The Agency proposes to update hospital rule to align with recently revised requirements in s. 395.1055, F.S. Revisions will update language and clarify requirements.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-3.246Licensed Programs

PURPOSE AND EFFECT: The Agency proposes to update hospital rule to align with recently revised requirements in s. 395.1055, F.S. Revisions will update language and clarify requirements.

SUMMARY: The Agency proposes to update hospital rule to align with recently revised statutory requirements. Section 395.1055, F.S. tasks the Agency with adding licensure requirements for transplant programs within hospitals.

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: A SERC has not been prepared by the agency. For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

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: 395.1055, 395.3038, 408.036, 408.0361 FS.

LAW IMPLEMENTED: 395.1055, 395.1065, 395.3038, 408.0361 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: April 22, 2019, 10:30 am - 12:00 pm

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room D, Tallahassee, FL 32308

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 3 days before the workshop/meeting by contacting: Jessica Munn, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [phone]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jessica Munn at [phone] or email at [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-3.246 Licensed Programs.

(1) Adult Diagnostic Cardiac Catheterization Program. All licensed hospitals that establish adult diagnostic cardiac catheterization laboratory services under section 408.0361, F.S., shall operate in compliance with the most recent guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories. Hospitals are considered to be in compliance with American College of Cardiology/American Heart Association guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The applicable guideline is the 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions Expert Consensus Document on Cardiac Catheterization Laboratory Standards Update. J Am Coll Cardiol 2012; 59:2221–305 (2012 ACC/SCAI Guidelines) which is hereby incorporated by reference and effective at adoption. The copyrighted material is available for public inspection at the Agency for Health Care Administration, Hospital and Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. A copy may be obtained from Elsevier Inc, Reprint Department by email at [e-mail] or online at https://www.sciencedirect.com/. Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. All such licensed hospitals shall have a department, service or other similarly titled unit which shall be organized, directed and staffed, and integrated with other units and departments of the hospitals in a manner designed to assure the provision of quality patient care.

(a) through (i) No change.

(j) Emergency Services.

1. All hospitals providing adult diagnostic cardiac catheterization program services, except hospitals licensed as a Level II adult cardiovascular services provider, shall have written transfer agreements developed specifically for diagnostic cardiac catheterization patients with one or more hospitals licensed as a Level II adult cardiovascular services provider. Written agreements must be in place with a ground ambulance service capable of advanced life support and Intra-Aortic Balloon Pump (IABP) transfer. Agreements may include air ambulance service, but must have ground ambulance backup. A transport vehicle must be on-site to begin transport within 30 20 minutes of a request and have a transfer time within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested once every 6 months, with appropriate documentation maintained, including the hospital’s internal log or emergency medical services data.

2. Patients at high risk for diagnostic catheterization complications shall be referred for diagnostic catheterization services to hospitals licensed as a Level II adult cardiovascular services provider. Hospitals not licensed as a Level II adult cardiovascular services provider must have documented patient selection and exclusion criteria and provision for identification of emergency situations requiring transfer to a hospital with a Level II adult cardiovascular services program. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

(k) through (m) No change

(2) through (5) No change

(6) Organ transplant programs. Licensure designations for organ transplant programs include heart, intestines, kidney, liver, lung, pancreas and islet cells, and bone marrow. Separate designations are required for adult and pediatric programs. Bone marrow programs must have separate designations for autologous and allogeneic programs. Licensure for multi-organ transplant programs such as heart-lung must apply for each licensure designation by age group and must meet program-specific requirements separately.

(a) A hospital issued a certificate of need to establish one or more organ transplant programs must request and obtain the corresponding licensure designation(s) by submitting written notification to the Agency’s Hospital and Outpatient Services Unit prior to scheduling its first transplant procedure in each program.

