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Good laboratory practices with waived test systems

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New lots of reagents, kits, testing devices. Quality control results. Patient test results ... Report test system problems. To manufacturer. To Food & Drug ... – PowerPoint PPT presentation

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Title: Good laboratory practices with waived test systems


1
Good laboratory practices with waived test
systems
  • January 2002
  • Washington State Department of Health
  • Office of Laboratory Quality Assurance
  • (206) 418-5600 www.doh.wa.gov/lqa.htm

2
What is a waived test?
  • Under CLIA, tests are categorized by complexity
  • Waived, PPMP, Moderate, High
  • Waived tests are
  • Simple lab examinations or procedures
  • Cleared by FDA for home use
  • Negligible likelihood of erroneous results
  • No reasonable risk of harm if performed
    incorrectly

3
What does waived mean?
  • Waived from most requirements established for
    tests of higher complexity
  • Site inspections are not routinely performed
  • Proficiency testing is not required
  • Personnel qualifications are not established

4
What do the Washington State regulations say for
waived testing?
  • Obtain a Medical Test Site license
  • Tell us which waived tests you perform
  • Follow manufacturers instructions for
    performance of the test

5
Waived tests are simple, but
  • Any test can produce erroneous results if not
    performed properly
  • Any test worth running should be associated with
    good laboratory practices
  • What are good laboratory practices?
  • What are good risk management practices?

6
Have a current product insert
  • Make sure it states CLIA waived
  • For some tests (defined in regulations) all are
    waived (i.e., fecal occult blood)
  • For some tests only certain specific test
    systems are waived (i.e., Strep antigen)
  • For some test kits test may be waived or
    moderate complexity, depending on specimen used
    (i.e., mononucleosis whole blood
    is waived, serum or plasma is moderate complexity

7
Focus on these sections
  • Intended use
  • Product storage
  • Precautions/Warnings
  • Patient preparation
  • Specimen collection
  • Test procedure
  • Procedural notes
  • Quality control
  • Results/Interpretation
  • Limitations
  • Expected results

8
  • In the following slides, we give examples (in
    quotations) from actual product inserts to show
    the kinds of information you will find in the
    various sections of the product insert

9
Intended use
  • Describes what is actually being measured
  • measures percent concentration of HgbA1C in
    blood
  • Qualitative versus quantitative
  • qualitative detection of Group A Strep antigen
    directly from throat swab
  • Type of specimen
  • not recommended for use with gastric specimens

10
Product storage
  • Kits, reagents, test devices
  • store refrigerated at 2 8 degrees C
  • keep 3 months at room temperature
  • cassettes must be stored in sealed foil pouches
  • store out of sunlight
  • strips must be kept in bottle with cap tightly
    closed

11
Precautions / Warnings
  • Proper handling of kits, reagents, test devices
  • do not use past expiration
  • do not mix components of different lots or kits
  • should not be interpreted by individuals with
    blue color deficiency (color blindness)
  • do not interchange caps on reagents

12
Patient preparation
  • Examples
  • CLO test
  • discontinue use of antibiotics and bismuth
    preparations 3 weeks before biopsy
  • Occult blood
  • for 7 days avoid non-steroidal
    anti-inflammatory drugs, for 3 days avoid
    vitamin C in excess of 250 mg a day, avoid red
    meats

13
Specimen collection, handling
  • Acceptable types of specimens
  • finger stick or venipuncture
  • can be stored at room temperature for 4 hours
    and up to 72 hours if refrigerated
  • do not use swabs that have cotton tips or wooden
    shafts
  • Acceptable anticoagulants
  • acceptable anticoagulants are EDTA, heparin,
    citrate, fluoride

14
Test procedure/Directions/Instructions
  • Follow exactly
  • Dont modify
  • Adhere to timing

15
Procedural notes
  • do not open foil pouch until ready to test
    avoid cross contamination read results within
    20 minutes
  • directions must be followed exactly, accurate
    timing is essential
  • allow specimen and test devices to warm to room
    temperature before use

16
Quality control
  • The types of controls to be tested vary with the
    specific test system used
  • External, Internal, Electronic
  • Test controls according to the manufacturers
    instructions
  • Read the entire Quality Control section carefully
  • Assure that you get the expected results for the
    controls tested

17
Quality control
  • External controls
  • Reference solutions or materials (i.e., swabs)
  • Added to test device like the patient sample
  • May be included with the test kit or you may need
    to purchase separately
  • Compare your control results to the expected
    ranges or values printed on the control vials or
    in the control product insert

18
Quality control
  • Internal (built-in, procedural) controls
  • Built into test reagent devices to ensure that
    reagents are active, reagents samples are added
    correctly, test performs according to
    specifications
  • Common with qualitative tests
  • (Strep antigen, pregnancy, H. pylori,
    mononucleosis)
  • Procedural controls typically include the
    appearance of a colored dot, line or bar in a
    control region and/or an expected appearance of
    the device background

19
Quality control
  • Electronic controls
  • Inert, reusable devices
  • (test strips, cartridges, cassettes)
  • Used to check instrument performance
    specifications
  • Available for use with some quantitative test
    systems
  • (hemoglobin, cholesterol, A1C, prothrombin time)
  • Compare the control results with the expected
    values

20
Results / Interpretation
  • Positive
  • Negative
  • Invalid
  • Reportable range of method
  • patient values are linear from 2.5 to 14.0
  • linear up to 23.5 g/dl

21
Limitations of procedure
  • Causes of false positives, false negatives
  • patients must have a total hemoglobin between 7
    and 24 g/dl
  • measuring range is 100 to 500

22
Expected results, values
  • the following values are considered normal
  • normal range is 4.3 - 5.7
  • 95 of prothrombin time values range from 10.6
    to 13.4 seconds
  • for the purposes of calculating the INR, normal
    is defined as 12.0 seconds
  • will detect 20 mIU/ml of HCG

23
Good laboratory practices
  • Test controls - Follow manufacturer instructions
  • positive and negative controls should be tested
    with each new lot or shipment of test materials
  • Daily Requirements Two levels of electronic
    quality control or two levels of liquid controls
    must be tested
  • a positive and negative control must be tested
    when opening a new test kit and with each change
    in operator within the test kit
  • check the calibration daily by using the control
    cuvette

24
Good laboratory practices
  • At minimum, test external controls with each new
    lot of kits, reagents, testing devices
  • To detect problems during shipment
  • Observe internal (built-in, procedural) controls
    with each patient test
  • To assure proper test performance, reagent
    integrity
  • Test electronic controls periodically
  • According to manufacturers instructions
    frequency

25
Good laboratory practices
  • Correlate test results with patient presentation,
    history, diagnosis
  • Participate in a proficiency testing (PT) program
  • Many PT companies offer 2 sample programs
  • Split sample program
  • Compare your results with reference laboratory

26
Training
  • Have new employees read the entire product insert
  • Not just the Quick Reference Card
  • Keep a record of training
  • Have each employee demonstrate competency
  • Initially
  • Periodically

27
Keep a simple log of results
  • By keeping results of the following in
    chronological order, you can detect potential
    problems
  • New lots of reagents, kits, testing devices
  • Quality control results
  • Patient test results

28
Report test system problems
  • To manufacturer
  • To Food Drug Administrations MedWatch
  • Call 1-800-FDA-1088

29
Questions?
  • Call the Office of Lab Quality Assurance
  • (206) 418-5600
  • Go to our website
  • www.doh.wa.gov/lqa.htm
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