DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS  
BUREAU OF COMMUNITY AND HEALTH SYSTEMS  
LICENSING HEALTH FACILITIES OR AGENCIES  
(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)  
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CONTENTS  
LICENSING HEALTH FACILITIES OR AGENCIES  
PART 1 – PART 10  
PART 1: GENERAL PROVISIONS  
PART 2: LICENSING  
PART 3: ADMINISTRATION  
SUBPART A: OWNERSHIP, GOVERNANCE, AND COMPLIANCE  
SUBPART B: POLICIES AND PROCEDURES  
SUBPART C: INFECTION PREVENTION AND CONTROL  
SUBPART D: EMERGENCY PREPAREDNESS  
SUBPART E: MEDICAL AUDIT AND UTILIZATION REVIEW  
SUBPART F: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT  
PROGRAM  
SUBPART G: CLOSURE  
PART 4: HUMAN RESOURCES  
PART 5: PATIENT AND ADMINISTRATIVE RECORDS  
PART 6: ANCILLARY CARE AND SERVICES  
PART 7: PATIENT RIGHTS AND RESPONSIBILITIES  
PART 8: COMPLAINTS, INVESTIGATIONS, AND HEARINGS  
SUBPART A: COMPLAINTS AND INVESTIGATIONS  
SUBPART B: HEARINGS  
PART 9: ENVIRONMENT OF CARE  
SUBPART A: PHYSICAL PLANT  
SUBPART B: MAINTENANCE, SANITATION, AND HOUSEKEEPING  
SUBPART C: COMMUNICATION AND SECURITY  
PART 10: SPECIAL REQUIREMENTS  
SUBPART A: FREESTANDING SURGICAL OUTPATIENT FACILITY  
SUBPART B: HOSPICE AND HOSPICE RESIDENCE  
SUBPART C: HOSPITAL  
SUBPART D: NURSING CARE FACILITY  
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PART 1: GENERAL PROVISIONS  
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 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.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45102 Application; rules; standards of care.  
Rule 102. The application of these rules, R 325.45101 to R 325.45385, by a health facility or  
agency and by the department shall be done in accordance with the services offered by the health  
facility or agency and relevant standards of care.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
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 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 a person who is qualified to administer anesthetic.  
(e) “Applicant” means 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.  
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(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.  
(j) “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.  
(k) “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.  
(l) “Business day” means a day other than a Saturday, Sunday, or any legal holiday.  
(m) “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.  
(n) “Code” means the public health code, 1978 PA 368, MCL 333.1101 to 333.25211.  
(o) “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.  
(p) “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.  
(r) “Department” means the department of licensing and regulatory affairs.  
(s) “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.  
(t) “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.  
Page 4  
(2) Unless otherwise specified, a term defined in the code has the same meaning when used in  
these rules.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45105 Definitions; G to L.  
Rule 105. As used in these rules:  
(a) “Governing body” means the person or persons who are legally responsible for the  
conduct of the health facility or agency, such as a board of directors or trustees. In the absence of  
an organized governing body, the owner, operator, or administrator shall carry out the functions  
of the governing body.  
(b) “Health facility or agency” means that term as defined in section 20106(1) of the code,  
MCL 333.20106, with the following exceptions:  
(i) An ambulance operation, aircraft transport operation, nontransport prehospital life  
support operation, or medical first response service.  
(ii) A health maintenance organization.  
(iii) A home for the aged.  
(c) “Hospice” means that term as defined in section 20106(4) of the code, MCL 333.20106  
(d) “Hospice administrator” means a person who is responsible to the hospice governing  
body, either directly or through the governing body’s chief executive officer, for the  
administrative operation of a hospice.  
(e) “Hospice interdisciplinary care team” means a group composed of, at a minimum, a doctor  
of medicine or osteopathy, a registered professional nurse, a social worker, and a pastoral or  
other counselor. One hospice staff member may represent more than 1 of the required  
disciplines on the hospice interdisciplinary care team for which the individual is qualified to  
practice and is licensed, if required.  
(f) “Hospice patient” means an individual in the terminal stage of an illness who has an  
anticipated life expectancy of 6 months or less and who has voluntarily requested admission and  
been accepted into a hospice.  
(g) “Hospice residence” means that term as defined in section 21401(1)(b) of the code, MCL  
333.21401.  
(h) “Hospice staff” means the individuals who work for the hospice, including volunteers.  
(i) “Hospital” means that term as defined in section 20106(5) of the code, MCL 333.20106.  
(j) “Hospital long-term care unit” means that term as defined in section 20106(6) of the code,  
MCL 333.20106.  
(k) “Involuntary transfer” means that term as defined in section 21702(3) of the code, MCL  
333.21702.  
(l) “License” means that term as defined in section 20108(2) of the code, MCL 333.20108.  
(m) “License record” means any of the following documents:  
(i) An application for a license.  
(ii) A copy of a license.  
(iii) Copies of reports of surveys and investigations made by or for the department.  
(iv) Responses of an applicant or licensee to the department.  
(v) Memoranda or other written communications with a licensee pertaining to the granting or  
denial of a license.  
Page 5  
(n) “Licensed bed capacity” means the authorized and licensed bed complement of a health  
facility as shown on or included within its license.  
(o) “Licensed practical nurse” means an individual who is licensed to practice nursing as a  
licensed practical nurse pursuant to part 172 of the code, MCL 333.17201 to MCL 333.17242.  
(p) “Licensee” means that term as defined in section 20108(3) of the code, MCL 333.20108.  
(q) “Long-term acute care hospital” means a specialty care hospital designed for patients with  
serious medical conditions that require intensive, special treatment for an extended period.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45107 Definitions; M to R.  
Rule 107. As used in these rules:  
(a) “Nursing care facility” means any of the following types of health facilities:  
(i) County medical care facility.  
(ii) Hospital long-term care unit.  
(iii) Nursing home.  
(b) “Nursing home” means that term as defined in section 20109(1) of the code, MCL  
333.20109.  
(c) “Nurse practitioner” means a registered professional nurse who has been granted a  
specialty certification in the health profession specialty field of nurse practitioner under section  
17210(1)(c) of the code, MCL 333.17210.  
(d) “Ownership” means the ownership or control of 5% or more of the equity in the capital of,  
or stock in, or interest in the profits of a health facility or agency.  
(e) “Patient” means that term as defined in section 21703(1) of the code, MCL 333.21703. In  
addition, “patient” means an individual who receives services from any type of health facility or  
agency.  
(f) “Patient and family unit” means a hospice patient and his or her relatives or other  
individuals with significant personal ties to the patient, who are designated by the hospice patient  
and the relative or individual by agreement.  
