The purpose is to update language, remove statutory duplication, and implement revised statute.

NOTICE OF PROPOSED RULE

 

DEPARTMENT OF HEALTH

Division of Disease Control

RULE NO.:RULE TITLE:

64D-2.002Definitions

64D-2.003Confidentiality

64D-2.004Testing Requirements

64D-2.006Registration of HIV Testing Programs

PURPOSE AND EFFECT: The purpose is to update language, remove statutory duplication, and implement revised statute.

SUMMARY: Rules address activities regarding: the requirements for persons conducting HIV testing in any setting, registering as a testing site, and the confidentiality of the persons tested.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The agency has determined that this rule 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: This rule decreases regulation by requiring notification rather than separate, specific informed consent prior to testing for HIV. Therefore, this rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in Section 120.541(2)(a), Florida Statute.

Any person who wishes to provide information regarding the statement of estimated regulatory costs, or to 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), 381.004(9), 381.0041(10), 384.33, FS.

LAW IMPLEMENTED: 381.0011, 381.003, 381.0031(4), 381.004, 381.0041, 384.31, 456.061, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Marlene LaLota, HIV/AIDS Section, Florida Department of Health, Bin A09, 4052 Bald Cypress Way, Tallahassee, FL 32399-1715, telephone [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64D-2.002 Definitions.

Unless defined below, words and phrases used in this chapter As used in this chapter, “HIV test,” “HIV test result,” “preliminary HIV test,” “Significant exposure,” and “Test subject” have the same meaning as in Section 381.004(1), F.S., and the following words and phrases shall have the following meanings:

(1) No change.

(2) “Blood Establishment” – Any facility in Florida where blood or blood components are collected, processed, stored, tested, or distributed, or other eligible activities authorized by Title 21 Parts 211 and 600-640, Code of Federal Regulations (effective 2011), that is required to operate in a manner consistent with Title 21 Parts 211 and 600-640, C.F.R., and as defined in Section 381.06014, F.S., and meeting the requirements of 21 C.F.R. pts. Title 21 Parts 211 and 600-640 (04/01/2015) C.F.R., as are incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-####              and https://www.flrules.org/Gateway/reference.asp?No=Ref-#### may be obtained from the Department of Health, HIV/AIDS and Hepatitis Program, 4052 Bald Cypress Way, Bin A09, Tallahassee, Florida 32399-1715, or may be found online at https://www.flrules.org/Gateway/reference.asp?No=Ref-02047 and https://www.flrules.org/Gateway/reference.asp?No=Ref-02048.

(3) “Confirmatory test” – A corroborative or supplemental HIV test, such as a Western Blot, licensed by the United States Food and Drug Administration (FDA) to validate a positive preliminary HIV test; or other supplemental or corroborative tests authorized by the HIV/AIDS and Hepatitis Program in consultation with either the Centers for Disease Control and Prevention (CDC), the Association of State and Territorial Public Health Laboratory Directors, or the FDA, e.g., the immunofluorescent assay (IFA) or Multispot.

(4) “Department” – Florida Department of Health.

(5) through (10) renumbered (4) through (9) No change.

Rulemaking Authority 381.003(2), 381.004(9), 381.0041(10) FS. Law Implemented 381.0011, 381.003, 381.004 FS. History–New 11-6-85, Formerly 10D-93.62, Amended 7-12-89, 5-30-90, 1-20-92, 5-1-96, Formerly 10D-93.062, Amended 8-24-99, 1-3-13,            .

 

64D-2.003 Confidentiality.

(1) Any person, including employees of the department, any county health department, contract provider, testing program authorized by the department or health care facility, and health care provider shall comply with the confidentiality provisions of Sections 381.004(2)(e) and , (f), F.S., and this rule in administering the HIV test, protecting the identity of the test subject, and managing records which contain laboratory reports of HIV test results or any report or notation of a laboratory report of an HIV test.

(2) No person, including employees of health care facilities and health care providers as defined in Rules subsections 64D-2.002(4) and (5) and (6), F.A.C., shall disclose or be compelled to disclose the identity of a test subject or his or her HIV test results, except to persons listed in Section 381.004(e)-(g), F.S., and the following persons:

(a) The subject of the test.

(b) Any person designated in a legally effective release executed by the test subject prior to or after the performance of the HIV test. The following releases are legally effective:

1. A specific release that states the test subject’s HIV test results can be disclosed to a named third party, except that third party payers need not be specifically identified.

2. A general release that states the test subject’s medical record can be disclosed to a named third party, except that third party payers need not be specifically identified, provided the general release is preceded by the test subject’s express written authorization.

a. The prior written authorization shall state that the test subject’s HIV test results can be disclosed to third party payers, who need not be specifically identified, and to other persons to whom the test subject subsequently issues a general release of medical information.

b. Health care providers and health care facilities shall not honor a general release without this express prior written authorization if the material to be released would disclose the identity of a test subject or his or her HIV test result.

