The Agency proposes to update an abortion clinic rule to align with recently revised statutory changes per Chapter 2018-24, Laws of Florida. Revisions will remove obsolete language and references related to the removal of the licensure requirement ...

 

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 update an abortion clinic rule to align with recently revised statutory changes per Chapter 2018-24, Laws of Florida. Revisions will remove obsolete language and references related to the removal of the licensure requirement for clinical laboratories.

SUMMARY: The removal of the licensure requirement for laboratories in abortion clinics.

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: 390.012(1) FS.

LAW IMPLEMENTED: 390.012(3)(d) 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: November 8, 2018, 9:30 a.m. – 11:00 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-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 shall comply with these patient care policies and procedures for patients undergoing second trimester abortions, to include 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, period of gestation, identification of any past surgeries, 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 period of gestation, 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. Urine or blood tests for pregnancy shall be performed before the abortion procedure.

(2) Laboratory Services.

(a) Laboratory services shall be provided onsite or through contractual 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 onsite 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 federal CLIA provisions of Chapter 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 onsite.

(4) Rh blood type D. Rh testing shall be performed on all patients, unless results of previous testing is available and documented in the medical record.

(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. Such documentation shall be retained on file at the clinic.

(8) A test for anemia shall be performed.

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

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(d) FS. History–New 9-25-06, Amended 1-2-14, 4-5-17,_________.

 

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: 10/03/2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 08/06/2018