651 Mass. Reg. 12.04 : — EXECUTIVE OFFICE OF ELDER AFFAIRSCertification Procedures and Standards for Assisted Living Residences — General Requirements for an Assisted Living Residence

An Assisted Living Residence shall meet the following requirements to obtain and maintain Certification:

(1) Physical Requirements.

(a) An Assisted Living Residence shall provide only single or double Units with lockable doors on the entry door of each Unit. Residents shall have exclusive rights to their Units with lockable doors at the entrance of their individual or shared Units, however, as part of a Resident's Service Plan, keys or access codes may be readily available to specified shift staff;

(b) All Newly Constructed Assisted Living Residences shall provide a private bathroom for each Unit which shall be equipped with one lavatory, one toilet, and one bathtub or shower stall;

(c) All other Assisted Living Residences shall provide at a minimum, a private half-bathroom ( i.e., equipped with one washstand and one toilet) for each living Unit and shall provide at least one Bathing Facility for every three Residents;

(d) All Assisted Living Residences shall provide at a minimum, either a kitchenette or access to a refrigerator, sink, and heating element for all Residents, however, as part of a Resident's Service Plan, such access may be limited to supervised access; and

(e) Every Assisted Living Residence shall meet the requirements, of all applicable federal and state laws and regulations including, but not limited to, the state sanitary codes, state building and fire safety codes and laws and regulations governing use and access by persons with disabilities.

(2) Service and Service Coordination Requirements.

(a) Each Assisted Living Residence shall designate at least one Service Coordinator. The Service Coordinator shall be qualified by training and experience and shall be responsible for the following:

1. Reviewing with the Resident the assessment and service options available to address needs and preferences identified under 651 CMR 12.04(6) and (7);

2. Implementation of the service plan developed under 651 CMR 12.04(7);

3. Monitoring the Resident's needs and the services provided by the Residence to address those needs;

4. Coordinating with and participating in the Quality Improvement and Assurance program, as set forth under 651 CMR 12.04(10); and

5. Maintaining complete and accurate records of service plans.

(b) The Sponsor of the Assisted Living Residence shall provide or arrange for the provision of the following services by personnel meeting standards for professional qualifications and training set forth in 651 CMR 12.05, 12.07, and 12.08:

1. For all Residents whose service plans so specify, supervision of and assistance with Activities of Daily Living, including at a minimum bathing, dressing, and ambulation and similar tasks; and supervision or assistance with Instrumental Activities of Daily Living including at a minimum laundry, housekeeping, socialization and similar tasks;

2. Self-administered Medication Management (SAMM) of prescription or over-the-counter medication, if specified by a Resident's service plan. When assisting a Resident to self-administer medication the individual performing SAMM must:

a. remind the Resident to take the medication;

b. check the package to ensure that the name on the package is that of the Resident;

c. observe the Resident take the medication; and

d. document in writing the observation of the Resident's actions regarding the medication ( e.g., whether the Resident took or refused the medication, the date and time).

If requested by the Resident, the individual performing SAMM may open prepackaged medication or open containers, read the name of the medication and the directions on the label to the Resident, and respond to any questions the Resident may have regarding those directions.

The Residence may assist a Resident with SAMM from a medication container that has been removed from its original pharmacy-labeled packaging or container by another person (e.g., by the Resident's family). Such assistance is not required of the Residence. If this service is to be provided, the Residence and Resident shall have a full written disclosure of the risks involved and consent by the Resident.

SAMM shall only be performed by an individual who has completed Personal Care Service Training as set forth in 651 CMR 12.07(4) or (8); a practitioner, as defined in M.G.L. c. 94C; or a nurse registered or licensed under the provisions of M.G.L. c. 112, § 74 or 74A to the extent allowed by laws, regulations and standards governing nursing practice in Massachusetts. Central storage of Residents' medications in an area outside of a Resident's Unit is prohibited. Residences shall provide a refrigerator to store medication in the Resident's Unit if refrigeration is required, and may employ a locked location in which to safely store medications within a Unit.

