Current through Register 1531, September 27, 2024
(1) Pursuant to
M.G.L. c. 19, the Department is responsible for developing and maintaining a
comprehensive area-based system of mental health services for citizens of the
Commonwealth. Critical to fulfilling this responsibility is striving to assure
that individuals in need of mental health services are able to access those
services in a timely manner and from a geographically reasonable location.
Facilities licensed in accordance with
104 CMR 27.00 fill an
essential role in the Commonwealth's mental health service system and as such
must be operated so as to meet the mental health needs of the Commonwealth as a
whole as such needs may be determined from time to time by the
Department.
(2) In determining the
needs of the Commonwealth, the Department shall consider the health needs of
persons with a mental illness in the commonwealth, including underserved
populations and persons with co-occurring mental illness and substance use
disorder, and in particular shall evaluate whether individuals have access to
the appropriate services that meet their specific behavioral health care needs
in a timely manner and, where possible, a geographically appropriate location.
The Department will evaluate factors across the delivery system including, but
not limited to, the number of beds in facilities that are licensed pursuant to
104 CMR 27.00 and in
operation, by region and by license type, i.e., general
psychiatric services, or services for specialty populations.
(3) The Department will review the needs of
the Commonwealth no less frequently than biannually to determine sufficiency of
licensed capacity for general and specialty populations and in conducting such
review may consider factors including, but not be limited to, emergency
department utilization and wait time, inpatient utilization and wait time, and
judicial referrals. In conducting this review, the Department will consult with
stakeholders including, but not limited to, commercial and public payers,
emergency departments, inpatient facilities, intermediate care providers, and
patients, and shall consult with and utilize data from the Department of Public
Health, the Center for Health Information and Analysis, and the Health Policy
Commission.
(4) All private, county
or municipal mental health facilities are subject to licensing by the
Department pursuant to M.G.L. c. 19, § 19. A hospital, clinic or nursing
home licensed by the Department of Public Health under M.G.L. c. 111 which
admits persons with mental illness only on voluntary status, need not be
licensed by the Department of Mental Health. All other hospitals licensed by
the Department of Public Health which admit persons with mental illness on any
admission status other than, or in addition to, voluntary status pursuant to
104 CMR 27.00, Subpart C
shall also be licensed by the Department of Mental Health.
(5)
General and Specialty
Populations.
(a) The Department
may establish clinical competencies and additional operational standards for
care and treatment of patients admitted to facilities licensed pursuant to
104 CMR 27.00, including for
specialty populations. Clinical competencies and operational standards
established by the Department shall incorporate national and local standards of
practice where such standards of practice exist, and to the extent deemed
appropriate by the Department.
(b)
No facility shall hold itself out as providing specialized care for
population(s) for which the Department has established clinical competencies
and operational standards, nor shall any facility preferentially admit patients
within such population(s), unless it has applied for and received a license
certifying that the facility meets the applicable clinical competencies and
operational standards for care and treatment of the specialty
population(s).
(c) Nothing in 104
CMR 27.03(5) shall permit a facility to have exclusion criteria that would
result in the refusal to admit a patient who meets the general admission
criteria for the facility, based solely upon the determination that the patient
may also meet the criteria for a specialty population.
(6) No original license shall be issued to
establish or maintain a facility subject to licensure under
104 CMR 27.00, unless there
is need for such a facility as determined by the Department, and the applicant
has the demonstrated ability, by virtue of current operation or by history to
meet such needs.
(7) All licensed
facilities shall provide services to commonwealth residents with public health
insurance on a non-discriminatory basis and shall report the facility's payer
mix to the Department on a quarterly basis in form and format as determined by
the Department; provided, however, the Department may accept payer mix reports
from existing public data sources including, but not limited to, those from the
Center for Health Information and Analysis, to meet these reporting
requirements.
(8)
Types
of Licenses. Licensed mental health facilities shall be issued a
single license which may incorporate one or more of the following classes:
(a)
Class II.
License to provide diagnosis and treatment of adults on voluntary status under
M.G.L. c. 123, § 10.
(b)
Class III. License to provide diagnosis and treatment
of adults on conditional voluntary status under M.G.L. c. 123, §§ 10
and 11, and on involuntary committed status under M.G.L. c. 123, §§
7, 8 and 12.
(c)
Class
IV. (Reserved).
(d)
Class V. License to provide evaluation, diagnosis and
treatment of patients committed under M.G.L. c. 123, §§ 15, 16, 17
and 18.
