Definitions, Licensure Procedures, Investigations and License and Validation Inspections, Physical Plant Requirements for Abortion Clinics When Providing Second Trimester Abortions, Clinic Supplies and Equipment Standards for Second Trimester ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-9.019Definitions

59A-9.020Licensure Procedures

59A-9.021Investigations and License and Validation Inspections

59A-9.022Physical Plant Requirements for Abortion Clinics When Providing Second Trimester Abortions

59A-9.0225Clinic Supplies and Equipment Standards for Second Trimester Abortions

59A-9.023Clinical Personnel

59A-9.024Clinic Policies and Procedures for Second Trimester Abortions

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

59A-9.026Second Trimester Abortion Procedure

59A-9.027Recovery Room Standards for Second Trimester Abortions

59A-9.028Post Procedure Follow-up Care for Patients Receiving Second Trimester Abortions

59A-9.029Abortion Clinic Incident Reporting for Second Trimester Abortions

59A-9.030Disposal of Fetal Remains

59A-9.031Clinical Records

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 42 No. 216, November 4, 2016 issue of the Florida Administrative Register.

On the Abortion Clinic Incident Report Form, AHCA Form 3130-1003, July 2016, the following changes have been made: the request for patient identifier in section 2 and the provider examples in section 3.C. have been removed.

 

On the Refusal to Permit Administration of Rh(D) Immunoglobulin, AHCA Form 3130-1002, July 2016, the following change will be made: all references to Rh(D) immunoglobulin will be changed to Rho(D) immune globulin.

 

The following sections of the proposed rule will be changed to read:

 

59A-9.019 Definitions.

No change.

Rulemaking Authority 390.012 FS. Law Implemented 390.011, 390.012 FS. History–New 6-13-90, Amended 4-17-91, Formerly 10D-72.019, Amended 8-24-94, 9-25-06, 1-6-15, ___________.

 

59A-9.020 Licensure Procedures.

No change.

Rulemaking Authority 390.012, 390.014(3), 408.033, 408.819 FS. Law Implemented 390.012, 390.014, 390.015, 408.033, 408.805, 408.806, 408.809, 408.810, 408.815 FS. History–New 6-13-90, Amended 4-17-91, 10-9-91, Formerly 10D-72.020, Amended 8-24-94, 9-25-06, 1-6-15, ___________.

 

59A-9.021 Investigations and License and Validation Inspections.

(1) No change.

(2) The Agency shall conduct an unannounced licensure inspection of all abortion clinics.

(2)(3) Representatives of the Agency shall conduct licensure inspections with the least possible disruption to clinic activities and in a manner considerate of the privacy and confidentiality of any patient who is present therein.

Rulemaking Authority 390.012, 408.819 FS. Law Implemented 390.012, 408.811 FS. History–New 6-13-90, Amended 4-17-91, 10-9-91, Formerly 10D-72.021, Amended 9-25-06, 1-6-15, _________.

 

59A-9.022 Physical Plant Requirements for Abortion Clinics When Providing Second Trimester Abortions.

The following are minimum standards of construction and specified minimum essential physical plant requirements which must be met when providing second trimester abortions.

(1) through (3) No change.

(4) Private procedure room(s) with adequate light and ventilation for abortion procedures;

(5) through (6) No change.

(7) Cleaning and sterilizing area(s) adequate for the cleaning and sterilizing of instruments;

(8) Adequate and Ssecure storage area(s) for the storage of medical records and necessary equipment and supplies; and,

(9) No change.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(a) FS. History–New 9-25-06, Amended _________.

 

59A-9.0225 Clinic Supplies and Equipment Standards for Second Trimester Abortions.

No change.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(b) FS. History–New 9-25-06, Amended _______.

 

59A-9.023 Clinic Personnel.

Abortions shall be performed only by a licensed physician who has admitting privileges at a hospital within reasonable proximity to the clinic. Physician admitting privileges are optional if the clinic has a written transfer agreement with a hospital within reasonable proximity. At the time of transfer to the clinic shall provide to the receiving hospital a copy of the patient’s medical records related to the pregnancy being terminated. specifying the patient’s complete medical record held by the clinic and physician shall accompany any patient transferred to the hospital. Each abortion clinic providing second trimester abortions shall have a staff that is adequately trained and capable of providing appropriate service and supervision to the patients. The clinic will have a position description for each position delineating duties and responsibilities and maintain personnel records for all employees performing or monitoring patients receiving a second trimester abortion.

