MLAB 2401: CLINICAL
CHEMISTRY
KERI BROPHY-MARTINEZ
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Point of Care Testing
POINT OF CARE TESTING
 Analytical
patient - testing
activities provided within the
institution, but performed
outside the physical facilities of
the clinical laboratories
 Alternative
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names
Bedside testing
Ancillary testing
Off-site testing
Waived testing
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POINT OF CARE TESTING
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CLIA 88
In 1988, Congress passed the Clinical Laboratory
Improvement Act.
 Regulations were not written until 1990, comments
were added, and changes were made.
 Implementation was September 1, 1992.
 Overseen by the FDA and CMS
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POINT OF CARE TESTING
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Types of Classified laboratories
Those performing waived tests only
 Those performing moderate complex testing
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Has allowance for “PPMP”: provider performed microscopy
procedures
Those performing highly complex tests.
Classification based on difficulty or complexity of
test procedures and level of training required to
accurately perform the test.
Laboratory standards differ for each of the
categories.
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POINT OF CARE TESTING
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Waived –
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Lab must have CLIA waiver certificate
No certification requirements of those performing the
test
No proficiency testing
No minimum training for testing personnel
Criteria of a waived test: if the results of the test
are in error, no immediate danger exists for the
patient.
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POINT OF CARE TESTING

Examples of waived tests
several methods for hemoglobin determination
 blood glucose by meters approved for home use
 Hb A1c
 fecal occult blood
 spun hematocrit
 ovulation tests
(by color comparison)
 urine pregnancy tests
 urine dipstick
 esr
 PT
 immunoassay for mononucleosis
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FDA’s website for waived testing
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POINT OF CARE TESTING
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Moderately Complex Testing
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Lab must have Certificate of Accreditation
Includes many manual procedures with limited steps
and preparation OR automated analyses that do not
require operator intervention during the analytical
process.
Requires
Proficiency testing.
 Responsible person (oversight structure) for the technical
and scientific oversight of the testing.
 Personnel have specific training and orientation to perform
the test. Continuing competency must be documented.
 Minimum high school diploma
 Lab must have lab director / technical consultant.
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POINT OF CARE TESTING
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Highly complex testing
Lab must have Certificate of Accreditation
 Must meet all criteria of moderately complex
testing lab
 Personnel must have minimum Associate Degree
or equivalent.
 Like the moderate complex level, Lab must have lab
director / technical consultant.
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POINT OF CARE TESTING
 Highly

complex testing
Testing can include procedures
Requiring considerable decision making, complex
judgment & analysis of results to provide
interpretation.
 Specialized scientific and technical knowledge
required.
 Test may require special preparation of reagents,
extensive technical and quality control measures
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POINT OF CARE TESTING
 Most
hospitals perform moderate to
highly complex testing and must:
follow hiring guidelines
 participate in proficiency testing
 maintain comprehensive record keeping
 have established quality assurance programs
 and are subject to government inspections
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POINT OF CARE TESTING
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Proficiency Testing (PT)
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PT is mandated by CLIA for all labs performing moderate or
high complexity testing as a method for evaluating
performance quality by an external agency.
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Process
 Labs are provided with samples of analyte; values are
known only to the testing program.
 The lab analyzes the specimens in the same manner as
patient specimens.
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If a lab fails in a particular analyte, it will have a chance to
reanalyze other specimens to prove its quality performance; if
it fails in that area again, there is a possibility it will not be
approved reimbursement from Medicare or Medicaid for that
analyte.
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POINT OF CARE TESTING: ADVANTAGES
Fast delivery of results
 Small sample volume
 Overall low cost
 Portable
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POINT OF CARE TESTING:
DISADVANTAGES
Quality of results
 Management and documentation issues
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POINT OF CARE TESTING
APPLICATIONS
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Glucose
 Highest volume
 Likely the first application of POCT (home testing)
 Instruments become very sophisticated and many
maintain log of QC results.
Chemistries and Blood Gases
Coagulation testing
 Activated clotting time - for monitoring heparin
therapy
Hematology
 Spun hematocrit - can have several opportunities for
error, therefore being replaced by hemoglobin
measurement
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POINT OF CARE TESTING
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POC Connectivity
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To eliminate error due to transcription of results;
most instruments now capable of electronically
sending test data
Most significant recent development in POCT
Three components of connectivity:
 Device: Instrument itself can store data.
 Data management: Instrument uploads data to
work station.
 Interface: Data manager transmits test results to
information system.
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REFERENCES
Bishop, M., Fody, E., & Schoeff, l. (2010). Clinical
Chemistry: Techniques, principles, Correlations.
Baltimore: Wolters Kluwer Lippincott Williams
& Wilkins.
 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfClia/testswaived.cfm?start_search=C
 http://www.aculabs.com/news.htm
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