June 28, 2006, Introduced by Reps. Caswell, Sak, Zelenko, Stakoe, Vander Veen, Shaffer and Hansen and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 20155 (MCL 333.20155), as amended by 2006 PA
195.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 20155. (1) Except as otherwise provided in this section,
the department shall make annual and other visits to each health
facility or agency licensed under this article for the purposes of
survey, evaluation, and consultation. A visit made pursuant to a
complaint shall be unannounced. Except for a county medical care
facility, a home for the aged, a nursing home, or a hospice
residence, the department shall determine whether the visits that
are not made pursuant to a complaint are announced or unannounced.
Beginning June 20, 2001, the department shall assure that each
newly hired nursing home surveyor, as part of his or her basic
training, is assigned full-time to a licensed nursing home for at
least 10 days within a 14-day period to observe actual operations
outside of the survey process before the trainee begins oversight
responsibilities. A member of a survey team shall not be employed
by a licensed nursing home or a nursing home management company
doing business in this state at the time of conducting a survey
under this section. The department shall not assign an individual
to be a member of a survey team for purposes of a survey,
evaluation, or consultation visit at a nursing home in which he or
she was an employee within the preceding 5 years.
(2) The department shall make at least a biennial visit to
each licensed clinical laboratory, each nursing home, and each
hospice residence for the purposes of survey, evaluation, and
consultation. The department shall semiannually provide for joint
training with nursing home surveyors and providers on at least 1 of
the 10 most frequently issued federal citations in this state
during the past calendar year. The department shall develop a
protocol for the review of citation patterns compared to regional
outcomes and standards and complaints regarding the nursing home
survey process. The review will result in a report provided to the
legislature. Except as otherwise provided in this subsection,
beginning with his or her first full relicensure period after June
20, 2000, each member of a department nursing home survey team who
is a health professional licensee under article 15 shall earn not
less than 50% of his or her required continuing education credits,
if any, in geriatric care. If a member of a nursing home survey
team is a pharmacist licensed under article 15, he or she shall
earn not less than 30% of his or her required continuing education
credits in geriatric care.
(3) The department shall make a biennial visit to each
hospital for survey and evaluation for the purpose of licensure.
Subject to subsection (6), the department may waive the biennial
visit required by this subsection if a hospital, as part of a
timely application for license renewal, requests a waiver and
submits both of the following and if all of the requirements of
subsection (5) are met:
(a) Evidence that it is currently fully accredited by a body
with expertise in hospital accreditation whose hospital
accreditations are accepted by the United States department of
health and human services for purposes of section 1865 of part C of
title XVIII of the social security act, 42 USC 1395bb.
(b) A copy of the most recent accreditation report for the
hospital issued by a body described in subdivision (a), and the
hospital's responses to the accreditation report.
(4) Except as provided in subsection (8), accreditation
information provided to the department under subsection (3) is
confidential, is not a public record, and is not subject to court
subpoena. The department shall use the accreditation information
only as provided in this section and shall return the accreditation
information to the hospital within a reasonable time after a
decision on the waiver request is made.
(5) The department shall grant a waiver under subsection (3)
if the accreditation report submitted under subsection (3)(b) is
less than 2 years old and there is no indication of substantial
noncompliance with licensure standards or of deficiencies that
represent a threat to public safety or patient care in the report,
in complaints involving the hospital, or in any other information
available to the department. If the accreditation report is 2 or
more years old, the department may do 1 of the following:
(a) Grant an extension of the hospital's current license until
the next accreditation survey is completed by the body described in
subsection (3)(a).
(b) Grant a waiver under subsection (3) based on the
accreditation report that is 2 or more years old, on condition that
the hospital promptly submit the next accreditation report to the
department.
(c) Deny the waiver request and conduct the visits required
under subsection (3).
