Bill Text: MN SF2241 | 2011-2012 | 87th Legislature | Introduced
Bill Title: Abortion facilities licensure requirement
Spectrum: Slight Partisan Bill (Republican 2-1)
Status: (Introduced - Dead) 2012-03-05 - Referred to Health and Human Services [SF2241 Detail]
Download: Minnesota-2011-SF2241-Introduced.html
1.2relating to health; establishing state licensure for abortion facilities; providing
1.3penalties;proposing coding for new law in Minnesota Statutes, chapter 144.
1.4BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.5 Section 1. [144.65] ABORTION FACILITIES; LICENSURE AND INSPECTION.
1.6 Subdivision 1. Definitions. For purposes of this section, the following terms have
1.7the meanings given.
1.8(a) "Abortion" means the use or prescription of any instrument, medicine, drug,
1.9or any other substance or device to terminate the pregnancy of a woman known to be
1.10pregnant with an intention other than to increase the probability of a live birth, to preserve
1.11the life or health of the child after live birth, or to remove a dead unborn child who died as
1.12the result of natural causes in utero, accidental trauma, or a criminal assault on the pregnant
1.13woman or her unborn child, and which causes the premature termination of the pregnancy.
1.14(b) "Abortion facility" or "facility" means any clinic, hospital, or outpatient surgical
1.15center, in which any second or third trimester elective abortion, or five or more first
1.16trimester elective abortions, are performed in a month, excluding any abortion performed
1.17due to a medical emergency as defined in this section.
1.18(c) "Clinic" means any facility, other than a hospital or outpatient surgical center, in
1.19which any second or third trimester, or five or more first trimester abortions are performed
1.20in a month.
1.21(d) "Commissioner" means the commissioner of health.
1.22(e) "Elective abortion" means an abortion for any reason other than to prevent the
1.23death of the mother upon whom the abortion is performed; provided, that an abortion may
2.1not be deemed one to prevent the death of the mother based on a claim or diagnosis that
2.2she will engage in conduct which would result in her death.
2.3(f) "Gestational age" means the time that has elapsed since the first day of the
2.4woman's last menstrual period.
2.5(g) "Hospital" has the meaning provided in section 144.50, subdivision 2.
2.6(h) "Medical emergency" means a condition that, in a reasonable medical judgment,
2.7so complicates the medical condition of the pregnant woman as to necessitate the
2.8immediate abortion of her pregnancy without first determining gestational age in order to
2.9avert her death, or for which a delay necessary to determine gestational age will create
2.10serious risk of substantial and irreversible physical impairment of a major bodily function.
2.11No condition shall be deemed a medical emergency if based on a claim or diagnosis that
2.12the woman will engage in conduct which would result in her death or in substantial and
2.13irreversible physical impairment of a major bodily function.
2.14(i) "Outpatient surgical center" has the meaning provided in section 144.55,
2.15subdivision 2, paragraph (a).
2.16 Subd. 2. License required. (a) An abortion facility shall be licensed in accordance
2.17with this section.
2.18(b) Any facility seeking licensure for the performance of abortions shall submit an
2.19application for a license to the commissioner on forms and in the manner required by the
2.20commissioner. The application shall contain information the commissioner requires,
2.21including evidence of the ability of the applicant to comply with reasonable standards and
2.22rules adopted under this section.
2.23(c) Upon receipt of an application and verification by the commissioner that the
2.24applicant is in compliance with all applicable requirements, the commissioner shall issue a
2.25license to the applicant.
2.26(d) A license issued under this section shall be posted in a conspicuous place in a
2.27public area within the facility. The issuance of a license does not guarantee adequacy of
2.28individual care, treatment, personal safety, fire safety, or the well-being of any occupant of
2.29such facility. A license is not assignable or transferable.
2.30(e) The license shall be effective for one year following the date of issuance.
2.31A license issued under this section shall apply only to the premises described in the
2.32application and in the license issued thereon, and only one location shall be described
2.33in each license.
2.34(f) At the time application for a license is made, the applicant shall pay a license fee
2.35in the amount of $500. Fees paid according to this section are not refundable.
3.1(g) The commissioner may make exceptions to the standards in this section if
3.2the commissioner determines that the health and welfare of the community require the
3.3services of the hospital or outpatient surgical center and that the exceptions, as granted,
3.4will have no significant adverse impact on the health, safety, or welfare of the patients of
3.5the hospital or outpatient surgical center.
3.6 Subd. 3. License renewal. Applicants for an annual license renewal shall file an
3.7application with the commissioner and pay the license fee according to subdivision 2.
3.8Applicants for an annual license renewal shall also be subject to a licensing inspection
3.9according to subdivision 5.
3.10 Subd. 4. Facility name. (a) No proposed facility shall be named, nor may any
3.11existing facility have its name changed to, the same or similar name as any other facility
3.12licensed according to this section. If a facility is affiliated with one or more other facilities
3.13with the same or similar name, then the facility licensed under this section shall have the
3.14geographic area in which it is located included as part of its name.
3.15(b) A facility shall apply for an amended license by submitting an application to the
3.16commissioner within 30 days after the occurrence of either:
3.17(1) a change of ownership either by purchase or lease; or
3.18(2) a change in the facility's name or address.
3.19 Subd. 5. Facility inspections. (a) The commissioner shall inspect each facility
3.20licensed under this section at least twice each calendar year and at other times as the
3.21commissioner determines necessary to protect the public health and safety and to
3.22implement and enforce the provisions of this section and any rules adopted hereunder. At
3.23least one unannounced inspection shall be made each calendar year and authorized agents
3.24of the commissioner shall have access to a facility during regular business hours.
3.25(b) Information received by the commissioner through filed reports, inspections, or
3.26as otherwise authorized under this section is classified as private data on individuals
3.27according to chapter 13 and shall not be disclosed publicly in any manner that would
3.28identify individuals.
3.29 Subd. 6. Enforcement; penalties. (a) When the commissioner determines that
3.30a facility is in violation of any applicable statute or rule relating to the operation or
3.31maintenance of a licensed facility, the commissioner, upon proper notice, may deny,
3.32suspend, or revoke the license of a facility, or assess a monetary penalty after notice and
3.33an opportunity for hearing has been given to the licensee.
