This chapter governs the requirements for quality assurance in an EMS operational program. Every EMS operational program shall have a written quality assurance plan approved by its medical director. The quality assurance plan shall include provisions for: Reviewing data concerning patient care rendered by EMS providers affiliated with the EMS operational program; Identifying and analyzing trends in EMS care rendered by EMS providers affiliated with the EMS operational program; Annually reporting to MIEMSS on quality assurance issues on a form required by MIEMSS; Providing remedial action to resolve any patient care issues involving EMS providers or the EMS system which should be addressed at the jurisdictional level; Identifying violations of the Maryland Medical Protocols for Emergency Medical Services Providers; Notifying MIEMSS within 30 days of discovery of any incidents, protocol variations, or trends which in the opinion of the medical director: May have resulted in harm to a patient, May require disciplinary action by MIEMSS, or Suggest the need for changes to the Statewide EMS system by MIEMSS; and Reviewing oral or written allegations that: An EMS provider failed to act in accordance with applicable law or protocols, or Prehospital patient care was below the applicable standard of care. Every EMS operational program shall have a medical review committee. The EMS operational program in conjunction with the EMS operational program medical director shall select the medical review committee. The medical review committee shall be a committee established in MIEMSS subject to the confidentiality and immunity provisions of Health Occupations Article, §1-401, Annotated Code of Maryland, as well as the other provisions of that statute. Each attendee at any meeting of a medical review committee shall be advised in writing of the confidential nature of committee proceedings. It shall be the duty of the quality assurance officer to carry out the quality assurance plan with the participation of the EMS operational program medical director and the Medical Review Committee. Each jurisdictional EMS operational program shall, within 24 hours of a call's dispatch, ensure the completion and submission of an eMEDS® patient care report for each unit: That responds to a call within the State; That responds to a call from within the State; That provides EMS care; That provides EMS transport; or That applies the Maryland Medical Protocols for Emergency Medical Services Providers. The highest medically licensed or certified EMS provider on each unit shall ensure the accurate and timely completion of the eMEDS® patient care report. The eMEDS® patient care report shall be complete without reference to any other documentation except another eMEDS® patient care report. EMS Documentation Delivered to the Receiving Facility. If a patient is transported to a health care facility, an eMEDS® patient care report shall, if possible, be completed and submitted before the EMS unit leaves the facility. If an eMEDS® patient care report is not completed and submitted prior to leaving the health care facility, the transporting unit shall: Provide documentation of the patient's prehospital care on the MIEMSS Preliminary EMS Report Short Form for inclusion in the patient care record before leaving the facility; and Complete and submit an eMEDS® patient care report no later than 24 hours after the call’s dispatch. Changes to a completed and submitted eMEDS® patient care report shall be managed as an amendment to the original record or dataset and will not overwrite the original file. eMEDS® patient care report data will be made available to a jurisdictional EMS operational program by MIEMSS in accordance with the Maryland Confidentiality of Medical Records Act, Health-General Article, §4-301 et seq., Annotated Code of Maryland, and, if applicable, the federal Health Insurance Portability and Accountability Act of 1996, the federal Health Information Technology for Economic and Clinical Health Act of 2009, and the regulations promulgated under those statutes, for treatment, quality assurance, and billing, if requested by the jurisdictional EMS operational program and pursuant to the terms of a memorandum of understanding with MIEMSS. Compliance with this regulation shall be required for a jurisdictional EMS operational program to meet the requirements for funding under Public Safety Article, §8-103(b)(7), Annotated Code of Maryland, (Amoss Fund) with respect to the Maryland Ambulance Information System and to be eligible for MIEMSS grants. For the purpose of quality assessment and quality improvement, an EMS provider licensed or certified by the EMS Board under Education Article §13-516, Annotated Code of Maryland, who has or has had a direct treatment relationship with a patient, may request and receive follow-up data or information on that patient pertinent to the treatment relationship from the facility to which the patient is transported by the EMS provider. A request for data or information under this regulation is a request for data or information from a person acting under the authority of MIEMSS. A person receiving data or information under this regulation may not disclose the data or information to any person other than a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland. Each EMS operational program shall deliver monthly to MIEMSS a report of occupational exposures to blood in a form acceptable to MIEMSS. Each EMS operational program shall designate a Quality Assurance (QA) Officer in concurrence with the EMS operational program medical director. Qualifications of an EMS Operational Program Quality Assurance Officer. An EMS operational program Quality Assurance Officer shall: Be certified or licensed as an emergency medical technician, CRT, or paramedic in Maryland; Either: Successfully complete a QA officer course as defined by MIEMSS within six months of designation; or Have been serving as a Quality Assurance Officer for an EMS operational program for a period of at least 5 years; and Successfully complete a Quality Assurance Officer continuing education course annually. Duties of an EMS Operational Program QA Officer. The EMS operational program QA officer shall be responsible for: Implementing the EMS operational program quality assurance plan under Regulation .02 of this chapter; Serving as a member of the EMS operational program Medical Review Committee; Internal audits of medical records and field evaluations to develop strategies for improvement; Remedial action plans for individual medical practice and system variances as directed by the Medical Review Committee; Tracking and investigating customer complaints and sentinel events; Completing reports to MIEMSS as required under COMAR 30.03.04; and Ensuring that issues regarding Advance Life Support providers are delegated to a member of the Medical Review Committee who is an Advance Life Support provider for review if the QA officer is certified as an emergency medical technician. Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland Effective date: December 15, 1999 (26:24 Md. R. 1859) Regulation .03C amended effective July 1, 2002 (29:12 Md. R. 931); December 19, 2005 (32:25 Md. R. 1945) Regulation .03E amended effective October 8, 2007 (34:20 Md. R. 1742) Regulation .04 repealed and new Regulation .04 adopted effective November 1, 2010 (37:21 Md. R. 1437) Regulation .04 amended effective January 6, 2014 (40:26 Md. R. 2166) Regulation .05 adopted effective December 15, 2003 (30:24 Md. R. 1746) Regulation .06 adopted effective December 19, 2005 (32:25 Md. R. 1946) Regulation .06 repealed and new Regulation .06 adopted effective November 1, 2010 (37:21 Md. R. 1437) Regulation .07 adopted effective December 19, 2005 (32:25 Md. R. 1946) Regulation .07 repealed effective November 1, 2010 (37:21 Md. R. 1437) Regulation .08 adopted effective October 8, 2007 (34:20 Md. R. 1742) Regulation .08B, C amended effective December 12, 2013 (40:24 Md. R. 2017)