Michigan Office of Administrative Hearings and Rules

611 W. Ottawa Street

Lansing, MI 48909

Phone: 517-335-8658 Fax: 517-335-9512

AGENCY REPORT TO THE

JOINT COMMITEE ON ADMNINISTRATIVE RULES (JCAR)

1. AgencyInformation

Agency name:

Licensing and Regulatory Affairs

Division/Bureau/Office:

Bureau of Community and Health Systems

Name of person completing this form:

Tammy Bagby

Phone Number of person completing this form:

517-335-4084

E-mail of person completing this form:

bagbyt@michigan.gov

Name of Department Regulatory Affairs Officer reviewing this Form:

Elizabeth Arasim

2. Rule Set Information

ORR assigned rule set number:

2017-101 LR

Title of proposed rule set:

Licensing Health Facilities or Agencies

3. Purpose for the proposed rules and background:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 2

There are six rule sets for licensing health facilities and agencies. Although most of them have

undergone periodic review and revision, it has been too long since a comprehensive review and

revision was done to assure they comport with current practice standards, to harmonize them with

current federal law and regulations, and to reflect the current organization of state licensing functions.

Some of these rules are obsolete and there is a significant amount of duplication between rule sets.

The purpose of promulgating a single new rule set for health facility licensing is to better protect the

health, safety, and welfare of individuals receiving care and services in or from a health facility or

agency, and to assure the medical accountability for reimbursed care provided by a certified health

facility or agency participating in a federal or state health program. The new rule set will: Focus on

core principles and standards of health facility licensing; fulfill statutory requirements; comport with

current practice standards; harmonize with federal law and regulations; and be free of redundant,

obsolete, or unnecessary language. The new rule set will replace the following six rule sets, which

will be rescinded: 1.Minimum Standards for Hospitals – R 325.1001 to R 325.1101. 2. Complaints –

R325.1213 to R325.1217. 3. Public Inspection of License Records–R 325.1281 to R325.1282. 4.

Freestanding Surgical Outpatient Facilities – R 325.3801 to R 325.3877. 5. Hospice Licensure Rules

– R 325.13101 to R 325.13541. 6. Nursing Homes and Nursing Care Facilities – R 325.20101 to R

325.22004.

4. Summary of proposed rules:

This new single set of administrative rules replaces six individual rules sets for the licensing health

facilities and agencies. This new rule set has been updated to comport with current practice standards,

to harmonize them with current federal law and regulations, and to reflect the current organization of

state licensing functions. The purpose of promulgating a single new rule set for health facility or

agency licensing is to better protect the health safety and welfare of individuals receiving care and

services in or from a health facility or agency and to assure the medical accountability for reimbursed

care provided by a certified health facility or agency participating in a federal or state health program.

5. List names of newspapers in which the notice of public hearing was published and

publication dates:

Jackson Citizen Patriot- May 14, 2019

Grand Rapids Press- May 14, 2019

The Mining Journal- May 16, 2019

6. Date of publication of rules and notice of public hearing in Michigan Register:

6/7/2019

7. Date, time, and location of public hearing:

Thursday, June 6, 2019; 2:00pm; G. Mennen Williams Building – Auditorium, 525 W. Ottawa Street,

Lansing, Michigan

8. Provide the link the agency used to post the regulatory impact statement and cost-

benefit analysis on its website:

https://dtmb.state.mi.us/ARS_Public/Transaction/RFRTransaction?TransactionID=9

9. List of the name and title of agency representative(s) attending public hearing: MCL

24.242 and 24.245

Agency Report to JCAR-Page 3

Tammy Bagby, Analyst Legislative Reporting, Rules, Training and FOIA Section; Larry Horvath,

Bureau of Community and Health Systems Director; Heather Hosey, Health Facility Licensing,

Permits and Support Division Director; Karen Krzanowski, Manager Legislative Reporting, Rules,

Training and FOIA.