(6) This section does not prohibit the department from citing
a violation of this part during a survey, conducting investigations
or inspections pursuant to section 20156, or conducting surveys of
health facilities or agencies for the purpose of complaint
investigations or federal certification. This section does not
prohibit the bureau of fire services created in section 1b of the
fire prevention code, 1941 PA 207, MCL 29.1b, from conducting
annual surveys of hospitals, nursing homes, and county medical care
facilities.
(7) At the request of a health facility or agency, the
department may conduct a consultation engineering survey of a
health facility and provide professional advice and consultation
regarding health facility construction and design. A health
facility or agency may request a voluntary consultation survey
under this subsection at any time between licensure surveys. The
fees for a consultation engineering survey are the same as the fees
established for waivers under section 20161(10).
(8) If the department determines that substantial
noncompliance with licensure standards exists or that deficiencies
that represent a threat to public safety or patient care exist
based on a review of an accreditation report submitted pursuant to
subsection (3)(b), the department shall prepare a written summary
of the substantial noncompliance or deficiencies and the hospital's
response to the department's determination. The department's
written summary and the hospital's response are public documents.
(9) The department or a local health department shall conduct
investigations or inspections, other than inspections of financial
records, of a county medical care facility, home for the aged,
nursing home, or hospice residence without prior notice to the
health facility or agency. An employee of a state agency charged
with investigating or inspecting the health facility or agency or
an employee of a local health department who directly or indirectly
gives prior notice regarding an investigation or an inspection,
other than an inspection of the financial records, to the health
facility or agency or to an employee of the health facility or
agency, is guilty of a misdemeanor. Consultation visits that are
not for the purpose of annual or follow-up inspection or survey may
be announced.
(10) The department shall maintain a record indicating whether
a visit and inspection is announced or unannounced. Information
gathered at each visit and inspection, whether announced or
unannounced, shall be taken into account in licensure decisions.
(11) The department shall require periodic reports and a
health facility or agency shall give the department access to
books, records, and other documents maintained by a health facility
or agency to the extent necessary to carry out the purpose of this
article and the rules promulgated under this article. The
department shall respect the confidentiality of a patient's
clinical record and shall not divulge or disclose the contents of
the records in a manner that identifies an individual except under
court order. The department may copy health facility or agency
records as required to document findings.
(12) The department may delegate survey, evaluation, or
consultation functions to another state agency or to a local health
department qualified to perform those functions. However, the
department shall not delegate survey, evaluation, or consultation
functions to a local health department that owns or operates a
hospice or hospice residence licensed under this article. The
delegation shall be by cost reimbursement contract between the
department and the state agency or local health department. Survey,
evaluation, or consultation functions shall not be delegated to
nongovernmental agencies, except as provided in this section. The
department may accept voluntary inspections performed by an
accrediting body with expertise in clinical laboratory
accreditation under part 205 if the accrediting body utilizes forms
acceptable to the department, applies the same licensing standards
as applied to other clinical laboratories, and provides the same
information and data usually filed by the department's own
employees when engaged in similar inspections or surveys. The
voluntary inspection described in this subsection shall be agreed
upon by both the licensee and the department.
(13) If, upon investigation, the department or a state agency
determines that an individual licensed to practice a profession in
this state has violated the applicable licensure statute or the
rules promulgated under that statute, the department, state agency,
or local health department shall forward the evidence it has to the
appropriate licensing agency.
(14) The department shall report to the appropriations
subcommittees, the senate and house of representatives standing
committees having jurisdiction over issues involving senior
citizens, and the fiscal agencies on March 1 of each year on the
initial and follow-up surveys conducted on all nursing homes in
this state. The report shall include all of the following
information:
(a) The number of surveys conducted.
(b) The number requiring follow-up surveys.
(c) The number referred to the Michigan public health
institute for remediation.
(d) The number of citations per nursing home.
(e) The number of night and weekend complaints filed.
(f) The number of night and weekend responses to complaints
conducted by the department.
(g) The average length of time for the department to respond
to a complaint filed against a nursing home.
