651 CMR 12.04
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. This access must be noted in the Resident's Service Plan.
(b) All Newly Constructed Assisted Living Residences shall provide a private bathroom for
each Unit which shall be equipped with at least 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;
(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 code, state
building and fire safety codes and regulations, and laws and regulations governing
handicapped accessibility;
(f) Every Residence shall have an automated external defibrillator (AED) and ensure its
proper upkeep.
(g) Every Residence shall have unexpired naloxone that is centrally located and readily
accessible to Residence staff.
(h) EveryResidence shall have unexpired epinephrine that is readilyaccessible to Residence
staff.
(i) EveryResidence shall provide a living area space which allows for communal dining and
social engagement opportunities within the Residence.
(j) All equipment and supplies shall be kept in sanitary and good working condition.
(k) The premises shall be free of any condition that could reasonably be determined to pose
a danger to Resident safety, especially in the event of an emergency or evacuation.
(l) Fire Protection.
1. All Residences shall have an approved annual fire inspection by the local fire
department.
2. At least once a year, the Residence shall obtain instruction by the head of the local fire
department or their representative on the duties of the Residence's employees in case of
fire, and note such instruction sought and the date and type of instruction provided in the
Residence's record.
3. Fire extinguishers shall be recharged and so labeled at least once a year.
4. If applicable, emergency lights shall be checked monthly by the individual in charge
of the Residence, and if deficient, repaired immediately.
5. All exits shall be clearly identified by exit signs, adequately lighted and free from
obstruction.
6. Clothes dryers must be kept in good working order and shall be inspected at the time
of installation and annually thereafter. The lint screen and vent in the dryer must be
properly maintained.
7. Kitchen hood extinguisher systems shall be properly maintained, inspected and
certified.
(m) Oxygen Use and Storage.
1. All oxygen shall be used or stored in accordance with the National Fire Protection
Association Code.
2. A carrier appropriate for the transportation of oxygen shall be used when delivering
or transporting oxygen.
3. Signs indicating oxygen is available, currently in use, or stored shall be conspicuously
posted.
4. Oxygen tanks shall be safely stored and labeled when empty.
(2) Service and Service Coordination Requirements.
(a) Each Assisted Living Residence shall designate at least one Resident Care Director. The
Resident Care Director 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(7) and (8);
2. Implementation of the Service Plan developed under 651 CMR 12.04(8);
3. Monitoringthe Resident's needs and the services provided bythe 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(11); and
5. Maintaining complete and accurate records of Service Plans.
6. If the Resident Care Director is not a licensed nurse, they must work with a licensed
nurse to ensure that the Resident's medical needs are being addressed and that the Service
Plan is signed by the licensed nurse.
(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,
which may include the use of a Transfer Assistive Device or Mobility Assistive Device
(if applicable) 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).
e. Allow for the following:
i. 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.
ii. 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.
f. Be performed only by:
(i) an individual who has completed Personal Care Services Provider Training
as set forth in 651 CMR 12.07(7) unless a relevant exemption set forth at
651 CMR 12.07(10) applies;
(ii) a practitioner, as defined in M.G.L. c. 94C; or
(iii) 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, and which does not include a nurse delegate
under M.G.L. c. 112, § 80B.
g. Central storage of a Resident's 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. The
personal emergency response system must always be active and accessible to the
Resident. Emergency response system calls must be answered in a timely and
appropriate manner. No response shall exceed ten minutes.
c. Anyadditional response systems EOAImayrequire in accordance with the service
needs of the Residents; and
d. Documented hourly safety checks in the SCR Units for twelve hours overnight.
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 U.S.C. § 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 registered dietitian review the Residence's dietary plans
at least every six months.
(3) Basic Health Services.
(a) The Provision of Basic Health Services.
1. Any Residence certified to provide Basic Health Services shall offer all such Basic
Health Services included in 651 CMR 12.02.
