SB-0884, As Passed Senate, May 10, 2012

SUBSTITUTE FOR

SENATE BILL NO. 884

     A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending section 20155 (MCL 333.20155), as amended by 2006 PA

195, and by adding section 20155a.

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

     Sec. 20155. (1) Except as otherwise provided in this section

and section 20155a, 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 according 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 according

to a complaint are announced or unannounced. Beginning June 20,

2001, the department shall assure ensure 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.

     (2) The state shall establish a process that ensures both of

the following:

     (a) A newly hired nursing home surveyor shall not make

independent compliance decisions during his or her training period.

     (b) A nursing home surveyor shall not be assigned as a member

of a survey team for a nursing home in which he or she received

training for 1 standard survey following the training received in

that nursing home.

     (3) Beginning October 1, 2012, the department shall perform a

criminal history check on all nursing home surveyors in the manner

provided for in section 20173a.

     (4) 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 3 years.

     (5) Representatives from all nursing facility provider

organizations and the state long-term care ombudsman or his or her

designee be invited to participate in the planning process for the

joint provider and surveyor training sessions. The department shall

include at least 1 representative from nursing facility provider

organizations that do not own or operate a nursing facility

representing at least 30 or more nursing facilities statewide in

internal surveyor group quality assurance training provided for the

purpose of general clarification and interpretation of existing or

new regulatory requirements and expectations.

     (6) The department shall make available online the general

civil service position description related to the required

qualifications for individual surveyors. The department shall use

the required qualifications to hire, educate, develop, and evaluate

surveyors.

     (7) The department shall ensure that at least 1 registered

nurse is a member of each annual survey team, and that additional

survey team members include a variation of qualified health

professionals not limited to social workers, therapists,

dietitians, pharmacists, administrators, physicians, sanitarians,

and others, who have the expertise necessary to evaluate specific

aspects of nursing home operation.

(8) (2) The Except as otherwise provided in this section and

section 20155a, 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

annually 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.

(9) (3) The department shall make a biennial visit to each

hospital for survey and evaluation for the purpose of licensure.

Subject to subsection (6) (12), 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) (11) 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.

(10) (4) Except as provided in subsection (8) (14),

accreditation information provided to the department under

subsection (3) (9) 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.

(11) (5) The department shall grant a waiver under subsection

(3) (9) if the accreditation report submitted under subsection

(3)(b) (9)(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).(9)(a).

     (b) Grant a waiver under subsection (3) (9) 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).(9).

(12) (6) This section does not prohibit the department from

citing a violation of this part during a survey, conducting

investigations or inspections pursuant according 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.

(13) (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).

(14) (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

under subsection (3)(b) (9)(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.

(15) (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.

(16) (10) The department shall maintain a record indicating

whether a visit and inspection is announced or unannounced.

Information Survey findings gathered at each health facility or

agency during each visit and inspection, whether announced or

unannounced, shall be taken into account in licensure decisions.

(17) (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 patient's clinical 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.

Surveyors shall use electronic resident information, whenever

available, as a source of survey-related data and shall request

facility assistance to access the system to maximize data export.

(18) (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.

(19) (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.

(20) (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.

(c) (d) The average number of citations per nursing home for

the most recent calendar year.

(d) (e) The number of night and weekend complaints filed.

(e) (f) The number of night and weekend responses to

complaints conducted by the department.

(f) (g) The average length of time for the department to

respond to a complaint filed against a nursing home.

(g) (h) The number and percentage of citations appealed.

(h) (i) The number and percentage of citations overturned or

modified, or both.

     (i) Information regarding the progress made on implementing

the administrative and electronic support structure to efficiently

coordinate all nursing facility licensing and certification

functions.

     (j) The number of annual standard surveys of nursing

facilities that were conducted during a period of open survey or

enforcement cycle.

     (k) The number of abbreviated complaint surveys that were not

conducted on consecutive days.

     (l) The percent of all form CMS-2567 reports of findings that

were released to the nursing facility within the 10-working-day

requirement.

     (m) The percent of provider notifications of acceptance or

rejection of a plan of correction that were released to the nursing

facility within the 10-working-day requirement.

     (n) The percent of first revisits that were completed within

60 days from the date of survey completion.