(h) The number and percentage of citations appealed.
(i) The number and percentage of citations overturned or
modified, or both.
(15) The department shall report annually to the standing
committees on appropriations and the standing committees having
jurisdiction over issues involving senior citizens in the senate
and the house of representatives on the percentage of nursing home
citations that are appealed and the percentage of nursing home
citations that are appealed and amended through the informal
deficiency dispute resolution process.
(16) Subject to subsection (17), a clarification work group
comprised of the department in consultation with a nursing home
resident or a member of a nursing home resident's family, nursing
home provider groups, the American medical directors association,
the state long-term care ombudsman, and the federal centers for
medicare and medicaid services shall clarify the following terms as
those terms are used in title XVIII and title XIX and applied by
the department to provide more consistent regulation of nursing
homes in Michigan:
(a) Immediate jeopardy.
(b) Harm.
(c) Potential harm.
(d) Avoidable.
(e) Unavoidable.
(17) All of the following clarifications developed under
subsection (16) apply for purposes of subsection (16):
(a) Specifically, the term "immediate jeopardy" means a
situation in which immediate corrective action is necessary because
the nursing home's noncompliance with 1 or more requirements of
participation has caused or is likely to cause serious injury,
harm, impairment, or death to a resident receiving care in a
nursing home.
(b) The likelihood of immediate jeopardy is reasonably higher
if there is evidence of a flagrant failure by the nursing home to
comply with a clinical process guideline adopted under subsection
(18) than if the nursing home has substantially and continuously
complied with those guidelines. If federal regulations and
guidelines are not clear, and if the clinical process guidelines
have been recognized, a process failure giving rise to an immediate
jeopardy may involve an egregious widespread or repeated process
failure and the absence of reasonable efforts to detect and prevent
the process failure.
(c) In determining whether or not there is immediate jeopardy,
the survey agency should consider at least all of the following:
(i) Whether the nursing home could reasonably have been
expected to know about the deficient practice and to stop it, but
did not stop the deficient practice.
(ii) Whether the nursing home could reasonably have been
expected to identify the deficient practice and to correct it, but
did not correct the deficient practice.
(iii) Whether the nursing home could reasonably have been
expected to anticipate that serious injury, serious harm,
impairment, or death might result from continuing the deficient
practice, but did not so anticipate.
(iv) Whether the nursing home could reasonably have been
expected to know that a widely accepted high-risk practice is or
could be problematic, but did not know.
(v) Whether the nursing home could reasonably have been
expected to detect the process problem in a more timely fashion,
but did not so detect.
(d) The existence of 1 or more of the factors described in
subdivision (c), and especially the existence of 3 or more of those
factors simultaneously, may lead to a conclusion that the situation
is one in which the nursing home's practice makes adverse events
likely to occur if immediate intervention is not undertaken, and
therefore constitutes immediate jeopardy. If none of the factors
described in subdivision (c) is present, the situation may involve
harm or potential harm that is not immediate jeopardy.
(e) Specifically, "actual harm" means a negative outcome to a
resident that has compromised the resident's ability to maintain or
reach, or both, his or her highest practicable physical, mental,
and psychosocial well-being as defined by an accurate and
comprehensive resident assessment, plan of care, and provision of
services. Harm does not include a deficient practice that only may
cause or has caused limited consequences to the resident.
(f) For purposes of subdivision (e), in determining whether a
negative outcome is of limited consequence, if the "state
operations manual" or "the guidance to surveyors" published by the
federal centers for medicare and medicaid services does not provide
specific guidance, the department may consider whether most people
in similar circumstances would feel that the damage was of such
short duration or impact as to be inconsequential or trivial. In
such a case, the consequence of a negative outcome may be
considered more limited if it occurs in the context of overall
procedural consistency with an accepted clinical process guideline
adopted pursuant to subsection (18), as compared to a substantial
inconsistency with or variance from the guideline.
