Section 173.100 - Minimum Standards of Operation(A)MIH Programs. An MIH Program shall meet the following minimum standards of operation:(1) If an MIH Program's on-scene personnel, after assessment and in accordance with medical direction, determines that the patient is experiencing a medical emergency, the MIH Program's on-scene personnel shall activate the 911 EMS system and continue to assess and treat the patient in accordance with clinical protocols until transfer of care to the responding ambulance service in accordance with 105 CMR 170.355(B)(2) and (4) and the applicable service zone plan.(2) When a primary ambulance service of a municipality, which is also part of a Department-approved MIH Program with ED Avoidance component, receives a 911 call to respond to a patient within its MIH program, the service shall respond in accordance 105 CMR 170.000: Emergency Medical Services System. If after assessment and consultation with on-line medical direction, the responding paramedic finds the patient may be more appropriately managed as an MIH patient or transported to a destination other than an emergency department, the EMS Personnel may initiate transfer of patient care to the MIH Program with the ED avoidance component in accordance with Department-established protocols and follow the process for timely coordination with the patient's primary care provider, or associated health care entity to establish a primary care relationship, pursuant to 105 CMR 173.100(A)(8)(h).(3) If an MIH Program deploys or intends to deploy a vehicle when responding to an MIH call or for a scheduled home visit, such vehicle must be appropriate for the clinical encounter as approved by the Department.(4) Each MIH Program shall file a written report with the Department within five calendar days of any serious incident involving its program, personnel or property. Such reportable serious incidents shall include, but are not limited to, any of the following covered by its Certificate of Approval: (a) Death that is unanticipated, not related to the natural course of the patient's illness or underlying condition, or that is the result of an error or other incident, as specified in guidelines of the Department;(b) Full or partial evacuation of the facility or residence to which the MIH program responds for any reason;(e) Serious criminal acts;(f) Pending or actual strike action by its employees, and contingency plans for operation of the MIH Program;(g) Any anesthesia-related complications that result in serious morbidity or death of a patient;(h) A motor vehicle crash involving an MIH vehicle reportable under M.G.L. c. 90, § 26;(i) Medication errors resulting in injury;(j) Failure to provide treatment in accordance with clinical protocols resulting in injury;(k) Major medical or communication device failure or other equipment failure or user error resulting in serious injury; or (l) Death, injury, or illness occurring within 24 hours of an MIH with ED Avoidance encounter. (5) Each MIH Program shall immediately report to the Department and appropriate authorities, for any patient treated by the MIH Program, any suspected instance(s) of abuse, neglect, mistreatment of that patient or misappropriation of that patient's property at or by a nursing home, rest home, home health, home maker, hospice, family member and/or others.(6) Each MIH Program shall report to the Department any other serious incident or accident occurring on premises covered by the MIH Program's Certificate of Approval that seriously affects the health and safety of a patient or that causes serious physical injury to a patient within seven calendar days of the date of occurrence of the event.(7) Each MIH Program shall comply with all guidelines established by the Department for submission of data required by 105 CMR 173.100(A)(8)(v).(8) Each MIH Program shall have written policies and procedures consistent with the requirements established in 105 CMR 173.100, Department guidelines, accepted standards of care for the delivery of health care services and treatment, and applicable laws. All policies and procedures required under 105 CMR 173.100(A) shall be provided to personnel providing services or treatment on behalf of an MIH Program. In addition, such policies and procedures shall be made available to the Department upon request. At a minimum, the policies and procedures shall address: (a) Documentation of organizational structure including medical control, affiliation agreements, lines of authority, responsibility, communication, personnel practices, and staff assignment;(b) Statement of goals, objectives and types of services offered by the program;(c) Capability of personnel providing services or treatment in the MIH Program, including confirmation that such personnel are currently certified, licensed or registered in accordance with applicable laws and regulations;(d) Medical control and medical direction, including authorization to practice of EMS personnel;(e) Process for development and periodic review of clinical protocols;(f) Process for obtaining a patient's informed consent at each clinical encounter;(g) Documentation of training