Fla. Admin. Code R. 59A-11.035
(2) Qualified Patients
(a) The advanced birth center:
1. May perform trial of labor after cesarean deliveries (TOLAC) for screened patients with no other risk factors pursuant to subsection 59A-11.009(4), F.A.C. TOLAC patients must not have had any uterine incisions other than low transverse incisions;
2. May perform planned low-risk cesarean deliveries;
3. May perform vaginal deliveries for laboring patients from the beginning of the 37th week of gestation through the end of the 41st week of gestation;
4. In the event that a cervical ripening agent is used or labor is induced or augmented, a minimum of two registered nurse (RN)s must be present in the facility at the time any such medication is administered to the patient;
(b) Patients must be low-risk. Low risk indicates that they do not have the risk criteria outlined pursuant to subsection 59A-11.009(4), F.A.C. and
1. Any cardiac conditions, chronic health conditions, gestational diabetes, auto-immune conditions, previous neonatal death or injury, advanced maternal age (aged 35 years or older), or infectious diseases, elevated BMI of 30 or greater, anemia, risk for postpartum hemorrhage or multiple gestation.
2. History of adverse birth related events defined as events of low birth weight, preterm birth, stillbirth, or perinatal deaths. Low birth weight (LBW) is defined as a newborn weighing less than 2,500 grams; preterm birth (PTB) is defined as a live infant delivery before 37 weeks of gestation; stillbirth is defined as a baby who passes away after 20 weeks as defined in section 382.002(17), F.S. Birth defects or congenital disorder is defined as a structural or functional abnormalities present at birth.
(3) Notification
(4) Departments and Services
(a) Surgical department. This department shall be organized under written policies and procedures relating to surgical staff privileges, anesthesia, functioning standards, staffing patterns and quality maintenance of the surgical suite.
1. A qualified person designated by the administrator shall be responsible for the daily functioning and maintenance of the surgical suite.
2. A surgery record shall be maintained on a current basis that contains the following information:
a. Patient’s name, patient number, pre-operative diagnosis, post-operative diagnosis, surgical procedure, anesthetic, and complications, if any; and,
b. Name of each member of the surgical team, including the surgeon, first assistant, anesthesiologist, nurse anesthetist, anesthesiologist assistant, circulating nurse and operating room technician.
3. Each center shall ensure each patient signs an informed consent for treatment at an advanced birth center acknowledging that only low-risk pregnancies and births are performed. Prior to any surgery being performed, signed informed consent for the procedure, verification of the identity of patient, operative site, and operative procedure to be performed must be in the patient’s medical record.
4. All infections of surgical cases shall be recorded and reported to the governing body or its designee and a procedure shall exist for the investigation of such cases.
5. Emergency equipment shall be provided as needed commensurate with the services of the center, maintained in functional condition, and capable of providing and maintaining cardiorespiratory functioning.
6. Written procedures in implementation of policies shall relate specifically to the functional activities of the surgical suite and include the following:
a. Surgical asepsis: preparation, handling, and maintenance of sterile equipment and supplies.
b. Medical asepsis: patients, staff, equipment, traffic, and equipment flow patterns.
c. Sterilization and disinfection standards and controls: equipment and supplies.
d. Housekeeping.
(b) Anesthesia service. This service shall be organized under written policies and procedures relating to anesthesia staff privileges, the administration of anesthesia, and the maintenance of strict safety controls.
1. All anesthesia shall be administered by an anesthesiologist, a credentialed and privileged physician, certified registered nurse anesthetist or anesthesiologist assistant.
2. An anesthesiologist or other physician or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist, shall be in the center during the anesthesia and post-anesthesia recovery period until all patients are cleared for discharge.
3. At least one registered nurse shall be in the recovery area during the patient’s recovery period.
4. Prior to the administration of anesthesia, patients shall have a history and physical examination including laboratory analysis when indicated.
5. Written policies and procedures relative to the administration of anesthesia shall be developed by the anesthesia service, approved by the medical staff and the governing body, and be reviewed annually, dated at time of each review, revised as necessary, and enforced.
6. Anesthetic safety regulations shall be developed, posted and enforced. Such regulations shall include the following requirements:
a. All operating room electrical and anesthesia equipment shall be inspected on no less than a semi-annual basis, and a written record of the results and corrective actions be maintained;
b. Flammable anesthetic agents shall not be employed in centers;
c. Electrical equipment in anesthetizing areas shall be on an audiovisual line isolation monitor, with the exception of radiologic equipment and fixed lighting more than 5 feet above the floor;
d. Each anesthetic gas machine shall have pin-index system or equivalent safety system and a minimum oxygen flow safety device; and,
e. All reusable anesthesia equipment in direct contact with the patient shall be cleaned or sterilized in the manner prescribed by current medical standards;
7. The following monitors shall be applied to all patients receiving conduction or general anesthesia:
a. Blood pressure cuff;
b. A continuous temperature device, readily available to measure the patient’s temperature;
c. Pulse oximeter;
d. Electrocardiogram; and,
e. An inspired oxygen concentration monitor and a capnograph shall be applied to all patients receiving general anesthesia.