(e)
Class
VI. License to provide diagnosis and treatment of minors on
voluntary or conditional voluntary status under M.G.L. c. 123, §§ 10
and 11, and on involuntarily committed status under M.G.L. c. 123, §§
7, 8 and 12.
(f)
Limited Class VI. License to provide diagnosis and
treatment of minors 16 through 17 years of age on adult units on voluntary or
conditional voluntary status under M.G.L. c. 123, §§ 10 and 11, and
on involuntarily committed status under M.G.L. c. 123, §§ 7, 8 and
12.
(g)
Class
VII. License to provide diagnosis and treatment of adolescents in
an Intensive Residential Treatment Program (IRTP) on voluntary or conditional
voluntary status under M.G.L. c. 123, §§ 10 and 11, and on
involuntarily committed status under M.G.L. c. 123, §§ 7 and 8. An
IRTP may not be granted a Class VIII license to administer electroconvulsive
treatment.
(h)
Class
VIII. License to administer electroconvulsive treatment in a
facility otherwise licensed by the Department.
(9)
Duration of License, Change
in Ownership or Location.
(a)
Licenses issued under 104 CMR 27.03 shall be valid for a term of two years and
may be renewed for like terms, subject to limitation, suspension or revocation
for cause.
(b) Licenses issued
under 104 CMR 27.03 are not transferrable without the approval of the
Department. Licensees wishing to transfer a license to another individual or
entity or to relocate to another location must submit an application for such
change in license to the Department and shall submit the fee established by the
Department. Approval of such application shall be subject to determination by
the Department that the facility continues to satisfy applicable provisions of
104 CMR
27.00.
(10)
Requirements for License or
Renewal.
(a) Every facility
applying for a license or for a subsequent renewal of such license shall use
the forms prescribed by the Department and shall submit the fee established by
the Department. A schedule of licensing fees may be obtained from the
Department.
(b) No application for
licensure or for renewal of a license shall be approved unless the facility
demonstrates, and the Department determines, that the facility it seeks to
license is:
1. responsible and suitable to
meet the needs of the Commonwealth; and
2. able to meet the clinical competencies and
operational standards for providing care and treatment to the population(s) it
will serve.
(c) Every
facility seeking a license shall submit the following:
1. a statement of ownership, a plan showing
the extent of the property, location and plans of existing buildings, and any
plans and specifications of buildings to be erected or renovated. Notice shall
be given to the Department by the facility of any changes in these
matters.
2. documentation which
demonstrates compliance with applicable provisions of the Facility Guidelines:
Institute Guidelines for Design and Construction of Health Care Facilities, or
other nationally recognized standards, for facilities of the type
licensed.
3. Written plans
describing:
a. its plan for delivery and
supervision of clinical services. All clinical services, as well as the
supervision of such services, shall be performed by personnel qualified by
license or experience in the field in which they are performing.
b. its plan for assuring adequate and
appropriate staffing to meet the needs of the patient population at all
times.
c. its plan for physical
adaptations, such as by providing single occupancy bedrooms, when necessary to
address behavioral acuity in its patient population, as needed.
d. its program of orientation, continuing
education and demonstration of competencies for all personnel who provide care
and treatment to patients.
e.
Attestation that the facility provides, or for an original license, will
provide, services to Commonwealth residents with public health insurance on a
non-discriminatory basis.
4. A comprehensive strategic plan to prevent,
reduce and, wherever possible, eliminate restraint and seclusion as required
and defined in
104
CMR
27.12(1).
(d) In its application for a license, or for
renewal of a license, the facility shall include a detailed description of its
physical facilities as well as its plan for providing age appropriate
programming and services. This plan and description shall be subject to
approval by the Department. The plan shall include, but not be limited to,
psychiatric, medical, nursing, social work and psychological services,
occupational therapy, physical therapy, if any, recreational activities and
equipment and person-centered treatment. In addition, for facilities licensed
as Class VI, Limited VI and VII, the plan shall include educational programs,
and youth guided and family driven treatment.
(e) A currently licensed facility seeking to
renovate or expand such that there is a change in its capacity, or a
significant change is its physical plant, or to significantly alter its service
delivery program shall submit for approval such documentation as the Department
may reasonably require demonstrating the facility's continued compliance with
the provisions of
104 CMR 27.00.
(f) The Department may at any time require a
facility which has been granted a license pursuant to
104 CMR 27.00 to demonstrate
its compliance with applicable law, accreditation or certification standards,
Department regulations, or implementation of any recommendations for
corrections or deficiencies, by submitting such documentation or reports or
permitting such inspection as may be requested by the Department. The
Department may require a validation survey of a licensed facility to verify
such compliance.
