HOUSE BILL No. 4792

May 17, 2005, Introduced by Reps. Zelenko, Green and Vander Veen and referred to the Committee on Senior Health, Security, and Retirement.

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

by amending section 20155 (MCL 333.20155), as amended by 2001 PA

 

218, 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 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 15 days after the visit

 

is conducted. Within 24 hours after the survey report is received,

 

a nursing home shall post the nursing home's survey report in a

 

conspicuous place within the nursing home for public review. Within

 


45 days after the survey report is received, a nursing home shall

 

notify the residents of the home that the survey report has been

 

received and is posted within the nursing home and 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 or

 

by posting a notice at the entrance of the nursing home. The

 

department shall post the report in a searchable format on the

 

department's website within 30 days after the visit is conducted.

 

     (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,  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 complaint

 

filed under section 21799a within the past 2 years.