POCT Q

1
POCT Q As Preparation for the upcoming JCAHO
Survey Fall 2000

• How To Navigate Use your Page up and Page
  down keys to walk through this presentation.

2
Act 1 Definitions Memory Refreshers

• Point of Care Test (POCT) Definition
• Regulation of POCT
• CLIA Waived
• JCAHO standards

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What is a Point of Care Test (POCT) ??

• Laboratory testing that is performed at the
  patients bedside, usually by non-laboratory
  employees.
• Examples include kits and instruments that are
  hand carried to the vicinity of the patient for
  testing.

4
Fact POCT is regulated by the Federal Government

• Through Federal Amendments (CLIA 88) passed by
  Congress.
• HCFA, the federal agency charged with the
  implementation and enforcement of CLIA, has
  granted deemed status to Accreditation Agencies
  (i.e. JCAHO, COLA) to oversee hospital
  compliance.
• HealthCare Financing Administration

5
What does CLIA Waived mean?

• POCTs are classified according to level of
  complexity these are the 3
• CLIA Waived, PPMP (Provider Performed Microscopy
  Procedures), and Moderately Complex.
• CLIA Waived POCTs employ methodologies that are
  so simple and accurate as to render the
  likelihood of erroneous results negligible.

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What are examples of CLIA Waived POC Tests ??

• Abbott SiGNIFY Strep A test
• Quidell Cards QS Urine Pregnancy test (serum
  pregnancy test is considered Mod Complex)
• Accudata Glucose
• UA dip (w/o microscopic analysis)
• Urine Clinitest (Note that stool Clinitest is mod
  complex)
• Clinical practices (whether inpatient or
  Outpatient) must have a current CLIA Waived
  Certificate or higher in order to perform these
  tests.

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Act 2 JCAHO Standards on Point of Care Testing

• The next few slides illustrate some of the JCAHO
  standards for waived testing UTMB must follow in
  order to avoid getting a Type I deficiency during
  JCAHO inspection.
• Try to get familiarized with these standards as
  these are the basis of UTMBs Point of Care
  Testing Program.

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Specific JCAHO standards on Waived Testing

• PE.1.11 The hospital defines the extent to which
  the test results are used in an individual's care
  (definitive or used only as a screen).
• Info may be found at the POCT Website at
  http//www2.utmb.edu/poc
• PE.1.12 The hospital identifies the staff members
  responsible for performing (operators) and
  supervising (TSMs or Test Site Managers) waived
  testing.
• Standards continued on next slide.

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Specific JCAHO standards on Waived Testing

• PE.1.13 Those performing tests have adequate,
  specific training and orientation to perform the
  tests, and demonstrate satisfactory levels of
  competence.
• Initial Employee Validation, Ongoing competency
  Test Site Manager to serve as mentor.
• PE.1.14 Policies and procedures governing
  specific testing-related processes are current
  and readily available.
• Current policies may be accessed and
  downloaded/printed from the POCT website at
• http//www2.utmb.edu/poc
• Standards continued on next slide.

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Specific JCAHO standards on Waived Testing

• PE.1.15 Quality control checks, as defined by the
  hospital, are conducted on each procedure (point
  of care test).
• UA dip QC is done weekly and documented on QC
  log
• Glucose (accudata) 2 Levels are run every 24
  hours and saved in data mgt. System
• Guaiac Performance monitors (PM) are developed
  after patient test. Patients result is not
  reported/documented unless PM perform as
  expected.
• PE.1.15.1 At a minimum, manufacturers'
  instructions are followed.
• All POC Policies procedures follow at a minimum
  manufacturers instructions
• PE.1.15.2 Appropriate quality control and test
  records are maintained.
• QC Logs must be maintained for a minimum of 2
  years

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Act 3 JCAHO Upcoming Inspection October 2000

• The information displayed next is based on hot
  buttons and related POCT issues Joint Commission
  will likely investigate this Fall.

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What do I say if a JCAHO surveyor asks me a POCT
question and I dont know the answer?

• Do not guess!
• State that you do not know but will check with
  your Test Site Manager (TSM) or nurse manager.
• OR
• say you will look it up on the Point of Care
  website at www2.utmb.edu/poc

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Where do I find various Point of Care Policies
Procedures?