     (o) The percent of second revisits that were completed within

85 days from the date of survey completion.

     (p) The percent of letters of compliance notification to the

nursing facility that were released within 10 working days of the

date of the completion of the revisit.

     (q) A summary of the discussions from the meetings required in

subsection (24).

     (r) The number of nursing facilities that participated in a

recognized quality improvement program as described under section

20155a(3).

(21) (15) The department shall report annually March 1 of each

year 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 all

of the following:

     (a) The percentage of nursing home citations that are appealed

and the through the informal dispute resolution process.

     (b) The number and percentage of nursing home citations that

are appealed and supported, amended, or deleted through the

informal deficiency dispute resolution process.

     (c) A summary of the quality assurance review of the amended

citations and related survey retraining efforts to improve

consistency among surveyors and across the survey administrative

unit that occurred in the year being reported.

(22) (16) Subject to subsection (17), (23), 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:this state:

     (a) Immediate jeopardy.

     (b) Harm.

     (c) Potential harm.

     (d) Avoidable.

     (e) Unavoidable.

(23) (17) All of the following clarifications developed under

subsection (16) (22) apply for purposes of subsection (16):(22):

     (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) (25) 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 under subsection (18), (25), 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 under subsection

(18) (25) 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 under subsection (18)

(25) is relevant information in considering whether a negative

outcome was avoidable or unavoidable and may be considered in the

application of that term.

     (24) The department shall invite to a quarterly meeting at

least 1 representative from each nursing facility provider

organization that does not own or operate a nursing facility

representing 30 or more nursing facilities statewide and the state

long-term care ombudsman or his or her designee to discuss, at a

minimum, all of the following:

     (a) Opportunities for enhanced promotion of nursing facility

performance, including, but not limited to, programs that encourage

and reward providers that strive for excellence.

     (b) Seeking quality improvement to the survey and enforcement

process, including clarifications to process-related policies and

protocols that include, but are not limited to, all of the

following:

     (i) Improving the surveyors' quality and preparedness.

     (ii) Enhanced communication between regulators, surveyors,

providers, and consumers.

     (iii) Ensuring fair enforcement and dispute resolution by

identifying methods or strategies that may resolve identified

problems or concerns.

     (c) Promoting transparency across provider and surveyor

communities, including, but not limited to, all of the following:

     (i) Applying regulations in a consistent manner and evaluating

changes that have been implemented to resolve identified problems

and concerns.

     (ii) Providing consumers with information regarding changes in

policy and interpretation.

     (iii) Identifying positive and negative trends, and factors

contributing to those trends, in the areas of resident care,

deficient practices, and enforcement.

(25) (18) Subject to subsection (19) (27), 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) Culture–change principles, person-centered caring, and

self-directed care.

(26) The department shall biennially review and update all

clinical process guidelines as needed and shall continue to develop

and implement clinical process guidelines for topics that have not

been developed from the list in subsection (25) and other topics

identified as a result of the meetings required in subsection (24).

The department shall include training on new and revised clinical

process guidelines in the joint provider and surveyor training

sessions as those clinical process guidelines are developed and

revised.

     (27) (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) (25). Beginning October 1, 2012, representatives from each

nursing facility provider organization that does not own or operate

a nursing facility representing 30 or more nursing facilities

statewide and the state long-term care ombudsman or his or her

designee shall be permanent members of the clinical advisory

committee created under this subsection. The department shall

appoint invite 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 based on

the expertise required for each content area. The clarification

work group created Beginning October 1, 2012, the department shall

invite representatives from each nursing facility provider

organizations that do not own or operate a nursing facility and the

state long-term care ombudsman or his or her designee as permanent

members of the clinical advisory committee. At the quarterly

meetings required under subsection (16) (24), the department and

the representatives from the nursing facility provider

organizations that do not own or operate a nursing facility

representing 30 or more nursing facilities statewide shall review

the new and revised clinical process guidelines and outcome

measures after the clinical advisory committee and shall make to

make the final recommendations to the department before the

clinical process guidelines are adopted. The department shall issue

survey certification memorandums to providers to announce or

clarify changes in the interpretation of regulations.

(28) (20) The department shall create a maintain the 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)

(25) to (27) 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.

