The Agency proposes to update the abortion clinic rules to align with revised statutory requirements and streamline language for clarity.

 

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-9.027 Recovery 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

PURPOSE AND EFFECT: The Agency proposes to update the abortion clinic rules to align with revised statutory requirements and streamline language for clarity.

SUMMARY: The rule chapter for abortion clinics will be revised to remove obsolete or duplicative language, clarify requirements and revise text to comply with recent legislative changes. In addition the revision will update statutory references and required forms.

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.

For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC.

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: 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, 390.014(3), 408.033, 408.819, FS.

LAW IMPLEMENTED: 381.0098, 390.011, 390.0111, 390.012, 390.014, 390.015, 408.033, 408.805, 408.806, 408.809, 408.810, 408.811, 408.815, 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: Tuesday, November 29, 2016, 1:30 pm – 2:30 pm

PLACE: Agency for Health Care Administration, Conference Room D, 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-9.019 Definitions.

The following definitions shall apply specifically to abortion clinics.

(1) “Anesthesiologist” means a person currently licensed to practice medicine or osteopathy pursuant to Chapters 458 or 459, F.S., and certified by the American Board of Anesthesiology.

(2) “Certified Registered Nurse Anesthetist, (CRNA)” means a person currently licensed pursuant to Chapter 464, F.S., and certified by the Council on Certification of Nurse Anesthetists.

(1)(3) “Clinical staff” means the individuals employed full or part time by an abortion clinic who are licensed or certified to provide care prior to, during, or after an abortion.

(4) “F.A.C.” means the Florida Administrative Code.

(2)(5) “Facility” means those objects, including physical plant, equipment, and supplies necessary for providing required services.

(3)(6) “Licensed” means that person or facility to which the term is applied has a current or valid license, certificate or registration issued by the State of Florida to follow his profession or vocation within the State of Florida, and when applied to a health care facility means that the facility has a current license issued by the Aagency.

(7) “Licensure” means the process of obtaining official or legal permission to operate an abortion clinic.

(4)(8) “Medical Director” means a physician currently licensed to practice medicine or osteopathy pursuant to under Chapters 458 or 459, F.S., and who has admitting privileges at a licensed hospital in this state or has a transfer agreement with a licensed hospital licensed by the state located within reasonable proximity to of the abortion clinic.

(5)(9) “Patient” means any woman receiving services in an abortion clinic.

(6) “Period of gestation” means one of three trimesters as defined in Section 390.011, F.S. corresponding to the age of the fetus at the time of abortion.

(10) “Person” means any individual, firm, partnership, corporation, or association.

(7)(11) “Premises” means those buildings, beds, and facilities of the clinic and all other buildings, beds, and facilities for the performance of abortions located at in such reasonable proximity to the main address of the licensee and appear to the public to be under the domain and the control of the licensee.

(8)(12) “Reasonable proximity” means a distance not to exceed thirty (30) minutes transport time by emergency vehicle.

(13) “Registered Professional Nurse, (R.N.)” means a person currently licensed as a R.N. pursuant to Chapter 464, F.S.

(14) “Trimester” means a 12-week period of pregnancy.

(a) First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period).

(b) Second Trimester. That portion of a pregnancy following the 12th week and extending through the 24th week of gestation.

(c) Third Trimester. That portion of pregnancy beginning with the 25th week of gestation.

(9)(15) “Volunteer” means a person who is not employed by the clinic facility who interacts with patients on behalf of the abortion clinic.

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.

(1) All applicants persons requesting licensure for planning the operation of an abortion clinic under the provisions of Chapters 408 and 390, F.S., shall make application for a license to the Agency on the Health Care Licensing Application, Abortion Clinic, AHCA Form 3130-1000, July 2016 2014, which is incorporated by reference. The form can be obtained at https://www.flrules.org/Gateway/reference.asp?No=Ref-07596 https://www.flrules.org/Gateway/reference.asp?No=Ref-04819 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 Aagency website at: http://ahca.myflorida.com/HQAlicensureforms. Applicants for renewal of an abortion clinic license may submit the Health Care Licensing Online Application, Abortion Clinics, AHCA Form 3130-1000OL, July 2016, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-07597. The application forms are available online at http://www/ahca.myflorida.com/HQAlicensureforms or, for online renewal submissions, at: http://apps.ahca.myflorida.com/SingleSignOnPortal.

