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The Florida Senate

2018 Florida Statutes

Title XXIX PUBLIC HEALTH
Chapter 395 HOSPITAL LICENSING AND REGULATION Entire Chapter
SECTION 1055
Rules and enforcement.
F.S. 395.1055
395.1055 Rules and enforcement.—
(1) The agency shall adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this part, which shall include reasonable and fair minimum standards for ensuring that:
(a) Sufficient numbers and qualified types of personnel and occupational disciplines are on duty and available at all times to provide necessary and adequate patient care and safety.
(b) Infection control, housekeeping, sanitary conditions, and medical record procedures that will adequately protect patient care and safety are established and implemented.
(c) A comprehensive emergency management plan is prepared and updated annually. Such standards must be included in the rules adopted by the agency after consulting with the Division of Emergency Management. At a minimum, the rules must provide for plan components that address emergency evacuation transportation; adequate sheltering arrangements; postdisaster activities, including emergency power, food, and water; postdisaster transportation; supplies; staffing; emergency equipment; individual identification of residents and transfer of records, and responding to family inquiries. The comprehensive emergency management plan is subject to review and approval by the local emergency management agency. During its review, the local emergency management agency shall ensure that the following agencies, at a minimum, are given the opportunity to review the plan: the Department of Elderly Affairs, the Department of Health, the Agency for Health Care Administration, and the Division of Emergency Management. Also, appropriate volunteer organizations must be given the opportunity to review the plan. The local emergency management agency shall complete its review within 60 days and either approve the plan or advise the facility of necessary revisions.
(d) Licensed facilities are established, organized, and operated consistent with established standards and rules.
(e) Licensed facility beds conform to minimum space, equipment, and furnishings standards as specified by the department.
(f) All hospitals submit such data as necessary to conduct certificate-of-need reviews required under part I of chapter 408. Such data shall include, but shall not be limited to, patient origin data, hospital utilization data, type of service reporting, and facility staffing data. The agency may not collect data that identifies or could disclose the identity of individual patients. The agency shall utilize existing uniform statewide data sources when available and shall minimize reporting costs to hospitals.
(g) Each hospital has a quality improvement program designed according to standards established by their current accrediting organization. This program will enhance quality of care and emphasize quality patient outcomes, corrective action for problems, governing board review, and reporting to the agency of standardized data elements necessary to analyze quality of care outcomes. The agency shall use existing data, when available, and shall not duplicate the efforts of other state agencies in order to obtain such data.
(h) Licensed facilities make available on their Internet websites, no later than October 1, 2004, and in a hard copy format upon request, a description of and a link to the patient charge and performance outcome data collected from licensed facilities pursuant to s. 408.061.
(i) All hospitals providing organ transplantation, neonatal intensive care services, inpatient psychiatric services, inpatient substance abuse services, or comprehensive medical rehabilitation meet the minimum licensure requirements adopted by the agency. Such licensure requirements must include quality of care, nurse staffing, physician staffing, physical plant, equipment, emergency transportation, and data reporting standards.
(2) Separate standards may be provided for general and specialty hospitals, ambulatory surgical centers, and statutory rural hospitals as defined in s. 395.602.
(3) The agency shall adopt rules with respect to the care and treatment of patients residing in distinct part nursing units of hospitals which are certified for participation in Title XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act skilled nursing facility program. Such rules shall take into account the types of patients treated in hospital skilled nursing units, including typical patient acuity levels and the average length of stay in such units, and shall be limited to the appropriate portions of the Omnibus Budget Reconciliation Act of 1987 (Pub. L. No. 100-203) (December 22, 1987), Title IV (Medicare, Medicaid, and Other Health-Related Programs), Subtitle C (Nursing Home Reform), as amended. The agency shall require level 2 background screening as specified in s. 408.809(1)(e) pursuant to s. 408.809 and chapter 435 for personnel of distinct part nursing units.
(4) The agency shall adopt rules with respect to the care and treatment of clients in intensive residential treatment programs for children and adolescents and with respect to the safe and healthful development, operation, and maintenance of such programs.
(5) The agency shall enforce the provisions of part I of chapter 394, and rules adopted thereunder, with respect to the rights, standards of care, and examination and placement procedures applicable to patients voluntarily or involuntarily admitted to hospitals providing psychiatric observation, evaluation, diagnosis, or treatment.
(6) No rule shall be adopted under this part by the agency which would have the effect of denying a license to a facility required to be licensed under this part, solely by reason of the school or system of practice employed or permitted to be employed by physicians therein, provided that such school or system of practice is recognized by the laws of this state. However, nothing in this subsection shall be construed to limit the powers of the agency to provide and require minimum standards for the maintenance and operation of, and for the treatment of patients in, those licensed facilities which receive federal aid, in order to meet minimum standards related to such matters in such licensed facilities which may now or hereafter be required by appropriate federal officers or agencies in pursuance of federal law or promulgated in pursuance of federal law.
(7) Any licensed facility which is in operation at the time of promulgation of any applicable rules under this part shall be given a reasonable time, under the particular circumstances, but not to exceed 1 year from the date of such promulgation, within which to comply with such rules.
(8) The agency may not adopt any rule governing the design, construction, erection, alteration, modification, repair, or demolition of any public or private hospital, intermediate residential treatment facility, or ambulatory surgical center. It is the intent of the Legislature to preempt that function to the Florida Building Commission and the State Fire Marshal through adoption and maintenance of the Florida Building Code and the Florida Fire Prevention Code. However, the agency shall provide technical assistance to the commission and the State Fire Marshal in updating the construction standards of the Florida Building Code and the Florida Fire Prevention Code which govern hospitals, intermediate residential treatment facilities, and ambulatory surgical centers.
(9) The agency shall establish a technical advisory panel, pursuant to s. 20.052, to develop procedures and standards for measuring outcomes of pediatric cardiac catheterization programs and pediatric cardiovascular surgery programs.
(a) Members of the panel must have technical expertise in pediatric cardiac medicine, shall serve without compensation, and may not be reimbursed for per diem and travel expenses.
(b) Voting members of the panel shall include: 3 at-large members, including 1 cardiologist who is board certified in caring for adults with congenital heart disease and 2 board-certified pediatric cardiologists, neither of whom may be employed by any of the hospitals specified in subparagraphs 1.-10. or their affiliates, each of whom is appointed by the Secretary of Health Care Administration, and 10 members, and an alternate for each member, each of whom is a pediatric cardiologist or a pediatric cardiovascular surgeon, each appointed by the chief executive officer of the following hospitals:
1. Johns Hopkins All Children’s Hospital in St. Petersburg.
2. Arnold Palmer Hospital for Children in Orlando.
3. Joe DiMaggio Children’s Hospital in Hollywood.
4. Nicklaus Children’s Hospital in Miami.
5. St. Joseph’s Children’s Hospital in Tampa.
6. University of Florida Health Shands Hospital in Gainesville.
7. University of Miami Holtz Children’s Hospital in Miami.
8. Wolfson Children’s Hospital in Jacksonville.
9. Florida Hospital for Children in Orlando.
10. Nemours Children’s Hospital in Orlando.