(g) “Patient room” means a room containing licensed patient beds. Patient room does not  
include rooms used for observation or preoperative or postoperative care.  
(h) “Patient’s representative” means that term as defined in section 21703(2) of the code,  
MCL 333.21703.  
(i) “Physician” means an individual licensed to engage in the practice of medicine or the  
practice of osteopathic medicine and surgery under part 170 or 175 of the code, MCL 333.17001  
to 333.17084 and 333.17501 to 333.17556. For a freestanding surgical outpatient facility, an  
individual licensed to engage in the practice of dentistry or podiatric medicine and surgery under  
part 166 or 180 of the code, MCL 333.16601 to 333.16659 and 333.18001 to 333.18058, when  
acting within his or her scope of practice, may carry-out the duties and responsibilities assigned  
to a physician in these rules.  
(j) “Physician’s assistant” means an individual licensed to engage in practice as a physician’s  
assistant under part 170 of the code, MCL 333.17001 to 333.17084.  
(k) “Registered professional nurse” means an individual who is licensed to practice nursing  
pursuant to part 172 of the code, MCL 333.17201 to 333.17242.  
(l) “Resident” means that term as defined in section 21703(4) of the code, MCL 333.21703.  
In addition, “resident” means an individual who resides in a residential health care facility.  
Page 6  
(m) “Residential health care facility” means a category of facilities in which long term health  
services are provided, including but not limited to a nursing care facility or hospice residence.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45109 Definitions; S to Z.  
Rule 109. As used in these rules:  
(a) “Supervision” means that term as defined in section 16109 of the code, MCL 333.16109.  
(b) “Surgery” means the treatment of human beings by a physician in an operating room,  
procedure room, examination room, or other setting as determined by the physician to safely  
perform 1 or more of the following procedures:  
(i) Cutting into any part of the body by surgical scalpel, electro-cautery, or other means for  
diagnosis; the removal or repair of diseased or damaged tissue, organs, tumors, or foreign bodies;  
or a Caesarean section.  
(ii) Reduction of fractures or dislocations of a bone, joint, or bony structure.  
(iii) Repair of malformations or body defects resulting from injury, birth defects, or other  
causes that require cutting and manipulation or suture.  
(iv) Instrumentation of the uterine cavity, including the procedure commonly known as  
dilatation and curettage, for diagnostic or therapeutic purposes.  
(v) Any instrumentation of or injection of any substance into the uterine cavity of a woman  
for terminating a pregnancy.  
(vi) Human sterilization procedures.  
(vii) Endoscopic procedures.  
(c) “Transfer” means that term as defined in section 21703(5) of the code, MCL 333.21703.  
In addition, “transfer” means the movement of a patient from one health facility or agency to  
another health facility or agency.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
PART 2: LICENSING  
R 325.45111 Application; application review process; licensure.  
Rule 111. (1) As authorized in article 17, an application for initial licensure or licensure  
change, including change in ownership, bed capacity, bed designation, location, and business  
name, must be made on the most recent applicable form authorized and provided by the  
department.  
(2) An application is not deemed complete by the department until all of the following are  
received:  
(a) Completed application form and required attachments.  
(b) Application or licensing fee as applicable.  
(c) Applicable certificate of need approval.  
(d) Applicable occupancy transmittal for the physical space.  
(3) The department shall conduct a pre-licensure survey within 3 months of an application for  
initiation being deemed complete.  
Page 7  
(4) Upon determination of compliance with article 17 and these rules, the department shall  
issue a license that identifies all of the following:  
(a) Name of the licensee person or entity.  
(b) Business name of the health facility or agency.  
(c) Physical address of the health facility or agency.  
(d) Type of health facility or agency.  
(e) Licensed bed capacity, if applicable.  
(5) The licensee shall post the license in a conspicuous public area of the health facility or  
agency.  
(6) Before a license may be transferred to a different owner through a change of ownership  
application, or transferred from one physical location to another physical location through an  
application to relocate the health facility or agency, the application must be approved by the  
department and the department shall issue a new license.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45113 License renewal process.  
Rule 113. (1) The renewal of a license must be completed through an electronic web-based  
system authorized and provided by the department.  
(2) A license is renewed and valid only upon electronic payment of the applicable renewal fee.  
(3) A license must be renewed before August 1 of each calendar year, unless otherwise  
specified on the license.  
(4) The department may require changes or corrections to a license prior to renewal.  
(5) If a license is not renewed within 30 days after the expiration date, the department may take  
any enforcement action authorized by section 20165 of the code, MCL 333.20165.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45115 Survey and evaluation process.  
Rule 115. (1) A pre-licensure survey must be scheduled and announced. All other licensure  
surveys and complaint investigations must be unannounced.  
(2) A licensure survey or complaint investigation may be conducted by the department during  
any hours of operation of the licensed health facility or agency.  
(3) An applicant or licensee shall provide access to the health facility or agency and relevant  
documents that are required to be maintained for the department to evaluate compliance with the  
code and these rules.  
(4) A department employee shall obtain the verbal consent of the patient or the patient’s  
representative before observing direct care and treatment of a patient.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45117 Waiver from licensure survey.  
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Rule 117. (1) The department shall provide and make publicly available a procedure for when  
a licensee may be eligible for a waiver from licensure survey. The procedure will include  
maintaining a list of approved accrediting bodies for health facilities or agencies.  
(2) On or before October 1 of each year, the department shall publish a list of health facilities  
and agencies to be visited for a state licensure survey in the next calendar year.  
(3) Providers who maintain accreditation from an approved accrediting agency may request a  
waiver from state licensure survey. Eligible licensees may request a waiver on or before  
November 1 of each year. A waiver request must be submitted on a form authorized by the  
department.  
(4) On or before January 1 of the survey year, the department will provide in writing an  
approval or denial of the waiver to the licensee.  
(5) Denial of a waiver request is not subject to an appeal and will result in an unannounced  
onsite state licensure survey and evaluation during the survey year.  
(6) An approved waiver does not prohibit the department from conducting an onsite state  
licensure survey and evaluation at any point in the future to protect the health, safety, and  
welfare of individuals receiving care and services in or from a health facility or agency.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
Rule 325.45119 Licensed bed capacity.  
Rule 119 (1) A licensee shall maintain the approved physical space to support the number of  
beds listed on the license in compliance with article 17 and these rules.  
(2) If a patient room is being utilized for another purpose, the department may reduce the  
licensee’s bed capacity if the licensee cannot demonstrate compliance with subrule (1) of this  
rule within 48 hours, unless the licensee has an approved building program agreement with the  
department in accordance with section 20144 of the code, MCL 333.20144.  
