# COMAR Title 30 — Maryland Institute for Emergency Medical Services Systems (MIEMSS)

## Subtitle 06 — Public Access Automated External Defibrillator Program

### Chapter 02 — Approval of Facilities and Compliance

**Authority:** Education Article, §13-517, Annotated Code of Maryland

**Administrative History:** Effective date:

**Administrative History:** Regulations .01—.06 adopted as an emergency provision effective January 1, 2000 (27:2 Md. R. 142); adopted permanently effective April 17, 2000 (27:7 Md. R. 707)

**Administrative History:** Regulation .01 amended effective June 5, 2006 (33:11 Md. R. 952); May 4, 2009 (36:9 Md. R. 654)

**Administrative History:** Regulation .01B amended effective October 15, 2004 (31:20 Md. R. 1486)

**Administrative History:** Regulation .01I amended and J adopted effective March 31, 2003 (30:6 Md. R. 423)

**Administrative History:** Regulation .02 amended effective May 4, 2009 (36:9 Md. R. 654)

**Administrative History:** Regulation .03 amended effective May 4, 2009 (36:9 Md. R. 654)

**Administrative History:** Regulation .04 amended effective May 4, 2009 (36:9 Md. R. 654)

**Administrative History:** Regulation .04C amended effective June 5, 2006 (33:11 Md. R. 952)

**Administrative History:** Regulation .05 amended effective May 4, 2009 (36:9 Md. R. 654)

**Administrative History:** Regulation .06B amended effective May 4, 2009 (36:9 Md. R. 654)

**Administrative History:** Chapter revised effective January 7, 2013 (39:26 Md. R. 1666)

**Administrative History:** Regulation .08C amended effective October 12, 2015 (42:20 Md. R. 1265)

#### Regulation .01 Criteria for Registration of Facilities.

*COMAR 30.06.02.01*

To be eligible for registration, or renewal of registration, to operate an AED under this subtitle, a registered facility shall:

A. Designate an AED coordinator who shall:

  (1) Have successfully completed CPR and AED Training, and subsequent refresher training, in accordance with their training course requirements that at a minimum includes content consistent with the recommendations for layperson CPR and AED training in the most current publication of the American Heart Association Guidelines for CPR and ECC;

  (2) Be responsible for implementing and administering the AED program at the registered facility; and

  (3) Ensure that monthly safety inspections of all supplemental and AED equipment, including assurance of adequate battery charge, per the manufacturer’s guidelines are conducted and maintain written logs of the inspections.

B. Provide information regarding the operation, maintenance, and location of the registered facility's AEDs to all individuals employed by or volunteering for the registered facility;

C. Place all AEDs in locations which are visible and readily accessible to any person willing to operate the AED in the event of a cardiac arrest;

D. Have a telephone or other communication service available at all times at each site at which an AED is operated, for the notification of the public safety answering point;

E. Submit data or other information concerning the AED program which may be periodically requested by MIEMSS; and

F. Ensure that expected operators have completed CPR and AED Training, and subsequent refresher training, in accordance with their training course requirements that at a minimum includes content consistent with the recommendations for layperson CPR and AED training in the most current publication of the American Heart Association Guidelines for CPR and ECC.

#### Regulation .02 Protocol.

*COMAR 30.06.02.02*

All personnel who are expected to operate an AED at a registered facility shall utilize the AED in accordance with their training. When an individual's training conflicts with the auditory and visual prompts of the device, the individual shall follow the auditory and visual prompts.

#### Regulation .03 Quality Assurance and Maintenance.

*COMAR 30.06.02.03*

Each registered facility shall:

A. Comply the federal Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992;

B. Maintain:

  (1) The certificate issued by MIEMSS in a place where it is readily available;

  (2) Each AED and all related equipment and supplies in accordance with the standards established by the device manufacturer and the federal Food and Drug Administration;

  (3) Supplemental equipment with the AED at all times as follows:

    (a) Two sets of defibrillator chest pads;

    (b) Disposable gloves; and

    (c) Maryland Facility AED Report Forms for Cardiac Arrest;

