The Commonwealth of Massachusetts
Executive Office of Health and Human Services
Department of Public Health
Center for Quality Assurance and Control
99 Chauncy Street, 2nd Floor, Boston, MA 02111
617-753-8000

DEVAL L. PATRICK
GOVERNOR
TIMOTHY P. MURRAY
LIEUTENANT GOVERNOR
JUDYANN BIGBY, MD
SECRETARY
PAUL J. COTE, JR.
COMMISSIONER	

Circular Letter:  DHCQ 07-02-472

TO:		Hospital Chief Executive Officers, Acute Care Hospitals

FROM: 	Paul I. Dreyer, Ph.D., Associate Commissioner, Center for Quality Assurance and Control

RE:		Medical Control Service Regulations

DATE:           February 7, 2007

The purpose of this memorandum is to inform hospitals of the Department of Public Health’s impending amendment of hospital licensure regulations to create a “Medical Control Service,” which means the organized provision of medical control by a hospital to a licensed Emergency Medical Services (EMS) provider (ambulance service or EMS first response service).  Until hospitals have an opportunity to file an application for licensure of the service, Medical Control Services will continue to be provided under the existing system.  Thus, although the Department of Public Health (the Department) will officially promulgate the amendments by filing them with the Secretary of the Commonwealth to be effective by the end of February, 2007, the Department will deem all existing providers of medical control to comply with all requirements set forth in 105 CMR 130.1500 through .1504 until June 30, 2007.  Effective July 1, 2007, no hospital may provide Medical Control Services unless the service is licensed by the Department.

The goal of the amendments is to improve the provision of medical oversight of EMS by establishing “Medical Control Service” as a new category of service the Department may license hospitals to provide.  Hospitals in Massachusetts have long provided medical control for EMS care to ambulance services and their emergency medical technicians (EMTs) through contracts called affiliation agreements.  Under the Department’s EMS System Regulations, at 105 CMR 170.300, EMS services at the advanced life support (ALS) level for years have been required to have these affiliation agreements, which had to contain, at a minimum, a number of elements described in the regulations.

The Department has worked with the Medical Services subcommittee of its statutorily-established advisory committee, the Emergency Care Advisory Board (EMCAB), to improve the quality of medical oversight and to minimize disparities in the practice of medical control across the Commonwealth.   The Department developed standards for hospitals based on the elements for affiliation agreements set out in the EMS System regulations and the recommendations of the Medical Services subcommittee for hospitals that choose to provide a Medical Control Service. 

These new hospital standards, which will be promulgated as 105 CMR 130.1500 through .1504, set forth the requirements for hospitals to be licensed to provide Medical Control Services, including the designation of an affiliate hospital medical director (AHMD); provision of medical control data to the Department; making available on-line medical direction to EMS personnel 24 hours a day; ensuring a process for skill maintenance and review; providing remedial training opportunities in the hospital emergency department and in operating rooms and skill laboratories; operating an effective QA/QI program for the EMS service in accordance with the hospital’s own QA/QI standards and protocols; and making available hospital emergency department physicians and nurses to meet with EMS personnel in morbidity and mortality rounds and chart reviews.

The amendments also further define the duties of the affiliate hospital medical director and require hospitals to ensure that the medical director performs those duties.  These duties begin with ensuring the clinical competence of EMS personnel and authorizing them to practice.  The Department certifies EMS personnel, but in addition, EMS personnel certified at the Advanced Life Support (ALS) level must be authorized to practice by their EMS service’s AHMD.  The regulations also make AHMDs responsible for ensuring that EMS personnel are provided remedial education when found to be deficient in practice.  These amendments make AHMDs responsible for ensuring that all physicians providing on-line medical direction to EMS personnel do so in conformance with the EMS pre-hospital Statewide Treatment Protocols, which set out the clinical practice standards for EMS personnel.  This includes the responsibility to provide appropriate orientation to these physicians to make sure that they are conversant with the Statewide Treatment Protocols and EMS practice, including the capabilities of local EMS providers.  The amendments hold AHMDs responsible for coordinating the QA/QI program, providing information to the Regional Medical Director and maintaining their own skills and knowledge in EMS care through continuing education.

The amendments also establish qualifications for on-line medical control physicians as well as for affiliate hospital medical directors.  Under these regulations, on-line medical direction physicians must be currently credentialed to practice in the hospital emergency department, and must demonstrate proficiency in the clinical application of the current Statewide Treatment Protocols.  In addition, they must be proficient in EMS radio communications.  Finally, in addition to meeting the same requirements as on-line medical direction physicians, the AHMD must be board-certified in emergency medicine.

A copy of the amended regulation is enclosed (Addendum A).  Also enclosed are an application and related documents for licensure of a Medical Control Service.  Each acute care hospital must notify the Department on the enclosed forms if the hospital intends to provide Medical Control Services or not.  In order for a hospital to operate a licensed Medical Control Service, a completed application for licensure must be submitted to the Department for review and approval.

•	If the hospital intends to provide Medical Control Services, complete the Application for Licensure of the Medical Control Service.

•	If the hospital plans to provide Medical Control Services at more than one campus, complete an Application for each location.

•	If the hospital does not wish to provide Medical Control Services at this time  
sign and only return Page 7 of the application.

Please return the completed forms to the Department of Public Health by 
March 2, 2007.  Mail the documents to:

Mr. Dennis Corbett  
Massachusetts Department of Public Health 
Division of Health Care Quality
99 Chauncy Street, 2nd Floor
Boston, MA 02111

Responses to the Application for Licensure of the Medical Control Service will be used to assess your facility’s compliance with regulatory requirements.  Following receipt and review of the completed application a Department representative may contact the hospital to review the application, if necessary.  When the hospital is deemed to meet regulatory requirements, the hospital will receive written notification of licensure of the Medical Control Service.  Subsequent on-site reviews may be conducted during routine hospital relicensure surveys or complaint investigations.

If you have general questions regarding this correspondence please contact 
Mr. Dennis Corbett or Ms. Gail Palmeri at 617-753-8000.  For assistance with the questionnaire or interpretation of regulations please call or email gail.palmeri@state.ma.us .

*Circular Letter DHCQ: 07-02-472 and the Medical Control Service amendments are available on the Department of Public Health, Division of Health Care Quality website.  The URL address for the Division's home page is: http://www.mass.gov/dph/dhcq

Statewide Treatment Protocols and Office of Emergency Medical Services regulations are available on the Department of Public Health, Office of Emergency Medical Services (OEMS) website.  The URL address for the OEMS home page is: http://www.mass.gov/dph/oems.