(2) A licensure fee as listed on the application of $545.05 shall accompany each the application for a license or a license renewal. The licensure fee shall be made payable to the Aagency and is not refundable. The licensure fee will be established as prescribed by Sections 408.805 and 390.014, F.S.

(3) Each license shall be valid only for the persons or entity to whom it is issued and shall not be subject to sale, assignment, or other transfer, voluntary or involuntary, nor shall a license be valid for any premises other than for which it was orginally issued.

(3)(4) A current license shall be posted in a conspicuous place within the licensed premises where it can be viewed by patients.

(4)(5) A license, unless sooner suspended or revoked, shall automatically expire two years from the date of issuance, and shall be renewable biennially upon application for renewal and payment of the fee prescribed by the application these rules, provided that the applicant and abortion clinic meet the requirements established under Chapters 408 and 390, F.S. and Chapters 59A-35 and 59A-9, F.A.C. Application for renewal of a license shall be made not less than 60 days prior to expiration of a license.

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) The Aagency has the right to enter upon the premises of any an abortion clinic or applicant to make or cause to be made such inspections and investigations as are necessary to:

(a) Assure compliance with the licensure requirements and standards as specified in statute and rule;

(b) Respond to complaints; and, investigate allegations of unlicensed activity;

(c) Protect the public health and safety.

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

(3) Representatives of the Aagency shall conduct licensure inspections have the right to enter upon the premises of any facility licensed, or applying for license, pursuant to this chapter, at any reasonable time in order to determine the state of compliance with the provisions of Chapters 408 and 390, F.S. and Chapters 59A-35 and 59A-9, F.A.C., providing that such entry and inspection shall be made 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. All inspections shall be unannounced.

Rulemaking Authority 390.012, 408.819 FS. Law Implemented 390.012, 390.014, 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. These requirements shall apply to all new abortion clinic construction and shall apply to any abortion clinics receiving an initial license after the effective date of these rules when the abortion clinic provides second trimester abortions. Any abortion clinic which provides second trimester abortions and is in operation at the time of adoption of this rule shall be given one year within which to comply with the physical plant requirements.

(1) Consultation room(s) with adequate private space specifically designated for interviewing, counseling, and medical evaluations;

(2) Dressing rooms designated for staff and patients;

(3) Handwashing station(s) equipped with a mixing valve and wrist blades and located in each patient exam/procedure room or area;

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

(5) Post procedure recovery room(s) equipped to meet the patient’s needs;

(6) Emergency exits wide enough to accommodate a standard stretcher or gurney;

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

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

(9) If not otherwise required by the Florida Building Code, at least one general use toilet room equipped with a hand washing station.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(a), 390.013 FS. History–New 9-25-06, Amended,__________.

 

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

(1) Each abortion clinic providing second trimester abortions shall provide essential clinic supplies and equipment as required in subsections (1) through (7) when performing second trimester abortions. Any such abortion clinic which is in operation at the time of adoption of this rule and providing second trimester abortions shall be given one year within which to meet these standards as follows:

(1) The following equipment shall be maintained in functional condition:

(a) A surgical or gynecological examination table(s);

(b) A bed or recliner(s) suitable for recovery;

(c) Oxygen with flow meters and masks or equivalent;

(d) Mechanical suction;

(e) Resuscitation equipment to include, at a minimum, resuscitation bags and oral airways;

(f) Emergency medications, intravenous fluids, and related supplies and equipment;

(g) Sterile suturing equipment and supplies;

(h) Adjustable examination light;

(i) Containers for soiled linen and waste materials with covers; and,;

(j) Appropriate equipment for the administering of general anesthesia, if applicable.

