The purpose is to streamline the rule, update obsolete language, and incorporate recommendations from the Joint Administrative Procedures Committee.

 

DEPARTMENT OF HEALTH

Division of Disease Control

RULE NO.:RULE TITLE:

64D-2.005Blood and Human Tissue Donations

PURPOSE AND EFFECT: The purpose is to streamline the rule, update obsolete language, and incorporate recommendations from the Joint Administrative Procedures Committee.

SUMMARY: This rule describes the testing for infectious diseases that must be performed on donated blood and human tissue prior to transplantation or transfusion and notification procedures for the donor and recipient if the blood or human tissue is found to be HIV-positive.

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: The new language added requiring infectious disease testing replaced old language requiring the same. The new language adopts, and does not exceed, federal laws and regulations that are applicable to the regulated subject matter. 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), 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: 381.0041(10) FS.

LAW IMPLEMENTED: 381.0041 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 and Hepatitis Section, Florida Department of Health, Bin #A09, 4052 Bald Cypress Way, Tallahassee, FL 32399-1715, telephone number [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64D-2.005 Blood and Human Tissue Donations.

(1) The HIV test shall be performed by a laboratory licensed under Chapter 483, F.S., in compliance with the standards of the Clinical Laboratory Improvement Act of 1967 (CLIA) [42 U.S.C. 263a (1988)], or be licensed under standards equivalent to the minimum requirements of Chapter 483, F.S., in the state in which it is located, and must successfully participate in an HIV proficiency testing program, provided the clinical laboratory is qualified to perform the test.

(1)(2) No blood, plasma, organ, skin, semen, or other human tissue from donors whose blood is reactive to HIV shall be released for transfusion or transplantation to another. Such blood shall be retested using a confirmatory test prior to release of test results outside the facility. Test results may be released immediately to the physician of an organ donation recipient, prior to confirmatory testing. Donated blood, organs and tissue must also be tested for infectious diseases identified by the federal government in 21 CFR s. 610.40 (2013) (donated blood), incorporated by reference, which can be found online at https://www.flrules.org/Gateway/reference.asp?No=Ref-03426; 21 CFR s.1270.21 (2013) (donated tissue), incorporated by reference, which can be found online at https://www.flrules.org/Gateway/reference.asp?No=Ref-03427; and in the Federal Health Resources and Services Administration’s Organ Procurement and Transplantation Network Policy 2.2, as revised 9-1-2012 (donated organs), incorporated by reference, which can be found online at https://www.flrules.org/Gateway/reference.asp?No=Ref-03428.

(2)(3) The recipient’s physician shall be notified of HIV confirmatory test results within 24 hours by the medical director of the facility in the event that blood, plasma, organ, skin, semen, or other tissue is transferred and is subsequently reported positive on confirmatory test. The donor or their his legal representative shall also be notified in accordance with the Model Protocol for Counseling Blood, Organ or Tissue Donors.

(3)(4) The Model Protocol for Counseling Blood, Organ or Tissue Donors, effective December 2012, developed pursuant to Section 381.0041(8), F.S., and incorporated herein by reference provides a list of the information that shall be included in the letter of notification to donors who test positive for to HIV based on confirmatory testing. The Model Protocol for Counseling Blood, Organ or Tissue Donors, 7-12-89, is available through the Department of Health, Bureau of HIV/AIDS and Hepatitis Section, 4052 Bald Cypress Way, Bin A09, Tallahassee, Florida 32399-1715, or online at https://www.flrules.org/Gateway/reference.asp?No=Ref-03429.

(5) Any blood, plasma, organ, skin, semen, or other human tissue from a donor whose blood test for HIV or hepatitis is repeatedly reactive, or originating from an individual diagnosed with AIDS or ARC, shall not be shipped or used for transfer to another, except as provided by Title 42 Part 72, Title 49 Part 173, and Title 39 Part III, Code of Federal Regulations. Such human tissue shall be destroyed, treated, or disposed, in accordance with Section 381.0098, F.S., and Chapter 64E-16, F.A.C. with the rules promulgated to implement Chapter 88-130, Laws of Florida, relating to bio hazardous waste.

(4)(6) No change.

Rulemaking Specific Authority 381.0041(10) FS. Law Implemented 381.0041 FS. History–New 7-12-89, Amended 5-1-96, Formerly 10D-93.073, Amended               .

 

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: October 1, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 23, 2013