PART 3: ADMINISTRATION  
SUBPART A: OWNERSHIP, GOVERNANCE, AND COMPLIANCE  
R 325.45121 Ownership.  
Rule 121. Ownership, whether by the individual desiring to establish, conduct, or maintain a  
licensed health facility or agency, or by the authorized representative of an individual, co-  
partnership, corporation, or association desiring to establish, conduct, or maintain a health  
facility or agency, must be disclosed to the department upon initial licensure application.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45123 Governing body.  
Rule 123. (1) A licensee shall have an organized governing body that assumes responsibility  
for the management of the health facility or agency, the provision of all services, its fiscal  
operations, and continuous quality assessment and performance improvements.  
Page 9  
(2) The governing body is responsible for ensuring the establishment of policies and  
procedures for the management, operation, and evaluation of the health facility or agency. The  
governing body shall ensure that these policies and procedures are reviewed at least every 3  
years and revised as appropriate. Dates of reviews and revisions must be a matter of record in  
the health facility or agency.  
(3) The governing body shall meet according to its bylaws, but at least once a year, to carry out  
its obligations and shall keep a written record of its actions.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45125 Compliance; local; state; federal; law; rule; regulation; standard.  
Rule 125. (1) The applicant or licensee shall comply with applicable local, state, and federal  
laws, rules, regulations, and standards.  
(2) During review of an application or a licensure survey or complaint investigation, the  
department may request from the health facility or agency documentation of noncompliance  
from local, state, or federal authorities if such documentation exists.  
(3) The department may only cite this rule if the local, state, or federal authority that has  
jurisdiction over the specific law, rule, regulation, or standard has found the applicant or licensee  
to be non-compliant, in writing, and there is a need to protect the health, safety, and welfare of  
individuals receiving care and services in or from the health facility or agency.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45127 Fiscal audit.  
Rule 127. (1) The department may request financial documents including all of the following:  
(a) Invoices.  
(b) Purchase orders.  
(c) Order confirmations.  
(d) Receipts.  
(e) Other non-proprietary financial documents maintained in the normal course of business and  
that demonstrate the provision of care and services.  
(2) A request for financial documents in subrule (1) of this rule must be made only when the  
department requires these documents to evaluate the delivery of care and services in limited  
circumstances for state licensing purposes including bankruptcies or a state licensing survey that  
has clearly identified a lack of resources to support the care and services offered.  
(3) The department shall notify an applicant or licensee of information relied upon in issuing a  
decision. If the department relies on information other than that submitted by the applicant or  
licensee, the department shall cite the information it relied upon in its decision.  
(4) This rule does not limit the department's authority to consider other relevant financial  
information from other governmental entities. However, the department shall have a duty to  
maintain the confidentiality of this information.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
Page 10  
SUBPART B: POLICIES AND PROCEDURES  
R 325.45129 Admission; policy; procedure.  
Rule 129. (1) A health facility or agency shall have a written admission policy and procedure  
that is provided to the patient or any other person or agency responsible for the patient upon  
request.  
(2) An admitting diagnosis must be recorded promptly on each patient.  
(3) At the time of admission of a patient, a physician must be designated to be responsible for  
the medical care of the patient. This designation may be transferred to another physician who  
accepts responsibility for the medical care of the patient in accordance with the health facility or  
agency’s policy and procedures.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45131 Discharge; transfer; policy; procedure; planning.  
Rule 131. (1) A health facility or agency shall have a written discharge policy and procedure  
that is provided to the patient or any other person or agency responsible for the patient upon  
request.  
(2) A health facility or agency shall have a written transfer policy and procedure that is  
provided to the patient or any other person or agency responsible for the patient upon request.  
(3) In addition to subrule (2) of this rule, a nursing care facility shall have a written involuntary  
transfer policy and procedure in compliance with R 325.45385.  
(4) Discharge or transfer planning must be provided for each patient in conjunction with  
patient care planning.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
SUBPART C: INFECTION PREVENTION AND CONTROL  
R 325.45133 Infection prevention and control program.  
R 133. An applicant or licensee shall have an infection prevention and control program and  
allocate resources to provide all of the following:  
(a) A qualified health care professional must be designated in writing to be responsible for the  
program. The designee shall have completed training in the principles and methods of infection  
control and maintain qualification through ongoing education and training. Ongoing education  
and training may be demonstrated by any one of the following:  
(i) Certification in infection control (CIC).  
(ii) Certification as an ambulatory infection preventionist (CAIP).  
(iii) Completion of an infection control course.  
(iv) Participation in meetings that include infection control and are organized by recognized  
professional societies or other associations applicable to the services offered by the health  
facility or agency.  
(b) A designated, multi-disciplinary infection control team to collect, analyze, and report data.  
Page 11  
(c) Authority and procedures to conduct outbreak investigations.  
(d) Implementation of basic measures for infection prevention.  
(e) Prioritize infection control program needs and design infection control program initiatives  
accordingly.  
(f) Ongoing evaluation and revision of the infection prevention and control program.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45135 Infection prevention and control policies and procedures.  
Rule 135. (1) An applicant or licensee shall maintain written, evidence-based infection  
prevention and control policies and procedures that are appropriate for the services offered.  
These policies and procedures must be available in electronic or written format. These policies  
and procedures must represent the complexity of the healthcare provided and the characteristics  
of the patient population served.  
(2) The policies and procedures for standard precautions must include, but are not limited to,  
all of the following:  
(a) Hand hygiene.  
(b) Use of personal protective equipment.  
(c) Respiratory hygiene and cough etiquette.  
(d) Safe injection practices.  
(e) Safe handling of potentially contaminated equipment or surfaces in the patient  
environment, which for hospice agencies includes a private residence.  
(3) The policies and procedures for transmission-based precautions must include, but are not  
limited to, all of the following:  
(a) Contact precautions.  
(b) Droplet precautions.  
(c) Airborne precautions.  
(d) Multi-route transmission-based precautions.  
(4) The policies and procedures for a sanitary and functional environment must include, but are  
not limited to, all of the following:  
(a) Cleaning and disinfecting environmental surfaces, floors, and furniture.  
(b) Cleaning and disinfecting objects that are shared by patients, staff, and visitors.  
(c) Disposal of regulated and non-regulated medical and non-medical waste.  
(d) Screening for and management of patients infested with ectoparasites.  
(e) With the exception of a hospice patient’s private residence, single use disposable hand  
towels must be used for hand hygiene. The use of a common-use hand towel is prohibited.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45137 Ongoing surveillance and prevention program; communicable disease  
reporting.  
