HF 1841

as introduced - 87th Legislature (2011 - 2012) Posted on 01/24/2012 10:34am

A bill for an act
relating to health; establishing state licensure for abortion facilities; providing
penalties; proposing coding for new law in Minnesota Statutes, chapter 144.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [144.65] ABORTION FACILITIES; LICENSURE AND INSPECTION.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin For purposes of this section, the following terms have
the meanings given.
new text end

new text begin (a) "Abortion" means the use or prescription of any instrument, medicine, drug,
or any other substance or device to terminate the pregnancy of a woman known to be
pregnant with an intention other than to increase the probability of a live birth, to preserve
the life or health of the child after live birth, or to remove a dead unborn child who died as
the result of natural causes in utero, accidental trauma, or a criminal assault on the pregnant
woman or her unborn child, and which causes the premature termination of the pregnancy.
new text end

new text begin (b) "Abortion facility" or "facility" means any clinic, hospital, or outpatient surgical
center, in which any second or third trimester elective abortion, or five or more first
trimester elective abortions, are performed in a month, excluding any abortion performed
due to a medical emergency as defined in this section.
new text end

new text begin (c) "Clinic" means any facility, other than a hospital or outpatient surgical center, in
which any second or third trimester, or five or more first trimester abortions are performed
in a month.
new text end

new text begin (d) "Commissioner" means the commissioner of health.
new text end

new text begin (e) "Elective abortion" means an abortion for any reason other than to prevent the
death of the mother upon whom the abortion is performed; provided, that an abortion may
not be deemed one to prevent the death of the mother based on a claim or diagnosis that
she will engage in conduct which would result in her death.
new text end

new text begin (f) "Gestational age" means the time that has elapsed since the first day of the
woman's last menstrual period.
new text end

new text begin (g) "Hospital" has the meaning provided in section 144.50, subdivision 2.
new text end

new text begin (h) "Medical emergency" means a condition that, in a reasonable medical judgment,
so complicates the medical condition of the pregnant woman as to necessitate the
immediate abortion of her pregnancy without first determining gestational age in order to
avert her death, or for which a delay necessary to determine gestational age will create
serious risk of substantial and irreversible physical impairment of a major bodily function.
No condition shall be deemed a medical emergency if based on a claim or diagnosis that
the woman will engage in conduct which would result in her death or in substantial and
irreversible physical impairment of a major bodily function.
new text end

new text begin (i) "Outpatient surgical center" has the meaning provided in section 144.55,
subdivision 2, paragraph (a).
new text end

new text begin Subd. 2. new text end

new text begin License required. new text end

new text begin (a) An abortion facility shall be licensed in accordance
with this section.
new text end

new text begin (b) Any facility seeking licensure for the performance of abortions shall submit an
application for a license to the commissioner on forms and in the manner required by the
commissioner. The application shall contain information the commissioner requires,
including evidence of the ability of the applicant to comply with reasonable standards and
rules adopted under this section.
new text end

new text begin (c) Upon receipt of an application and verification by the commissioner that the
applicant is in compliance with all applicable requirements, the commissioner shall issue a
license to the applicant.
new text end

new text begin (d) A license issued under this section shall be posted in a conspicuous place in a
public area within the facility. The issuance of a license does not guarantee adequacy of
individual care, treatment, personal safety, fire safety, or the well-being of any occupant of
such facility. A license is not assignable or transferable.
new text end

new text begin (e) The license shall be effective for one year following the date of issuance.
A license issued under this section shall apply only to the premises described in the
application and in the license issued thereon, and only one location shall be described
in each license.
new text end

new text begin (f) At the time application for a license is made, the applicant shall pay a license fee
in the amount of $500. Fees paid according to this section are not refundable.
new text end

new text begin (g) The commissioner may make exceptions to the standards in this section if
the commissioner determines that the health and welfare of the community require the
services of the hospital or outpatient surgical center and that the exceptions, as granted,
will have no significant adverse impact on the health, safety, or welfare of the patients of
the hospital or outpatient surgical center.
new text end

