Existing Rule 59A-3.2085, F.A.C. is large and encompasses many different topics. The Agency proposes to divide this rule into multiple new rules in order to improve readability. Substantive edits to the section for Licensed Programs are required ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-3.240Nutritional Services

59A-3.241Pharmacy Services

59A-3.242Laboratory, Radiology, and Respiratory Services

59A-3.243Nursing Services

59A-3.244Ambulatory, Obstetrical, and Special Care Units

59A-3.245Surgical and Anesthesia Departments

59A-3.246Licensed Programs

59A-3.247Housekeeping Services

PURPOSE AND EFFECT: Existing Rule 59A-3.2085, F.A.C. is large and encompasses many different topics. The Agency proposes to divide this rule into multiple new rules in order to improve readability. Substantive edits to the section for Licensed Programs are required due to outdated guidelines and legislation enacted per HB 785 (2017).

SUMMARY: The Agency proposes to divide the rule covering hospital services and departments into multiple new sections. Revisions will clarify language, amend requirements, correct references, and update guidelines. Once the new rules are adopted, the Agency plans to repeal Rule 59A-3.2085, F.A.C.

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.

For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC.

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: 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, 395.401, 408.036, 408.0361, FS.

LAW IMPLEMENTED: 395.001, 395.1055, 395.1065, 395.3038, 395.401, 408.036, 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 24, 2018, 2:00 p.m. – 3:30 p.m.

PLACE: Agency for Health Care Administration, Conference Room D, 2727 Mahan Drive, Building #3, 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-3.240 Nutritional Services.

All licensed hospitals shall have a dietetic 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 appropriate nutritional care and quality food service.

(1) The dietetic department shall be directed on a full-time basis by a registered dietitian or other individual with education or specialized training and experience in food service management, who shall be responsible to the chief executive officer or his designee for the operations of the dietetic department.

(2) If the director of the dietetic department is not a registered dietitian, the hospital shall employ a registered dietitian at a minimum on a part-time or consulting basis to supervise the nutritional aspects of patient care and assure the provision of quality nutritional care to patients. The consulting dietitian shall regularly submit reports to the chief executive officer concerning the extent of services provided.

(3) Whether employed full-time, part-time or on a consulting basis, a registered dietitian shall provide the following services to the hospital on the premises on a regularly scheduled basis:

(a) Liaison with administration, medical and nursing staffs;

(b) Patient and family counseling as needed;

(c) Approval of menus and modified diets;

(d) Required nutritional assessments;

(e) Participation in development of policies, procedures and continuing education programs; and

(f) Evaluation of dietetic services.

(4) Annually, a registered dietitian shall conduct a review and evaluation of the dietetic department to include:

(a) A review of menus for nutritional adequacy;

(b) A review of tray identification methods, patients who are not receiving oral intake, and the elapsed time between the evening meal and the next substantial meal;

(c) A review of the counseling and instruction given to patients and their families with special dietary needs;

(d) A review of committee activities concerning nutritional care; and

(e) A review of the appearance, palatability, serving temperature, patient acceptability and choice, and retention of nutrient value of food served by the dietetic department.

(5) Nothing in this section shall prevent a hospital from employing an outside food management company for the provision of dietetic services, provided the requirements of this section are met, and the contract specifies this compliance.

(6) The dietetic department, service or other similarly titled unit shall employ sufficient qualified personnel under competent supervision to meet the dietary needs of patients.

(7) Personnel in the dietetic department shall receive, as appropriate to their level of responsibility, instruction in:

(a) Personal hygiene and infection control;

(b) Food handling, preparation, serving and storage; cleaning and safe operation of equipment;

(c) Waste disposal;

(d) Portion control;

(e) Diet instruction; and

(f) The writing of modified diets and the recording of pertinent dietetic information in the patient’s medical record.

(8) Personnel in the dietetic department shall receive quarterly in-service training of which a record shall be kept by the dietetic department.

(9) The dietetic department, service or other similarly titled unit shall be guided by written policies and procedures that cover food procurement, preparation and service. Dietetic department policies and procedures shall be developed by the director of the dietetic department with nutritional care policies and procedures developed by a registered dietitian, shall be subject to annual review, revised as necessary, dated to indicate the time of last review, and enforced. Written dietetic policies shall include the following:

(a) A description of food purchasing, storage, inventory, preparation, service, and disposal policies and procedures.

(b) A requirement that diet orders be recorded in the patient’s medical record by an authorized individual before the diet is served to the patient.

(c) The proper use and adherence to standards for nutritional care as specified in a diet manual which is based on the current National Academy of Medicine, Food and Nutrition Board, Dietary Reference Intakes (DRIs).

(d) A requirement for patients who are on oral intake and do not have specific dietary requirements, that a minimum of three meals or their equivalent be provided daily, with not more than a 15 hour span between the evening meal and breakfast.

(e) A requirement that temperatures for holding and serving cold foods be below 45 degrees F, and for hot foods be above 140 degrees F.

(f) A requirement that a supply of non-perishable foods sufficient to serve a hospital’s patients for a minimum of a one week period be available.

(g) A requirement that written reports of sanitary inspections be kept on file, with a record of actions undertaken to comply with recommendations.

(h) A description of the role of the dietetic department in the hospital's internal and external disaster plans.

(i) Menus.

(j) The role of the dietetic department in the preparation, storage, distribution and administration of enteric feeding, tube feeding and total parenteral nutrition programs.

(k) Alterations in diets or diet schedules, including the provision of food service to patients who do not receive regular meal service.

(l) Ancillary dietetic services, as appropriate, including food storage and kitchens on patient care units, formula supply, cafeterias, vending operations and ice making.

(m) Personal hygiene and health of dietetic personnel.

(n) A description of dietetic department policies and procedures designed to provide for infection control including a monitoring system to assure that dietetic personnel are free from communicable infections and open skin lesions.

(o) A description of the identification system used for patient trays and other methods for assuring that each patient receives the appropriate diet as ordered,

(p) Safety practices, including the control of electrical, flammable, mechanical, and as appropriate, radiation hazards.

(10) The dietetic department shall be designed and equipped to facilitate the safe, sanitary, and timely provision of food service to meet the nutritional needs of patients.

(11) The dietetic department shall have adequate equipment and facilities to prepare and distribute food, protect food from contamination and spoilage, to store foods under sanitary and secure conditions, and to provide adequate lighting, ventilation and humidity control.

(12) The dietetic department shall thoroughly cleanse and sanitize food contact surfaces, utensils, dishes and equipment between periods of use, shall ensure that toilet, hand-washing and hand-drying facilities are conveniently available, and provide for dishwashing and utensil washing equipment that prevent recontamination and are apart from food preparation areas.

(13) The dietetic department shall ensure that all walk-in refrigerators and freezers can be opened from inside and that all food and nonfood supplies are clearly labeled. Where stored in the same refrigerator, all nonfood supplies and specimens shall be stored on separate shelves from food supplies.

(14) The dietetic department shall implement methods to prevent contamination in the making, storage, and dispensing of ice.

(15) The dietetic department shall ensure that disposable containers and utensils are discarded after one use, and that worn or damaged dishes and glassware are discarded.

(16) The dietetic department shall hold, transfer, and dispose of garbage in a manner which does not create a nuisance or breeding place for pests or otherwise permit the transmission of disease.

(17) Information on specifications, operation and maintenance of all major and fixed dietetic department equipment shall be maintained. A preventive and corrective maintenance program on such equipment shall be conducted and recorded.

(18) Dietetic services shall be provided in accordance with written orders by the health professional responsible for the patient and appropriate information shall be recorded in the patient’s medical record. Such information shall include:

(a) A summary of the dietary history and a nutritional assessment when the past dietary pattern is known to have a bearing on the patient’s condition;

(b) Timely and periodic assessments of the patient’s nutrient intake and tolerance to the prescribed diet modification, including the effect of the patient’s appetite and food habits on food intake and any substitutions made; and

(c) A description or copy of diet information forwarded to another organization when a patient is discharged.

(19) Within 24 hours of admission and within 24 hours of any subsequent orders for diet modification, the diet order shall be confirmed by the practitioner responsible for the patient receiving oral alimentation.

(20) Each hospital shall establish appropriate quality control mechanisms to assure that:

(a) All menus are evaluated for nutritional adequacy.

(b) There is a means for identifying those patients who are not receiving oral intake.

(c) Special diets are monitored.

(d) The nutritional intake of patients is assessed and recorded as appropriate.

(e) Effort is made to assure appetizing appearance, palatability, proper serving temperature, and retention of nutritional value of food.

(f) Whenever possible, patient food preferences are respected and appropriate dietary substitutions are made available.

(g) Surveys of patient acceptance of food are conducted, particularly for long-stay patients.

Rulemaking Authority 395.1055, FS. Law Implemented 395.1055, FS. History–New _______,

 

59A-3.241 Pharmacy Services.

Each Class I and Class II hospital shall have on the premises, and each Class III hospital shall have on the premises or by contract, a pharmacy, pharmaceutical department or service, or similarly titled unit, and, when applicable, shall present evidence that it holds a current institutional or community pharmacy permit under the provisions of the Florida Pharmacy Act, Chapter 465, F.S. The pharmacy department shall have a licensed pharmacist serve as pharmacy director on a full time or consulting basis. The director shall develop and monitor procedures to ensure the proper use of medications. Such procedures shall address prescription and ordering, preparation and dispensing, administration, and patient monitoring for medication effects.