(11)
Staffing.
(a) All
facilities subject to licensure shall meet the following staffing requirements:
1. The facility shall have sufficient staff
who have training and demonstrate competencies in functions consistent with
their job responsibilities and, if required, have certification, and who
demonstrate competencies, in such specialty services as the facility may
provide.
2. The facility shall
maintain staffing to meet the operational capacity of the facility at levels
deemed adequate by the Department.
3. If the facility is operating below its
licensed capacity, it shall specify in its application the reasons for
operating below its licensed capacity and its plan to meet the staffing
requirements for its full licensed capacity.
4. The nursing and other clinical personnel
shall be adequately prepared by education, training and experience to provide
care and treatment for persons with mental illness.
(b) Facilities licensed as Class II, III, V,
VI, Limited VI, VIII, or any combination thereof, shall meet the following
requirements:
1. The facility director shall
hold an advanced degree from an accredited college or university in a
discipline appropriate to the care and treatment of persons with mental
illness. If the director is not a fully licensed physician, there shall be a
director of psychiatric or medical services for such facility who is a
physician fully licensed to practice medicine under Massachusetts law, and who
is certified or eligible to be certified by the American Board of Psychiatry
and Neurology in psychiatry; provided that in the discretion of the Department,
and subject to such conditions as the Department may impose, experience and
expertise may be considered in lieu of Board certification or
eligibility.
2. The facility shall
have a physician, under full or limited licensure as defined by Massachusetts
law, or a Qualified APRN, on the premises at all times.
a. If the physician or Qualified APRN is not
designated pursuant to
104
CMR 33.02, the facility may apply for a
waiver of such designation in accordance with 104 CMR 27.03(24).
b. After business hours and during weekends
and holidays, the requirements of 104 CMR 27.03(11)(b)2. may be satisfied
through utilization of telemedicine or other technology pursuant to protocols
approved by the Department that assure visual communication with an
off-premises physician or Qualified APRN who is either designated pursuant to
104
CMR 33.02: Designation of Physicians
Pursuant to M.G.L. c. 123, § 12(b) or has received a waiver in
accordance with 104 CMR 27.03(24), and adequate on-premises medical and
clinical staff. Any such protocol shall require that the facility have an
on-call designated or waived physician or Qualified APRN who can be physically
present at the facility within one hour.
3. There shall be an identified nurse leader
of the facility, (e.g., Director of Nursing, Chief Nursing
Officer, Vice President of Nursing or Nurse Manager), who shall hold an
advanced degree in psychiatric nursing, or an advanced degree in nursing and at
least five years of experience in psychiatric nursing leadership, and shall be
licensed to practice professional nursing. If the nurse leader does not meet
the degree or experience requirements, the facility shall provide for a person
with such a degree, experience and license to provide supervision to the nurse
leader and to coordinate and oversee the training for its nursing
personnel.
4. A registered nurse
licensed to practice professional nursing under Massachusetts law shall be on
duty on each unit of the facility at all times.
(c) A facility licensed as Class VI, Limited
VI or VII shall have on its staff or, as consultants, a pediatrician and a
pediatric neurologist, both of whom shall be fully licensed to practice
medicine under Massachusetts law.
(12)
Additional Requirements for
Class VIII Facilities. In addition to complying with all
applicable standards in
104 CMR 27.00, a facility
licensed as Class VIII shall comply with the following requirements:
(a) The facility shall have policies and
procedures for the administration of electroconvulsive treatment (ECT) in
compliance with the standards set forth by the Joint Commission, or other
nationally recognized accreditation agency approved by the Department, and the
current practice guidelines established by the American Psychiatric
Association.
(b) All facilities
administering ECT to inpatients or outpatients shall maintain such data as the
Department may determine, which shall be available to the Department for
inspection upon request and at the time of the facility's licensing
survey.
(13)
Additional Requirements for Facilities or Programs That Provide
Certain Substance Use Disorder Treatment Services.
(a) Definitions applicable to 104 CMR
27.03(13):
Adverse Drug Event. An undesirable
effect reasonably associated with use of a drug that may occur as part of the
pharmacological action of the drug or may be unpredictable in its occurrence.
Adverse Drug Event does not include all adverse events
observed during use of a drug; only those adverse events for which there is
some basis to believe there is a causal relationship between the drug and the
occurrence of the adverse drug event.