new text begin Subd. 3. new text end

new text begin License renewal. new text end

new text begin Applicants for an annual license renewal shall file an
application with the commissioner and pay the license fee according to subdivision 2.
Applicants for an annual license renewal shall also be subject to a licensing inspection
according to subdivision 5.
new text end

new text begin Subd. 4. new text end

new text begin Facility name. new text end

new text begin (a) No proposed facility shall be named, nor may any
existing facility have its name changed to, the same or similar name as any other facility
licensed according to this section. If a facility is affiliated with one or more other facilities
with the same or similar name, then the facility licensed under this section shall have the
geographic area in which it is located included as part of its name.
new text end

new text begin (b) A facility shall apply for an amended license by submitting an application to the
commissioner within 30 days after the occurrence of either:
new text end

new text begin (1) a change of ownership either by purchase or lease; or
new text end

new text begin (2) a change in the facility's name or address.
new text end

new text begin Subd. 5. new text end

new text begin Facility inspections. new text end

new text begin (a) The commissioner shall inspect each facility
licensed under this section at least twice each calendar year and at other times as the
commissioner determines necessary to protect the public health and safety and to
implement and enforce the provisions of this section and any rules adopted hereunder. At
least one unannounced inspection shall be made each calendar year and authorized agents
of the commissioner shall have access to a facility during regular business hours.
new text end

new text begin (b) Information received by the commissioner through filed reports, inspections, or
as otherwise authorized under this section is classified as private data on individuals
according to chapter 13 and shall not be disclosed publicly in any manner that would
identify individuals.
new text end

new text begin Subd. 6. new text end

new text begin Enforcement; penalties. new text end

new text begin (a) When the commissioner determines that
a facility is in violation of any applicable statute or rule relating to the operation or
maintenance of a licensed facility, the commissioner, upon proper notice, may deny,
suspend, or revoke the license of a facility, or assess a monetary penalty after notice and
an opportunity for hearing has been given to the licensee.
new text end

new text begin (b) Either before or after formal charges have been filed, the commissioner and the
facility may enter into a stipulation which shall be binding upon the commissioner and
the facility. The commissioner may enter findings of fact and issue an enforcement order
based on a stipulation without filing any formal charges or holding hearings in the case.
An enforcement order based on a stipulation may include any disciplinary action against
the facility authorized by this subdivision.
new text end

new text begin (c) The commissioner may temporarily suspend or limit the license of any facility if
the commissioner determines that there is reason to believe that grounds exist under this
section for immediate action against the facility and that the facility's continued operation
would constitute an imminent danger to the public health and safety.
new text end

new text begin (d) Violations of this section or rules adopted hereunder are one of the following:
new text end

new text begin (1) Class I violations are those that the commissioner determines present an
imminent danger to the health, safety, or welfare of the patients of the facility or present
a substantial probability that death or serious physical harm could result. A physical
condition, or practice, mean, method, or operation in use in a facility, may constitute
a violation. The condition or practice constituting a Class I violation shall be abated
or eliminated immediately unless a fixed period of time, as set by the commissioner,
is required for correction. Each day the violation exists after the expiration of time is
considered a subsequent violation.
new text end

new text begin (2) Class II violations are those other than Class I violations that the commissioner
determines to have a direct or immediate relationship to the health, safety, or welfare of
the facility's patients. The citation of a Class II violation shall specify the time in which
the violation must be corrected. Each day a violation exists after expiration of the time to
correct is considered a subsequent violation.
new text end

new text begin (3) Class III violations are those that are not classified as Class I or II or those that
are against the best practices as determined by the commissioner. The citation of a Class
III violation shall specify the time in which the violation must be corrected. Each day a
violation exists after expiration of the time to correct is considered a subsequent violation.
new text end

new text begin (e) The commissioner shall consider the following factors when determining the
severity of a violation:
new text end

