IV. Management Considerations in Developing and Implementing a Facility-based Rapid HIV Testing Protocol for Women in Labor: Preparation and Training

A. Key Players

Training is essential when introducing a new procedure to labor and delivery care. The entire patient care team should be educated about rapid HIV testing during labor. The hospital laboratory staff should be involved in developing and maintaining a quality assurance program.

B. Training of Labor and Delivery Staff?Rapid HIV Testing for Women in Labor

It is essential to provide ongoing training for labor and delivery staff in providing information about HIV infection and rapid testing for women in labor whose HIV status is unknown. Without such training, many nurses, obstetricians, nurse-midwives, residents, and house staff may not have up-to-date information about perinatal HIV transmission or the experience, comfort, or skill to use sensitivity when providing women with accurate information about rapid HIV testing or to perform rapid HIV testing during labor and delivery.

Who should be trained

Training in rapid HIV testing and intrapartum or neonatal ARV prophylaxis to reduce perinatal HIV transmission should be available for all staff who provide care for pregnant women, women in labor, and neonates. These staff members include obstetricians, residents and house staff, family practice physicians, nurse-midwives, labor and delivery nurses, perinatal nurse educators and managers, nurse practitioners, pediatricians, and infection control practitioners.

In nonteaching hospitals, the labor and delivery nurse is the person most likely to assess the woman’s medical record for documentation of HIV testing and to provide the woman with information about rapid HIV testing. In teaching hospitals, medical residents, house staff, obstetricians, or nurse-midwives are most likely to have the responsibility for offering rapid testing. However, the labor and delivery nurse plays an important role in admission assessment, patient teaching, and support.

Content

The training should include the following:

• The failure of risk-based HIV testing to identify HIV-infected pregnant women
• Local, regional, and national HIV/AIDS statistics for women
• CDC guidelines for HIV testing for women in labor
• Factors that influence perinatal HIV transmission
• Interventions to reduce transmission during labor and postpartum
• Short-course ARV prophylaxis for mother and infant
• Strategies to ensure confidentiality
• Approaches to providing information during labor
• Methods for interpreting rapid test results
• Local referrals and follow-up care for the HIV-infected woman and her infant

Training in ARV prophylaxis should include the options for preventing MTCT, strategies for ensuring the availability of medication, specifics of medication administration for mother and infant, and teaching and follow-up for mother and infant.

Teaching strategies and methods for staff: Didactic or independent learning (computer-based or Web-based) works well for HIV statistics, factors that influence perinatal transmission, current research, treatment to reduce perinatal transmission, and specifics about the rapid test.

Case-study discussion in small groups can be the best approach for skill building and problem solving and for exploring attitudes. One or two cases can be discussed in approximately 30 minutes.

Role-playing can be used separately or with case-study discussion to practice discussions about rapid testing of the mother during labor or rapid testing of the infant during the postpartum period. One session of role-playing can usually be completed and discussed in 30-45 minutes.

Opportunities to provide training

The busy labor and delivery suite does not offer many opportunities for formal in-service training. Thought is needed to present content and make it available at times that are convenient for obstetric staff and providers. Motivation for learning can be increased if CME (continuing medical education) credit and nursing CE (continuing education) contact hours are provided.

In the fall of 2003, CDC funded the Health Research Education Trust, the research and education affiliate of the American Hospital Association (www.hret.org) and the
François-Xavier Bagnoud Center (www.fxbcenter.org) to develop model policies, tools, and training materials to assist hospitals and birthing centers implement rapid HIV testing programs in labor and delivery units.