(c) Nursing service. This service shall be organized under written policies and procedures relating to patient care, establishment of standards for nursing care and mechanisms for evaluating such care, and nursing services.
1. A registered nurse designated by the administrator shall be responsible for coordinating and supervising all nursing services.
2. There shall be a sufficient staffing pattern of registered nurses to provide quality nursing care to each surgical patient from admission through discharge. Such additional trained nursing service personnel shall be on duty as may be needed commensurate with the service of the center.
3. A registered nurse shall be assigned as the circulating nurse for one patient at a time for the duration of the surgical procedure for any procedure performed in the center.
4. A registered nurse shall be present in the recovery area at all times when a patient is present.
5. A record shall be currently maintained of all nursing personnel and include regular and relief as well as full-time and part-time staff. The record shall include the current license number of each licensed person.
6. A current job description delineating duties and responsibilities shall be maintained for each nursing service position.
7. Written procedures in implementation of policies and to assure quality nursing care shall relate specifically to the functional activities of nursing service and include the following:
a. Patient admission;
b. Pre- and Post-Operative care;
c. Medical orders from physicians and other members of the medical staff;
d. Standing orders with required signatures;
e. Medications: storage and administration;
f. Treatments;
g. Surgical asepsis;
h. Medical asepsis;
i. Sterilization and disinfection;
j. Documentation: medical records and center records;
k. Patient discharge;
l. Patient transfer;
m. Emergency measures;
n. Isolation measures;
o. Incident reports;
p. Personnel orientation;
q. Inservice education record;
r. Equipment and supplies: availability and maintenance; and,
s. Visitors.
(d) Clinical laboratory services. The center laboratory, and any contracted laboratory providing services for center patients, must be certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments (CLIA) and the federal rules adopted thereunder in all specialties or subspecialties in which testing is performed. Each advanced birth center shall have a laboratory onsite, either directly or by contract.
1. Routine and stat laboratory testing shall be available at all times.
2. CLIA specialties and subspecialties shall include diagnostic immunology including syphilis serology and general immunology; hematology, including coagulation studies; chemistry, including routine chemistry and urinalysis, immunohematology, including ABO Group and Rh type, antibody detection, and compatibility testing; and additional specialties and subspecialties as determined by the center’s govering body.
(e) Radiological services. Each center shall provide within the institution, or through arrangement, radiological services commensurate with the needs of the center.
1. If radiological services are provided by center staff, the service shall be maintained free of hazards for patients and personnel.
2. New installations of radiological equipment, and subsequent inspections for the identification of radiation hazards shall be made as required by Chapter 64E-5, F.A.C.
3. Personnel monitoring shall be maintained for each individual working in the area of radiation. Readings shall be on at least a monthly basis and reports kept on file and available for review.
a. Personnel – The center shall have a licensed practitioner, as defined in Section 468.301(11), F.S., to supervise the service and to discharge professional radiological services.
b. A technologist shall be on duty or on call at all times when there are patients within the center.
c. The use of all radiological apparatus shall be limited to appropriately licensed personnel.
4. If provided under arrangement with an outside provider, the radiological services must be directed by a qualified radiologist and meet the standards as required by Chapter 64E-5, F.A.C.
(g) Pediatric services.
1. A center providing surgical services to patients under the age of 18 years (pediatric) must include age- and size- appropriate criteria in written policies and procedures regarding admissions, surgical services, anesthesia services, post-operative recovery, and discharge planning. The policies and procedures must be approved by the medical staff and the governing body, and be reviewed annually, dated at the time of each review, revised as necessary, and enforced.
2. All patients shall meet admission and preoperative clearance criteria established by the medical staff and approved by the governing body.
3. Accommodations must be made for the parent or guardian to remain at the center from admission through discharge.
4. Surgical services may be provided to patients for conditions that are not emergency medical conditions.
5. Each center must include its pediatric cases in the quality assessment and improvement system as described in paragraph 59A-11.035(12)(i), F.A.C. that includes peer review, multidisciplinary review and the monitoring of processes and outcomes.
6. One or more persons currently certified in Pediatric Advanced Life Support (PALS) must be present and available to the pediatric patient who is sedated, anesthetized, recovering from anesthesia, or receiving perioperative opioids.
7. Each center providing surgical services requiring a length of stay past midnight must be staffed with the following professionals with specialized training and expertise in the treatment of pediatric patients:
a. A surgeon who is board-certified or eligible in a pediatric surgical subspecialty or a board-certified or eligible surgeon with additional training and expertise with pediatric patients acceptable to the governing body.
b. An anesthesiologist or other physician or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist shall be present in the room with the pediatric patient throughout all general anesthesia, regional anesthesia, and monitored anesthesia care.
c. Nursing and other direct care staff must have specialized training and experience with pediatric patients. Nursing personnel must be PALS and/or Advanced Cardiac Life Support certified. There must be at least one registered nurse on duty at all times.
8. Each center providing surgical services requiring a length of stay past midnight must have facilities and equipment available to store ready-to-eat foods and beverages. Equipment must include handwashing facilities and a refrigerator.
9. Age- and size-appropriate equipment and resources related to the care of pediatric patients must be available on site, including
a. Operating tables;
b. Pre- and post-operative beds;
c. Anesthesia equipment and supplies;
d. Resuscitation devices;
e. Oxygen saturation monitors;
f. Pharmacologic supplies; and,
g. Blood pressure cuffs.
(5) Surgical Services
(6) Infection Control
(a) Each center shall establish an infection control program involving members of the medical staff, nursing staff, other professional and administrative staff as appropriate. The program shall provide for:
1. The surveillance, prevention, and control of infection among patients and personnel;
2. The establishment of a system for identification, reporting, evaluating, and maintaining records of infections;
(d) The policies and procedures devised by the infection control program shall be approved by the governing body, and shall contain at least the following:
1. Specific policies for the shelf life of all stored sterile items.
2. Specific policies and procedures related to occupational exposure to blood and body fluids.
3. Specific policies related to the handling and disposal of biomedical waste in accordance with Chapter 64E-16, F.A.C. and, OSHA 29 CFR Part 1910.1030, Bloodborne Pathogens.
4. Specific policies related to the selection, storage, handling, use and disposition of disposable items.
5. Specific policies related to decontamination and sterilization activities performed at the center, including but not limited to a requirement that steam, gas (ETO) and hot air sterilizers be tested with live bacterial spores at least weekly.
6. Specific policies regarding the indications for universal precautions, body substance isolation, CDC isolation guidelines, or equivalent and the types of isolation to be used for the prevention of the transmission of infectious diseases.
7. A requirement that soiled linen be collected in such a manner as to minimize microbial dissemination into the environment.
8. A requirement that all cases of communicable diseases as set forth in Chapter 64D-3, F.A.C., be promptly and properly reported in accordance with the provisions of that rule;
(7) Patient Rights
(a) Patients have the right to:
1. Civil and religious liberties
2. Be free from physical, verbal, sexual, and mental abuse and neglect.
3. Dignity
4. Privacy, with their communication, health care information, and personal privacy.
5. Be informed about their medical care and treatment.
6. Refuse any treatment.
7. Know what facility rules and regulations apply to patient conduct.
8. Express grievances to a health care provider, a health care facility, or the appropriate state licensing agency regarding alleged violations of patients’ rights. A patient has the right to know the health care provider’s or health care facility’s procedures for expressing a grievance.
9. Treatment for any emergency medical condition that will deteriorate from failure to provide such treatment.
10. Refuse participation in experimental research.
11. Access their medical records.
12. Know what their rights and responsibilities are.
(b) Each center shall develop and adopt policies and procedures to ensure the protection of patient rights and safety. Patient safety policies and procedures must include, at a minimum:
1. A policy for maternal and fetal monitoring which incorporates a maternal early warning/rapid response system to identify clinical indications for transfer to a hospital and prenatal visits at established intervals as established in paragraph (2)(e) to determine the continued low-risk status of the pregnant woman and a policy for responding to any neonatal complication including stabilization and transfers as clinically indicated.
2. Policies for responding to obstetric emergencies to include, but not limited to: obstetric hemorrhage, severe hypertension/preeclampsia, sepsis, assessment and screening for substance use during labor and delivery, a policy to transfer patients presenting in labor and positive for substances known to affect neonatal transition to life, policies for identifying and reporting harm to a child defined in section 39.01(37)(g)1., F.S. The policy for responding to obstetric hemorrhage must include provisions relating to transfusion services.
3. An advanced birth center is prohibited from the intentional delivery of a fetus with known exposure to maternal use of a controlled substance (as defined by section 893.02(4), F.S.) and must make and document efforts to identify and transfer a patient suspected of positive substance use presenting for delivery to a facility capable of treating a substance-exposed newborn.
