 manufacturer’s approaches and
develops additional practices to detect/minimize
errors that remain
EP18 (quality tool) error matrix
Pre-analytical
Potential source of error
(critical points)
Patient ID
Collection technique
Hemolysis
Time of collection
Interfering substances
Device
capabilities
(function
checks, EQC,
etc.)
Liquid QC
Frequency of
checks
Training/
Policies/
Maintenance
EP18 (quality tool) error matrix
Analytical
Potential source of error
(critical points)
Reaction temperature
Sample volume
Reagent storage
Reagent failure
Poor precision
Device
capabilities
(function
checks, EQC,
etc.)
Liquid QC
Frequency of
checks
Training/
Policies/
Maintenance
EP18 (quality tool) error matrix
Post-analytical
Potential source of error
(critical points)
Nonsense result
Result outside of
reportable range
No result recorded
Incorrect information
recorded
Device
capabilities
(function
checks, EQC,
etc.)
Liquid QC
Frequency of
checks
Training/
Policies/
Maintenance
A real-world example for using EP18
The Biosite Triage® Cardiac
System
Triage® Cardiac System
Pre-analytical
Potential source of
error
(critical points)
Patient ID
Device
Liquid QC
capabilities
(function checks,
EQC, etc.)
X
Frequency of
checks*
Each patient
Training/
Policies/
Maintenance
X
Patient info
X
Specimen collection
X
Wrong sample
X
Triage® Cardiac System
Analytical
Potential source of
error
(critical points)
Device
capabilities
(function
checks, EQC,
etc.)
Cartridge integrity
X
Authorized operator
X
Sample application
X
Precision
Liquid QC
Frequency of
checks*
Training/
Policies/
Maintenance
M
X
X
M
X
X
X
M
Inaccuracy
X
X
M
Meter status
X
* M = with each measurement
M
X
Triage® Cardiac System
Post-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
X
M
X
Critical value recognized
Result in patient chart
X (connectivity)
X
X
X
Results uploaded to data
management system
* M = with each measurement
Error management
Quality System EP18

Users must
– identify relevant sources of error
– develop strategies to ensure quality test results

Tools
– manufacturer’s approaches
– additional protocols (QC and QA practices)
training
 protocols—policies and procedures

What Defines Quality for Patient
Testing?
 Right
test
 Right time
 Right patient
 Right specimen
 Right (accurate) result
 Leading to the right therapeutic action