(1) The director shall ensure a hospital formulary or drug list is developed, maintained, and regularly updated by authorized hospital staff. The formulary shall include the availability of non-legend medications, but does not preclude the use of unlisted drugs. Where unlisted drugs are used, there shall be a written policy and procedure for their prescription and procurement. Selection of medications for inclusion on the formulary shall be based on need, effectiveness, risks, and costs.

(2) The director shall ensure that individuals who prescribe or order medications are legally authorized through the granting of clinical privileges.

(3) All drugs shall be prepared and stored under proper conditions of sanitation, temperature, light, moisture, ventilation, security and segregation to promote patient safety and proper utilization and efficacy.

(4) All medications shall be appropriately labeled as to applicable accessory or cautionary statements and their expiration date, shall be dispensed in as ready-to-administer forms as possible, and in quantities consistent with the patient’s needs which are designed to ensure minimization of errors and diversion.

(5) A pharmacist shall review each order before dispensing the medication, with the exception of situations in which a licensed independent practitioner with appropriate clinical privileges controls prescription ordering, preparation and administration of medicine. The pharmacist shall verify the order with the prescriber when there is a question.

(6) All medications shall be prepared and dispensed consistent with applicable law and rules governing professional licensure and pharmacy operation and in accordance with professional standards of pharmacy practice.

(7) A medication profile shall be developed and maintained by the pharmacy department for each patient and shall be available to staff responsible for the patient’s care. The medication profile shall include the name, birth date, sex, pertinent health problems and diagnoses, current medication therapy, medication allergies or sensitivities, and potential drug or food interactions.

(8) The director shall develop and implement a process for providing medications when the pharmacy is closed that ensures control, accountability, and the appropriate use of medications.

(9) The director shall ensure there is an adequate and proper supply of emergency drugs within the pharmacy and in designated areas of the hospital.

(10) Receipt, distribution and administration of controlled drugs are documented by the pharmacy, nursing service and other personnel, to ensure control and accountability in accordance with state and federal law.

(11) The director shall ensure that the administration of drugs shall take place in accordance with written policies, approved by the professional staff and designed to ensure that all medications are administered safely and efficiently.

(12) The director may supervise satellite pharmacies. The director of the hospital pharmacy, or other licensed pharmacists who are properly designated, shall be available to the hospital at all times, whether on duty or on call.

(13) Administration of drugs shall be undertaken only upon the orders of authorized members of the professional staff, where the orders are verified before administration, the patient is identified, and the dosage and medication is noted in the patient’s chart or medical record.

(14) Investigational medications shall be used only in accordance with specific hospital policy which addresses:

(a) Review and approval of hospital participation in investigational studies by the appropriate hospital committee;

(b) Requirements for informed consent by the patient;

(c) Administration in accordance with an approved protocol;

(d) Administration by personnel approved by the principal investigator after they have received information and demonstrated an understanding of the basic pharmacologic information about the medications; and

(e) Documentation of doses dispensed, administered and destroyed.

(15) Each hospital shall have a system for the ongoing monitoring of each patient for medication effectiveness and actual or potential adverse effects or toxicity which includes:

(a) A collaborative assessment of the effect of the medication on the patient based on observation and information gathered and maintained in the patient’s medical record and medication profile;

(b) A process for the definition, identification, and review of significant medication errors and adverse drug reactions are reported in a timely manner in accordance with written procedures. Significant adverse drug reactions shall be reported promptly to the Food and Drug Administration;

(c) Information from the medication monitoring is used to assess the continued administration of the medication; and

(d) Conclusions and findings of the medication monitoring are communicated to the appropriate health care personnel involved in the patient’s care.

(16) Each hospital shall have written policies and procedures governing the selection, procurement, distribution, administration, and record-keeping of all drugs, including provision for maintaining patient confidentiality. The policies and procedures shall be reviewed at least annually, dated to indicate time of last review, revised as necessary, and enforced.

(17) Parenteral nutrition services, when provided, shall be designed, implemented, and maintained to address assessment and reassessment of the patient, initial ordering and ongoing maintenance of medication orders, preparation and dispensing, administration, and assessing the effects on the patient.

 

Rulemaking Authority 395.1055, FS. Law Implemented 395.1055, FS. History–New _______,

 

 

59A-3.242 Laboratory, Radiology, and Respiratory Services.

(1) Clinical and Pathology Laboratory Services. Each hospital must provide on the premises or by contract with a laboratory licensed under Chapter 483, Part I, F.S., clinical and pathology laboratory services commensurate with the hospital’s needs and which conforms to the provisions of Chapter 483, Part I, F.S., and Chapter 59A-7, F.A.C. The clinical and pathology laboratory department or similarly titled unit shall have a physician member of the organized medical staff serve as medical director.

(a) The medical director shall maintain and enforce policies and procedures for the provision of clinical and pathology laboratory examinations.

(b) Provisions shall be made for assuring the availability of emergency laboratory services. Such services shall be available 24 hours a day, seven days a week, including holidays.

(c) Reports of all examinations shall be filed with the patient’s medical record.

(d) All specimens removed in operations shall be examined by a pathologist, except when another suitable means of verification of removal is routinely employed, when there is an authenticated report to document the removal, and when quality of care will not be compromised by the exception. Hospitals may establish a policy for excepting certain categories of specimens from examination when it determines quality of care will not be compromised or examination will yield no useful information. Signed reports on all specimens removed in an operation, whether documented by a pathologist or through an alternative means, shall be filed with the patient’s medical record.

(e) All hospitals utilizing blood and blood products, shall:

1. Maintain facilities for procurement, safekeeping and transfusion of blood and blood products, or have them readily available;

2. Maintain a temperature alarm system for blood storage facilities, where applicable, which is tested and inspected quarterly and is otherwise safe.

3. The alarm system must be audible, and must monitor proper blood and blood product storage temperature over a 24-hour period.

4. Tests of the alarm system must be documented.

5. If blood is stored or maintained for transfusion outside of a monitored refrigerator, the hospital must ensure and document that storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product.

6. Promptly dispose of blood which has exceeded its expiration date.

7. Keep records on file indicating the receipt and disposition of all blood provided to patients in the facility.

(f) Hospitals not utilizing blood and blood products need not maintain blood storage facilities.

(2) Radiology Services. Each Class I and Class II hospital shall provide on the premises, and each Class III hospital shall provide on the premises or by contract, diagnostic imaging facilities commensurate with the hospital’s needs and conform to Chapter 404, F.S., Chapter 64E-5, F.A.C., Chapter 468, Part IV, F.S., and Chapter 64E-3, F.A.C. The radiology department or similarly titled unit shall have a radiologist to serve as medical director on a full time or part time consulting basis to discharge professional radiology services.

(a) The radiology department or other similarly titled part shall be maintained free of hazards for patients and personnel.

(b) Each hospital shall have certified radiologic technologists or basic x-ray machine operators in hospitals of 150 beds or less, and shall be on duty or on call at all times, pursuant to Chapter 468, Part IV, F.S.; and Chapter 64E-3, F.A.C.

(c) The use of all diagnostic imaging apparatus shall be limited to personnel designated as specified in Chapter 468, Part IV, F.S., and Chapter 64E-3, F.A.C.

(d) The credentials of each person providing diagnostic and therapeutic radiation, imaging and nuclear medicine services, including formal training, on-the-job experience, and certification or licensure where applicable, shall be maintained on file at all times.

(e) The medical director shall maintain and enforce policies and procedures for the provision of all diagnostic and therapeutic radiation, imaging, and nuclear medicine services, and ensure compliance with the requirements of Chapter 64E-5, F.A.C. Such policies and procedures shall be written, reviewed annually, and revised as necessary in conformance with Chapter 64E-5, F.A.C., and shall be dated as to time of last review.

(f) The medical director shall require that all radiology, imaging or nuclear medicine services be performed only upon written order of a licensed physician or by another licensed health professional if that health professional is acting within their scope of practice as defined by applicable laws and rules of the licensing board.  Nothing herein shall be construed to expand or restrict such laws and rules pertaining to the practice of various health professions. The request and all results must be recorded in the patient’s medical record;

(g) The medical director shall ensure documentation, and reporting to the Bureau of Radiation Control of the Department of Health of all misadministration of radioactive materials, as those terms are defined by Chapter 64E-5, F.A.C.

(h) The medical director shall maintain and document in writing a quality control program designed to minimize the unnecessary duplication of radiographic studies, to minimize exposure time of patients and personnel, and to maximize the quality of diagnostic information and therapy provided.

(3) Respiratory Therapy. Each hospital shall have written policies and procedures describing the scope of respiratory services provided to patients of the hospital. This document shall contain written guidelines for the transfer or referral of patients requiring respiratory care services not provided at the hospital.

(a) When respiratory care services are provided outside the hospital, the hospital shall ensure by contract or other enforceable mechanism that such services meet all safety requirements and quality control measures required by the hospital.

(b) Respiratory care services provided within a hospital shall have medical direction provided by a physician member of the organized medical staff with special interest and knowledge in the management of acute and chronic respiratory problems. The physician director shall be responsible for the overall direction of respiratory services, for conducting a review of the quality, safety and appropriateness of respiratory care services quarterly, and shall be available for any required respiratory care consultation.

