HOUSE BILL No. 4447

 

April 14, 2015, Introduced by Rep. Pscholka and referred to the Committee on Appropriations.

 

      A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

by amending sections 6237, 6238, 20104, 20106, 20145, 20155, 20161,

 

20501, 20521, and 20551 (MCL 333.6237, 333.6238, 333.20104,

 

333.20106, 333.20145, 333.20155, 333.20161, 333.20501, 333.20521,

 

and 333.20551), sections 6237 and 6238 as amended by 2012 PA 501,

 

section 20104 as amended by 2010 PA 381, section 20106 as amended

 

by 2014 PA 449, section 20145 as amended by 2004 PA 469, section

 

20155 as amended by 2012 PA 322, and section 20161 as amended by

 

2013 PA 137; and to repeal acts and parts of acts.

 

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

 1        Sec. 6237. The Until October 1, 2019, the department shall

 

 2  issue a license assess a $500.00 fee for licenses on an annual

 

 3  basis upon determining that the applicant has complied with this


 1  part and rules promulgated under this part. A licensee shall

 

 2  prominently display the license while it is in effect.

 

 3        Sec. 6238. A standard license issued under this part is

 

 4  effective for no longer than 1 year after the date of issuance. The

 

 5  department may issue a provisional license to an applicant

 

 6  temporarily unable to comply with this part or the rules

 

 7  promulgated under this part. The department may renew or extend a

 

 8  provisional license issued under this section for not more than 1

 

 9  year. The department may issue a temporary, nonrenewable permit for

 

10  not more than 90 days if additional time is needed for the

 

11  department to properly investigate or for the applicant to

 

12  undertake remedial action.

 

13        Sec. 20104. (1) "Certification" means the issuance of a

 

14  document by the department to a health facility or agency attesting

 

15  to the fact that the health facility or agency meets both of the

 

16  following:

 

17        (a) It complies with applicable statutory and regulatory

 

18  requirements and standards.

 

19        (b) It is eligible to participate as a provider of care and

 

20  services in a specific federal or state health program.

 

21        (2) "Clinical laboratory" means a facility patronized by, or

 

22  at the direction of, a physician, health officer, or other person

 

23  authorized by law to obtain information for the diagnosis,

 

24  prevention, or treatment of disease or the assessment of a medical

 

25  condition by the microbiological, serological, histological,

 

26  hematological, immunohematological, biophysical, cytological,

 

27  pathological, or biochemical examination of materials derived from


 1  the human body, except as provided in section 20507.

 

 2        (2) (3) "Consumer" means a person who is not a provider of

 

 3  health care as defined in section 1531(3) of title 15 of the public

 

 4  health service act, 42 USC 300n.

 

 5        (3) (4) "County medical care facility" means a nursing care

 

 6  facility, other than a hospital long-term care unit, which that

 

 7  provides organized nursing care and medical treatment to 7 or more

 

 8  unrelated individuals who are suffering or recovering from illness,

 

 9  injury, or infirmity and which that is owned by a county or

 

10  counties.

 

11        (4) (5) "Direct access" means access to a patient or resident

 

12  or to a patient's or resident's property, financial information,

 

13  medical records, treatment information, or any other identifying

 

14  information.

 

15        (5) (6) "Freestanding surgical outpatient facility" means a

 

16  facility, other than the office of a physician, dentist,

 

17  podiatrist, or other private practice office, offering a surgical

 

18  procedure and related care that in the opinion of the attending

 

19  physician can be safely performed without requiring overnight

 

20  inpatient hospital care. It Freestanding surgical outpatient

 

21  facility does not include a surgical outpatient facility owned by

 

22  and operated as part of a hospital.

 

23        (6) (7) "Good moral character" means that term as defined in

 

24  section 1 of 1974 PA 381, MCL 338.41.

 

25        Sec. 20106. (1) "Health facility or agency", except as

 

26  provided in section 20115, means:

 

27        (a) An ambulance operation, aircraft transport operation,


 1  nontransport prehospital life support operation, or medical first

 

 2  response service.

