65-4a09. Rules and regulations; secretary of health and environment. (a) The secretary shall adopt rules and regulations for the licensure of facilities for the performance of abortions.

(b) The secretary shall adopt rules and regulations concerning sanitation, housekeeping, maintenance, staff qualifications, emergency equipment and procedures to provide emergency care, medical records and reporting, laboratory, procedure and recovery rooms, physical plant, quality assurance, infection control, information on and access to patient follow-up care and any other areas of medical practice necessary to carry out the purposes of K.S.A. 65-4a01 through 65-4a12, and amendments thereto, for facilities for the performance of abortions. At a minimum these rules and regulations shall prescribe standards for:

(1) Adequate private space that is specifically designated for interviewing, counseling and medical evaluations;

(2) dressing rooms for staff and patients;

(3) appropriate lavatory areas;

(4) areas for preprocedure hand washing;

(5) private procedure rooms;

(6) adequate lighting and ventilation for abortion procedures;

(7) surgical or gynecologic examination tables and other fixed equipment;

(8) postprocedure recovery rooms that are supervised, staffed and equipped to meet the patients' needs;

(9) emergency exits to accommodate a stretcher or gurney;

(10) areas for cleaning and sterilizing instruments; and

(11) adequate areas for the secure storage of medical records and necessary equipment and supplies.

(c) The secretary shall adopt rules and regulations to prescribe facility supplies and equipment standards, including supplies and equipment, that are required to be immediately available for use or in an emergency. At a minimum these rules and regulations shall:

(1) Prescribe required equipment and supplies, including medications, required for the conduct, in an appropriate fashion, of any abortion procedure that the medical staff of the facility anticipates performing and for monitoring the progress of each patient throughout the procedure and recovery period;

(2) require that the number or amount of equipment and supplies at the facility is adequate at all times to assure sufficient quantities of clean and sterilized durable equipment and supplies to meet the needs of each patient;

(3) prescribe required equipment, supplies and medications that shall be available and ready for immediate use in an emergency and requirements for written protocols and procedures to be followed by staff in an emergency, such as the loss of electrical power;

(4) prescribe required equipment and supplies for required laboratory tests and requirements for protocols to calibrate and maintain laboratory equipment at the facility or operated by facility staff;

(5) require ultrasound equipment in facilities; and

(6) require that all equipment is safe for the patient and the staff, meets applicable federal standards and is checked annually to ensure safety and appropriate calibration.

(d) The secretary shall adopt rules and regulations relating to facility personnel. At a minimum these rules and regulations shall require that:

(1) The facility designate a medical director of the facility who is licensed to practice medicine and surgery in Kansas;

(2) physicians performing surgery in a facility are licensed to practice medicine and surgery in Kansas, demonstrate competence in the procedure involved and are acceptable to the medical director of the facility;

(3) a physician with admitting privileges at an accredited hospital located within 30 miles of the facility is available;

(4) another individual is present in the room during a pelvic examination or during the abortion procedure and if the physician is male then the other individual shall be female;

(5) a registered nurse, nurse practitioner, licensed practical nurse or physician assistant is present and remains at the facility when abortions are performed to provide postoperative monitoring and care until each patient who had an abortion that day is discharged;

(6) surgical assistants receive training in the specific responsibilities of the services the surgical assistants provide; and

(7) volunteers receive training in the specific responsibilities of the services the volunteers provide, including counseling and patient advocacy as provided in the rules and regulations adopted by the director for different types of volunteers based on their responsibilities.

(e) The secretary shall adopt rules and regulations relating to the medical screening and evaluation of each facility patient. At a minimum these rules and regulations shall require:

(1) A medical history including the following:

(A) Reported allergies to medications, antiseptic solutions or latex;

(B) obstetric and gynecologic history; and

(C) past surgeries;

(2) a physical examination including a bimanual examination estimating uterine size and palpation of the adnexa;

(3) the appropriate laboratory tests including:

(A) For an abortion in which an ultrasound examination is not performed before the abortion procedure, urine or blood tests for pregnancy performed before the abortion procedure;

(B) a test for anemia as indicated;

(C) Rh typing, unless reliable written documentation of blood type is available; and

(D) other tests as indicated from the physical examination;

(4) an ultrasound evaluation for all patients who elect to have an abortion of an unborn child. The rules shall require that if a person who is not a physician performs an ultrasound examination, that person shall have documented evidence that the person completed a course in the operation of ultrasound equipment as prescribed in rules and regulations. The physician or other health care professional shall review, at the request of the patient, the ultrasound evaluation results with the patient before the abortion procedure is performed, including the probable gestational age of the unborn child; and

(5) that the physician is responsible for estimating the gestational age of the unborn child based on the ultrasound examination and obstetric standards in keeping with established standards of care regarding the estimation of fetal age as defined in rules and regulations and shall verify the estimate in the patient’s medical history. The physician shall keep original prints of each ultrasound examination of a patient in the patient’s medical history file.

(f) The secretary shall adopt rules and regulations relating to the abortion procedure. At a minimum these rules and regulations shall require:

(1) That medical personnel is available to all patients throughout the abortion procedure;

(2) standards for the safe conduct of abortion procedures that conform to obstetric standards in keeping with established standards of care regarding the estimation of fetal age as defined in rules and regulations;

(3) appropriate use of local anesthesia, analgesia and sedation if ordered by the physician;

(4) the use of appropriate precautions, such as the establishment of intravenous access at least for patients undergoing second or third trimester abortions; and

(5) the use of appropriate monitoring of the vital signs and other defined signs and markers of the patient’s status throughout the abortion procedure and during the recovery period until the patient’s condition is deemed to be stable in the recovery room.

