HB-4792, As Passed House, October 19, 2005
SUBSTITUTE FOR
HOUSE BILL NO. 4792
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 20155 and 21799a (MCL 333.20155 and
333.21799a), section 20155 as amended by 2001 PA 218 and section
21799a as amended by 2004 PA 189, and by adding section 21753.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 20155. (1) Except as otherwise provided in this section,
the
department of consumer and industry services 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 of consumer and industry services 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 nursing home
surveyor shall post in a conspicuous place within the nursing home
a
notice that a survey is currently being conducted. The department
of
consumer and industry services 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 of consumer
and
industry services 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
of consumer and industry services 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 of consumer and industry services 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 U.S.C. 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 of consumer and industry
services
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 of consumer and industry services 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 state fire marshal 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
of consumer and industry services 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 of consumer and industry services
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 of consumer and industry services 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 of consumer and industry services 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 of consumer and industry services 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 of consumer and industry services 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 of consumer and
industry
services 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 of consumer and industry services 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 of consumer and industry services 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 of consumer and industry services 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 department of community health,
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.
(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 the
amendatory act that added this subsection. 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, of the year following the year in which the
amendatory
act that added this subsection takes effect 2002.
(23)
The department of consumer and industry services 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 The department shall transmit a written or
electronic
copy of the results of each visit and survey conducted under this
section to the nursing home visited within 10 business days after
the visit is conducted. Except as otherwise provided under
subsection (25), within 24 hours after the survey report is
received or within 24 hours after receiving notice that the
department has approved the nursing home's plan of correction, a
nursing home shall post the nursing home's survey report or
approved plan of correction in a conspicuous place within the
nursing home for public review. Within 30 days after the survey
report or the approved plan of correction is posted, a nursing home
shall notify the residents of the home that the survey report or
the approved plan of correction is posted within the nursing home
and that a summary of the survey report is available on the
internet through the department of community health's website. A
nursing home may satisfy the notification requirement of this
subsection by including a notification in a monthly newsletter, or
other written documentation, distributed to the resident, the
resident's family, or the resident's designated representative. If
the survey report or the plan of correction includes an immediate
jeopardy citation, the nursing home shall include in the required
notification a description of that citation along with a
description of how the situation was corrected. The department
shall make the summary of the report available in a searchable
format on the department's website or via a link on its website. As
used in this subsection, "business day" means a day of the year
excluding a Saturday, Sunday, or legal holiday.
(25) If the department issues a nursing home a notice of an
immediate jeopardy situation, immediately following the removal of
the immediate jeopardy situation the nursing home shall post that
notice, along with the nursing home's plan to rectify the immediate
jeopardy situation, in a conspicuous place within the nursing home
for public review for a period of not less than 7 days. If the
immediate jeopardy situation results in a serious injury or a
change in the health status of a resident or residents within that
nursing home, the nursing home shall immediately notify that
resident's or those residents' family or designated representatives
of the immediate jeopardy situation.
(26) (25)
Nothing in this amendatory act shall be construed
to limit the requirements of related state and federal law.
(27) (26)
As used in this section:
(a) "Title XVIII" means title XVIII of the social security
act,
chapter 531, 49 Stat. 620, 42 U.S.C. 1395 to 1395b, 1395b-2,
1395b-6
to 1395b-7, 1395c to 1395i, 1395i-2 to 1395i-5, 1395j to
1395t,
1395u to 1395w, 1395w-2 to 1395w-4, 1395w-21 to 1395w-28,
1395x
to 1395yy, and 1395bbb to 1395ggg 42 USC 1395 to 1395hhh.
(b)
"Title XIX" means title XIX of the social security act,
chapter
531, 49 Stat. 620, 42 U.S.C. 1396 to 1396f, 1396g-1 to
1396r-6,
and 1396r-8 to 1396v 42 USC 1396 to 1396v.
Sec. 21753. Before renewing a license, the department shall
review the most recent inspection, survey, and evaluation of that
facility and any written determination made concerning a
substantiated complaint filed under section 21799a within the past
2 years.
Sec. 21799a. (1) A person who believes that this part, a rule
promulgated under this part, or a federal certification regulation
applying to a nursing home may have been violated may request an
investigation of a nursing home. The person may submit the request
for investigation to the department as a written complaint, or the
department shall assist a person in reducing an oral request made
under subsection (2) to a written complaint as provided in
subsection (2). A person filing a complaint under this subsection
may file the complaint on a model standardized complaint form
developed and distributed by the department under section 20194(3)
or file the complaint as provided by the department on the
internet.