(b) In addition to the definitions contained in Rule 59A-3.065, F.A.C., the following definitions shall apply to this subsection:

1. “Bone Marrow Transplantation” means human blood precursor cells administered to a patient to restore normal hematological and immunological functions following ablative or nonablative therapy with curative or life-prolonging intent. Human blood precursor cells may be obtained from the patient in an autologous transplant or from a medically acceptable related or unrelated donor, and may be derived from bone marrow, circulating blood, or a combination of bone marrow and circulating blood.

2. “Pediatric Patient” means a patient under the age of 15 years. Pediatric transplant programs at a Medicaid designated transplant center may perform transplants for patients under the age of 21. In case of conflict between provisions in this rule, the provision of this subsection shall prevail.

4. “Research Hospital” means a hospital which devotes clearly defined space, staff, equipment, and other resources for research purposes and has documented teaching affiliations with an accredited school of medicine in Florida or another state.

5. “Research Program” means an organized program that conducts clinical trial research, collects treatment data, assesses outcome data, and publishes statistical reports showing research activity and findings.

7. “Teaching Hospital” means any hospital which the Secretary of the Agency for Health Care Administration has determined meets the conditions specified in Section 408.07(44), F.S.

8. “Transplantation Program” means the offering of administrative, surgical, and support services by a hospital through which one or more types of organ transplants are provided to one or more patients; and the offering of some or all phases of bone marrow transplantation.

(c) All hospitals providing organ transplant services must meet and maintain the general and program-specific service requirements. Hospitals providing organ transplant services for heart, intestines, kidney, liver, lung, or pancreas and islet cells must:

1. Be a member of the Organ Procurement and Transplantation Network (OPTN);

2. Have a written agreement with an Organ and Tissue Procurement Organization (OPO) licensed under chapter 765, F.S.; and

3. Have equipment for cooling, flushing, and transporting organs. If cadaveric transplants are performed, equipment for organ preservation through mechanical perfusion is required. This requirement may be met through an agreement with an OPO.

(d) All hospitals providing any organ transplant service must have:

1. An age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation when required;

2. A clinical review committee for evaluation and decision-making regarding the suitability of a transplant candidate;

3. Services and facilities for inpatient and outpatient care, available on a 24-hour basis, for the patient’s chronic illness prior to transplantation, during transplantation, and in the post-operative period;

4. Policies and procedures for patient care specifying patient selection criteria for patient management and evaluation during the pre-hospital, in-hospital, and immediate post-discharge phases of the program;

5. Detailed therapeutic and evaluative procedures for the acute and long-term management of each patient and the management of common complications;

6. A program for the education and training of staff regarding the special care of transplantation patients;

7. Education services including home and hospital programs to minimize interruption in the patient’s school education;

8. A program for the education of patients, their families and the patient’s primary care physician regarding post-operative and post-discharge care for transplantation patients; and

9. Clinical and pathology laboratory services meeting the requirements in Rule 59A-3.242(1), F.A.C. Services may be provided directly as a hospital service or by contract to meet the needs of the patients. CLIA certified specialties must include Histocompatibility for transplant services, Microbiology, Chemistry, Hematology, Immunohematology (blood bank), and Histopathology with the capability of studying and promptly reporting the patient’s response to the organ transplantation surgery, and analyzing appropriate biopsy material;

(e) All hospitals providing organ transplant services must meet the following staffing requirements:

1. A staff of physicians licensed pursuant to chapters 458 or 459, F.S. with expertise in caring for age-appropriate patients with end-stage disease requiring organ transplantation. The physicians shall be members of the organized medical staff and have medical specialties or sub-specialties appropriate for the type of transplant program. Each transplant program shall have a designated physician member of the organized medical staff, meeting the education, training, certification, and experience qualifications required by the hospital’s governing board or delegated committee, to serve as:

a. The program director, responsible for the day-to-day administration of the transplant program;

b. The primary transplant physician, responsible for providing and coordinating the pre- and post-transplantation care of patients; and

c. The primary transplant surgeon, responsible for providing and coordinating the transplantation surgical services.

