# Presentation: 861908

## Quality System Considerations for Over-The-Counter HIV Testing 

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

**FDA Blood Products Advisory Committee**
**November 3, 2005**

## Outline

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

## 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...

## Path of Workflow for Home Testing

**Pre-analytic**

**Analytic**

**Post-analytic**

- Obtain test
- Read instructions
- Set up test area
- Collect specimen

- Perform test
- Read result

- Processes:

- Interpret result
- Obtain follow-up testing, counseling, as needed

## Quality System Essentials

- Documents and records
- Organization
- Personnel*
- Equipment
- Purchasing and inventory*
- Process control*
- Information management*
- Occurrence management*
- Internal and external assessment
- Process improvement
- Customer service/satisfaction
- Facilities and safety*

- *  Apply to OTC testing

- 	CLSI, Application of a Quality System Model for Laboratory Services, GP26-A3, 2004

## Basic Components of Testing

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

## 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

## Characteristics of the Test Environment

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

## Characteristics of the Test Materials

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

## 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**

## CLIA Waiver Requirements

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

## Most Frequently Performed Waived Tests

## 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

## Quality Practices in CW Sites

- CMS surveys 2002-2004 (n=4214):
- 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

## Quality Practices in CW Sites (continued)

- 	From CDC Laboratory Medicine Sentinel Monitoring Network studies (1999-2002):
- 57% followed manufacturers’ instructions (WA, n=306)
- 58% used liquid controls (AK, n=211)
- 68% followed recommended QC (NY, n=607)

- 	Steindel, et al,  Practice patterns of testing waived under the Clinical Laboratory Improvement Amendments, Arch Pathol Lab Med, 126:1471-1479, 2002

## 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

## 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.

## 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

## 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

## 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