C. Submit:

  (1) A report for each incident of suspected cardiac arrest at the facility on the Maryland Facility AED Report Form for Cardiac Arrests, including, when available, any event (code) summary, recording, or tape created by the AED to MIEMSS, and be available for follow up as necessary; and

  (2) If the AED fails when operated, in addition to submitting the required report to the federal Food and Drug Administration, a copy of the report to MIEMSS; and

D. Ensure the confidentiality of any medical records maintained by the registered facility as required by law.

#### Regulation .04 Application and Registration Process.

*COMAR 30.06.02.04*

A. A facility seeking registration or renewal of registration shall submit an application and all required documentation to MIEMSS on the form required by MIEMSS.

B. MIEMSS may make the inspection and require the verification necessary to ensure that an applicant meets the requirements of this chapter, including an inspection of the facility, any sites, equipment, and records.

C. MIEMSS shall issue a certificate of registration or renewal to a facility that meets the requirements of Regulation .01 of this chapter.

D. The certificate of registration or renewal is valid for a period of 3 years.

#### Regulation .05 Denial of Registration.

*COMAR 30.06.02.05*

A. MIEMSS may deny an application if it finds that the applicant fails to meet the requirements of this chapter.

B. Notice of Denial.

  (1) MIEMSS shall issue a written notice of denial to an applicant that includes the reasons for denial.

  (2) The notice shall conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland.

C. An applicant denied approval may file an appeal with the EMS Board under Regulation .05 of this chapter.

D. If an applicant does not file a timely appeal under Regulation .05 of this chapter, the decision is final.

E. If an application is denied, the applicant may reapply under this chapter.

#### Regulation .06 Compliance.

*COMAR 30.06.02.06*

A. MIEMSS may initiate a compliance review of a registered facility upon information that the registered facility has failed to comply with this subtitle.

B. MIEMSS shall give written notice of the compliance review to the registered facility.

C. In the course of its compliance review, MIEMSS may:

  (1) Inspect all:

    (a) Sites where the registered facility maintains an AED;

    (b) Records relating to the AED maintained by the facility; and

    (c) Equipment related to the AED; and

  (2) Interview employees of the registered facility regarding the AED program.

D. If MIEMSS finds that a registered facility has failed to comply with this subtitle, MIEMSS may:

  (1) Suspend the facility's registration;

  (2) Revoke the facility's registration;

  (3) Refuse to renew a facility's registration; or

  (4) Take other action as appropriate.

E. Within 30 days after the conclusion of the compliance review, MIEMSS shall provide its findings, decision and any proposed action in writing to the:

  (1) Registered facility; and

  (2) EMS Board.

F. The report shall:

  (1) Conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland; and

  (2) Contain the reasons for the decision and the proposed action.

G. Upon receipt of the report and proposed action, a registered facility may file an appeal with the EMS Board under Regulation .05 of this chapter.

H. If an applicant does not file a timely appeal under Regulation .05 of this chapter, MIEMSS' proposed decision is final.

#### Regulation .07 Procedure for Appeals.

*COMAR 30.06.02.07*

A. An applicant or registered facility may appeal a disputed decision by filing a notice of appeal to the EMS Board with the Executive Director of MIEMSS not later than 20 days after receipt of the decision.

B. The appeal shall state with specificity the reasons why the disputed decision should be modified.

C. An applicant or registered facility that files an appeal shall be granted a hearing before the:

  (1) EMS Board; or

  (2) Office of Administrative Hearings, if the Board so elects and notifies the applicant or registered facility.

D. An appeal hearing shall be governed by COMAR 28.02.01.

E. If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 also apply.

F. An applicant or registered facility which has participated in a hearing under this regulation may seek judicial review of the EMS Board's final action under State Government Article, §10-222, Annotated Code of Maryland. The EMS Board shall be party to the proceeding.

#### Regulation .08 Confidentiality of Records.

*COMAR 30.06.02.08*

MIEMSS shall maintain the confidentiality of records referred to in this subtitle in accordance with:

A. Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland;

B. Health Occupations Article, Title 1, Subtitle 4, Annotated Code of Maryland; and

C. General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland.