The Agency proposes to update birth center rules to align with recently revised statutory requirements per Chapters 2018-24 and 2018-98, Laws of Florida. Revisions will remove obsolete language, clarify requirements and update statutory references.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-11.002Definitions

59A-11.003Licensure Procedures

59A-11.005Requirements for Licensure

59A-11.009Risk Status Criteria for the Acceptance of Clients and Continuation of Care

59A-11.014Surgical Services

59A-11.016Postpartum Care

59A-11.019Reports

59A-11.030Pharmaceuticals and Anesthetics

PURPOSE AND EFFECT: The Agency proposes to update birth center rules to align with recently revised statutory requirements per Chapters 2018-24 and 2018-98, Laws of Florida. Revisions will remove obsolete language, clarify requirements and update statutory references.

SUMMARY: Birth Center Standards and Licensure

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.

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: 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. 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: 383.305, 383.309, 408.805, 408.819 FS.

LAW IMPLEMENTED: 20.42(2)(a), 383.04, 383.14, 383.302, 383.305, 383.307, 383.308, 383.309, 383.31, 383.313, 383.315, 383.316, 383.318, 383.32, 383.327, 383.335, 408.805, 408.806, 408.809, 408.810 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: September 18, 2018, 8:30 a.m. – 10:00 a.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room D, 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-11.002 Definitions.

(1) “AAAHC” means the Accreditation Association for Ambulatory Health Care.

(2) “Accrediting Organization” means a recognized organization whose standards are comparable to the licensure regulations required by this state. “Adjacent” means nearby and easily accessible.

(3) “Agency” means the Agency for Health Care Administration.

(4) “CABC” means the Commission for the Accreditation of Birth Centers.

(5) “CLIA certification” means having applied for and received a federal Clinical Laboratory Improvement Amendments (CLIA) certificate documenting compliance with Title 42, Chapter IV, Subchapter G, Part 493 of the Code of Federal Regulations. “Ordinary” construction means that type of housing commonly found in residential areas.

(6) “Qualified personnel” means that an the individual is trained and competent in the services which he or she provides and is licensed or certified when required by statute or professional standard.

Rulemaking Authority 383.309 FS. Law Implemented 383.309 FS. History–New 3-4-85, Formerly 10D-90.02, 10D-90.002, Amended 9-17-96, 5-15-14,               .

 

59A-11.003 Licensure Procedures.

(1) An applicant or licensee requesting licensure for All persons contemplating the operation of a birth center under the provision of Chapter 383, F.S., shall make application to the Agency on the Health Care Licensing Application, Birth Center, AHCA Form 3130-3001, June 2018 July 2014, which is incorporated by reference, and shall receive a standard or provisional license prior to the acceptance of clients. The form is available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. https://www.flrules.org/Gateway/reference.asp?No=Ref-04594 and available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #31, Tallahassee, Florida 32308, or at the web address at: http://ahca.myflorida.com/HQAlicensureforms. Applicants for renewal and change during licensure period may submit the Health Care Licensing Online Application, Birth Center, AHCA Form 3130-3001OL, June 2018, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX. The application forms are also available at http://www.ahca.myflorida.com/HQAlicensureforms or, for online submissions, at: http://apps.ahca.myflorida.com/SingleSignOnPortal.

(2) Each birth center applying for a license shall be designated by a distinctive name and the name shall not be changed without first notifying the Agency and receiving approval in writing. Duplication of an existing birth center’s name is prohibited in new birth centers. The birth center’s occupancy permit and in the case of persons applying for a license prior to purchase, where the birth center is licensed under other ownership, a signed agreement to correct physical deficiencies listed in the most recent licensure inspection and the most recent life safety inspection, unless otherwise modified herein, shall accompany the initial application.

(3) In addition to the requirements found in Chapter 408, Part II, F.S., an application for initial licensure shall include proof of compliance with local zoning requirements for the address of record.