10. Persons submitting comments of support:

a. Margaret Chamberlain

b. Dan Holmes, NSF International

c. Andrew Ward, NSF International

d. Andrew Beck and Merissa Kovach, of the American Civil Liberties Union, on behalf of

the Women’s Center of Saginaw and Women’s Center of Flint.

e. Shelly Miller, of Scotsdale Women’s Center

f. Andrew Gwinnell, of Truvista Surgery Center

g. Cara Jansma, of Spectrum Health

h. Salli Pung, State Long Term Care Ombudsman

i. Karen Cafeo, Angela Hospice.

11. Persons submitting comments of opposition:

None.

12. Identify any changes made to the proposed rules based on comments received during the

public comment period:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 4

Comments made at Written Agency Rationale

Rule number

& citation

changed

Name &

Organization public hearing

Comments

for change

1

Cara L. Jansma

Deputy

General

Counsel

Spectrum

Health

See email

Clarified the

definition of

“governing body”

to mean “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

R 325.45105

(a)

message from

Ms. Jansma on

June 7, 2019,

regarding the

definition of

“governing

body.” She

expressed

concern that the

proposed

definition could

be problematic

for health

organized

governing body,

the owner,

operator, or

systems that have

multiple health

facilities. She

requested a

administrator

shall carry out the

functions of the

governing body.”

This definition is

consistent with

the definition used

by the Centers for

Medicare and

revision to make

the definition

consistent with

the definition of

“governing

body” that is

used by the

federal Centers

for Medicare and

Medicaid

Medicaid Services

(CMS).

MCL 24.242 and 24.245

Agency Report to JCAR-Page 5

See email

2

Andrew

The definition of R 325.45107

(i)

Gwinnell,

MHSA, CASC

Executive

Director

Truvista

surgery Center

He was

message from Mr. “physician” was

Gwinnell on June expanded to mean

7, 2019

concerning the

definition of

“physician.” He

pointed-out that,

in freestanding

surgical

“an individual

licensed to engage

in the practice of

medicine or the

practice of

osteopathic

medicine and

representing the

Michigan

surgery under part

170 or 175 of the

code, MCL

Ambulatory

Surgical

Association

(MASA)

outpatient

facilities, the term

“physician” is not

only used in

333.17001 to

333.17084 and

333.17501 to

reference to an

allopathic

333.17556. Fora

freestanding

physician and an

osteopathic

surgical outpatient

facility, an

individual licensed

to engage in the

practice of

physician, but

could also mean a

doctor of dentistry

or a doctor of

podiatry. CMS

recognizes all

four types of

physicians as

performing

dentistry or

podiatric medicine

and surgery under

part 166 or 180 of

the code, MCL

333.16601 to

surgery in

ambulatory

333.16659 and

333.18001 to

surgical facilities.

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.” This is

consistent with the

CMS definition.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 6

3

Margaret

Chamberlain

Consider adding

Revised the

definition of

R 325.45109

(b)

language in Part 10,

Subpart A, which

pertains to

freestanding surgical

outpatient facilities,

that the location of the

surgical procedure is

decided by the

physician based on

the procedure and the

medical condition of

the patient.

“surgery” to mean

“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:

“

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

See email This requirement R 325.45137

4

Andrew

Gwinnell,

MHSA, CASC

Executive

Director

Truvista

surgery Center

He was

message from Mr. was revised as

Gwinnell on June follows: “(a) An

(a)

7, 2019

concerning an

active

surveillance

program for

infection

active surveillance

program for

infection detection

through ongoing

data collection and

analysis that

representing the

Michigan

detection through includes patients

Ambulatory

Surgical

Association

(MASA)

ongoing data

collection an

analysis that

and personnel who

have access to or

contact with active

includes patients, patient care

personnel,

including

areas, and other

individuals

contract workers identified by the

who have access health facility or

to or contact with

active patient

care areas.

agency policies

and procedures.”

MASA is

concerned that

gathering this

type of data on

contract workers

who have very

little exposure

to active patient

care areas

would be overly

burdensome.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 8

See email The proposed rule R 325.45139

5

Karen Cafeo,

BSN, RN,

message from

was revised to

(3)

CHPN, CPHQ

Director of

Ms. Cafeo, June reference the

6, 2019,

current CDC

Quality

regarding

recommendations.

