Quality System Considerations for Over-The-Counter HIV Testing

1
Quality System Considerations for
Over-The-Counter HIV Testing
FDA Blood Products Advisory Committee November 3,
2005

• Devery Howerton, Ph.D.
• Chief, Laboratory Practice Evaluation and
  Genomics Branch, Division of Public Health
  Partnerships,
• National Center for Health Marketing, CDC
• Atlanta, GA

2
Outline

• Quality System essentials
• Basic components of testing
• CLIA-waived testing
• Issues to consider in test evaluation

3
Quality System

• provides a basic framework for laboratories and
  other healthcare units to direct and control
  activities and functions along the path of
  workflow with a focus on managing quality

4
Path of Workflow for Home Testing
Processes
Analytic
Post-analytic
Pre-analytic
Obtain test Read instructions Set up test
area Collect specimen
Perform test Read result
Interpret result Obtain follow-up testing,
counseling, as needed
5
Quality System Essentials

1. Documents and records
2. Organization
3. Personnel
4. Equipment
5. Purchasing and inventory
6. Process control
7. Information management
8. Occurrence management
9. Internal and external assessment
10. Process improvement
11. Customer service/satisfaction
12. Facilities and safety

Apply to OTC testing
CLSI, Application of a Quality System Model for
Laboratory Services, GP26-A3, 2004
6
Basic Components of Testing

• Apply no matter where a test is done
• Person doing the test (tester)
• Testing environment
• Test materials

7
Characteristics of the Self-Tester

• Ability and willingness to
• read instructions
• follow instructions
• evaluate results and take appropriate action
• Awareness of the need to follow instructions
  explicitly

8
Characteristics of the Test Environment

• Temperature
• Humidity
• Lighting
• Level, stable work surface

9
Characteristics of the Test Materials

• Robustness at temperature and humidity extremes
• Shelf life
• Test instructions
• Packaging and configuration
• Specimen collection device

10
CLIA-Waived Testing

• Tests that are
• Cleared by FDA for home use
• Employ methodologies that are so simple and
  accurate as to render the likelihood of erroneous
  results negligible or
• Pose no reasonable risk of harm to the patient if
  the test is performed incorrectly.

Clinical Laboratory Improvement Amendments of
1988
11
CLIA Waiver Requirements

• Obtain Certificate of Waiver (CW)
• Follow manufacturer instructions
• Permit inspections by HHS

12
Most Frequently Performed Waived Tests
13
OTC Tests

• Monitoring
• Glucose, glycated hemoglobin, ketone
• Cholesterol, HDL, triglycerides
• Screening
• Fecal occult blood
• Urine dipstick chemistries (e.g., microalbumin,
  pH, nitrites, billirubin)
• Fertility/pregnancy
• Substance abuse

14
Quality Practices in CW Sites

• CMS surveys 2002-2004 (n4214)
• 12 did not have current instructions
• 21 did not routinely check for changes
• RE following manufacturers instructions, sites
  did not
• perform quality control 21
• adhere to expiration dates 6
• use appropriate specimen 2

MMWR, in press
15
Quality Practices in CW Sites (continued)

• From CDC Laboratory Medicine Sentinel Monitoring
  Network studies (1999-2002)
• 57 followed manufacturers instructions (WA,
  n306)
• 58 used liquid controls (AK, n211)
• 68 followed recommended QC (NY, n607)

Steindel, et al, Practice patterns of testing
waived under the Clinical Laboratory Improvement
Amendments, Arch Pathol Lab Med, 1261471-1479,
2002
16
Recommendations and Guidance for Waived Testing

• FDA sales restrictions for rapid HIV testing
• CDC QA guidelines for testing with OraQuick Rapid
  HIV test
• Good laboratory practices (GLP) for waived
  testing sites CLIAC (MMWR 11/05)
• CMS GLP guidance document
• Professional organizations, e.g., COLA

17
Issues to Consider in Test Evaluation

• Instructions and device familiarization
• Evaluation materials, test specimens
• Specimen collection
• Reproducibility
• Antibody concentrations near the cutoff
• Comparison with existing method or gold standard
• Clinical diagnosis

CLSI, User Protocol for Evaluation of
Qualitative Test Performance, EP12-A,
2002. CLSI, Specifications for Immunological
Testing for Infectious Diseases, I/LA18-A2, 2001.
18
Issues to Consider in Test Evaluation (continued)

• Test kit stability
• Variability in reagent lots and source materials
• Adequacy of specimen
• Test performance (timing, reading)
• Analytic sensitivity/specificity
• Methods for assuring quality in the absence of
  external controls

19
Issues to Consider in Test Evaluation (continued)

• Follow-up action to be taken by tester
• Reactive result
• Confirmatory testing
• Post-test counseling
• Accessing care
• Non-reactive result
• Considerations for retesting
• Manufacturer oversight
• Adverse event reporting
• Production changes
• Lot variability

20
Summary

• Basic quality systems approach can be applied to
  home testing
• Quality recommendations and guidance developed to
  address gaps in CLIA-waived testing
• Recommendations for test evaluation include
  evaluation of the total testing process