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Nebraska Public Health LaboratoryPoint of Care Waived Testing
for
Long Term Care Facilities
1
Karen Stiles, MT(ASCP)SMCMState Training CoordinatorNebraska
Public Health [email protected]
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The College of American Pathologists (CAP) defines POCT as
“testing that is performed near
or at the site of a patient with the result leading to a
possible change in the care of the patient.”
POCT is usually performed by non-laboratory trained individuals
such as nurses, physicians,
nursing assistants, and anesthesia.
Point of Care Testing (POCT)
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Clinical Laboratory Improvement Amendments of 1988 (CLIA)
Congress enacted the CLIA Act to ensure:• accuracy and
reliability of all laboratory testing. • extended Federal
regulation to all laboratories – hospital,
independent, and physician office laboratories, etc.• perform
testing on human specimens for the purpose of diagnosing
or treating a disease, illness, or assessment of the health of
human beings.
• (CMS) has primary responsibility under CLIA for regulating
laboratories
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CLIA Certificates
• Many POCT procedures are identified by CLIA as waived while
others are moderately to high complexity.
• A site performing only waived tests must have a “Certificate
of Waiver” license but will not be routinely inspected.
• They must however adhere to manufacturer’s instructions for
performing the test.
• “Good Laboratory Practice” dictates appropriate quality
testing practices • training of testing personnel, • competency
evaluation and • performance of quality control.
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Point-of-Care Versus Lab-Based Testing: Striking a
BalanceAdvantages• portable, easy-to-operate devices• return
results quickly• enabling immediate treatment or
intervention• speed and efficiency often greatly
improves both patient outcomes and patient satisfaction.
https://www.aacc.org/publications/cln/articles/2016/july/point-of-care-versus-lab-based-testing-striking-a-balance
https://www.aacc.org/publications/cln/articles/2016/july/point-of-care-versus-lab-based-testing-striking-a-balance
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Point-of-Care Versus Lab-Based Testing: Striking a
BalanceDisadvantages• not as precise and accurate as lab-based
methods• fall short of the sensitivity and specificity associated
with
laboratory analyzers.• inability to detect interferences, such
as hemolysis, icterus
and lipemia in whole blood samples, can lead to inaccurate test
results.
• Certain POCT methods are intended only for screening purposes
and should not be utilized for diagnosis
•
https://www.aacc.org/publications/cln/articles/2016/july/point-of-care-versus-lab-based-testing-striking-a-balance
https://www.aacc.org/publications/cln/articles/2016/july/point-of-care-versus-lab-based-testing-striking-a-balance
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What factors can affect POCT accuracy?• Pre-analytical specimen
collection errors – specimen labeling AFTER collection• Interfering
substances including certain medications and over-the-counter
supplements • Altitude • Temperature • Humidity • Failure to follow
manufacturer instructions for calibration and quality control •
Failure to recognize and resolve instrument flags indicating an
erroneous test result • Improper instrument maintenance • Inability
to effectively troubleshoot failed instrument calibration, quality
control, or
error codes • Failure to ask questions!!
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POCT: Waived versus non-waived
• POCT that is non-waived must follow all regulations for
non-waived testing and have the appropriate CLIA certificate for
compliance.
• Must follow manufacturer’s instructions• Not subject to
routine inspections • CoW Site Visits - Announced, designed to help
educate on sound
laboratory practices• POC manufacture must have EUA with FDA in
order to use
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https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-antigen
[gcc02.safelinks.protection.outlook.com]).
https://urldefense.com/v3/__https:/gcc02.safelinks.protection.outlook.com/?url=https*3A*2F*2Fwww.fda.gov*2Fmedical-devices*2Fcoronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices*2Fvitro-diagnostics-euas*23individual-antigen&data=02*7C01*7CMatthew.Donahue*40nebraska.gov*7C6b72bad22cfd4129e34d08d859cefad0*7C043207dfe6894bf6902001038f11f0b1*7C0*7C0*7C637358092783721450&sdata=9KMwtRXzhxQBWrLHqJYqx5HyS1EzL4nt0wcr3T9GFqg*3D&reserved=0__;JSUlJSUlJSUlJSUlJSUlJQ!!JkUDQA!eiL1mxYe8XFEx680N4N5A_YAj_VzMfIVp2BjHWJ5SBUeXUSqz2ilTGTY6Ipw1pk$
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PPE & Safety Considerations
PPE – same precautions as collection:• Gown• Gloves• Face
Shield• Mask
Doffing of PPE – Self Contamination
https://repository.netecweb.org/files/original/851535e52c508d4104cebdc6c95bd715.pdf
https://repository.netecweb.org/files/original/851535e52c508d4104cebdc6c95bd715.pdf
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Safety Considerations
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Safety Considerations –Why is it Important during POC
Testing?
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3.18. Rapid Tests (Kits)• Whether a rapid test is conducted in
the laboratory or at the point of care, used testing kits are
considered contaminated and should be disposed of appropriately.•
Limit the use of rapid testing kits to a specific area of the
laboratory to maximize efficiency of environmental controls that
can prevent aerosol exposures when manipulating reagents, samples,
and control organisms.• Disposable, flexible, polyethylene
film–backed, nonskid, highly absorbent surface liners are
recommended to contain spills and minimize contamination of test
kit materials and boxes.• Wipe the outside of test kits with
appropriate laboratory disinfectant before returning them to the
storage area.
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Additional POC Testing Topics
• PPE – ICAP and NETEC resources, hand hygiene between specimen
tests?• Placement – separate room, no traffic. Set up work area
with absorbent
surface liner• Collection & Labeling – Full Name, DOB,
Collection Date & Time, Initials• Pipetting – Aerosolization
MUST WEAR FULL PPE!!• Testing – Watch specific company video on
actual testing• Medical Waste – Not trash, specimen couriers not
trained to transport• Results – Prone to Errors. Report to
physician ASAP, what is facility plan?• Disinfection – Wipe down
kits and testing area with disinfectant• Reporting results to state
–
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Good Laboratory Practice
Quality ControlReagent StorageOrderingDocumentation
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Nebraska Public Health Laboratory�Point of Care Waived Testing
for �Long Term Care Facilities�The College of American Pathologists
(CAP) defines POCT as “testing that is performed near or at the
site of a patient with the result leading to a possible change in
the care of the patient.” POCT is usually performed by
non-laboratory trained individuals such as nurses, physicians,
nursing assistants, and anesthesia. Clinical Laboratory Improvement
Amendments of 1988 (CLIA)CLIA CertificatesPoint-of-Care Versus
Lab-Based Testing: Striking a BalancePoint-of-Care Versus Lab-Based
Testing: Striking a BalanceWhat factors can affect POCT
accuracy?POCT: Waived versus non-waived Slide Number 9 PPE &
�Safety ConsiderationsSafety Considerations Safety Considerations –
�Why is it Important during POC Testing?Slide Number 13Additional
POC Testing TopicsSlide Number 15Good Laboratory Practice��Quality
Control�Reagent Storage�Ordering�DocumentationSlide Number 17
