The Agency proposes to revise rules related to abortion clinic standards and licensure.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-9.025Medical Screening and Evaluation of Patients Receiving Second Trimester Abortions

PURPOSE AND EFFECT: The Agency proposes to revise rules related to abortion clinic standards and licensure.

SUMMARY: The revisions will modify existing rules to: add language that all abortion clinics must comply with Section 390.0111, F.S., relating to termination of pregnancies; and strike language that conflicts with Section 390.012, F.S., which requires an ultrasound of patients before an abortion procedure is performed.

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.

Agency review of the proposed revisions determined the changes will reduce confusion and enhance compliance activity for regulated entities. 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: Agency review of the proposed revisions determined the changes will reduce confusion and enhance compliance activity for regulated entities. A SERC has not been prepared by the agency.

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: 390.012, 408.819 FS.

LAW IMPLEMENTED: 390.0111, 390.012(3)(d), 390.012(4), 390.013 FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: October 29, 2013, 10:00 a.m. – 11:00 a.m.

PLACE: The Agency for Health Care Administration, Building 3, Conference Room D, 2727 Mahan Drive, Tallahassee, Florida 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 1 days before the workshop/meeting by contacting: Kim Stewart, [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: Kim Stewart, [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-9.025 Medical Screening and Evaluation of Patients Receiving Second Trimester Abortions.

(1) Each abortion clinic that provides second trimester abortions shall formulate and adhere to written patient care policies and procedures designed to ensure professional and safe care for patients undergoing second trimester abortions and shall maintain a medical record for each such patient that records history, care and services. Any abortion clinic that performs second trimester abortions which is in operation at the time of adoption of this rule shall be given six months within which to comply with these patient care policies and procedures for patients undergoing second trimester abortions, to include but not limited to the following:

(a) Admission criteria and procedures;

(b) Identification in the medical record of physician(s) and nurse(s) involved in providing the services offered for patients undergoing second trimester abortions;

(c) Specific details regarding the pre-operative procedures performed, to include:

1. History and physical examination, to include verification of pregnancy, estimation of gestational age, identification of any preexisting conditions or complications; including allergies to medications, antiseptic solutions, or latex; and a complete obstetric and gynecological history.

2. Special examinations, lab procedures, and/or consultations required, to include ultrasonography to confirm gestational age and a physical examination including a bimanual examination estimating uterine size and palpation of the adnexa. The physician shall keep original prints of each ultrasound examination of a patient in the patient's medical history file. For an abortion in which an ultrasound examination is not performed before the abortion procedure, Uurine or blood tests for pregnancy shall be performed before the abortion procedure.

(2) Laboratory Services.

(a) Laboratory services shall be provided on-site or through arrangement with a laboratory that holds the appropriate federal Clinical Laboratory Improvement Amendments (CLIA) certificate and state of Florida clinical laboratory license issued pursuant to Chapter 483, Part I, F.S.

(b) All laboratory services provided on-site shall be performed in compliance with state of Florida clinical laboratory licensure and federal CLIA provisions.

(3) Laboratory Equipment and Supplies.

(a) All equipment and supplies for the collection, storage, and testing of specimens shall meet the provisions of Rule 59A-7 F.A.C., and shall be maintained according to manufacturer’s instructions and in a manner that ensures accurate test results.

(b) Temperature controlled spaces for the storage of specimens or testing supplies shall be monitored and recorded to ensure that the proper storage temperature is maintained.

(c) All dated supplies and materials shall not be used beyond their expiration date.

(d) Adequate facilities and supplies for the collection, storage and transportation of laboratory specimens shall be available on site.

(4) Rh factor. Rh testing for Rh negative patients shall be conducted, unless reliable written documentation of blood type is available.

(5) All laboratory test reports shall be placed in the patient’s medical record.

(6) All laboratory test and storage areas, records and reports shall be available for inspection by the agency.

(7) If a person who is not a physician performs an ultrasound examination, that person shall have documented evidence that he or she has completed a course in the operation of ultrasound equipment. The physician, registered nurse, licensed practical nurse, advanced registered nurse practitioner, or physician assistant shall, at the request of the patient and before the abortion procedure is performed, review the ultrasound evaluation results with the patient, including an estimate of the probable gestational age of the fetus.

(8) A test for anemia shall be performed.

(9) Each abortion clinic must be in compliance with Section 390.0111, F.S.

Rulemaking Specific Authority 390.012(1), 408.819 FS. Law Implemented 390.0111, 390.012(3)(d), 390.012(4), 390.013 FS. History–New 9-25-06, Amended__________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Kim Stewart, [phone]

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 6, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 20, 2013