651 CMR 12.09
Compliance Reviews and Findings of Noncompliance of Assisted Living Residences
(1) Purpose. EOAI or its authorized designee shall conduct a compliance review of an Assisted
Living Residence prior to the issuance of any initial or renewal Certification to determine
compliance with M.G.L. c. 19D and 651 CMR 12.00. An authorized designee shall not be a
Sponsor of an Assisted Living Residence.
(2) Frequency. EOAI or its authorized designee shall conduct compliance reviews of Assisted
Living Residences prior to initial certification, no less than once every two years at Residences'
biennial certification in accordance with 651 CMR 12.09(3)(a) and no less than once every year
for Residences certified to provide Basic Health Services in accordance with 651 CMR
12.09(3)(b). In addition, EOAI may conduct a compliance review any time it has cause to
believe that an Assisted Living Residence is in violation of an applicable section of M.G.L.
c. 19D or any applicable EOAI regulation, in accordance with 651 CMR 12.09(3)(c).
(3) Compliance Reviews and Findings of Noncompliance.
(a) Initial and Biennial Certification Compliance Review. A compliance review conducted
as part of an initial or biennial certification shall include, at a minimum, the following:
1. A review of the operating plan and an inspection of every part of the common areas
of the Assisted Living Residence. The inspector may, in their discretion, interview the
Applicant or Sponsor, Executive Director, staff and Residents of the Assisted Living
Residence. An inspector shall have the authoritytoconfidentiallyand privatelyinterview
the Applicant or Sponsor, Executive Director, staff, and Residents. Interviews with
Residents shall be conducted privately and shall be confidential;
2. An inspection of the living quarters of any Resident, but only with the Resident's prior
consent;
3. An examination of any and all documents within a Resident's record, including
Service Plans and written progress reports, incident reports (or similar documents),
Residency Agreement, and any other financial or contractual agreements specific to the
Resident. The Resident may give consent in writing, on a form developed by EOAI,
orally, or by a sign of affirmation if the Resident is not able to give consent by other
means. Consent may include consent to photocopy such materials. If consent is obtained
by a means other than writing, confirmation of the consent shall be written in the review
record;
4. A review of staff and contracted provider records, including personnel files;
5. Reviews of Residences certified to provide Basic Health Services shall also include
an inspection of records associated with the provision of Basic Health Services, a review
of Residence employee qualifications, the Residence's operating plan as it pertains to the
provision of Basic Health Services, and the documentation created and maintained bythe
Residence for Residents who received Basic Health Services during the previous
12-month period;
6. A review of all other books, records, and other documents maintained in relation to
the operations of the Residence; and
7. A review of the quality improvement and assurance plans, including Resident
satisfaction surveys.
(b) Annual Compliance Review for Basic Health Services. A compliance review of a
Residence certified to provide Basic Health Services will be conducted annually on the years
that the compliance review for biennial recertification in accordance with 651 CMR
12.09(3)(a) is not conducted. Such compliance review for Basic Health Services will include
review of the compliance for the provision of Basic Health Services and related requirements
pursuant to 651 CMR 12.09(3)(a)5., and may include a review of a portion or subset of
additional items described at 651 CMR 12.09(3)(a), or such other items determined to be
relevant to such annual compliance review for Basic Health Services in EOAI's sole
authority.
(c) Interim Compliance Review. EOAI may conduct compliance reviews other than those
described at 651 CMR 12.09(3)(a) and 12.09(3)(b) at the discretion of EOAI at such other
times EOAI has cause to believe that a Residence is in violation of an applicable section of
M.G.L. c. 19D or 651 CMR 12.00. The interim compliance review may include a review of
a portion or subset of the items described at 651 CMR 12.09(3)(a), or such other items
determined to be relevant to such interim compliance review in EOAI's sole authority.