2. Prior to providing Basic Health Services to a Resident, the Residence must:
a. obtain the written consent of the Resident or the Resident's Legal Representative
or the Health Care Agent, as applicable, to receive Basic Health Services and
document the written consent in the Resident record;
b. inform the Resident they have the option of retaining a third-party provider of
their choice to provide equivalent Basic Health Services;
c. ensure that a Registered Nurse updates the Resident's Service Plan with the
Resident's Medical Order and reviews with the Resident, Resident Representative,
Health Care Agent, or Legal Representative, as applicable, said Service Plan;
d. provide and discuss the fees associated with the provision of Basic Health
Services;
e. update the Resident's Residency Agreement to reflect the inclusion of Basic
Health Services and any associated fees; and
f. include documentation in the Resident record to ensure the coordination of Basic
Health Services with SAMM or LMA, as appropriate.
3. After obtaining Resident consent for the Residence to provide Basic Health Services,
the Residence must update the Resident's Residency Agreement or amend it with a
supplemental agreement that identifies the Basic Health Services to be provided to the
Resident and any associated costs.
4. In the event a Resident retains a third-party provider of Basic Health Services, the
Residence must coordinate with the third-party provider to the extent practicable and
provide or obtain Resident records sufficient to ensure continuity of care and the safe
provision of Basic Health Services. The Residence may not retaliate against a Resident
who elects to retain a third-party provider of Basic Health Services.
5. The Residence must identify whether the Resident has a Health Care Proxy, whether
the Health Care Proxy is invoked, and establish a means of contact with the Health Care
Agent. If the Health Care Proxy is invoked, the Health Care Agent must be notified
regarding the provision of Basic Health Services.
6. AnyResidence providingBasic Health Services shall complywith all state and federal
standards regarding specimen collection and the completion of a home diagnostic test
(e.g. a Certificate of Waiver for the Clinical Laboratory Improvement Amendments).
7. Medical Orders.
a. Basic Health Services may only be provided to a Resident in accordance with a
valid Medical Order issued by a Licensed Independent Provider. The Medical Order
shall be signed and dated by the Licensed Independent Provider.
b. Documentation of a Resident's Medical Order must be retained in the Resident
record.
c.
The Residence must regularly communicate with the Resident or Legal
Representative or the Resident's Health Care Agent, if applicable. The Residence
must maintain contact information for the Resident's Licensed Independent Provider
to ensure the most recent Medical Order is on file and the Residence is aware of any
potential changes to the Resident's needs.
d. In the event a new Medical Order is issued, the Residence must conduct an
evaluation pursuant to 651 CMR 12.04(3)(a)8.
e. Basic Health Services may only be provided if the Resident's setting is deemed
medically appropriate for such services and the proper equipment, including an
automated external defibrillator (AED), medication, and supplies are readily
available.
8. Before Basic Health Services are provided by the Residence, the Resident must be
assessed and evaluated by a Registered Nurse to ensure:
a. the provision of Basic Health Services can be provided in a safe and effective
manner that is consistent with scope of practice;
b. the Resident is properly identified and consents to such services;
c. a Resident's Medical Order is valid and up to date; and
d. any significant change in the Resident's condition is reported to the Resident's
Licensed Independent Provider before the provision of Basic Health Services.
9. Service Requirements.
a. Basic Health Services must be provided by a Clinical Professional who has the
training and demonstrated competency in providing such services within their scope
of practice.
b. The Clinical Professional must identify the Basic Health Services provided and
document each date and time such services are provided, as well as any assessment
findings in the Resident's record.
c. Basic Health Services provided by the Residence must meet the standard of care
for Clinical Professionals.
d. The Residence must coordinate with any licensed hospice provider for hospice
care provided to a Resident pursuant to 651 CMR 12.04(4)(b)1 to ensure continuity
of care.
e. All Residence staff providing care to a Resident receiving Basic Health Services
must monitor the Resident's condition and notify the Clinical Professional as well as
the Resident, or the Resident's Legal Representative or Health Care Agent, if
applicable, and the Resident's Licensed Independent Provider, regarding any change
in the Resident's condition.
10. Resident Service Plan, Resident Record, and Communication Log.
a. The Residence's Registered Nurse must develop the Resident's Service Plan in
accordance with 651 CMR 12.04(8).
b. Upon the implementation of any revision to a Resident's Service Plan that
includes the provision of Basic Health Services, the Residence shall review with the
Resident, Resident Representative, or Legal Representative, as applicable, any
changes to the fees associated with the provision of Basic Health Services established
by the Resident's Residency Agreement, and shall document such review in the
Resident record.
c. Documentation of all Basic Health Services provided to a Resident must be
included in the Resident record.
d. The provision of Basic Health Services delivered to participating Residents shall
be included in the staff communication log as needed to communicate information
necessary to maintain the continuity of care for Residents receiving Basic Health
Services.
11. Residence Discontinuance.
a. A Residence opting to discontinue the provision of Basic Health Services must
provide at least 120 days' notice to:
i. EOAI;
ii. all Residents, their Legal Representatives and Resident Representatives, as
appropriate;
iii. the Residents' Licensed Independent Providers;
iv. the Residents' Health Care Agents, if applicable; and
v. the Long-Term Care Ombudsman.
b. The notice must include, at a minimum:
i. a statement of the Residence's intent to discontinue the provision of Basic
Health Services and the basis for its decision;
ii. a proposed date of discontinuance not earlier than 120 days after the date of
the notice; and
iii. a plan to ensure Residents are able to continue to receive Basic Health
Services until other arrangements can be made.
c. The notice to be submitted to EOAI must also identify all affected Residents and
include contact information for Residence staff responsible for managing the
discontinuance of Basic Health Services, including the staff responsible for issuing
the required notices to Residents and ensuring the continuity of care for affected
Residents.
d. Upon the discontinuance of providing Basic Health Services, the Basic Health
Services Certification will be amended to reflect the change in the Residence's
operation.
(4) Skilled Care Services.
(a) The Sponsor may arrange for the provision of ancillary health services in the Residence.
With the exception of the care included within the definition of Basic Health Services
provided by Residences certified to provide Basic Health Services, 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 admit a Resident who requires 24-hour skilled
nursing supervision unless such Resident elects to receive Basic Health Services from
Residences that are certified to provide such services and from qualified third parties who
are capable of providing Skilled Nursing Care that is not included in Basic Health Services
or the Resident elects to receive Skilled Nursing Care from a qualified third-party. No
Assisted Living Residence shall provide Skilled Nursing Care or admit or retain a Resident
in need of Skilled Nursing Care where such Resident receives services from qualified third
parties unless the following criteria are met:
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, including as related to a nurse delegate
under M.G.L. c. 112, § 80B.
(5) 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(5) 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
EOAI 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 alarmed and 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 anySpecial 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(5)(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(11). The Residence shall document the results of these reviews.
(6) Optional Services.
(a) The Assisted Living Residence may provide or arrange for the provision of the following
optional services, including but not limited to:
1. Local transportation for medical and recreational purposes;
2. Barber or beauty services, sundries for personal consumption and other amenities;
3. Assistance to Residents with accessing telehealth services;
4. Basic Health Services for Residents whose Service Plans include Basic Health
Services, in accordance with the requirements set forth within M.G.L. c. 19D and
651 CMR 12.00, bypersonnel who meet the standards for professional qualifications and
training set forth in regulations promulgated pursuant to M.G.L. c. 19D;
5. Ancillary services for health-related care including, but not limited to, restorative
therapies, podiatry, hospice care, home health or other such services; provided, however,
that such services shall be delivered by an individual licensed to provide such care;
6. Money management and other financial arrangements to be performed by an
independent party for any Resident unable to manage their funds or property. The
Sponsor shall not allow any employee of an Assisted Living Residence to control or
manage the funds or propertyof 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. The Sponsor shall detail such agreements
in the Resident's Service Plan; and
7. Limited Medication Administration (LMA) for Residents whose Service Plan include
LMA.
a. The Residence must perform LMA from an original, pharmacy-filled and
pharmacy-labeled container.
b. In addition to the requirements and limitations set forth in 651 CMR 12.04(4), 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, medical patches, as necessary oxygen, suppositories). LMA performed by a
licensed nurse must be completed in accordance with all applicable laws, regulations
and standards governing the medication administration process by a nurse, including
documentation requirements.
c. 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.
(b) Discontinuance of Optional Services.
