Section 170.300 - Affiliation Agreements(A) To be licensed to provide ALS services, each ambulance or EFR service must have a current written contract, called an affiliation agreement, with one or more hospitals licensed by the Department to provide medical control, in accordance with 105 CMR 170.300(D). This agreement shall contain a reasonable and effective plan for medical control and include the following features:(1) Treatment protocols and point-of-entry plans using regional guidelines that are in conformance with the Statewide Treatment Protocols, and other relevant regulations, policies and administrative requirements of the Department;(2) Designation of an affiliate hospital medical director, who shall have authority over the clinical and patient care aspects of the affiliated EMS service including, but not limited to, the authorization to practice of its EMS personnel;(3) Provision of on-line medical direction in accordance with the Statewide Treatment Protocols 24 hours per day, seven days per week, by a hospital-based physician;(4) Operation of an effective quality assurance/quality improvement (QA/QI) program coordinated by the affiliate hospital medical director and with participation of on-line medical direction physician(s) and service medical director, if different from the affiliate hospital medical director, that includes, but is not limited to, regular review of patient care reports and other statistical data pertinent to the EMS service's operation, in accordance with the hospital's QA/QI standards and protocols;(5) Operation of a program for skill maintenance and review for EMS personnel;(6) Ensuring EMS personnel have access to remediation, training and retraining, as necessary, under the oversight of the affiliate hospital medical director or his or her designee;(7) Regular consultation between medical and nursing staffs and EMS personnel providing ALS services including, but not limited to, attendance at morbidity and mortality rounds and chart reviews;(8) A procedure by which a physician can maintain recorded direct verbal contact with the EMS personnel regarding a particular patient's condition and order, when appropriate, the administration of a medication or treatment for a patient, to which such physician or his or her designee shall sign the patient care report documenting the patient's care and transport by the EMS personnel;(9) Policies and procedures for obtaining medications, in accordance with the level of licensure of the EMS service, from the hospital's pharmacy;(10) A procedure by which the service shall notify its affiliate hospital medical director within 72 hours of Department action against any EMT's or EFR's certification (denial, suspension, revocation or refusal to renew certification), or other Department disciplinary action (letter of censure, letter of clinical deficiency, advisory letter) against any EMS personnel employed by the service; and(11) If the service has more than one affiliation agreement, in accordance with 105 CMR 170.300(D), the identity of all hospitals with which the service has affiliation agreements and policies and procedures that set forth the duties and responsibilities of each affiliate hospital.(B) To be licensed to provide BLS services, each ambulance or EFR service must have a current written contract, called an affiliation agreement, with one hospital licensed by the Department to provide medical control; except that more than one ambulance or EFR service at the BLS level that each averages less than 200 calls per year may be covered by the same written contract for medical control. BLS affiliation agreements shall meet all the requirements of 105 CMR 170.300(A), in accordance with these services' licensure level.(C) An affiliation agreement, shall be kept current, be reviewed and updated or renewed at intervals of no more than every four years.(D) A service that has bases of operation in more than one EMS region shall maintain an affiliation agreement in each of the EMS regions in which it operates. A service that maintains more than one place of business within a single EMS region may maintain more than one affiliation agreement, provided that the Department approves the additional agreement. No service that maintains a single place of business may enter into more than one affiliation agreement.(E) On-line medical direction may be delegated by the affiliate hospital to physicians at another hospital licensed by the Department to provide medical control. If on-line medical direction is routinely delegated to physicians at another hospital, then such hospital may be a party to the affiliation agreement between the service and the affiliate hospital.Amended, Mass Register Issue 1257, eff. 3/28/2014.Amended by Mass Register Issue 1321, eff. 9/9/2016.Amended by Mass Register Issue 1486, eff. 1/6/2023.