(d) Findings of Noncompliance. EOAI may make findings of noncompliance with M.G.L.
c. 19D or 651 CMR 12.00 as a result of conducting a compliance review or when EOAI has
cause to determine a Residence fails to meet the requirements of M.G.L. c. 19D or 651 CMR
12.00.
(e) Refusal to grant EOAI timely access to Residents, staff, all books, records, and other
documents maintained regarding the operations of the Residence shall constitute valid basis
to modify, suspend, revoke or deny an application for an initial or renewal Certification, or
issue a fine of not more than $500 for each day of such failure or refusal to comply. EOAI
shall be authorized to photocopy such materials or request the Residence send copies of
identified materials to EOAI via facsimile or other electronic means.
(4)
Compliance Review Reports, Findings of Noncompliance, Actions by EOAI, and
Responses. Whenever a compliance review is conducted, or where EOAI otherwise makes
determinations of findings of noncompliance with the requirements of 651 CMR 12.00, EOAI
or its designee shall prepare written findings summarizing all pertinent information obtained
during such compliance review or such other determination of findings and shall not disclose
confidential or privileged information obtained in connection with the review or determination
of findings.
(a) Notice of Compliance. If EOAI finds that the Applicant or Sponsor is in compliance
with M.G.L. c. 19D or 651 CMR 12.00, EOAI shall mail a copy of its findings to the
Applicant or Sponsor within ten days after the compliance review is completed.
(b)
Notice of Noncompliance. If EOAI finds that the Applicant or Sponsor is not in
compliance with M.G.L. c. 19D or 651 CMR 12.00, EOAI shall forward a notice of
noncompliance to the Applicant or Sponsor. The notice shall describe the noncompliance
with particularity, indicate the specific portion of the law(s) or regulation(s) which have been
violated, and shall include the corrective action to be taken by the Applicant or Sponsor
within a time period deemed reasonable by the Secretary. The notice of noncompliance also
shall include a description of the action that may be taken by the Secretary if the corrective
action is not completed. The notice shall be delivered by hand or by certified mail, return
receipt requested, or by first-class mail postage prepaid, and by email, within ten days after
completion of the review of the Assisted Living Residence.
(c) Corrective Action. Whenever EOAI finds, upon inspection or through information in
its possession, that a Residence is not in compliance with anylaw(s), regulation(s), governing
such program, EOAI may, in its discretion, require the Residence to implement any
corrective action it deems necessary, including:
1. Ceasing the enrollment of new Residents;
2. Reducing the number of Residents served;
3. Changing the staffing patterns or staffing levels, or staffing qualifications; or
4. Requiring additional training of the Executive Director or staff.
5. Factors which may be considered by EOAI in determining the nature of the corrective
action to be imposed include, but are not limited to:
a. Any instances of noncompliance at the Residence;
b. The risk that the instances of noncompliance present to the health, safety, and
welfare of residents;
c. The nature, scope, severity, degree, number, and frequency of the instances of
noncompliance;
d. The Applicant or Sponsor's failure to correct the noncompliance;
e. Any ongoing pattern of noncompliance;
f. Any previous enforcement action(s); and
g. The results of any past corrective action plans or orders.
(d)
Modification, Suspension, Revocation or Refusal to Issue or Renew Certification.
EOAI may modify, suspend, revoke, deny or refuse to issue or renew a Certification, which
may solely be applicable to the Certification to provide Basic Health Services as determined
by EOAI, in any case in which it finds any of the following:
1. There has been a failure or refusal to comply with any applicable law, regulation,
corrective order, notice of sanction, or suspension agreement;
2. The Applicant or Sponsor submitted any misleading or false statement or report
required under 651 CMR 12.00;
3. The Applicant or Sponsor refused to submit any report or make available any records
required under 651 CMR 12.00;
4. The Applicant or Sponsor refused to admit, at a reasonable time, any employee of
EOAI authorized by the Secretaryto investigate or inspect, in accordance with 651 CMR
12.00; or
5. The Applicant or Sponsor failed to obtain Certification prior to opening a program or
residence or prior to changing the location of a program or residence except as allowed
in 651 CMR 12.00.