(4) In addition to the requirements found in Chapter 408, Part II, F.S., an application for a change of ownership shall include:

(a) Proof of accreditation, if applicable;

(b) A signed agreement with the Agency to correct deficiencies listed in the most recent licensure and life safety inspections; and,

(c) A copy of the closing documents, which must include an effective date and the signatures of both the transferee and the transferor.

(5)(3) A licensure license fee of $392.80 per birth center shall accompany the application for an initial, renewal or change of ownership license. licensure. Licensure fees may be annually adjusted as outlined in Section 408.805, F.S. The licensure fee shall be made payable to the Agency for Health Care Administration and is not refundable.

(4) An application for licensure is required when a majority of the ownership or controlling interest of a licensed facility has been transferred or assigned and when a lessee agrees to undertake or provide services to the extent that legal liability for operation of the facility rests with the lessee. The application for a license reflecting such change shall be made at least 60 days but no more than 120 days prior to the date of the sale, transfer, assignment or lease and must meet all application requirements as outlined in Chapter 408, F.S and Chapter 59A-35, F.A.C.

(5) Each license shall be returned to the Agency by the licensee immediately upon change in ownership or classification, suspension, revocation, or voluntary cessation of operations.

(6) A licensee shall notify the Agency of impending voluntary closure of a birth center not less than 30 days prior to such closure. The birth center shall be responsible for advising the licensing agency as to the placement of patients and disposition of medical records.

(7) Upon receipt of a complete application, the Agency shall conduct a survey to determine compliance with Chapters 383 and 408, F.S. and Chapters 59A-11 and 59A-35, F.A.C.

(8) When the applicant and birth center is in compliance with Chapters 383 and 408, F.S. and Chapters 59A-11 and 59A-35, F.A.C., the Agency shall issue a standard license.

Rulemaking Authority 383.305, 383.309, 408.805, 408.819 FS. Law Implemented 383.305, 408.805, 408.806, 408.809, 408.810 FS. History–New 3-4-85, Formerly 10D-90.03, 10D-90.003, Amended 9-27-94, 2-12-96, 9-17-96, 9-28-14,                .

 

59A-11.005 Requirements for Licensure.

In addition to other requirements specified in these rules, all licensed birth centers shall have at least the following:

(1) A governing body organized under and have written bylaws, rules and regulations, which it reviews at least every two years, denotes dates to indicate time of last review, and revises as necessary and enforces. The governing body bylaws shall state the role and purpose of the birth center, including an organizational chart defining the lines of authority.

(2) A chief executive officer or other similarly titled official to whom the governing body delegates the full-time authority for the operation of the birth center in accordance with the established policy of the governing body;

(3) An organized clinical staff to which the governing body delegates responsibility for maintaining proper standards of medical and other health care, which responsibilities include:

(a) The clinical staff of the birth center shall be responsible for maintaining quality of care provided to the clients patients by:

1. Having at least one clinical staff member available for every two clients in labor;

2. Having a clinical staff member or qualified personnel available on site during the entire time the client is in the birth center. Services during labor and delivery shall be provided by physicians or by certified nurse midwives or licensed midwives, assisted by at least one other staff member, under protocols developed by the clinical staff and approved by the governing body in accordance with accepted standards of care;

3. Ensuring all qualified personnel and clinical staff of the birth center shall be trained in infant and adult resuscitation. Clinical staff or qualified personnel who have demonstrated ability to perform neonatal resuscitation procedures shall be present during each birth;

4. Maintenance of clinical records describing the history, conditions, treatment and progress of the client patient in sufficient completeness and accuracy to assure transferable comprehension of the case at any time;

5. Clinical record reviews to evaluate the quality of clinical care on the basis of documented evidence;

6. Review of admissions with respect to eligibility, course of pregnancy and outcome, evaluation of services, condition of mother and newborn on discharge, or transfer to other providers; and,

7. Surveillance of infection risk and cases and the promotion of a preventive and corrective program designed to minimize these hazards.