3.34(b) Either before or after formal charges have been filed, the commissioner and the
3.35facility may enter into a stipulation which shall be binding upon the commissioner and
3.36the facility. The commissioner may enter findings of fact and issue an enforcement order
4.1based on a stipulation without filing any formal charges or holding hearings in the case.
4.2An enforcement order based on a stipulation may include any disciplinary action against
4.3the facility authorized by this subdivision.
4.4(c) The commissioner may temporarily suspend or limit the license of any facility if
4.5the commissioner determines that there is reason to believe that grounds exist under this
4.6section for immediate action against the facility and that the facility's continued operation
4.7would constitute an imminent danger to the public health and safety.
4.8(d) Violations of this section or rules adopted hereunder are one of the following:
4.9(1) Class I violations are those that the commissioner determines present an
4.10imminent danger to the health, safety, or welfare of the patients of the facility or present
4.11a substantial probability that death or serious physical harm could result. A physical
4.12condition, or practice, mean, method, or operation in use in a facility, may constitute
4.13a violation. The condition or practice constituting a Class I violation shall be abated
4.14or eliminated immediately unless a fixed period of time, as set by the commissioner,
4.15is required for correction. Each day the violation exists after the expiration of time is
4.16considered a subsequent violation.
4.17(2) Class II violations are those other than Class I violations that the commissioner
4.18determines to have a direct or immediate relationship to the health, safety, or welfare of
4.19the facility's patients. The citation of a Class II violation shall specify the time in which
4.20the violation must be corrected. Each day a violation exists after expiration of the time to
4.21correct is considered a subsequent violation.
4.22(3) Class III violations are those that are not classified as Class I or II or those that
4.23are against the best practices as determined by the commissioner. The citation of a Class
4.24III violation shall specify the time in which the violation must be corrected. Each day a
4.25violation exists after expiration of the time to correct is considered a subsequent violation.
4.26(e) The commissioner shall consider the following factors when determining the
4.27severity of a violation:
4.28(1) specific conditions and the impact or potential impact on the health, safety, or
4.29welfare of the facility's patients;
4.30(2) efforts by the facility to correct the violation;
4.31(3) overall conditions of the facility;
4.32(4) the facility's history of compliance; and
4.33(5) any other pertinent conditions that may be applicable.
4.34(f) Any monetary penalty assessed by the commissioner shall be assessed according
4.35to the following schedule:
5.1(1) for Class I violations, the following number of violations within a 24-month
5.2period shall result in the corresponding penalty amount:
5.3(i) one violation, a penalty of not less than $200 and not more than $1,000;
5.4(ii) two violations, a penalty of not less than $500 and not more than $2,000;
5.5(iii) three violations, a penalty of not less than $1,000 and not more than $5,000; and
5.6(iv) four or more violations, a penalty of $5,000;
5.7(2) for Class II violations, the following number of violations within a 24-month
5.8period shall result in the corresponding penalty amount:
5.9(i) one violation, a penalty of not less than $100 and not more than $200;
5.10(ii) two violations, a penalty of not less than $200 and not more than $1,000;
5.11(iii) three violations, a penalty of not less than $500 and not more than $2,000;
5.12(iv) four violations, a penalty of not less than $1,000 and not more than $5,000; and
5.13(v) five or more violations, a penalty of $5,000;
5.14(3) for Class III violations, the following number of violations within a 24-month
5.15period shall result in the corresponding penalty amount:
5.16(i) one violation, there shall be no penalty;
5.17(ii) two violations, a penalty of not less than $100 and not more than $500;
5.18(iii) three violations, a penalty of not less than $200 and not more than $1,000;
5.19(iv) four violations, a penalty of not less than $500 and not more than $2,000;
5.20(v) five violations, a penalty of not less than $1,000 and not more than $5,000; and
5.21(vi) six or more violations, a penalty of $5,000.
5.22 Subd. 7. Abortions must be performed in licensed facilities. Except in the case of
5.23a medical emergency, as defined in this act, an abortion performed when the gestational
5.24age of the unborn child is 22 weeks or more shall be performed in a hospital or outpatient
5.25surgical center licensed according to this section. All other abortions shall be performed in
5.26a hospital, outpatient surgical center, or clinic licensed according to this section, except
5.27that a hospital or outpatient surgical center that does not meet the definition of an abortion
5.28facility under this section and is licensed under section 144.55 may perform abortions.
5.29 Subd. 8. Criminal penalties; unprofessional conduct. (a) It is unlawful to operate
5.30an abortion facility in Minnesota without possessing a valid license issued annually by the
5.31commissioner according to this section.
5.32(b) It is unlawful for a person to perform or induce an abortion unless the person is a
5.33physician, with clinical privileges at a hospital located within 30 miles of the facility.
5.34(c) A violation of paragraph (a) or (b) is a gross misdemeanor and constitutes
5.35unprofessional conduct under section 147.091.
6.1 Subd. 9. Licensure requirements. (a) The commissioner shall adopt rules and
6.2regulations for the licensure of abortion facilities.
6.3(b) The commissioner shall adopt rules and regulations concerning sanitation,
6.4housekeeping, maintenance, staff qualifications, emergency equipment and procedures
6.5to provide emergency care, medical records and reporting, laboratory, procedure and
6.6recovery rooms, physical plant, quality assurance, infection control, information on and
6.7access to patient follow-up care, and any other areas of medical practice necessary to
6.8carry out the purposes of this section for clinics for the performance of abortions. At a
6.9minimum these rules and regulations shall set standards for:
6.10(1) adequate private space that is specifically designated for interviewing,
6.11counseling, and medical evaluations;
6.12(2) dressing rooms for staff and patients;
6.13(3) appropriate lavatory areas;
6.14(4) areas for hand washing prior to a procedure;
6.15(5) private procedure rooms;
6.16(6) adequate lighting and ventilation for abortion procedures;
6.17(7) surgical or gynecologic examination tables and other fixed equipment;
6.18(8) postprocedure recovery rooms that are supervised, staffed, and equipped to
6.19meet the patients' needs;
6.20(9) emergency exits to accommodate a stretcher or gurney;
6.21(10) areas for cleaning and sterilizing instruments; and
6.22(11) adequate areas for the secure storage of medical records and necessary
6.23equipment and supplies.