(2) Emergency equipment shall be provided for immediate use, maintained in functional condition, and capable of providing at least the following services:

(a) Inhalation therapy;

(b) Defibrillation;

(c) Cardiac monitoring;

(d) Suctioning; and,

(e) Maintenance of patient airway.

(3) Anesthesia.

(a) The clinic shall have anesthesia equipment maintained in proper working order for the appropriate administering of general and local anesthesia, analgesia, and sedation if ordered by the physician.

(b) All reusable anesthesia equipment in direct contact with the patient shall be cleaned or sterilized as appropriate after each use and such cleaning and sterilization shall be documented.

(4) Resuscitative Medications Required.

The clinic shall have a crash cart at the location the anesthetizing is being carried out. The crash cart must include, at a minimum, those emergency medications to support the procedures performed as determined by the medical director.

(5) Sterilization Equipment.

Sterilizing equipment of appropriate type shall be available and of adequate capacity shall be available to properly sterilize instruments and materials. The sterilizing equipment shall have approved control and safety features.

(6) Ultrasound equipment shall be located in the clinic.

(7) Equipment Maintenance.

(a) When patient monitoring equipment is utilized, a written preventive maintenance program shall be developed and implemented. This equipment shall be checked and/or tested in accordance with manufacturer’s specifications at periodic intervals, not less than annually, to insure proper operation, and a state of good repair. After repairs and/or alterations are made to any equipment, the equipment shall be thoroughly tested for proper calibration before returning it to service. Records shall be maintained on each piece of equipment to indicate its history of testing and maintenance.

(b) All anesthesia and surgical equipment shall have a written preventive maintenance program developed and implemented. Equipment shall be checked and tested in accordance with the manufacturer’s specifications at designated intervals, not less than annually, to ensure proper operation and a state of good repair.

(c) All surgical instruments shall have a written preventive maintenance program developed and implemented. Surgical instruments shall be cleaned and checked for function after use to ensure proper operation and a state of good repair.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(b), 390.013 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 to the clinic 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. Any abortion clinic which is in operation at the time of adoption of this rule and performing second trimester abortions shall be given six months within which to comply with these clinical staff requirements as follows:

(1) Physicians.

The clinic shall designate a licensed physician to serve as a medical director. Only physicians authorized by the medical director and the clinic shall perform abortions.

(2) Nursing Personnel.

Nursing personnel in the clinic shall be governed by written policies and procedures relating to patient care, establishment of standards for nursing care and mechanisms for evaluating such care, and nursing services.

(3) Allied health professionals, working under appropriate direction and supervision, may be employed to work only within areas where their competency has been established.

(4) Orientation. Each clinic facility shall have and execute a written orientation program to familiarize each new staff member, including volunteers, with the clinic facility and its policies and procedures, to include, at a minimum, fire safety and other safety measures, medical emergencies, and infection control.

(5) In-service Training. In-service training programs shall be planned and provided for all employees including full time, part time and contract employees, at the beginning of employment and no less than at least annually thereafter and will also apply to all volunteers to insure and maintain their understanding of their duties and responsibilities. Records shall be maintained to reflect program content and individual attendance. The following training shall be provided no less than at least annually, and for surgical assistants and volunteers, must include training in counseling, patient advocacy and specific responsibilities associated with the services they provide:

(a) Infection control, to include at a minimum, universal precautions against blood-borne diseases, general sanitation, personal hygiene such as hand washing, use of masks and gloves, and instruction to staff if there is a likelihood of transmitting a disease to patients or other staff members.

(b) Fire protection, to include evacuating patients, proper use of fire extinguishers, and procedures for reporting fires;

(c) Confidentiality of patient information and records, and protecting patient rights;

(d) Licensing regulations; and,

(e) Incident reporting.