3. A hospital can honor a general release without prior written authorization, provided the hospital first obtains the test subject’s written informed consent in accordance with Rule 64D-2.004, F.A.C., and releases the information in accordance with Section 395.3025, F.S. The informed consent shall include a statement to the effect that the test subject’s HIV test results can be released to anyone to whom the test subject gives written permission to see or to copy his or her medical record.

(c) Any medical personnel who experience a significant exposure during the course of employment or in the performance of professional duties, or non-medical personnel who experience a significant exposure while providing emergency assistance.

(d) An authorized agent or employee of a health care facility or health care provider if:

1. The health care facility or health care provider itself is authorized to know or obtain the identity of a test subject or his or her HIV test result; and

2. The agent or employee has a “need to know” as defined in subparagraph 64D-2.003(2)(d)3., F.A.C., and performs one of the following functions:

a. Participates in or administers the business operations of a health care provider or health care facility;

b. Provides or participates in providing patient care; or

c. Handles or processes specimens of body fluids, blood, blood components, organs, skin, semen, or other human tissue or body part.

(a)3.No change.

1.a. No change.

(I) through (III) renumbered a. through c. No change.

d.(IV) Supervisors responsible for the activities described in sub-subparagraph 2. below 64D-2.003(2)(d)3.b., F.A.C.

2.b. No change.

(I) through (II) renumbered a. through b. No change.

3c. No change.

(I) through (II) renumbered a. through b. No change.

€ Health care providers involved in the care or treatment of a test subject and consulting between or among themselves or with health care facilities to determine diagnosis or treatment of a test subject. This is not an exception to Section 395.3025, F.S., which requires hospitals to obtain written authorization before furnishing patient records to anyone other than the patient.

(b)1. A health care provider involved in the delivery of a child can note the mother’s HIV test results on the child’s medical record.

2. For the purpose of paragraph 64D-2.003(2)(e), F.A.C., health care providers shall include licensed health care professionals employed by or associated with state, county or municipal detention facilities when such health care professionals are acting exclusively for the purpose of providing diagnosis or treatment of persons in the care, custody, or control of such facilities.

(f) The department, in accordance with rules for reporting and controlling the spread of disease, as otherwise provided by state law.

(g) A health care facility or health care provider which procures, processes, distributes, or uses:

1. A human body part from a deceased person, with respect to medical information regarding the person; or

2. Semen provided prior to July 6, 1988, for the purpose of artificial insemination.

(h) Health care facility staff committees for the purposes of conducting program monitoring, program evaluation or service reviews. Health care facility staff committees include medical review committees as defined in Section 766.101, F.S.

(i) Authorized medical or epidemiological researchers who can not further disclose any identifying characteristics or information.

(c)(j) Those persons authorized under Section 796.08(3), F.S., to receive HIV test results of convicted prostitutes tested pursuant to Section 796.08(3), F.S. Authorized persons include:

1. Medical personnel which includes those involved in the diagnosis or treatment of the person tested.

2. Appropriate state agencies which include those diagnosing, treating or making payment or administrative determinations related to HIV testing.

3. Courts of appropriate jurisdiction in the case, including appellate courts, and any persons so ordered by the court, including probation officers if treatment and counseling are conditions of release from probation, community control, or incarceration.

(d)(k) Pursuant to Sections 960.003(2)-(5), F.S., and Section 775.0877(2), F.S., the victim of a criminal offense involving the transmission of body fluids from one person to another shall, upon request, obtain the HIV test results of the person charged with or convicted of the criminal offense. The test results shall be disclosed in accordance with Section 381.004(2)(e), F.S. The test results shall not be disclosed to any other person except as expressly authorized by law or court order.

(e)(l) In accordance with specific circumstances established in Section 456.061, F.S., a practitioner regulated through the Division of Medical Quality Assurance of within the Department of Health can disclose the identity of an HIV positive patient to the patient’s sex or needle-sharing partner. Any notification of a sex or needle-sharing partner pursuant to this section shall be done in accordance with the “Partner Notification Protocol for Practitioners”, (dated April 2012), incorporated by reference in this rule and available. This protocol can be obtained from the Department of Health, HIV/AIDS and Hepatitis Program, 4052 Bald Cypress Way, Bin A09, Tallahassee, Florida 32399-1715, or online at the program’s website at http://www.doh.state.fl.us/disease_ctrl/aids/legal/protocols.html or at https://www.flrules.org/Gateway/reference.asp?No=Ref-02049.