(c) Respiratory care services in a hospital may be supervised by a technical director who is registered or certified by the National Board of Respiratory Care Inc., or has the documented equivalent education, training and experience. Other respiratory care personnel shall provide respiratory care commensurate with their documented training, experience, and competence.

(d) The formal training of respiratory therapy students shall be carried out only in programs accredited by appropriate professional educational organizations. Individuals in student status shall be directly supervised when engaged in patient care activities.

(e) The education, training and experience of personnel who provide respiratory care services shall be documented, and shall be related to each individual’s level of participation in the provision of respiratory care services.

(f) Nonphysician respiratory care personnel shall not perform patient procedures associated with a potential hazard, including arterial puncture for obtaining blood samples, unless authorized in writing by the physician director of the respiratory care service acting in accordance with professional staff policy.

(g) The physician director shall be responsible for ensuring all personnel providing respiratory care services participate in education programs designed to augment the personnel’s knowledge of pertinent new developments in respiratory care services and maintain current competency. Such participation shall occur annually, and shall include instruction in safety, infection control, and cardiopulmonary resuscitation.

(h) There shall be written policies and procedures specifying the scope and conduct of patient care rendered in the provision of respiratory care services. All policies and procedures must be approved by the physician director, reviewed annually, revised as necessary, dated to indicate the time of last review, and enforced. Respiratory care policies shall include the following:

1. Specification as to who may perform specific procedures and provide instruction, under what circumstances, and under what degree of supervision.

2. Assembly and sequential operation of equipment and accessories to implement therapeutic regimens.

3. Steps to be taken in the event of adverse reactions, and other emergencies.

4. Procurement, handling, storage and dispensing of therapeutic gases.

5. Infection control measures, including specifics as to changing and cleansing of equipment.

6. Administration of medications in accordance with the physician’s order.

(i) The respiratory care service shall have equipment and facilities to assure the safe, effective and timely provision of respiratory care service to patients.

1. All equipment shall be calibrated and operated according to manufacturer’s specifications, and shall be periodically inspected and maintained.

2. Where piped-in gas is used, an evaluation shall be made prior to use to assure identification of the gas and its delivery within an established safe pressure range.

3. Ventilators used for continuous assistance or controlled breathing shall have operative alarm systems at all times.

(j) Prescriptions for respiratory care shall specify the type, frequency and duration of treatment and, as appropriate, the type and dose of medication, the type of dilutent, and the oxygen concentration, and shall be incorporated into the patient’s medical record.

Rulemaking Authority 395.1055, FS. Law Implemented 395.1055, FS. History–New  _______,

 

59A-3.243 Nursing Services.

Each hospital shall have a nursing department organized and staffed to provide quality nursing care to each patient. The relationship of the nursing department to other units of the hospital shall be documented by an organizational chart.

(1) The nursing department shall have a written organizational plan that delineates lines of authority, accountability and communication, and shall assure that the following nursing management functions are fulfilled:

(a) Review and approval of policies and procedures that relate to qualifications and employment of nurses.

(b) Establishment of standards for nursing care and mechanisms for evaluating such care.

(c) Implementing approved policies of the nursing department.

(d) Assuring that a written evaluation is made of the performance of registered nurses and ancillary nursing personnel at the end of any probationary period and at a defined interval thereafter.

(2)  The nursing department shall have written standards of nursing practice and related policies and procedures to define and describe the scope and conduct of patient care provided by the nursing staff. These policies and procedures shall be reviewed annually, revised as necessary, dated to indicate the time of the last review, signed by the responsible reviewing authority, and enforced.

(3) The nursing department shall maintain a list of licensed personnel, including private duty and per diem nurses, with each individual’s current license number, and documentation of the nurses’ hours of employment, and unit of employment within the hospital.

(4) Each hospital shall employ a registered nurse on a full time basis who shall have the authority and responsibility for managing nursing services and taking all reasonable steps to assure that a uniformly optimal level of nursing care is provided throughout the hospital.

(a) The registered nurse shall be responsible for ensuring that a review and evaluation of the quality and appropriateness of nursing care is accomplished. The review and evaluation shall be based on written criteria, shall be performed quarterly, and shall examine the provision of nursing care and its effect on patients.

(b) The registered nurse shall ensure that education and training programs for nursing personnel are available and are designed to augment nurses’ knowledge of pertinent new developments in patient care and maintain current competence. Cardiopulmonary resuscitation training shall be conducted as often as necessary, but not less than annually, for all nursing staff members who cannot otherwise document their competence.

(c) The registered nurse shall be responsible for determining the number of qualified registered nurses to be on duty at all times. The number of qualified nurses shall be sufficient to ensure immediate availability of a registered nurse for bedside care of any patient when needed, to assure prompt recognition of an untoward change in a patient’s condition, and to facilitate appropriate intervention by nursing, medical or other hospital staff members.

(5) The nursing process of assessment, planning, intervention and evaluation shall be documented for each hospitalized patient from admission through discharge.

(a) Each patient’s nursing needs shall be assessed by a registered nurse at the time of admission or within the period established by each hospital’s policy.

(b) Nursing goals shall be consistent with the therapy prescribed by the responsible member of the organized medical staff.

(c) Nursing intervention and patient response, and patient status on discharge from the hospital, must be noted on the medical record.

(6) Each Class I and Class II hospital shall have a minimum of one licensed registered nurse on duty at all times on each nursing unit or similarly titled part of the hospital for rendering patient care services.

Rulemaking Authority 395.1055, FS. Law Implemented 395.1055, FS. History–New _______,

 

59A-3.244 Ambulatory, Obstetrical, and Special Care Units. 

(1) Ambulatory Care Services. Each hospital offering ambulatory care services under its hospital license shall establish policies and procedures to ensure that quality care based on the needs of the patient will be delivered at all times.

(a) Ambulatory care services shall be under the direction of a licensed physician(s) responsible for the clinical direction of patient care and treatment services, and whose qualifications, authority, and responsibilities are defined in writing as approved by the governing board.

(b) Ambulatory care services shall be staffed with appropriately trained and qualified individuals to provide the scope of services anticipated to meet the needs of the patients.

(c) Each patient’s general medical condition shall be managed by a member of the organized medical staff with appropriate clinical privileges, as determined by medical staff bylaws.

(d) When any ambulatory care services are provided by non-hospital employees, the provider shall meet all safety requirements, abide by all pertinent rules and regulations of the hospital and medical staff, and document the quality improvement measures to be implemented.

(e) The provisions of ambulatory nursing care shall be supervised by a registered nurse who is qualified by relevant training and experience in ambulatory care.

(f) Sufficient personnel shall be on duty to provide efficient and effective patient care services.

(g) The scope of services offered, and the relationship of the ambulatory services program to other hospital units, as well as all supervisory relationships within the program, shall be defined in writing, and must be provided in accordance with the standards set by the governing board’s bylaws and the rules and regulations of the medical staff.

(h) Written policies and procedures to guide the operation of the ambulatory services program shall be developed, reviewed, and revised as necessary, dated to indicate the time of last revision, and enforced.

(i) A medical record must be maintained on every patient who receives ambulatory care services. Medical records shall be managed and maintained in accordance with acceptable professional standards and practices. Confidentiality and disclosure of patient information contained in the medical record must be maintained in accordance with hospital policy and state and federal law. Each patient’s medical record must include the following information, and be updated as necessary:

1. Patient identification;

2. Relevant history of the illness or injury and of physical findings;

3. Diagnostic and therapeutic orders;

4. Clinical observations, including the results of treatment;

5. Reports of procedures and tests, and their results;

6. Diagnosis or impression;

7. Allergies;

8. Referrals to practitioners or providers of services internal or external to the hospital;

9. Communications to and from practitioners or providers of service external to the hospital;

10. Growth charts for children and adolescents as needed when the service is the source of primary care; and

11. Immunization status of children and adolescents and others as determined by law and/or hospital policy.

(j) To facilitate the ongoing provision of care, a problem list of known significant diagnoses, conditions, procedures, drug allergies and medications shall be maintained for each patient who receives ambulatory services. The problem list shall be initiated no later than the third visit and include items based on any initial medical history and physical examination, and updated on subsequent visits with additional information as necessary. The problem list shall include the following items:

1. Known significant medical diagnoses and conditions;

2. Known significant surgical and invasive procedures;

3. Known adverse and allergic reactions to drugs; and

4. Medications known to be prescribed for and/or used by the patient.

(2) Obstetrical Department. If provided, obstetrical services shall include labor, delivery, and nursery facilities, and be formally organized and operated to provide complete and effective care for each patient.

(a) Except in hospitals licensed for 75 beds or less, the obstetrical service shall be separated from other patient care rooms and shall have separate nursing staff. When obstetrical services are provided in hospitals of 75 beds or less, there shall be:

1. A written and enforced policy concerning the placement of obstetrical patients in a manner most conducive to meet their special needs, and

2. Nursing staff who possess specialized skills in obstetrics and neonatal care, whether by training or experience, and can provide service to obstetrical patients and their infants on a 24 hour basis, whether on duty, on call, or on a consultative basis.

(b) In those hospitals with a formally organized obstetrical department, clean gynecological and surgical patients may be admitted to the unit under specific written controls approved by the medical staff and governing board when there is a written demonstrated need in each case.

