The purpose is to revise rules to comply with updated statutes and streamline the HIV testing process in county health department clinic sites.

DEPARTMENT OF HEALTH
Division of Disease Control

RULE NO.: RULE TITLE:
64D-2.002: Definitions
64D-2.003: Confidentiality
64D-2.004: Testing Requirements
64D-2.006: Registration of HIV Testing Programs

PURPOSE AND EFFECT: The purpose is to revise rules to comply with updated statutes and streamline the HIV testing process in county health department clinic sites.

SUMMARY: The rules describe activities regarding: the requirements for persons conducting HIV testing in any setting, the receiving of consent from the person being tested, 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 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 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), 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: 381.0011, 381.003, 381.004, 381.0041(10), 384.33 FS.
LAW IMPLEMENTED: 381.0011, 381.003, 381.004, 381.0031, 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 FAW.

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

 

THE FULL TEXT OF THE PROPOSED RULES IS:

64D-2.002 Definitions.

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)(2), F.S., and the following words and phrases shall have the following meanings:

(1) “Blood” – Whole human blood or components of human blood, including plasma.

(2) “Blood Establishment Bank” – 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 licensed under Chapter 483, Part I, F.S., including plasma centers, where blood or plasma is procured, donated, processed, stored or distributed. Title 21 Parts 211 and 600-640, C.F.R., are incorporated by reference and 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_______.

(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 State HIV/AIDS and Hepatitis Program in consultation with 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)(4) “Health care facility” – A hospital, nursing home, clinic, blood bank, plasma center, sperm bank, clinical laboratory, intermediate care facility, ambulatory surgical center, public health facility licensed under Chapter 154, F.S., mental health facility licensed under Chapter 394, F.S., or drug treatment or rehabilitation facility licensed under Chapter 397, F.S., emergency center, walk-in emergency clinic, birthing center, or health maintenance organization.

(6)(5) “Health care provider” – Any licensed physician, dentist, podiatrist, naturopath, nurse, advanced registered nurse practitioner (ARNP), physician assistant, dental assistant, dental hygienist, paramedic, emergency medical technician, psychologist, mental health professional, lay midwife, any person licensed under the Division of Medical Quality Assurance at the DOH, an administrator, employee or agent of a health care facility or other person providing medical, nursing, psychological, or other health care services or medical or other students receiving training as health care professionals at a health care facility.

(7)(6) “Laboratory” – Any facility licensed under Chapter 483, F.S., where HIV tests are performed. This definition does not include blood establishment banks or plasma centers.

(8)(7) “Medical personnel” – An authorized agent or employee of a health care facility, health care provider, health care professional, blood establishment bank or plasma center; a licensed or certified health care professional; a medical or other student receiving training as a health care professional at a health care facility; a paramedic or emergency medical technician certified by the Department to perform life support procedures pursuant to the provisions of Section. 401.23, F.S.

(9)(8) “Reasonable attempt” – A documented effort to locate an individual, for example: contact by last known phone number, relative’s phone number, agency contacts, or certified mail.

(10) “Residential facility” - A facility providing room and board and personal care for people in their care.

Rulemaking Specific Authority 381.0011(13), 381.003(2), 381.004(9)(10), 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,_______.

 

64D-2.003 Confidentiality.

(1) Any person, including employees of the department, and any county health department, contract provider, testing program authorized by the department or health care facility, and health care provider or health care facility shall comply with the confidentiality provisions of Section 381.004(2)(3)(e), (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 subsections 64D-2.002(4) and (5), 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 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 payors 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 payors 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 payors, 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 or tissues.

3. An agent or employee has a need to know the identity of a test subject or his or her HIV test result if:

a. The agent or employee has a need to know the identity of a test subject or his or her HIV test result to discharge properly his or her duties in the ordinary course of participating in or administering the business operations of a health care facility or health care provider. Examples of these agents or employees are:

(I) Financial staff who compile or review patient records as part of routine billing activities.

(II) Transcribers who enter medical information into computers or records.

(III) Personnel involved in utilization review, risk management or peer review activities in which patient records are normally shared among reviewers.

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

b. through c. No change.

(e) through (f) No change.

(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) through (j) No change.

(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)(3)(c), F.S. The test results shall not be disclosed to any other person except as expressly authorized by law or court order.

(l) In accordance with specific circumstances established in Section 456.061 455.674, F.S., a practitioner regulated through the Division of Medical Quality Assurance 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 March 1999, incorporated by reference in this rule. This protocol can be obtained from the Department of Health, Bureau of 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________.

(m) Employees of the Ddepartment 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 subsection 65C-28.004(9) 10M-6.120, 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 _______or_______.

(n) No change.

(o) A person allowed access by a court order which is issued in compliance with Section 381.004(2)(3)(e)9., F.S.

(p) No change.

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

(a) through (d) No change.

(4)(e) 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)(4) 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.

(6)(5) The anonymity of individuals tested for HIV in county health department anonymous test sites or other testing programs approved through the department registration process to conduct anonymous testing, shall be ensured as follows:

(a) through (d) No change.

Rulemaking Specific Authority 381.0011, 381.004(10), 381.0041(9)(10), 384.33 FS. Law Implemented 381.0011, 381.0031(4), 381.004, 381.0041, 456.061 455.674 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,_________.