(b) Services of a consultant physician are required in those birth centers which do not have a physician on the clinical staff who is certified or eligible for certification by the American Board of Obstetrics and Gynecology, the American Board of Osteopathic Obstetricians and Gynecologists or has hospital obstetrical privileges.

(c) The responsibilities and functions of the consultant shall be specifically described in the policy and procedure manual and the client patient care protocols.

(d) The governing body shall maintain in writing a consultation agreement, signed within the current license year, with each consultant who agrees to provide advice and services to the birth center as requested.

(e) Any facility which as of June 15, 1984, has an agreement with a consultant who is licensed pursuant to Chapters 458 or 459, F.S., but who is not practicing obstetrics, shall be exempt from the provisions of Chapter 383, F.S., requiring that the consultant be certified or eligible for certification by the American Board of Obstetrics and Gynecology, the American Board of Osteopathic Obstetricians and Gynecologists or has hospital obstetrical privileges.

(4) The birth center shall have a defined client record system, policies and procedures which provide for identification, security, confidentiality, control, retrieval, and preservation of client care data and information. A current and complete clinical record for each client patient accepted for care in the birth center shall include at a minimum, the following data:

(a) Identifying information including client’s name, address and telephone number;

(b) Initial history and physical examination including laboratory findings and dates;

(c) Obstetrical risk assessments and pre-term labor risk assessments including the dates of the assessments;

(d) The dates and topics of the educational sessions attended;

(e) The date and time of the onset of labor;

(f) The course of labor including all pertinent examinations and findings;

(g) The exact date and time of birth, the presenting part, the sex of the newborn, the numerical order of birth in the event of more than one newborn, to include filing of the birth certificate, and the Apgar score at one minute and five minutes;

(h) Time of expulsion and condition of placenta;

(i) All treatments rendered to the mother and newborn including prescribing prescriptions, the time, type, and dose of eye prophylaxis;

(j) Copy of the metabolic Metobolic screening report;

(k) Condition of the mother and newborn including any complications and action taken;

(l) All medical consultations relevant to the client specifically;

(m) Referrals for medical care and transfers to hospitals including that information germane to the circumstances;

(n) Examinations of the newborn and postpartum mother; and,

(o) Information and iInstructions given to the client regarding postpartum care as outlined in Rule 59A-11.016, F.A.C., family planning, care of the newborn, arrangements for metabolic testing, immunizations, and follow-up pediatric care.

1. All entries shall be dated and signed by the attending clinical staff members.

2. The clinical record is confidential and shall not be released without the written consent of the client except under the following conditions:

a. When the client is transferred to another source of care; and,

b. For audit by the agency during licensure inspection or complaint investigation.

3. The clinical records shall be kept on file for a minimum of seven years from the date of last entry.

4. The clinical record shall be immediately available at the time of the client’s admission to the birth center in labor and to the practitioner or hospital when the client is transferred.

(5) A policy requiring that all clients patients be accepted on the authority of and under the care of a member of the organized clinical staff;

(6) A procedure for providing care and transfer in an emergency;

(a) The birth center shall have a written protocol which shall include at a minimum:

1. The name, address, telephone numbers and contact persons of the licensed ambulance service, the hospital licensed to provide emergency obstetrical and neonatal services, and other hospitals in the vicinity;

2. The conditions specified in the arrangements between the birth center and the ambulance service and the hospital, including financial responsibility for services rendered; and,

3. Criteria to determine risk status which require medical consultation or transfer to a hospital of the newborn or the mother for any conditions such as:

a. Premature labor, meaning labor occurring at less than 37 weeks gestation;

b. Estimated fetal weight less than 2,500 grams or greater than 4,000 grams;

c. Hypertension;

d. Pre-eclampsia;

e. Failure to progress in labor;

f. Evidence of an infectious process;

g. Premature rupture of the membranes, meaning rupture occurring more than 12 hours before onset of active labor;

h. Suspected placenta praevia or abruptio;

i. Non-vertex presentation;

j. Hemorrhage of greater than 500 cc of blood;

k. Anemia consisting of less than 10 grams of hemoglobin per 100 milliliters of blood or 30 percent hematocrit;

1. Persistent fetal tachycardia (heart rate more than 160 beats per minute), repetitive fetal bradycardia (heart beat less than 120 beats per minute) or undiagnosed abnormalities of the fetal heart tones; and,

m. Persistent hypothermia in the newborn.