Angela Hospice

Ms. Cafeo was

representing the

Michigan

recommendation

s from the

Centers for

Disease

HomeCare and

Hospice

Association

(MHHA).

Prevention and

Control (CDC)

for Tuberculosis

Screening,

Testing, and

Treatment of

U.S. Health Care

Personnel. She

pointed-out that,

since the

proposed rules

were submitted

for public

comment, the

CDC updated its

recommendation

See email

6

CaraL. Jansma

Deputy

This rule was

revised to be

R 325.45171

message from

General

Ms. Jansma, June consistent with the

Counsel

7, 2019,

CMS regulation.

Spectrum

Health

regarding the

requirement for

the governing

body to appoint

an administrator.

For hospitals, she

requested to have

the term

“administrator”

replaced with

“chief executive

officer,” which is

consistent with

CMS regulations.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 9

See email

7

Cara L. Jansma

Deputy General

Counsel

Spectrum

Health

This proposed rule R 325.45173

message from Ms. was revised to

Jansma, June 7,

2019, regarding

Medical Director.

She pointed-out

that the proposed

language in this

rule doesn’t fit

well with

hospitals because

they have elected

medical staffs

who are

responsible for

oversight of the

medical care

provided in

hospitals.

ensure that it fits

well for all types of

health facilities and

agencies; and, to

make it consistent

with CMS

regulations. The

revised rules reads:

“Rule 173.

(1) The governing

body must 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.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 10

See email

8

Andrew

The proposed rule R 325.45183

Gwinnell,

MHSA, CASC

Executive

Director

Truvista

surgery Center

He was

representing the

Michigan

Ambulatory

Surgical

Association

(MASA)

message from Mr. was revised to

Gwinnell, June 7, provide these

clarifications. It

now reads: “Rule

183. A health

facility or agency

shall maintain a

record for each

employee that

includes all of the

following: (a)

Relevant

2019, regarding

employee

records. He asked

for clarification

on what

communicable

diseases will

employees need

to be screened for

and have a record

maintained. He

also asked for

clarification on

when an

professional

license or

registration

number. (b)

Relevant

employee is

credentialing and

education. (c)

Beginning date of

employment and

position for which

employed. (d)

Results of baseline

screening for

considered to be a

former employee.

communicable

disease as set forth

in R 325.45139. (e)

For former

employees, the

date employment

is severed.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 11

See email

9

Cara L. Jansma

Deputy General

Counsel

Subrule (3) of the R 325.45199

revised to read:

message from Ms. proposed rule was (3)

Jansma, June 7,

2019, regarding “When verbal or

Spectrum

orders. Subrule

(3) of the

proposed rule

required a

telephone orders

are used, they

must only be

Health

accepted by

licensed health

professional to

persons who are

authorized to do

record a verbal or so by the health

telephone order. facility or

Ms. Jansma

pointed-out that and procedures

CMS and the consistent with

agency’s policy

Joint Commission federal and state

allow hospitals to law. Orders must

specify who is

be recorded in the

qualified to record patient record,

a verbal order.

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.”

The department

sought advice

from T.R.

10

Cara L. Jansma

Deputy General

Counsel

Spectrum

Health

See email

R 325.45213

(5)

message from

Ms. Jansma, June

7, 2019,

Wentworth II,

Supervisor,

regarding

radiological

services. Rule

Radioactive

Materials Unit,

213, subrule (5), Materials

required a health Management

facility or agency Division,

MCL 24.242 and 24.245

Agency Report to JCAR-Page 12

to immediately

report any

Michigan

Department of

adverse testing or Environment,

machine error or Great Lakes, and

adverse patient

reaction to the

appropriate

Energy. Rule 213,

subrule (5) was

revised to read:

“The health

licensed health

care professional facility or agency

as soon as

possible and

record this

shall immediately

document any

adverse testing or

information in the machine error that

patient’s record. may cause an

Any corrective

action must be

adverse patient

reaction.

initiated promptly Investigation and

and recorded in corrective action

the patient’s

record. Ms.

must be initiated

promptly. Any

Jansma points-out investigation and

that standard of corrective action

care should

dictate

taken in response

to an adverse

documentation

patient reaction

that goes in the must be reported

patient record.