(c) Every infant born in a hospital shall be properly identified immediately at the time of birth. Identification of the infant shall be done in the delivery room, birthing room, or other place of birth within the hospital, before either the mother or the infant is transferred to another part of the facility.

(3) Special Care Units. The hospital shall ensure that a special care unit is a physically and functionally distinct entity within the hospital, has controlled access, and has an effective means of isolation for patients suffering from communicable or infectious disease or acute mental disorder.

(a) Special care units shall provide:

1.  Direct or indirect visual observation by unit staff of all patients from one or more vantage points;

2.  A direct intercommunication or alarm system between the nurse’s station and the bedside; and

3. Beds that are adjustable to positions required by the patient, that are easily movable, and that have a locking or stabilizing mechanism to attain a secure, stationary position. Headboards, when present, shall be removable or adjustable to permit ready access to the patient’s head.

(b) Each special care unit shall be advised by a physician who is a member of the organized medical staff.

(c) Each special care unit shall have its relationship to other departments and units of the hospital specified in writing (organizational chart).

(d) All staff shall participate in annual in-service education programs concerning cardiopulmonary resuscitation and safety and infection control requirements.

(e) Written policies and procedures shall be developed concerning the scope and provision of care in each special care unit. Such policies and procedures shall be reviewed annually, revised as necessary, dated to indicate the time of last review, enforced, and include the following:

1. Specific criteria for the admission and discharge of patients;

2. A system for informing the responsible member of the organized medical staff of changes in the patient's condition;

3. Methods for procurement of equipment and drugs at all times;

4. Specific procedures relating to infection and traffic control;

5. Specification as to who may perform special procedures, under what circumstances, and under what degree of supervision; and specific policies as to the use of standing orders; and

6. A protocol for handling emergency conditions related to the breakdown of essential equipment.

(f) No hospital shall hold itself out as a Trauma Center unless it has been verified by the Department of Health in accordance with the Trauma Center provisions of Section 395.401, F.S., and Chapter 64J-2, F.A.C. Any violation of the Trauma Center provisions shall subject any violator to appropriate remedies provided by Section 395.1065, F.S.

Rulemaking Authority 395.1055, 395.401, 408.036, FS. Law Implemented 395.1055, 395.401, 408.036, FS. History–New _______,

 

59A-3.245 Surgical and Anesthesia Departments.

(1) Surgical Department. Each Class I and Class II hospital, and each Class III hospital providing operative and other invasive procedures, shall have a functionally and physically distinct surgical department within the hospital, organized under written policies and procedures regarding surgical privileges, maintenance of the operating rooms, and evaluation and recording of treatment of the patient. The surgical department shall have a physician member of the organized medical staff serve as medical advisor to the surgical department and a registered nurse to direct nursing services within the operating rooms of a surgical department. All surgical department policies and procedures shall be available to the Agency, shall be reviewed annually, dated to indicate time of last review, revised as necessary, and enforced.

(a) The determination of the appropriateness of the procedure for a patient shall be based on:

1. The patient’s medical, anesthetic, and drug history;

2. The patient’s physical status;

3. Diagnostic data;

4. The risks and benefits of the procedure; and,

5. The need to administer blood or blood components.

(b) The risks and benefits of the procedure shall be discussed with the patient prior to documenting informed consent and include:

1. Other treatment options, if they exist;

2. The need and risk of blood transfusions and available alternatives; and

3. Anesthesia options and risks.

(c) A preanesthesia evaluation of the patient shall be performed prior to surgery, except in the case of extreme emergency.

(d) Plans of care for the patient shall be formulated and documented in the medical record prior to the performance of surgery and shall include a plan for anesthesia, nursing care, the operative or invasive procedure, and the level of post-procedure care.

(e) The measurement of the patient’s physiological status shall be assessed during the administration of anesthesia and the surgical procedure.

(f) The post-procedure status of the patient shall be assessed on admission to the recovery area and prior to discharge from the recovery area.

(g) The patient shall be discharged from the recovery area by a member of the organized medical staff.

(h) The operating room and accessory services shall be located in a manner to prevent through traffic, control traffic in and out, and maximize infection control.

(i) All infections of clean surgical cases shall be recorded and reported to the appropriate infections control authority, and a procedure shall exist for the investigation of such cases.

(j) The registered nurse shall document that all surgical nursing staff have received annual continuing education in safety, infection control and cardiopulmonary resuscitation.

(k) A roster of members of the organized medical staff specifying the surgical privileges of each, shall be maintained, reviewed annually and revised as necessary.

(l) A roster of “on-call” surgeons shall be promptly available at the operating room nursing stations. An on-call surgeon must be available to the hospital when a call for services has been placed.

(m) A record shall be maintained on a current basis that contains the following information:

1. Patient’s name;

2. Hospital number;

3. Preoperative diagnosis;

4. Post-operative diagnosis;

5. Procedure;

6. Names of surgeon, first assistant, and anesthetist;

7. Type of anesthetic; and,

8. Complications, if any.

(n) Regardless of whether surgery is classified as major or minor, the surgical department shall ensure, prior to any surgery being performed, except in emergency situations:

1. That there is a complete history and physical workup in the chart of every patient or, if such has been transcribed, but not yet recorded in the patient’s chart, that there is a statement to that effect in the chart; and,

2. That there is evidence of informed consent for the operation in the patient’s chart.

(o) The surgical department shall ensure that immediately following each surgery, there is an operative report describing techniques and findings that is written or dictated and signed by the surgeon.

(p) The following equipment shall be in each operating room suite:

1. Call-in system;

2. Oxygen, and means of administration;

3. Mechanical ventilatory assistance equipment, including airways, manual breathing bag, and ventilator and respirator;

4. Cardiac defibrillator with synchronization capability;

5. Respiratory and cardiac monitoring equipment;

6. Thoracentesis and closed thoracostomy sets;

7. Tracheostomy set, tourniquets, vascular cutdown sets, infusion pumps, laryngoscopes and endotracheal tubes;

8. Tracheobronchial and gastric suction equipment; and

9. A portable x-ray which shall be available, but need not be physically present in the operating suite.

(2) Anesthesia Department. Each Class I and Class II hospital, and each Class III hospital providing surgical or obstetrical services, shall have an anesthesia department, service or similarly titled unit directed by a physician member of the organized professional staff.

(a) The anesthesia department of each hospital shall have written policies and procedures that are approved by the organized medical staff, are reviewed annually, dated at time of last review, revised, and enforced as necessary. Such written policies and procedures shall include the following requirements:

1. A preanesthesia evaluation of the patient by the physician, or qualified oral surgeon in the case of patients without medical problems admitted for dental procedures, or certified registered nurse anesthetist where authorized by established protocol approved by the medical staff, except in the case of emergencies.

2. A review of the patient’s condition immediately prior to induction of anesthesia.

3. A mechanism for release of patients from postanesthesia care.

4. A recording of all pertinent events taking place during the induction of, maintenance of, and emergence from anesthesia.

5. Guidelines for the safe use of all general anesthetic agents used in the hospital.

(b) The responsibilities and qualifications of all anesthesia personnel, including physician, nurse and dentist anesthetists and all trainees, must be defined in a policy statement, job description, or other appropriate document.

(c) Anesthetic safety regulations shall be developed, posted, and enforced. Such regulations shall include the following:

1. A requirement that all operating room electrical and anesthesia equipment be inspected on an annual basis and at intervals not exceeding the manufacturer’s recommendations. A written record of the inspection results and corrective action shall be maintained by the hospital.

2. A requirement that flammable anesthetic agents be employed only in areas in which a conductive pathway can be maintained between the patient and a conductive floor.

3. A requirement that each anesthetic gas machine have a pin-index or equivalent safety system.

4. A requirement that all reusable anesthesia equipment coming in direct contact with the patient be cleaned or sterilized in the manner prescribed by current medical standards.

Rulemaking Authority 395.1055, FS. Law Implemented 395.1055, FS. History–New _______,

 

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, effective at adoption, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. 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) Licensure.

1. A hospital may apply for a license for an adult diagnostic cardiac catheterization laboratory services program by submitting a hospital licensure application as specified in subsection 59A-3.066(2), Florida Administrative Code, indicating the addition of an adult diagnostic cardiac catheterization laboratory services program, and attaching AHCA Form 3130-5003, January 2018, License Application  Adult Inpatient Diagnostic Cardiac Catheterization, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. Both of these forms are available at: http://ahca.myflorida.com/MCHQ/HQALicensureForms/index.shtml. The license application form must be signed by the hospital’s Chief Executive Officer, confirming the hospital’s intent and ability to comply with Section 408.0361(1), F.S.

2. Hospitals with adult diagnostic cardiac catheterization services programs must renew their licenses at the time of the hospital licensure renewal, providing the information in Section 408.0361(1), F.S. Failure to renew the hospital’s license or failure to update the information in Section 408.0361(1), F.S., shall cause the license to expire.

(b) Definitions. The following definitions shall apply specifically to all adult diagnostic cardiac catheterization programs, as described in this subsection:

1. “Diagnostic Cardiac Catheterization” means a procedure requiring the passage of a catheter into one or more cardiac chambers of the left and right heart, with or without coronary arteriograms, for the purpose of diagnosing congenital or acquired cardiovascular diseases, or for determining measurement of blood pressure flow; and also includes the selective catheterization of the coronary ostia with injection of contrast medium into the coronary arteries.