4. Criteria to determine risk status which require immediate emergency transfer to a hospital of the newborn or mother for any condition such as:

a. Prolapsed cord;

b. Uncontrolled hemorrhage;

c. Placenta abruptio;

d. Convulsions;

e. Major anomaly of the newborn;

f. Apgar score four or less at five minutes;

g. Fetal heart rate of 90 or less beats per minute for three minutes;

h. Thick meconium staining;

i. Respiratory distress in the newborn; and,

j. Weight less than 2,000 grams.

5. The criteria and protocols for transfer shall be readily accessible to clinical staff members at all times.

(b) The names and telephone numbers of the ambulance service, neonatal transport service, and hospital shall be clearly posted at each telephone in the birth center.

(c) A written report of the transfer shall be documented and available for quality assurance review and agency inspection. The report shall include:

1. The client’s name;

2. The date of the event;

3. The reason for transfer;

4. The provider and mode of transportation to the hospital;

5. The exact time of the initial call, any subsequent calls;

6. Arrival of the emergency personnel;

7. Departure of the client;

8. Arrival at the hospital;

9. Name of the hospital;

10. Initiation of emergency medical services;

11. The condition of the client at the time of transfer; and,

12. Any information regarding the medical care of the client and outcome.

(d) The clinical staff, consultants, and governing body shall review and evaluate the criteria, protocols, and emergency transfer reports annually. The findings of the evaluation shall be documented.

(7) A method and policy for infection control.

(a) There shall be an Infection Control Committee, composed of the clinical staff and consultants, delegated responsibility for developing and maintaining current written policies and procedures for the prevention, control and investigation of infection in the birth center, and for assuring the effectiveness of current procedural techniques.

(b) There shall be current written policies and procedures to assure, define, and validate infection control for any of the following subjects and areas:

1. Medical asepsis;

2. Surgical asepsis;

3. Sterilization and disinfection;

4. Housekeeping;

5. Clean and soiled utility areas;

6. Linen;

7. Traffic flow patterns;

8. Staff health status requirements;

9. Infection control inservice education for all personnel;

10. Recording and reporting of all potential infections;

11. Bacteriological testing of potential infections, recording results and reporting to Infection Control Committee;

12. Management of clients with specific or suspected infections;

13. Postpartum follow-up system; and,

14. Reporting of notifiable communicable disease in an infectious stage.

(8) An ongoing program to enhance the quality of client patient care and review the appropriateness of utilization of services. To ensure the program is effective, the following will be accomplished:

(a) An interdisciplinary committee shall be appointed to do periodic quality assurance review. Two members of the committee shall have clinical expertise in maternal-infant care such as a physician or registered nurse. All members of the committee will be health care providers who are involved in the care or treatment of the clients patients being audited.

(b) Clinical records shall be audited by the clinical staff at least every three months and a sample audited by the quality assurance committee at least every six months. The audit shall evaluate the following:

1. Initial history, physical examination, risk assessments and laboratory tests;

2. Documentation of clinical observations, examinations and treatments;

3. Evidence that appropriate actions have been taken in response to clinical findings;

4. Counseling, education, consultation, and referral activities are recorded;

5. Consent forms are signed as required by subsections 59A-11.010(2), (3), F.A.C.; and,

6. All entries are legible, dated, and signed.

(c) The quality assurance committee shall analyze the incidence of maternal and perinatal morbidity and mortality, obstetrical risk assessments, pre-term labor risk assessments, consultants' referrals and outcomes, and transfers of care and outcomes.

(9) Laboratory testing may be provided onsite by qualified birth center staff or by written agreement with a laboratory that holds the appropriate federal Clinical Laboratory Improvement Amendments (CLIA) certificate. The birth center must maintain CLIA certification in order for staff to perform the laboratory tests required by this rule.