6.24(c) The commissioner shall adopt rules to set standards for facility supplies and
6.25equipment, including supplies and equipment that must be immediately available for use
6.26or in an emergency. At a minimum these rules shall:
6.27(1) prescribe required equipment and supplies, including medications, required to
6.28conduct, in an appropriate fashion, any abortion procedure that the medical staff of the
6.29facility anticipates performing and for monitoring the progress of each patient throughout
6.30the procedure and recovery period;
6.31(2) require adequate equipment and supplies at the facility to ensure sufficient
6.32quantities of clean and sterilized durable equipment and supplies to meet the needs
6.33of each patient;
6.34(3) prescribe required equipment, supplies, and medications that shall be available
6.35and ready for immediate use in an emergency and requirements for written protocols and
6.36procedures to be followed by staff in an emergency, such as the loss of electrical power;
7.1(4) prescribe required equipment and supplies for required laboratory tests and
7.2requirements for protocols to calibrate and maintain laboratory equipment at the facility or
7.3operated by facility staff;
7.4(5) require ultrasound equipment in facilities; and
7.5(6) require that all equipment is safe for the patient and the staff, meets applicable
7.6federal standards, and is checked annually to ensure safety and appropriate calibration.
7.7(d) The commissioner shall adopt rules relating to facility personnel. At a minimum
7.8these rules shall require that:
7.9(1) the abortion facility designate a medical director of the facility who is licensed to
7.10practice medicine and surgery in the state;
7.11(2) physicians performing surgery in a facility are licensed to practice medicine and
7.12surgery in the state, have demonstrated competence in the procedure involved, and are
7.13acceptable to the medical director of the facility;
7.14(3) a physician with admitting privileges at an accredited hospital located within 30
7.15miles of the abortion facility is available;
7.16(4) another individual is present in the room during a pelvic examination or during
7.17the abortion procedure, and if the physician is male then the other individual must be
7.18female;
7.19(5) a registered nurse, nurse practitioner, licensed practical nurse, or physician
7.20assistant is present and remains at the facility when abortions are performed to provide
7.21postoperative monitoring and care until each patient who had an abortion that day is
7.22discharged;
7.23(6) surgical assistants receive training in the specific responsibilities of the services
7.24the surgical assistants provide; and
7.25(7) volunteers receive training in the specific responsibilities of the services
7.26the volunteers provide, including counseling and patient advocacy as provided in the
7.27procedures adopted by the director for different types of volunteers based on their
7.28responsibilities.
7.29(e) The commissioner shall adopt rules relating to the medical screening and
7.30evaluation of each facility patient. At a minimum these rules shall require:
7.31(1) a medical history including the following:
7.32(i) reported allergies to medications, antiseptic solutions, or latex;
7.33(ii) obstetric and gynecologic history; and
7.34(iii) past surgeries;
7.35(2) a physical examination including a bimanual examination estimating uterine
7.36size and palpation of the adnexa;
8.1(3) the appropriate laboratory tests including:
8.2(i) for an abortion in which an ultrasound examination is not performed before the
8.3abortion procedure, urine or blood tests for pregnancy performed before the abortion
8.4procedure;
8.5(ii) a test for anemia as indicated;
8.6(iii) Rh typing, unless reliable written documentation of blood type is available; and
8.7(iv) other tests as indicated from the physical examination;
8.8(4) an ultrasound evaluation for all patients who elect to have an abortion of an
8.9unborn child. If a person who is not a physician performs an ultrasound examination,
8.10that person shall have documented evidence that the person completed a course in the
8.11operation of ultrasound equipment as prescribed by rule. The physician or other health
8.12care professional shall review, at the request of the patient, the ultrasound evaluation
8.13results with the patient before the abortion procedure is performed, including the probable
8.14gestational age of the unborn child; and
8.15(5) that the physician is responsible for estimating the gestational age of the unborn
8.16child based on the ultrasound examination and obstetric standards in keeping with
8.17established standards of care regarding the estimation of fetal age and shall verify the
8.18estimate in the patient's medical history. The physician shall keep original prints of each
8.19ultrasound examination of a patient in the patient's medical history file.
8.20(f) The commissioner shall adopt rules relating to the abortion procedure. At a
8.21minimum these rules shall require:
8.22(1) that medical personnel is available to all patients throughout the abortion
8.23procedure;
8.24(2) standards for the safe conduct of abortion procedures that conform to obstetric
8.25standards in keeping with established standards of care regarding the estimation of fetal
8.26age;
8.27(3) appropriate use of local anesthesia, analgesia, and sedation if ordered by the
8.28physician;
8.29(4) the use of appropriate precautions, such as the establishment of intravenous
8.30access at least for patients undergoing second or third trimester abortions; and
8.31(5) the use of appropriate monitoring of the vital signs and other defined signs and
8.32markers of the patient's status throughout the abortion procedure and recovery period until
8.33the patient's condition is deemed to be stable in the recovery room.
8.34(g) The commissioner shall adopt rules that prescribe minimum recovery room
8.35standards. At a minimum, these rules shall require that:
9.1(1) immediate postprocedure care consists of observation in a supervised recovery
9.2room for as long as the patient's condition warrants;
9.3(2) the facility arrange hospitalization if any complication occurs beyond the
9.4management capability of the staff;
9.5(3) a licensed health professional who is trained in the management of the recovery
9.6area and is capable of providing basic cardiopulmonary resuscitation and related
9.7emergency procedures remains on the premises of the facility until all patients are
9.8discharged;
9.9(4) a physician or nurse who is certified in advanced cardiovascular life support shall
9.10remain on the premises of the facility until all patients are discharged or to facilitate the
9.11transfer of emergency cases if hospitalization of the patient or viable unborn child is
9.12necessary. A physician or nurse shall be readily accessible and available until the last
9.13patient is discharged;
9.14(5) a physician or trained staff member discusses Rho(d) immune globulin with
9.15each patient for whom it is indicated and ensures it is offered to the patient in the
9.16immediate postoperative period or that it will be available to her within 72 hours after
9.17completion of the abortion procedure. If the patient refuses, a refusal form approved by
9.18the commissioner of the Department of Health shall be signed by the patient and a witness
9.19and included in the medical record;
9.20(6) written instructions with regard to postabortion activities, signs of possible
9.21problems, and general aftercare are given to each patient. Each patient shall have specific
9.22instructions regarding access to medical care for complications, including a telephone
9.23number to call for medical emergencies;
9.24(7) there is a specified minimum length of time that a patient remains in the recovery
9.25room by type of abortion procedure and gestational age of the unborn child;
9.26(8) the physician ensures that a licensed health professional from the facility makes
9.27a good-faith effort to contact the patient by telephone, with the patient's consent, within
9.2824 hours after surgery to assess the patient's recovery; and
9.29(9) equipment and services are located in the recovery room to provide appropriate
9.30emergency resuscitative and life support procedures pending the transfer of the patient or
9.31viable unborn child to the hospital.