 

 3        (b) A clinical laboratory.

 

 4        (b) (c) A county medical care facility.

 

 5        (c) (d) A freestanding surgical outpatient facility.

 

 6        (d) (e) A health maintenance organization.

 

 7        (e) (f) A home for the aged.

 

 8        (f) (g) A hospital.

 

 9        (g) (h) A nursing home.

 

10        (h) (i) A hospice.

 

11        (i) (j) A hospice residence.

 

12        (j) (k) A facility or agency listed in subdivisions (a) to (h)

 

13  (g) located in a university, college, or other educational

 

14  institution.

 

15        (2) "Health maintenance organization" means that term as

 

16  defined in section 3501 of the insurance code of 1956, 1956 PA 218,

 

17  MCL 500.3501.

 

18        (3) "Home for the aged" means a supervised personal care

 

19  facility, other than a hotel, adult foster care facility, hospital,

 

20  nursing home, or county medical care facility that provides room,

 

21  board, and supervised personal care to 21 or more unrelated,

 

22  nontransient, individuals 60 years of age or older. Home for the

 

23  aged includes a supervised personal care facility for 20 or fewer

 

24  individuals 60 years of age or older if the facility is operated in

 

25  conjunction with and as a distinct part of a licensed nursing home.

 

26  Home for the aged does not include an area excluded from this

 

27  definition by section 17(3) of the continuing care community


 1  disclosure act, 2014 PA 448, MCL 554.917.

 

 2        (4) "Hospice" means a health care program that provides a

 

 3  coordinated set of services rendered at home or in outpatient or

 

 4  institutional settings for individuals suffering from a disease or

 

 5  condition with a terminal prognosis.

 

 6        (5) "Hospital" means a facility offering inpatient, overnight

 

 7  care, and services for observation, diagnosis, and active treatment

 

 8  of an individual with a medical, surgical, obstetric, chronic, or

 

 9  rehabilitative condition requiring the daily direction or

 

10  supervision of a physician. Hospital does not include a mental

 

11  health hospital licensed or operated by the department of community

 

12  health or a hospital operated by the department of corrections.

 

13        (6) "Hospital long-term care unit" means a nursing care

 

14  facility, owned and operated by and as part of a hospital,

 

15  providing organized nursing care and medical treatment to 7 or more

 

16  unrelated individuals suffering or recovering from illness, injury,

 

17  or infirmity.

 

18        Sec. 20145. (1) Before contracting for and initiating a

 

19  construction project involving new construction, additions,

 

20  modernizations, or conversions of a health facility or agency with

 

21  a capital expenditure of $1,000,000.00 or more, a person shall

 

22  obtain a construction permit from the department. The department

 

23  shall not issue the permit under this subsection unless the

 

24  applicant holds a valid certificate of need if a certificate of

 

25  need is required for the project pursuant to under part 222.

 

26        (2) To protect the public health, safety, and welfare, the

 

27  department may promulgate rules to require construction permits for


 1  projects other than those described in subsection (1) and the

 

 2  submission of plans for other construction projects to expand or

 

 3  change service areas and services provided.

 

 4        (3) If a construction project requires a construction permit

 

 5  under subsection (1) or (2), but does not require a certificate of

 

 6  need under part 222, the department shall require the applicant to

 

 7  submit information considered necessary by the department to assure

 

 8  that the capital expenditure for the project is not a covered

 

 9  capital expenditure as defined in section 22203(9).

 

10        (4) If a construction project requires a construction permit

 

11  under subsection (1), but does not require a certificate of need

 

12  under part 222, the department shall require the applicant to

 

13  submit information on a 1-page sheet, along with the application

 

14  for a construction permit, consisting of all of the following:

 

15        (a) A short description of the reason for the project and the

 

16  funding source.

 

17        (b) A contact person for further information, including

 

18  address and phone number.

 

19        (c) The estimated resulting increase or decrease in annual

 

20  operating costs.

 

21        (d) The current governing board membership of the applicant.