(8) Organized Medical Staff
(g) Committees – The structure of committee organization shall be determined by the organized medical staff provided the following required committee functions are carried out with sufficient periodicity to assure that objectives are achieved by separate committee, combined committees, or committee of the whole:
1. Approval of the policies, procedures, and the activities of all departments and services.
2. Interim decision making for the organized medical staff between staff meetings, under such limitations as shall be set by the medical staff.
3. Follow-up and appropriate disposition of all reports dealing with the various staff functions.
4. Medical records currently maintained in sufficient completeness to assure comprehension of transfer of patient information at any time.
5. Clinical evaluation of the quality of medical care provided to all patients on the basis of documented evidence.
6. Review of center admissions with respect to need for admission, discharge practices and evaluation of the services ordered and provided.
7. Surveillance of the center’s infection potentials and cases and the promotion of a preventive and corrective program designed to minimize these hazards.
8. Surveillance of pharmacy policies and procedures, and standards of practice are maintained, including review of at least monthly on-site consultant pharmacist visits, and proper disposal of outdated prescription and controlled drugs in accordance with Rules 64B16-28.702, 64B16-28.110, 64B16-28.303, F.A.C. and Chapters 465 and 893, F.S.
9. All transfers to a higher level of care must be reviewed monthly for quality assurance and risk reduction planning.
(9) Physical Plant Maintenance
(10) Fire Control
(11) Quality Assessment and Improvement
(b) Each center shall have in place a systematic process to collect data on process outcomes, priority issues chosen for improvement, and the satisfaction of the patient. Processes measured shall include:
1. Appropriate surgical procedures;
2. Preparation of patient for the procedure;
3. Performance of the procedure and monitoring of the patient;
4. Provision of post-operative care;
5. Use of medications including administration and monitoring of effects;
6. Risk management activities;
7. Quality assessment and improvement activities including clinical laboratory services and radiology services;
8. Results of autopsies if needed.
9. Number and type of lacerations, and treatment for lacerations;
10. Number and indication for cesarean sections;
11. Newborn Appearance, Pulse, Grimace, Activity and Respiration (APGAR) Score less than 7 and outcome;
12. Maternal and newborn transfers.
(c) Each center shall have a process to assess data collected to determine:
1. The level and performance of existing activities and procedures,
2. Priorities for improvement, and,
3. Actions to improve performance.
(12) Plans Submission and Fee Requirements
(b) Approval to start construction limited to demolition, site work, foundation, and building structural frame may be obtained prior to the approval of Stage III construction documents when the following is submitted for review and approval:
1. A preliminary Stage II approval letter from the Office of Plans and Construction granted by the Agency when the design complies with applicable life safety code requirements, flood requirements, and the layout will accommodate all required functional spaces as evidenced by a thorough examination of the documents submitted to the Agency as required in this rule for Stage II preliminary plans.
2. Construction documents, specifications and construction details for all work to be undertaken.
3. A letter from the facility holding the agency harmless for any changes that may occur to the project as a result of the final construction document review.
4. An Infection Control Risk Assessment (ICRA) and a life safety plan indicating temporary egress and detailed phasing plans indicating how the area(s) to be demolished or constructed is to be separated from all occupied areas shall be submitted when demolition or construction in and around occupied buildings is to be undertaken. Submissions that fail to provide an ICRA or depict the safety measures prescribed by the ICRA will not be approved.
(i) For projects involving only equipment changes or system renovations, only Stage III, construction documents will be accepted. These documents shall include the following:
1. Life safety plans showing the fire/smoke compartments in the area of renovation.
2. Detailed phasing plans indicating how the new work will be separated from all occupied areas.
3. Engineering plans and specifications for all of the required work.
(j) Stage I, Schematic Plans.
1. The following shall be incorporated into the schematic plans:
a. Single-line drawings of each floor that indicates the relationship of the various activities or services to each other and the room arrangement in each.
b. The function of each room or space shall be noted in or near the room or space.
c. The proposed roads and walkways, service and entrance courts, parking, and orientation shown on either a small plot plan or on the first floor plan.
d. A simple cross-section diagram showing the anticipated construction.
e. A schematic life safety plan showing smoke and fire compartments, exits, exit passageways and gross areas of required smoke and fire compartments.
f. Indicate which areas are sprinklered, both new and existing.
2. If the proposed construction is an addition or is otherwise related to existing buildings on the site, the schematic plans shall show the facilities and general arrangement of those buildings.
