Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 140.000 - Licensure Of Clinics › Section 140.020 - Definitions

Current through Register 1525, July 5, 2024
The following terms as used in
				105 CMR
				140.000 shall be interpreted as follows, unless the
				context or subject matter clearly requires a different interpretation:
Ambulatory Surgery Center (ASC)
. An
				entity subject to licensure or licensed under M.G.L. c. 111, § 51 and
				105 CMR
				140.000 to provide surgical services.
Birth Center
. A home-like facility
				where low risks births are planned to occur following normal, uncomplicated
				pregnancy.
Birth Center Services
. Professional
				midwifery services provided to low risk childbearing women during pregnancy,
				birth, and puerperium and to the infant during the immediate newborn period by
				nurse-midwives or by obstetricians or family practitioners. Birth center
				services are provided in a free standing facility.
Certified Nurse Midwife
. An individual
				authorized by the Board of Registration in Nursing under M.G.L. c. 112, §
				80C and authorized to practice as a nurse-midwife pursuant to
				244 CMR 4.00:
Advanced
				Practice Registered Nursing
.
CLIA
. Clinical Laboratories
				Improvements Amendments and its implementing regulations set forth in 42 CFR
				493.
Clinic
. Any entity, however organized,
				whether conducted for profit or not for profit, is advertised, announced,
				established, or maintained for the purpose of providing ambulatory medical,
				surgical, dental, physical rehabilitation, or mental health services. In
				addition, clinic shall include any entity, however organized, whether conducted
				for profit or not for profit, advertised, announced, established, or maintained
				under a name includes the word clinic, "dispensary", or "institute", and
				suggests that ambulatory medical, surgical, dental, physical rehabilitation, or
				mental health services are rendered. With respect to any entity is not
				advertised, announced, established, or maintained under one of the names in the
				preceding sentence,
Clinic
shall not include a medical
				office building, or one or more practitioners engaged in a solo or group
				practice, whether conducted for profit or not for profit, and however
				organized, so long as such practice is wholly owned and controlled by one or
				more of the practitioners so associated, or, in the case of a not for profit
				organization, its only members are one or more of the practitioners so
				associated or a clinic established solely to provide service to employees or
				students of such corporation or institution. Notwithstanding the foregoing,
Clinic
shall include any entity certified or has
				applied for certification as an ambulatory surgery center by the Centers for
				Medicare and Medicaid Services for participation in the Medicare program. No
				matter how the clinic is named, clinic shall not include a clinic conducted by
				a hospital licensed under M.G.L. c. 111, § 51 or by the federal
				government, or the commonwealth.
Clinic
shall not
				include dental clinics operated by local schools and health departments for the
				sole purpose of providing education and dental hygiene services, including
				routine examinations, cleaning and topical fluoride applications.
Clinic
shall not include ad hoc health promotion and
				screening programs.
Clinic Pharmacy
. A pharmacy not
				registered as a retail drug business pursuant to M.G.L. c. 112, § 39 and
				which is maintained and operated by a clinic.
Clinical Laboratory Services
. The
				biological, serological, chemical, immunohematological, cytological,
				pathological, or other examinations of materials derived from a human
				body.
Commissioner
. The Commissioner of the
				Massachusetts Department of Public Health or his or her designee.
Dentist
. An individual registered by
				the Board of Registration in Dentistry under M.G.L. c. 112, § 45.
Department
. The Massachusetts
				Department of Public Health.
Diagnostic Radiology
. The use of
				ionizing radiation or ultrasonic procedures for diagnostic purposes
				only.
Host Site
. The location off the
				premises of the clinic where a clinic provides mobile services.
Licensee
. Any person holding a license
				to operate a clinic. In the case of a licensee that is not a natural person,
Licensee
shall also mean any shareholder owning 5% or
				more of any class of the outstanding stock of a privately-held corporation; any
				limited partner owning 5% or more of the partnership interests and any general
				partner of a partnership licensee; any trustee of any trust licensee; any sole
				proprietor of any licensee that is a sole proprietorship; any mortgagee in
				possession; and any executor or administrator of an estate of a
				licensee.
Mental Health
. Any condition
				pertaining to mental health as defined by the 5th
				edition of the Diagnostic and Statistical Manual of Mental Disorders.
