1 Quality System Quality System Considerations for Over- Considerations for Over- The-Counter The-Counter HIV Testing HIV Testing Devery Howerton, Ph.D. Devery Howerton, Ph.D. Chief, Laboratory Practice Evaluation and Genomics Chief, Laboratory Practice Evaluation and Genomics Branch, Division of Public Health Partnerships, Branch, Division of Public Health Partnerships, National Center for Health Marketing, CDC National Center for Health Marketing, CDC Atlanta, GA Atlanta, GA FDA Blood Products Advisory Committee November 3, 2005
20
Embed
1 Quality System Considerations for Over-The-Counter HIV Testing Devery Howerton, Ph.D. Chief, Laboratory Practice Evaluation and Genomics Branch, Division.
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
1
Quality System Quality System Considerations for Over-Considerations for Over-
The-Counter The-Counter
HIV TestingHIV Testing
Devery Howerton, Ph.D.Devery Howerton, Ph.D.Chief, Laboratory Practice Evaluation and Genomics Chief, Laboratory Practice Evaluation and Genomics
Branch, Division of Public Health Partnerships, Branch, Division of Public Health Partnerships, National Center for Health Marketing, CDCNational Center for Health Marketing, CDC
Atlanta, GAAtlanta, GA
FDA Blood Products Advisory CommitteeNovember 3, 2005
2
OutlineOutline
Quality System essentialsQuality System essentials Basic components of testingBasic components of testing CLIA-waived testingCLIA-waived testing Issues to consider in test evaluationIssues to consider in test evaluation
3
Quality System Quality System
……provides a basic framework for provides a basic framework for laboratories and other healthcare laboratories and other healthcare units to direct and control activities units to direct and control activities and functions along the path of and functions along the path of workflow with a focus on managing workflow with a focus on managing quality…quality…
4
Path of Workflow for Home Path of Workflow for Home TestingTesting
Obtain follow-Obtain follow-up testing, up testing, counseling, counseling, as neededas needed
5
Quality System Quality System EssentialsEssentials
1.1. Documents and recordsDocuments and records2.2. OrganizationOrganization3.3. Personnel*Personnel*4.4. EquipmentEquipment5.5. Purchasing and inventory*Purchasing and inventory*6.6. Process control*Process control*7.7. Information management*Information management*8.8. Occurrence management*Occurrence management*9.9. Internal and external assessmentInternal and external assessment10.10. Process improvementProcess improvement11.11. Customer service/satisfactionCustomer service/satisfaction12.12. Facilities and safety*Facilities and safety*
* Apply to * Apply to OTC testingOTC testing
CLSI, Application of a Quality System Model for CLSI, Application of a Quality System Model for Laboratory Services, GP26-A3, 2004Laboratory Services, GP26-A3, 2004
6
Basic Components of Basic Components of TestingTesting
Apply no matter where a test is done:Apply no matter where a test is done: Person doing the test (tester)Person doing the test (tester) Testing environmentTesting environment Test materialsTest materials
7
Characteristics of the Characteristics of the Self-TesterSelf-Tester
Ability and willingness to Ability and willingness to read instructionsread instructions follow instructionsfollow instructions evaluate results and take appropriate evaluate results and take appropriate
actionaction Awareness of the need to follow Awareness of the need to follow
instructions explicitlyinstructions explicitly
8
Characteristics of the Test Characteristics of the Test EnvironmentEnvironment
TemperatureTemperature HumidityHumidity LightingLighting Level, stable work surfaceLevel, stable work surface
9
Characteristics of the Characteristics of the Test MaterialsTest Materials
Robustness at temperature and Robustness at temperature and humidity extremeshumidity extremes
Shelf life Shelf life Test instructionsTest instructions Packaging and configurationPackaging and configuration Specimen collection deviceSpecimen collection device
10
CLIA*-Waived TestingCLIA*-Waived Testing
Tests that are Tests that are 1.1. Cleared by FDA for home use; Cleared by FDA for home use;
2.2. Employ methodologies that are so Employ methodologies that are so simple and accurate as to render the simple and accurate as to render the likelihood of erroneous results likelihood of erroneous results negligible; or negligible; or
3.3. Pose no reasonable risk of harm to the Pose no reasonable risk of harm to the patient if the test is performed patient if the test is performed incorrectly. incorrectly.