Rulemaking Authority 390.012, 408.819 FS. Law Implemented 381.0012, 382, 390.011, 390.0111(2), 390.012, 390.013 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.

An abortion clinic providing second trimester abortions shall have written policies and procedures to implement policies and to assure that quality patient care shall relate specifically to the functional activities of clinic services. These written procedures shall apply to second trimester abortions and shall be available and accessible to clinic personnel and shall be reviewed and approved annually by the clinic’s medical director. Any abortion clinic which is in operation at the time of adoption of this rule and providing second trimester abortions shall be given six months within which to comply with these clinic policies and procedure requirements which These policies and procedures shall include but not be limited to the following:

(1) Patient admission;

(2) Pre- and post-operative care;

(3) Physician’s orders;

(4) Standing orders with required signatures;

(5) Medications, storage and administration;

(6) Treatments;

(7) Surgical asepsis;

(8) Medial asepsis;

(9) Sterilization and disinfection;

(10) Documentation: Medical records and clinic facility records;

(11) Patient discharge;

(12) Patient transfer;

(13) Emergency measures;

(14) Incident reports;

(15) Personnel orientation;

(16) Inservice education record;

(17) Anesthesia;

(18) Equipment and supplies: availability and maintenance;

(19) Volunteers; and,

(20) Visitors.

Rulemaking Authority 390.012(1), FS. Law Implemented 390.012(3)(c), 390.013 FS. History–New 9-25-06, Amended,________.

 

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 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, period of gestation estimation of gestational age, 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, 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. Urine 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 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 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 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 on site.

(4) Rh blood type D factor. Rh testing shall be performed on all patients 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 Aagency.

(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.

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

 

59A-9.026 Second Trimester Abortion Procedure.

Any abortion clinic which is providing second trimester abortions must be in compliance with the following standards relative to second trimester abortion procedures. Any abortion clinic in operation at the time of adoption of this rule, when performing second trimester abortions, shall be given six months within which to comply.

(1) A physician, registered nurse, licensed practical nurse, advanced registered nurse practitioner, or physician assistant shall be available to all patients throughout the abortion procedure.

(2) The abortion procedure will be performed in accordance with obstetric standards and in keeping with established standards of care regarding the estimation of the period of gestation gestational age of the fetus.

(3) Anesthesia service shall be organized under written policies and procedures relating to anesthesia staff privileges, the administration of anesthesia, and the maintenance of strict safety controls.

(4) Prior to the administration of anesthesia, patients shall have a history and physical examination by the individual administering anesthesia, including laboratory analysis when indicated.

(5) Appropriate precautions, such as the establishment of intravenous access at least for patients undergoing post-first trimester abortions.

(6) Appropriate monitoring of the patient’s vital signs by professionals licensed and qualified to assess the patient’s condition will occur throughout the abortion procedure and during the recovery period until the patient’s condition as specified by the type of abortion procedure performed, is deemed to be stable in the recovery room.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(e), 390.013 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. Any abortion clinic providing second trimester abortions and in operation at the time of adoption of this rule shall be given one year within which to comply with these standards.

(1) Following the procedure, post procedure recovery rooms will be supervised and staffed to meet the patient’s needs. A physician or physician assistant, a licensed registered nurse, a licensed practical nurse or an advanced registered nurse practitioner who is trained in the management of the recovery area shall be available to monitor the patient in the recovery room until the patient is discharged. The individual must be certified in basic cardiopulmonary resuscitation. A patient in the post-operative or recovery room shall be observed for as long as the patient’s condition warrants.

(2) The clinic shall arrange hospitalization if any complication beyond the medical capability of the staff occurs or is suspected. The clinic shall ensure that all appropriate equipment and services are readily accessible to provide appropriate emergency resuscitative and life support procedures pending the transfer of the patient or a viable fetus to the hospital. A physician shall sign the discharge order and be readily accessible and available until the last patient is discharged to facilitate the transfer of emergency cases if hospitalization of the patient or viable fetus is necessary. The clinic medical records documenting care provided shall accompany the patient. These records will include the contact information for the physician who performed the procedure at the clinic.

