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. Go to next section |