1. Resident Discontinuance.
a. Planned Discontinuance or Pause in Services.
i. A Resident may pause or discontinue receiving optional services, including,
but not limited to, Basic Health Services and Limited Medication Administration,
from the Residence upon written notice to the Residence.
ii. For any planned pause or discontinuance of optional services, the Resident
shall give the Residence at least 14 days' advance written notice of the date on
which services are to be paused or discontinued.
iii. A Resident who has properly submitted written notice under 651 CMR
12.04(6)(b)1.a.ii. shall not be charged a cancellation fee or a fee for services not
provided due to such planned pause or discontinuance.
b. Unplanned Discontinuance or Pause.
i. If a Resident must pause or discontinue optional services because of an
unplanned or emergent event (e.g., hospitalization, acute illness, or other
unexpected change in condition), the Resident or their representative, if
applicable, shall notify the Residence in writing as soon as reasonably
practicable.
ii. Upon receipt of such written notice, the Residence shall accommodate the
change immediately. The Residence may not assess a fee for the optional
services not provided 24 hours after receipt of the written notice. In accordance
with M.G.L. c. 19D, § 10, a Resident shall not be charged a cancellation fee or
a fee for services not provided due to the discontinuation of Basic Health
Services.
(7) Screening and Assessment.
(a) Prior to signing a Residency Agreement and a Resident moving in, the Residence must
arrange for an in-person initial assessment conducted by a nurse shall determine:
1. The prospective Resident's service needs and preferences and the ability of the
Residence to meet those needs;
2. The Resident's physical and functional abilities;
3. The Resident's cognitive status and psychosocial condition;
4. Whether a medication program (e.g. SAMM or LMA) is appropriate and which
medication program, 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 requires Basic Health Services;
6. Whether the Resident is at risk for elopement;
7. Whether the Resident is suitable for a Special Care Residence; and
8. Whether the Resident requires special assistance during an emergency or evacuation.
The assessment must specify what type of assistance the Resident requires.
9. Whether the Resident has any special dietary needs or requirements.
(b) The nurse's assessment must validate any information provided by the Resident, their
Legal Representative, or Resident Representative, if applicable. The nurse's assessment must
also include an evaluation by the Resident's physician or authorized practitioner, of the
prospective Resident's physical, cognitive, functional, and psychosocial condition conducted
within the past 90 days. The preadmission assessment shall note the name of any Legal
Representative, Health Care Agent, or any other person who has been documented as having
decision-making authority for the Resident and the scope of their authority. The Residence
shall collect any relevant documentation before move-in.
(c) The initial assessment findings shall be documented and disclosed to the Resident, their
Legal Representative and Resident Representative, if any, prior to the Service Plan
development and before the Resident moves into the Residence, and must be reviewed by
a nurse employed by the Residence.
(8) Service Plan Development.
(a) The nurse and Resident Care Director shall develop an individualized Service Plan for
each Resident in accordance with the findings of the initial screening described in 651 CMR
12.04(7).
1. Said Service Plan shall be developed before the Resident moves into the Residence
and be based on information provided by the Resident, their Legal Representative and
Resident Representative, if applicable.
2. 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,
any Health Care Agent, or Resident Representative to the extent that they are authorized,
willing, and able to be involved. The parties must have a thorough conversation that
must be documented by the Residence. The conversation must include:
a. the services that will be provided to the Resident, including a breakdown of
associated costs;
b. any potential or anticipated future services that may be required based on the
Resident's changing needs as well as an estimated cost for such services; and
c. anyother information that maybe necessaryto ensure the Resident's health, safety,
and welfare.
3. If the Resident's Licensed Independent Provider has issued a Medical Order for the
provision of Basic Health Services, a Registered Nurse, shall consult with said Licensed
Independent Provider when developing the Resident's Service Plan.
(b) 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
their representative to have the physician's or authorized practitioner's evaluation completed.
This evaluation may be the same evaluation that is required in 651 CMR 12.04(7)(a).