(2) The department shall provide a toll-free telephone
consumer complaint line. The complaint line shall be accessible 24
hours per day and monitored at a level to ensure that each priority
complaint is identified and that a response is initiated to each
priority complaint within 24 hours after its receipt. The
department shall establish a system for the complaint line that
includes at least all of the following:
(a) An intake form that serves as a written complaint for
purposes of subsections (1) and (5).
(b) The forwarding of an intake form to an investigator not
later than the next business day after the complaint is identified
as a priority complaint.
(c) Except for an anonymous complaint, the forwarding of a
copy of the completed intake form to the complainant not later than
5 business days after it is completed.
(3) The substance of a complaint filed under subsection (1) or
(2) shall be provided to the licensee no earlier than at the
commencement of the on-site inspection of the nursing home that
takes place in response to the complaint. The nursing home
investigator shall post in a conspicuous place within the nursing
home a notice that an inspection is currently being conducted.
(4) A complaint filed under subsection (1) or (2), a copy of
the complaint, or a record published, released, or otherwise
disclosed to the nursing home shall not disclose the name of the
complainant or a patient named in the complaint unless the
complainant or patient consents in writing to the disclosure or the
investigation results in an administrative hearing or a judicial
proceeding, or unless disclosure is considered essential to the
investigation by the department. If the department considers
disclosure essential to the investigation, the department shall
give the complainant the opportunity to withdraw the complaint
before disclosure.
(5) Upon receipt of a complaint under subsection (1) or (2),
the department shall determine, based on the allegations presented,
whether this part, a rule promulgated under this part, or a federal
certification regulation for nursing homes has been, is, or is in
danger of being violated. Subject to subsection (2), the department
shall investigate the complaint according to the urgency determined
by the department. The initiation of a complaint investigation
shall commence within 15 days after receipt of the written
complaint by the department.
(6) If, at any time, the department determines that this part,
a rule promulgated under this part, or a federal certification
regulation for nursing homes has been violated, the department
shall list the violation and the provisions violated on the state
and federal licensure and certification forms for nursing homes.
The department shall consider the violations, as evidenced by a
written explanation, when it makes a licensure and certification
decision or recommendation.
(7) In all cases, the department shall inform the complainant
of its findings unless otherwise indicated by the complainant.
Subject to subsection (2), within 30 days after receipt of the
complaint, the department shall provide the complainant a copy, if
any, of the written determination, the correction notice, the
warning notice, and the state licensure or federal certification
form, or both, on which the violation is listed, or a status report
indicating when these documents may be expected. The department
shall include in the final report a copy of the original complaint.
The complainant may request additional copies of the documents
described in this subsection and upon receipt shall reimburse the
department for the copies in accordance with established policies
and procedures.
(8) The department shall make a written determination,
correction notice, or warning notice concerning a complaint
available for public inspection, but the department shall not
disclose the name of the complainant or patient without the
complainant's or patient's consent. If the department determines
that a violation existed as a result of the complaint
investigation, within 30 days after the nursing home receives the
written determination, correction notice, or warning notice
concerning that violation, the nursing home shall notify each
resident, the resident's family, or the resident's designated
representative that a complaint had been filed, an investigation
was conducted, and the written determination, correction notice, or
warning notice concerning the complaint is posted within the
nursing home and is available upon request from the department or
the nursing home. A nursing home may satisfy the notification
requirement of this subsection by including a notification in a
monthly newsletter, or other written documentation, distributed to
the resident, the resident's family, or the resident's designated
representative. The department and the nursing home shall make
available upon request a copy of the written determination,
correction notice, or warning notice. The department and nursing
home may charge a reasonable, cost-based fee for providing copies
under this subsection.
(9) The department shall report a violation discovered as a
result of the complaint investigation procedure to persons
administering sections 21799c to 21799e. The department shall
assess a penalty for a violation, as prescribed by this article.
(10) A complainant who is dissatisfied with the determination
or investigation by the department may request a hearing. A
complainant shall submit a request for a hearing in writing to the
director within 30 days after the mailing of the department's
findings as described in subsection (7). The department shall send
notice of the time and place of the hearing to the complainant and
the nursing home.
(11) As used in this section, "priority complaint" means a
complaint alleging an existing situation that involves physical,
mental, or emotional abuse, mistreatment, or harmful neglect of a
resident that requires immediate corrective action to prevent
serious injury, serious harm, serious impairment, or death of a
resident while receiving care in a facility.