3. Timely assistance to Residents and prompt response to urgent or emergency needs:

a. By the presence of 24 hour per day on-site staff;

b. By the provision of personal emergency response systems for each Resident if the service plan requires or other means for the purpose of signaling such staff; and

c. Any additional response systems EOEA may require in accordance with the service needs of the Residents.

4. Up to three regularly scheduled meals daily (minimum of one meal per day). All Assisted Living Residences shall use daily recommended dietary allowances as established by the Food and Nutrition Board of the National Research Council of the National Academy of Sciences set forth in the Title III of the Older Americans Act as amended ( 42 USC 3030g) as a minimum dietary standard. In addition to the foregoing, at a minimum an Assisted Living Residence shall provide or arrange for the availability of food selections that would permit a Resident to adhere to a diet consistent with the most recent edition of Dietary Guidelines for Americans and dietary plans that do not require complex calculations of nutrients or preparation of special food items. These dietary plans shall include sodium restricted, sugar restricted and low fat. The Residence shall have a qualified dietitian review the Residence's dietary plans at least every six months.

(3) Skilled Care Services.

(a) The Sponsor may arrange for the provision of ancillary health services in the Residence. The Sponsor may not use Assisted Living Residence staff for these services unless said staff is functioning as an employee of a Certified Provider of Ancillary Health Services or as an employee of a licensed hospice;

(b) No Assisted Living Residence shall provide, admit or retain any Resident in need of Skilled Nursing Care unless:

1. The Skilled Nursing Care will be provided by a Certified Provider of Ancillary Health Services or by a licensed hospice; and

2. The Certified Provider of Ancillary Health Services does not train the Assisted Living Residence staff to provide the Skilled Nursing Care.

(c) Nursing services provided by a Certified Provider of Ancillary Health Services such as injection of insulin or other drugs used routinely for maintenance therapy of a disease may be provided to Residents.

(d) Neither nurses employed by Residences nor nurses contracted by Residences shall direct any non-licensed staff to perform Skilled Nursing Care or to administer any medications to Residents, nor oversee nor supervise such practice.

(4) Special Care. Any Residence that chooses to advertise, market, otherwise promote or provide special care for Residents shall administer such care and services in accordance with the requirements of 651 CMR 12.04(4) in addition to all other requirements of 651 CMR 12.00. A Residence may not operate a Special Care Residence without submitting an operating plan to EOEA that explains how the Special Care Residence or Residences will meet the specialized needs of its resident population, including those who may need assistance in directing their own care due to cognitive or other impairments. This includes a description of the physical design of the structure and the units, physical environment, specialized safety features, enrichment activities, and the ongoing training of staff.

(a) All Special Care Residences shall be administered in accordance with the following safeguards:

1. Entry and exit doors in the common use areas within Special Care Residences shall be secured in accordance with local, state and federal laws and regulations. All doors must automatically unlock in the case of fire, power outage or emergency situation;

2. Staff shall be trained and assigned according to the requirements of 651 CMR 12.06 and 12.07;

3. The Residence shall develop and implement a 24-hour preparedness plan by assessing the needs of each occupant of any Special Care Residence for emergency assistance, and devise an appropriate method to provide the necessary assistance;

4. The Residence shall develop and implement policies and procedures to assess and reduce the risk of potential hazards in the physical environment related to the special characteristics of the population. Such policies and procedures must include an annual written statement describing in detail how the physical characteristics of any Special Care Residence have been or will be modified to promote the safety of its Residents;

5. The Residence shall develop Special Care Residence policies and procedures that address potentially unsafe Resident behaviors such as unsupervised wandering, and verbally or physically aggressive behavior including coercive or inappropriate sexual behavior;

6. The Residence shall develop policies and procedures governing the transition of Residents moving in or out of any Special Care Residence;

7. The Residence shall provide a multipurpose activity space; and

8. All Special Care Residences that commence an initial certification process after October 1, 2015 shall provide a secure outdoor space.