9.32(h) The commissioner shall adopt rules that prescribe standards for follow-up visits.
9.33At a minimum these rules shall require that:
9.34(1) if accepted by the patient, a postabortion medical visit is offered and scheduled
9.35within four weeks after the abortion, including a medical examination and a review of
9.36the results of all laboratory tests;
10.1(2) a urine pregnancy test is obtained at the time of the follow-up visit to rule
10.2out continuing pregnancy. If a continuing pregnancy is suspected, the patient shall be
10.3evaluated and a physician who performs or induces abortions shall be consulted; and
10.4(3) the physician performing or inducing the abortion, or a person acting on behalf
10.5of the physician performing or inducing the abortion, shall make all reasonable efforts
10.6to ensure that the patient returns for a subsequent examination so that the physician can
10.7assess the patient's medical condition. A brief description of the efforts made to comply
10.8with these requirements, including the date, time, and identification by name of the person
10.9making these efforts, shall be included in the patient's medical record.
10.10(i) The commissioner shall adopt rules to prescribe minimum facility incident
10.11reporting. At a minimum these rules shall require that:
10.12(1) the facility record each incident resulting in a patient's or viable unborn child's
10.13serious injury occurring at a facility and shall report them in writing to the department
10.14within ten days after the incident. For the purposes of this paragraph, "serious injury"
10.15means an injury that occurs at a facility and that creates a serious risk of substantial
10.16impairment of a major body organ;
10.17(2) if a patient's death occurs, other than an unborn child's death properly reported
10.18according to law, the facility shall report the death to the Department of Health no later
10.19than the next department business day; and
10.20(3) incident reports are filed with the Department of Health and appropriate
10.21professional regulatory boards.
10.22(j) The commissioner shall adopt rules requiring each facility to establish and
10.23maintain an internal risk management program which, at a minimum, shall consist of:
10.24(1) a system for investigation and analysis of the frequency and causes of reportable
10.25incidents within the facility;
10.26(2) measures to minimize the occurrence of reportable incidents and the resulting
10.27injuries within the facility; and
10.28(3) a reporting system based upon the duty of all health care providers staffing the
10.29facility and all agents and employees of the facility directly involved in the delivery of
10.30health care services to report reportable incidents to the chief of the medical staff, chief
10.31administrative officer, or risk manager of the facility.
10.32As used in this paragraph, "reportable incident" means an act by a health care
10.33provider that: (i) is or may be below the applicable standard of care and has a reasonable
10.34probability of causing injury to a patient; or (ii) may be grounds for disciplinary action by
10.35the appropriate licensing agency.
11.1(k) The rules adopted by the commissioner according to this subdivision do not limit
11.2the ability of a physician or other health care professional to advise a patient on any
11.3health issue. The commissioner shall periodically review and update current practice and
11.4technology standards under this section and, based on current practice or technology,
11.5amend adopted rules.
11.6(l) The provisions of this section and the rules adopted according to this section are
11.7in addition to any other laws that are applicable to facilities defined under this section.
11.8(m) In addition to any other penalty provided by law, whenever the commissioner
11.9determines a person has engaged, or is about to engage, in any act or practice that
11.10constitutes, or will constitute, a violation of this section or rules adopted under this section,
11.11the commissioner shall make application to a court of competent jurisdiction for an order
11.12enjoining the act or practice, and upon a showing by the commissioner that the person has
11.13engaged, or is about to engage, in a prohibited act or practice, an injunction, restraining
11.14order, or other order shall be granted by the court without bond.
11.15 Subd. 10. Abortions to be performed by licensed physician. (a) No abortion
11.16shall be performed or induced by any person other than a physician licensed to practice
11.17medicine in this state. When RU-486 (mifepristone) or any drug is used for the purpose of
11.18inducing an abortion, the drug must be administered by or in the same room and in the
11.19physical presence of the physician who prescribed, dispensed, or otherwise provided the
11.20drug to the patient.
11.21(b) The physician inducing the abortion, or a person acting on behalf of the physician
11.22inducing the abortion, shall make all reasonable efforts to ensure that the patient returns
11.2312 to 18 days after the administration or use of such drug for a subsequent examination
11.24so that the physician can confirm that the pregnancy has been terminated and assess the
11.25patient's medical condition. A brief description of the efforts made to comply with this
11.26paragraph, including the date, time, and identification by name of the person making the
11.27efforts shall be included in the patient's medical record.
11.28(c) A violation of this subdivision shall constitute unprofessional conduct under
11.29section 147.091.
11.30 Subd. 11. Prohibited abortions. Nothing in this section shall be construed as
11.31creating or recognizing a right to abortion. Notwithstanding any provision of this section,
11.32a person shall not perform an abortion that is prohibited by law.
11.33 Subd. 12. Severability. If any one or more provision, section, subsection,
11.34sentence, clause, phrase, or word of this section or the application thereof to any
11.35person or circumstance is found to be unconstitutional, the same is hereby declared
11.36to be severable and the balance of the section shall remain effective notwithstanding
12.1such unconstitutionality. The legislature hereby declares that it would have passed this
12.2section and each provision, section, subsection, sentence, clause, phrase, or word thereof,
12.3irrespective of the fact that any one or more provision, section, subsection, sentence,
12.4clause, phrase, or word be declared unconstitutional.