Rule 137. The applicant or licensee shall provide and maintain an ongoing surveillance and  
prevention program that includes, but is not limited to, all of the following:  
(a) An active surveillance program for infection detection through ongoing data collection  
and analysis that includes patients and personnel who have access to or contact with active  
Page 12  
patient care areas, and other individuals identified by the health facility or agency policies and  
procedures.  
(b) Communicable disease reporting in compliance with section 5111 of the code, MCL  
333.5111, and the communicable and related diseases rules, R 325.171 to R 325.199.  
(c) An ongoing program to prevent, control, and investigate healthcare associated infections.  
(d) Implementation of healthcare associated infections risk mitigation including, but not  
limited to, all of the following:  
(i) Monitoring personnel hand hygiene.  
(ii) Monitoring infections caused by organisms that are multidrug-resistant.  
(iii) Monitoring device-associated infections.  
(iv) Monitoring antibiotic use.  
(v) Monitoring safe practices for injecting medication, saline, or other infusates.  
(vi) Monitoring use of disinfectants and germicides in accordance with manufacturers’  
instructions.  
(vii) Monitoring use of medical equipment, including air filtration equipment, ultra-violet  
lights, and other equipment used to control the spread of infectious agents in accordance with  
manufacturers’ recommendations.  
(viii) Monitoring sterilization and disinfection practices and reporting failures.  
(ix) Monitoring cleaning procedures used in patient care areas.  
(x) Monitoring surgical services in accordance with standards of care for all of the  
following:  
(A) Appropriate use of antibiotic prophylaxis to prevent surgical site infection, such as  
protocol to assure that antibiotic prophylaxis to prevent surgical site infection for procedures is  
administered at the appropriate time, done with an appropriate antibiotic, and discontinued  
appropriately after surgery.  
(B) Aseptic technique practices are used in surgery, including sterilization or high-level  
disinfection of instruments, as appropriate.  
(C) Skin antisepsis methods.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45139 Personnel; communicable disease screening; immunization; mitigation.  
Rule 139. (1) An applicant or licensee shall adopt written policies and procedures to ensure  
that all of the following communicable disease prevention measures are implemented:  
(a) Evaluation of the immunization status of personnel for vaccine preventable diseases as  
designated in the “Healthcare Personnel Vaccination Recommendations,” 2017 edition,  
published by the Immunization Action Coalition (IAC). These recommendations are adopted by  
reference and are available for inspection and distribution at cost at the Lansing office of the  
Department of Licensing and Regulatory Affairs. They are available free of charge at the  
Immunization Action Coalition, 2550 University Avenue West, Suite 415 North, Saint Paul, MN  
(b) Identification of the authority and circumstances under which the licensee screens  
personnel for infections likely to cause spread of communicable disease or other risks to exposed  
patients and personnel.  
(c) Identification of the authority and circumstances under which the licensee restricts  
personnel who are infectious from providing direct patient care or from entry into the health  
Page 13  
facility or agency, as recommended by the Centers for Disease Prevention and Control (CDC) in  
its “Guideline for Infection Control in Health Care Personnel 1998,” published in the American  
Journal of Infection Control, v. 23, no. 3, p. 289-354. This guideline is adopted by reference and  
is available for inspection and distribution at cost at the Lansing office of the Department of  
Licensing and Regulatory Affairs. It is available free of charge at  
(2) A licensee shall screen employees upon hire for communicable disease, including  
tuberculosis (TB).  
(3) A licensee shall follow the “CDC Guidelines for Preventing the Transmission of  
Mycobacterium tuberculosis in Health-Care Settings, 2005,” published in MMWR 2005; 54 (No.  
RR-17); and, the 2019 update to these recommendations by Sosa LE, Njie GJ, Lobato MN, et al.  
Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel:  
Recommendations from the National Tuberculosis Controllers Association and CDC, 2019.  
MMWR Morb Mortal Wkly Rep 2019;68439-443. DOI:  
are available for inspection at the Lansing office of the Department of Licensing and Regulatory  
Affairs. They are available free of charge at  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45141 Infection control education and training.  
Rule 141. (1) The licensee shall maintain an ongoing program of education and training on  
methods to prevent or reduce the transmission of infectious agents for all personnel upon hire  
and at ongoing intervals as applicable, including employees, onsite contract workers, medical  
providers, students, medical residents, and volunteers.  
(2) The licensee shall document compliance with initial and ongoing training for personnel in  
methods of infection prevention and control.  
(3) The licensee shall make available information to patients and visitors on methods to  
prevent or reduce the transmission of infectious agents within the health facility or agency.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45143 Infection prevention and control program; quality assurance and  
performance improvement.  
Rule 143. (1) The applicant or licensee shall document how its infection prevention and  
control program is integrated into its quality assurance and performance improvement program.  
Documentation must include, but is not limited to, both of the following:  
(a) Actions taken in response to data analysis to improve infection control performance and  
patient outcomes.  
(b) Infection prevention activities, including the measures selected for monitoring, data  
collection, analytical methods, actions taken, and outcomes.  
(2) Infection prevention and control and quality assurance and performance improvement  
activities must be continuous and ongoing based on surveillance data results.  
Page 14  
(3) Monitoring may include follow-up with patients after discharge to gather evidence of  
whether the patient has developed an infection associated with their stay with the licensee.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45145 Employee; health; communicable disease.  
Rule 145. (1) The licensee shall ensure that an employee is free from communicable disease.  
A health facility or agency shall maintain employee files containing baseline screening for  
communicable diseases or immunizations, and records of illness and accidents occurring on duty.  
(2) Employees, contract personnel, students, volunteers, and other persons who have direct  
physical contact with patients or food while providing care or services in the facility may  
participate only when free of signs of infection.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
SUBPART D: EMERGENCY PREPAREDNESS  
R 325.45147 Emergency preparedness program.  
Rule 147. The applicant or licensee shall have an all-hazard emergency preparedness program  
to meet the health and safety needs of its patient population and personnel. The emergency  
preparedness program must provide guidance on how to respond to emergency situations that  
could impact the operation of the health facility or agency, such as natural or man-made  
disasters. The emergency preparedness program must include all of the following components:  
(a) A risk assessment.  
(b) A written emergency response plan.  
(c) Written policies and procedures that support the successful execution of the emergency  
response plan.  
(d) A written communication plan.  
(e) A written training and testing plan.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45149 Risk assessment.  