BSAS. The Bureau of Substance
Addiction Services within the Department of Public Health.
(b) In addition to complying with all
applicable standards in this title, a facility that provides substance use
disorder treatment services, as provided in 104 CMR 27.03(13), shall comply
with the following requirements, if applicable.
1. A facility that is within a general
hospital licensed by the Department of Public Health under M.G.L. c. 111,
§ 51 that offers a separate, identifiable inpatient substance use disorder
treatment unit or program, or that holds itself out as providing substance use
disorder treatment or services as a primary or specialty service, shall meet
the requirements of
105 CMR
164.012(D)(2).
2. A facility that is not within a general
hospital licensed by the Department of Public Health under M.G.L. c. 111,
§ 51 that offers a separate, identifiable inpatient substance use disorder
treatment unit or program, or that holds itself out as providing substance use
disorder treatment or services as a primary or specialty service shall apply
for and obtain a BSAS license from a Department of Mental Health licensed
facility as provided in
105 CMR
164.012(D)(3).
3. A facility that provides substance use
disorder treatment or services incidental to the evaluation, diagnostic and
treatment services for which it is licensed under
104 CMR 27.00, and that does
not offer a separate, identifiable inpatient substance use disorder treatment
unit or program, or holds itself out as providing substance use disorder
treatment or services as a primary or specialty service, shall:
a. Adopt and follow BSAS approved protocols
for the provision of medically monitored detoxification or opioid
treatment.
b. Include in its
application for a license or renewal of a license a description of the
inpatient substance use disorder treatment or services it provides, including a
copy of the protocols it has adopted pursuant to 104 CMR 27.03(13)(b)3.a., a
statement of the approximate percentage of its patients who receive such
services, and a statement attesting that it does not hold itself out as
providing substance use disorder treatment or services as a primary or
specialty service.
c. Include in
its application for a license a description of its group and individual
substance use disorder programming for patients who are dually diagnosed with a
mental illness and a substance use disorder, including its plan for assisting
patients in obtaining care coordination upon discharge from inpatient acute
level care.
(c) In addition to the reporting requirements
provided in
104 CMR 32.00:
Investigation and Reporting Responsibilities, a facility that
provides substance use disorder treatment or services as provided in 104 CMR
27.03(13) shall report any adverse drug events that occur in connection with
such treatment or services to the DMH Director of Licensing no later than the
next business day following the occurrence of such adverse
event.
(14)
Accreditation.
(a) A
facility seeking a license as Class II, III, V, VI, Limited VI, VIII, or any
combination thereof, or a renewal of such license, shall be accredited by the
Joint Commission or other nationally recognized accreditation agency approved
by the Department utilizing the applicable standards as promulgated by said
Joint Commission or agency. Facilities that have not yet attained accreditation
must be in substantial compliance with those standards, and must submit a plan
for obtaining accreditation within a reasonable period of time.
(b) A facility seeking a license as Class
VII, or a renewal of such license, shall be accredited as a residential
treatment program by the Joint Commission or other nationally recognized
accreditation agency approved by the Department. Facilities that have not yet
attained accreditation must be in substantial compliance with the standards for
residential treatment programs set forth by said Joint Commission or agency,
and must submit a plan for obtaining accreditation within a reasonable period
of time.
(15)
Deemed Status. In addition to the Departmental action
on license applications as set forth in 104 CMR 27.03(15)(a) through (i), and
any additional requirements for Class VII facilities set forth in
104 CMR 27.04, the
Department may approve licensure of accredited facilities in accordance with
the following requirements for deemed status:
(a) In its application for licensure or for
renewal of a license, an accredited facility which desires to obtain or retain
deemed status shall provide a copy of the facility's current accreditation
letter and the accrediting agency's explanation of its survey findings. The
facility shall also:
1. Provide the
Department with notice of any survey or inspection conducted by the accrediting
agency, including notice of the time and place of summation conferences
scheduled at the completion of any such survey or inspection; provided however,
that in the event of an unannounced survey or inspection, such notice shall be
provided as soon as possible after the initiation of such survey or
inspection;
2. Permit Department
observers at the summation conferences scheduled at the completion of any
survey or inspection conducted by the accrediting agency;
3. Provide copies of any accreditation
letters, the accrediting agency's explanation of its survey findings received
while its license is in effect; and any other accreditation information
requested.