12.5EFFECTIVE DATE.This section is effective the day following final enactment.
1.3penalties;proposing coding for new law in Minnesota Statutes, chapter 144.
1.4BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.5 Section 1. [144.65] ABORTION FACILITIES; LICENSURE AND INSPECTION.
1.6 Subdivision 1. Definitions. For purposes of this section, the following terms have
1.7the meanings given.
1.8(a) "Abortion" means the use or prescription of any instrument, medicine, drug,
1.9or any other substance or device to terminate the pregnancy of a woman known to be
1.10pregnant with an intention other than to increase the probability of a live birth, to preserve
1.11the life or health of the child after live birth, or to remove a dead unborn child who died as
1.12the result of natural causes in utero, accidental trauma, or a criminal assault on the pregnant
1.13woman or her unborn child, and which causes the premature termination of the pregnancy.
1.14(b) "Abortion facility" or "facility" means any clinic, hospital, or outpatient surgical
1.15center, in which any second or third trimester elective abortion, or five or more first
1.16trimester elective abortions, are performed in a month, excluding any abortion performed
1.17due to a medical emergency as defined in this section.
1.18(c) "Clinic" means any facility, other than a hospital or outpatient surgical center, in
1.19which any second or third trimester, or five or more first trimester abortions are performed
1.20in a month.
1.21(d) "Commissioner" means the commissioner of health.
1.22(e) "Elective abortion" means an abortion for any reason other than to prevent the
1.23death of the mother upon whom the abortion is performed; provided, that an abortion may
2.1not be deemed one to prevent the death of the mother based on a claim or diagnosis that
2.2she will engage in conduct which would result in her death.
2.3(f) "Gestational age" means the time that has elapsed since the first day of the
2.4woman's last menstrual period.
2.5(g) "Hospital" has the meaning provided in section 144.50, subdivision 2.
2.6(h) "Medical emergency" means a condition that, in a reasonable medical judgment,
2.7so complicates the medical condition of the pregnant woman as to necessitate the
2.8immediate abortion of her pregnancy without first determining gestational age in order to
2.9avert her death, or for which a delay necessary to determine gestational age will create
2.10serious risk of substantial and irreversible physical impairment of a major bodily function.
2.11No condition shall be deemed a medical emergency if based on a claim or diagnosis that
2.12the woman will engage in conduct which would result in her death or in substantial and
2.13irreversible physical impairment of a major bodily function.
2.14(i) "Outpatient surgical center" has the meaning provided in section 144.55,
2.15subdivision 2, paragraph (a).
2.16 Subd. 2. License required. (a) An abortion facility shall be licensed in accordance
2.17with this section.
2.18(b) Any facility seeking licensure for the performance of abortions shall submit an
2.19application for a license to the commissioner on forms and in the manner required by the
2.20commissioner. The application shall contain information the commissioner requires,
2.21including evidence of the ability of the applicant to comply with reasonable standards and
2.22rules adopted under this section.
2.23(c) Upon receipt of an application and verification by the commissioner that the
2.24applicant is in compliance with all applicable requirements, the commissioner shall issue a
2.25license to the applicant.
2.26(d) A license issued under this section shall be posted in a conspicuous place in a
2.27public area within the facility. The issuance of a license does not guarantee adequacy of
2.28individual care, treatment, personal safety, fire safety, or the well-being of any occupant of
2.29such facility. A license is not assignable or transferable.
2.30(e) The license shall be effective for one year following the date of issuance.
2.31A license issued under this section shall apply only to the premises described in the
2.32application and in the license issued thereon, and only one location shall be described
2.33in each license.
2.34(f) At the time application for a license is made, the applicant shall pay a license fee
2.35in the amount of $500. Fees paid according to this section are not refundable.
3.1(g) The commissioner may make exceptions to the standards in this section if
3.2the commissioner determines that the health and welfare of the community require the
3.3services of the hospital or outpatient surgical center and that the exceptions, as granted,
3.4will have no significant adverse impact on the health, safety, or welfare of the patients of
3.5the hospital or outpatient surgical center.
3.6 Subd. 3. License renewal. Applicants for an annual license renewal shall file an
3.7application with the commissioner and pay the license fee according to subdivision 2.
3.8Applicants for an annual license renewal shall also be subject to a licensing inspection
3.9according to subdivision 5.
3.10 Subd. 4. Facility name. (a) No proposed facility shall be named, nor may any
3.11existing facility have its name changed to, the same or similar name as any other facility
3.12licensed according to this section. If a facility is affiliated with one or more other facilities
3.13with the same or similar name, then the facility licensed under this section shall have the
3.14geographic area in which it is located included as part of its name.
3.15(b) A facility shall apply for an amended license by submitting an application to the
3.16commissioner within 30 days after the occurrence of either:
3.17(1) a change of ownership either by purchase or lease; or
3.18(2) a change in the facility's name or address.
3.19 Subd. 5. Facility inspections. (a) The commissioner shall inspect each facility
3.20licensed under this section at least twice each calendar year and at other times as the
3.21commissioner determines necessary to protect the public health and safety and to
3.22implement and enforce the provisions of this section and any rules adopted hereunder. At
3.23least one unannounced inspection shall be made each calendar year and authorized agents
3.24of the commissioner shall have access to a facility during regular business hours.
3.25(b) Information received by the commissioner through filed reports, inspections, or
3.26as otherwise authorized under this section is classified as private data on individuals
3.27according to chapter 13 and shall not be disclosed publicly in any manner that would
3.28identify individuals.
3.29 Subd. 6. Enforcement; penalties. (a) When the commissioner determines that
3.30a facility is in violation of any applicable statute or rule relating to the operation or
3.31maintenance of a licensed facility, the commissioner, upon proper notice, may deny,
3.32suspend, or revoke the license of a facility, or assess a monetary penalty after notice and
3.33an opportunity for hearing has been given to the licensee.