Rule 149. (1) An applicant or licensee shall conduct a risk assessment or use a risk assessment  
conducted by its municipal or county emergency management agency. If an emergency  
management agency’s risk assessment is used, the applicant or licensee shall maintain a copy of  
it and is required to work with the agency that developed it to ensure that the facility’s  
emergency response plan is in alignment. The risk assessment must be used to assist the health  
facility or agency to address the needs of its patient population, identify essential services and  
vendors to provide support during an actual emergency, and identify alternate service providers  
and vendors to assure continuity of operations.  
(2) The risk assessment must be available to the department upon request.  
Page 15  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45151 Emergency response plan.  
Rule 151. (1) An applicant or licensee shall have a written emergency response plan. The plan  
must be based on the risk assessment.  
(2) The emergency response plan must address capacities and capabilities critical for a  
response to and recovery from the types of emergencies likely to impact the health facility or  
agency that could result in 1 of the following:  
(a) Equipment and power failures.  
(b) Interruptions in communications that could include cyber-attacks.  
(c) Loss of all or a portion of a physical facility.  
(d) Extraordinary staffing shortages where the health facility or agency continues to operate.  
(e) Interruptions in the normal supply of essentials such as food and water, medications, or  
medical supplies including medical gases where the health facility or agency continues to  
operate.  
(3) The licensee shall review, update, and approve the emergency response plan annually.  
(4) The emergency response plan must be available to the department upon request.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45153 Policies and procedures for emergency preparedness.  
Rule 153. (1) An applicant or licensee shall have written policies and procedures for  
emergency preparedness and recovery that are based on the risk assessment.  
(2) The policies and procedures must address, but are not limited to, all of the following  
subjects:  
(a) Subsistence needs of patients receiving inpatient or residential services.  
(b) Evacuation.  
(c) Shelter in place.  
(d) Tracking patients and personnel.  
(e) Patient transfers for continuity of care that may include transfer agreements or other  
arrangements based upon the services offered and needs of the patients.  
(f) Preservation and transfer of patient records.  
(g) Continuity of operations and recovery.  
(3) The policies and procedures must be available to the department upon request.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45155 Communication plan.  
Rule 155. (1) As part of its emergency preparedness program, an applicant or licensee shall  
have a written communication plan. The communication plan must include, but is not limited to,  
notification of the following as appropriate to the emergent event:  
(a) Local emergency response agencies.  
(b) Personnel.  
(c) Patients.  
Page 16  
(d) Patient’s guardian, family, or other persons designated by the patient.  
(e) Patient’s physician.  
(f) Utility maintenance and repair vendors.  
(g) Information management support.  
(h) Other essential suppliers and vendors.  
(i) The department.  
(2) The communication plan must include a provision for the transfer of patients and their  
records to a receiving health facility or agency.  
(3) The communication plan must be available to the department upon request.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45157 Emergency preparedness training and testing program.  
Rule 157. (1) An applicant or licensee shall develop and implement an emergency  
preparedness training and testing program. The training and testing program must include initial  
emergency response training for new and existing personnel, as well as annual refresher  
trainings.  
(2) Each year the licensee shall exercise its emergency response plan at least twice. This  
requirement may be fulfilled by participating in 1 or more community-based exercises, facility-  
based exercises, or by activating its emergency plan in response to one or more actual incidents.  
One of the two exercises may be a paper-based table-top exercise.  
(3) The training and testing program plan, exercise manual, and after-action reports must be  
retained for a minimum of 4 years or according to the licensee’s records retention schedule,  
whichever is longer; and they must be available to the department upon request.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
SUBPART E: MEDICAL AUDIT AND UTILIZATION REVIEW  
R 325.45159 Medical audit; utilization review; document access.  
Rule 159. (1) A health facility or agency shall establish a process for medical audits of  
individual patient cases. Medical audits shall be conducted on a representative sample of patient  
cases. A medical audit is to ensure proper documentation of clinical information, continuity and  
coordination of patient care, and the quality and safety of medical and other health care services  
provided.  
(2) A health facility or agency shall establish a process for utilization review of care and  
services on a systemic and aggregated basis. A utilization review is to ensure the provision and  
utilization of health care services provided in terms of cost, effectiveness, efficiency, and quality.  
(3) Medical audit and utilization review documents may be accessed by the department during  
a survey or complaint investigation when necessary to determine compliance with the code and  
these rules. The department shall maintain and protect these documents in accordance with state  
and federal laws, including privacy laws.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
Page 17  
SUBPART F: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT  
PROGRAM  
R 325.45161 Quality assessment and performance improvement program.  
Rule 161. The governing body shall ensure the health facility or agency has a quality  
assessment and performance improvement program that is defined, implemented, maintained,  
and includes all of the following:  
(a) Addresses identified priorities.  
(b) Evaluates improvements for effectiveness.  
(c) Specifies data collection methods, frequency, and detail.  
(d) Establishes an expectation for patient safety and quality health care services.  
(e) Allocates staff, time, information systems, and training to implement the quality  
assessment and performance improvement program.  
(f) Is evaluated and revised on a periodic basis in accordance with the applicable subject  
matter.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45163 Quality assessment and performance improvement program; monitor  
quality; ongoing program; measurable improvements.  
Rule 163. (1) The quality assessment and performance improvement program must monitor  
quality in all areas of operations that may adversely affect patient care or core services,  
demonstrate measurable improvements in patient health or palliative outcomes, and improve  
patient safety.  
(2) A quality assessment and performance improvement program must:  
(a) Be data driven.  
(b) Identify problems.  
(c) Reduce medical errors.  
(d) Improve patient safety.  
(e) Evaluate systems and processes.  
(f) Be ongoing.  
(3) The selection and prioritization of quality assessment and performance improvement  
program activities must be based on the complexity and scope of services provided and focus on  
high risk, high volume, problem-prone areas, and new services provided.  
(4) Data collected must be used to:  
(a) Monitor effectiveness and safety of services.  
(b) Monitor quality of care.  
(c) Act to make improvements.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45165 Performance improvement initiatives; indicators.  
Page 18  
Rule 165. The quality assessment and performance improvement program must establish  
performance improvement initiatives that focus on high risk, high volume, and problem-prone  
areas. If no performance improvement projects are conducted in a calendar year, justification  
explaining why no performance improvement projects were conducted must be documented.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45167 Documentation; evidence; program activities; data usage.  
Rule 167. A health facility or agency shall maintain documentation and demonstrate evidence  
of an ongoing quality assessment and performance improvement program that includes both of  
the following:  
(a) Methods and reports demonstrating systematic identification, reporting, investigation,  
analysis, and prevention of adverse events.  