Appointments made under subparagraphs 1.-10. are contingent upon the hospital’s maintenance of pediatric certificates of need and the hospital’s compliance with this section and rules adopted thereunder, as determined by the Secretary of Health Care Administration. A member appointed under subparagraphs 1.-10. whose hospital fails to maintain such certificates or comply with standards may serve only as a nonvoting member until the hospital restores such certificates or complies with such standards.

(c) The Secretary of Health Care Administration may appoint nonvoting members to the panel. Nonvoting members may include:
1. The Secretary of Health Care Administration.
2. The Surgeon General.
3. The Deputy Secretary of Children’s Medical Services.
4. Any current or past Division Director of Children’s Medical Services.
5. A parent of a child with congenital heart disease.
6. An adult with congenital heart disease.
7. A representative from each of the following organizations: the Florida Chapter of the American Academy of Pediatrics, the Florida Chapter of the American College of Cardiology, the Greater Southeast Affiliate of the American Heart Association, the Adult Congenital Heart Association, the March of Dimes, the Florida Association of Children’s Hospitals, and the Florida Society of Thoracic and Cardiovascular Surgeons.
(d) The panel shall meet biannually, or more frequently upon the call of the Secretary of Health Care Administration. Such meetings may be conducted telephonically, or by other electronic means.
(e) The duties of the panel include recommending to the agency standards for quality of care, personnel, physical plant, equipment, emergency transportation, and data reporting for hospitals that provide pediatric cardiac services.
(f) Beginning on January 1, 2020, and annually thereafter, the panel shall submit a report to the Governor, the President of the Senate, the Speaker of the House of Representatives, the Secretary of Health Care Administration, and the State Surgeon General. The report must summarize the panel’s activities during the preceding fiscal year and include data and performance measures on surgical morbidity and mortality for all pediatric cardiac programs.
(10) Based on the recommendations of the advisory panel in subsection (9), the agency shall adopt rules for pediatric cardiac programs which, at a minimum, include:
(a) Standards for pediatric cardiac catheterization services and pediatric cardiovascular surgery including quality of care, personnel, physical plant, equipment, emergency transportation, data reporting, and appropriate operating hours and timeframes for mobilization for emergency procedures.
(b) Outcome standards consistent with nationally established levels of performance in pediatric cardiac programs.
(c) Specific steps to be taken by the agency and licensed facilities when the facilities do not meet the outcome standards within a specified time, including time required for detailed case reviews and the development and implementation of corrective action plans.
(11) A pediatric cardiac program shall:
(a) Have a pediatric cardiology clinic affiliated with a hospital licensed under this chapter.
(b) Have a pediatric cardiac catheterization laboratory and a pediatric cardiovascular surgical program located in the hospital.
(c) Have a risk adjustment surgical procedure protocol following the guidelines established by the Society of Thoracic Surgeons.
(d) Have quality assurance and quality improvement processes in place to enhance clinical operation and patient satisfaction with services.
(e) Participate in the clinical outcome reporting systems operated by the Society of Thoracic Surgeons and the American College of Cardiology.
(12) The agency may adopt rules to administer the requirements of part II of chapter 408.
History.—ss. 26, 30, ch. 82-182; s. 5, ch. 83-244; ss. 40, 49, ch. 83-334; s. 41, ch. 87-92; s. 27, ch. 90-344; ss. 27, 98, ch. 92-289; s. 28, ch. 93-129; s. 24, ch. 93-211; s. 1, ch. 94-317; s. 31, ch. 96-169; s. 6, ch. 98-89; s. 99, ch. 98-200; s. 7, ch. 98-303; s. 104, ch. 99-8; ss. 22, 135, ch. 2000-141; ss. 34, 37, ch. 2001-186; ss. 3, 6, ch. 2001-372; s. 6, ch. 2004-297; s. 47, ch. 2007-230; s. 271, ch. 2011-142; s. 1, ch. 2017-151; s. 32, ch. 2018-24.
Note.—Former s. 395.005.