Michigan Office of Administrative Hearings and Rules

MOAHR-Rules@michigan.gov

AGENCY REPORT TO THE

JOINT COMMITEE ON ADMNINISTRATIVE RULES (JCAR)

1. Agency Information

Agency name:

Health and Human Services

Division/Bureau/Office:

Public Health Administration

Name of person completing this form:

Talisa Gauthier

Phone number of person completing this form:

517-241-0048

E-mail of person completing this form:

gauthiert1@michigan.gov

Name of Department Regulatory Affairs Officer reviewing this form:

Mary Brennan

2. Rule Set Information

MOAHR assigned rule set number:

2022-20 HS

Title of proposed rule set:

EMS Life Support Agencies and Medical Control

3. Purpose for the proposed rules and background:

The rules address the licensing requirements for emergency medical services (EMS) life support

agencies and medical control authorities (MCA). Since the introduction of these rules in 2004, there

has not been a complete review of the rules to keep up with the changes that have occurred within the

EMS system since that time. There were redundancies in some of the rules and other advances in

evidence-based EMS practice that have been implemented as a result of the previous rules set that

needed additional clarification or modifications, for example the changes in technology that have

occurred since 2004. The last change to this rule set was in 2018 and it was R 325.22181. In addition,

the Certificate of Need for air ambulance services Section 22215 of Act No. 368 of the Public acts of

1978 as amended and sections 7 and 8 of Act No. 306 of the Public Acts of 1969, as amended, MCL

333.22215, 24.207 and 24.208 are being discontinued due to the Airline Deregulation Act. There is no

longer the requirement for the Certificate of Need for air ambulances. However, this necessitates

ensuring that appropriate portions of those statutes that address medical care requirements for air

ambulances are contained in these proposed rules.

4. Summary of proposed rules:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 2

The general purpose of the EMS Life Support Agencies and Medical Control addresses the licensing

requirements for EMS life support agencies and medical control authorities in the advances in

evidence-based EMS practice that have been implemented and ensuring that appropriate portions of

the Certificate of Need that address medical care requirements for air ambulances are contained in the

rules.

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

publication dates:

Battle Creek Enquirer, July 25, 2022; Oakland Press, July 27, 2022; Marquette Mining Journal, July

26, 2022.

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

8/1/2022

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

8/15/2022 09:00 AM at JAR Conference Room , 1001 Terminal Road Lansing, Michigan 48909

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

analysis on its website:

https://ARS.apps.lara.state.mi.us/Transaction/RFRTransaction?TransactionID=1379

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

Sabrina Kerr, EMS Section Manager, Bureau of EMS, Trauma, and Preparedness

10. Persons submitting comments of support:

None - suggestions only.

11. Persons submitting comments of opposition:

None - suggestions only.

12. Persons submitting other comments:

Robert Dunne, MD, FACEP, Medical Director for Detroit East MCA (DEMCA). Robert Olkowski,

EMT-P IC, Assistant Chief, Detroit Fire Department-EMS

13. 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 3

Name &

Organization public hearing

Comments made at Written

Agency Rationale Rule number

for Rule Change & citation

and Description changed

of Change(s)

Comments

Made

1

Robert

Language needs DHHS partially

to be consistent agrees/opposes

R 325.22116

R 325.22133

R 325.22136

Olkowski, EMT

-P IC, Assistant

Chief, Detroit

Fire

Department-

EMS

throughout the

document. In

this comment.

There were some R 325.22183

several instances instances in this

ambulance rule set where

operation is used "ambulance

even though life operation" should

support agency is have been "life

the new

terminology.

support agency".

Those have been

identified and

changed.

2

Robert

If I am reading

DHHS agrees with R 325.22111

Olkowski

this right it means this comment.

(3)

the state may

override the

This should say

"shall" instead of

MCA and allow "may".

an agency to be

licenses even if

they do not meet

a MCA

requirements.

Should be

changed to will

not.

3

Robert

Olkowski

Needs to specify Subrule 6 has been R 325.22111

the same MCA. rewritten with an (6)

According to

what I read as

additional subrule R 325.22111

7 added to end

(7)

long as I have a confusion.

MA agreement

with any licensed

agency I am

good.

4

Robert

Olkowski

Once again

should be will not "Shall" placed

back in document.

DHHS agrees.

R 325.22113

(1)

MCL 24.242 and 24.245

Agency Report to JCAR-Page 4

5

6

7

Robert

Olkowski

“A minimum

of…”

DHHS agrees. "a R 325.22117

minimum of"

added to the rule

for those entities

keeping files

longer.

Robert

Olkowski

Define

DHHS has added R 325.22123

language that the (1)

"exceptional

circumstances"

shall be defined in

policy.

