Mich. Admin. Code R. 325.22207 - Medical control authority; protocol development; promulgation of protocols; emergency protocol

Rule 207.

(1) Each medical control authority shall establish protocols, as that term is defined in section 20919 of the code, MCL 333.20919, which must include, but are not limited to all the following:

(a) The acts, tasks, or functions that may be performed by each level of emergency medical services personnel licensed under this part. Emergency medical services personnel shall not provide life support at a level that exceeds the life support agency license and approved medical control authority protocols.

(b) Procedures to ensure that life support agencies are providing clinical competency assessments to emergency medical services personnel before the individual provides emergency medical services within the medical control authority area.

(c) Medical protocols to require the appropriate dispatching of a life support agency based upon medical need and the capability of the emergency medical services system.

(d) A do-not-resuscitate protocol consistent with section 20919(1)(c) of the code, MCL 333.20919.

(e) A protocol consistent with part 56B of the code, MCL 333.5671 to 333.5685.

(f) Protocols defining the process, actions, and sanctions a medical control authority may use in holding life support agency or personnel accountable. This must include disciplinary action against a life support agency or emergency medical services personnel.

(g) Protocols defining the process to immediately remove medical control if the medical control authority determines that an immediate threat to the public health, safety, or welfare exists. These protocols must specify that a medical control authority has 3 business days to hold a hearing and make a determination.

(h) Protocols establishing that if medical control has been removed or suspended from a participant, that the participant shall not provide prehospital services in that until medical control is reinstated. If medical control is removed or suspended from a participant in the medical control authority, then the department and life support agency shall be notified within 1 business day of the removal. Medical control shall inform the department when medical control is reinstated.

(i) Protocols that ensure a quality improvement program as follows:

(i) The quality improvement program must include a requirement that each life support agency collects and submits data to the medical control authority.

(ii) Data must be reviewed by the medical control authority professional standards review organization.

(iii) Data must be protected in accordance with section 20919(1)(g) of the code, MCL 333.20919.

(j) Protocols that ensure an appeals process of a medical control decision is in effect.

(k) Protocols that specify that if life support agencies transport prehospital patients to hospitals outside of their originating medical control authority area, they will comply with their own medical control authority protocols.

(2) Each medical control authority shall develop standards for the withdrawal or restoration of a hospital or free-standing surgical outpatient facility, or off-campus emergency department with provider-based status, as described in R 325.22112(1)(c), to a medical control authority. The protocol must include a provision to notify the regional trauma network of the withdrawal or restoration of a facility.

(3) Each medical control authority shall develop specific protocols applicable to the acquisition, storage, and use of drugs, intravenous fluids, and medical devices. Protocols must include all of the following:

(a) All drugs must be under the control of a pharmacist licensed in this state affiliated with a participating medical control authority hospital, free-standing surgical outpatient facility, or off-campus emergency department with provider-based status, as described in R 325.22112(1)(c).

(b) The medical control authority participating pharmacy shall provide medication and intravenous fluid exchange services in accordance with the protocols developed by the individual medical control authority and approved by the medical control authority medical control director and the department.

(c) In the instance of a recall relating to medical control authority participating pharmacy supplied medications or devices, the pharmacy shall notify the medical control authorities.

(d) All medication storage containers must be numbered. Each medication storage container must be inspected and inventoried by a medical control authority-approved pharmacy at least annually.

(e) All medication storage containers must have at least the following information affixed to the outside of the container:

(i) The name of the medical control approved pharmacy that most recently restocked the container.

(ii) The date of the most recent restock.

(iii) The name and date of the medications with the earliest expiration dates.

(iv) Notation of the licensed pharmacy personnel who completed and sealed the medication container.

(f) The medical control authority participating facility or agency in possession of intravenous fluids, tubing, and supplies shall have a method for verifying and tracking that the supplies are within their expiration date and do not have any active recall notices.

(g) The medication containers must be stored in a method that maintains the stability, integrity, and effectiveness of the medication contained therein.

(4) Emergency protocols developed in accordance with section 20919(3)(e) of the code, MCL 333.20919, must be submitted to the department, within 5 business days, for review and must remain in effect for not more than 60 days unless approved by the department.

Notes

Mich. Admin. Code R. 325.22207

2004 AACS; 2023 MR 10, Eff. 5/26/2023