2. “Adult” means a person fifteen years of age or older.

(c) Therapeutic Procedures. An adult diagnostic cardiac catheterization program established pursuant to Section 408.0361, F.S., shall not provide therapeutic services, such as percutaneous coronary intervention or stent insertion, intended to treat an identified condition or the administering of intra-coronary drugs, such as thrombolytic agents.

(d) Diagnostic Procedures. Procedures performed in the adult diagnostic cardiac catheterization laboratory shall include the following:

1. Left heart catheterization with coronary angiography and left ventriculography;

2. Right heart catheterization;

3. Hemodynamic monitoring line insertion;

4. Aortogram;

5. Emergency temporary pacemaker insertion;

6. Myocardial biopsy;

7. Diagnostic trans-septal procedures;

8. Intra-coronary ultrasound (CVIS);

9. Fluoroscopy; and

10. Hemodynamic stress testing.

(e) Support Equipment. A crash cart containing the necessary medication and equipment for ventilatory support shall be located in each cardiac catheterization procedure room. A listing of all crash cart contents shall be readily available. At the beginning of each shift, the crash cart shall be checked for intact lock; the defribrillator and corresponding equipment shall be checked for function and operational capacity. A log shall be maintained indicating review.

(f) Radiographic Cardiac Imaging Systems. A quality improvement program for radiographic imaging systems shall include measures of image quality, dynamic range and modulation transfer function. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

(g) Physical Plant Requirements. The Florida Building Code contains the physical plant requirements for cardiac catheterization facilities.

(h) Personnel Requirements. There shall be trained personnel available to meet the needs of the patient. At a minimum, a team involved in cardiac catheterization shall consist of a physician, one registered nurse, and one technician.

(i) Quality Improvement Program. A quality improvement program for the adult diagnostic cardiac catheterization program laboratory shall include an assessment of proficiency in diagnostic coronary procedures, as described in the 2012 ACC/SCAI Guidelines. Essential data elements for the quality improvement program include the individual physician procedural volume and major complication rate; the institutional procedural complication rate; patient clinical and demographic information; verification of data accuracy; and procedures for patient, physician and staff confidentiality. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

(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 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) Policy and Procedure Manual for Medicaid and Charity Care.

1. Each provider of adult diagnostic cardiac catheterization services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.

2. The policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for adult diagnostic cardiac catheterization services.

(l) Enforcement. Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C.

(m) In case of conflict between the provisions of this rule and the 2012 ACC/SCAI Guidelines, the provisions of this part shall prevail.

(2) Level I Adult Cardiovascular Services.

(a) Licensure.

1. A hospital may apply for a license for a Level I adult cardiovascular services program by submitting a hospital licensure application as specified in subsection 59A-3.066(2), Florida Administrative Code, indicating the addition of a Level I adult diagnostic cardiac catheterization services program, and attaching AHCA Form 3130-8010, January 2018, License Application Level I Adult Cardiovascular Services, incorporated herein by reference and available at http://www.flruless.org/Gateway/reference.asp?No=Ref-XXXXX.  Both of these forms are available at: http://ahca.myflorida.com/MCHQ/HQALicensureForms/index.shtml. The hospital licensure application and AHCA Form 3130-8010, January 2018, must be signed by the hospital’s Chief Executive Officer, confirming that for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred a minimum of 300 inpatients with the principal diagnosis of ischemic heart disease (defined by ICD-10-CM codes I20-I25).

a. Reportable cardiac catheterization procedures are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session.

b. Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant.

2. The request shall confirm the hospital’s intent and ability to comply with the 2012 ACC/SCAI Guidelines and the 2014 Update on Percutaneous Coronary Intervention Without Onsite Surgical Backup: Dehmer et al, SCAI/ACC/AHA Expert Consensus Document,  Circulation.  2014; 129:2610-2626 (2014 SCAI/ACC/AHA Update), which is hereby incorporated by reference, effective at adoption, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. Requests shall confirm the hospital’s intent and ability to comply with the guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety.

3. The request shall confirm the hospital’s intent and ability to comply with physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in the Florida Building Code.

4. The request shall confirm the hospital has one or more written transfer agreements with hospitals that operate a Level II adult cardiovascular services program, including written transport protocols to ensure safe and efficient transfer of an emergency patient 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.

5. All providers of Level I adult cardiovascular services programs shall operate in compliance with subsection 59A-3.246(1), F.A.C., the 2012 ACC/SCAI Guidelines and the 2014 SCAI/ACC/AHA Update regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention.

6. The applicable guidelines are the 2012 ACC/SCAI Guidelines and the 2014 SCAI/ACC/AHA Update.  Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the guideline related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide open heart surgery are not applicable to this rule.

7. Hospitals are considered to be in compliance with the 2012 ACC/SCAI Guidelines and the 2014 SCAI/ACC/AHA Update 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. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program and the percutaneous coronary intervention program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry.

8. Level I adult cardiovascular service providers shall report to the American College of Cardiology-National Cardiovascular Data Registry in accordance with the timetables and procedures established by the Registry. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the American College of Cardiology-National Cardiovascular Data Registry. By submitting data to the American College of Cardiology-National Cardiovascular Data Registry in the manner set forth herein, each hospital shall be deemed to have certified that the data submitted for each time period is accurate, complete and verifiable. The licensee of each hospital licensed to provide Level I adult cardiovascular services shall:

a. Execute the required agreements with the American College of Cardiology-National Cardiovascular Data Registry to participate in the data registry;

b. Stay current with the payment of all fees necessary to continue participation in the American College of Cardiology-National Cardiovascular Data Registry;

c. Release the data reported by the American College of Cardiology-National Cardiovascular Data Registry to the Agency;

d. Use the American College of Cardiology-National Cardiovascular Data Registry data sets and use software approved by the American College of Cardiology for data reporting;

e. Ensure that software formats are established and maintained in a manner that meets American College of Cardiology-National Cardiovascular Data Registry transmission specifications and encryption requirements. If necessary, each hospital shall contract with a vendor approved by the American College of Cardiology-National Cardiovascular Data Registry for software and hardware required for data collection and reporting;

f. Implement procedures to transmit data via a secure website or other means necessary to protect patient privacy to the extent required by the American College of Cardiology-National Cardiovascular Data Registry;

g. Ensure that all appropriate data is submitted on every patient that receives medical care and is eligible for inclusion in the American College of Cardiology-National Cardiovascular Data Registry;

h. Maintain an updated and current institutional profile with the American College of Cardiology-National Cardiovascular Data Registry;

i. Ensure that data collection and reporting will only be performed by trained, competent staff and that such staff shall adhere to the American College of Cardiology-National Cardiovascular Data Registry standards;

j. Submit corrections to any data submitted to the American College of Cardiology-National Cardiovascular Data Registry as discovered by the hospital or by the American College of Cardiology-National Cardiovascular Data Registry. Such corrections shall be submitted within thirty days of discovery of the need for a correction or within such other time frame as set forth by the American College of Cardiology-National Cardiovascular Data Registry. Data submitted must be at a level that the American College of Cardiology-National Cardiovascular Data Registry will include the data in national benchmark reporting; and

k. Designate an American College of Cardiology-National Cardiovascular Data Registry site manager that will serve as a primary contact between the hospital and the American College of Cardiology-National Cardiovascular Data Registry with regard to data reporting.

9. Notwithstanding guidelines to the contrary in the 2012 ACC/SCAI Guidelines and the 2014 SCAI/ACC/AHA Update all providers of Level I adult cardiovascular services programs may provide emergency and elective percutaneous coronary intervention procedures.  Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule.

10. Hospitals with Level I adult cardiovascular services programs are prohibited from providing the following procedures:

a. Any therapeutic procedure requiring transseptal puncture,

b. Any lead extraction for a pacemaker, biventricular pacer or implanted cardioverter defibrillator.

c. Any rotational or other atherectomy devices, or

d. Treatment of chronic total occlusions

11. Hospitals with Level I adult cardiovascular services programs must renew their licenses at the time of the hospital licensure renewal, providing the information in two through five above.  Failure to renew the hospital’s license or failure to update the information in two through five above shall cause the license to expire.

(b) Staffing. All staff participating as members of the catheterization team, including physicians, nurses, and technical cathererization laboratory staff shall maintain Advanced Cardiac Life Support certification, and must participate in a 24-hour-per-day, 365 day-per-year call schedule.

1. At initial licensure, each cardiologist shall be an experienced physician who has performed a minimum of 50 interventional cardiology procedures, including at least 11 primary cardiology interventional procedures, exclusive of fellowship training, and within the previous 12 months from the date of the Level I adult cardiovascular licensure application.

2. At licensure renewal, interventional cardiologists shall perform a minimum of 50 interventional cardiology procedures per year averaged over a 2-year period or be confirmed by the review process described in 59A-3.246(3)(b)3.

3. The providers of Level I adult cardiovascular services shall develop internal review processes to assess interventional cardiologists performing less than the required annual volume. Low volume operators must be evaluated and confirmed by an independent institutional committee consisting of physicians and other healthcare personnel as selected by the hospital, or an external review organization. Factors that shall be considered in assessing operator competence include operator volume, lifetime experience, institutional volume, individual operator’s other cardiovascular interventions and quality assessment of the operator’s ongoing performance.