(g) The secretary shall adopt rules and regulations that prescribe minimum recovery room standards. At a minimum these rules and regulations shall require that:

(1) Immediate postprocedure care consists of observation in a supervised recovery room for as long as the patient’s condition warrants;

(2) the facility arrange hospitalization if any complication beyond the management capability of the staff occurs or is suspected;

(3) a licensed health professional who is trained in the management of the recovery area and is capable of providing basic cardiopulmonary resuscitation and related emergency procedures remains on the premises of the facility until all patients are discharged;

(4) a physician or a nurse who is advanced cardiovascular life support certified shall remain on the premises of the facility until all patients are discharged and to facilitate the transfer of emergency cases if hospitalization of the patient or viable unborn child is necessary. A physician or nurse shall be readily accessible and available until the last patient is discharged;

(5) a physician or trained staff member discusses Rho(d) immune globulin with each patient for whom it is indicated and assures it is offered to the patient in the immediate postoperative period or that it will be available to her within 72 hours after completion of the abortion procedure. If the patient refuses, a refusal form approved by the department shall be signed by the patient and a witness and included in the medical record;

(6) written instructions with regard to postabortion coitus, signs of possible problems and general aftercare are given to each patient. Each patient shall have specific instructions regarding access to medical care for complications, including a telephone number to call for medical emergencies;

(7) there is a specified minimum length of time that a patient remains in the recovery room by type of abortion procedure and gestational age of the unborn child;

(8) the physician assures that a licensed health professional from the facility 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; and

(9) equipment and services are located in the recovery room to provide appropriate emergency resuscitative and life support procedures pending the transfer of the patient or viable unborn child to the hospital.

(h) The secretary shall adopt rules and regulations that prescribe standards for follow-up visits. At a minimum these rules and regulations shall require that:

(1) A postabortion medical visit is offered and scheduled within four weeks after the abortion, if accepted by the patient, including a medical examination and a review of the results of all laboratory tests;

(2) a urine pregnancy test is 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 or induces abortions shall be consulted; and

(3) the physician performing or inducing the abortion, or a person acting on behalf of the physician performing or inducing the abortion, shall make all reasonable efforts to ensure that the patient returns for a subsequent examination so that the physician can assess the patient's medical condition. A brief description of the efforts made to comply with this [these] requirements, including the date, time and identification by name of the person making such efforts, shall be included in the patient's medical record.

(i) The secretary shall adopt rules and regulations to prescribe minimum facility incident reporting. At a minimum these rules and regulations shall require that:

(1) The facility records each incident resulting in a patient’s or viable unborn child's serious injury occurring at a facility and shall report them in writing to the department within 10 days after the incident. For the purposes of this paragraph, ‘‘serious injury’’ means an injury that occurs at a facility and that creates a serious risk of substantial impairment of a major body organ;

(2) if a patient’s death occurs, other than an unborn child's death properly reported pursuant to law, the facility shall report such death to the department of health and environment not later than the next department business day; and

(3) incident reports are filed with the department of health and environment and appropriate professional regulatory boards.

(j) (1) The secretary shall adopt rules and regulations requiring each facility to establish and maintain an internal risk management program which, at a minimum, shall consist of:

(A) A system for investigation and analysis of the frequency and causes of reportable incidents within the facility;

(B) measures to minimize the occurrence of reportable incidents and the resulting injuries within the facility; and

(C) a reporting system based upon the duty of all health care providers staffing the facility and all agents and employees of the facility directly involved in the delivery of health care services to report reportable incidents to the chief of the medical staff, chief administrative officer or risk manager of the facility.

(2) As used in this subsection, the term "reportable incident" means an act by a health care provider which:

(A) Is or may be below the applicable standard of care and has a reasonable probability of causing injury to a patient; or

(B) may be grounds for disciplinary action by the appropriate licensing agency.

(k) The rules and regulations adopted by the secretary pursuant to this section do not limit the ability of a physician or other health care professional to advise a patient on any health issue. The secretary periodically shall review and update current practice and technology standards under K.S.A. 65-4a01 through 65-4a12, and amendments thereto, and based on current practice or technology adopt by rules and regulations alternative practice or technology standards found by the secretary to be as effective as those enumerated in K.S.A. 65-4a01 through 65-4a12, and amendments thereto.

(l) The provisions of K.S.A. 65-4a01 through 65-4a12, and amendments thereto, and the rules and regulations adopted pursuant thereto shall be in addition to any other laws and rules and regulations which are applicable to facilities defined as clinics under K.S.A. 65-4a01, and amendments thereto.

(m) In addition to any other penalty provided by law, whenever in the judgment of the secretary of health and environment any person has engaged, or is about to engage, in any acts or practices which constitute, or will constitute, a violation of this section, or any rules and regulations adopted under the provisions of this section, the secretary shall make application to any court of competent jurisdiction for an order enjoining such acts or practices, and upon a showing by the secretary that such person has engaged, or is about to engage, in any such acts or practices, an injunction, restraining order or such other order as may be appropriate shall be granted by such court without bond.

History: L. 2011, ch. 82, § 9; July 1.