Mental Health Outreach Program
. A
				mental health program, which may include treatment of cooccurring substance use
				disorder treatment, delivered off the premises of a clinic or any of its
				satellite clinics that provides services in patients' homes or other community
				environments, including practitioners' offices or community health centers
				defined as free-standing or hospital licensed community health centers licensed
				by the Department pursuant to M.G.L. c. 111, § 51.
For the purposes of
				105 CMR
				140.000, outreach services do not include patient
				visits to a practitioner's home or office.
Mobile Unit
. A specially equipped,
				self-contained vehicle that may be driven, moved, towed or transported from one
				location to another, such as a van or trailer.
Mobile/Portable Unit
. A mobile unit
				from which, from time to time, equipment and supplies may be removed to offer
				services at a location outside the mobile unit at which the clinic will provide
				licensed services. A
Mobile/Portable Unit
shall not
				mean a satellite of the clinic.
Notice of Intent Form
. A form
				prescribed by the Department through which an applicant notifies the Department
				of its intent to acquire a clinic and/or to apply for a license to operate a
				clinic.
Nurse Practitioner
. A registered nurse
				who holds authorization in advanced nursing practice as a nurse practitioner
				under M.G.L. c. 112, § 80B.
Nutritionist
. A person who has an M.S.
				in public health nutrition, community nutrition, or human nutrition, from an
				accredited institution or who has a B.S. and is registered by the American
				Dietetic Association.
Physician
. An individual registered by
				the Board of Registration in Medicine under M.G.L. c. 112, § 2 as a
				qualified physician.
Physician Assistant
. A person who
				meets the requirements for registration set forth in M.G.L. c. 112, § 9I
				and who may provide medical services appropriate to his or her training,
				experience and skills under the supervision of a registered physician.
Podiatrist
. An individual registered
				by the Board of Registration in Podiatry under M.G.L. c. 112, § 16.
Point-of-care Testing
. The analysis of
				clinical specimens at the site of patient care, in order to provide immediate
				results to the health care provider. Examples of point-of-care tests include
				blood glucose tests, urine strip tests and other tests that do not require
				submission of the specimens to an outside laboratory.
Portable Unit
. A vehicle that only
				transports equipment, supplies and/or personnel to a host site location at
				which the clinic will provide licensed services. A
Portable
				Unit
may be an extension/addition of services provided by a clinic
				with an existing licensed physical site, an addition/extension of services
				provided by a mobile unit, or a clinic that is exclusively portable, with no
				licensed physical site or mobile unit in which services are provided.
Practice
. An enterprise involving the
				diagnosis or treatment of medical, surgical, dental, physical rehabilitation,
				or mental health problems. The supervision and direction of clinical staff, the
				assignment of patients to practitioners or other clinical staff, and the
				maintenance of patient records shall be deemed to be part of a practice.
				Billing and collection services, rental of space and rental of equipment shall
				also be considered part of a practice; however, the provision by a
				nonpractitioner of any one of these services to practitioner(s) shall not by
				itself mean such nonpractitioner shares in the control of the practice.
Practitioner
. Any individual who holds
				a license, registration or authorization pursuant to M.G.L. c. 112 that
				authorizes the individual to diagnose and treat medical, surgical, dental,
				physical rehabilitation, or mental health problems within the scope of practice
				for his or her profession.
Primary Care Provider
. A health care
				professional qualified to provide general medical care for common health care
				problems, who supervises, coordinates, prescribes or otherwise provides or
				proposes health care services, initiates referrals for specialist care and
				maintains continuity of care within the scope of practice.
Psychiatric Day Treatment Program
. A
				specialized mental health program providing a planned combination of
				diagnostic, treatment, and rehabilitative services to individuals seeking
				treatment for mental health conditions, which may include co-occurring
				substance use disorder, who need more active or inclusive treatment than is
				typically available through a weekly visit to a mental health center or
				hospital outpatient department, but who do not need full-time hospitalization
				or institutionalization. Such a program utilizes multiple, intensive, and
				focused activities in a supportive environment to enable such persons to
				acquire more realistic, skillful, and effective behavior patterns, attitudes,
				and skills to support sustained independent functioning in the community. A
				clinic may provide psychiatric day treatment services only if it is licensed to
				provide mental health services.
Registered Nurse
. An individual
				registered under M.G.L. c. 112, § 74.
Registered Pharmacist
. An individual
				registered by the Board of Registration in Pharmacy pursuant to M.G.L. c. 112,
				§ 24.