2. A staff of registered professional nurses, including advanced practice registered nurses, if applicable, with experience in the care of chronically ill patients and their families;

3. A registered professional nurse or other licensed clinician approved by the program director to serve as clinical transplant coordinator;

4. Maintain contractual agreements with consultants who have expertise in immunohematology and are capable of meeting the unique needs of transplant patients on a long-term basis;

5. A pharmacist with expertise in the pharmacological needs of transplant patients;

6. A registered dietician with expertise in the nutritional needs of transplant patients;

7. A staff of respiratory therapists with expertise in the needs of transplant patients; and,

8. A staff of social workers, psychologists, psychiatrists, and other individuals skilled in performing comprehensive psychological assessments, counselling patients and families of patients, providing assistance with financial arrangements, and making arrangements for use of community resources.

(f) Liver, lung, pancreas and islet cells, intestines, multi-organ, and bone marrow programs, excluding bone marrow programs for adults providing autologous transplants only, are limited to a teaching or research hospital with training programs relevant to the transplant program.

1. Lung, pancreas and islet cells, intestines, and multi-organ transplant programs must have interactive programs of basic and applied research in organ failure, transplantation, immunoregulatory responses, and related biology.

2. Bone marrow programs, excluding bone marrow programs for adults providing autologous transplants only, must have an ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital. The program must include outcome monitoring and long-term patient follow-up.

3. Bone marrow programs for adults providing only autologous transplants may be established at

a. Teaching hospitals;

b. Research hospitals; or

c. Community hospitals with a research program or affiliated with a research program. The research program may be integrated within the hospital, by written agreement with a bone marrow transplant center operated by a teaching hospital, or by an agreement with an outpatient provider with a research program. Under the agreement, the outpatient research program may perform one or more of the following outpatient phases of bone marrow transplantation: blood screening tests, mobilization of stem cells, stem cell rescue, chemotherapy, and reinfusion of stem cells.

(g) Heart transplant programs must maintain:

1. A cardiologist member of the organized medical staff meeting the age appropriate education, training, and certification requirements as established by the program director;

2. An anesthesiologist member of the organized medical staff meeting the age appropriate education, training, and certification requirements as established by the program director, and experienced in both open heart surgery and heart transplantation; and

3. A single occupancy isolation room in an age-appropriate intensive care unit.

(h) Liver transplant programs must maintain:

1. Staff trained in liver transplantation and in the care of patients with hepatic diseases; and

2. The following available in the hospital or by contract:

a. A department of gastroenterology, including clinics and procedure rooms;

b. Radiology services to provide complex biliary procedures, including transhepathic cholangiography, portal venography and arteriography; and

c. A patient convalescent unit for monitoring patient’s progress post-discharge.

(i) Kidney transplant programs must maintain:

1. A nephrologist member of the organized medical staff meeting the age appropriate education, training, and certification requirements as established by the program director;

2. An anesthesiologist member of the organized medical staff meeting the age appropriate education, training, and certification requirements as established by the program director, and experienced in kidney transplantation;

3. Nursing staff experienced in nursing care of patients with permanent kidney failure;

4. Inpatient renal dialysis available onsite at all times, including a separate pediatric dialysis unit if pediatric patients are served;

5. Outpatient services, including renal dialysis services and ambulatory renal clinic services; and

6. Ancillary services, including nutritional, radiologic, and nursing services capable of monitoring and support during dialysis and assisting with educating the patient in home care vascular access and home dialysis management, when applicable.

