Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 173.000 - Mobile Integrated Health Care and Community Ems Programs › Section 173.100 - Minimum Standards of Operation

Current through Register 1525, July 5, 2024
(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;
(c) Fire;
(d) Apparent suicide;
(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; and
2. 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; and
3. any additional training required by
			 Department guidelines.
(g) Coordinate the MIH Program's continuous
			 quality assurance and improvement program.