(b) Documentation demonstrating the development, implementation, and evaluation of  
corrective actions resulting from quality assessment and performance improvement activities.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
SUBPART G: CLOSURE  
R 325.45169 Proposed closure of a health facility or agency; notification; closure plan;  
patient referral package.  
Rule 169. (1) At least 30 days prior to the proposed closure date, a licensee shall notify the  
department in writing and identify all of the following:  
(a) The name and address of the health facility or agency.  
(b) The proposed closure date.  
(c) The patient census at the time of notification.  
(d) The name, title, telephone number, and email address of the individual who is designated  
by the governing body to serve as the contact person for the closure process.  
(2) The department may modify, at its discretion, requirements and timeframes set forth in  
this rule upon a showing of good cause and solely for the purposes of an involuntary or  
emergency closure. The department shall not modify any provision that will affect the safety and  
welfare of patients.  
(3) A licensee shall submit a closure plan to the department. The licensee shall not initiate  
any closure activity until the department reviews and approves the closure plan. If the  
department disapproves a closure plan, the licensee will have the opportunity to correct and  
resubmit the plan for additional review.  
(4) The closure plan must include all the following as applicable to the services offered:  
(a) A timeline and system to discontinue admissions.  
(b) A method to ensure adequate staffing throughout the closure process.  
(c) Provisions for the maintenance, storage, and safekeeping of patient records and, if  
applicable, by including the name of the organization, the address, and the contact information  
where patient records will be stored, pursuant to sections 20175 and 20175a of the code, MCL  
333.20175 and 333.20175a.  
Page 19  
(d) Provisions for notifying all affected state, federal, and local governmental authorities of  
the proposed closure.  
(e) The voluntary surrendering of any license and federal certification, including any de-  
licensure or transfer of licensed beds.  
(f) The disposition of onsite drugs, biologicals, chemicals, and radioactive materials.  
(g) Appropriate methods for labeling, safekeeping, and transferring patients’ belongings  
during relocation.  
(h) A method to identify a new health facility or agency or other appropriate location for  
each patient that includes all of the following:  
(i) Assessment of patient needs.  
(ii) Determination regarding availability of bed space in local health facilities or agencies.  
(iii) Provision of information to patients and families about other health facilities or  
agencies.  
(iv) Evaluation of patient and family needs concerning geographic location, public  
transportation, and type of health facility or agency.  
(5) At the time of discharge or transfer of a patient, the licensee shall prepare and deliver a  
referral package, in a secure manner, to each patient and individuals designated by the patient,  
and to a receiving facility, if applicable. The referral package must include, but is not limited to,  
all of the following:  
(a) A current patient assessment, medical evaluation, and care plan.  
(b) Medication and treatment records.  
(c) Discharge summary, if the patient is being discharged.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
PART 4: HUMAN RESOURCES  
R 325.45171 Administrator.  
Rule 171. (1) The governing body shall appoint one individual who is responsible for  
managing the health facility or agency, including but not limited to the following duties:  
(a) Directing all day-to-day activities.  
(b) Ensuring the implementation of all policies and procedures.  
(c) Ensuring regulatory compliance.  
(2) For a hospital, this individual shall be the Chief Executive Officer.  
(3) For a nursing home, this individual shall be a Nursing Home Administrator licensed  
pursuant to part 173 of the code, MCL 333.17301 to 333.17319.  
(4) This role may be delegated, in writing, to another qualified individual as needed to assure  
continuity of operations and in accordance with the health facility or agency’s policy.  
(5) If a licensed nursing home administrator is also licensed as a registered professional nurse,  
and the nursing home has less than 50 licensed nursing home or long-term care beds, then the  
nursing home administrator may also serve as the director of nursing.  
(6) As used in this rule, “nursing home” does not include a hospital long-term care unit or an  
extended care services program, commonly known as a swing bed program.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
Page 20  
Editor's Note: An obvious error in R 325.45171 was corrected at the request of the promulgating agency, pursuant to  
Section 56 of 1969 PA 306, as amended by 2000 PA 262, MCL 24.256. The rule containing the error was published  
in Michigan Register, 2020 MR 4. The memorandum requesting the correction was published in Michigan Register,  
2020 MR 4.  
R 325.45173 Medical Staff.  
Rule 173. (1) The governing body shall ensure that medical staff requirements are met and that  
the medical staff is accountable to the governing body.  
(2) A physician must be designated as the leader of the medical staff and be assigned the  
responsibility for the organization and conduct of the medical staff.  
(3) The leader of the medical staff may delegate this role in writing to another qualified  
physician as needed to ensure continuous medical direction and in accordance with the health  
facility or agency’s policy.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45175 Director of nursing.  
Rule 175. (1) A health facility or agency shall designate a registered professional nurse to  
serve as the director of nursing.  
(2) The director of nursing shall direct all nursing services.  
(3) A health facility or agency may assign a different title to this position.  
(4) The director of nursing may delegate this role in writing to another qualified registered  
professional nurse as needed to ensure continuous nursing services and in accordance with the  
health facility or agency’s policy.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45177 Nursing personnel.  
Rule 177. At all times during each shift, a health facility or agency shall meet the minimum  
staffing requirements specified in the code. For the purposes of determining compliance with  
nursing personnel-to-patient ratios specified in the code, a member of the nursing staff who  
works less than 2 continuous hours may be counted as part of full-time equivalent personnel only  
if such member was scheduled to work more than 2 continuous hours.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45179 Independently licensed health professional.  
Rule 179. A health facility or agency may employ, contract, or grant privileges to a qualified  
individual who is independently licensed to practice a health profession pursuant to article 15 of  
the code.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
Page 21  
R 325.45181 Ancillary personnel.  
Rule 181. A health facility or agency may employ or contract ancillary personnel to assist in  
patient care within the areas of their competence if the individual is adequately trained and  
working under appropriate supervision.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45183 Employee records.  
Rule 183. A health facility or agency shall maintain a record for each employee that includes  
all of the following:  
(a) Relevant professional license or registration number.  
(b) Relevant credentialing and education.  
(c) Beginning date of employment and position for which employed.  
(d) Results of baseline screening for communicable disease as set forth in R 325.45139.  
(e) For former employees, the date employment is severed.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45185 Credentialing; clinical privileges; policy; procedure; record.  
Rule 185. A health facility or agency shall maintain policies and procedures for the  
credentialing and granting of clinical privileges to medical and allied health professionals.  
Records must be maintained and include the individual’s education, training, and experience.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
PART 5: PATIENT AND ADMINISTRATIVE RECORDS  
R 325.45191 Patient record; required information.  
