DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS
BUREAU OF COMMUNITY AND HEALTH SYSTEMS
LICENSING HEALTH FACILITIES OR AGENCIES
Filed with the secretary of state on
These rules become effective immediately after filing with the secretary of state unless adopted under section 33, 44, or 45a(9) of the administrative procedures act of 1969, 1969 PA 306, MCL 24.233, 24.244, or 24.245a. Rules adopted under these sections become effective 7 days after filing with the secretary of state.
(By authority conferred on the department of licensing and regulatory affairs by sections 20115, 20131, 20132, 20141, 20171, 21419, 21521, 21523, 21561, 21562, 21563, 21615, 21741, and 21795 of the public health code, 1978 PA 368, MCL 333.20115, 333.20131, 333.20132, 333.20141, 333.20171, 333.21419, 333.21521, 333.21523, 333.21561, 333.21562, 333.21563, 333.21615, 333.21741, and 333.21795, and Executive Reorganization Order Nos. 1994-1, 1996-1, 1997-4, 2003-1, 2009-20, 2011-4, and 2015-1, MCL 333.26322, 330.3101, 333.26324, 445.2011, 333.26366, 445.2030, and 400.227)
R 325.45101, R 325.45103, and R 325.45193 of the Michigan Administrative Code are amended, and R 325.45341 and R 325.45343 are rescinded, as follows:
R 325.45101 Applicability.
Rule 101. (1) Rules 325.45103 to 325.45323 are applicable to all of the following:
(a) Freestanding surgical outpatient facility.
(b) Hospice.
(c) Hospital.
(d) Nursing care facility.
(2) Rules 325.45331 to 325.45343
325.45339 are only applicable to a freestanding surgical outpatient
facility.
(3) Rules 325.45345 to 325.45367 are only applicable to a hospice.
(4) Rules 325.45369 to 325.45375 are only applicable to a hospital.
(5) Rules 325.45377 to 325.45385 are only applicable to a nursing care facility.
R 325.45103 Definitions; A to F.
Rule 103. (1) As used in these rules:
(a) “Anesthesia” means a state of loss of feeling or sensation and is normally used to denote the loss of sensation to pain that is purposely induced using a specific gas or drug to permit the performance of surgery or other painful procedure.
(b) “Anesthesiologist” means a
physician who specializes in the field of anesthesiology and who may or may not
be a diplomate of the physician’s his or her specialty board.
(c) “Anesthetic” means a drug, gas, or other agent used to abolish the sensation of pain. There are 3 classifications as follows:
(i) “General anesthetic” means an anesthetic agent that produces a temporary loss of consciousness by the administration of a gas; oral, intramuscular, or intravenous drugs; or a combination of these methods.
(ii) “Local anesthetic” means a drug whose action is limited to an area of the body around the site of its application.
(iii) “Spinal,” “epidural,” or “caudal” anesthetic means the injection of a local anesthetic into the spinal canal epidural area to produce a loss of sensitivity to the body areas at and below the sensory nerve distribution at the level of the injection.
(d) “Anesthetist” means an
individual a person who is qualified to administer anesthetic.
(e) “Applicant” means an
individual a person applying to the department for a health facility
or agency license.
(f) “Article 15” means article 15 of the code, MCL 333.16101 to 333.18838.
(g) “Article 17” means article 17 of the code, MCL 333.20101 to 333.22260.
(h) “Attending physician”
means that term as defined in section 20102(4) of the code, MCL 333.20102.
(i) “Authorized
representative” means that term as defined in section 20102(5) of the code, MCL
333.20102.
(jh) “Bereavement
services” means emotional, psychosocial, or spiritual support services provided
to the family before or after the death of the patient to assist the family in
coping with issues related to grief, loss, or adjustment.
(ki) “Building
change” means alterations to an existing building involving a change in the
interior configuration or intended use, including alterations to the
mechanical, electrical, or plumbing systems. This term does not include
routine maintenance or replacement with comparable mechanical, electrical, or
plumbing equipment that does not alter the current physical structure.
(lj) “Business
day” means a day other than a Saturday, Sunday, or any legal holiday.
(mk) “Change of
ownership” means the transfer of a health facility or agency from 1 owner to
another if the licensee changes. This term does not include a transfer of a
health facility or agency from 1 owner to another if the licensee does not
change.
(nl) “Code”
means the public health code, 1978 PA 368, MCL 333.1101 to 333.25211.
(om) “Complainant”
means an individual who files a complaint with the department alleging that a
person has violated the code, an order issued under the code, or administrative
rules promulgated thereunder.
(pn) “Correction
notice” means a notice from the department to a health facility or agency
specifying violations of the code or these rules, corrective action to be
taken, and the period in which the corrective action is to be completed.