and assessment standards for all personnel providing treatment and services;(h) Process for coordinating care with a patient's primary care provider, or associated health care entity to establish a primary care relationship;(i) Process for obtaining medications from a pharmacy in accordance with 105 CMR 700.000: Implementation of M.G.L. c. 94C;(j) Compliance with applicable federal and state laws and regulations, including, but not limited to such laws and regulations governing possession and administration of controlled substances;(k) Process for ensuring that each health care provider providing services and treatment in the MIH Program maintains an appropriate and current registration to possess controlled substances and instruments for administration of controlled substances in accordance with 105 CMR 700.000: Implementation of M.G.L. c. 94C; (l) Compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and regulatory requirements in 42 CFR Part 493; (m) Process for ensuring that each health care provider providing services or treatment in the MIH Program obtains CLIA certificates appropriate for the type of testing to be performed; (n) Maintenance of equipment and medical devices in accordance with manufacturers' recommendations; (o) Compliance with federal and state confidentiality laws and regulations;(p) Security of and access to patient medical records and information;(q) Management of patients who experience a medical emergency and require activation of the 911 EMS system in accordance with the provision of 105 CMR 173.100(A); (r) Management of 911 EMS Patients by a designated primary ambulance service that is part of an approved MIH Program with an ED avoidance component pursuant to 105 CMR 173.050 when the primary ambulance service's responding paramedic appropriately determines whether a patient may be more appropriately managed as an MIH patient or transported to a destination other than an emergency department in accordance with the provision of 105 CMR 173.100(B) and Department guidelines; (s) Dispatch and communications;(t) Infection control procedures;(u) Continuous quality assurance and improvement program;(v) Collection and maintenance of data relative to access, availability, quality, and cost associated with delivery of program services, to be submitted on a quarterly basis in accordance with Department guidelines;(w) Non-discrimination; and(x) Serious incident response and reports in accordance with 105 CMR 173.100(A)(4). (9) An MIH Program's medical director's responsibilities shall include but not be limited to the following: (a) Develop and update clinical protocols appropriate to: 1. the unique medical needs of the MIH Program's patient population; and2. the particular personnel providing MIH services including, but not limited to, Community Paramedics, EMS Personnel, nurses, Nurse Practitioners, Physician Assistants and others;(b) Grant authorization to practice to Community Paramedics and other EMS Personnel providing health care services on behalf of MIH Programs;(c) Ensure that all MIH Program personnel are properly trained and provide health care services or treatment: 1. within the scope of their practice;2. in accordance with the clinical protocols developed for the MIH Program; and,3. in accordance with any additional training required by Department guidelines;(d) Ensure that the MIH Program maintains a secure and effective telecommunication system and that all on-line medical direction is recorded;(e) Make on-line medical direction available to MIH Program personnel during all hours of operation;(f) Ensure that all physicians and other primary care providers who provide on-line medical direction to MIH Program personnel receive appropriate training in: 1. the scope of practice of each type of MIH Program personnel;2. the specific clinical protocols developed for the MIH Program; and3. any additional training required by Department guidelines.(g) Coordinate the MIH Program's continuous quality assurance and improvement program. (B)Community EMS Programs. A Community EMS Program shall meet the following minimum standards of operation: (1) If a Community EMS Program's on-scene personnel, after assessment and in accordance with medical direction, determines that the patient is experiencing a medical emergency, the personnel shall activate the 911 EMS system and continue to assess and treat the patient in accordance with clinical protocols until transfer of care to the responding ambulance service in accordance with 105 CMR 170.355(B)(2) and (4) and the applicable service zone plan.(2) If a Community EMS Program deploys or intends to deploy a vehicle when responding to a Community EMS call or a scheduled home visit, such vehicle must be appropriate for the clinical encounter as approved by the Department.(3) Each Community EMS Program shall have written policies and procedures consistent with the requirements established in Department guidelines, accepted standards of care for the delivery of health care services and treatment, and applicable laws.Adopted by Mass Register Issue 1373, eff. 9/7/2018.Amended by Mass Register Issue 1375, eff. 9/7/2018.