Rule 191. (1) A health facility or agency shall keep and maintain a record for each patient in  
compliance with sections 20175 and 20175a of the code, MCL 333.20175 and 333.20175a.  
(2) The patient record must include, as a minimum, all of the following:  
(a) Patient identification, including name, address, and birthdate.  
(b) Admission date or date services are initiated.  
(c) Information submitted by a referral source, if any.  
(d) Admitting diagnosis.  
(e) Medical history and physical examination.  
(f) Clinical diagnostic tests and findings.  
(g) Physician and other health professional orders.  
(h) Health professional progress notes.  
(i) Medication and treatment records.  
(j) Notes and observations by other personnel providing care.  
(k) Final diagnosis, including pathological findings if any.  
(l) Record of discharge, transfer, or death.  
Page 22  
(m) Patient designated representative for care, if applicable, and emergency contact  
information.  
(n) Consent forms as required and appropriate.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
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) 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.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45195 Hospice patient record; additional requirement.  
Rule 195. In addition to R 325.45191, a hospice agency or residence shall keep and maintain in  
the patient record the individual’s terminal prognosis in compliance with section 21417 of the  
code, MCL 333.21417.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45197 Nursing care facility patient record; additional requirements.  
Rule 197. In addition to R 325.45191, a nursing care facility shall document in the patient  
record that a clinical history and physical examination was performed by a physician within 5  
Page 23  
days before or on admission, including a physician’s treatment plan. The patient’s record must  
be completed within 30 days following discharge.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45199 Standing order; written order; verbal order; telephone order.  
Rule 199. (1) Treatment rendered to a patient must be in accordance with the specific  
standing, written, verbal, or telephone order of a physician or other licensed health professional  
ordering within their scope of practice and clinical privileges.  
(2) Standing and written orders must be recorded in the patient record and be signed by the  
licensed health professional who issued the order in accordance with the policy of the health  
facility or agency.  
(3) When verbal or telephone orders are used, they must only be accepted by persons who are  
authorized to do so by the health facility or agency’s policy and procedures consistent with  
federal and state law. Orders must be recorded in the patient record, restated back to the  
ordering licensed health professional, and then signed by the person who recorded the order.  
The licensed health professional who issued the order shall subsequently sign the order in  
accordance with the health facility or agency’s policy and procedures.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45201 Administrative record.  
Rule 201. (1) A health facility or agency shall maintain administrative records that include all  
of the following:  
(a) Daily census records.  
(b) Staffing records.  
(c) Incident and accident reports.  
(d) Transfer of patient to hospital records.  
(2) The retention of administrative records is 1 year or in accordance with the health facility or  
agency’s record retention schedule, whichever is longer.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45203 Patient and administrative records; storage.  
Rule 203. (1) Patient and administrative records must be preserved and readily available to  
assure necessary access by appropriate health care professionals and staff to deliver needed care.  
(2) Records must be secured to assure confidentiality and protect them from access by  
unauthorized persons and maintained in accordance with section 20175 of the code, MCL  
333.20175.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
Page 24  
R 325.45205 Patient and administrative records; survey and review by department;  
confidentiality.  
Rule 205. (1) Relevant patient and administrative records must be available for survey and  
complaint investigation by an employee assigned by the department as a surveyor.  
(2) Records must be maintained as confidential documents with the following exceptions:  
(a) Information required under these rules.  
(b) Information required by law.  
(c) Information authorized for disclosure by written release of the patient or the patient’s  
designated representative.  
(3) Notwithstanding subrule (2) of this rule, a health care facility or agency shall maintain the  
confidentiality of all non-essential information and documents.  
(4) The department shall maintain records received as confidential to the extent permitted by  
law.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45207 Data collection; informal advisory group.  
Rule 207. (1) In addition to the collection of information and documents necessary to  
determine compliance during a licensure survey or complaint investigation, the department may  
also collect non-personally identifiable patient information and aggregated data from licensees  
including, but not limited to, all of the following:  
(a) Availability of services.  
(b) Hours of operation.  
(c) Demographic data.  
(d) Morbidity and mortality data.  
(e) Volume of care provided to patients.  
(2) Prior to any data collection under this rule, the department shall establish an informal  
advisory group, with representation from providers, to determine the data elements to be  
collected.  
(3) The licensee shall provide the required data on an individual basis for each licensed site in a  
format and media designated by the department.  
(4) The department may elect to verify the data through onsite review of appropriate records.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
PART 6: ANCILLARY CARE AND SERVICES  
R 325.45211 Laboratory services.  
Rule 211. Where medically necessary, a health facility or agency shall provide, directly or  
through contract, laboratory services. These laboratory services must be in compliance with the  
Clinical Laboratory Improvement Amendments (CLIA) regulations, 42 CFR part 493 (2017).  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
Page 25  
R 325.45213 Radiological and imaging services.  
Rule 213. (1) Where medically necessary, a health facility or agency shall provide, directly or  
through contract, radiological and imaging services.  
(2) These services must be offered on a regular schedule based on the health facility’s or  
agency’s hours of operation.  
(3) The staff responsible shall be trained, qualified, and competent for the services being  
offered. The health facility or agency shall maintain documentation demonstrating the staff’s  
training, qualifications, and competencies.  
(4) A health facility or agency shall have written policies and procedures for the maintenance  
of equipment related to this service that consider applicable manufacturers’ guidelines.  
(5) The health facility or agency shall immediately document any adverse testing or machine  
error that may cause an adverse patient reaction. Investigation and corrective action must be  
initiated promptly. Any investigation and corrective action taken in response to an adverse  
patient reaction must be reported to the appropriate licensed health care professional and  
recorded in the patient’s record.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45215 Pharmacy services.  
Rule 215. (1) Medical supplies and appliances, durable medical equipment, drugs and  
biologicals related to patient care and treatment, as identified in the patient’s plan of care, must  
be provided by the health facility or agency while the patient is under its care.  
(2) Where medically necessary, a health facility or agency shall provide, directly or through  
contract, pharmacy services.  
(3) Pharmacy services offered directly within a health facility or agency must be licensed. A  
health facility or agency contracting pharmacy services shall ensure these services are licensed.  
(4) These services must be offered on a regular schedule based on the health facility’s or  
agency’s hours of operation.  
(5) The staff responsible must be trained, qualified, and competent for the services being  
offered. A health facility or agency shall maintain documentation demonstrating the staff’s  
training, qualifications, and competencies.  
(6) A health facility or agency shall have written policies and procedures for both of the  
following:  
(a) Drug control.  
(b) Maintenance of equipment related to this service that consider applicable manufacturers’  
guidelines.  