(b) A facility
requesting deemed status shall submit for Department review and approval
written plans, policies and procedures that demonstrate compliance with
Department regulations governing restraint and seclusion, human rights,
investigation of complaints, interpreter services, and delivery and supervision
of clinical services.
(c) The
Department may at any time require a facility which has been granted deemed
status to demonstrate its compliance with applicable law, accreditation
standards, Department regulations, or implementation of any recommendations for
corrections or deficiencies, by submitting such documentation or reports or
permitting such inspection as may be requested by the Department. The
Department may require a validation survey of an accredited facility to verify
such compliance.
(d) A facility
which has been granted deemed status shall immediately notify the Department of
any change in its accreditation status.
(e) The Department may revoke the deemed
status of an accredited facility if:
1. The
facility loses its accreditation;
2. The facility fails to cooperate with the
Department's validation survey or requests for documentation or
reports;
3. The facility fails to
cooperate with a Department investigation in accordance with
104 CMR 32.00:
Investigation and Reporting Responsibilities;
4. The facility is out of compliance with
applicable accreditation standards and a significant deficiency is determined
to exist;
5. The facility is out of
conformity with its plans for compliance with Department regulations on
restraint and seclusion, human rights, including reasonable access to fresh
air, investigation of complaints and interpreter services; or
6. The facility is out of compliance with
other applicable Department regulations.
(f) A facility whose deemed status has been
revoked may be subject to a licensing review or full survey pursuant to
104 CMR 27.00.
(g) A facility may request an informal
administrative review of a decision to deny or revoke deemed status. The
facility must request an informal administrative review in writing within 15
days of the date it receives notice of the denial or revocation of its deemed
status by the Department. The request shall state the reasons why the facility
considers the denial or revocation of deemed status incorrect. The written
request shall be accompanied by any supporting evidence or arguments.
(h) The Department shall notify the facility,
in writing, of the results of the informal administrative review within 20 days
of receipt of the request for review. Failure of the Department to respond
within that time shall be considered confirmation of the denial or revocation
of deemed status.
(i) Following
denial or revocation under 104 CMR 27.03(15)(e), the Department may, upon
application of the facility, reinstate deemed status to an accredited facility
if the Department finds the facility meets the requirements of 104 CMR
27.03(15).
(16) If a
facility is not yet accredited or if an accredited facility chooses not to
apply for deemed status, it shall be subject to a full survey for licensure by
the Department.
(17)
Renewal of License.
(a) Facilities seeking renewal of a license
shall meet all requirements for licensure specified in
104 CMR 27.00 and
104 CMR 32.00:
Investigation and Reporting Responsibilities.
(b) Facilities seeking renewal of a license
must submit to the Department completed forms and fees required by the
Department at least 60 days prior to the expiration of the current license or
approval.
(c) If the complete
renewal application is timely filed with the Department, the facility's then
current license or approval shall not expire until the Department makes a
determination on the renewal application.
(18)
Provisional
Licenses.
(a) The Department may
issue a provisional license or approval in response to a new application for a
facility not currently in operation for which compliance cannot be fully
determined without an evaluation of the facility operation.
(b) When the Department finds that a facility
that is applying for re-licensure has not complied with all applicable
regulations, but is in substantial compliance and has submitted an acceptable
plan of correction for bringing the facility into full compliance, the
Department may issue a provisional license, provided that:
1. The facility demonstrates to the
Department's satisfaction a good faith intent to meet all the
requirements;
2. The Department
finds that the service offered protects the health and safety of the facility's
patients; and
3. The Department
finds that the facility evidences the potential for full compliance within a
reasonable period of time, not to exceed six months.
(c) A provisional license or approval is
valid for a period not to exceed six months, but may be extended for additional
periods not to exceed six months at the Department's discretion, subject to
such terms or restrictions as the Department may determine. The Department may
issue a provisional license or approval only when a facility submits a written
plan for full compliance with the requirements of
104 CMR 27.00. This written
plan shall include specific target dates for achieving full
compliance.
(19)
Departmental Action on License Application.
(a) Upon receipt and review of all required
documentation, and after any site visit or survey deemed necessary by the
Department, the Department may take one of the following actions:
1. Approve the facility for licensure, if:
a. no deficiencies are outstanding;
b. the application meets criteria of
responsibility and suitability for meeting the needs of the Commonwealth as
determined by the Department; and
c. the application assures that no patient
who meets the clinical criteria for involuntary commitment pursuant to M.G.L.
c. 123, § 12(b), or who has been committed pursuant to M.G.L. c. 123,
§ 12(e) will be rejected for admission; provided however, that a facility
may deny admission to such a patient only if it complies with the provisions of
104 CMR
27.05(3).
