In this subtitle, the following terms have the meanings indicated. Terms Defined. “Automated external defibrillator (AED)” means a medical heart monitor and defibrillator device that: Is cleared for market by the federal Food and Drug Administration; Recognizes the presence or absence of ventricular fibrillation or rapid ventricular tachycardia; Determines, without intervention by the operator, whether defibrillation should be performed; On determining that defibrillation should be performed, automatically charges; and Either: Requires operator intervention to deliver the electrical impulse, or Automatically continues with delivery of electrical impulse. “Event (code) summary” means the electronic report of an AED operation produced by an AED. “Expected operator” means any individual identified by a registered facility to operate an AED at a registered facility “Facility” means an agency, association, corporation, firm, partnership, or other entity. “Operate” means to use or attempt to use an AED to defibrillate an individual whether or not any electrical impulse is delivered. “Public safety answering point (PSAP)” has the meaning stated in Public Safety Article, §1-301(q), Annotated Code of Maryland. Registered Facility. “Registered facility” means an organization, business, association, or agency that meets the requirements of the EMS Board for providing automated external defibrillation. “Registered facility” may include multiple sites. “Response” means the removal of the AED from its storage location for the purposes of rendering care whether or not the care is actually rendered. “Site” means a building, plant, unit, branch, vehicle, or other ancillary location that is part of or affiliated with a facility. Education Article, §13-517, Annotated Code of Maryland Effective date: Regulation .01 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) Regulation .01B amended effective June 5, 2006 (33:11 Md. R. 952); May 4, 2009 (36:9 Md. R. 654); January 7, 2013 (39:26 Md. R. 1666) To be eligible for registration, or renewal of registration, to operate an AED under this subtitle, a registered facility shall: Designate an AED coordinator who shall: 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; Be responsible for implementing and administering the AED program at the registered facility; and 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. 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; 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; 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; Submit data or other information concerning the AED program which may be periodically requested by MIEMSS; and 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. 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. Each registered facility shall: Comply the federal Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992; Maintain: The certificate issued by MIEMSS in a place where it is readily available; 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; Supplemental equipment with the AED at all times as follows: Two sets of defibrillator chest pads; Disposable gloves; and Maryland Facility AED Report Forms for Cardiac Arrest; Submit: 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 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 Ensure the confidentiality of any medical records maintained by the registered facility as required by law. A facility seeking registration or renewal of registration shall submit an application and all required documentation to MIEMSS on the form required by MIEMSS. 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. MIEMSS shall issue a certificate of registration or renewal to a facility that meets the requirements of Regulation .01 of this chapter. The certificate of registration or renewal is valid for a period of 3 years. MIEMSS may deny an application if it finds that the applicant fails to meet the requirements of this chapter. Notice of Denial. MIEMSS shall issue a written notice of denial to an applicant that includes the reasons for denial. The notice shall conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland. An applicant denied approval may file an appeal with the EMS Board under Regulation .05 of this chapter. If an applicant does not file a timely appeal under Regulation .05 of this chapter, the decision is final. If an application is denied, the applicant may reapply under this chapter. MIEMSS may initiate a compliance review of a registered facility upon information that the registered facility has failed to comply with this subtitle. MIEMSS shall give written notice of the compliance review to the registered facility. In the course of its compliance review, MIEMSS may: Inspect all: Sites where the registered facility maintains an AED; Records relating to the AED maintained by the facility; and Equipment related to the AED; and Interview employees of the registered facility regarding the AED program. If MIEMSS finds that a registered facility has failed to comply with this subtitle, MIEMSS may: Suspend the facility's registration; Revoke the facility's registration; Refuse to renew a facility's registration; or Take other action as appropriate. Within 30 days after the conclusion of the compliance review, MIEMSS shall provide its findings, decision and any proposed action in writing to the: Registered facility; and EMS Board. The report shall: Conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland; and Contain the reasons for the decision and the proposed action. 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. If an applicant does not file a timely appeal under Regulation .05 of this chapter, MIEMSS' proposed decision is final. 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. The appeal shall state with specificity the reasons why the disputed decision should be modified. An applicant or registered facility that files an appeal shall be granted a hearing before the: EMS Board; or Office of Administrative Hearings, if the Board so elects and notifies the applicant or registered facility. An appeal hearing shall be governed by COMAR 28.02.01. If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 also apply. 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. MIEMSS shall maintain the confidentiality of records referred to in this subtitle in accordance with: Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; Health Occupations Article, Title 1, Subtitle 4, Annotated Code of Maryland; and General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland. Education Article, §13-517, Annotated Code of Maryland Effective date: 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) Regulation .01 amended effective June 5, 2006 (33:11 Md. R. 952); May 4, 2009 (36:9 Md. R. 654) Regulation .01B amended effective October 15, 2004 (31:20 Md. R. 1486) Regulation .01I amended and J adopted effective March 31, 2003 (30:6 Md. R. 423) Regulation .02 amended effective May 4, 2009 (36:9 Md. R. 654) Regulation .03 amended effective May 4, 2009 (36:9 Md. R. 654) Regulation .04 amended effective May 4, 2009 (36:9 Md. R. 654) Regulation .04C amended effective June 5, 2006 (33:11 Md. R. 952) Regulation .05 amended effective May 4, 2009 (36:9 Md. R. 654) Regulation .06B amended effective May 4, 2009 (36:9 Md. R. 654) Chapter revised effective January 7, 2013 (39:26 Md. R. 1666) Regulation .08C amended effective October 12, 2015 (42:20 Md. R. 1265) Education Article, §13-517, Annotated Code of Maryland Effective date: Regulations .01—.03 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) Regulation .02 amended effective June 5, 2006 (33:11 Md. R. 952) Regulation .03 amended effective March 31, 2003 (30:6 Md. R. 423); October 15, 2004 (31:20 Md. R. 1486); June 5, 2006 (33:11 Md. R. 952) Regulation .03 repealed and new Regulation .03 adopted as an emergency provision effective December 15, 2006 (34:3 Md. R. 296); emergency status extended at 34:13 Md. R. 1150 Regulation .03 repealed and new Regulation .03 adopted effective June 4, 2007 (34:11 Md. R. 972) Chapter revised effective May 4, 2009 (36:9 Md. R. 654) Regulation .01 amended effective November 28, 2011 (38:24 Md. R. 1503) Regulation .01 repealed effective January 7, 2013 (39:26 Md. R. 1666) Effective date: Regulations .01—.02 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) Regulation .01 amended effective May 4, 2009 (36:9 Md. R. 654) Regulation .02 amended effective May 4, 2009 (36:9 Md. R. 654) Regulation .02B, C amended effective June 5, 2006 (33:11 Md. R. 952) Regulation .02D amended effective March 31, 2003 (30:6 Md. R. 423); June 5, 2006 (33:11 Md. R. 952) Regulation .02E amended effective June 5, 2006 (33:11 Md. R. 952) Regulations .01—.02 repealed effective January 7, 2013 (39:26 Md. R. 1666) Effective date: Regulations .01—.04 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) Regulation .01 amended effective October 15, 2004 (31:20 Md. R. 1486); June 5, 2006 (33:11 Md. R. 952); May 4, 2009 (36:9 Md. R. 654) Regulation .01C amended and D adopted effective March 31, 2003 (30:6 Md. R. 423) Regulation .02A amended effective March 31, 2003 (30:6 Md. R. 423) Regulations .01—.04 repealed effective January 7, 2013 (39:26 Md. R. 1666)