(q) “County medical care
facility” means that term as defined in section 20104 of the code, MCL
333.20104.
(ro) “Department”
means the department of licensing and regulatory affairs.
(sp) “Discharge”
means that term as defined in section 21702(1) of the code, MCL
333.21702. In addition, as used in these rules, “discharge” means the
voluntary or involuntary movement of a patient out of any type of health
facility or agency.
(tq) “Freestanding
surgical outpatient facility” or “FSOF” means a facility as defined in section
20104(7) of the code, MCL 333.20104, and includes, but is not limited
to, a private practice office that performs 120 or more surgical abortions per
year and publicly advertises outpatient abortion services. Characteristics
of a freestanding surgical outpatient facility include, but are not limited to,
patient encounters with a physician, dentist, podiatrist, or other provider
primarily for performing surgical procedures or related diagnosis,
consultation, observation, and postoperative care, and the owner or operator
may make the facility available to other physicians, dentists, podiatrists, or
other providers who comprise its professional staff. This term does not
include a private office of a physician, dentist, podiatrist, or other health
professional whose patients are limited to those of the individual licensed
professional maintaining and operating the office or the combined patients of
individually licensed professionals practicing together in a legally
constituted professional corporation, association, or partnership and sharing
office space, if the private office is maintained and operated by a licensed
health professional in accordance with usual practice patterns according to the
type of practice and patient encounters in the office are for diagnosis and
treatment and are not limited primarily to the performance of surgical
procedures and related care.
(2) Unless otherwise specified, a term defined in the code has the same meaning when used in these rules.
R 325.45193 Surgical patient record; required information; informed consent.
Rule 193. (1) In addition to R 325.45191, a freestanding surgical outpatient facility and a hospital shall keep and maintain in the surgical patient record all of the following:
(a) Name of the surgeon.
(b) Name of the anesthesiologist or anesthetist, if other than the surgeon, if applicable.
(c) Preoperative study and diagnosis details if medically necessary.
(d) Provider notes including preoperative and postoperative vital signs and other relevant observations to document the patient’s stabilized condition at the time of discharge.
(e) Product name and dosage of any sedative and anesthetic used.
(f) Method of anesthesia and any pertinent information concerning results or reactions.
(g) Operation and treatment notes and consultations.
(h) The postoperative diagnosis, including pathological findings.
(i) Social or social service information relevant to the case.
(j) Surgeon's operative note including all of the following:
(i) Name of each procedure performed.
(ii) Duration of procedure and any unusual problems or occurrences encountered.
(iii) Surgeon's description of gross appearance of any tissues removed.
(k) Summary of instructions given for follow-up observation and care.
(2) The facility shall obtain
informed consent from a patient, or the responsible relative or guardian in the
case of an unemancipated minor, before the performance of a surgical procedure
and maintain the signed written consent form(s) form or forms in
the patient's record.
(3) A facility that
performs pregnancy terminations shall require that informed consent be obtained
in compliance with sections 17015 and 17015a of the code, MCL 333.17015 and
333.17015a. In the case of an unemancipated minor, informed consent must also
be obtained in compliance with the parental rights restoration act, 1990 PA
211, MCL 722.901 to 722.908.
R 325.45341 Counseling;
referral. Rescinded.
Rule 341. (1) A
freestanding surgical outpatient facility that performs 120 or more surgical
abortions per year and publicly advertises outpatient abortion services shall
make available and offer non-directive, non-coercive counseling and referral for
subsequent indicated care. These counseling and referral services may be
provided by a physician, physician’s assistant, nurse, social worker,
counselor, or other licensed health professional under article 15.
(2) The facility shall
maintain liaisons with and make indicated referrals to community counseling,
family planning, or other social and health service agencies to help assure
appropriate and adequate subsequent care of the patient.
(3) The individual who
provides the counseling shall consult with the physician concerning results of
counseling and the initiation of any referrals that seem necessary.
(4) An appropriate method
for providing information to and receiving information from legitimate referral
sources must be established.
R 325.45343
Waiver or modification provisions. Rescinded.
Rule 343. (1) In
accordance with section 20115(4) of the code, MCL 333.20115, for a freestanding
surgical outpatient facility that performs 120 or more surgical abortions per
year and publicly advertises outpatient abortion services, the department may
modify or waive 1 or more of the rules contained in part 9 of these rules.
(2) The licensee may submit
to the department a written request for variance.
(3) The variance may be
granted and remain in effect for as long as the facility continues to comply
with the conditions of the variance, or the variance may be granted for a set
period of time as designated in the variance approval.
(4) A variance that was
granted pursuant to licensure before the effective date of these rules remains
in effect for as long as the facility continues to comply with the conditions
of the variance.