Robert

/or; /and

DHHS has

R 325.22126

Olkowski

changed "add" to (1)

"or" in the first

sentence and is

keeping "or" in the

same sentence for

this subrule.

8

Robert Dunne,

MD, FACEP,

Medical

Director for

Detroit East

MCA

As far as

DHHS agrees.

R 325.22214

removing the IRB After reviewing

section on pg 29, the language with

with the addition DHHS

of section H, it

looks like they

are trying to

exempt

nonpublished

special studies

from IRB

requirements

such as

Institutional

Review Board

staff, the language

in subrules (2) and

(3) now read as

follows: (2) A

medical control

authority that

(DEMCA)

intends to

unpublished

QA/QI or

establish a

protocol involving

investigation of a skills, techniques,

new established procedures, or

intervention

outside of

equipment that is

not included in

research. It is a this state’s

bit weird that approved

publishing or not curriculum, and is

is the standard for not consistent with

IRB approval or its level of

not- in general

licensure requires

the standard for a special study and

IRB approval is must comply with

MCL 24.242 and 24.245

Agency Report to JCAR-Page 5

whether or not

human subject

all of the

following:

research is taking (a) Provide any

place. This could available studies

be modified to "If or supporting

the study

amounts to

documentation

indicating the

human subjects practice has been

research as

studied. Published

studies supporting

the safety and

efficacy of its

applications within

the emergency

defined by the

common rule,

Institutional

Review Board

approval or the

letter of

setting must also

exemption status be submitted.

shall be

(b) The medical

submitted for the control authority

study."

provides an

educational outline

that will be

implemented to

instruct the

emergency

medical services

personnel in the

new skill,

technique,

procedure, or

equipment, as well

as the verification

of competency

that will be

utilized and the

plan for continued

competency

assurance, such as

a continuing

education plan.

(c) Provide a

letter of support,

justifying the need

for the practice,

signed by the

medical director

for the medical

MCL 24.242 and 24.245

Agency Report to JCAR-Page 6

control authority

participating in the

special study.

(d) The medical

control authority

shall submit

protocols that will

be used for the

practice.

(e) Identify life

support agencies

involved in the

special study, their

licensure level, the

number of

emergency

medical services

personnel to be

trained, and their

respective

licensure levels.

(f) Submit a

timeline indicating

the proposed

duration of the

study.

(g) Describe the

proposed data to

be submitted to

this state during

the study.

Generally, data

submission is

required quarterly.

(h) If the

medical control

authority designs

the study to

develop or

contribute to

generalizable

knowledge, it must

also submit

documentation of

Institutional

Review Board

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

approval,

exemption, or not

regulated status

for the study.

(3) A medical

control authority

that intends to

establish a

protocol involving

skills, techniques,

procedures, or

equipment that is

not included in

this state’s

approved

curriculum and is

not consistent with

either the level of

licensure or scope

of practice,

involves human

subject research

under 45 CFR part

46, or intends the

human subject

research to be

published, must

require a special

study if it

complies with all

the following:

(a) Provide any

available studies

or supporting

documentation

indicating the

practice has been

studied. Published

studies supporting

the safety or

efficacy of its

application within

the emergency

setting must also

be submitted.

(b) Submit initial

MCL 24.242 and 24.245

Agency Report to JCAR-Page 8

and refresher

education

requirements and

provide an

educational outline

to be implemented

to instruct the

emergency

medical services

personnel in the

new skill,

technique,

procedure, or

equipment, as well

as verification of

competency that

will be utilized.

Refresher

education

requirements must

include frequency

and content of

refresher to

maintain

proficiency in

skill, technique,

procedure, or

equipment.

(c) Identify life

support agencies

involved, their

licensure level, the

number of

emergency

medical services

personnel to be

trained, and their

respective

licensure levels.

(d) If providing

mutual aid outside

its medical control

authority region,

the medical

control authority

shall have a

MCL 24.242 and 24.245

Agency Report to JCAR-Page 9

written agreement

with another

medical control

authority to

continue to utilize

its protocols.

(e) Identify the

quality review

process that will

be implemented.

(f) Submit

protocols that will

be included in the

special study.

(g) Identify data

parameters to be

collected and the

quality review

process that will

be implemented.

The medical

control authority

shall submit

quarterly reports,

and upon

completion of the

study, submit a

final report to the

department.

(h) Obtain and

submit an

institutional

review board

approval or an

institutional

review board

official exemption.

If the medical

control authority

used a randomized

study, include the

consent form,

method of

institutional

review board

approval, and

MCL 24.242 and 24.245

Agency Report to JCAR-Page 10

institutional

review board

approval letter.

14.Date report completed:

4/5/2023

MCL 24.242 and 24.245