(c) 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. Fall risk, especially nighttime fall risk and risk of falling from the bed during sleep;
6. The need for assistance in emergency situations or evacuations. The Service Plan
must detail what type of assistance the Resident requires during an emergency or
evacuation;
7. If the Resident requires a new Mobility Assistive Device or there is a change in the
current use of the device, an assessment must be completed by a Massachusetts licensed
occupational therapist or physical therapist. An assessment must also be completed after
any significant change in condition.
8. If the Resident requires a new Transfer Assistive Device or there is a change in the
current use of the device, an assessment must be completed by a Massachusetts licensed
occupational therapist or physical therapist. An assessment must also be completed after
any significant change in condition. For a Transfer Assistive Device that is affixed to a
Resident's bed, a Massachusetts licensed occupational therapist or physical therapist must
conduct an assessment every six months.
9. The need for assistance with transfers that require the use of a Lift Device, if
applicable;
10. 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;
11. Level of personal care needs, including ability to perform ADLs and IADLs;
12. Ability of the Resident to manage medication, including the ability to take
medication on an as-needed basis; and
13. The type and frequency of Basic Health Services to be provided, if applicable.
(d) The Resident Care Director 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 their Legal
Representative, and by the Sponsor or their representative.
(9) Service Plan Requirements.
(a) Each Service Plan shall be based on a current assessment of the Resident, and indicate
the following:
1. A description of all the services to be provided, along with all the fees for services;
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. Details regarding the provision of Basic Health Services, if applicable;
d. Description of services, including the provision of Basic Health Services, if
applicable, 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
e. The need for a meal plan prescribed or ordered by a Resident's physician. The
Residence shall have a qualified registered dietitian review the Resident's dietary
needs, and provide the Resident with diet management counseling; and
3. The identification of staff or categories of staff who will provide the services;
4. The schedule and methods of monitoring assessments and services of the Resident;
5. The schedule and methods of monitoring staff providing services;
6. The use of a Transfer Assistive Device or Mobility Assistive Device(s) by or for a
Resident. A Transfer Assistive Device or Mobility Assistive Device may only be used
for the purpose of enhancing Resident independence in mobility and transfers. The
Residence must collaborate with the Resident or Legal Representative, as applicable.
The Service Plan must:
a. Include the purpose and intended outcome for use of the Transfer Assistive Device
or Mobility Assistive Device. The Transfer Assistive Device or Mobility Assistive
Device must be assessed for proper use by the Resident.
b. Distinguish between devices that:
i. Enhance mobility;
ii. Provide positional support;
iii. Provide transfer support; or
iv. Address specific medical needs.
c. Address the circumstances under which the Transfer or Mobility Assistive Device
should and should not be used.
i. The Transfer or Mobility Assistive Device must not have the effect of
restricting the Resident's voluntary movement.
ii. The Resident must be able to enter and exit a bed freely and independently
with no additional assistance when using a Transfer Assistive Device affixed to
a Resident's bed.
iii. The use of any bed rail is limited to those that cover less than half the length
of the bed. The use of full-length bed rails is prohibited.
iv. Service planning and assessment for Residents who utilize Transfer Assistive
Devices or Mobility Assistive Devices shall address the Resident's physical and
cognitive abilities to safely and effectively use the device and shall identify any
necessary supports, supervisions, or interventions required to promote Resident
safety.
d. Note the staff positions trained to assist with the use of Transfer or Mobility
Assistive Devices.
e. Include the consent of the Resident or Legal Representative, as applicable.
f. Include documentation that the Residence provided written disclosure(s) and
information explaining the risks associated with a Transfer Assistive Device or
Mobility Assistive Device to the Resident or their Legal Representative, if applicable.
g. Include usage guidelines. The usage guidelines must be strictly followed by either
trained staff or, where appropriate, the Resident, to mitigate the risks of falls or injury
during movement and transfers.
7. 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(5).
8. The need for assistance during an emergency or an evacuation. The Service Plan must
detail what type of assistance the Resident requires during an emergency or an
evacuation.
(b) All Service Plans shall be in writing, signed and dated by the Resident or their Legal
Representative, and any Health Care Agent, if applicable, and by the Sponsor or their
representative. A copy of the Resident's Service Plan shall be given to the Resident or their
Legal Representative, as applicable.