4. Technical catheterization laboratory staff shall be credentialed as Registered Cardiovascular Invasive Specialist or shall complete a hospital based education and training program at a hospital providing Level I or Level II adult cardiovascular services. This training program shall include a minimum of 500 hours proctored clinical experience, including participation in a minimum of 120 interventional cardiology procedures and didactic education components of hemodynamics, pharmacology, arrhythmia recognition, radiation safety, and interventional equipment.

5. Coronary care unit nursing staff must be trained and experienced with invasive hemodynamic monitoring, operation of temporary pacemaker, management of Intra-Aortic Balloon Pump (IABP), management of in-dwelling arterial/venous sheaths and identifying potential complications such as abrupt closure, recurrent ischemia and access site complications.

(c) Emergency Services. All providers of Level I adult cardiovascular program services shall have written transfer agreements developed specifically for emergency transfer of interventional cardiology 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 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 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.

(d) Policy and Procedure Manual for Medicaid and Charity Care.

1. Each provider of Level I adult cardiovascular services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.

2. The policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for Level I adult cardiovascular services.

(e) Physical Plant Requirements. The Florida Building Code contains the physical plant requirements for cardiac catheterization laboratories operated by a licensed hospital.

(f) Enforcement.

1. Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C.

2. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level I adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency.

3. Failure of the hospital with a Level I adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction.

(g) In case of conflict between the provisions of this rule and the guidelines in the 2012 ACC/SCAI Guidelines and the 2014 SCAI/ACC/AHA Update the provisions of this part shall prevail.

(3)  Level II Adult Cardiovascular Services.

(a) Licensure.

1. A hospital may apply for a license for a Level II adult cardiovascular services program by submitting a hospital licensure application as specified in subsection 59A-3.066(2), Florida Administrative Code, indicating the addition of a Level II adult cardiac catheterization services program, and attaching AHCA Form 3130-8011, January 2018, License Application Level II Adult Cardiovascular Services, incorporated herein by reference and available at http://www.rules.org/Gateway/reference.asp?No=Ref-XXXX. Both of these forms are available at: http://ahca.myflorida.com/MCHQ/HQALicensureForms/index.shtml. The hospital licensure application and AHCA Form 3130-8011, January 2018, and must be signed by the hospital’s Chief Executive Officer, confirming that for the most recent 12-month period, the hospital has provided a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic cardiac catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-10-CM codes I20-I25). Reportable cardiac catheterization procedures shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant.

2. The request shall confirm to the hospital’s intent and ability to comply with applicable guidelines in the 2012 ACC/SCAI Guidelines and the 2014 SCAI/ACC/AHA Update including guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety.

3. The request shall confirm to the hospital’s intent and ability to comply with physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in the Florida Building Code.

4. All providers of Level II adult cardiovascular services programs shall operate in compliance with subparagraphs (1) and (2) of this rule and the applicable guidelines of the American College of Cardiology/American Heart Association regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery.

a. The applicable guidelines are the 2012 ACC/SCAI Guidelines and the 2014 SCAI/ACC/AHA Update; and

b. Aspects of the guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule.

5. Hospitals are considered to be in compliance with the guidelines in the 2012 ACC/SCAI Guidelines and the 2014 SCAI/ACC/AHA Update 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. Hospitals must also document an ongoing quality improvement plan to ensure that the cardiac catheterization program, the percutaneous coronary intervention program and the cardiac surgical program meet or exceed national quality and outcome benchmarks reported by the American College of Cardiology-National Cardiovascular Data Registry and the Society of Thoracic Surgeons.

6. In addition to the requirements set forth in subparagraph (2)(a)7. of this rule, each hospital licensed to provide Level II adult cardiovascular services programs shall participate in the Society of Thoracic Surgeons National Database. By submitting data to the Society of Thoracic Surgeons National Database and the American College of Cardiology-National Cardiovascular Data Registry in the manner set forth herein, each hospital shall be deemed to have certified that the data submitted for each time period is accurate, complete and verifiable. The licensee of each hospital licensed to provide Level II adult cardiovascular services shall:

a. Report to the Society of Thoracic Surgeons National Database in accordance with the timetables and procedures established by the Database. All data shall be reported using the specific data elements, definitions and transmission format as set forth by the Society of Thoracic Surgeons;

b. Stay current with the payment of all fees necessary to continue participation in the Society of Thoracic Surgeons National Database;

c. Release the data reported by the Society of Thoracic Surgeons National Database to the Agency;

d. Use the the Society of Thoracic Surgeons National Database and use software approved by the Society of Thoracic Surgeons for data reporting;

e. Ensure that software formats are established and maintained in a manner that meets Society of Thoracic Surgeons transmission specifications and encryption requirements.  If necessary, each hospital shall contract with a vendor approved by the Society of Thoracic Surgeons National Database for software and hardware required for data collection and reporting;

f. Implement procedures to transmit data via a secure website or other means necessary to protect patient privacy.To the extent required by the Society of Thoracic Surgeons National Database;

g. Ensure that all appropriate data is submitted on every patient who receives medical care and is eligible for inclusion in the Society of Thoracic Surgeons National Database;

h. Each hospital licensed to provide Level II adult cardiovascular services shall maintain an updated and current institutional profile with the Society of Thoracic Surgeons National Database;

i. Each hospital licensed to provide Level II adult cardiovascular services shall ensure that data collection and reporting will only be performed by trained, competent staff and that such staff shall adhere to Society of Thoracic Surgeons National Database standards;

j. Submit corrections to any data submitted to the Society of Thoracic Surgeons National Database as discovered by the hospital or by the Society of Thoracic Surgeons National Database.  Such corrections shall be submitted within thirty days of discovery of the need for a correction or within such other time frame as set forth by the Society of Thoracic Surgeons National Database. Data submitted must be at a level that the Society of Thoracic Surgeons National Database will include the data in national benchmark reporting; and

k. Designate a Society of Thoracic Surgeons National Database site manager that will serve as a primary contact between the hospital and the Society of Thoracic Surgeons National Database with regard to data reporting.

7. Hospitals with Level II adult cardiovascular services programs must renew their licenses at the time of the hospital licensure renewal, providing the information in two through four above. Failure to renew the hospital’s license or failure to update the information in two through four above shall cause the license to expire.

(b) Staffing. All staff participating as members of the catheterization team, including physicians, nurses, and technical cathererization laboratory staff shall maintain Advanced Cardiac Life Support certification, and must participate in a 24-hour-per-day, 365 day-per-year call schedule.

1. Each cardiac surgeon shall be Board certified.

a. New surgeons shall be Board certified within 4 years after completion of their fellowship.

b. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification.

2. At initial licensure and licensure renewal, interventional cardiologists shall perform a minimum of 50 coronary interventional procedures per year averaged over a 2-year period which includes at least 11 primary cardiology interventional procedures per year or be confirmed by the review process described in 59A-3.246(4)(b)3.

3. The providers of Level II adult cardiovascular services shall develop internal review processes to assess interventional cardiologists performing less than the required annual volume. Low volume operators must be evaluated and confirmed by an independent institutional committee consisting of physicians and other healthcare personnel as selected by the hospital, or an external review organization. Factors that shall be considered in assessing operator competence include operator volume, lifetime experience, institutional volume, individual operator’s other cardiovascular interventions and quality assessment of the operator’s ongoing performance.

4. Technical catheterization laboratory staff shall be credentialed as Registered Cardiovascular Invasive Specialist or shall complete a hospital based education and training program at a hospital providing Level I or Level II adult cardiovascular services. This training program shall include a minimum of 500 hours proctored clinical experience, including participation in a minimum of 120 interventional cardiology procedures and didactic education components of hemodynamics, pharmacology, arrhythmia recognition, radiation safety, and interventional equipment.

5. Coronary care unit nursing staff must be trained and experienced with invasive hemodynamic monitoring, operation of  temporary pacemaker, management of IABP, management of in-dwelling arterial/venous sheaths and identifying potential complications such as abrupt closure, recurrent ischemia and access site complications.

(c) Policy and Procedure Manual for Medicaid and Charity Care.

1. Each provider of Level II adult cardiovascular services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.

2. The policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for Level II adult cardiovascular services.

(d) Physical Plant Requirements.

The Florida Building Code contains the physical plant requirements for cardiac catheterization laboratories and operating rooms for cardiac surgery operated by a licensed hospital.

(e) Enforcement.

1. Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C.

2. Unless in the view of the Agency there is a threat to the health, safety or welfare of patients, Level II adult cardiovascular services programs that fail to meet provisions of this rule shall be given 15 days to develop a plan of correction that must be accepted by the Agency.

3. Failure of the hospital with a Level II adult cardiovascular services program to make improvements specified in the plan of correction shall result in the revocation of the program license. The hospital may offer evidence of mitigation and such evidence could result in a lesser sanction.

(f) In case of conflict between the provisions of this rule and the guidelines in the 2012 ACC/SCAI Guidelines and the 2014 SCAI/ACC/AHA Update, the provisions of this part shall prevail.

(4)  Stroke centers.