3.34(b) Either before or after formal charges have been filed, the commissioner and the
3.35facility may enter into a stipulation which shall be binding upon the commissioner and
3.36the facility. The commissioner may enter findings of fact and issue an enforcement order
4.1based on a stipulation without filing any formal charges or holding hearings in the case.
4.2An enforcement order based on a stipulation may include any disciplinary action against
4.3the facility authorized by this subdivision.
4.4(c) The commissioner may temporarily suspend or limit the license of any facility if
4.5the commissioner determines that there is reason to believe that grounds exist under this
4.6section for immediate action against the facility and that the facility's continued operation
4.7would constitute an imminent danger to the public health and safety.
4.8(d) Violations of this section or rules adopted hereunder are one of the following:
4.9(1) Class I violations are those that the commissioner determines present an
4.10imminent danger to the health, safety, or welfare of the patients of the facility or present
4.11a substantial probability that death or serious physical harm could result. A physical
4.12condition, or practice, mean, method, or operation in use in a facility, may constitute
4.13a violation. The condition or practice constituting a Class I violation shall be abated
4.14or eliminated immediately unless a fixed period of time, as set by the commissioner,
4.15is required for correction. Each day the violation exists after the expiration of time is
4.16considered a subsequent violation.
4.17(2) Class II violations are those other than Class I violations that the commissioner
4.18determines to have a direct or immediate relationship to the health, safety, or welfare of
4.19the facility's patients. The citation of a Class II violation shall specify the time in which
4.20the violation must be corrected. Each day a violation exists after expiration of the time to
4.21correct is considered a subsequent violation.
4.22(3) Class III violations are those that are not classified as Class I or II or those that
4.23are against the best practices as determined by the commissioner. The citation of a Class
4.24III violation shall specify the time in which the violation must be corrected. Each day a
4.25violation exists after expiration of the time to correct is considered a subsequent violation.
4.26(e) The commissioner shall consider the following factors when determining the
4.27severity of a violation:
4.28(1) specific conditions and the impact or potential impact on the health, safety, or
4.29welfare of the facility's patients;
4.30(2) efforts by the facility to correct the violation;
4.31(3) overall conditions of the facility;
4.32(4) the facility's history of compliance; and
4.33(5) any other pertinent conditions that may be applicable.
4.34(f) Any monetary penalty assessed by the commissioner shall be assessed according
4.35to the following schedule:
5.1(1) for Class I violations, the following number of violations within a 24-month
5.2period shall result in the corresponding penalty amount:
5.3(i) one violation, a penalty of not less than $200 and not more than $1,000;
5.4(ii) two violations, a penalty of not less than $500 and not more than $2,000;
5.5(iii) three violations, a penalty of not less than $1,000 and not more than $5,000; and
5.6(iv) four or more violations, a penalty of $5,000;
5.7(2) for Class II violations, the following number of violations within a 24-month
5.8period shall result in the corresponding penalty amount:
5.9(i) one violation, a penalty of not less than $100 and not more than $200;
5.10(ii) two violations, a penalty of not less than $200 and not more than $1,000;
5.11(iii) three violations, a penalty of not less than $500 and not more than $2,000;
5.12(iv) four violations, a penalty of not less than $1,000 and not more than $5,000; and
5.13(v) five or more violations, a penalty of $5,000;
5.14(3) for Class III violations, the following number of violations within a 24-month
5.15period shall result in the corresponding penalty amount:
5.16(i) one violation, there shall be no penalty;
5.17(ii) two violations, a penalty of not less than $100 and not more than $500;
5.18(iii) three violations, a penalty of not less than $200 and not more than $1,000;
5.19(iv) four violations, a penalty of not less than $500 and not more than $2,000;
5.20(v) five violations, a penalty of not less than $1,000 and not more than $5,000; and
5.21(vi) six or more violations, a penalty of $5,000.
5.22 Subd. 7. Abortions must be performed in licensed facilities. Except in the case of
5.23a medical emergency, as defined in this act, an abortion performed when the gestational
5.24age of the unborn child is 22 weeks or more shall be performed in a hospital or outpatient
5.25surgical center licensed according to this section. All other abortions shall be performed in
5.26a hospital, outpatient surgical center, or clinic licensed according to this section, except
5.27that a hospital or outpatient surgical center that does not meet the definition of an abortion
5.28facility under this section and is licensed under section 144.55 may perform abortions.
5.29 Subd. 8. Criminal penalties; unprofessional conduct. (a) It is unlawful to operate
5.30an abortion facility in Minnesota without possessing a valid license issued annually by the
5.31commissioner according to this section.
5.32(b) It is unlawful for a person to perform or induce an abortion unless the person is a
5.33physician, with clinical privileges at a hospital located within 30 miles of the facility.
5.34(c) A violation of paragraph (a) or (b) is a gross misdemeanor and constitutes
5.35unprofessional conduct under section 147.091.
6.1 Subd. 9. Licensure requirements. (a) The commissioner shall adopt rules and
6.2regulations for the licensure of abortion facilities.
6.3(b) The commissioner shall adopt rules and regulations concerning sanitation,
6.4housekeeping, maintenance, staff qualifications, emergency equipment and procedures
6.5to provide emergency care, medical records and reporting, laboratory, procedure and
6.6recovery rooms, physical plant, quality assurance, infection control, information on and
6.7access to patient follow-up care, and any other areas of medical practice necessary to
6.8carry out the purposes of this section for clinics for the performance of abortions. At a
6.9minimum these rules and regulations shall set standards for:
6.10(1) adequate private space that is specifically designated for interviewing,
6.11counseling, and medical evaluations;
6.12(2) dressing rooms for staff and patients;
6.13(3) appropriate lavatory areas;
6.14(4) areas for hand washing prior to a procedure;
6.15(5) private procedure rooms;
6.16(6) adequate lighting and ventilation for abortion procedures;
6.17(7) surgical or gynecologic examination tables and other fixed equipment;
6.18(8) postprocedure recovery rooms that are supervised, staffed, and equipped to
6.19meet the patients' needs;
6.20(9) emergency exits to accommodate a stretcher or gurney;
6.21(10) areas for cleaning and sterilizing instruments; and
6.22(11) adequate areas for the secure storage of medical records and necessary
6.23equipment and supplies.