(f)(m) Employees of the Department of Children and Families, child placing or child-caring agencies, or of family foster homes licensed pursuant to Section 409.175, F.S., who are directly involved in the placement, care, control, or custody of a test subject and have a need to know such information pursuant to Rule subsection 65C-28.004(9), F.A.C. (effective 5/4/2006); the adoptive parents of the test subject pursuant to Rule 65C-16.011, F.A.C. (effective 11/30/2008); or the adult custodian, adult relative or other person who is responsible for the child’s welfare, if the test subject was not tested pursuant to Section 384.30, F.S., and if, after a reasonable attempt, the parent or legal guardian cannot be located and informed of the test result. The details of the reasonable attempt must be documented in the medical record of the child. The rules of the Department of Children and Families are incorporated by reference and can be obtained from the Department or online at https://www.flrules.org/Gateway/reference.asp?No=Ref-02050 and https://www.flrules.org/Gateway/reference.asp?No=Ref-02051.

(n) Employees of residential facilities or community-based care programs licensed under Chapter 393, F.S., for developmentally disabled persons if the employees are directly involved in the care, control, or custody of such test subject and have a need to know such information.

(o) A person allowed access by a court order which is issued in compliance with Section 381.004(2)(e)9., F.S.

(p) A person allowed access by order of a judge of compensation claims of the Division of Workers’ Compensation of the Department of Labor and Employment Security. Such order shall not be issued by a judge of compensation claims unless the person seeking the test results has demonstrated a compelling need for the test results which cannot be accommodated by other means.

(3) All patient records, client records or medical records containing HIV test results shall be kept in the following manner:

(a) The written informed consent form or Ddocumentation of informed consent or refusal to be tested and HIV test results shall be kept in a patient’s medical record. The confidentiality requirements of this rule shall not prohibit the computerization of medical records including HIV test results when such records are kept in accordance with sound practices of record keeping.

(b) When an HIV test is performed without informed consent, the test results shall be disclosed only as provided in this rule and shall be kept according to the confidentiality requirements of this rule.

(c) and (d) renumbered (b) and (c) No change.

(4) A subpoena for medical records containing HIV test results is not sufficient to release such records, except for HIV testing performed in hospitals as provided in Section 381.004(3)(g), F.S.

(5) Pursuant to Section 381.004(3)(f), F.S., oral disclosure of HIV test results shall be accompanied by oral notice and followed by a written notice within 10 days. This written notice shall include the following statement: “This information has been disclosed to you from records whose confidentiality is protected by state law. State law prohibits you from making any further disclosure of such information without the specific written consent of the person to whom such information pertains, or as otherwise permitted by state law. A general authorization for the release of medical or other information is NOT sufficient for this purpose.” This written statement shall not be required for disclosures made in accordance with Sections 381.004(3)(e)3., and 4., F.S.

(4)(6) No change.

Rulemaking Authority 381.004, 381.0041(10)(9), 384.33 FS. Law Implemented 381.0011, 381.0031(4), 381.004, 381.0041, 456.061 FS. History–New 11-6-85, Formerly 10D-93.64, Amended 7-12-89, 5-30-90, 1-20-92, Formerly 10D-93.064, Amended 8-24-99, 1-3-13,            .

 

64D-2.004 Testing Requirements.

(1) Prior to testing for HIV, the notification and consent requirements of Pursuant to Sections 381.004(2)(a) and (b), F.S., must be met informed consent shall be obtained prior to testing for HIV except in the limited situations outlined in Section 381.004(2)(h), F.S. Informed consent shall include an explanation that the information identifying the test subject and the results of the test are confidential and protected against further disclosure to the extent provided by law. Information shall also be included on the fact that persons who test positive will be reported to the local county health department, that anonymous testing is available and the locations of anonymous testing sites.

(2) Informed consent to perform a test for HIV need not be in writing, except in the situations listed below in subsection 64D-2.004(3), F.A.C., if there is documentation in the medical record that the test has been explained and consent has been obtained.

(3) Informed consent to perform a test for HIV shall be in writing for the following:

(a) From the potential donor or from the donor’s legal representative Pprior to the first donation of blood, blood components, organs, skin, semen, or other human tissue or body part in accordance with section 381.0041, F.S. The consent form must specify that the donor is consenting to repeated HIV testing of each of his donations for the subsequent year. The consent form must be signed annually prior to transfusion or other use;

(b) through (c) No change.

(4) The following minors can be tested for HIV without parental consent provided the minor gives informed consent:

(a) Any minor who requests examination, testing, consultation or treatment for a sexually transmissible disease, including HIV, in accordance with Section 384.30, F.S., and who demonstrates sufficient knowledge and maturity to make an informed judgment.

(b) Any minor who has reached the age of 17 years who gave consent to the donation of his or her blood, in compliance with Section 743.06, F.S.

(c) Any married minor or unwed pregnant minor, in accordance with Sections 743.01 and 743.065, F.S.