Satellite Clinic
. A clinic operation
				off the premises of a clinic at which health services are provided, other than
				a mobile service. A Mental Health Outreach Program as defined in 105 CMR
				140.020 shall not be considered a satellite clinic.
Social Worker
. An individual who is
				currently licensed to practice social work in Massachusetts pursuant to M.G.L.
				c. 112, § 131 under the licensure categories of Licensed Independent
				Practitioner of Clinical Social Work, or Licensed Certified Social
				Worker.
Solo
or
Group
				Practice
. The primary enterprise of the practitioner(s) as
				identified with the practitioner's licensing authority.
Specific Service
. Any one of the
				following:
(1)
Surgical Service
. A service
				providing diagnosis or care through endoscopic procedures, or operative
				procedures requiring regional or general anesthesia.
(2)
Dental Service
. A service
				providing oral diagnostic, maintenance, preventive and restorative care and
				treatment to relieve dental pain and infection.
(3)
Physical Rehabilitation Service
. A
				service that provides physical restoration to physically handicapped and
				disabled persons through such therapies as physical therapy, occupational
				therapy and speech therapy.
(4)
Mental Health Service
. A separate,
				identifiable service providing diagnosis and treatment to individuals seeking
				treatment for mental health conditions, which may integrate treatment for
				co-occurring substance use disorder, and their families.
(5)
Medical Service
. A service
				providing diagnosis or treatment of illness or other medical services that are
				distinct from the services provided under 105 CMR 140.020:
Specific
				Service
(1) through (9).
(6)
Mobile Service
. A service
				providing diagnostic or treatment services through a mobile unit, a portable
				unit or a mobile/portable unit.
(7)
Substance Use Disorder Treatment
				Service
. A separate, identifiable service for individuals seeking
				treatment for substance use disorders which may integrate treatment for
				co-occurring mental health conditions.
(8)
Birth Center Service
. A service
				providing professional midwifery services to low risk childbearing women during
				pregnancy, birth, and puerperium, and to the infant during the immediate
				newborn period by nurse-midwives or by obstetricians or family
				practitioners.
(9)
Limited Services
. Diagnosis,
				treatment, management and monitoring of acute and chronic disease, wellness and
				preventive services of a nature that may be provided within the scope of
				practice of a nurse practitioner using available facilities and equipment,
				including shared toilet facilities for point-of-care testing. Limited Services
				shall not mean surgical services, dental services, physical rehabilitation
				services, mental health services, substance use disorder services, or birth
				center services as defined in 105 CMR 140.020:
Specific
				Service
(1) through (8), which require a separate licensure
				designation.
Substance Use Disorder
. Any condition
				pertaining to substance use disorder as defined by the
				5th edition of the Diagnostic and Statistical Manual
				of Mental Disorders.
Transfer of Ownership
. Includes, but
				not be limited to, the following transfers:
(1) a transfer of a majority interest in the ownership of a
				clinic;
(2) in the case of a privately-held for-profit corporation,
				transfer of a majority of any class of the stock thereof;
(3) in the case of a partnership, transfer of a majority of the
				partnership interest;
(4) in the case of a trust, change of the trustee or a majority
				of trustees; or
(5) in the case of a nonprofit corporation, such changes in the
				corporate membership and/or trustees as the Department determines to constitute
				a shift in control of the clinic.
Transfer of Ownership
also means any
				change in the ownership interest or structure of the clinic or the clinic's
				organization or parent organization(s) that the Commissioner determines to
				effect a change in control of the operation of the clinic. A transfer of
				ownership shall also be deemed to have occurred where foreclosure proceedings
				have been instituted by a mortgagee in possession. The Commissioner may, in his
				or her discretion, determine a proposed transaction does not rise to the level
				of a transfer of ownership.
Urgent Care
. Delivery of episodic care
				for the diagnosis, treatment, management or monitoring of acute and chronic
				disease or injury that is:
(1) for the treatment of illness or injury that is immediate in
				nature, but does not require emergency services;
(2) generally provided on a walk-in basis without prior
				appointment; and
(3) available to the general public; and not intended as the
				patient's primary care provider.
Urgent Care
shall not
				mean surgical services, dental services, physical rehabilitation services,
				mental health services, substance use disorder services, birth center services
				or limited services as defined in 105 CMR 140.020:
Specific
				Service
(1) through (9), which require a separate licensure
				designation; or Emergency Service or Satellite Emergency Facility as defined in
				105 CMR 130.020:
Hospital Licensure
.