6.24(c) The commissioner shall adopt rules to set standards for facility supplies and
6.25equipment, including supplies and equipment that must be immediately available for use
6.26or in an emergency. At a minimum these rules shall:
6.27(1) prescribe required equipment and supplies, including medications, required to
6.28conduct, in an appropriate fashion, any abortion procedure that the medical staff of the
6.29facility anticipates performing and for monitoring the progress of each patient throughout
6.30the procedure and recovery period;
6.31(2) require adequate equipment and supplies at the facility to ensure sufficient
6.32quantities of clean and sterilized durable equipment and supplies to meet the needs
6.33of each patient;
6.34(3) prescribe required equipment, supplies, and medications that shall be available
6.35and ready for immediate use in an emergency and requirements for written protocols and
6.36procedures to be followed by staff in an emergency, such as the loss of electrical power;
7.1(4) prescribe required equipment and supplies for required laboratory tests and
7.2requirements for protocols to calibrate and maintain laboratory equipment at the facility or
7.3operated by facility staff;
7.4(5) require ultrasound equipment in facilities; and
7.5(6) require that all equipment is safe for the patient and the staff, meets applicable
7.6federal standards, and is checked annually to ensure safety and appropriate calibration.
7.7(d) The commissioner shall adopt rules relating to facility personnel. At a minimum
7.8these rules shall require that:
7.9(1) the abortion facility designate a medical director of the facility who is licensed to
7.10practice medicine and surgery in the state;
7.11(2) physicians performing surgery in a facility are licensed to practice medicine and
7.12surgery in the state, have demonstrated competence in the procedure involved, and are
7.13acceptable to the medical director of the facility;
7.14(3) a physician with admitting privileges at an accredited hospital located within 30
7.15miles of the abortion facility is available;
7.16(4) another individual is present in the room during a pelvic examination or during
7.17the abortion procedure, and if the physician is male then the other individual must be
7.18female;
7.19(5) a registered nurse, nurse practitioner, licensed practical nurse, or physician
7.20assistant is present and remains at the facility when abortions are performed to provide
7.21postoperative monitoring and care until each patient who had an abortion that day is
7.22discharged;
7.23(6) surgical assistants receive training in the specific responsibilities of the services
7.24the surgical assistants provide; and
7.25(7) volunteers receive training in the specific responsibilities of the services
7.26the volunteers provide, including counseling and patient advocacy as provided in the
7.27procedures adopted by the director for different types of volunteers based on their
7.28responsibilities.
7.29(e) The commissioner shall adopt rules relating to the medical screening and
7.30evaluation of each facility patient. At a minimum these rules shall require:
7.31(1) a medical history including the following:
7.32(i) reported allergies to medications, antiseptic solutions, or latex;
7.33(ii) obstetric and gynecologic history; and
7.34(iii) past surgeries;
7.35(2) a physical examination including a bimanual examination estimating uterine
7.36size and palpation of the adnexa;
8.1(3) the appropriate laboratory tests including:
8.2(i) for an abortion in which an ultrasound examination is not performed before the
8.3abortion procedure, urine or blood tests for pregnancy performed before the abortion
8.4procedure;
8.5(ii) a test for anemia as indicated;
8.6(iii) Rh typing, unless reliable written documentation of blood type is available; and
8.7(iv) other tests as indicated from the physical examination;
8.8(4) an ultrasound evaluation for all patients who elect to have an abortion of an
8.9unborn child. If a person who is not a physician performs an ultrasound examination,
8.10that person shall have documented evidence that the person completed a course in the
8.11operation of ultrasound equipment as prescribed by rule. The physician or other health
8.12care professional shall review, at the request of the patient, the ultrasound evaluation
8.13results with the patient before the abortion procedure is performed, including the probable
8.14gestational age of the unborn child; and
8.15(5) that the physician is responsible for estimating the gestational age of the unborn
8.16child based on the ultrasound examination and obstetric standards in keeping with
8.17established standards of care regarding the estimation of fetal age and shall verify the
8.18estimate in the patient's medical history. The physician shall keep original prints of each
8.19ultrasound examination of a patient in the patient's medical history file.
8.20(f) The commissioner shall adopt rules relating to the abortion procedure. At a
8.21minimum these rules shall require:
8.22(1) that medical personnel is available to all patients throughout the abortion
8.23procedure;
8.24(2) standards for the safe conduct of abortion procedures that conform to obstetric
8.25standards in keeping with established standards of care regarding the estimation of fetal
8.26age;
8.27(3) appropriate use of local anesthesia, analgesia, and sedation if ordered by the
8.28physician;
8.29(4) the use of appropriate precautions, such as the establishment of intravenous
8.30access at least for patients undergoing second or third trimester abortions; and
8.31(5) the use of appropriate monitoring of the vital signs and other defined signs and
8.32markers of the patient's status throughout the abortion procedure and recovery period until
8.33the patient's condition is deemed to be stable in the recovery room.
8.34(g) The commissioner shall adopt rules that prescribe minimum recovery room
8.35standards. At a minimum, these rules shall require that:
9.1(1) immediate postprocedure care consists of observation in a supervised recovery
9.2room for as long as the patient's condition warrants;
9.3(2) the facility arrange hospitalization if any complication occurs beyond the
9.4management capability of the staff;
9.5(3) a licensed health professional who is trained in the management of the recovery
9.6area and is capable of providing basic cardiopulmonary resuscitation and related
9.7emergency procedures remains on the premises of the facility until all patients are
9.8discharged;
9.9(4) a physician or nurse who is certified in advanced cardiovascular life support shall
9.10remain on the premises of the facility until all patients are discharged or to facilitate the
9.11transfer of emergency cases if hospitalization of the patient or viable unborn child is
9.12necessary. A physician or nurse shall be readily accessible and available until the last
9.13patient is discharged;
9.14(5) a physician or trained staff member discusses Rho(d) immune globulin with
9.15each patient for whom it is indicated and ensures it is offered to the patient in the
9.16immediate postoperative period or that it will be available to her within 72 hours after
9.17completion of the abortion procedure. If the patient refuses, a refusal form approved by
9.18the commissioner of the Department of Health shall be signed by the patient and a witness
9.19and included in the medical record;
9.20(6) written instructions with regard to postabortion activities, signs of possible
9.21problems, and general aftercare are given to each patient. Each patient shall have specific
9.22instructions regarding access to medical care for complications, including a telephone
9.23number to call for medical emergencies;
9.24(7) there is a specified minimum length of time that a patient remains in the recovery
9.25room by type of abortion procedure and gestational age of the unborn child;
9.26(8) the physician ensures that a licensed health professional from the facility makes
9.27a good-faith effort to contact the patient by telephone, with the patient's consent, within
9.2824 hours after surgery to assess the patient's recovery; and
9.29(9) equipment and services are located in the recovery room to provide appropriate
9.30emergency resuscitative and life support procedures pending the transfer of the patient or
9.31viable unborn child to the hospital.