(b) Special Care Residences shall prepare a planned activity program that includes structured activities with designated staff a minimum of three times within a 24-hour period, seven days per week. The planned activity program shall address Resident needs in the following areas of Resident function, as applicable:

1. Gross motor activities;

2. Self-care activities;

3. Social activities; and

4. Sensory and memory enhancement activities.

(c) The Residence shall document and make available upon request all plans, policies and procedures required under 651 CMR 12.04(4)(a) and (b) in accordance with the disclosure requirements of 651 CMR 12.08(3).

(d) Administrative staff of the Residence qualified by training and experience shall review the operations of any Special Care Residence twice each year. The reviews may be conducted as part of the Residence Quality Improvement and Assurance program prescribed under 651 CMR 12.04(10). The Residence shall document the results of these reviews.

(5) Optional Services. The Assisted Living Residence may provide or arrange for the provision of the following optional services, including but not limited to:

(a) Local transportation (medical and recreational);

(b) Barber or beauty services, sundries for personal consumption and other amenities;

(c) Money management and other financial arrangements to be performed by an independent party for any Resident unable to manage his or her funds or property. The Sponsor shall not allow any personnel of an Assisted Living Residence to control or manage the funds or property of a Resident; provided that the Sponsor may, at the request of the Resident or their Legal Representative, hold and disburse Resident funds, not to exceed $200, for personal use of the Resident not otherwise covered by the Residency Agreement. The Sponsor shall detail such agreements in the Resident's service plan; and

(d) Limited Medication Administration (LMA). The Residence must perform LMA from an original, pharmacy-filled and pharmacy-labeled container.

In addition to the requirements and limitations set forth in 651 CMR 12.04(3), a nurse with a valid Massachusetts nursing license employed by the Assisted Living Residence may administer non-injectable medications, prescribed or ordered by an authorized prescriber, by oral or other methods (e.g. topical, inhalers, eye and ear drops, medicated patches, as necessary oxygen, suppositories). LMA performed by a nurse must be completed in accordance with all applicable laws, regulations and standards governing the medication administration process by a nurse, including documentation requirements.

In accordance with the standards of nursing practice, a nurse may only administer medication from an original, pharmacy-filled and pharmacy-labeled container. All medication must be kept in the Resident's Unit and stored in such a manner that the nurse can adequately verify the integrity of the medication.

(6) Screening and Assessment.

(a) Prior to a Resident moving in, a nurse shall conduct an initial screening to assess and determine:

1. The prospective Resident's service needs and preferences and the ability of the Residence to meet those needs;

2. The Resident's functional abilities;

3. The Resident's cognitive status and its impact on functional abilities;

4. Whether SAMM is appropriate for the Resident based on the following:

a. The completion of an observational assessment by a nurse to determine whether the resident is capable of performing the particular method(s) of independent medication administration; and,

b. A written statement by that nurse documenting the Resident's capability of performing the particular method(s) of independent medication administration;

5. Whether the Resident is at risk for elopement; and,

6. Whether the Resident is suitable for a Special Care Residence.

(b) The preadmission assessment shall note the name of any Legal Representative, Health Care Proxy, or any other person who has been documented as having decision-making authority for the Resident and the scope of his or her authority.

(c) The initial screening findings shall be documented and disclosed to the Resident, his or her Legal Representative and Resident Representative, if any, before the Resident moves into the Residence.

(7) Service Plan Development. The nurse and Service Coordinator shall develop an individualized Service Plan for each Resident in accordance with the findings of the initial screening described in 651 CMR 12.04(6). Said service plan shall be developed before the Resident moves into the Residence and be based on information provided by the Resident, his or her Legal Representative or Resident Representative. The Residence shall ensure the Resident's participation in the development of the service plan to the maximum extent possible and shall include the Legal Representative or Resident Representative to the extent that he or she is authorized, willing and able to be involved.

