The statutory change in section 395.1055, F.S., directs the agency to adopt rules for quality of care, nurse staffing, physician staffing, and equipment standards related to the delivery of surgical care to children in ambulatory ....

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-5.0085Departments and Services

PURPOSE AND EFFECT: The statutory change in section 395.1055, F.S., directs the agency to adopt rules for quality of care, nurse staffing, physician staffing, and equipment standards related to the delivery of surgical care to children in ambulatory surgical centers. Language will also address pediatric standards for operative procedures that require a length of stay past midnight.

SUMMARY: The Agency is addressing standards for pediatric patient care in ambulatory surgical centers per change to section 395.1055, F.S.

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.

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 FS.

LAW IMPLEMENTED: 395.009, 395.1055, 395.1011 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: Wednesday, December 9, 2020, 3:00 p.m.

PLACE: No public face-to-face meeting. This hearing will be conducted via teleconference. Participate by dialing the Open Voice conference line, 1(888)585-9008, then enter the conference room number followed by the pound sign, 476-211-242#. The agenda and related materials can also be found on the web at: https://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Rulemaking.shtml

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, Hospital & Outpatient Services Unit, 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, Hospital & Outpatient Services Unit, Bureau of Health Facility Regulation, [phone], email: [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-5.0085 Departments and Services.

(1) through (3) No change.

(4) Clinical laboratory services. The ambulatory surgical center laboratory, and any contracted laboratory providing services for ambulatory surgical 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. Laboratories. Clinical Laboratory – Each center shall provide on the premises or by written agreement with a laboratory licensed under Chapter 483, F.S. and Chapter 59A-7, F.A.C., a clinical laboratory to provide those services commensurate with the center’s needs and which conform to the provisions of Chapter 483, F.S. and Chapter 59A-7, F.A.C.

(5) Radiological Radiolocical services. Each center shall provide within the institution, or through arrangement, radiological services commensurate with the needs of the center.

(a) through (d) No change.

(6) No change

(7) Pediatric services.

(a) 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 reviewed annually by the pediatric medical director, and signed and dated at the time of review.

1. Patients must be at least 6 months of age.

2. Patients less than 24 months of age must be admitted and discharged on the same calendar day.

3. Patients who were born less than 37 completed weeks gestation (premature) must be at least 15 months of age, weaned off apnea monitors, and have the patient’s primary care physician clearance for the procedure in an ambulatory surgical center setting.

4. Patients must not be oxygen dependent at baseline.

5. Patients must have a Body Mass Index in the range of 5th to 85th percentile.

6. Patients must not have a Do Not Resuscitate status.

7. Patients must undergo preoperative screening by an anesthesiologist to assess the pre-anesthesia medical co-morbidities.  The screening must assign a classification, such as the American Society of Anesthesiologists Physical Status Classification System.  Only patients classified as healthy or with mild systemic disease, as defined by the center’s organized medical staff, may be admitted for surgical services.

(b) Accommodations must be made for the parent or guardian to remain at the center from admission through discharge.

(c) Surgical services may be provided to patients for elective procedures only. Procedures utilizing general anesthesia must be under 4 hours.

(d) Each center must have a specific pediatric quality assessment and improvement system as described in 59A-5.019, F.A.C. that includes peer review, multidisciplinary review and the monitoring of processes and outcomes.

(e) Each center must have a written transfer agreement with a hospital providing pediatric surgical services. Centers must ensure the mode of emergency transportation has age- and size-appropriate equipment.

(f) A pediatric anesthesiologist or pediatric surgeon must serve as pediatric medical director.

(g) 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.

(h) 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:

1. 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 pediatric medical director.

2. Anesthesia personnel, as described in subsection (2) shall be present in the room with the pediatric patient throughout all general anesthesia, regional anesthesia and monitored anesthesia care.

3. Nursing and other direct care staff must have specialized training and experience with pediatric patients. Nursing personnel must be PALS and Advanced Cardiac Life Support certified. There must be at least one registered professional nurse for each pediatric patient at all times.

(i) Each center providing surgical services requiring a length of stay past midnight must have kitchen facilities and equipment available to store ready-to-eat foods and beverages. Equipment must include handwashing facilities and a refrigerator.

(j) Age- and size-appropriate equipment and resources related to the care of pediatric patients must be available on site, including

1. Operating tables;

2. Pre- and post-operative beds;

3. Anesthesia equipment and supplies;

4. Resuscitation devices;

5. Oxygen saturation monitors;

6. Pharmacologic supplies and administration devices; and

7. Blood pressure cuffs.

(8) The Agency will review this rule five years from the effective date and re-promulgate, amend or repeal the rule as appropriate, in accordance with Section 120.54, F.S. and Chapter 1-1, F.A.C.

Rulemaking Authority 395.1055 FS. Law Implemented 395.009, 395.1055, 395.1011 FS. History–New 12-12-96, 9-28-14, Amended            ­_ .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jack Plagge

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Shevaun L. Harris

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 10/23/2020

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 10/31/2019