AHCA Proposes Rule Revision on Ultrasound Requirements

Back in May, the Agency for Health Care Administration (AHCA) began the process of implementing changes to the rules on ultrasounds given prior to an abortion.  The ultrasound requirement–which provides the woman with the  right to decline to view and hear the ultrasound–was enacted in 2011 as an amendment to sections 390.0111 and 390.012, Florida Statutes.

Earlier this month, AHCA posted its proposed changes to the rule.  As expected, the proposed change to the rule clarifies that section 390.0111 applies and that the ultrasound requirement is non-discretionary for the abortion clinic.  The proposed language is reproduced below, with underlines and strikethroughs marking the changes from the existing rule:

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, (850)412-4302

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

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