(5) Any health care provider attending a pregnant woman for conditions related to her pregnancy shall cause the woman to be tested for HIV in accordance with Section 384.31, F.S., and Rule 64D-3.042, F.A.C.

(5)(6) Pursuant to Section 381.004(7), F.S., the Department of Health developed the Model Protocol for HIV Counseling and Testing In Health Care Settings, dated August 1, 2015 July 20, 2012, and the Model Protocol for HIV Counseling and Testing In Non-Health Care Settings, dated August 1, 2015 July 20, 2012, consistent with the provisions of this section and incorporates these documents by reference in this rule. The model protocols can be obtained at https://www.flrules.org/Gateway/reference.asp?No=Ref-##### and https://www.flrules.org/Gateway/reference.asp?No=Ref-##### from the Department of Health, HIV/AIDS and Hepatitis Program, 4052 Bald Cypress Way, Bin A09, Tallahassee, Florida 32399-1715, or online at the program’s website at: http://www.doh.state.fl.us/disease_ctrl/aids/legal/ctfornonchd.htm and http://www.doh.state.fl.us/disease_ctrl/aids/legal/ctforchd.htm, or at https://www.flrules.org/Gateway/reference.asp?No=Ref-02052 and https://www.flrules.org/Gateway/reference.asp?No=Ref-02053.

(6)(7) Persons ordering an HIV test must ensure that all reasonable efforts are made to notify the test subject of the test result and relate certain information to the test subject in accordance with Section 381.004(2)(c), F.S., and the applicable Model Protocol for HIV Counseling and Testing specified in subsection (5) above 64D-2.004(6), F.A.C. If the test subject was tested in a facility, such as a jail or hospital emergency department, and was released before being notified of a positive HIV test result, the facility may inform the county health department to notify the test subject. Blood establishments and persons who collect blood, organs, skin, semen, or other human tissue or body parts shall comply with Rule 64D-2.005, F.A.C., and Sections 381.0041(5), (6), F.S.

Rulemaking Authority 381.004(9), 381.0041(10), 384.33 FS. Law Implemented 381.0011, 381.0031(4), 381.004, 381.0041, 384.31 FS. History–New 11-6-85, Formerly 10D-93.67, Amended 7-12-89, 1-20-92, 5-1-96, Formerly 10D-93.067, Amended 8-24-99, 1-3-13,__.

 

64D-2.006 Registration of HIV Testing Programs.

(1)(a) All county health departments and persons who conduct or make any personal, telephone or mail contact or other communication to a person, or make any announcement, solicitation, display, or advertisement to inform the general public that they are conducting a testing program as defined in paragraph 64D-2.006(1)(b), F.A.C., must first register with the Department of Health, HIV/ AIDS Section and Hepatitis Program, and must reregister annually. Initial registration and subsequent reregistration shall be approved by the department based upon compliance with Section 381.004(4), F.S.

(b) For the purpose of this rule, an HIV testing program is a program which provides HIV testing services with the sole purpose of identifying HIV infection. This definition does not apply to any health care provider who performs or provides HIV testing services as part of routine medical care which are incidental to the primary diagnosis or care of a patient if the health care provider does not announce, solicit, display or advertise to the general public that they are conducting a testing program.

(c) When the testing program satisfactorily completes the registration or reregistration requirements, the department shall send via electronic or regular mail a certificate of registration to the program.

(2) An application for initial registration or reregistration to conduct an HIV testing program shall be made to the department on DH Form 1781, (2/05), Application for Registration and Reregistration of HIV Testing Programs, incorporated by reference in this rule and available . The application can be obtained from the Department of Health, HIV/AIDS and Hepatitis Program, 4052 Bald Cypress Way, Bin A09, Tallahassee, Florida 32399-1715, or online at https://www.flrules.org/Gateway/reference.asp?No=Ref-02054 A completed application shall be mailed to the Department of Health, HIV/AIDS and Hepatitis Program, Attention: Counseling and Testing Program Registration at the same address and shall be accompanied by the $100.00 initial registration fee in accordance with Sections 381.004(8)(a)-(b), F.S. No fee is required for reregistration.

(3) The initial registration fee of $100.00 shall be made payable to the department and will be deposited in the Department of Health Deputy Secretary for Health Grants and Donations Trust Fund.

(4) No change.

(5) HIV testing programs must reregister with the department annually. No fee is required for reregistration. The application form for reregistration, DH Form 1781, 2/05, will be mailed by the Department of Health, HIV/AIDS and Hepatitis Program, to the registered testing program 60 days prior to the program’s reregistration date.

(6) through (12) No change.

Rulemaking Authority 381.004(9) FS. Law Implemented 381.004 FS. History–New 11-29-89, Amended 5-1-96, Formerly 10D-93.076, Amended 8-24-99, 1-3-13,            .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Marlene LaLota

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Interim State Surgeon General

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 25, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 10, 2015