The service plan shall include an evaluation, conducted within the past three months by the Resident's physician or authorized practitioner, of the prospective Resident's physical, cognitive, functional, and psychosocial condition. It is the responsibility of the Resident or his or her representative to have the physician's or authorized practitioner's evaluation completed. In addition:

(a) The Residence shall, at a minimum, document its assessment findings for the Resident on the following:

1. Allergies;

2. Diagnoses;

3. Medications (including dosage, method of administration and frequency);

4. Dietary needs;

5. Need for assistance in emergency situations;

6. History of psychosocial issues including the presence of manifestations of distress, or behaviors which may present a risk to the health and safety of the Resident or others;

7. Level of personal care needs, including ability to perform ADLs and IADLs; and

8. Ability of the Resident to manage medication, including the ability to take medication on an as-needed basis.

(b) The Service Coordinator or nurse shall review the Resident's initial service plan within 30 days of the commencement of residency and document the review to ensure the Resident's needs and preferences are accurately incorporated therein and that the Residence is capable of meeting the Resident's needs in accordance with 651 CMR 12.00. The initial service plan shall be in writing, signed and dated by the Resident or his or her Legal Representative, and by the Sponsor or his or her representative.

(8) Service Plan Requirements.

(a) Each service plan shall be based on a current assessment of the Resident, and indicate the following:

1. The services needed, including the minimum service package provided for a monthly fee and any additional services the Resident needs;

2. The Resident's goals, and the frequency and duration of all services provided to address the Resident's particular physical, cognitive, psychological and social needs, including but not limited to the following:

a. Details of the manner in which the Residence shall provide for the presence of a 24 hour per day, on site staff, and the manner in which the Residence shall provide for personal emergency response devices or procedures;

b. Details of the types of assistance with medications that the Residence shall provide, if any;

c. Description of services that will be provided by a person or entity not affiliated with the Assisted Living Residence or by a certified provider of ancillary health services ( e.g. VNA services, private duty aides, adult day care) if the Resident, Resident Representative, or Legal Representative notifies the Assisted Living Residence that he or she has arranged for such services; and

d. The need for a meal plan prescribed or ordered by a Resident's physician. The Residence shall have a qualified dietitian review the Resident's dietary needs, and provide the Resident with diet management counseling; and

3. The service plans for Residents residing in Special Care Units must indicate the enrichment activities provided to them as set forth in 651 CMR 12.04(4).

(b) All service plans shall be in writing, signed and dated by the Resident or his or her Legal Representative, and by the Sponsor or his or her representative.

(c) Following the Service Plan reassessment required by 651 CMR 12.04(7)(b), the Service Coordinator or nurse shall review the Service Plan not less than every six months, or at any time upon identifying an improvement in the Resident's condition or a decline in a Resident's condition that will not normally resolve itself without intervention by staff, is not self-limiting, impacts more than one area of the Resident's health status, and requires interdisciplinary review and/or revision of the Service Plan. The Service Coordinator or nurse shall document the Service Plan review to ensure the Resident's needs and preferences are accurately incorporated therein and that the Residence is capable of meeting the Resident's needs in accordance with 651 CMR 12.00.

The service plan shall be confidential except to the extent necessary to provide services and manage the operations of the Assisted Living Residence; provided that EOEA may review the service plan at any time with the consent of the Resident or his or her Legal Representative.

(9) Ombudsman Requirements. The Applicant or Sponsor of an Assisted Living Residence is required to assist the Assisted Living Ombudsman Program in its duties as a condition of maintaining Certification. See 651 CMR 13.00: Statewide Assisted Living Ombudsman Program.

