CAP/POCT
2003
Carol Riley-Hunte, RRT
Senior Education Specialist
Bayer HealthCare
Point of Care Testing
• Point of Care Testing Checklist must be
completed and accompanied by the
Laboratory General Checklist (since the
contents of that checklist apply to all
laboratory activity, whether occurring in
dedicated space or not).
What is POCT/Which Checklist Do I
Use?
• Temporarily brought to patient care
location - surgery, ICU, etc.
– POCT Checklist and/or Section Specific
Checklist(e.g. Hematology,Microbiology)
and
– Lab General Checklist
Point of Care Testing
If records are maintained in a central
location only one copy of the POC
checklist need be completed. If records
are not maintained centrally a POC
checklist must be completed for each
location. POC programs may be inspected
as sections or the central laboratory if they
are registered under the same CLIA-88
number.
Top POC Deficiencies
• Following the manufacturer’s instructions
• Documentation of patient results in patient
records
• Patient identification
• Operator identification
• Failure to do QC
Top POC Deficiencies
• Failure to respond to out-of-control
situations
• Unauthorized tester
• Using outdated/ expired reagents
• Failure to observe safety requirements
Checklist Topics
•
•
•
•
•
•
•
•
•
Proficiency Testing
Quality Control and Improvement
Procedure Manual
Specimen Handling
Results Reporting
Reagents
Instruments and Equipment
Calibration and Standards
Personnel
Sources Of Information
• CLIA ‘88
www.HCFA.gov/medicaid/clia/cliahome.ht
m
• CAP
– www.cap.org
• JCAHO
– www.jcaho.org
• NCCLS
– www.nccls.org
POCT-Proficiency Testing
POC.03200
Is the POCT program enrolled in the
appropriate available graded CAP Surveys
or a CAP approved alternate proficiency
testing program for the patient testing
performed?
Proficiency Testing
POC-03225
For analytes where proficiency testing is
not available, are other procedures used to
validate performance at least semiannually?
Proficiency Testing
• Labs must be enrolled
• Samples integrated with normal workload
• Run by personnel normally involved in
patient testing
• Should be handled and run as if it were a
typical sample received in the laboratory
Proficiency Testing
• Evidence of active review of survey results
– suggest laboratory manager and medical
director sign and date results
• Evidence of evaluation and corrective
action (if indicated) in response to
unacceptable result
– written documentation of corrective action
and ongoing monitoring of problem
• Response must include action taken to
prevent reoccurrence
Quality Control
• System in place to immediately detect and
correct
– Analytical errors
– Unusual results
• How?
– Review by supervisor, qualified person
– Automatic “traps” for improbable results
Quality Control
• Minimum weekly review of QC results by
section supervisor
– review needs to be documented
• Minimum monthly review by lab director or
designee
– review needs to be documented
• If It Isn’t Documented It Isn’t Done!
Quality Control
• A good quality control program includes:
– levels run by shift, define time to be run
• CLIA defines a shift in 8 hour increments
– type or level of control to be run
• blood gas, HcT
– frequency
– control limits defined by laboratory
– required response to out of control
situations
– documentation
• time, results, and employee
– review by supervisor
Procedure Manual
• Procedure manual should reflect routine
review and updating of procedures as
appropriate
• Procedures should include but not limited
to: specimen collection, processing and
test procedures
– review by Lab Manager and Medical
Director
– reference ranges, reportable ranges and
critical ranges
– QC procedures, maintenance procedures
and calibration procedures
Specimen Handling
• Pre-analytical
– sample preparation
– sample transport
– sample ID
• Analytical
– running the sample
• Post-analytical
– documentation
Results Reporting
• POC 04500: When applicable, are all patient
results reported with accompanying reference
ranges?
Results Reporting
• POC.04525: Are reference intervals
(normal ranges) established or verified for
the population being tested?
– specific for age and sex
– specific for typical patient population
Results Reporting
• POC.04550 Are critical limits established
for the results of certain tests important for
prompt patient management decisions?
• POC.04700 Do the records indicate who
performed each test?
Reagents
• POC 04800: Are all reagents properly labeled
with the following elements, as applicable and
appropriate
– content and strength, concentration, or titer
– storage requirements
– date prepared or received
– date placed in service
– expiration date
Instruments and Equipment
• Is there evidence of active review of
instrument maintenance and function,
temperature, etc. for routine procedures on
all shifts?
– routine maintenance
– corrective maintenance
– preventive maintenance
Calibration and Standards
Quantitative Testing
POC.08700: Are multiple instruments
that perform the same assays checked at
least twice a year for calibration
agreement and correlation of patient
results?
Calibration and Standards
• Are upper and lower limits of the
CLINICALLY REPORTABLE RANGE for
all reportable parameters on instrument
systems defined, so results that fall
outside these limits are reported
appropriately?
Calibration - Why?
• To provide a known relationship between
the response measurement and the value
of the substance being measured.
• Ensures instrument integrity
Calibration Verification
The process of confirming that the current
calibration settings remain valid for a
method
• Required biannually
• POC.08300:Are criteria established for
calibration verification, and it’s compliance
documented?
Calibration Verification
• “ Calibration Verification” is required:
– At changes of reagent lots for chemically or
physically active or critical components.
– When indicated by QC data
– After major maintenance or service
– When recommended by the manufacturer
– minimum of every six months
Data Management
• Information Management
• Instrument Control
Questions
Disclaimer
•
The information just presented is to provide
you with some tools, and to stimulate thought
processes.
• Bayer Diagnostics does not claim
responsibility for your inspection, this is an
educational service we provide to assist our
customers.
• The regulations change constantly, Bayer
Diagnostics recommends you check the
websites for updates