Fla. Admin. Code Ann. R. 59A-1.011 - Adverse Reactions

(1) General. Each agency shall inform physicians and hospital personnel involved in the transplantation of organs, tissues, and eyes of policies and procedures regarding the reporting of adverse reactions to agencies. It is the responsibility of each physician and organization that utilizes organs and tissues for transplantation to notify the providing organ procurement organization, tissue bank, or eye bank in writing of any and all adverse reactions with regard to transmission of infections or other diseases. The providing organization shall notify the medical examiner if the adverse reaction involves donation from a medical examiner's case. Every reasonable effort shall be made by each providing agency to inform each receiving agency or physician of this fact and to provide a mechanism for follow-up (e.g., pre-addressed follow-up cards, a toll free number, etc.) to report such instance.

(2) Notification of adverse reaction.

(a) In accordance with subsection 59A-1.005(14), F.A.C., each agency shall, upon notification of an adverse reaction by a transplanting physician or hospital:

1. Immediately notify the Agency for Health Care Administration, Division of Health Quality Assurance, by telephone of a potential adverse reaction;

2. Immediately suspend distribution of grafts coming from that donor;

3. Initiate an investigation to determine whether or not the adverse reaction was due to the donor organs and tissues; and

4. Submit to the Agency for Health Care Administration, Division of Health Quality Assurance, within two working days, Part I of the AHCA's Organ and Tissue Adverse Reaction Reporting Form, AHCA Form 3140-2003-OCT 95. This entire form is incorporated herein by reference and available from the Agency for Health Care Administration, Division of Health Quality Assurance, Ft. Knox Office Building, 2727 Mahan Drive, Tallahassee, Florida 32308.

(3) Follow-up procedures.

(a) Where it is determined that the adverse reaction was due to the donor organs and tissues, each agency shall institute recall procedures in accordance with subsection 59A-1.005(15), F.A.C., and look back procedures in accordance subsection 59A-1.005(16) F.A.C.

(b) Once a final determination of the cause of an adverse reaction is made, each agency shall submit Part II of the AHCA's Organ and Tissue Adverse Reaction Reporting Form, AHCA Form 3140-2003-OCT 95, to the Division of Health Quality Assurance.

Notes

Fla. Admin. Code Ann. R. 59A-1.011

Rulemaking Authority 765.541(2) FS. Law Implemented 765.541 FS.

New 11-26-92, Amended 8-20-96.

New 11-26-92, Amended 8-20-96.