 

22        (e) The entity, if any, that owns the applicant.

 

23        (5) The information filed under subsection (4) shall be made

 

24  publicly available by the department by the same methods used to

 

25  make information about certificate of need applications publicly

 

26  available.

 

27        (6) The review and approval of architectural plans and


 1  narrative shall require that the proposed construction project is

 

 2  designed and constructed in accord with applicable statutory and

 

 3  other regulatory requirements. In performing a construction permit

 

 4  review for a health facility or agency under this section, the

 

 5  department shall, at a minimum, apply the standards contained in

 

 6  the document entitled "Minimum Design Standards for Health Care

 

 7  Facilities in Michigan" published by the department and dated March

 

 8  1998. July 2007. The standards are incorporated by reference for

 

 9  purposes of this subsection. The department may promulgate rules

 

10  that are more stringent than the standards if necessary to protect

 

11  the public health, safety, and welfare.

 

12        (7) The department shall promulgate rules to further prescribe

 

13  the scope of construction projects and other alterations subject to

 

14  review under this section.

 

15        (8) The department may waive the applicability of this section

 

16  to a construction project or alteration if the waiver will not

 

17  affect the public health, safety, and welfare.

 

18        (9) Upon request by the person initiating a construction

 

19  project, the department may review and issue a construction permit

 

20  to a construction project that is not subject to subsection (1) or

 

21  (2) if the department determines that the review will promote the

 

22  public health, safety, and welfare.

 

23        (10) The department shall assess a fee for each review

 

24  conducted under this section. The fee is .5% of the first

 

25  $1,000,000.00 of capital expenditure and .85% of any amount over

 

26  $1,000,000.00 of capital expenditure, up to a maximum of

 

27  $60,000.00.


 1        (11) As used in this section, "capital expenditure" means that

 

 2  term as defined in section 22203(2), except that it capital

 

 3  expenditure does not include the cost of equipment that is not

 

 4  fixed equipment.

 

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

 

 6  and section 20155a, the department shall make annual triennial and

 

 7  other visits to each health facility or agency licensed under this

 

 8  article for the purposes of survey, evaluation, and consultation. A

 

 9  visit made according to a complaint shall be unannounced. Except

 

10  for a county medical care facility, a home for the aged, a nursing

 

11  home, or a hospice residence, the department shall determine

 

12  whether the visits that are not made according to a complaint are

 

13  announced or unannounced. Beginning June 20, 2001, the The

 

14  department shall ensure that each newly hired nursing home

 

15  surveyor, as part of his or her basic training, is assigned full-

 

16  time to a licensed nursing home for at least 10 days within a 14-

 

17  day period to observe actual operations outside of the survey

 

18  process before the trainee begins oversight responsibilities.

 

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

 

20  the following:

 

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

 

22  independent compliance decisions during his or her training period.

 

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

 

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

 

25  training for 1 standard survey following the training received in

 

26  that nursing home.

 

27        (3) Beginning November 1, 2012, the The department shall


 1  perform a criminal history check on all nursing home surveyors in

 

 2  the manner provided for in section 20173a.

 

 3        (4) A member of a survey team shall not be employed by a

 

 4  licensed nursing home or a nursing home management company doing

 

 5  business in this state at the time of conducting a survey under

 

 6  this section. The department shall not assign an individual to be a

 

 7  member of a survey team for purposes of a survey, evaluation, or

 

 8  consultation visit at a nursing home in which he or she was an

 

 9  employee within the preceding 3 years.

 

10        (5) Representatives from all nursing home provider

 

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

 

12  designee shall be invited to participate in the planning process

 

13  for the joint provider and surveyor training sessions. The

 

14  department shall include at least 1 representative from nursing

 

15  home provider organizations that do not own or operate a nursing

 

16  home representing 30 or more nursing homes statewide in internal

 

17  surveyor group quality assurance training provided for the purpose

 

18  of general clarification and interpretation of existing or new

 

19  regulatory requirements and expectations.