(a) Licensure. A hospital may apply for designation as an acute stroke ready center, primary stroke center, or comprehensive stroke center by submitting a hospital licensure application as specified in subsection 59A-3.066(2), Florida Administrative Code, and attaching AHCA Form 3130-8009, January 2018, License Application Stroke Center Affidavit, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. The application and affidavit are available at: http://ahca.myflorida.com/MCHQ/HQALicensureForms/index.shtml and must be signed by the hospital’s Chief Executive Officer, attesting that the stroke program meets:

1. The criteria for one of the designations as specified in this rule, or

2. Is certified as a stroke center by The Joint Commission, the Health Facilities Accreditation Program, or DNV GL.

(b) Screening. Organized medical staff shall establish specific procedures for screening patients that recognize that numerous conditions, including cardiac disorders, often mimic stroke in children. Organized medical staff shall ensure that transfer to an appropriate facility for specialized care is provided to children and young adults with known childhood diagnoses.

(c) Acute Stroke Ready Centers (ASR). An ASR shall have an acute stroke team available 24 hours per day, 7 days per week, capable of responding to patients who are in the emergency department or an inpatient unit within 15 minutes of being called. 

1. An ASR team shall consist of a physician and one or more of the following:

a. a registered professional nurse;

b. an advanced registered nurse practitioner; or

c. a physician assistant.

2. Each ASR team member must receive 4 or more hours of education related to cerebrovascular disease annually.

3. An ASR shall fulfill the educational needs of its acute stroke team members, emergency department staff, and prehospital personnel by offering ongoing professional education at least twice per year.

4. An ASR shall designate a physician with knowledge of cerebrovascular disease to serve as the ASR medical director. The medical director shall be responsible for implementing the stroke services protocols. The qualifications for the medical director shall be determined by the hospital’s governing board.

5. An ASR shall have the following services available 24 hours per day, 7 days per week:

a. A dedicated emergency department;

b. Clinical laboratory services as specified in subsection 59A-3.255(6)(g), Florida Administrative Code;

c. Diagnostic imaging to include head computed tomography (CT) and magnetic resonance imaging (MRI);

d. Administration of intravenous thrombolytic;

e. Reversal of anticoagulation;

f. Neurologist services, available in person or via telemedicine; and

g. A transfer agreement with a primary stroke center or comprehensive stroke center.

(d) Primary Stroke Centers (PSC). A PSC shall have an acute stroke team available 24 hours per day, 7 days per week, capable of responding to patients who are in the emergency department or an inpatient unit within 15 minutes of being called. 

1. A PSC team shall consist of a physician and one or more of the following:

a. a registered professional nurse;

b. an advanced registered nurse practitioner; or

c. a physician assistant.

2. Each acute stroke team member must receive 8 or more hours of education related to cerebrovascular disease annually.

3. A PSC shall fulfill the educational needs of its acute stroke team members, emergency department staff, and prehospital personnel by offering ongoing professional education at least twice per year.

4. A PSC shall designate a physician with knowledge of cerebrovascular disease to serve as the PSC medical director. The medical director shall be responsible for implementing the stroke services protocols. The qualifications for the medical director shall be determined by the hospital’s governing board.

5. A PSC shall have the following services available 24 hours per day, 7 days per week:

a. A dedicated emergency department;

b. Clinical laboratory services as specified in subsection 59A-3.255(6)(g), Florida Administrative Code;

c. Diagnostic imaging to include head computed tomography (CT), CT angiography (CTA), brain and cardiac magnetic resonance imaging (MRI), magnetic resonance angiography (MRA), and  transthoracic and/or transesophageal echocardiography;

d. Administration of intravenous thrombolytic;

e. Reversal of anticoagulation; and

f. Neurologist services, available in person or via telemedicine.

6. The following services may be available on-site or via a transfer agreement:

a. Neurosurgical services within 2 hours of being deemed clinically necessary;

b. Physical, occupational, or speech therapy; and

c. Neurovascular interventions for aneurysms, stenting of carotid arteries, carotid endartectomy, and endovascular therapy.

7. Quality Improvement and Clinical Outcomes Measurement.

a. The PSC shall develop a quality improvement program designed to analyze data, correct errors, identify system improvements and ongoing improvement in patient care and delivery of services.

b. A multidisciplinary institutional Quality Improvement Committee shall meet on a regular basis to monitor quality benchmarks and review clinical complications.

c. Specific benchmarks, outcomes, and indicators shall be defined, monitored, and reviewed by the Quality Improvement Committee on a regular basis for quality assurance purposes.

(e) Comprehensive Stroke Center (CSC). A comprehensive stroke center shall have health care personnel with clinical expertise in a number of disciplines available.

1. Health care personnel disciplines in a CSC shall include:

a. A designated comprehensive stroke center medical director;

b. Neurologists, neurosurgeons, surgeons with expertise performing carotid endartrectomy, diagnostic neuroradiologist(s), and physician(s) with expertise in endovascular neuroInterventional procedures and other pertinent physicians;

c. Emergency department (ED) physician(s) and nurses trained in the care of stroke patients;

d. Nursing staff in the stroke unit with particular neurologic expertise who are trained in the overall care of stroke patients;

e. Nursing staff in intensive care unit (ICU) with specialized training in care of patients with complex and/or severe neurological/neurosurgical conditions;

f. Advanced Practice Nurse(s) with particular expertise in neurological and/or neurosurgical evaluation and treatment, physician(s) with specialized expertise in critical care for patients with severe and/or complex neurological/neurosurgical conditions;

g. Physician(s) with specialized expertise in critical care for patients with severe and/or complex neurological/neurosurgical conditions;

h. Physician(s) with expertise in performing and interpreting trans-thoracic echocardiography, transesophageal echocardiography, carotid duplex ultrasound and transcranial Doppler;

i. Physician(s) and therapist(s) with training in rehabilitation, including physical, occupational and speech therapy; and

j. A multidisciplinary team of health care professionals with expertise or experience in stroke, representing clinical or neuropsychology, nutrition services, pharmacy (including a Pharmacy Doctorate (Pharm D) with stroke expertise), case management and social workers.

2. A CSC shall have the following availability of medical personnel:

a. Neurosurgical expertise must be available in a CSC on a 24 hours per day, 7 days per week basis and in-house within 2 hours. The attending neurosurgeon(s) at a CSC shall have expertise in cerebrovascular surgery.

b. Neurologist(s) with special expertise in the management of stroke patients shall be available 24 hours per day, 7 days per week.

c. Endovascular/Neurointerventionist(s) shall be on active full-time staff. However, when this service is temporarily unavailable, pre-arranged transfer agreements must be in place for the rapid transfer of patients needing these treatments to an appropriate facility.

3. A CSC shall have the following advanced diagnostic capabilities:

a. Magnetic resonance imaging (MRI) and related technologies;

b. Catheter angiography;

c. Computed Tomography (CT) angiography;

d. Extracranial ultrasonography;

e. Carotid duplex;

f. Transcranial Doppler;

g. Transthoracic and transesophageal echocardiography;

h. Tests of cerebral blood flow and metabolism;

i. Comprehensive hematological and hypercoagulability profile testing;

3. Neurological Surgery and Endovascular Interventions;

a. Angioplasty and stenting of intracranial and extracranial arterial stenosis;

b. Endovascular therapy of acute stroke;

c. Endovascular treatment (coiling) of intracranial aneurysms;

d. Endovascular and surgical repair of arteriovenous malformations (AVM) and arteriovenous fistulae (AVF);

e. Surgical clipping of intracranial aneurysms;

f. Intracranial angioplasty for vasospasm;

g. Surgical resection of AVMs and AVFs;

h. Placement of ventriculostomies and ventriculoperitoneal shunts;

i. Evacuation of intracranial;.

j. Carotid endarterectomy; and

k. Decompressive craniectomy.

4. A CSC shall have the following specialized infrastructure:

a. Emergency Medical Services (EMS) Link – The CSC collaborates with EMS leadership:

(I) To ensure that EMS assessment and management at the scene includes the use of a stroke triage assessment tool (consistent with the Florida Department of Health sample);

(II) To ensure that EMS assessment/management at the scene is consistent with evidence-based practice.

(III) To facilitate inter-facility transfers; and

(IV) To maintain an on-going communication system with EMS providers regarding availability of services.

b. Referral and Triage – A CSC shall maintain:

(I) An acute stroke team available 24 hours per day, 7 days per week, including: ED physician(s), nurses for ED patients, neurologist, neurospecialist RNs, radiologist with additional staffing/technology including: 24 hours per day, 7 days per week CT availability, STAT lab testing/pharmacy and registration;

(II) A system for facilitating inter-facility transfers; and

(III) Defined access telephone numbers in a system for accepting appropriate transfer.

c. Inpatient Units – These specialized units must have a subspecialty Medical Director with particular expertise in stroke (intensivist, pulmonologist, neurologist, neurosurgeon or neuro-intensivist) who demonstrates ongoing professional growth by obtaining at least 6 CME credits in cerebrovascular care annually. A CSC shall provide:

(I) An Intensive Care Unit with medical and nursing personnel who have special training, skills and knowledge in the management of patients with all forms of neurological/neurosurgical conditions that require intensive care; and

(II) An Acute Stroke Unit with medical and nursing personnel who have training, skills and knowledge sufficient to care for patients with neurological conditions, particularly acute stroke patients, and who are trained in neurological assessment and management.

d. Rehabilitation and Post Stroke Continuum of Care –

(I) A CSC shall provide inpatient post-stroke rehabilitation.