C. Training Essentials for Persons Performing Point-of-Care Rapid HIV Testing

The OraQuick rapid HIV test is used as an illustration of a test that can be performed in the labor and delivery unit. The laboratory, medical, or nursing staff may lead the training session. Including the following suggested points will allow trainees to:

• Review the OraQuick package insert along with the facility’s standard operating procedure.
• View the OraQuick rapid HIV antibody testing video
• Observe a demonstration of setting up the OraQuick Rapid HIV Antibody Test
• Perform a panel of 5 known specimens and obtain 100% accuracy
• Take a competency test on the OraQuick rapid HIV test-100% accuracy or counseling documented for incorrect answers
• The following points should be emphasized as part of training staff to carry out rapid HIV testing:
  • Handle requests for rapid HIV testing stat.
  • Verify that appropriate positive and negative controls have been performed on the lot number in use and match expected results before setting up a patient’s specimen.
  • Read the OraQuick Test 20 minutes after setup. Do not exceed 40 minutes. A timer can be clipped onto one’s uniform to ensure that the test is read within time limit.
  • Report results as soon as possible (no longer than 60 minutes after receipt of specimen).
  • Document all rapid HIV test results and inform the patient’s health care provider according to protocol.
  • Refer all specimens that test preliminary positive to the appropriate laboratory for confirmatory testing.

In October 2003, CDC began to offer a training course called Fundamentals of HIV Testing Using the OraQuick Rapid HIV-1 Antibody Test in various locations throughout the United States. Information about the training and a regularly updated list of the cities can be found at http://www.cdc.gov/hiv/rapid_testing/. In early 2004, CDC will partner with the François-Xavier Bagnoud Center to offer regional training specific to perinatal HIV prevention, with emphasis on rapid HIV testing in labor and delivery settings. In addition, to assist with local training, OraSure, for example, offers a short training video about performing the OraQuick HIV-1 antibody test.

D. Ensuring Staff Proficiency and Competency to Carry Out Rapid HIV Testing in Labor and Delivery Settings

Implementation of a rapid HIV testing program is essential to effect the quick ( no longer than 60 minutes) turnaround time of results, which is needed to offer timely prophylaxis to women in labor whose HIV status is undocumented but whose specimens are reactive (positive) to the rapid HIV test. All laboratories and testing sites must adhere to the minimum requirements of the Clinical Laboratory Improvement Act of 1988 (CLIA88). Because of the critical clinical implications of this test result, it is of the utmost importance to ensure accurate testing and the reporting of all results. CDC has developed quality assurance guidelines for performing rapid HIV testing, which are available at http://www.cdc.gov/hiv/rapid_testing/.

The keys to successful performance of rapid HIV testing and reporting are

• Clear and concise procedures
• Training of personnel
• Verification of competence of personnel
• Proper performance of quality control procedures
• Recognition of when the testing does not comply with procedures

In a laboratory, these duties would be managed by a Quality Control or Quality Assurance Compliance Officer. In a point-of-care testing (POCT) setting, it is important to establish a POCT coordinator (typically a laboratorian) who is responsible for training, quality control, and quality assurance issues.

One way to assess the capacity of the laboratory or testing site to accurately test and report rapid HIV results is through proficiency testing, “an external program in which samples are periodically sent . . . for analysis.” The results from the individual participants are compared to the expected values. Each site receives a graded individualized report and a summary report showing their performance and the performance of all the participants. Proficiency testing is desirable, even for the CLIA-waived OraQuick test, because the decision to administer ARV prophylaxis will be based initially on a single, preliminary positive result. CLIA-certified laboratories and testing sites are required to participate in a proficiency testing program that is approved by the Center for Medicare and Medicaid Services for any test that is not certified by CLIA as waived (e.g., Reveal).

Another mechanism for ensuring the accuracy of test results is continued competency testing of personnel. Competency testing refers to the periodic evaluation of a person’s ability to “perform a test and use the testing device.” CLIA88 requires each person who is authorized to perform rapid HIV testing that has not been waived by CLIA (e.g., Reveal) and report results to perform competency testing semiannually the first year and at least annually thereafter. Competency testing can take many forms, including performance of the test on known specimens, direct observation, a written examination on the test, and a Web-based competency test. Although this testing is not explicitly required for CLIA-waived tests (e.g., OraQuick), it is recommended to ensure competency, and it is desirable because the decision to administer ARV prophylaxis will be based on 1 preliminary positive result of a rapid HIV test.

For testing done in the labor and delivery unit, the POCT coordinator would keep records of all training and competency verification of personnel, quality control, patient testing, and proficiency testing.

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