 

20        (6) The department shall make available online the general

 

21  civil service position description related to the required

 

22  qualifications for individual surveyors. The department shall use

 

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

 

24  surveyors.

 

25        (7) The department shall ensure that each annual survey team

 

26  is composed of an interdisciplinary group of professionals, 1 of

 

27  whom must be a registered nurse. Other members may include social


 1  workers, therapists, dietitians, pharmacists, administrators,

 

 2  physicians, sanitarians, and others who may have the expertise

 

 3  necessary to evaluate specific aspects of nursing home operation.

 

 4        (8) Except as otherwise provided in this section and section

 

 5  20155a, the department shall make at least a biennial triennial

 

 6  visit to each licensed clinical laboratory, each nursing home , and

 

 7  each hospice residence for the purposes of survey, evaluation, and

 

 8  consultation. The department shall semiannually provide for joint

 

 9  training with nursing home surveyors and providers on at least 1 of

 

10  the 10 most frequently issued federal citations in this state

 

11  during the past calendar year. The department shall develop a

 

12  protocol for the review of citation patterns compared to regional

 

13  outcomes and standards and complaints regarding the nursing home

 

14  survey process. The review will be included in the report required

 

15  under subsection (20). Except as otherwise provided in this

 

16  subsection, beginning with his or her first full relicensure period

 

17  after June 20, 2000, each member of a department nursing home

 

18  survey team who is a health professional licensee under article 15

 

19  shall earn not less than 50% of his or her required continuing

 

20  education credits, if any, in geriatric care. If a member of a

 

21  nursing home survey team is a pharmacist licensed under article 15,

 

22  he or she shall earn not less than 30% of his or her required

 

23  continuing education credits in geriatric care.

 

24        (9) The department shall make a biennial triennial visit to

 

25  each hospital health facility and agency for survey and evaluation

 

26  for the purpose of licensure. Subject to subsection (12), the

 

27  department may waive the biennial triennial visit required by this


 1  subsection if a hospital, health facility or agency, as part of a

 

 2  timely application for license renewal, requests a waiver and

 

 3  submits both of the following and if all of the requirements of

 

 4  subsection (11) are met:

 

 5        (a) Evidence that it is currently fully accredited by a body

 

 6  with expertise in hospital accreditation whose hospital

 

 7  accreditations are the health facility or agency type and the

 

 8  accrediting organization is accepted by the United States

 

 9  department of health and human services Department of Health and

 

10  Human Services for purposes of section 1865 of part C of title

 

11  XVIII of the social security act, 42 USC 1395bb.

 

12        (b) A copy of the most recent accreditation report, for the

 

13  hospital or executive summary, issued by a body described in

 

14  subdivision (a), and the hospital's health facility's or agency's

 

15  responses to the accreditation report is submitted to the

 

16  department within 30 days from license renewal. Submission of an

 

17  executive summary does not prevent or prohibit the department from

 

18  requesting the entire accreditation report if the department

 

19  considers it necessary.

 

20        (10) Except as provided in subsection (14), accreditation

 

21  information provided to the department under subsection (9) is

 

22  confidential, is not a public record, and is not subject to court

 

23  subpoena. The department shall use the accreditation information

 

24  only as provided in this section and shall return the accreditation

 

25  information to the hospital within a reasonable time properly

 

26  destroy the documentation after a decision on the waiver request is

 

27  made.


 1        (11) The department shall grant a waiver under subsection (9)

 

 2  if the accreditation report submitted under subsection (9)(b) is

 

 3  less than 2 years old and there is no indication of substantial

 

 4  noncompliance with licensure standards or of deficiencies that

 

 5  represent a threat to public safety or patient care in the report,

 

 6  in complaints involving the hospital, health facility or agency or

 

 7  in any other information available to the department. If the

 

 8  accreditation report is 2 or more years old, the department may do

 

 9  1 of the following:

 

10        (a) Grant an extension of the hospital's health facility's or

 

11  agency's current license until the next accreditation survey is

 

12  completed by the body described in subsection (9)(a).