(10) Quality Assurance and Performance Improvement. The Residence shall establish an effective, ongoing quality improvement and assurance program to evaluate its operations and services to continuously improve services and operations, and to assure Resident health, safety, and welfare. The program should encompass oversight and monitoring of Residence services, ongoing quality improvement, and implementation of any plan that addresses improved quality of services. Residence staff shall periodically gather, review and analyze data at least quarterly to evaluate its provision of services to its residents and assess the overall outcome of services and planning and Resident experience of care. The program must be based on analysis of relevant information focusing on Resident safety, well-being and satisfaction. The program shall include but not be limited to review and assessment of the following operations:

(a) Service Planning. The Residence shall review a random sample of Resident assessments, service plans and progress notes at least once each year to ensure that the Residents' service plans have been implemented and meet the Resident's general needs and any self-identified goals.

(b) Resident Safety Assurances. The Residence shall review policies and procedures designed to ensure a safe environment for all residents. Such policies and procedures shall include an Evidence Informed Falls Prevention Program.

(c) Medication Quality Plan. The Residence shall develop and implement systems that support and promote safe SAMM, and if applicable, LMA programs. The Medication quality plan shall include but need not be limited to the following components:

1. Semiannual evaluation of each Personal Care worker that examines his or her awareness of SAMM and LMA regulations and applicable policies, and verifies his or her demonstrated ability to comply with SAMM and LMA regulations and related Residence policies and procedures; and

2. A quarterly audit of a random sample of the Residence medication documentation sheets required under 651 CMR 12.04(2)(b)2. to ensure compliance with SAMM and LMA protocols and Residence policies.

(d) A system shall be in place to facilitate the detection of issues and problems, to expedite the implementation of action, to resolve problems and communicate outcomes of actions taken or refused. Information solicited from Residents should be collected in a manner which offers anonymity ( e.g., suggestion box, resident satisfaction surveys, etc.).

(e) Data analysis shall be used to identify and implement changes that will improve performance or reduce the risk of Resident harm. The Residence shall maintain documentation demonstrating it has collected and analyzed data, implemented appropriate actions to address identified issues and resolve problems, and shall note any recommended follow-up actions and whether or not they were performed.

(f) The result of the quality assurance and performance improvement program cannot be the sole basis for a determination of non-compliance pursuant to 651 CMR 12.09.

(11) Emergency Preparedness Plan and Reporting Requirements. Each Residence shall have a comprehensive emergency management plan to meet potential disasters and emergencies, including fire; flood; severe weather; loss of heat, electricity, or water services; and resident-specific crises, such as a missing resident. The plan shall be designed to reasonable ensure the continuity of operations of the Residence.

(a) Plan Requirements.

1. The plan and any changes to the plan, which shall be developed in conjunction with local and state emergency planners, must include the following elements:

a. an evacuation strategy for both immediate evacuations, for such events as fires or gas leaks, as well as delayed evacuations, for such events as impending severe weather;

b. an established Mutual Aid plan that addresses essential issues, such as supplies, staff, and beds;

c. actions necessary to ensure supply, equipment and pharmaceutical support in the event such services are interrupted;

d. an established relationship with local public safety officials and with local Emergency Management Services (EMS) officials;

e. participation in Health and Homeland Alert Network (HHAN);

f. and protocols for full participation in the Silver Alert System (a system to register people at risk of wandering with participating local or county law enforcement to expedite their safe recovery in the event they become lost).

2. The plan shall indicate the location of emergency exits; evacuation procedures; and the telephone numbers of police, fire, ambulance, and emergency medical transport to be contacted in an emergency;

3. The plan shall address the physical and cognitive needs of residents, and shall include special staff response, including the procedures needed to ensure the safety of any resident. The plan shall include provisions related to individuals residing in a Special Care Residence, and shall be amended or revised whenever any resident with unusual needs is admitted;

4. The plan shall provide for the conducting of annual simulated evacuation drills and rehearsals for all shifts;

5. The Residence shall provide every Resident with a copy of the instructions they will be given under the Disaster and Emergency Preparedness Plan, and shall have available for their review a copy of the Plan.