Rulemaking Authority 383.309 FS. Law Implemented 20.42(2)(a), 383.302, 383.307, 383.308, 383.309, 383.313, 383.315, 383.316, 383.318, 383.32, 383.327, 383.335 FS. History–New 3-4-85, Formerly 10D-90.05, 10D-90.005, Amended 2-12-96, 9-17-96,                 .

 

59A-11.009 Risk Status Criteria for the Acceptance of Clients and Continuation of Care.

(1) Birth center clients are limited to those women who are initially determined to be at low maternity risk and who are evaluated regularly throughout pregnancy to assure that they remain at low risk for a poor pregnancy outcome.

(2) Each birth center shall establish a written risk assessment system which shall be a part of the policy and procedure manual. The individual risk assessment shall be included in the client’s clinical record.

(3) The general health status and risk assessment shall be determined by a physician, certified nurse midwife, licensed midwife, licensed physician assistant or advanced practice registered nurse practitioner after obtaining a detailed medical history, performing a physical examination, and taking into account family circumstances and other social and psychological factors.

(4) The following criteria shall be used as a minimum baseline upon which the risk status of clients shall be determined. These criteria shall be applied to all clients prior to acceptance for birth center services and throughout the pregnancy for continuation of services. Clients with any of the following risk factors shall be referred to a physician for continuing maternity care and hospital delivery:

(a) Age limits to be determined on an individual basis.

(b) Major medical problems including but not limited to:

1. Chronic hypertension, heart disease, or pulmonary embolus;

2. Congenital heart defects assessed as pathological by a cardiologist, placing mother and/or fetus at risk;

3. Severe renal disease;

4. Drug addiction or required use of anticonvulsant drugs;

5. Diabetes mellitus or thyroid disease which is not maintained in a euthyroid state, or

6. Bleeding disorder or hemolytic disease.

(c) Previous history of significant obstetrical complications, including, but not limited to:

1. Rh sensitization;

2. Previous uterine wall surgery including Caesarean section;

3. Seven or more term pregnancies;

4. Previous placenta abruptio.

(d) Significant signs or symptoms of:

1. Hypertension;

2. Preeclampsia;

3. Poly or oligo hydramnios;

4. Abruptio placenta;

5. Chorioamnionitis;

6. Severe fetal anomalies;

7. Multiple gestation;

8. Intrauterine growth restriction;

9. Non-reassuring fetal status;

10. Alcoholism or drug addiction;

11. Thrombophlebitis, or

12. Pyelonephritis.

(5) With the exception of those facilities exempted under Section 383.335, F.S., Acceptance acceptance for and continuation of care throughout pregnancy and labor is limited to those women for whom it is appropriate to give birth in a setting where anesthesia is limited to local infiltration of the perineum or a pudendal block and where analgesia is limited.

Rulemaking Authority 383.309 FS. Law Implemented 383.309, 383.31, 383.335 FS. History–New 3-4-85, Formerly 10D-90.09, Amended 7-20-92, Formerly 10D-90.009, Amended 2-21-17,               .

 

59A-11.014 Surgical Services.

No surgical procedures shall be performed except episiotomy, repair of episiotomy or laceration, or circumcision except in those birth centers exempted pursuant to Section 383.335, F.S.

Rulemaking Authority 383.309 FS. Law Implemented 383.313 FS. History–New 3-4-85, Formerly 10D-90.14, 10D-90.014,______.

 

59A-11.016 Postpartum Care.

(1) A cord blood sample shall be secured for laboratory testing for type, Rh determination, and direct Coombs test when the mother is Rh negative.

(2) The newborn shall be weighed, measured, inspected for abnormalities and examined for complications. An identification tape shall be placed on the newborn if more than one newborn is at the center at the same time.

(3) One half milligram of Vitamin K shall be administered to the newborn within 24 hours after birth. If no one on the birth center staff is licensed to administer this medication, the parents shall be instructed to take the infant to a private physician or clinic for the injection.