(II) A CSC shall utilize healthcare professionals who can assess and treat cognitive, behavioral, and emotional changes related to stroke (i.e., clinical psychologists or clinical neuropsychologists).

(III) A CSC shall ensure discharge planning that is appropriate to the level of post-acute care required.

(IV) A CSC shall ensure continuing arrangements post-discharge for rehabilitation needs and medical management.

(V) A CSC shall ensure that patients meeting acute care rehabilitation admission criteria are transferred to a CARF/JCAHO accredited acute rehabilitation facility.

e. Education –

(I) The CSC shall fulfill the educational needs of its medical and paramedical professionals by offering ongoing professional education for all disciplines.

(II) The CSC shall provide education to the public as well as to inpatients and families on risk factor reduction/management, primary and secondary prevention of stroke, the warning signs and symptoms of stroke, and the medical management and rehabilitation for stroke patients.

(III) The CSC shall supplement community resources for stroke and stroke support groups.

f. Professional standards for nursing – The CSC shall provide a career development track to develop neuroscience nursing, particularly in the area of cerebrovascular disease.

(I) ICU and neuroscience/stroke unit nursing staff will be familiar with stroke specific neurological assessment tools such as the National Institute for Health (NIH) Stroke Scale.

(II) ICU nursing staff must be trained to assess neurologic function and be trained to provide all aspects of neuro critical care.

(III) Nurses in the ICU caring for stroke patients, and nurses in neuroscience units must obtain at least 8 hours of continuing education credits (4 hours continuing education in the formalized CEU credits and 4 hours of continuing education related to their specialty that can be verified through documentation of participation).

g. Research – A CSC shall have the professional and administrative infrastructure necessary to conduct clinical trials, have participated in stroke clinical trials within the last year, and be actively participating in ongoing clinical stroke trials.

5. A CSC will have a quality improvement program for the analysis of data, correction of errors, systems improvements, and ongoing improvement in patient care and delivery of services that include:

a. A multidisciplinary institutional Quality Improvement Committee that meets on a regular basis to monitor quality benchmarks and review clinical complications;

b. Specific benchmarks, outcomes, and indicators defined, monitored, and reviewed on a regular basis for quality assurance purposes. Outcomes for procedures such as carotid endarterectomy, carotid stenting, intravenous tissue plasminogen activator (IVtPA), endovascular/interventional stroke therapy, intracerebral aneurysm coiling, and intracerebral aneurysm clipping will be monitored;

c. An established database and/or registry that allows for tracking of parameters such as length of stay, treatments received, discharge destination and status, incidence of complications (such as aspiration pneumonia, urinary tract infection, deep venous thrombosis), and discharge medications and comparing to institutions across the United States; and

d. Participation in a national and/or state registry (or registries) for acute stroke therapy clinical outcomes, including IVtPA and endovascular/interventional stroke therapy.

(5)  Burn Units.

(a) All licensed hospitals that operate burn units under Section 408.0361(2), F.S., shall comply with the guidelines published by the American College of Surgeons, Committee on Trauma. Hospitals are considered to comply with the American College of Surgeons guidelines when they adhere to guidelines regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The applicable guidelines, herein incorporated by reference, are “Guidelines for the Operation of Burn Centers,” in Resources for Optimal Care of the Injured Patient, Committee on Trauma, American College of Surgeons, (2014); Chapter 14, pages 100 through 106. These guidelines are available at: http://ameriburn.org/wp-content/uploads/2017/05/acs-resources-burn-chapter-14.pdf. The determination of compliance with the guidelines is based on the burn unit providing evidence of verification from the American Burn Association.

(b) A hospital may apply for the initial licensure of a burn unit by submitting a hospital licensure application as specified in subsection 59A-3.066(2), Florida Administrative Code, indicating the addition of burn unit services, and attaching License Application Burn Unit Services, AHCA Form 3130-8012, January 2018, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. Both of these forms are available at: http://ahca.myflorida.com/MCHQ/HQALicensureForms/index.shtml. The Burn Unit Services Application must be signed by the hospital’s Chief Executive Officer. The applicant shall complete this form indicating the date that burn unit services will begin and that the hospital is in compliance with “Guidelines for the Operation of Burn Centers” but has not received initial verification as a burn unit. During this initial licensure period, the hospital license will indicate that the burn unit is “provisional”. The provisional status will be lifted upon completion of the verification process with the American Burn Association, and the burn unit will be fully licensed with the service listed on the hospital license.

(c) At the time of licensure renewal, burn unit operators shall submit current documentation from the American Burn Association that verifies the hospital’s adherence to the guidelines incorporated in paragraph (5)(b).  

(d) Each provider of burn unit services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.

(e) Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C.

Rulemaking Authority 395.1055, 395.3038, 408.036, 408.0361, FS. Law Implemented 395.1055, 395.1065, 395.3038, 408.036, 408.0361, FS. History–New, _______,

 

59A-3.247 Housekeeping Services. 

Each hospital shall have an organized housekeeping department with a qualified person designated as responsible for all housekeeping functions. The designated supervisor of housekeeping shall be responsible for developing written policies and procedures for coordinating housekeeping services with other departments, developing a work plan and assignments for housekeeping staff, and developing a plan for obtaining relief housekeeping personnel.

(1) A sufficient number of housekeeping personnel shall be employed to fulfill the responsibilities of the housekeeping department seven days a week.

(2) When housekeeping services are provided by a third party, the hospital shall have a formal written agreement with the third party provider on file.

(3) The designated supervisor of housekeeping shall develop, implement, and maintain an effective housekeeping plan to ensure that the facility is maintained in compliance with the following:

(a) The facility and its contents shall be kept free from dust, dirt, debris, and noxious odors;

(b) All rooms and corridors shall be maintained in a clean, safe, and orderly condition, and shall be properly ventilated to prevent condensation, mold growth, and noxious odors;

(c) All walls and ceilings, including doors, windows, skylights, screens, and similar closures shall be kept clean;

(d) All mattresses, pillows, and other bedding; window coverings, including curtains, blinds, and shades, cubicle curtains and privacy screens; and furniture shall be kept clean;

(e) Floors shall be kept clean and free from spillage, and non-skid wax shall be used on all waxed floors;

(f) Articles in storage shall be elevated from the floor;

(g) Aisles in storage areas shall be kept unobstructed;

(h) All garbage and refuse from patient areas shall be collected daily and stored in a manner to make it inaccessible to insects and rodents;

(i) Garbage or refuse storage rooms, if used, shall be kept clean, shall be vermin-proof, and shall be large enough to store the garbage and refuse containers that accumulate. Outside garbage or refuse storage areas or enclosures shall be large enough to store the garbage and refuse containers that accumulate, and shall be kept clean. Outside storage of unprotected plastic bags, wet strength paper bags, or baled units containing garbage or refuse is prohibited. Garbage and refuse containers, dumpsters, and compactor systems located outside shall be stored on or above a smooth surface of non-absorbent material, such as concrete or machine-laid asphalt, that is kept clean and maintained in good repair; and

(j) Garbage and refuse shall be removed from both interior and outside storage areas as often as necessary to prevent sanitary nuisance conditions. If garbage and refuse are disposed of on the facility premises, the method of disposal shall not create a sanitary nuisance and shall comply with the provisions of Chapter 62-701, F.A.C.

(4) The designated supervisor of housekeeping shall ensure that:

(a) There is a sufficient quantity of linen, including at least sheets, pillow cases, drawsheets or their alternative, blankets, towels and washcloths to provide comfortable, clean and sanitary conditions for each patient at all times;

(b) Written policies and procedures for linen and laundry services, including methods of collection, storage, and transportation are developed, implemented, and maintained in conjunction with the policies and procedures developed by the infection control committee;

(c) Soiled linen and laundry are collected in a way that minimizes microbial dissemination into the environment;

(d) Separate containers are used for transporting clean linen and laundry, and soiled linen and laundry;

(e) Soiled linen and laundry are stored in a ventilated area separate from any other supplies, and are not stored, sorted, rinsed, or laundered in patient rooms, bathrooms, areas of food preparation or storage, or areas in which clean material and equipment are stored; and

(f) When linen and laundry services are provided by a third party, the third party provider shall be required to maintain the standards contained herein, and shall ensure that clean linen is packaged and protected from contamination until received by the facility.

(5) Effective control methods shall be employed to protect against the entrance into the facility and the breeding or presence on the premises of flies, roaches, rodents, and other vermin. Use of pesticides shall be in accordance with Chapter 5E-14, Part No. 1, F.A.C.

(6) The designated supervisor of housekeeping shall develop and implement, in coordination with the infection control committee, written procedures for the cleaning of the physical plant, equipment, and reusable supplies. Such procedures shall include:

(a) Special written procedures for cleaning all infectious disease areas;

(b) Special written procedures for cleaning all operating room suites, delivery suites, nurseries, intensive and other critical care units, the emergency suite, and other areas performing similar functions; and

(c) Special written procedures for the separate handling and storage of both clean and dirty linen, with special attention being given to identification, separation and handling of linens from isolation or infectious disease areas.

Rulemaking Authority 395.1055, FS. Law Implemented 395.1055, FS. History–New _______,

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jessica Munn

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Justin M. Senior

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 22, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: November 4, 2015