3. If the project involves increasing, decreasing, relocating or transferring licensed beds, a schedule showing the total number of beds, types of bedrooms and types of ancillary spaces must be provided.
(k) Stage II, Preliminary Plans. The following shall be incorporated into the preliminary plans.
1. A Vicinity Map. For new center construction, provide a vicinity map showing the major local highway intersections.
2. Site Development Plans.
3. Plans depicting existing grades and proposed improvements.
4. Building location dimensions.
5. Location of the fire protection services water source to the building.
6. Architectural Plans.
a. Floor plans, 1/8-inch scale minimum, showing door swings, windows, case work and mill work, fixed equipment and plumbing fixtures. Indicate the function of each space.
b. Typical large-scale interior and exterior wall sections to include typical rated fire and fire/smoke partitions and a typical corridor partition.
c. All exterior building elevations.
7. Equipment which is not included in the construction contract that requires mechanical or electrical service connections or construction modifications shall be identified to assure coordination with the architectural, mechanical and electrical phases of construction.
8. If the project is located in an occupied facility, preliminary phasing plans indicating how the project is to be separated from all occupied areas.
9. Life Safety Plans. Life safety plans must include the following:
a. Single-sheet floor plans depicting required fire and smoke compartmentation, all means of egress and all exit signs. If smoke compartmentation is required, depict and provide the dimension for the longest path of travel in each smoke compartment to the door(s) accessing the nearest adjoining smoke compartment, calculate the total area of the smoke compartment in square feet, and tabulate exit inches.
b. All sprinklered areas.
c. All fire extinguishers.
d. All fire alarm devices and pull station locations.
10. If the project is an addition, or conversion of an existing building, fully developed life safety plans must be submitted.
11. If the project is a renovation in an existing building, life safety plans of the floor being renovated and the required exit egress floor(s) must be submitted.
12. When demolition or construction in and around occupied buildings will be undertaken, a life safety plan indicating temporary egress, and detailed phasing plans indicating how the area(s) to be demolished or constructed will be separated from all occupied areas must be submitted.
13. Mechanical Engineering Plans.
a. Single-sheet floor plans with a one-line diagram of the ventilating system with relative pressures of each space. Provide a written description and drawings of the anticipated smoke control system, passive or active, and a sequence of operation correlated with the life safety plans.
b. The general location of all fire and smoke dampers, all duct smoke detectors and fire stats.
c. If the building is equipped with fire sprinklers, indicate the location of the sprinkler system risers and the point of connection for the fire sprinkler system. State the method of design for the existing and new fire sprinkler systems.
d. The locations of all plumbing fixtures and other items of equipment requiring plumbing services and/or gas services.
e. The locations of any fume, radiological or chemical hoods.
f. The locations of all medical gas outlets, piping distribution risers, terminals, alarm panel(s), low pressure emergency oxygen connection, isolation/zone valve(s), and gas source location(s).
g. The locations and relative size of major items of mechanical equipment such as chillers, air handling units, fire pumps, medical gas storage, boilers, vacuum pumps, air compressors and fuel storage vessels.
h. The locations of hazardous areas and the volume of products to be contained therein.
i. The location of fire pump, standpipes, and sprinkler riser(s).
14. Electrical Engineering Drawings.
a. A one-line diagram of normal and essential electrical power systems showing service transformers and entrances, switchboards, transfer switches, distribution feeders and over-current devices, panel boards and step-down transformers. The diagram shall include a preliminary listing and description of new and existing, normal and emergency loads, preliminary estimates of available short-circuit current at all new equipment and existing equipment serving any new equipment, short-circuit and withstand ratings of existing equipment serving new loads and any new or revised grounding requirements.
b. Show fire alarm zones and correlate with the life safety plan.
15. Outline Specifications. Outline specifications must include a general description of the construction, including construction classification and ratings of components, interior finishes, general types and locations of acoustical material, floor coverings, ventilating equipment, plumbing fixtures, fire protection equipment, medical gas equipment and electrical equipment.
16. Whenever an existing building is to be converted to a health care facility, the general layout of spaces of the existing structure shall be submitted with the preliminary plans for the proposed facility.
17. Whenever an addition, alteration, renovation or remodeling to an existing facility is proposed, the general layout of spaces of the existing facility shall be submitted with the preliminary plans.
(l) Stage III, Construction Documents. The Stage III, construction documents shall be an extension of the Stage II, preliminary plan submission and shall provide a complete description of the contemplated construction. Construction documents shall be signed, sealed and dated and submitted for written approval to the Office of Plans and Construction by a Florida-registered architect and Florida-registered professional engineer. These documents shall consist of work related to civil, structural, mechanical, and electrical engineering, fire protection, lightning protection, landscape architecture and all architectural work. In addition to the requirements for Stage II submission, the following shall be incorporated into the construction documents:
1. Site and civil engineering plans indicating building and site elevations, site utilities, paving plans, grading and drainage plans and details, locations of the two fire hydrants utilized to perform the water supply flow test, and landscaping plans.