 

13        (b) Grant a waiver under subsection (9) based on the

 

14  accreditation report that is 2 or more years old, on condition that

 

15  the hospital health facility or agency promptly submit the next

 

16  accreditation report to the department.

 

17        (c) Deny the waiver request and conduct the visits required

 

18  under subsection (9). Denial of a waiver request by the department

 

19  is not subject to appeal.

 

20        (12) This section does not prohibit the department from citing

 

21  a violation of this part during a survey, conducting investigations

 

22  or inspections according to section 20156, or conducting surveys of

 

23  health facilities or agencies for the purpose of complaint

 

24  investigations or federal certification. This section does not

 

25  prohibit the bureau of fire services created in section 1b of the

 

26  fire prevention code, 1941 PA 207, MCL 29.1b, from conducting

 

27  annual surveys of hospitals, nursing homes, and county medical care


 1  facilities.

 

 2        (13) At the request of a health facility or agency, the

 

 3  department may conduct a consultation engineering survey of a

 

 4  health facility and provide professional advice and consultation

 

 5  regarding health facility construction and design. A health

 

 6  facility or agency may request a voluntary consultation survey

 

 7  under this subsection at any time between licensure surveys. The

 

 8  fees for a consultation engineering survey are the same as the fees

 

 9  established for waivers under section 20161(10).20161(8).

 

10        (14) If the department determines that substantial

 

11  noncompliance with licensure standards exists or that deficiencies

 

12  that represent a threat to public safety or patient care exist

 

13  based on a review of an accreditation report submitted under

 

14  subsection (9)(b), the department shall prepare a written summary

 

15  of the substantial noncompliance or deficiencies and the hospital's

 

16  health facility's or agency's response to the department's

 

17  determination. The department's written summary and the hospital's

 

18  health facility's or agency's response are public documents.

 

19        (15) The department or a local health department shall conduct

 

20  investigations or inspections, other than inspections of financial

 

21  records, of a county medical care facility, home for the aged,

 

22  nursing home, or hospice residence without prior notice to the

 

23  health facility or agency. An employee of a state agency charged

 

24  with investigating or inspecting the health facility or agency or

 

25  an employee of a local health department who directly or indirectly

 

26  gives prior notice regarding an investigation or an inspection,

 

27  other than an inspection of the financial records, to the health


 1  facility or agency or to an employee of the health facility or

 

 2  agency, is guilty of a misdemeanor. Consultation visits that are

 

 3  not for the purpose of annual or follow-up inspection or survey may

 

 4  be announced.

 

 5        (16) The department shall maintain a record indicating whether

 

 6  a visit and inspection is announced or unannounced. Survey findings

 

 7  gathered at each health facility or agency during each visit and

 

 8  inspection, whether announced or unannounced, shall be taken into

 

 9  account in licensure decisions.

 

10        (17) The department shall require periodic reports and a

 

11  health facility or agency shall give the department access to

 

12  books, records, and other documents maintained by a health facility

 

13  or agency to the extent necessary to carry out the purpose of this

 

14  article and the rules promulgated under this article. The

 

15  department shall not divulge or disclose the contents of the

 

16  patient's clinical records in a manner that identifies an

 

17  individual except under court order. The department may copy health

 

18  facility or agency records as required to document findings.

 

19  Surveyors shall use electronic resident information, whenever

 

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

 

21  facility assistance to access the system to maximize data export.

 

22        (18) The department may delegate survey, evaluation, or

 

23  consultation functions to another state agency or to a local health

 

24  department qualified to perform those functions. However, the The

 

25  department shall not delegate survey, evaluation, or consultation

 

26  functions to a local health department that owns or operates a

 

27  hospice or hospice residence licensed under this article. The


 1  delegation shall be by cost reimbursement contract between the

 

 2  department and the state agency or local health department. Survey,

 

 3  evaluation, or consultation functions shall not be delegated to

 

 4  nongovernmental agencies, except as provided in this section. The

 

 5  department may accept voluntary inspections performed by an

 

 6  accrediting body with expertise in clinical laboratory

 

 7  accreditation under part 205 if the accrediting body utilizes forms

 

 8  acceptable to the department, applies the same licensing standards

 

 9  as applied to other clinical laboratories, and provides the same

 

10  information and data usually filed by the department's own

 

11  employees when engaged in similar inspections or surveys. The

 

12  voluntary inspection described in this subsection shall be agreed

 

13  upon by both the licensee and the department.

