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Proposed Project
CDC Model Performance Evaluation Program (MPEP) for Retroviral and AIDS-Related Testing, OMB No. 0920-0274—Revision—Public Health Practice Program Office (PHPPO), Centers for Disease Control and Prevention (CDC).
In 1986, the Centers for Disease Control and Prevention (CDC) implemented the Model Performance Evaluation Program (MPEP) to evaluate the performance of laboratories conducting testing to detect human immunodeficiency virus type 1 (HIV-1) antibody (Ab), and to support CDC's mission of improving public health and preventing disease through continuously improving laboratory practices.
High-quality HIV-1 antibody testing is essential to meeting the public health objectives for the prevention and control of this retrovirus infection. High-quality CD4+ T-cell determinations and HIV-1 viral RNA (viral load) determinations are essential to HIV-infected patient care and management, and the mission of reducing retrovirus-associated morbidity and mortality. Prevention programs, diagnostic clinics, and seroprevalence studies rely not only on accurate antibody testing results to document HIV infection but also accurate CD4+ T-cell determinations and HIV-1 viral RNA determinations. The impetus for developing this program came from the recognized need to assess the quality of retroviral and AIDS-related laboratory testing and to ensure that the quality of testing was adequate to meet medical and public health needs. The objectives of the MPEP are to: (1) Develop appropriate methods for evaluating quality in laboratory testing systems (including test selection, sample collection, and reporting and interpreting test results); (2) develop strategies for identifying and correcting testing quality failures; and (3) evaluate the effect of testing quality on public health.
This external quality assessment program will be made available at no cost (for receipt of sample panels) to sites conducting testing to detect human immunodeficiency virus type 1 (HIV-1) antibody (Ab), CD4+ T-cell determinations, and HIV-1 viral RNA determinations. This program will offer laboratories/testing sites an opportunity for:
- Assuring accurate tests are being provided by the laboratory/testing site through external quality assessment;
- Improving testing quality through self-evaluation in a non-regulatory environment;
- Testing well-characterized samples from a source outside the test kit manufacturer;
- Discovering potential testing problems so that procedures can be adjusted to eliminate them;
- Comparison of testing results with others at a national and international level; and
- Ability to consult with CDC staff to discuss testing issues.
The burden is estimated to be approximately 1057 hours.
| Form name | Number of respondents | Number of responses per respondent | Average burden per response (in hrs.) |
|---|---|---|---|
| Enrollments (new) | 100 | 1 | 3/60 |
| HIV Testing Survey | 1,000 | 1 | * 1 |
| CD4+ T-cell determinations Survey | 325 | 1 | *30/60 |
| HIV-1 Ab PE Results Form | 900 | 2 | 10/60 |
| HIV-1 RNA PE Results Form | 210 | 2 | 10/60 |
| CD4+ T-cell determinations PE Results Form | 300 | 2 | 10/60 |
| * Both the HIV and the CD4+ T-cell determinations surveys are performed every other year; therefore, the total hour burden for these two surveys are divided by two. |
Dated: August 5, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
[FR Doc. 04-18437 Filed 8-11-04; 8:45 am]
BILLING CODE 4163-18-P