new text begin (1) specific conditions and the impact or potential impact on the health, safety, or
welfare of the facility's patients;
new text end

new text begin (2) efforts by the facility to correct the violation;
new text end

new text begin (3) overall conditions of the facility;
new text end

new text begin (4) the facility's history of compliance; and
new text end

new text begin (5) any other pertinent conditions that may be applicable.
new text end

new text begin (f) Any monetary penalty assessed by the commissioner shall be assessed according
to the following schedule:
new text end

new text begin (1) for Class I violations, the following number of violations within a 24-month
period shall result in the corresponding penalty amount:
new text end

new text begin (i) one violation, a penalty of not less than $200 and not more than $1,000;
new text end

new text begin (ii) two violations, a penalty of not less than $500 and not more than $2,000;
new text end

new text begin (iii) three violations, a penalty of not less than $1,000 and not more than $5,000; and
new text end

new text begin (iv) four or more violations, a penalty of $5,000;
new text end

new text begin (2) for Class II violations, the following number of violations within a 24-month
period shall result in the corresponding penalty amount:
new text end

new text begin (i) one violation, a penalty of not less than $100 and not more than $200;
new text end

new text begin (ii) two violations, a penalty of not less than $200 and not more than $1,000;
new text end

new text begin (iii) three violations, a penalty of not less than $500 and not more than $2,000;
new text end

new text begin (iv) four violations, a penalty of not less than $1,000 and not more than $5,000; and
new text end

new text begin (v) five or more violations, a penalty of $5,000;
new text end

new text begin (3) for Class III violations, the following number of violations within a 24-month
period shall result in the corresponding penalty amount:
new text end

new text begin (i) one violation, there shall be no penalty;
new text end

new text begin (ii) two violations, a penalty of not less than $100 and not more than $500;
new text end

new text begin (iii) three violations, a penalty of not less than $200 and not more than $1,000;
new text end

new text begin (iv) four violations, a penalty of not less than $500 and not more than $2,000;
new text end

new text begin (v) five violations, a penalty of not less than $1,000 and not more than $5,000; and
new text end

new text begin (vi) six or more violations, a penalty of $5,000.
new text end

new text begin Subd. 7. new text end

new text begin Abortions must be performed in licensed facilities. new text end

new text begin Except in the case of
a medical emergency, as defined in this act, an abortion performed when the gestational
age of the unborn child is 22 weeks or more shall be performed in a hospital or outpatient
surgical center licensed according to this section. All other abortions shall be performed in
a hospital, outpatient surgical center, or clinic licensed according to this section, except
that a hospital or outpatient surgical center that does not meet the definition of an abortion
facility under this section and is licensed under section 144.55 may perform abortions.
new text end

new text begin Subd. 8. new text end

new text begin Criminal penalties; unprofessional conduct. new text end

new text begin (a) It is unlawful to operate
an abortion facility in Minnesota without possessing a valid license issued annually by the
commissioner according to this section.
new text end

new text begin (b) It is unlawful for a person to perform or induce an abortion unless the person is a
physician, with clinical privileges at a hospital located within 30 miles of the facility.
new text end

new text begin (c) A violation of paragraph (a) or (b) is a gross misdemeanor and constitutes
unprofessional conduct under section 147.091.
new text end

new text begin Subd. 9. new text end

new text begin Licensure requirements. new text end

new text begin (a) The commissioner shall adopt rules and
regulations for the licensure of abortion facilities.
new text end

new text begin (b) The commissioner 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 this section for clinics for the performance of abortions. At a
minimum these rules and regulations shall set standards for:
new text end

new text begin (1) adequate private space that is specifically designated for interviewing,
counseling, and medical evaluations;
new text end

new text begin (2) dressing rooms for staff and patients;
new text end

new text begin (3) appropriate lavatory areas;
new text end

new text begin (4) areas for hand washing prior to a procedure;
new text end

new text begin (5) private procedure rooms;
new text end

new text begin (6) adequate lighting and ventilation for abortion procedures;
new text end

new text begin (7) surgical or gynecologic examination tables and other fixed equipment;
new text end

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

new text begin (9) emergency exits to accommodate a stretcher or gurney;
new text end

new text begin (10) areas for cleaning and sterilizing instruments; and
new text end

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

new text begin (c) The commissioner shall adopt rules to set standards for facility supplies and
equipment, including supplies and equipment that must be immediately available for use
or in an emergency. At a minimum these rules shall:
new text end

new text begin (1) prescribe required equipment and supplies, including medications, required to
conduct, in an appropriate fashion, 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;
new text end

new text begin (2) require adequate equipment and supplies at the facility to ensure sufficient
quantities of clean and sterilized durable equipment and supplies to meet the needs
of each patient;
new text end

new text begin (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;
new text end

new text begin (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;
new text end

new text begin (5) require ultrasound equipment in facilities; and
new text end

new text begin (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.
new text end

new text begin (d) The commissioner shall adopt rules relating to facility personnel. At a minimum
these rules shall require that:
new text end

new text begin (1) the abortion facility designate a medical director of the facility who is licensed to
practice medicine and surgery in the state;
new text end

new text begin (2) physicians performing surgery in a facility are licensed to practice medicine and
surgery in the state, have demonstrated competence in the procedure involved, and are
acceptable to the medical director of the facility;
new text end

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

new text begin (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 must be
female;
new text end

new text begin (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;
new text end

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

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

new text begin (e) The commissioner shall adopt rules relating to the medical screening and
evaluation of each facility patient. At a minimum these rules shall require:
new text end

new text begin (1) a medical history including the following:
new text end

new text begin (i) reported allergies to medications, antiseptic solutions, or latex;
new text end

new text begin (ii) obstetric and gynecologic history; and
new text end

new text begin (iii) past surgeries;
new text end

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

new text begin (3) the appropriate laboratory tests including:
new text end

new text begin (i) 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;
new text end

new text begin (ii) a test for anemia as indicated;
new text end

new text begin (iii) Rh typing, unless reliable written documentation of blood type is available; and
new text end

new text begin (iv) other tests as indicated from the physical examination;
new text end

new text begin (4) an ultrasound evaluation for all patients who elect to have an abortion of an
unborn child. 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 by rule. 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
new text end

new text begin (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 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.
new text end

new text begin (f) The commissioner shall adopt rules relating to the abortion procedure. At a
minimum these rules shall require:
new text end

new text begin (1) that medical personnel is available to all patients throughout the abortion
procedure;
new text end

new text begin (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;
new text end

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

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

new text begin (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 recovery period until
the patient's condition is deemed to be stable in the recovery room.
new text end

new text begin (g) The commissioner shall adopt rules that prescribe minimum recovery room
standards. At a minimum, these rules shall require that:
new text end

new text begin (1) immediate postprocedure care consists of observation in a supervised recovery
room for as long as the patient's condition warrants;
new text end

new text begin (2) the facility arrange hospitalization if any complication occurs beyond the
management capability of the staff;
new text end

new text begin (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;
new text end

new text begin (4) a physician or nurse who is certified in advanced cardiovascular life support shall
remain on the premises of the facility until all patients are discharged or 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;
new text end

new text begin (5) a physician or trained staff member discusses Rho(d) immune globulin with
each patient for whom it is indicated and ensures 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 commissioner of the Department of Health shall be signed by the patient and a witness
and included in the medical record;
new text end

new text begin (6) written instructions with regard to postabortion activities, 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;
new text end

new text begin (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;
new text end

new text begin (8) the physician ensures 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
new text end

new text begin (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.
new text end

new text begin (h) The commissioner shall adopt rules that prescribe standards for follow-up visits.
At a minimum these rules shall require that:
new text end