 

14        (19) If, upon investigation, the department or a state agency

 

15  determines that an individual licensed to practice a profession in

 

16  this state has violated the applicable licensure statute or the

 

17  rules promulgated under that statute, the department, state agency,

 

18  or local health department shall forward the evidence it has to the

 

19  appropriate licensing agency.

 

20        (20) The department may consolidate all information provided

 

21  for any report required under this section and section 20155a into

 

22  a single report. The department shall report to the appropriations

 

23  subcommittees, the senate and house of representatives standing

 

24  committees having jurisdiction over issues involving senior

 

25  citizens, and the fiscal agencies on March 1 of each year on the

 

26  initial and follow-up surveys conducted on all nursing homes in

 

27  this state. The report shall include all of the following


 1  information:

 

 2        (a) The number of surveys conducted.

 

 3        (b) The number requiring follow-up surveys.

 

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

 

 5  most recent calendar year.

 

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

 

 7        (e) The number of night and weekend responses to complaints

 

 8  conducted by the department.

 

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

 

10  to a complaint filed against a nursing home.

 

11        (g) The number and percentage of citations disputed through

 

12  informal dispute resolution and independent informal dispute

 

13  resolution.

 

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

 

15  modified, or both.

 

16        (i) The review of citation patterns developed under subsection

 

17  (8).

 

18        (j) Implementation of the clinical process guidelines and the

 

19  impact of the guidelines on resident care.

 

20        (k) Information regarding the progress made on implementing

 

21  the administrative and electronic support structure to efficiently

 

22  coordinate all nursing home licensing and certification functions.

 

23        (l) The number of annual standard surveys of nursing homes

 

24  that were conducted during a period of open survey or enforcement

 

25  cycle.

 

26        (m) The number of abbreviated complaint surveys that were not

 

27  conducted on consecutive surveyor workdays.


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

 

 2  were released to the nursing home within the 10-working-day

 

 3  requirement.

 

 4        (o) The percent of provider notifications of acceptance or

 

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

 

 6  home within the 10-working-day requirement.

 

 7        (p) The percent of first revisits that were completed within

 

 8  60 days from the date of survey completion.

 

 9        (q) The percent of second revisits that were completed within

 

10  85 days from the date of survey completion.

 

11        (r) The percent of letters of compliance notification to the

 

12  nursing home that were released within 10 working days of the date

 

13  of the completion of the revisit.

 

14        (s) A summary of the discussions from the meetings required in

 

15  subsection (24).

 

16        (t) The number of nursing homes that participated in a

 

17  recognized quality improvement program as described under section

 

18  20155a(3).

 

19        (21) The department shall report March 1 of each year to the

 

20  standing committees on appropriations and the standing committees

 

21  having jurisdiction over issues involving senior citizens in the

 

22  senate and the house of representatives on all of the following:

 

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

 

24  through the informal dispute resolution process.

 

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

 

26  are appealed and supported, amended, or deleted through the

 

27  informal dispute resolution process.


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

 

 2  citations and related survey retraining efforts to improve

 

 3  consistency among surveyors and across the survey administrative

 

 4  unit that occurred in the year being reported.

 

 5        (22) Subject to subsection (23), a clarification work group

 

 6  comprised of the department in consultation with a nursing home

 

 7  resident or a member of a nursing home resident's family, nursing

 

 8  home provider groups, the American medical directors association,

 

 9  Medical Directors Association, the state long-term care ombudsman,

 

10  and the federal centers for medicare and medicaid services Centers

 

11  for Medicare and Medicaid Services shall clarify the following

 

12  terms as those terms are used in title XVIII and title XIX and

 

13  applied by the department to provide more consistent regulation of

 

14  nursing homes in this state:

 

15        (a) Immediate jeopardy.