2. Approve the facility for
licensure, subject to demonstrated progress by the facility in implementing a
plan of correction approved by the Department addressing any deficiencies or
failure to meet requirements under of 104 CMR 27.03(19)(a)1.
3. Approve the facility for a provisional
license subject to such conditions as noted in 27.03(18), or as the Department
deems necessary.
4. Disapprove the
facility for licensure until such time as identified deficiencies are
corrected.
(b) For
applications for license renewal, the Department's determination that the
facility is meeting the needs the Commonwealth shall include:
1. a review of admission data submitted by
the facility pursuant to
104 CMR
27.05(3)(e); and
2. an assessment of whether the facility is
in compliance with clinical competencies and operational standards as
established by the Department and adherence to all licensure requirements set
forth in
104 CMR 27.00.
(20)
Departmental Surveys and Inspection; Deficiency Notices, Plans of
Corrections.
(a) The Department
shall conduct a survey at least every two years of each facility to determine
the facility's compliance with applicable provisions of M.G.L. c. 19, § 19
and the Department's regulations. The survey of a facility granted deemed
status shall be for the purpose of determining the facility's compliance with
Department regulations governing restraint and seclusion, human rights,
investigation of complaints, and interpreter services, and its plan for
delivery and supervision of clinical services.
(b) Notwithstanding the provisions of 104 CMR
27.03(20)(a), the Department may, at any time, conduct announced or unannounced
inspections of any facility licensed hereunder to determine compliance with
accreditation standards or the applicable provisions of the Department's
regulations. Such inspections need not pertain to any actual or suspected
deficiency in compliance with accreditation standards or applicable provisions
of the Department's regulations. Refusal to permit inspections shall be
sufficient cause for revocation of a facility's license.
(c) The scope of the Department's inspections
shall include any aspect of the operation of the facility and may include, but
is not limited to, confidential interviews with patients and staff, and
examination and review of all records, including those of current and
discharged patients.
(d) The
Department shall provide a copy of the survey or inspection report and any
deficiency notice to the facility director.
The notice shall include a statement of the deficiencies
found, and the provision(s) of law and regulation relied upon, and shall
specify a reasonable time, not more than 60 days after receipt of the notice,
by which time the facility shall remedy or correct each deficiency cited in the
notice; provided however, that in the case of a deficiency which, in the
opinion of the Department, is not capable of correction within 60 days, the
Department's statement of deficiencies shall prescribe the time within which
such deficiency shall be corrected. A deficiency notice issued pursuant to 104
CMR 27.03(20)(d) shall also include notice of actions the Department may take
in the event facility fails to remedy or correct a cited deficiency by the date
specified in the written deficiency notice or fails to remedy or correct a
cited deficiency by the date specified in a plan for correction, as accepted or
modified by the Department, pursuant to 104 CMR 27.03(20)(e).
(e)
Plan of
Correction. The facility shall submit to the Department a written
plan for correction of each violation cited in a deficiency notice within a
time period specified by the Department in the deficiency notice.
1. The plan of correction shall set forth,
with respect to each deficiency, the specific corrective step(s) to be taken, a
timetable for each step, and the date by which full compliance will be
achieved. The timetable and the compliance dates shall be consistent with
achievement of compliance in the most expeditious manner possible. The plan of
correction shall be signed by the facility director or his or her
designee.
2. Unless the Department
states in the deficiency notice that more urgent corrective action is
necessary, based on the seriousness of the deficiency, the facility shall be
given no more than 60 days from receipt of the deficiency notice to remove the
deficiency. The Department may specify a different date by which the
corrections shall be completed, in the event that the facility requests
additional time and the Department determines that it is necessary.
3. The Department shall review the plan of
correction and will provide written notice of either the acceptance or
rejection of the plan. In such written notice, the Department may modify, or
order the modification of, a nonconforming written plan for correction. A
nonconforming plan must be amended and resubmitted within ten business days of
the date of notice of rejection; provided however, that
4. Not more than seven days after the receipt
of notice of such a modification of a written plan for correction, the facility
may file a written request with the Department for administrative
reconsideration of the modified plan for correction or any portion
thereof.