(29) (21) The Upon availability of funds, the department may

shall give grants, awards, or other recognition to nursing homes to

encourage the rapid implementation or maintenance of the clinical

process guidelines adopted under subsection (18).(25).

(30) (22) The department shall assess the effectiveness of

2001 PA 218. The department shall file an annual report with

ongoing analysis 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.

(31) (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) (25) in citing deficiencies.

(32) (24) A nursing home shall post the nursing home's survey

report in a conspicuous place within the nursing home for public

review.

(33) (25) Nothing in this amendatory act shall be construed to

limit the requirements of related state and federal law.

(34) (26) As used in this section:

     (a) "Consecutive days" means calendar days, but does not

include Saturday, Sunday, or state- or federally-recognized

holidays.

     (b) "Form CMS-2567" means the federal centers for medicare and

medicaid services' form for the statement of deficiencies and plan

of correction or a successor form serving the same purpose.

(c) (a) "Title XVIII" means title XVIII of the social security

act, 42 USC 1395 to 1395hhh.

(d) (b) "Title XIX" means title XIX of the social security

act, chapter 531, 42 USC 1396 to 1396v.1396w-2.

     Sec. 20155a. (1) Nursing home health survey tasks shall be

facilitated by the licensing and regulatory affairs bureau of

health systems to ensure consistent and efficient coordination of

the nursing home licensing and certification functions for standard

and abbreviated surveys. The department shall develop and implement

an electronic system to support coordination of these activities by

December 31, 2013.

     (2) When preparing to conduct an annual standard survey, the

department shall determine if there is an open survey cycle and

make every effort to confirm that substantial compliance has been

achieved by implementation of the nursing facility's accepted plan

of correction before initiating the annual standard survey while

maintaining the federal requirement for standard annual survey

interval and state survey average of 12 months.

     (3) A high-performing nursing facility means any nursing

facility that has a current standard survey with no citations above

a level d and the previous 1 year's abbreviated survey results

having no citations above a level d. The nursing facility may apply

to the department for a grant, up to $5,000.00, from the civil

monetary fund to be used for participation in a recognized quality

improvement program. The department shall seek approval from the

centers for medicare and medicaid services for high-performing

nursing facilities to be eligible to receive a grant, up to

$5,000.00 per nursing facility for each 2 standard survey cycle

period. Each high-performing nursing facility that receives a grant

under this subsection shall submit a report to the department that

describes the final outcome from participation in a recognized

quality improvement program.

     (4) All abbreviated complaint surveys shall be conducted on

consecutive days until complete. All form CMS-2567 reports of

survey findings shall be released to the nursing facility within 10

consecutive days after completion of the survey.

     (5) Departmental notifications of acceptance or rejection of a

nursing facility's plan of correction shall be reviewed and

released to the nursing facility within 10 consecutive days of

receipt of that plan of correction.

     (6) A nursing-facility-submitted plan of correction in

response to any survey must have a completion date not to exceed 40

days from the exit date of survey. All survey first revisits shall

be conducted not more than 60 days from the exit date of survey.

     (7) Letters of compliance notification to nursing facilities

shall be released to the nursing facility within 10 consecutive

days of all survey revisit completion dates.

     (8) The department may accept a nursing facility's evidence of

substantial compliance instead of requiring a post survey on-site

first or second revisit as the department considers appropriate in

accordance with the centers for medicare and medicaid services

survey protocols. A nursing facility requesting consideration of

evidence of substantial compliance in lieu of an on-site revisit

must include an affidavit that asserts the nursing facility is in

substantial compliance as shown by the submitted evidence for that

specific survey event. There may be no deficiencies with a scope

and severity originating higher than level D. If there is no

enforcement action, the nursing facility's evidence of substantial

compliance may be reviewed administratively and accepted as

evidence of deficiency correction.

     (9) Informal dispute resolution conducted by the Michigan peer

review organization shall be given strong consideration upon final

review by the department. In the annual report to the legislature,

the department shall include the number of Michigan peer review

organization-referred reviews and, of those reviews, the number of

citations that were overturned by the department.

     (10) Citation levels used in this section mean citation levels

as defined by the centers for medicare and medicaid services'

survey protocol grid defining scope and severity assessment of

deficiency.