• On the Point of Care website at
  www2.utmb.edu/poc. Policies are divided by
  category of complexity, and include but are not
  limited to
• Patient preparation
• Sample type
• Quality control
• Test Performance
• QC Logs may be found at the same site as well as
  other tools such as POC supplies ordering
  information, validation tools, rosters, Monthly
  QC Data collection Tool.

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What is competency assessment?

• A method for monitoring testing personnel to
  ensure that they are performing all phases of
  laboratory work correctly. Basically a skill
  assessment.
• Employee competency assures the patient his
  caregiver is able to turn out accurate and
  reliable results.

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How do we prove our competence?

• Employees competency is validated every 2 years
  (except for glucose) by
• completion of online test
• successful performance of sample unknowns
• A Validation Tool containing documentation of the
  above is placed in employees file.
• Integrated on PAS
• In addition, employee competence is assessed on
  an ongoing basis by
• Proficiency testing or,
• Personal observation of performance or,
• Routine quality control program.

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Who can perform POC tests on your unit?

• Only staff who have been trained and demonstrate
  competency may perform POC tests.
• Refer JCAHO inspector to your Test Site Manager
  (TSM) for a list of what personnel is validated
  in your unit.
• Remember your Test Site Manager is also your
  immediate source of guidance on Point of Care
  Testing.

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Competency and Employee Validation

• Blood Glucose Testing
• Competency assessed yearly
• Completion of successful low high QC results
• Urine Dipstick
• Competency assessed biannually
• Documentation on Validation Tool
• Passing online test (100)
• successful completion of (2) patient results
• Continued on next slide

18
Competency and Employee Validation

• Urine Pregnancy Test
• Competency assessed biannually
• Documentation on Validation Tool
• Passing online test (100)
• successful completion of (1) patient sample or
  unknown.
• Fecal Occult Blood (Guaiac )
• Competency assessed biannually
• Documentation on Validation Tool
• Passing online test (100)
• successful completion of (1) patient sample or
  unknown.
• Continued on next slide

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Competency and Employee Validation

• Hemoglobin (Hemacue)
• Competency assessed Biannually
• Documentation on Validation Tool
• Passing online test (100)
• successful completion of (1) patient sample or
  unknown.
• Microhematocrit
• Competency assessed Biannually
• Documentation on Validation Tool
• Passing online test (100)
• successful completion of (1) patient sample or
  unknown.

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Why do I perform quality control ?

• QC is performed to check that internal
  components within the test system are working
  properly
• Examples of internal components
• pads on UA reagent strips,
• reactive ingredients in Accudata strip,
• reagent present on guaiac cards
• reactive platforms in both pregnancy Strep A
  tests

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How often do I perform quality control ?

• Accudata QC performed every 24 hours.
• Urine dipstick Weekly, also with each new open
  vial.
• Hemoccult and Gastroccult positive negative
  Performance Monitors (PM) must be developed each
  time and verified before reporting patient
  result.
• Urine pregnancy test (Quidell Cards QS)
  Internal Controls must be verified and documented
  each day of patient testing. No liquid controls
  are required for this kit.
• Continued on next slide

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How often do I perform quality control?

• Abbott SiGNIFY Strep A Liquid controls must be
  run every 25 tests w/ change of operators.
• Prothrombin EQC daily, Liquid controls must be
  run weekly.
• Hemocue Cal check done each day of patient
  testing.
• Clinitest (urine or stool) Liquid controls (use
  UA controls) must be run weekly w/ change of
  lot number.
• pH Liquid Controls (use UA controls) are run
  monthly.

23
Make certain that the open date is written on all
controls reagents bottles/kits!

• Some expiration dates are shortened once the
  container is opened or kept at room temperature
  (this is called the discard date).

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Final words of advice

• Be ready to answer to the following
• Where you can find your POCT policies
  procedures.
• Which POC tests are done in your unit
• Who can perform POC testing in your unit
• Who your Test Site Manager is
• Why you do QC how often

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End of presentation

• Click here to go back to the POCT main Homepage.
• References
• Quality Point of Care Testing A Joint Commission
  Handbook. JC, Illinois, 1999.