5. Nothing in 104 CMR
27.03(20) shall be construed to prohibit the Department from enforcing a rule,
regulation, deficiency notice or plan for correction, administratively or in
court, without first affording the facility with formal opportunity to make
correction or to seek administrative reconsideration where, in the opinion of
the Department, the violation of such rule, regulation, deficiency notice or
plan for correction jeopardizes the health or safety of patients or the public
or seriously limits the capacity of a facility to provide adequate care, or
where the violation of such rule, regulation, deficiency notice or plan for
correction is the second or subsequent such violation occurring during a period
of 12 months.
(21)
Failure to Comply with
Requirements for Licensure.
(a)
Failure to comply with the requirements for licensure as set forth in
104 CMR 27.00 may constitute
sufficient cause for the Department to deny, suspend, revoke, or restrict the
applicability of, or refuse to renew, one or more classes of
licenses.
(b) If a facility fails
to remedy or correct a cited deficiency by the date specified in the written
deficiency notice or fails to remedy or correct a cited deficiency by the date
specified in a plan for correction, as accepted or modified by the Department,
the Department may:
1. suspend, limit,
restrict or revoke the license of the facility;
2. impose a fine upon the facility;
3. pursue any other sanction as the
Department may impose administratively upon the facility; or
4. impose any combination of the penalties
set forth in 104 CMR 27.03(21)(b)1. through 3.
(c) A fine imposed pursuant to 104 CMR
27.03(21) shall not exceed $1,000 per deficiency for each day the deficiency
continues to exist beyond the date prescribed for correction.
(d) A facility has the right to appeal any
Department action to suspend, limit, restrict or revoke the license of the
facility or to impose a fine upon the facility, pursuant to 104 CMR 27.03(21)
under
801 CMR 1.01:
Formal Rules by filing with the Director of Licensing a Notice
of Claim for an Adjudicatory Proceeding within 14 days of receipt of notice of
such action.
(22)
Grounds for Denial, Refusal to Renew, Restriction, Suspension or
Revocation of License. Each of the following, in and of itself,
shall constitute full and adequate grounds to deny, revoke, suspend, restrict,
or refuse renewal of a license:
(a) Failure
to meet the applicable requirements for licensure as specified in
104 CMR 27.00;
(b) Failure to meet the requirements of
applicable federal or state law or regulations, including failure to comply
with the laws of the Commonwealth related to taxes and child support, workers
compensation, or failure to maintain professional and commercial insurance
coverage.
(c) Violation of any
applicable requirement of
104 CMR 27.00 and
104 CMR 32.00:
Investigation and Reporting Responsibilities.
(d) Failure to give proper care and treatment
to patients.
(e) Failure to submit
an acceptable plan of correction pursuant to 104 CMR 27.03(20).
(f) Failure to remedy or correct a cited
violation.
(g) Denial of entry to
agents of the Department or attempt to impede the work of a duly authorized
representative of the Department.
(h) Knowingly making an omission of material
information or providing false or misleading statements orally or in writing to
the Department.
(i) Operating
without a required license or approval or after the expiration of a license or
approval if the facility has not timely submitted an application for
renewal.
(j) Determination by the
Department that there is a discrepancy between the representations by a
facility as to the treatment services to be afforded patients and the treatment
services actually rendered or to be rendered.
(k) Conviction of a person with significant
financial or management interest in the facility of Medicare or Medicaid fraud
or other criminal offense related to the operation of the facility.
(l) Conviction of a facility or a person with
significant financial or management interest in the facility of a violent crime
against a person, which indicates that operation of the facility may endanger
the public health or safety.
(m)
Other Grounds. Nothing in 104 CMR 27.03(22) shall
limit the Department's adoption of policies and grounds for denial, refusal to
renew, or revocation through formal and informal rule making.
(23)
Required
Notifications to the Department. In addition to, and
notwithstanding, any other provision of
104 CMR 27.00 or
104 CMR 32.00:
Investigation and Reporting Responsibilities, facilities shall
comply with the following notification requirements:
(a)
Change of Name, Ownership, or
Location. At least 90 days prior to a change in location, name,
ownership or control of the facility, the facility shall notify the Department
in writing of the proposed change as provided in 104 CMR 27.03(9). Upon receipt
of such notice, the Department shall determine whether additional action is
required.
(b)
Change in
Accreditation or Certification; Notices of Termination, Immediate Jeopardy, and
Corrective Action Orders. A facility shall immediately notify the
Department of any change, or notice of change, in its accreditation or Center
for Medicare and Medicaid Services (CMS) certification status including, but
not limited to, Notices of Termination, Notices of Immediate Jeopardy, or
issuance of corrective action orders by the accrediting entity or CMS. A
facility's response to any such notice, order or other change, or notice of
change, in accreditation or certification status shall be delivered to the
Department simultaneously with delivery to the accreditation entity or
CMS.