(b) Staff Training. The Residence shall ensure disaster and emergency preparedness by orienting new employees at the time of employment to the Residence's emergency preparedness plan, periodically reviewing the plan with employees, and making certain that all personnel are trained to perform the tasks assigned to them.

(c) Reporting Emergency Situations. Upon the occurrence of any emergency situation that displaces Residents from their Units for eight hours or more, the manager of the Residence or his or her designee must immediately provide a report to the EOEA Assisted Living Residence Certification Unit. This report shall include, at a minimum:

1. the name and location of the Residence;

2. the nature of the problem;

3. the number of Residents displaced;

4. the number of Units rendered unusable due to the occurrence, and the anticipated length of time before the Residents may return to them;

5. remedial action taken by the Residence; and

6. other State or local agencies notified about the problem.

(d) Reporting Resident-specific Emergencies. A Residence shall report to EOEA the occurrence of an incident or accident that arises within a Residence or its property, that has or may have a Significant Negative Effect on a resident's health, safety or welfare, as defined by 651 CMR 12.02. A Significant Negative Effect shall be assumed whenever, as a result of an incident or accident, any unplanned or unscheduled visit to a hospital or medical treatment is necessary.

(e) Any report required under 651 CMR 12.04(11)(c) or 12.04(11)(d) shall be filed with the Assisted Living Certification Unit within 24 hours after the occurrence of the incident or accident via EOEA's online filing system. In the event the online filing system is inaccessible, a Residence must submit a temporary report by facsimile and telephone and formally submit the official report via the online filing system as soon as the service becomes accessible. The information submitted in the incident report must be accurate and include all details associated with the incident. This requirement is in addition to the requirements of M.G.L. c. 19A, § 15, and of any other applicable law.

(12) Communicable Disease Control Plan. The Residence must implement a plan to prevent and limit the spread of communicable disease. The plan shall conform to the currently accepted standards for principles of universal precautions based on DPH guidelines and shall include, but need not be limited to, the following components:

(a) A system to effectively identify and manage communicable diseases;

(b) Organized arrangements to provide the necessary supplies, equipment and protective clothing, consistent with universal precautions under DPH guidelines; and

(c) A process for maintaining records of illnesses and associated incidents involving staff pursuant to 651 CMR 12.06(8)(a).

(13) Reports to EOEA.

(a) Annual Reports.

1. A Sponsor shall file annually, within 90 days following the end of an Assisted Living Residence's fiscal year, a financial disclosure form prescribed by EOEA which sets forth a statement by the Sponsor based on reviewed or audited financial statements prepared by a certified public accountant. All financial statements must be sufficient to permit EOEA to assess the Residence's fiscal condition and ability to meet the requirements of the service plans established for its Residents is adequate. Upon written request to EOEA, the Secretary may extend such 90-day period by an additional period, not to exceed 30 days.

2. Each Residence shall file annually, on a form approved by EOEA, a report of aggregate information regarding Residents which is based, where applicable, on the most recent Resident assessments and service plans. The reporting period shall be January 1 ^st through December 31 ^st, and the report shall be submitted to EOEA no later than March 1 ^st of the next year. Failure to timely submit each annual report will result in a finding of noncompliance at the next Certification review. The report shall indicate:

a. As of December 31 ^st:

i. The number of current Residents, their ages, and self-identified gender;

ii. The percentage of all current Residents with a medical diagnosis of Alzheimer's disease or related dementia; and

iii. The number of Special Care Residents;

iv. Percentage of residents currently receiving SAMM, LMA or both SAMM and LMA;

v. The average and numerical range of ADLs with which current Residents receive assistance; and

vi. For any Residence that participates in the MassHealth Group Adult Foster Care (GAFC) program, the percentage of Residents enrolled in GAFC, in the SSI-G living arrangement, or receiving a Section 8 housing subsidy.

b. For the entire reporting period:

i. The average Resident census for the reporting period and the total Resident census for each month of the reporting period;

ii. The total number of Resident tenancies concluded during the reporting period, categorized by the reason for termination ( e.g., anticipated and Unanticipated Death, greater care needs, moved to another Residence); and

iii. The average length of stay for all Resident tenancies concluded during the reporting period.