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

new text begin (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
new text end

new text begin (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 these requirements, including the date, time, and identification by name of the person
making these efforts, shall be included in the patient's medical record.
new text end

new text begin (i) The commissioner shall adopt rules to prescribe minimum facility incident
reporting. At a minimum these rules shall require that:
new text end

new text begin (1) the facility record 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 ten 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;
new text end

new text begin (2) if a patient's death occurs, other than an unborn child's death properly reported
according to law, the facility shall report the death to the Department of Health no later
than the next department business day; and
new text end

new text begin (3) incident reports are filed with the Department of Health and appropriate
professional regulatory boards.
new text end

new text begin (j) The commissioner shall adopt rules requiring each facility to establish and
maintain an internal risk management program which, at a minimum, shall consist of:
new text end

new text begin (1) a system for investigation and analysis of the frequency and causes of reportable
incidents within the facility;
new text end

new text begin (2) measures to minimize the occurrence of reportable incidents and the resulting
injuries within the facility; and
new text end

new text begin (3) 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.
new text end

new text begin As used in this paragraph, "reportable incident" means an act by a health care
provider that: (i) is or may be below the applicable standard of care and has a reasonable
probability of causing injury to a patient; or (ii) may be grounds for disciplinary action by
the appropriate licensing agency.
new text end

new text begin (k) The rules adopted by the commissioner according to this subdivision do not limit
the ability of a physician or other health care professional to advise a patient on any
health issue. The commissioner shall periodically review and update current practice and
technology standards under this section and, based on current practice or technology,
amend adopted rules.
new text end

new text begin (l) The provisions of this section and the rules adopted according to this section are
in addition to any other laws that are applicable to facilities defined under this section.
new text end

new text begin (m) In addition to any other penalty provided by law, whenever the commissioner
determines a person has engaged, or is about to engage, in any act or practice that
constitutes, or will constitute, a violation of this section or rules adopted under this section,
the commissioner shall make application to a court of competent jurisdiction for an order
enjoining the act or practice, and upon a showing by the commissioner that the person has
engaged, or is about to engage, in a prohibited act or practice, an injunction, restraining
order, or other order shall be granted by the court without bond.
new text end

new text begin Subd. 10. new text end

new text begin Abortions to be performed by licensed physician. new text end

new text begin (a) No abortion
shall be performed or induced by any person other than a physician licensed to practice
medicine in this state. When RU-486 (mifepristone) or any drug is used for the purpose of
inducing an abortion, the drug must be administered by or in the same room and in the
physical presence of the physician who prescribed, dispensed, or otherwise provided the
drug to the patient.
new text end

new text begin (b) The physician inducing the abortion, or a person acting on behalf of the physician
inducing the abortion, shall make all reasonable efforts to ensure that the patient returns
12 to 18 days after the administration or use of such drug for a subsequent examination
so that the physician can confirm that the pregnancy has been terminated and assess the
patient's medical condition. A brief description of the efforts made to comply with this
paragraph, including the date, time, and identification by name of the person making the
efforts shall be included in the patient's medical record.
new text end

new text begin (c) A violation of this subdivision shall constitute unprofessional conduct under
section 147.091.
new text end

new text begin Subd. 11. new text end

new text begin Prohibited abortions. new text end

new text begin Nothing in this section shall be construed as
creating or recognizing a right to abortion. Notwithstanding any provision of this section,
a person shall not perform an abortion that is prohibited by law.
new text end

new text begin Subd. 12. new text end

new text begin Severability. new text end

new text begin If any one or more provision, section, subsection,
sentence, clause, phrase, or word of this section or the application thereof to any
person or circumstance is found to be unconstitutional, the same is hereby declared
to be severable and the balance of the section shall remain effective notwithstanding
such unconstitutionality. The legislature hereby declares that it would have passed this
section and each provision, section, subsection, sentence, clause, phrase, or word thereof,
irrespective of the fact that any one or more provision, section, subsection, sentence,
clause, phrase, or word be declared unconstitutional.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end