2. Life safety plans for the entire project. Projects located on floors above or below the exit discharge level must also include life safety plans for the exit discharge serving the project area.
3. Architectural Plans.
a. Typical large-scale details of all typical interior and exterior walls and smoke walls, horizontal exits and exit passageways.
b. Comprehensive ceiling plans that show all utilities, lighting fixtures, smoke detectors, ventilation devices, sprinkler head locations and fire-rated ceiling suspension member locations where applicable.
c. Floor/ceiling and roof/ceiling assembly descriptions for all conditions.
d. Details and other instructions to the contractor on the construction documents describing the techniques to be used to seal floor construction penetrations necessary to prevent smoke migration from floor to floor during a fire.
4. Structural engineering plans, schedules, and details.
5. Mechanical engineering plans including fire and smoke control plans. Include all equipment that requires mechanical utilities. Provide a clear and concise narrative control sequence of operations for each item of mechanical equipment including but not limited to air conditioning, heating, ventilation, medical gas, plumbing, and fire protection and any interconnection of the equipment of the systems. Mechanical engineering drawings shall depict completely the systems to be utilized, whether new or existing, from the point of system origination to termination. Provide a tabular schedule giving the required air flow (as computed from the information contained on the ventilation rate table) in cubic feet per minute (cfm) for supply, return, exhaust, outdoor, and ventilation air for each space, as applicable, shown on the architectural documents. The schedule shall also contain the HVAC system design air flow rates and the resulting space relative pressures. The schedule or portion of the schedule as applicable shall be placed on each floor plan drawing sheet containing the spaces depicted on the drawing.
6. Fire protection system layout documents as defined by the Department of Business and Professional Regulation in Rule 61G15-32.002, F.A.C., where applicable, that shall include the existing system as necessary to define the new work. These documents shall be signed and sealed by a Florida-registered professional engineer.
7. Electrical engineering plans describing complete power, lighting, alarm, communications and lightning protection systems and power system study.
8. A power study that shall include a fault study complete with calculations to demonstrate that over-current devices, transfer switches, switchboards, panel boards, motor controls, transformers and feeders are adequately sized to safely withstand available phase-to-phase and phase-to-ground faults. The study shall also include an analysis of generator performance under fault conditions and a coordination study resulting in the tabulation of settings for all over-current device adjustable trips, time delays, relays and ground fault coordination. This must be provided for all new equipment and existing equipment serving any new equipment. Power studies for renovations of existing distribution systems shall include only new equipment and existing equipment upstream to the normal and emergency sources of the new equipment. Renovations involving only branch circuit panel boards without modifications to the feeder do not require a full power study; instead, the power study shall be limited to the calculation of new and existing loads of the branch circuit panel.
(m) A complete set of specifications for all work to be undertaken.
1. All project required contractor supplied testing and/or certification reports shall be submitted in writing, on standard forms, reviewed and accepted by the Engineer of Record prior to presenting to the agency for review.
2. The specifications shall require a performance verification test and balance air quantity values report with the specified air filters installed for each air handling unit system operating in the minimum pressure drop condition (clean filter state) and at the maximum pressure drop condition (dirty filter state).
(n) All construction documents shall be coordinated to provide consistency of design intent throughout the documents and phasing plans shall be clear and provide continuity of required services. It is specifically required that in the case of additions to existing institutions, the mechanical and electrical, especially existing essential electrical systems and all other pertinent conditions shall be a part of this submission.
1. All subsequent addenda, change orders, field orders and other documents altering the above shall also be signed, sealed and dated and submitted in advance to the Office of Plans and Construction for review. The Agency will either approve or disapprove the submission based on compliance with all applicable codes and standards and shall provide a listing of deficiencies in writing.
2. All submissions will be acted upon by the agency within 60 days of the receipt of properly executed construction documents and the initial payment of the plan review fee. The Agency will either approve or disapprove the submission and shall provide a listing of deficiencies in writing. All deficiencies noted by the agency must be satisfactorily corrected before final approval will be provided from the Agency.
(13) Physical Plant Requirements
(a) The Agency provides technical assistance to the Florida Building Commission and the State Fire Marshal in developing and maintaining standards for the design and construction of advanced birth centers. These standards are included in the following:
1. The building codes in Rule 61G20-1.001, F.A.C.; as adopted by the Florida Building Commission.
2. The fire codes in Chapter 69A-60, F.A.C.; as adopted by the State Fire Marshal.
3. The handicap accessibility standards in Chapter 553, Part V, F.S. and Rule 61G20-4.002, F.A.C; as adopted by the Florida Building Commission.
