The Agency is proposing to amend Rule 59A-11.009, F.A.C., Risk Status Criteria for the Acceptance of Clients and Continuation of Care, to update language to allow for additional health care practitioners to operate within their scope of practice in ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

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

59A-11.012Prenatal Care

PURPOSE AND EFFECT: The Agency is proposing to amend Rule 59A-11.009, F.A.C., Risk Status Criteria for the Acceptance of Clients and Continuation of Care, to update language to allow for additional health care practitioners to operate within their scope of practice in a birth center setting and remove outdated language. Proposed amendments to Rule 59A-11.012, F.A.C. will update statutory references, remove language outside the Agency’s authority and remove an outdated form.

SUMMARY: Rule 59A-11.009, F.A.C., outlines the risk criteria that must be evaluated before a woman can deliver in a birth center. The proposed change will update language to better align with Rule 64B24-7.004, F.A.C., Risk Assessment, and allow an additional health care practitioner to operate within his or her scope of practice. In addition, the Agency will remove outdated language. 59A-11.012 outlines requirements of prenatal care. The proposed changes will update statutory references, remove language outside the Agency’s authority and remove an outdated form.

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: 383.309 FS.

LAW IMPLEMENTED: 383.309, 383.31, 383.312, 383.313, 383.335 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: Friday, October 14, 2016, 9:30 a.m. – 10:00 a.m.

PLACE: Agency for Health Care Administration, Conference Room C, 2727 Mahan Drive, Building #3, Tallahassee, FL 32308

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 3 days before the workshop/meeting by contacting: Jessica Munn, 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-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 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. An exception to this rule is permissible for all centers which are participating in the Vaginal Birth after a Caesarean (VBAC) Section study sponsored by the National Association of Childbearing Centers. Centers planning to participate in this study should notify the State Health Office. Every VBAC candidate shall be evaluated and approved for a birth center delivery by an obstetrician or physician with hospital obstetrical privileges. This evaluation and approval shall be documented in the client’s record;

3. Seven or more term pregnancies;

4. Previous placenta abruptio.

(d) Significant signs or symptoms of:

1. Hypertension;

2. Toxemia;

3. Poly or oligo hydramnios;

4. Abruptio placenta;

5. Chorioamnionitis;

6. Malformed fetus;

7. Multiple gestation;

8. Intrauterine growth retardation;

9. Fetal distress;

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 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.

 

59A-11.012 Prenatal Care.

(1) Initial Visit shall include:

(a) A comprehensive health history shall be completed which includes medical, emotional, dietary, and obstetrical data including a pre-term delivery risk assessment.

(b) A physical examination shall be completed by a physician, or certified nurse midwife or advanced registered nurse practitioner, or licensed midwife, which includes measurement of height and weight, vital signs including blood pressure and examination of the skin, head and neck, heart and lungs, breasts, abdomen, pelvis and neurologic reactions.

(c) The following tests are required:

1. Hemoglobin or hematocrit, urinalysis by dipstick for protein, sugar, and ketones; serological test for syphilis; cervical cytology, and Rh determination and blood type. Results of a cervical cytology done within one year is acceptable. The hemoglobin test and urinalysis may be performed by a clinical staff member or qualified personnel.

(2) Return visits shall include at a minimum:

(a) Measurements of the weight, blood pressure, fundal height, and fetal heart rate when applicable;

(b) Urinalysis by dipstick for protein and sugar;

(c) Hemoglobin or hematocrit should be repeated at least twice and more often if indicated during the course of the pregnancy;

(d) Review of signs and symptoms of complications of pregnancy and risk status; and,

(e) Examination to determine the estimated weeks of gestation, fetal position and presentation.

(3) Return prenatal visits shall be scheduled at least every four weeks until the 32nd week, every two weeks until the 36th week and then every week until delivery unless the client’s condition requires more frequent visits.

(4) A Pprenatal delivery risk assessment shall be determined and documented on a “Prenatal Risk Assessment Form”, HRS-H Form 3123, May 92, which is incorporated herein by reference and is provided by the AHCA, Office of Health Facility Regulation, Tallahassee, Florida. The request for social security number disclosure is for the purpose of data analysis and is voluntary; refusal to provide this information will not result in denial of services. The assessment shall be performed during the initial visit and repeated at 28 weeks gestation.

(5) All patients shall receive specific instruction regarding pre-term labor including the potential hazards, preventive measures, symptoms, detection and timing of contractions, and the need for prompt notification of the health provider.

(6) All clients found to be at high obstetrical risk pursuant to criteria described in Rule 59A-11.009, F.A.C., shall be referred to a qualified physician for continued care.

(7) The Healthy Start Prenatal Screening Instrument, as described in Rule 64C-7.009, F.A.C., must be offered as specified to each pregnant woman at the first prenatal contact.

Rulemaking Authority 383.309 FS. Law Implemented 20.42(2)(a), 383.312, 383.313, 383.14 FS. History–New 3-4-85, Formerly 10D-90.12, 10D-90.012, Amended 9-27-94, 9-17-96, _______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jessica Munn

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 8/25/2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 5/25/2016