(c) Following the Service Plan review required by 651 CMR 12.04(8)(d), the Resident Care
Director or nurse shall:
1. Reassess the Service Plan not less than every six months, or
i. at any time upon identifying an improvement in the Resident's condition;
ii. at any time upon identifying a decline in the 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; or,
iii. at any time upon receipt of a new or modified Medical Order for a Resident who
receives Basic Health Services.
2. Reassess the Service Plan not less than every three months for Residents who receive
Basic Health Services;
3. 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.
4. Ensure that the Service Plan has been signed by the Resident or their Legal
Representative, and any Health Care Agent, if applicable, after a Service Plan review has
occurred.
5. Sign the Service Plan any time a review of the Resident's Service Plan has occurred.
(d) The Service Plan shall be confidential except to the extent necessary to provide services
and manage the operations of the Assisted Living Residence or to the extent the Service Plan
is subject to disclosure as required by law; provided that EOAI may review the Service Plan
at any time with the consent of the Resident or their Legal Representative.
(10) Ombudsman Requirements. The Applicant or Sponsor of an Assisted Living Residence
is required to assist the Long-Term Care Ombudsman Program in its duties as a condition of
maintaining Certification. See 101 CMR 30.00: Statewide Long-Term Care Ombudsman
Program.
(11) 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 gather, review and analyze data at least annually unless
otherwise specified 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 Plan and progress notes at least once each year to ensure that the
Residents' Service Plans have been implemented and meet the Residents' 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. The emergency response system
must be tested at a minimum quarterly. These tests must be documented. In addition, the
Residence must monitor response call times and utilize a documented Quality Assurance and
Performance Improvement (QAPI) process, at least quarterly, to reduce response times and
immediately address and prevent extended response times. The Residence must be able to
obtain and provide all response times as well as average response times by month. The
Residence must perform quarterlychecks to ensure that the Residence is free from conditions
that could reasonably be determined to pose a danger to Resident safety, especially in the
event of an emergency or evacuation.
(c) Medication Quality Plan. The Residence shall develop and implement systems that
support and promote safe SAMM, and if applicable, LMA and Basic Health Services
programs. The Medication quality plan shall include but need not be limited to the following
components:
1. Semiannual evaluation of each Personal Care Staff that examines their awareness of
SAMM and LMA regulations and applicable policies, and verifies their demonstrated
ability to comply with SAMM and LMA regulations and related Residence policies and
procedures;
2. A quarterly audit of a random sample of the Residence medication documentation
sheets required under 651 CMR 12.04(2)(b)2. or 651 CMR 12.04(6)(a)7.b. to ensure
compliance with SAMM and LMA protocols and Residence policies; and
3. A quarterly audit of all Medication Errors. All Medication Errors occurring at a
Residence shall be recorded, tracked, and reviewed.
(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.
(g) Quality Assurance and Performance Improvement (QAPI) Committee. Residences
providing Basic Health Services must establish a quality assurance and performance
improvement committee, which must consist of, at a minimum, a Clinical Professional and
the Executive Director of the Residence, and, as needed, a physician, advanced practice
registered nurse, or a representative of the relevant pharmacy. Quality Assurance and
Performance Improvement Committee meetings shall be held quarterly at a minimum and
whenever a Serious Incident or Medication Error involving Basic Health Services occurs.
(12) Disaster and Emergency Preparedness Plan and Reporting Requirements. Each Residence
shall have a comprehensive disaster and emergencypreparedness 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
reasonably ensure the continuity of operations of the Residence. The Residence must review
and update the plan every year. This review of the plan must be documented in the plan.
(a) Plan Requirements.
1. The plan shall be developed in conjunction with local and state emergency planners
as well as local and state fire and safety experts. The plan and any changes to the plan
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. the provisions of subsistence needs for staff and Residents, whether they evacuate
or shelter in place, including, but not limited to the following:
i. food, water, medical, and pharmaceutical supplies;
ii. alternate sources of energy to maintain:
1. Temperatures to protect Resident health and safety and for the safe and
sanitary storage of provisions;
2. Emergency lighting;
3. Fire detection, extinguishing, and alarm systems; and
4. Sewage and waste disposal;
c. an established relationship with local public safety officials and with local
Emergency Management Services (EMS) officials;
d. participation in Health and Homeland Alert Network (HHAN);
e. protocols for full participation in safety alert or notification systems or processes
for missing and vulnerable persons and elopements, such as 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); and
f. A documented, Residence-based and community-based risk assessment utilizing
an all-hazards approach, including missing Residents.
2. The plan shall indicate the locations of alarm signals and fire extinguishers, the
locations of emergency exits; the evacuation routes and the procedures for evacuating
Residents; and the assignment of specific tasks and responsibilities to the personnel of
each shift;
3. The plan must include protocols for regularly checking and documenting compliance
with all physical building and premises requirements, including routine checks of the
Residence by staff to confirm that the building is safe, accessible, and free from
conditions that could reasonably be determined to pose a danger to Resident safety,
especially in the event of an emergency or evacuation;
4. The plan must specify the persons to be notified during an emergency and must
include the telephone numbers of police, fire, ambulance, and emergency medical
transport to be contacted in an emergency;
5. 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. The plan must provide a means for the Residence to be able to
remotely access copies of the Residents' records electronically, such as during an
emergency;
6. The plan shall provide for the conducting of quarterly elopement and fire drills and
rehearsals for all shifts, and annual simulated evacuation drills, and rehearsals for all
shifts. Each staff person must participate at least annually in each of the following drills:
simulated evacuation drill, elopement drill, and fire drill. These drills shall test the
effectiveness of the plan;
7. Residences must seek to include Residents who are willing and able to participate in
simulated evacuation drills at least annually, and must encourage and support such
participation of all such Residents;
8. The Residence shall provide every Resident with a copy of the instructions they will
be given under the plan, and shall have available for their review a copy of the plan.
9. The emergency procedures and evacuation route shall be posted in conspicuous
locations throughout the Residence as well as in each Unit on the back of the door.
10. Each Residence shall ensure a reliable means is available at all times, in accordance
with EOAI guidelines; for:
(a) sending information to the EOAI regarding incidents and emergencies occurring
on the premises;
(b) receiving information from EOAI and other state and local authorities in the
event of an emergency; and
(c) activating Mutual Aid.
11. The plan must include a communications section to ensure that Residents and their
Resident Representatives, Legal Representatives, and Health Care Agents, as applicable,
are able to receive communications and information from the Residence in the event of
a storm or power outage.
(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, performing quarterly reviews of the emergency preparedness plan with
employees, and making certain that all personnel are trained to perform the tasks assigned
to them. Staff must also be trained on procedures regarding elopements, including the
process for using elopement notification systems, such as the Silver Alert system.
(c) Serious Incident Reporting.
1. The Executive Director or their designee must provide a report in a form and format
prescribed by EOAI to the EOAI Assisted Living Residence Certification Unit for any
Serious Incident as defined in 651 CMR 12.02 occurring at the Residence. The
Residence additionally must perform an incident investigation which may include, but
is not limited to, determining whether any Resident has been harmed or placed at risk of
harm and take appropriate action to treat the Resident, which may include sending the
Resident to a healthcare facility for a medical evaluation or removing the risk of harm.
2. If a Resident has been harmed or placed at risk of harm, the Residence must notify the
Resident, Health Care Agent, Resident Representative, or Legal Representative, if
applicable.
3. Any incident involving theft must be reported to local law enforcement.
4. A facility-wide Serious Incident shall include, but is not limited to:
a. an outbreak of a serious communicable disease that is listed in 105 CMR 300.100:
Diseases Reportable to Local Boards of Health;
b.
an employee of a Residence found to be infected with a disease in a
communicable form that is listed in 105 CMR 300.100;
c. pest infestation;
d. food poisoning as defined in 105 CMR 300.020: Definitions;
e. fire, flooding, or other natural disaster;
f. structural damage to the Residence; and
g. A situation that displaces Residents from their Units for eight hours or more.
i. A situation that displaces Residents from their Units for eight hours or more
must be reported to the EOAI Assisted Living Residences Certification Unit
immediately.
