1. (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.

   1. (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.
   2. (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.
   3. (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.
   4. (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.
   5. (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.
   6. (f) Sufficient personnel shall be on duty to provide efficient and effective patient care services.
   7. (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.
   8. (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.

   9. (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.

   10. (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. (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.

   1. (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.

   2. (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.
   3. (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. (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.

   1. (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.

   2. (b) Each special care unit shall be advised by a physician who is a member of the organized medical staff.
   3. (c) Each special care unit shall have its relationship to other departments and units of the hospital specified in writing (organizational chart).
   4. (d) All staff shall participate in annual in-service education programs concerning cardiopulmonary resuscitation and safety and infection control requirements.

   5. (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.

   6. (f) No hospital shall hold itself out as a Trauma Center unless it has been verified as a Trauma Center by the Department of Health. 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, 408.036 FS. Law Implemented 395.1055 FS. History–New 8-15-18.