*Clinical Laboratory Improvement Amendments of 1988
11
CLIA Waiver CLIA Waiver RequirementsRequirements
1.1.Obtain Certificate of Waiver (CW)Obtain Certificate of Waiver (CW)
Quality Practices in Quality Practices in CW SitesCW Sites
CMS surveys 2002-2004 (n=4214):CMS surveys 2002-2004 (n=4214): 12% did not have current instructions12% did not have current instructions 21% did not routinely check for changes21% did not routinely check for changes RE: following manufacturers’ instructions, RE: following manufacturers’ instructions,
sites did notsites did not perform quality control perform quality control 21%21% adhere to expiration datesadhere to expiration dates 6% 6% use appropriate specimenuse appropriate specimen 2% 2%
MMWR, in pressMMWR, in press
15
Quality Practices in Quality Practices in CW Sites CW Sites (continued)(continued)
From CDC Laboratory Medicine Sentinel From CDC Laboratory Medicine Sentinel Monitoring Network studies (1999-Monitoring Network studies (1999-2002):2002):
57% followed manufacturers’ instructions (WA, 57% followed manufacturers’ instructions (WA, n=306)n=306)
58% used liquid controls (AK, n=211)58% used liquid controls (AK, n=211) 68% followed recommended QC (NY, n=607)68% followed recommended QC (NY, n=607)
Steindel, et al, Practice patterns of testing waived Steindel, et al, Practice patterns of testing waived under the Clinical Laboratory Improvement under the Clinical Laboratory Improvement Amendments, Arch Pathol Lab Med, 126:1471-1479, Amendments, Arch Pathol Lab Med, 126:1471-1479, 20022002
16
Recommendations and Recommendations and Guidance for Waived Guidance for Waived
TestingTesting FDA sales restrictions for rapid HIV FDA sales restrictions for rapid HIV
testingtesting CDC QA guidelines for testing with CDC QA guidelines for testing with
OraQuick Rapid HIV testOraQuick Rapid HIV test Good laboratory practices (GLP) for Good laboratory practices (GLP) for
CMS GLP guidance documentCMS GLP guidance document Professional organizations, e.g., COLAProfessional organizations, e.g., COLA
17
Issues to Consider in Issues to Consider in Test EvaluationTest Evaluation
Instructions and device familiarizationInstructions and device familiarization Evaluation materials, test specimensEvaluation materials, test specimens Specimen collectionSpecimen collection ReproducibilityReproducibility Antibody concentrations near the cutoffAntibody concentrations near the cutoff Comparison with existing method or gold Comparison with existing method or gold
standard standard Clinical diagnosisClinical diagnosis
CLSI, User Protocol for Evaluation of Qualitative Test CLSI, User Protocol for Evaluation of Qualitative Test Performance, EP12-A, 2002.Performance, EP12-A, 2002.
CLSI, Specifications for Immunological Testing for CLSI, Specifications for Immunological Testing for Infectious Diseases, I/LA18-A2, 2001.Infectious Diseases, I/LA18-A2, 2001.
18
Issues to Consider in Issues to Consider in Test Evaluation Test Evaluation (continued)(continued)
Test kit stabilityTest kit stability Variability in reagent lots and source Variability in reagent lots and source
materialsmaterials Adequacy of specimenAdequacy of specimen Test performance (timing, reading)Test performance (timing, reading) Analytic sensitivity/specificityAnalytic sensitivity/specificity Methods for assuring quality in the Methods for assuring quality in the
absence of external controlsabsence of external controls
19
Issues to Consider in Issues to Consider in Test Evaluation Test Evaluation (continued)(continued)
Follow-up action to be taken by tester Follow-up action to be taken by tester Reactive resultReactive result
Confirmatory testingConfirmatory testing Post-test counselingPost-test counseling Accessing careAccessing care
Non-reactive resultNon-reactive result Considerations for retestingConsiderations for retesting
Manufacturer oversightManufacturer oversight Adverse event reportingAdverse event reporting Production changesProduction changes Lot variabilityLot variability
20
SummarySummary
Basic quality systems approach can Basic quality systems approach can be applied to home testingbe applied to home testing
Quality recommendations and Quality recommendations and guidance developed to address gaps guidance developed to address gaps in CLIA-waived testingin CLIA-waived testing
Recommendations for test evaluation Recommendations for test evaluation include evaluation of the total testing include evaluation of the total testing processprocess