(7) Pharmacy services offered must be appropriate to the patient needs and treatment and  
recorded in the patient’s record. Medication and other pharmaceutical services must be provided  
on the order of a licensed health professional authorized to do so under article 15.  
(8) All medications and other pharmaceutical products must be properly labeled and identified  
with pertinent information such as use, storage, expiration, and other necessary information.  
(9) A health facility or agency shall comply with the Clinical Laboratory Improvement  
Amendments (CLIA) regulations, 42 CFR part 493 (2017), as related to pharmacy services and  
as applicable.  
Page 26  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45217 Dietary services.  
Rule 217. A health facility or agency that offers dietary services shall do all of the following:  
(a) Meet all the dietary and nutritional needs of the patient in accordance with the patient  
assessment and treatment plan.  
(b) Obtain a diet order for each patient upon admission, written by a physician or other  
qualified health professional, based on patient condition, diagnosis, food restrictions,  
preferences, and nutritional assessment. After the diet order is obtained, information must be  
provided to the patient regarding their diet order and how the patient can make food choices from  
the offerings on the facility menu.  
(c) Offer nutrition counseling and interventions to patients regarding appropriate nutritional  
intake in accordance with their condition and treatment plan. Nutrition counseling must be  
provided by a qualified individual.  
(d) Develop and adopt policies and procedures including a diet manual that outlines facility  
diet orders.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45219 Communication services.  
Rule 219. A health facility or agency shall assure the availability of appropriate methods and  
tools to communicate with patients who are non-English speaking or have communication  
impairments. While a patient is receiving services, a health facility or agency shall safeguard  
any patient sensory items such as eye glasses, dentures, and hearing aids.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45221 Transportation services.  
Rule 221. (1) A health facility offering inpatient or residential services shall arrange and  
provide for appropriate transportation services if diagnostic, medical, or other services are  
necessary and not available onsite.  
(2) Excluding a hospital with an emergency department, a health facility or agency shall have  
protocols for obtaining emergency transportation services for patients requiring emergency  
medical treatment. When indicated, a qualified health professional from the health facility or  
agency shall accompany a patient requiring transfer to a facility for emergency medical  
treatment.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
PART 7: PATIENT RIGHTS AND RESPONSIBILITIES  
Page 27  
R 325.45231 Patient rights and responsibilities; policies and procedures.  
Rule 231. (1) A health facility or agency shall develop, adopt, implement, post, and distribute  
written policies and procedures to protect the rights and responsibilities of patients as provided in  
sections 20201, 20202, and 20203 of the code, MCL 333.20201, 333.20202, and 333.20203.  
(2) Before a patient’s admission, and if requested after admission, policies and procedures  
related to rights and responsibilities must be made available to all of the following:  
(a) The patient.  
(b) The patient’s guardian.  
(c) The patient’s representative.  
(3) Information transmitted to a patient, or to the person legally responsible for the patient,  
must be in a manner that he or she can reasonably be expected to understand.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
PART 8: COMPLAINTS, INVESTIGATIONS, AND HEARINGS  
SUBPART A:COMPLAINTS AND INVESTIGATIONS  
R 325.45241 Complaint filed with health facility or agency; procedure.  
Rule 241. (1) A health facility or agency shall adopt written policies and procedures for the  
initiation, investigation, and resolution of complaints filed by a patient, or the patient’s legal  
guardian or designated representative when that person has standing. The procedure to file a  
complaint must be made available to the patient at the time of admission and upon request. The  
procedure must contain, at a minimum, all of the following:  
(a) A notice that an individual may file a complaint, orally or in writing, with the health  
facility or agency, the department, or both.  
(b) The name, title, and contact information of the health facility or agency staff member who  
is responsible for receiving complaints.  
(c) The contact information necessary to file a complaint with the department.  
(d) Resources to assist the individual with writing a complaint if needed.  
(2) If a complaint does not allege serious injury, harm, impairment, or death and is resolved to  
the individual’s satisfaction prior to the completion of the investigation, the investigation may be  
discontinued.  
(3) If a standard complaint form is used, a copy of the form must be provided to each patient or  
the patient’s legal guardian or designated representative upon request.  
(4) Investigation of a complaint that alleges serious injury, harm, impairment, or death must  
start within 3 business days of receipt of the complaint.  
(5) Investigation of a complaint that does not allege serious injury, harm, impairment, or death  
must start within 7 business days of receipt of the complaint.  
(6) A complaint investigation must be completed within 15 business days of initiation of the  
investigation. If the investigation is not completed within 15 business days, the health facility or  
agency shall document the reason for the delay and notify the complainant of the anticipated  
completion date.  
Page 28  
(7) A health facility or agency shall deliver to the individual the written results within 10  
business days of completion of the investigation. This subrule does not apply when a complaint  
is filed anonymously.  
(8) A comment on a patient satisfaction survey or other method used by a health facility or  
agency to gather feedback does not constitute a complaint.  
(9) The individual’s allegation must be of a nature that describes a possible violation of state  
law or rule. The individual does not need to cite the specific state law or rule.  
(10) A health facility or agency shall maintain for 3 years any complaints filed under its  
complaint procedure, all complaint investigation reports, and correspondence delivered to each  
individual that filed a complaint.  
History: 2020 MR 4, Eff. Feb. 21. 2020.  
R 325.45243 Complaint filed with department; procedure.  
Rule 243. (1) When a complainant files a complaint with the department pursuant to section  
20176 or 21799a of the code, MCL 333.20176 or 333.21799a, it must be filed within 12 months  
of the alleged violation. If it is not filed within 12 months of the alleged violation, the  
department may investigate the complaint if the complainant shows good cause for the delay in  
filing the complaint.  
(2) A complaint must be submitted using the department’s hotline or in writing using the US  
Postal Service, e-mail, online form, fax, or other method provided for on the department’s  
(3) The complaint must be limited to matters involving an alleged violation of an applicable  
law or rule affecting the complainant or, in the case of a public interest group, affecting the  
public or a portion thereof.  
(4) A complainant shall provide enough information to identify the specific health facility or  
agency where the alleged violation took place. Such information includes but is not limited to  
the name and address of the health facility or agency.  
(5) A complaint may be filed anonymously.  
(6) The department shall receive, evaluate, and, if warranted, investigate a filed complaint.  
The department shall not investigate a complaint that, as alleged, does not violate a law or rule  
regulated by the department. The department shall send a letter of acknowledgement to each  
complainant upon evaluation of the complaint, except when a complaint is submitted  
anonymously.  
(7) The department shall notify the health facility or agency of the nature of the complaint no