 

16        (b) Harm.

 

17        (c) Potential harm.

 

18        (d) Avoidable.

 

19        (e) Unavoidable.

 

20        (23) All of the following clarifications developed under

 

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

 

22        (a) Specifically, the term "immediate jeopardy" means a

 

23  situation in which immediate corrective action is necessary because

 

24  the nursing home's noncompliance with 1 or more requirements of

 

25  participation has caused or is likely to cause serious injury,

 

26  harm, impairment, or death to a resident receiving care in a

 

27  nursing home.


 1        (b) The likelihood of immediate jeopardy is reasonably higher

 

 2  if there is evidence of a flagrant failure by the nursing home to

 

 3  comply with a clinical process guideline adopted under subsection

 

 4  (25) than if the nursing home has substantially and continuously

 

 5  complied with those guidelines. If federal regulations and

 

 6  guidelines are not clear, and if the clinical process guidelines

 

 7  have been recognized, a process failure giving rise to an immediate

 

 8  jeopardy may involve an egregious widespread or repeated process

 

 9  failure and the absence of reasonable efforts to detect and prevent

 

10  the process failure.

 

11        (c) In determining whether or not there is immediate jeopardy,

 

12  the survey agency should consider at least all of the following:

 

13        (i) Whether the nursing home could reasonably have been

 

14  expected to know about the deficient practice and to stop it, but

 

15  did not stop the deficient practice.

 

16        (ii) Whether the nursing home could reasonably have been

 

17  expected to identify the deficient practice and to correct it, but

 

18  did not correct the deficient practice.

 

19        (iii) Whether the nursing home could reasonably have been

 

20  expected to anticipate that serious injury, serious harm,

 

21  impairment, or death might result from continuing the deficient

 

22  practice, but did not so anticipate.

 

23        (iv) Whether the nursing home could reasonably have been

 

24  expected to know that a widely accepted high-risk practice is or

 

25  could be problematic, but did not know.

 

26        (v) Whether the nursing home could reasonably have been

 

27  expected to detect the process problem in a more timely fashion,


 1  but did not so detect.

 

 2        (d) The existence of 1 or more of the factors described in

 

 3  subdivision (c), and especially the existence of 3 or more of those

 

 4  factors simultaneously, may lead to a conclusion that the situation

 

 5  is one in which the nursing home's practice makes adverse events

 

 6  likely to occur if immediate intervention is not undertaken, and

 

 7  therefore constitutes immediate jeopardy. If none of the factors

 

 8  described in subdivision (c) is present, the situation may involve

 

 9  harm or potential harm that is not immediate jeopardy.

 

10        (e) Specifically, "actual harm" means a negative outcome to a

 

11  resident that has compromised the resident's ability to maintain or

 

12  reach, or both, his or her highest practicable physical, mental,

 

13  and psychosocial well-being as defined by an accurate and

 

14  comprehensive resident assessment, plan of care, and provision of

 

15  services. Harm does not include a deficient practice that only may

 

16  cause or has caused limited consequences to the resident.

 

17        (f) For purposes of subdivision (e), in determining whether a

 

18  negative outcome is of limited consequence, if the "state

 

19  operations manual" or "the guidance to surveyors" published by the

 

20  federal centers for medicare and medicaid services Centers for

 

21  Medicare and Medicaid Services does not provide specific guidance,

 

22  the department may consider whether most people in similar

 

23  circumstances would feel that the damage was of such short duration

 

24  or impact as to be inconsequential or trivial. In such a case, the

 

25  consequence of a negative outcome may be considered more limited if

 

26  it occurs in the context of overall procedural consistency with an

 

27  accepted clinical process guideline adopted under subsection (25),


 1  as compared to a substantial inconsistency with or variance from

 

 2  the guideline.