 

64D-2.004 Testing Requirements.

(1) Pursuant to Section 381.004(2)(3)(a), F.S., informed consent shall be obtained prior to testing for HIV except in the limited situations outlined in Section 381.004(2)(3)(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) In addition to the information on confidentiality, reporting and anonymous testing listed above, an explanation of the following information constitutes sound and reasonable practice in providing information sufficient to secure informed consent:

(a) An HIV test is a test to determine if an individual is infected with the virus which causes AIDS;

(b) The potential uses and limitations of the test;

(c) The procedures to be followed; and

(d) HIV testing is voluntary and consent to be tested can be withdrawn at any time prior to testing.

(2)(3) 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)(4), F.A.C., if there is documentation in the medical record that the test has been explained and consent has been obtained.

(3)(4) 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 prior to the first donation of blood, blood components plasma, organs, skin, semen, or other human tissue or body part. 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)(5) The following minors can be tested for HIV without parental consent provided the minor gives informed consent:

(a) through (c) No change.

(5)(6) Any health care provider attending a pregnant woman for conditions related to her pregnancy shall cause the woman to be tested for HIV counsel the woman on the potential benefits, potential risks and limitations of treatment to reduce the risk of transmission from infected women to their babies and offer HIV testing in accordance with Section 384.31, F.S., and Rule 64D-3.042, F.A.C.

(6)(7) Pursuant to Section 381.004(7)(8), F.S., the Department of Health developed the Model Protocol for HIV Counseling and Testing In Health Care Settings for County Health Departments and Registered Testing Programs, dated July 20, 2012 March 29, 1999, and the Model Protocol for HIV Counseling and Testing In Non-Health Care Settings Conducted Outside County Health Departments and Registered Testing Programs, dated July 20, 2012 March 29, 1999, consistent with the provisions of this section and incorporates these documents by reference in this rule. The model protocols can be obtained from the Department of Health, Bureau of HIV/AIDS and Hepatitis Program, 4052 Bald Cypress Way 2020 Capital Circle, S. E., 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______or_______.

(7)(8) 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)(3)(c), F.S., and the applicable Model Protocol for HIV Counseling and Testing specified in subsection 64D-2.004(6)(7), 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 banks 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 Specific Authority 381.0011, 381.004(9)(10), 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,________.

 

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 Rule 64D-2.006(1)(b), F.A.C., below, must first register with the Department of Health, Bureau of HIV/ AIDS 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)(5), F.S.

(b) No change.

(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 to conduct an HIV testing program shall be made to the department on DH Form 1781, 2/05 11/98, Application for Registration and Reregistration of HIV Testing Programs, incorporated by reference in this rule. The application can be obtained from the Department of Health, Bureau of HIV/AIDS and Hepatitis Program, 4052 Bald Cypress Way, S. E., Bin A09, Tallahassee, Florida 32399-1715, or online at______. A completed application shall be mailed to the Department of Health, Bureau of 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 accorance with Sections 381.004(8)(a)-(b), F.S.. No fee is required for reregistration.

(3) No change.

(4) Persons or facilities receiving funding pursuant to Section 381.004(3)(4), F.S., shall be exempt from payment of the initial registration fee.

(5) Effective October 1, 1998, HIV testing programs must reregister with the department annually. The application form for reregistration, DH Form 1781, 2/05 11/98, will be mailed by the Department of Health, Bureau of HIV/AIDS and Hepatitis Program, to the registered testing program 60 days prior to the program’s reregistration date. Reregistration dates have been established as follows:

(a) Testing programs registered with the department prior to October 1, 1998, will be notified in writing of their reregistration date by January 31, 1999.

(b) Testing programs who register with the department on or after October 1, 1998, will be sent a certificate of registration with a designated reregistration date.

(6) through (9) No change.

(10) The department shall deny, suspend, or revoke the registration of a person or agency which:

(a) fails to comply with Section 381.004(4)(5), F.S., or the rules in implementation thereof; or

(b) causes to happen an intentional or negligent act which physically or materially affects the health, safety, or welfare of the person receiving services.

(11) Pursuant to Section 381.004(4)(5)(a), F.S., the program shall be directed by a person with a minimum of 15 contact hours of experience in counseling persons with human immunodeficiency virus. Examples of counseling include: informing a test subject of an HIV-positive test result; providing case management services to HIV-infected persons; facilitating a support group for HIV-infected persons; and providing medical care.

(12) Each person providing post-test counseling to a patient with a positive test result shall have received specialized training which shall be equivalent to the Department of Health specialized training in providing post-test counseling to HIV-positive clients. Specialized training must include information on the following:

(a) Confidentiality, the meaning of a positive test result and the importance of not donating blood, blood components products, human tissues, organs, body parts, or sperm;

(b) Early intervention, referrals and linkages to care/services;

(c) Prevention of secondary HIV transmission;

(d) Partner counseling and referral services;

(e) HIV infection reporting; and

(f) Documentation of test results.

Rulemaking Specific Authority 381.004 FS. Law Implemented 381.004 FS. History–New 11-29-89, Amended 5-1-96, Formerly 10D-93.076, Amended 8-24-99,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Marlene LaLota

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, M.D., State Surgeon General

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 24, 2012

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: July 6, 2012