(j) Pediatric kidney transplant programs must meet the following additional requirements:

1. The program director must be board certified or eligible in pediatric nephrology;

2. The head nurse of the dialysis unit must have special training and expertise in pediatric dialysis;

3. The nurse to patient ratio in the pediatric dialysis unit must be 1:1;

4. The registered dietician must have expertise in nutritional needs of children with chronic renal disease; and

5. The radiology service must have specialized equipment for obtaining x-rays on pediatric patients.

(k) Bone marrow programs for pediatric patients must meet the following common requirements:

1. The program director must have formal training in pediatric bone marrow transplantation, and shall be board certified as a hematologist or oncologist with experience in the treatment and management of pediatric acute oncological cases involving high dose chemotherapy or high dose radiation therapy;

2. Nursing staff must be dedicated full time to the program and have experience with the care of critically ill immuno-suppressed patients;

3. The transplantation team must have expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoietic and lymphopoietic malignancies, and non-neoplastic disorders;

4. An interdisciplinary team must direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications;

5. A radiation therapy division, under the direction of a board certified radiation oncologist, must be available onsite and capable of sub-lethal x-irradiation, bone marrow ablation, and total lymphoid irradiation; and

6. Pediatric inpatient post-transplantation care must be provided in a laminar air flow room; or in a single occupancy room with positive pressure, reverse isolation procedures, and terminal high efficiency particulate aerosol filtration on air blowers. This unit can be part of a program that also manages patients with leukemia or similar disorders.

(l) In addition to paragraph (k) above, bone marrow programs providing allogeneic transplants to pediatric patients must have:

1. A pediatric convalescent facility to provide a temporary residence for patients during the prolonged convalescence;

3. A pediatric outpatient unit for close supervision of discharged patients;

3. An onsite laboratory equipped for the evaluation and cryopreservation of bone marrow; and

4. A laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, T-cell depletion, and separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements.

(m) Bone marrow programs for adults must meet the following common requirements:

1. The program director must have formal training in bone marrow transplantation and be a board certified hematologist or oncologist with experience in the treatment and management of adult acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The hospital’s governing board may appoint a board eligible hematologist or oncologist with at least one year of experience performing autologous bone marrow transplants to serve as program director if transplants are limited to autologous transplantations;

2. Nursing staff must be dedicated full time to the program and have experience with the care of critically ill immuno-suppressed patients;

3. An interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoietic and lymphopoietic malignancies, and non-neoplastic disorders shall direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications;

4. Adult inpatient post-transplantation care must be provided in a laminar air flow room or in a single occupancy room with positive pressure, reverse isolation procedures, and terminal high efficiency particulate aerosol filtration on air blowers. This unit can be part of a program that also manages patients with leukemia or similar disorders; and

5. A radiation therapy division, under the direction of a board certified radiation oncologist, must be available onsite and capable of sub-lethal x-irradiation, bone marrow ablation, and total lymphoid irradiation.

(n) In addition to paragraph (m) above, bone marrow programs providing allogeneic transplants to adults must have:

1. A laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, T-cell depletion, and separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements;

2. An onsite laboratory equipped for the evaluation and cryopreservation of bone marrow;

3. An adult convalescent facility to provide a temporary residence for patients during the prolonged convalescence; and

4. An adult outpatient unit for close supervision of discharged patients.

(o) Bone marrow programs providing allogeneic transplants may also provide autologous transplants without separate licensure as an autologous bone marrow transplant program.

(p) Each licensed organ transplant program must perform a minimum of 10 transplants per year averaged over 2 years. Hospitals providing adult and pediatric programs must meet the minimum volume requirement for each age group separately.

(q) Hospitals with licensed organ transplant programs must include organ transplant utilization data with the quarterly data submission required under section 395.1055 and chapter 408, part I, F.S.

Rulemaking Authority 395.1055, 395.3038, 408.036, 408.0361 FS. Law Implemented 395.1055, 395.1065, 395.3038, 408.0361 FS. History–New 8-15-18, ­Formerly 59A-3.2085(13), 59A-3.2085(14), 59A-3.2085(15), 59A-3.2085(16), 59A-3.2085(17),  59A-3.2085(81), Amended, __________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jack Plagge

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Mary C. Mayhew

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 03/20/2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 11/08/2018