5. A Resident-specific Serious Incident shall include, but is not limited to:
a. accidental injury;
b. a significant injury, including trauma to a Resident's head;
c. a Resident fall that resulted in a fracture or suspected fracture or head trauma;
d. a preventable pressure injury;
e. Unanticipated Death;
f. suicide or suicide attempt;
g. a physical or sexual assault by or against a Resident;
h. a complaint of Resident abuse, neglect, or exploitation; a complaint of suspected
Resident abuse, neglect, or exploitation; or referral of a complaint of Resident abuse,
neglect, or exploitation to a local or state authority;
i. a Medication Error requiring medical attention;
j. any use of a Restraint;
elopement with an absence of greater than 30 minutes;
k. misuse of a Resident's funds by the Residence or its staff;
l. any incident or injury involving Basic Health Services; and
m. Medication Diversion.
6. Any report required under 651 CMR 12.04(12)(c) shall be filed with the Assisted
Living Certification Unit within 24 hours after the occurrence of the incident or accident
via EOAI's online filing system. In the event the online filing system is inaccessible, a
Residence must submit a temporary report via email 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.
7. A Residence must cooperate with EOAI and other relevant authorities at all times,
including investigations involving the provision of Basic Health Services.
(13) 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 personal
protective equipment (PPE), consistent with transmission-based precautions under DPH
guidelines; and
(c)
A process for maintaining records of illnesses and associated incidents involving
Residents as well as staff pursuant to 651 CMR 12.06(9)(a).
(14) Reports to EOAI.
(a) Annual Reports.
1. A Sponsor shall file annually, within 90 days following the end of an Assisted Living
Residence's fiscal year on a form prescribed by EOAI, a statement and professional
opinion prepared by a certified public accountant or comparable reviewer indicating
whether the Assisted Living Residence is in sound fiscal condition and is maintaining
sufficient cash flow and reserves to meet the requirements of the Service Plans
established for its Residents. Upon written request to EOAI, 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 prescribed by EOAI, a completed 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 1st through December 31st, and the report shall be submitted to EOAI no later
than March 1st of the next year. Failure to timely submit a completed annual report will
result in a finding of noncompliance.
(b) Additional Reporting Requirements.
1. The Sponsor must notify EOAI in a form and format prescribed by EOAI 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. The notice shall be filed with EOAI at least 30 days prior to the
effective date of the Alteration.
2. In addition to the requirements of 651 CMR 12.04(12)(c), the Sponsor shall forward
to EOAI 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.
3. Within 5 business days after an Assisted Living Residence Executive Director or
Resident Care Director leaves their position, the Residence shall forward the contact
information for any interim or new Executive Director or Resident Care Director to
EOAI, including telephone number(s) and email address.
4. EOAI may determine further reporting is necessary and issue written notice to all
Residences specifying the additional information required, including the prescribed
format and any applicable submission deadlines. Each Residence shall, within the time
frame provided in such notice, furnish the requested additional information in accordance
with the instructions established by EOAI.
5. All information required by 651 CMR 12.03(2) or otherwise required by the Secretary
shall be kept current by each Applicant or Sponsor.
(15) 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, LMA, or Basic Health Services. Such procedures shall include:
(a) a reporting process by which any such incidents of theft or diversion are reported,
documented and investigated;
(b) safeguards for the storage and disposal of all controlled substances that have been
prescribed for Residents participating in SAMM, LMA, and Basic Health Services; and
(c) prompt reporting of any theft or diversion of any Controlled Substance to all appropriate
agencies, including local law enforcement.
(16) 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 EOAI 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(16)(a).
(d)
Each Residence shall make available to EOAI proof that it is in compliance with
651 CMR 12.04(16)(a) through (c) upon request, or at the time of compliance review.
(17) Exemptions.
(a) At their discretion, the Secretarymaygrant an exemption from the requirements set forth
in 651 CMR 12.04(1)(b), (c), and/or (5)(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.
(b) The Applicant/Sponsor shall request such an exemption in writing and shall enclose
supporting documentation. The Secretary may grant such an exemption at their discretion.
(c)
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 presumptivelyuntimelyunless 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.