(4) The newborn shall be referred to physician or hospital care if the following conditions occur:

(a) Low birthweight (under 2500 grams);

(b) Apgar score of six or less at five minutes;

(c) Signs of pre or post maturity;

(d) Jaundice;

(e) Persistent hypothermia consisting of a body temperature of less than 97 degrees Fahrenheit for more than two hours after birth;

(f) Respiratory difficulties;

(g) Major congenital anomalies;

(h) Exaggerated tremors; and,

(i) Any other condition requiring medical care.

(5) The condition of the mother shall be monitored frequently to detect signs of hemorrhage, or other complications, requiring prompt transfer to a physician or hospital.

(6) The mother and infant shall be discharged from the birth center within 24 hours after the birth occurs except under the following conditions:

(a) The mother is in a deep sleep when the 24 hour period is completed. In this case the mother shall be discharged as soon after waking as feasible; or

(b) The 24 hour period is completed during the middle of the night.

(7) If the mother, or infant, is retained at the birth center longer than 24 hours after birth, except as identified in paragraphs 59A-11.016(6)(a) and (b), F.A.C., a report shall be filed with the local county public health unit within 48 hours after the birth describing the circumstances and reasons for the decision.

(8) A postpartum examination shall be performed within 72 hours after delivery and at approximately four to six weeks after delivery.

(a) The examination within 72 hours shall include at a minimum:

1. Interval history;

2. Mental health screening;

3.2. Blood pressure measurement; and,

4.3. Observation of the breasts, perineum and abdomen.

(b) The examination at four to six weeks shall include all of the above and also:

1. Weight;

2. Hemoglobin or hematocrit; and,

3. Bi-manual pelvic examination.

(9) The mother shall be counseled regarding breast feeding, perineal care, family planning, signs of common complications, postpartum depression including the provision of the telephone number of the Family Health Line operated pursuant to Section 383.011, F.S., activities and exercises, sex relations, care and feeding of the newborn, and changing family relationships.

(10) The metabolic screening test shall be performed on the newborn in accordance with Section 383.14, F.S.

(11) The parents shall be referred to providers of pediatric care and instructed about immunization.

(12) If complications in the mother or newborn occur during the postpartum period, a consultation or referral shall be made to the appropriate source of secondary or tertiary care.

(13) If the mother refuses to permit eye prophylaxis on account of religious beliefs contrary to the use of drugs, Vitamin K injection, or metabolic screening test, a waiver indicating this decision shall be signed by the mother, witnessed by a clinical staff member, and filed with the clinical record.

(14) The Healthy Start Postnatal Screening Instrument, shall be offered as specified in Rule 64C-7.008, F.A.C.

Rulemaking Authority 383.309, 408.819 FS. Law Implemented 20.42(2)(a), 383.04, 383.14, 383.318 FS. History–New 3-4-85, Formerly 10D-90.16, 10D-90.016, Amended 9-27-94, 2-12-96,______.

 

59A-11.019 Reports.

Each birth center shall submit a Birth Center Annual Report on AHCA Form 3130-3004OL, XXXXX 2018 3130-3004, February 2015, which is incorporated by reference. The form is only accepted electronically and is available at: https://apps.ahca.myflorida.com/SingleSignOnPortal/Login.aspx. http://www.flrules.org/Gateway/reference.asp?No=Ref-06268 A copy of the form can also be found at: http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX and available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 31, Tallahassee, Florida 32308, or at the web address at: http://ahca.myflorida.com/HQAlicensureforms. The report shall include a summary of client information for the period from July 1 of the previous year to June 30 of the current year. The report shall be due July 30th each year. Failure to submit this report so that it is timely received by the Agency will result in an administrative fine being imposed pursuant to Section 383.33, F.S.

Rulemaking Authority 383.309 FS. Law Implemented 383.327 FS. History–New 3-4-85, Formerly 10D-90.19, 10D-90.019, Amended 9-27-94, 2-12-96, 3-16-16,               .