(14) Price Transparency and Patient Billing
(a) Website. Each center shall make available to patients and prospective patients price transparency and patient billing information on its website regarding the availability of estimates of costs that may be incurred by the patient, financial assistance, billing practices, and a hyperlink to the Agency’s service bundle pricing website. The content on the center’s website shall be reviewed at least every 90 days and updated as needed to maintain timely and accurate information. For the purpose of this rule, service bundles means the reasonably expected center services and care provided to a patient for a specific treatment, procedure, or diagnosis as posted on the Agency’s website. The center’s website must include:
1. A hyperlink to the Agency’s pricing website upon implementation of the same that provides information on payments made to the facilities for defined service bundles and procedures. The Agency’s pricing website is located at: http://pricing.floridahealthfinder.gov;
2. A statement informing patients and prospective patients that the service bundle information is a non-personalized estimate of costs that may be incurred by the patient for anticipated services and that actual costs will be based on services actually provided to the patient;
3. A statement informing patients and prospective patients of their right to request a personalized estimate from the center;
4. A statement informing patients of the center’s financial assistance policy, charity care policy, and collection procedure;
5. A list of names and contact information of health care practitioners and medical practice groups contracted to provide services within the center, grouped by specialty or service; and,
6. A statement informing patients to contact the health care practitioners anticipated to provide services to the patient while in the center regarding a personalized estimate, billing practices and participation with the patient’s insurance provider or health maintenance organization (HMO) as the practitioners may not participate with the same health insurers or HMO as the center.
(b) Estimate. The center shall provide an estimate upon request of the patient, prospective patient, or legal guardian for nonemergency medical services.
1. An estimate or an update to a previous estimate shall be provided within 7 business days from receipt of the request. Unless the patient requests a more personalized estimate, the estimate may be based upon the average payment received for the anticipated service bundle. Every estimate shall include:
a. A statement informing the requestor to contact their health insurer or HMO for anticipated cost sharing responsibilities,
b. A statement advising the requestor that the actual cost may exceed the estimate,
c. The web address to financial assistance policies, charity care policy, and collection procedure,
d. A description and purpose of any facility fees, if applicable,
e. A statement that services may be provided by other health care providers who may bill separately,
f. A statement, including a web address if different from above, that contact information for health care practitioners and medical practice groups that are expected to bill separately is available on the center’s website; and,
g. A statement advising the requestor that the patient may pay less for the procedure or service at another facility or in another health care setting.
2. If the center provides a non-personalized estimate, the estimate shall include a statement that a personalized estimate is available upon request.
3. A personalized estimate must include the charges specific to the patient’s anticipated services.
(c) Itemized statement or bill. The center shall provide an itemized statement or bill upon request of the patient or the patient’s survivor or legal guardian. The itemized statement or bill shall be provided within 7 business days after the patient’s discharge or release, or 7 business days after the request, whichever is later. The itemized statement or bill must include:
1. A description of the individual charges from each department or service area by date;
2. Contact information for health care practitioners or medical practice groups that are expected to bill separately based on services provided; and,
3. The center’s contact information for billing questions and disputes.
(15) Pharmaceuticals
(16) Comprehensive Emergency Management Plan
(b) The plan shall include:
1. Provisions for internal and external disasters, and emergencies;
2. Information about how the center plans to implement specific procedures outlined in its comprehensive emergency management plan;
3. Precautionary measures, including voluntary cessation of center operations, to be taken by the center in preparation and response to warnings of inclement weather, including hurricanes and tornadoes, or other potential emergency conditions;
4. Provisions for the management of patients, including the discharge or transfer of patients and staff to a hospital, at the direction of the center’s administrator, in the event of an evacuation order, or when a determination is made by the Agency that the condition of the center is sufficient to render it a hazard to the health and safety of patients and staff. Such provisions shall address the role and responsibility of the physician in the decision to move or relocate patients;
5. Provisions for coordinating with hospitals that would receive patients to be transferred;
6. Provisions for the management of staff, including the distribution and assignment of responsibilities and functions, and the assignment of staff to accompany patients to a hospital or subacute care facility;
7. A provision that a verification check will be made to ensure patients transferred to a hospital arrive at the designated hospital;
8. A provision that ensures that copies of medical records and orders accompany patients transferred to a hospital;
9. Provisions for the management of patients who may be treated at the center during an internal or external disaster or emergencies, including control of patient information and medical records, individual identification of patients, transfer of patients to hospital(s) and treatment of mass casualties;
10. Provisions for contacting relatives and necessary persons advising them of patient location changes. A procedure must also be established for responding to inquiries from patient families and the press;
11. A provision for educating and training personnel in carrying out their responsibilities in accordance with the adopted plan;