(g) For purposes of subdivision (e), if the publications
described in subdivision (f) do not provide specific guidance, the
department may consider the degree of a nursing home's adherence to
a clinical process guideline adopted pursuant to subsection (18) in
considering whether the degree of compromise and future risk to the
resident constitutes actual harm. The risk of significant
compromise to the resident may be considered greater in the context
of substantial deviation from the guidelines than in the case of
overall adherence.
(h) To improve consistency and to avoid disputes over
avoidable and unavoidable negative outcomes, nursing homes and
survey agencies must have a common understanding of accepted
process guidelines and of the circumstances under which it can
reasonably be said that certain actions or inactions will lead to
avoidable negative outcomes. If the "state operations manual" or
"the guidance to surveyors" published by the federal centers for
medicare and medicaid services is not specific, a nursing home's
overall documentation of adherence to a clinical process guideline
with a process indicator adopted pursuant to subsection (18) is
relevant information in considering whether a negative outcome was
avoidable or unavoidable and may be considered in the application
of that term.
(18) Subject to subsection (19), the department, in
consultation with the clarification work group appointed under
subsection (16), shall develop and adopt clinical process
guidelines that shall be used in applying the terms set forth in
subsection (16). The department shall establish and adopt clinical
process guidelines and compliance protocols with outcome measures
for all of the following areas and for other topics where the
department determines that clarification will benefit providers and
consumers of long-term care:
(a) Bed rails.
(b) Adverse drug effects.
(c) Falls.
(d) Pressure sores.
(e) Nutrition and hydration including, but not limited to,
heat-related stress.
(f) Pain management.
(g) Depression and depression pharmacotherapy.
(h) Heart failure.
(i) Urinary incontinence.
(j) Dementia.
(k) Osteoporosis.
(l) Altered mental states.
(m) Physical and chemical restraints.
(n) Lift equipment.
(19) The department shall create a clinical advisory committee
to review and make recommendations regarding the clinical process
guidelines with outcome measures adopted under subsection (18). The
department shall appoint physicians, registered professional
nurses, and licensed practical nurses to the clinical advisory
committee, along with professionals who have expertise in long-term
care services, some of whom may be employed by long-term care
facilities. The clarification work group created under subsection
(16) shall review the clinical process guidelines and outcome
measures after the clinical advisory committee and shall make the
final recommendations to the department before the clinical process
guidelines are adopted.
(20) The department shall create a process by which the
director of the division of nursing home monitoring or his or her
designee or the director of the division of operations or his or
her designee reviews and authorizes the issuance of a citation for
immediate jeopardy or substandard quality of care before the
statement of deficiencies is made final. The review shall be to
assure that the applicable concepts, clinical process guidelines,
and other tools contained in subsections (17) to (19) are being
used consistently, accurately, and effectively. As used in this
subsection, "immediate jeopardy" and "substandard quality of care"
mean those terms as defined by the federal centers for medicare and
medicaid services.
(21) The department may give grants, awards, or other
recognition to nursing homes to encourage the rapid implementation
of the clinical process guidelines adopted under subsection (18).
(22) The department shall assess the effectiveness of 2001 PA
218. The department shall file an annual report on the
implementation of the clinical process guidelines and the impact of
the guidelines on resident care with the standing committee in the
legislature with jurisdiction over matters pertaining to nursing
homes. The first report shall be filed on July 1, 2002.
(23) The department shall instruct and train the surveyors in
the use of the clarifications described in subsection (17) and the
clinical process guidelines adopted under subsection (18) in citing
deficiencies.
(24) A nursing home shall post the nursing home's survey
report in a conspicuous place within the nursing home for public
review.
(25) Nothing in this amendatory act shall be construed to
limit the requirements of related state and federal law.
(26) As used in this section:
(a) "Title XVIII" means title XVIII of the social security
act, 42 USC 1395 to 1395hhh.
(b)
"Title XIX" means title XIX of the social security act,
chapter
531, 42 USC 1396 to 1396v.