 

59A-11.030 Pharmaceuticals and Anesthetics.

(1) There shall be written prescriptions or protocols signed by a practitioner legally authorized to prescribe for all drugs administered to clients within the birth center. Systemic analgesics and local anesthetics may be administered under the following conditions:

(a) The clinical staff member who administers the systemic analgesic or local anesthetic is legally authorized to do so and shall be present in the birth center during the use of intravenous analgesics;

(b) The dosage and drugs are specifically noted in the protocols for clinical services; and,

(c) The use of such drugs is in conformance with the policies and procedures of the birth center.

(2) General and conduction anesthesia shall not be administered at birth centers. except in those birth centers exempted from restrictions pursuant to Section 383.335, F.S., and only when the following conditions are met:

(a) The anesthesia service shall have written policies and procedures that are approved by the governing body and clinical staff, are reviewed annually, signed and dated at the time of review, revised and enforced as necessary;

(b) A qualified anesthesiologist or certified registered nurse anesthetist designated by the governing body shall be responsible for coordinating the functions, equipment, and supplies of the service;

(c) All general anesthesia shall be administered by an anesthesiologist or certified registered nurse anesthetist;

(d) A physician shall be present in the birth center during the anesthesia and post-anesthesia recovery period until the client is fully alert;

(e) Prior to the administration of anesthesia, the patient's condition shall be assessed;

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

(g) Anesthetic safety regulations shall be developed, posted and enforced. Such regulations shall include at least the following requirements:

1. All operating room electrical and anesthesia equipment shall be inspected on no less than a quarterly basis, and a written record of the results and corrective actions shall be maintained;

2. Flammable anesthetic agents shall not be employed in birth centers;

3. Each anesthetizing location shall be identified by a prominently posted permanent sign that clearly states that the anesthetizing location is not approved for flammable anesthetic agents;

4. Electrical equipment in anesthetizing areas shall be on an audiovisual line isolation monitor, with the exception of radiological equipment and fixed lighting more than five feet above the floor;

5. Each anesthetic gas machine shall have a pin-index system, a fail-safe mechanism, a minimum oxygen flow safety device which will prevent administration of less than 25% percent oxygen and less than 300 milliliters per minute oxygen flow, and an in-line oxygen monitor; and,

6. All reusable anesthesia equipment in direct contact with the patient shall be cleaned or sterilized as appropriate after each use;

7. At a minimum, the following monitors shall be applied to all patients receiving conduction or general anesthesia:

a. Precordiol or esophageal stethoscope;

b. Blood pressure cuff;

c. Electrocardiogram;

d. Continuous temperature device; and,

e. Inspired oxygen concentration.

(3) There shall be policies and procedures addressing the receiving, transcribing, and implementing of orders for administration of drugs.

(4) Written policies shall be established addressing the type and intended use of any drug to be used by clients patients within the facility.

(5) Anesthetic agents other than systemic analgesics and local anesthetics for pudendal blocks shall not be used.

(6) Drugs shall be administered only by personnel or clinical staff licensed to administer drugs.

(7) Drugs, medications, and chemicals kept anywhere in the center shall be handled pursuant to Chapters 465 and 499, F.S., and rules promulgated thereunder.

(8) Drugs, chemicals, and medications shall be stored and secured in specifically designated cabinets, closets, drawers, or storerooms and made accessible only to authorized persons pursuant to the provisions in Chapters 465 and 499, F.S., and rules promulgated thereunder.

(9) Poisonous chemicals, caustic materials, or drugs shall show appropriate warning or poison labels and shall be stored separately from other drugs. Drugs for external use shall be separated from drugs for internal use.

Rulemaking Authority 383.309 FS. Law Implemented 383.308, 383.309, 383.313, 383.335, 465, 499 FS. History–New 3-4-85, Formerly 10D-90.30, 10D-90.030, Amended 9-17-96,              .

 

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: 08/14/2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 06/19/2018