12. Identification of mutual aid agreements or statements of understanding for services; and,
13. Provisions for coordination with designated agencies.
(17) Transfer Agreements
(18) Audits/Trainings
(19) Food Service
(e) The Food and Nutrition Services department, service or other similarly titled unit shall be guided by written policies and procedures that cover food procurement, preparation and service. Food and Nutrition Services department policies and procedures shall be developed by the director of the Food and Nutrition Services 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:
1. A description of food purchasing, storage, inventory, preparation, service, and disposal policies and procedures.
2. A requirement that the proper use and adherence to standards for nutritional care, including dietary reference intakes are specified by the provider’s diet manual, which must be current within the last five years and relevant to maternal and infant nutrition.
3. Menus.
4. Therapeutic and modified diets.
5. Food safety and sanitation in accordance with the standards set forth in the latest edition of the US Public Health Service, Food and Drug Administration Food Code.
(f) Personnel in the Food and Nutrition Service department shall receive, as appropriate to their level of responsibility, orientation and inservice training in:
1. Food safety and sanitation;
2. Food preparation and service;
3. Therapeutic and modified diets;
(20) Medical Records
(a) Each center shall establish processes to obtain, manage, and utilize information to enhance and improve individual and organizational performance in patient care, management, and support processes. Such processes shall:
1. Be planned and designed to meet the center’s internal and external information needs;
2. Provide for confidentiality, integrity and security;
3. Provide education and training in information management principles to decision-makers and other center personnel who generate, collect, and analyze information; and,
4. Provide for information in a timely and accurate manner;
(e) The medical records service shall:
1. Maintain a system of identification and filing to ensure the prompt location of a patient’s medical record. Patient records may be stored on electronic medium such as computer, microfilm or optical imaging;
2. Maintain a current and complete medical record for every patient admitted to the center.
3. All clinical information pertaining to the patient’s medical treatment shall be centralized in the patient’s medical record.
4. Ensure that each medical record shall contain the following, as appropriate to the service provided:
a. Identification data;
b. Chief complaint;
c. Present illness;
d. Past personal history;
e. Family medical history;
f. Physical examination report;
g. Provisional and pre-operative diagnosis;
h. Clinical laboratory reports;
i. Radiology, diagnostic imaging, and ancillary testing reports;
j. Consultation reports;
k. Medical and surgical treatment notes and reports;
l. The appropriate informed consent signed by the patient;
m. Record of medication and dosage administered;
n. Tissue reports;
o. Physician orders;
p. Physician and nurse progress notes;
q. Final diagnosis;
r. Discharge summary; and,
s. Autopsy report, if appropriate.
5. Ensure that:
a. Operative reports signed by the surgeon shall be recorded in the patient’s record immediately following surgery or that an operative progress note is entered in the patient record to provide pertinent information; and,
b. Postoperative information shall include vital signs, level of consciousness, medications, blood or blood components, complications and management of those events, identification of direct providers of care, discharge information from post-anesthesia care area.
6. Index, and maintain on a current basis, all medical records according to surgical procedure and physician.
(21) Reporting
(b) Adverse Incident Reporting.
1. For purposes of reporting to the agency pursuant to this section, the term “adverse incident” means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which results in one of the following injuries:
a. Death;
b. Brain or spinal damage;
c. Permanent disfigurement;
d. Fracture or dislocation of bones or joints;
e. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;
f. Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or,
g. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care.
2. Any of the following adverse incidents, whether occurring in the licensed facility or arising from health care prior to admission in the licensed facility, shall be reported by the facility to the agency within 15 calendar days after its occurrence on Advanced Birth Center Adverse Incident, AHCA Form 3140-2005 OL, August 2025, which is hereby incorporated by reference and available at: HYPERLINK "https://flrules.org/Gateway/reference.asp?No=Ref-19209"https://flrules.org/Gateway/reference.asp?No=Ref-19209, and through the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at: https://apps.ahca.myflorida.com/SingleSignOnPortal:
a. The death of a patient;
b. Brain or spinal damage to a patient;
c. Permanent disfigurement;
d. Fracture or dislocation of bones or joints;
e. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;
f. Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or,
g. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care.
Rulemaking Authority 383.3081, 383.309 FS. Law Implemented 383.3081, 383.309 FS. History–New 6-9-26.