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Developing Protocols for Limited Service Laboratories Seeking to Offer Rapid HIV Testing in New York State

Introduction

Organizations and agencies that are interested in offering Rapid HIV Testing must be registered as a limited service laboratory with the NYSDOH Clinical Laboratory Evaluation Program (CLEP). At the time registration is sought, a written protocol consistent with manufacturer's instructions for test performance must be submitted. The protocol must address staff training, quality control procedures, such as temperature monitoring, product storage, as well as procedures for proper disposal of regulated medical waste, client confidentiality, and a process for follow up to ensure that individuals who test positive are linked to medical care and confirmatory testing is performed by a laboratory holding a New York State permit. Please be advised that HIV testing must be conducted in accordance with applicable NYS public health laws and regulations.

Protocols should be provided at the time a laboratory submits a Limited Testing Laboratory Registration form; for the specific test product(s) being added to the laboratory's test menu. If a protocol is not provided, or the submitted protocol is not acceptable, CLEP will contact the laboratory by telephone.

Policies and procedures must be developed to ensure compliance with NYS public health law and regulations as well as FDA requirements and manufacturer's recommendation for test performance. Policies and procedures for HIV testing using a rapid test device, as well as staff training, should address:

  • Article 27F and Informed Consent for HIV testing.
  • Appropriate information regarding the rapid test result.
  • Arrangements and tracking for confirmatory testing.
  • Referrals and linkage to medical care.

To assist laboratories in developing protocols, the outline below is provided and should be modified and/or enhanced to reflect specific details related to each laboratory's procedures, environment and other circumstances, provided the protocol remains consistent with the manufacturer's instructions for test performance. Product specific details can be found in manufacturers product information pamphlets. Protocols submitted to CLEP should include a complete description of the procedure that staff follows. Staff should receive training and the protocol must be available at all times to all staff that will conduct rapid HIV antibody tests. The protocol, and any revisions, should be reviewed and signed and dated by the laboratory director.

Outline for HIV Rapid Antibody Testing

Prior to conducting rapid testing, staff members will:

  • Read the manufacturers product information
  • Ensure that external control has been run according to the instructions
  • Record the results and ensure provided control results are expected.
  • Take corrective action pursuant to a pre-established plan, if control results generated do not give expected results.

Each staff member conducting a rapid test will:

  1. Establish test area readiness:
    • To ensure lighting will be acceptable for testing, direct observation will provide information for corrective action, include providing additional lamps, and adjustment to natural light (blinds, curtains) appropriately.
    • To ensure temperature ranges are maintained to meet the requirements, a thermometer will be placed in the testing room and prior to conducting testing, staff will record temperatures on a testing log. If temperatures fall outside of the product range, testing will cease and adjustment to the environment (heat/air conditioning) will be made accordingly.
    • Appropriate space and a flat surface will be available in each testing site. Hand washing facilities are in close proximity to the room or hand sanitizer will be used.
  2. Ensure storage temperature requirements for testing are met:
    • Test devices will be stored in ____(define area). A thermometer will be placed in this area and on a daily basis checked (note acceptable range for product used). The temperature will be recorded on a log each day testing is performed. Corrective action will include adjustment to environmental conditions (heat/air conditioner). If storage temperature falls out of range, an external control will be performed on the supply to ensure product quality.
    • Test controls will be stored in a refrigerator. To ensure the temperature is within the limits of the acceptable range of 35 to 46° F, a daily reading of the thermometer inside the refrigerator will be documented daily.
    • The controls, device and developer solution, once removed from the refrigerator, have come to room temperature before opening and using.
      • Note:In the event temperatures fall outside of the specified range, testing will cease, a supervisor will be notified and corrective action will be taken.
  3. Conduct HIV testing session in accordance with the NYS Public Health Law, 2005 HIV counseling and testing guidance appropriate for testing setting and the manufacturer's requirements:
    • Provide an explanation of the testing procedure and the nature of preliminary results to test subject (or guardian where applicable).
    • Obtain test subject (or guardian where applicable) signature on the informed consent form.
    • Provide the FDA Subject information to each person testing.
    • Label test device components and appropriate paperwork (if applicable).
    • Collect specimen and process test according to manufacturers guidelines.
    • Read and Record results on report form and log sheet.
    • Dispose of bio-hazardous waste when appropriate..
    • Report test results to the test subject (or guardian where applicable), as per post testing protocol.
    • If indicated, collect specimen for confirmatory testing, and/or recommend repeat testing according to client risk assessment.
    • Make any appropriate referral(s).

Additional Information

The AIDS Institute and Wadsworth Center have developed a "Rapid HIV Testing Workbook and Implementation Guidelines for Limited Service Laboratories in New York State. " The "Workbook" contains guidance as well as sample logs and other documents that Limited service laboratories may find useful.

Questions

Questions concerning CLEP requirements related to the Limited Service Laboratory Registration process and the protocol submission should be directed to James Holland at (518) 402-4141 or, via e-mail at JMH33@health.state.ny.us.