Implementing a Rapid HIV Testing Guideline for L&D NNEPQIN April 30, 2007

Objectives To review the recommended components of a protocol for Rapid HIV testing in L&D. To review the recommended components of a protocol for Rapid HIV testing in L&D. To review current barriers to the implementation of a protocol. To review current barriers to the implementation of a protocol. To review current New Hampshire state law regarding HIV testing, consent and reporting of results. To review current New Hampshire state law regarding HIV testing, consent and reporting of results. To discuss a proposed implementation plan for hospitals in New Hampshire. To discuss a proposed implementation plan for hospitals in New Hampshire.

What got us here? NNEPQIN did! NNEPQIN did! A motivated group of doctors and nurses who enjoy working together to improve patient care – The Elliot Perinatal Care Committee. A motivated group of doctors and nurses who enjoy working together to improve patient care – The Elliot Perinatal Care Committee. Great support from DHMC clinical staff, lobbying staff, and Elliot Hospital lab staff and committee workers. Great support from DHMC clinical staff, lobbying staff, and Elliot Hospital lab staff and committee workers.

What is driving change? Changing social attitudes about what it means to be HIV infected, or to be tested for HIV infection. Changing social attitudes about what it means to be HIV infected, or to be tested for HIV infection. Moving from screening only high risk populations to screening the general population. Moving from screening only high risk populations to screening the general population. Evidence that screening and treatment work. Evidence that screening and treatment work.

Clinical Rationale for Testing Modern care of the HIV+ pregnant woman is highly effective, safe, and prevents mother-to-child transmission. Modern care of the HIV+ pregnant woman is highly effective, safe, and prevents mother-to-child transmission. Interventions in the intrapartum period are effective at reducing the rate of transmission. Interventions in the intrapartum period are effective at reducing the rate of transmission. Rapid testing is accurate, and results are available in an appropriate time period. Rapid testing is accurate, and results are available in an appropriate time period.

A Brief History of CDC Recommendations Mid-1990’s: Universal and voluntary HIV testing of all pregnant women. Mid-1990’s: Universal and voluntary HIV testing of all pregnant women. 2001: Rapid testing to be offered if mother’s status is unknown. 2001: Rapid testing to be offered if mother’s status is unknown. April, 2003: “Opt-out” consent protocols should be implemented where possible. April, 2003: “Opt-out” consent protocols should be implemented where possible.

A Brief History of CDC Recommendations January 2004: “Rapid HIV-1 Antibody Testing During Labor and Delivery for Women of Unknown HIV Status, A Practical Guide and Model Protocol.” January 2004: “Rapid HIV-1 Antibody Testing During Labor and Delivery for Women of Unknown HIV Status, A Practical Guide and Model Protocol.” –Testing methods –Interpretation of results –Patient counseling –Staff education and training

Current CDC Recommendations September 22, 2006: “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings” MMWR, Vol. 55 No. RR-14 September 22, 2006: “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings” MMWR, Vol. 55 No. RR-14 –Opt-out consent of all pregnant women. –There should be no additional process or written documentation of informed consent beyond what is required for other routine prenatal tests.

Current CDC Recommendations September 22, 2006: Continued September 22, 2006: Continued –If a woman declines testing, this should be documented in the medical record. –Test as early in pregnancy as possible, repeat for high risk patients, or patients with symptoms. –Rapid testing in labor for all women with unknown HIV status. –Recommend immediate interventions for patients with a positive rapid test.

Current CDC Recommendations September 22, 2006: Continued September 22, 2006: Continued –HIV-negative test results can be conveyed to the patient without direct contact with the health care provider. –HIV test results should be provided in the same manner as results of other diagnostic or screening tests. –When reporting, ensure patient confidentiality and follow HIPPA regulations.

REALITY CHECK! Time consuming consent/counseling process Time consuming consent/counseling process Obtaining signatures Obtaining signatures Consent for transfer of results Consent for transfer of results “Confidential” lab reporting methods “Confidential” lab reporting methods Loss of insurability Loss of insurability

NH Law RSA 141- F:5: No person “…may test for … human immunodeficiency virus unless the person being tested consents after being informed about the medical interpretations of positive and negative test findings...” RSA 141-F:6: “…laboratories…shall require that any sample for testing be submitted with a written statement signed by a physician, or a person authorized by a physician to sign, attesting that the patient has given informed consent as required under RSA 141-F:5.

NH Law RSA 141-F:7: “…test results of samples submitted for laboratory analysis shall not be disclosed to any person or agency except the physician ordering the test or the person authorized by the physician.” RSA 141-F:8: “…the identity of a person tested for the human immunodeficiency virus may be disclosed in response to a written request if such person has given written authorization for such disclosure.”

HB 41 with Amendments Amended RSA 141-F:5: A person “may test, when the patient has consented, in accordance with the most current testing and consent recommendations of the Centers for Disease Control and Prevention.” Amended RSA 141-F:6: Removes the requirement for a signed consent to be submitted to a laboratory with the specimen for testing.

HB 41 with Amendments Amended RSA 141-F:7: Allows reporting of results to the ordering physician, and to the “patient’s confidential medical record”. Amended RSA 141-F:8: Eliminates the requirement for a separate patient signature for transfer of HIV results. General consent for transfer of medical information is sufficient.

After Legislative Change Guideline Development Guideline Development Education Education –Legislative changes –Guideline with recommendations –Practical implementation points Implementation of practice changes Implementation of practice changes –Inpatient setting –Outpatient setting

Elliot Hospital Guideline – Key Points Indications for testing Indications for testing Counseling regarding rapid testing Counseling regarding rapid testing Ensuring patient confidentiality Ensuring patient confidentiality Disclosure of results Disclosure of results

Elliot Hospital Guideline – Key Points Management if Rapid Test is POSITIVE Management if Rapid Test is POSITIVE –Assess the patient for HIV infection –Prevent transmission to the fetus Medical therapy Medical therapy Care of the mother and fetus Care of the mother and fetus Cesarean delivery(?) Cesarean delivery(?) –Active labor +/- ROM? –Newborn care postpartum

Proposed Implementation CME lecture at Elliot (Jan 2007) CME lecture at Elliot (Jan 2007) Increased awareness is improving outpatient testing and reporting Increased awareness is improving outpatient testing and reporting Guideline approval and rapid testing will drive office testing – PPV Guideline approval and rapid testing will drive office testing – PPV Nursing education Nursing education Patient education tool Patient education tool Communication with labs (EMR reporting) Communication with labs (EMR reporting)

The Near Future in NH HIV testing occurs as it should - just like all other prenatal screening