(3) A physician shall discuss Rh Rho (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 Rh Rho (D) immune globulin, refusal shall be documented on Form 3130-1002, January 2006, “Refusal to Permit Administration of Rh(D) Immunoglobulin”, AHCA Form 3130-1002, July 2016 which is herein 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. The form can be obtained by written request from the Agency for Health Care Administration, Hospital and Outpatient Services Unit, Mail Stop #31, 2727 Mahan Drive, Tallahassee, Florida 32308, or from the agency website at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/abortion.shtml.

(4) Written instructions with regard to post abortion coitus, signs of possible medical complications, and general aftercare shall be given to each patient. Each patient shall have specific written instructions regarding access to medical care for complications, including a telephone number to call for medical emergencies. The physician will ensure that either a registered nurse, licensed practical nurse, advanced registered nurse practitioner, or physician assistant from the abortion clinic makes a good faith effort to contact the patient by telephone, with the patient’s consent, within 24 hours after surgery to assess the patient's recovery. A contact for post-operative care from the clinic facility shall be available to the patient on a 24-hour basis.

(5) Clinic Facility procedures must specify the minimum length of time for recovery as warranted by the procedure type and gestation period of gestation.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(f), 390.013 FS. History–New 9-25-06, Amended,___________.

 

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

Each abortion clinic which is providing second trimester abortions shall comply with the following post procedure follow-up care requirements when providing a second trimester abortion. Any abortion clinic operating at the time of adoption of this rule shall be given six months within which to comply.

(1) The clinic shall offer a post abortion medical visit that includes a medical examination and a review of the results of all laboratory tests.

(2) A urine pregnancy test will be obtained at the time of the follow-up visit to rule out continuing pregnancy. If a continuing pregnancy is suspected, the patient shall be evaluated and a physician who performs abortions shall be consulted.

(3) The clinic shall provide for the education of the patient in post-procedure care, including specific instructions in case of emergency.

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(g), 390.013 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. Those abortion clinics providing second trimester abortions which are in operation at the time of adoption of this rule shall be given six months within which to comply with the following clinic incident reporting requirements.

(1) At a minimum Aan 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 as defined in Section 390.012(3)(h)1., F.S., or a viable fetus. at an abortion clinic and shall report an incident in writing to the agency within 10 days after the incident occurs. 

(1) Each incident must be reported to the Agency within 10 days after the incident occurs.

(2) The report must be submitted on the 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.

(2) 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), 390.013 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) Storage of Fetal remains at a clinic shall:

(a) Not exceed 30 days;

(b) Be in an interior restricted access location of the clinic; and

(c) Be packaged and sealed in impermiable, red plastic bags or sharps container.

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

(a) The name and address of the clinic;

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

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

Rulemaking Authority 390.012 FS. Law Implemented 381.0012, 382, 381.0098, 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.

(1) A permanent individual clinical record shall be kept on each clinic patient. Clinical records shall be complete, accurately documented, and systematically organized to facilitate storage and retrieval.

(a) Clinical records shall contain a printed image of the ultrasound used to determine the period of gestation. be complete, accurately documented, and systematically organized to facilitate storage and retrieval.

(b) Clinical records involving second trimester abortion procedures shall be kept confidential and secure.

(c) Operative reports signed by the physician performing the second trimester abortion shall be recorded in the clinical record immediately following the procedure or that an operative progress note is entered in the clinical record to provide pertinent information.

(2) Clinical records shall be kept on file for a minimum of five years from the date of the last entry.

Rulemaking Authority 390.012 FS. Law Implemented 381.0012, 382, 390.011, 390.012, 390.013 FS. History–New 6-13-90, Amended 4-17-91, Formerly 10D-72.031, Amended 9-25-06, ______.

 

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: September 29, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 27, 2016