3. Additional information that EOEA may require, on written notice to all certified Assisted Living Residences.

(b) Additional Reporting Requirements.

1. All information required by 651 CMR 12.03(2) or otherwise required by the Secretary shall be kept current by each Applicant or Sponsor. The Sponsor must notify the Secretary in writing at least 30 days prior to any Alteration of the Residence, its Units, or its operating plan. Such notice shall identify the specific changes made to any document which would amend, supplement, update or otherwise alter the operating plan, original Application or renewal for Certification shall be filed with EOEA at least 30 days prior to its effective date. In addition to the requirements of 651 CMR 12.04(11)(c), the Sponsor shall forward to EOEA a copy of any report or citation of a violation of applicable provisions of the State Sanitary Code, State Building Code, fire safety regulations or other regulations affecting the health, safety, or welfare of Residents within seven days of receipt of notice of such violation.

2. Within ten business days after an Assisted Living Residence Manager leaves his or her position, the Residence shall forward the contact information for any interim or new Residence Manager to EOEA, including telephone number(s) and email address.

(14) Controlled Substances. Each Residence shall create policies and procedures intended to prevent the theft or diversion of controlled substances prescribed to Residents who participate in SAMM or LMA. Such procedures shall include:

(a) a reporting process by which any such incidents of theft or diversion are reported, documented and investigated; and

(b) safeguards for the storage and disposal of all controlled substances that have been prescribed for Residents participating in SAMM and LMA.

(15) Distribution of Information on Palliative Care and End-of-life Options

(a) A Residence shall distribute culturally and linguistically suitable information regarding the availability of palliative care and end-of-life options to all Residents who have provided information indicating that their attending health care practitioner has:

1. diagnosed the Resident with a terminal illness or condition which can reasonably be expected to cause the Resident's death within six months, whether or not treatment is provided; or

2. determined that the Resident may benefit from hospice or palliative care services.

(b) This obligation shall be fulfilled by providing the Resident with:

1. information made available to the Residence by EOEA regarding the availability of palliative care and end-of-life options; or

2. information produced by the Residence that satisfies the requirements established by M.G.L. c. 111, § 227.

(c) Each Residence shall provide information to all physicians and nurse practitioners providing care within or on behalf of the Residence regarding the requirement of M.G.L. c. 111, § 227(c) that they offer to provide end-of-life counseling to Residents meeting the criteria established by 651 CMR 12.04(15)(a).

(d) Each Residence shall make available to EOEA proof that it is in compliance with 651 CMR 12.04(15)(a) through (c) upon request, or at the time of compliance review.

(16) Exemptions.

(a) At his or her discretion, the Secretary may grant an exemption from the requirements set forth in 651 CMR 12.04(1)(b), (c), and/or (4)(a)8. if it is determined that:

1. Public necessity and convenience requires such an exemption;

2. The granting of such an exemption shall prevent undue economic hardship; and

3. The Assisted Living Residence otherwise meets the purposes of assisted living to provide a home-like residential environment.

The Applicant/Sponsor shall request such an exemption in writing and shall enclose supporting documentation. The Secretary may grant such an exemption at his or her discretion.

(b) Exemption requests must be filed prior to the commencement of construction or renovation of the Residence. Any exemption request filed after construction or renovation has commenced will be deemed presumptively untimely unless the Applicant or Sponsor can demonstrate that there were specific and exigent circumstances that prevented the filing of the exemption request prior to commencement of construction or renovation of the residence.