104 Mass. Reg. 27.03 : DEPARTMENT OF MENTAL HEALTH — LICENSING AND OPERATIONAL STANDARDS FOR MENTAL HEALTH FACILITIES — LICENSING — Licensing; Generally

(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.