She states:

to the appropriate

licensed health

“Adverse testing, care professional

machine error, or and recorded in

adverse patient

the patient’s

reaction all could record.”

be

inconsequential,

and this level of

response may not

be necessary. If it

is material, any

investigation and

corrective action

is not appropriate

for

documentation in

the patient’s

record. Instead, a

requirement for

MCL 24.242 and 24.245

Agency Report to JCAR-Page 13

facility

investigation and

corrective action

alone should be

sufficient.

Facilities should

be able to

demonstrate to

surveyors our

process for

investigation and

corrective

action.”

11 Andrew

Gwinnell,

See email from

Mr. Gwinnell,

June 7, 2019,

The department

revised this rule

to be consistent

R 325.45277

(d)(ii)

MHSA, CASC

Executive

Director

Truvista

regarding scrub with the FGI

sinks. The

Guidelines for

Design and

proposed rule

surgery Center

He was

representing

the Michigan

Ambulatory

Surgical

stipulates that 2 Construction of

scrub positions Hospitals. The

with gooseneck rule was revised

outlets must be to read: “(ii) One

provided near the scrub sink with a

entrance to each gooseneck outlet

operating room. must be provided

Association

(MASA)

Mr. Gwinnell

asked if it is

necessary to

have 2 scrub

sinks for each

near the entrance

to each operating

room. A scrub

sink with two

positions may be

OR, or could that shared between

number be

reduced?

two adjacent

operating rooms,

provided that it is

located near the

entrances to both

rooms.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 14

12 Andrew

Gwinnell,

See email

Rule 295, subrule R 325.45295

(3) was revised to (3)

read: “A health

facility shall

provide locker

message from

Mr. Gwinnell,

June 7, 2019,

regarding

MHSA, CASC

Executive

Director

Truvista

individual

room space or

surgery Center

He was

representing

the Michigan

Ambulatory

Surgical

dressing rooms. other security

He stated that

“Some surgery

centers are one

resources for the

personal effects

of employees.

room ORs with a Individual

one room

dressing rooms

Association

(MASA)

dressing area.

Can that serve

both female and

male without the

need to build a

second dressing

room?”

must be

provided for

employees when

surgical attire is

required. A

lavatory and

water closet

must be located

convenient to the

break or locker

Rule 343 was

revised to add

subrule (4), which

reads: “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.

13 Margaret

In the general

Chamberlain, provisions for

R 325.45343

representing

herself.

surgery, consider

acknowledging past

physical plant waivers

and allowing those

waivers to remain in

effect. This pertains to

R 325.45343 Waiver

of modification

provisions.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 15

14 Salli Pung,

Long Term

Care

See her written

comment,

attached, which submitted for

Since the proposed R 325.45385

rules were

(2)

Ombudsma

n

pertains to R

325.45385.

public comment,

the name of the

Michigan

Administrative

Hearing System

was changed to the

Michigan Office

of Administrative

Hearings and

Rules (MOAHR).

Subrule (2) was

revised to use the

current name.

15 LARA-BCHS

Technical

Rule 367, subrule R 325.45367

correction by

(1) as revised to

(1)

adding the legal read: “The

hospice shall have

citation.

written policies

and procedures

for the

management and

disposal of drugs

and biologicals in

a patient’s home,

pursuant to

section 21418 of

the code, MCL

Technical

16 LARA-BCHS

None.

R 325.45303

(3)

correction to

delete “department

of environmental

quality” and

replace it with

“department of

environment, great

lakes and energy

(DEGLE).

MCL 24.242 and 24.245

Agency Report to JCAR-Page 16

None.

17 LARA-BCHS

Corrected a

R 325.45355

reference to other (1)

rules within this

rule set. Subrule

(1) was revised as

follows: “In

addition to the

human resources

requirements in

part 4 of these

rules, R

325.45171

...”

13.Date Report Completed:

10/15/2019

MCL 24.242 and 24.245