(e) Fine.
1. In General. If EOAI determines that there has been a failure or refusal to comply with
the requirements of 651 CMR 12.00 or any applicable statute or other legal requirement,
EOAI may issue a fine of not more than $500 for each day of each such failure or refusal
to comply.
2. Basic Health Services. In accordance with M.G.L. c. 19D, §§ 10(h) and 10(i)
a. If EOAI determines that a Residence provided or offered to provide Basic Health
Services without Certification to provide Basic Health Services, EOAI may issue a
fine of not more than $1,000.00 per day for each day of such provision or offering,
or both.
b. If EOAI determines an incident involving Basic Health Services results in injury
to a resident, EOAI may impose a fine or otherwise take an enforcement action.
(f) Effect. An Applicant or Sponsor shall not qualify for a Certification from EOAI for five
years after a final agency decision to revoke or refuse to issue or renew a Certification held
by the Applicant or Sponsor. Thereafter, an Applicant or Sponsor shall be eligible only if
he or she can demonstrate a significant change in circumstances. EOAI may, at its sole
discretion, consider an application for Certification prior to the expiration of the five-year
period, if it determines that a significant change in circumstances has occurred. Such
exercise of its discretion shall not be appealable.
(g) Emergency Action.
1. EOAI may, in its discretion, modify, suspend, revoke, or refuse to renew a Residence's
Certification without prior notice if EOAI finds at the time of the review, or at any other
time, that the Applicant or Sponsor is not in compliance with M.G.L. c. 19D or 651 CMR
12.00 and that such noncompliance presents an immediate threat to the health, safety, or
welfare of Residents. The Applicant or Sponsor shall be notified of any such
modification, suspension, or revocation of a Certification by written notice, hand
delivered, or mailed to the applicant or sponsor via first class mail, certified or registered,
return receipt requested.
2. Before imposing a modification, suspension, revocation, or refusing to renew a
Residence's Certification, EOAI may require immediate corrective action by the
Residence. In such cases, EOAI will identify the nature of the correction and the time
frame in which to make those corrections. The corrective action will be directly based
upon the nature of the findings, and the timeframe within which the action must be taken
will be reasonable.
3. The modification, suspension, or revocation of the Certification or refusal to renew
the Certification shall remain in effect pending resolution through the Administrative
Review and hearing process, if applicable.
(h) Response to Notice. The Applicant or Sponsor shall respond in writing to EOAI within
ten days after receiving the notice of noncompliance, and indicate its agreement or
disagreement with the EOAI findings. Failure of the Applicant or Sponsor to respond within
the ten-day period to the Notice of Noncompliance will be deemed to be agreement with the
findings.
1. If the Applicant or Sponsor agrees with the findings, a signed, written plan of
correction for each cited finding must be submitted to EOAI within a timeframe
acceptable to EOAI. Each plan of correction shall include the following details:
a. Corrective Actions. A specific description of the measures that have been or will
be taken to address the findings.
b. Preventative Measures. A description of the actions that will be implemented to
prevent the recurrence of the findings or similar issues.
c. Responsibility. The designation of the individual(s) responsible for monitoring
the implementation of the corrective actions to ensure that the findings do not recur;
and.
d. Timeline. The date by which the corrections will be achieved.
2. Following the receipt of a complete corrective action plan, EOAI will review the
submission and notify the Applicant or Sponsor of its acceptability.
3. If the Applicant or Sponsor disagrees with any of the EOAI findings or actions, an
Administrative Review may be initiated pursuant to 651 CMR 12.10.
(i) Consultation. The Applicant or Sponsor may request a consultation with EOAI about
findings of noncompliance and any action taken or to be taken by EOAI. Such request will
be granted at the discretion of EOAI. A consultation may take the form of an exit conference
at the conclusion of a compliance review or other format as determined by EOAI in its sole
authority.