(c)
Legal
Proceedings. The facility shall report in writing to the
Department any civil action or criminal charge that is brought against the
facility or any person employed by the facility that relates to the delivery of
the service or may affect the continued operation of the facility. The report
shall be given to the Department as soon as the facility is aware of the action
and no later than 24 hours of the facility becoming aware of any legal action
or within 24 hours of service of notice upon the facility or its agent,
whichever occurs first.
(d)
Closure. When a facility plans to cease operation, the
facility shall:
1. Notify the Department in
writing at least 90 days prior to cessation of operations and closure. Such
notification shall specify the date of closure and shall include the facility's
plan for closure. This notification requirement shall include closures due to
foreclosure or bankruptcy proceedings.
2. In the case of involuntary closure not due
to an action of the Department, notify the Department as soon as the facility
is aware of the pending closure and prior to cessation of operations and
closure.
(e)
Interruption or Suspension of Service. If a facility
determines that the health, safety or well-being of patients is in imminent
danger as a result of conditions existing within the service, program or
facility, the facility shall verbally notify the Department immediately, and in
writing within one business day, upon becoming aware of the danger to patients.
The Department shall consult with the facility regarding the need to interrupt
or suspend services.
(f)
Change of Program or Service Provision. A facility
shall notify the Department in writing at least 30 days before any substantial
change in program or service provision as provided in 104 CMR 27.03(9). The
Department shall determine whether such change requires re-licensure.
(g)
Change of Senior
Leadership. A facility shall notify the Department at least two
weeks before a planned change of senior leadership of the facility. In the
event of an unplanned departure of a senior leader, the facility shall notify
the Department in writing within two business days of the unplanned
departure.
(h)
Death,
Serious Incident, Accident or Fire, Safety and Health Conditions.
The facility shall verbally notify the Department immediately, and in writing
within one business day, of the following:
1.
upon learning of the death of any patient currently admitted to, or within 30
days of discharge from, the facility, regardless of where the death
occurs;
2. any serious incident
including, but not limited to, a complaint reportable pursuant to
104 CMR
32.04(2)(a), which occurs
under facility auspices, or concerning any patient currently admitted to, or
within 30 days of discharge from, the facility, regardless of
location;
3. any fire or other
event resulting in damage to the facility;
4. any alleged abuse or neglect, or sexual or
serious physical assault, which occurs between or among patients at the
facility, or which occurs between or among patients and staff regardless of
location, including any incident which is reported to another agency or law
enforcement including, but not limited to:
a.
any reports of child abuse or neglect made under M.G.L. c. 119, §
51A;
b. any reports of elder abuse
or neglect made under M.G.L. c. 19A, § 15; and
c. any reports of abuse of a disabled person
made under M.G.L. c. 19C;
5. any condition at the facility which poses
a threat to the health or safety of patients or staff; for example, conditions
which limit access, unsanitary conditions, fire hazards, loss of essential
services such as heat, hot water and electricity, regardless of whether the
conditions cause an interruption of service. The facility shall consult with
the Department to determine whether the condition requires an interruption or
suspension of service;
6. confirmed
cases among staff or patients of communicable diseases which are reportable
under
105 CMR 300.000:
Reportable Diseases; and
7. any complaint communicated to the facility
by the Occupational Safety and Health Administration (OSHA) or the Commonwealth
Division of Labor Standards (DLS), as well as any findings, citations,
agreements or other notifications from OSHA or DLS in connection with such
complaints.
(24)
Waiver.
(a) The requirements of
104 CMR 27.00 shall be
strictly enforced, and shall not be subject to waiver, except as specifically
authorized by the Department in accordance with the provisions of 104 CMR
27.03(24).
(b) No waiver may be
granted by the Department without written documentation supporting the request
for a waiver and a determination by the Department that:
1. The health, safety, or welfare of neither
patients nor staff may be adversely affected by granting the waiver;
and
2. In justification of the
waiver, a substitute provision or alternative standard has been stated and is
found by the Department to result in comparable services to the patients, and
to which the facility will be held accountable to the same degree and manner as
any provision of
104 CMR 27.00.
(c) Waivers may be granted for the
duration of a facility's license, or for such other period of time as the
Department may determine, and may be renewable.
(d) The granting of a waiver for any single
facility or period of time shall not require or signify the granting of a
waiver for any other facility or period of time.