9.32(h) The commissioner shall adopt rules that prescribe standards for follow-up visits.
9.33At a minimum these rules shall require that:
9.34(1) if accepted by the patient, a postabortion medical visit is offered and scheduled
9.35within four weeks after the abortion, including a medical examination and a review of
9.36the results of all laboratory tests;
10.1(2) a urine pregnancy test is obtained at the time of the follow-up visit to rule
10.2out continuing pregnancy. If a continuing pregnancy is suspected, the patient shall be
10.3evaluated and a physician who performs or induces abortions shall be consulted; and
10.4(3) the physician performing or inducing the abortion, or a person acting on behalf
10.5of the physician performing or inducing the abortion, shall make all reasonable efforts
10.6to ensure that the patient returns for a subsequent examination so that the physician can
10.7assess the patient's medical condition. A brief description of the efforts made to comply
10.8with these requirements, including the date, time, and identification by name of the person
10.9making these efforts, shall be included in the patient's medical record.
10.10(i) The commissioner shall adopt rules to prescribe minimum facility incident
10.11reporting. At a minimum these rules shall require that:
10.12(1) the facility record each incident resulting in a patient's or viable unborn child's
10.13serious injury occurring at a facility and shall report them in writing to the department
10.14within ten days after the incident. For the purposes of this paragraph, "serious injury"
10.15means an injury that occurs at a facility and that creates a serious risk of substantial
10.16impairment of a major body organ;
10.17(2) if a patient's death occurs, other than an unborn child's death properly reported
10.18according to law, the facility shall report the death to the Department of Health no later
10.19than the next department business day; and
10.20(3) incident reports are filed with the Department of Health and appropriate
10.21professional regulatory boards.
10.22(j) The commissioner shall adopt rules requiring each facility to establish and
10.23maintain an internal risk management program which, at a minimum, shall consist of:
10.24(1) a system for investigation and analysis of the frequency and causes of reportable
10.25incidents within the facility;
10.26(2) measures to minimize the occurrence of reportable incidents and the resulting
10.27injuries within the facility; and
10.28(3) a reporting system based upon the duty of all health care providers staffing the
10.29facility and all agents and employees of the facility directly involved in the delivery of
10.30health care services to report reportable incidents to the chief of the medical staff, chief
10.31administrative officer, or risk manager of the facility.
10.32As used in this paragraph, "reportable incident" means an act by a health care
10.33provider that: (i) is or may be below the applicable standard of care and has a reasonable
10.34probability of causing injury to a patient; or (ii) may be grounds for disciplinary action by
10.35the appropriate licensing agency.
11.1(k) The rules adopted by the commissioner according to this subdivision do not limit
11.2the ability of a physician or other health care professional to advise a patient on any
11.3health issue. The commissioner shall periodically review and update current practice and
11.4technology standards under this section and, based on current practice or technology,
11.5amend adopted rules.
11.6(l) The provisions of this section and the rules adopted according to this section are
11.7in addition to any other laws that are applicable to facilities defined under this section.
11.8(m) In addition to any other penalty provided by law, whenever the commissioner
11.9determines a person has engaged, or is about to engage, in any act or practice that
11.10constitutes, or will constitute, a violation of this section or rules adopted under this section,
11.11the commissioner shall make application to a court of competent jurisdiction for an order
11.12enjoining the act or practice, and upon a showing by the commissioner that the person has
11.13engaged, or is about to engage, in a prohibited act or practice, an injunction, restraining
11.14order, or other order shall be granted by the court without bond.
11.15 Subd. 10. Abortions to be performed by licensed physician. (a) No abortion
11.16shall be performed or induced by any person other than a physician licensed to practice
11.17medicine in this state. When RU-486 (mifepristone) or any drug is used for the purpose of
11.18inducing an abortion, the drug must be administered by or in the same room and in the
11.19physical presence of the physician who prescribed, dispensed, or otherwise provided the
11.20drug to the patient.
11.21(b) The physician inducing the abortion, or a person acting on behalf of the physician
11.22inducing the abortion, shall make all reasonable efforts to ensure that the patient returns
11.2312 to 18 days after the administration or use of such drug for a subsequent examination
11.24so that the physician can confirm that the pregnancy has been terminated and assess the
11.25patient's medical condition. A brief description of the efforts made to comply with this
11.26paragraph, including the date, time, and identification by name of the person making the
11.27efforts shall be included in the patient's medical record.
11.28(c) A violation of this subdivision shall constitute unprofessional conduct under
11.29section 147.091.
11.30 Subd. 11. Prohibited abortions. Nothing in this section shall be construed as
11.31creating or recognizing a right to abortion. Notwithstanding any provision of this section,
11.32a person shall not perform an abortion that is prohibited by law.
11.33 Subd. 12. Severability. If any one or more provision, section, subsection,
11.34sentence, clause, phrase, or word of this section or the application thereof to any
11.35person or circumstance is found to be unconstitutional, the same is hereby declared
11.36to be severable and the balance of the section shall remain effective notwithstanding
12.1such unconstitutionality. The legislature hereby declares that it would have passed this
12.2section and each provision, section, subsection, sentence, clause, phrase, or word thereof,
12.3irrespective of the fact that any one or more provision, section, subsection, sentence,
12.4clause, phrase, or word be declared unconstitutional.
12.5EFFECTIVE DATE.This section is effective the day following final enactment.
