This rule change is to clarify requirements for practitioners, including those in emergency departments, to conduct STD testing during pregnancy and to require attending practitioners to test at delivery. The change also ....

 

DEPARTMENT OF HEALTH

Division of Disease Control

RULE NO.:RULE TITLE:

64D-3.042STD Testing Related to Pregnancy

PURPOSE AND EFFECT: This rule change is to clarify requirements for practitioners, including those in emergency departments, to conduct STD testing during pregnancy and to require attending practitioners to test at delivery. The change also requires assessment of HIV care followed by treatment or referral for treatment, if appropriate.

SUMMARY: This rule change adds a requirement for practitioners attending women for prenatal care to test for certain STDs at delivery and adds or clarifies appropriate follow-up steps based on test results. The rule change also requires hospital emergency departments to provide STD testing to pregnant women under specific circumstances on site.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 381.003(2), 384.31, 384.33 FS

LAW IMPLEMENTED: 381.0011, 381.003(1)(c), 384.31 FS

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Amber Pepe at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64D-3.042 STD Testing Related to Pregnancy.

(1) Practitioners attending a woman for prenatal care shall cause the woman to be tested for chlamydia, gonorrhea, hepatitis B, HIV and syphilis as follows:

(a) At initial examination related to her current pregnancy, ideally at first trimester; and again.

(b) At 28 to 32 weeks gestation; and.

(c) At delivery.

(2) Exceptions to the testing outlined in subsection (1), above, are as follows:

(a) A woman, who testsed positive for hepatitis B surface antigen (HbsAg) at anduring the initial examination related to her current pregnancy, need not be re-tested for hepatitis B during her current pregnancy at 28-32 weeks gestation.

(b) A woman, with documented documentation of HIV infection or AIDS need not be re-tested for HIV during the current pregnancy but must be assessed for appropriate antiretroviral treatment and whether viral load is suppressed; pregnant women with HIV not receiving such treatment must be offered or referred for appropriate care.

(3) Women who had any serologic test for syphilis during pregnancy that was reactive, regardless of subsequent tests that were non-reactive, must be tested as soon as possible at or following delivery.

(4) (3) Women who appear at delivery or within 30 days postpartum, with no obtainable test results for the conditions listed in subsection (1) between the 28th:

(a) No record of prenatal care, or

(b) Prenatal care with no record of testing;

(c) Prenatal care with no record of testing after the 27th week of gestation through delivery, shall be considered at a high risk for sexually transmissible infections diseases and shall be tested for chlamydia, gonorrhea, hepatitis B surface antigen (HBsAg), HIV (unless previously documented as positive) and syphilis prior to discharge or at the time of postpartum visit.

(5) (4) Emergency dDepartments of hospitals licensed under Chapter 395, F.S., upon identification of a pregnant woman not in prenatal care, may satisfy the testing requirements under this rule by testing for chlamydia, gonorrhea, hepatitis B surface antigen (HBsAg), HIV and syphilis at the time of the visit. If, prior to discharge, the emergency department is unable to inform the patient of the test results or provide treatment based on those test results, the patient must be referred to a health care provider or county health department, along with the test results and treatment documentation. Referrals must be completed as follows: referring any woman identified as not receiving prenatal care after the 12th week of gestation, to the county health department.

(a) The referral shall be in writing or via electronic health record; and,

(b) A copy of any referral shall be submitted to the county health department having jurisdiction over the area in which the emergency department is located.

(6) (5) Prior to any testing required by this rule, practitioners shall:

(a) Notify the woman which tests will be conducted;

(b) Inform the woman of her right to refuse any or all tests; and

(c) Place a written statement of objection signed by the woman each time she refuses required testing in her medical record specifying which tests were refused and, if available, why testing was refused. If the woman refuses to sign the statement, the provider shall document the refusal in the medical record.  No testing shall occur for the infections specified in the refusal statement of objection.

(6) Women who had a serologic test for syphilis during pregnancy that was reactive, regardless of subsequent tests that were non-reactive shall be tested as soon as possible at or following delivery.

(7) through (8) No change.

(9) Nothing in this rule shall prohibit a practitioner from testing these women for other sexually transmissible infectionsdiseases in accordance withto prevailing national standards, community disease distribution, or the professional judgment of the practitioner.

Rulemaking Authority 381.003(2), 384.25, 384.31, 384.33 FS. Law Implemented 381.0011, 381.003(1)(c), 381.004(3), 384.31 FS. History–New 11-20-06, Amended 3-9-20,___.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Emma Spencer, PhD, MPH, Chief, Bureau of Communicable Diseases

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Joseph A. Ladapo, MD, PhD, State Surgeon General

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 20, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 19, 2021