(1) through (5) No change.

Rulemaking Authority 390.012 FS. Law Implemented 390.0111(2), 390.012 FS. History–New 6-13-90, Amended 4-17-91, Formerly10D-72.023, Amended 9-25-06, ____________.

 

59A-9.024 Clinic Policies and Procedures for Second Trimester Abortions.

No change.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012 FS. History–New 9-25-06, Amended _______.

 

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

(1) through (3) No change.

(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 reliable written documentation of blood type is available.

(5) through (6) No change.

(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) No change.

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

Rulemaking Authority 390.012(1) FS. Law Implemented 390.0111, 390.012(3)(d) FS. History–New 9-25-06, Amended 1-2-14, __________.

 

59A-9.026 Second Trimester Abortion Procedure.

No change.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(e) FS. History–New 9-25-06, Amended ____________.

 

59A-9.027 Recovery Room Standards for Second Trimester Abortions.

Each abortion clinic which is providing second trimester abortions shall comply with the following recovery room standards when providing second trimester abortions.

(1) through (2) No change.

(3) A physician shall discuss Rho Rh(D) immune globulin with each patient for whom it is indicated and will ensure that it is offered to the patient in the immediate postoperative period or that it will be available to the patient within 72 hours following completion of the abortion procedure. If the patient refuses the Rho Rh(D) immune globulin, refusal shall be documented on Refusal to Permit Administration of Rho Rh(D) Immune Globulin Immunoglobulin, AHCA Form 3130-1002, July 2016 which is incorporated by reference. The form can be obtained at https://www.flrules.org/Gateway/reference.asp?No=Ref-07598 and from the Agency for Health Care Administration, Hospital and Outpatient Services Unit, Mail Stop #31, 2727 Mahan Drive, Tallahassee, Florida 32308 or on the Agency website at: http://ahca.myflorida.com/HQAlicensureforms. The form shall be signed by the patient, physician, and a witness, and shall be included in the patient’s medical record.

(4) through (5) No change.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(f) FS. History–New 9-25-06, Amended _________.

 

59A-9.028 Post Procedure Follow-up Care for Patients Receiving Second Trimester Abortions.

No change.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(g) FS. History–New 9-25-06, Amended _________.

 

59A-9.029 Abortion Clinic Incident Reporting for Second Trimester Abortions.

This section shall apply to incidents involving patients receiving second trimester abortions in any abortion clinic providing second trimester abortions. An abortion clinic shall maintain a record of each incident that results in serious injury as defined in Section 390.012(3)(h)1., F.S. to a patient or a viable fetus.

(1) No change.

(2) The report must be submitted on the Abortion Clinic Incident Report Form, AHCA Form 3130-1003, July 2016, which is hereby incorporated by reference. The form can be obtained at https://www.flrules.org/Gateway/reference.asp?No=Ref-07599 and from the Agency for Health Care Administration, Hospital and Outpatient Services Unit, Mail Stop #31, 2727 Mahan Drive, Tallahassee, Florida 32308 or on the Agency website at: http://ahca.myflorida.com/HQAlicensureforms.

(3) If a patient death occurs the abortion clinic shall report the death to the Department and the appropriate regulatory board not later than the next workday. The report to the Department shall be filed as required by Rule 64V-1.0061, F.A.C.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(h) FS. History–New 9-25-06, Amended _________.

 

59A-9.030 Disposal of Fetal Remains.

Fetal remains shall be disposed of in a sanitary and appropriate manner and in accordance with standard health practices and Chapters 381 and 390, F.S. and Chapter 64E-16, F.A.C.

(1) No change.

(2) Packages or containers of fetal remains shall be labeled to include:

(a) No change.

(b) Medical record number or other identifier of the patient;

(b)(c) One of the following phrases: Biomedical Waste, Biohazardous Waste, Biohazard, Infectious Waste or Infectious Substance;.

Rulemaking Authority 390.012 FS. Law Implemented 381.0098, 390.0111 390.011, 390.012 FS. History–New 6-13-90, Amended 4-17-91, Formerly 10D-72.030, Amended 9-25-06, ____________.

 

59A-9.031 Clinical Records.

No change.

Rulemaking Authority 390.012 FS. Law Implemented 390.012 FS. History–New 6-13-90, Amended 4-17-91, Formerly 10D-72.031, Amended 9-25-06, _________.