 

 3        (g) For purposes of subdivision (e), if the publications

 

 4  described in subdivision (f) do not provide specific guidance, the

 

 5  department may consider the degree of a nursing home's adherence to

 

 6  a clinical process guideline adopted under subsection (25) in

 

 7  considering whether the degree of compromise and future risk to the

 

 8  resident constitutes actual harm. The risk of significant

 

 9  compromise to the resident may be considered greater in the context

 

10  of substantial deviation from the guidelines than in the case of

 

11  overall adherence.

 

12        (h) To improve consistency and to avoid disputes over

 

13  avoidable and unavoidable negative outcomes, nursing homes and

 

14  survey agencies must have a common understanding of accepted

 

15  process guidelines and of the circumstances under which it can

 

16  reasonably be said that certain actions or inactions will lead to

 

17  avoidable negative outcomes. If the "state operations manual" or

 

18  "the guidance to surveyors" published by the federal centers for

 

19  medicare and medicaid services Centers for Medicare and Medicaid

 

20  Services is not specific, a nursing home's overall documentation of

 

21  adherence to a clinical process guideline with a process indicator

 

22  adopted under subsection (25) is relevant information in

 

23  considering whether a negative outcome was avoidable or unavoidable

 

24  and may be considered in the application of that term.

 

25        (24) The department shall conduct a quarterly meeting and

 

26  invite appropriate stakeholders. Appropriate stakeholders shall

 

27  include at least 1 representative from each nursing home provider


 1  organization that does not own or operate a nursing home

 

 2  representing 30 or more nursing homes statewide, the state long-

 

 3  term care ombudsman or his or her designee, and any other clinical

 

 4  experts. Individuals who participate in these quarterly meetings,

 

 5  in conjunction with the department, may designate advisory

 

 6  workgroups to develop recommendations on the discussion topics that

 

 7  should include, at a minimum, all of the following:

 

 8        (a) Opportunities for enhanced promotion of nursing home

 

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

 

10  and reward providers that strive for excellence.

 

11        (b) Seeking quality improvement to the survey and enforcement

 

12  process, including clarifications to process-related policies and

 

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

 

14  following:

 

15        (i) Improving the surveyors' quality and preparedness.

 

16        (ii) Enhanced communication between regulators, surveyors,

 

17  providers, and consumers.

 

18        (iii) Ensuring fair enforcement and dispute resolution by

 

19  identifying methods or strategies that may resolve identified

 

20  problems or concerns.

 

21        (c) Promoting transparency across provider and surveyor

 

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

 

23        (i) Applying regulations in a consistent manner and evaluating

 

24  changes that have been implemented to resolve identified problems

 

25  and concerns.

 

26        (ii) Providing consumers with information regarding changes in

 

27  policy and interpretation.


 1        (iii) Identifying positive and negative trends and factors

 

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

 

 3  deficient practices, and enforcement.

 

 4        (d) Clinical process guidelines.

 

 5        (25) Subject to subsection (27), the department shall develop

 

 6  and adopt clinical process guidelines. The department shall

 

 7  establish and adopt clinical process guidelines and compliance

 

 8  protocols with outcome measures for all of the following areas and

 

 9  for other topics where the department determines that clarification

 

10  will benefit providers and consumers of long-term care:

 

11        (a) Bed rails.

 

12        (b) Adverse drug effects.

 

13        (c) Falls.

 

14        (d) Pressure sores.

 

15        (e) Nutrition and hydration including, but not limited to,

 

16  heat-related stress.

 

17        (f) Pain management.

 

18        (g) Depression and depression pharmacotherapy.

 

19        (h) Heart failure.

 

20        (i) Urinary incontinence.

 

21        (j) Dementia.

 

22        (k) Osteoporosis.

 

23        (l) Altered mental states.

 

24        (m) Physical and chemical restraints.

 

25        (n) Culture-change principles, person-centered caring, and

 

26  self-directed care.

 

27        (26) The department shall biennially review and update all


 1  clinical process guidelines as needed and shall continue to develop

 

 2  and implement clinical process guidelines for topics that have not

 

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

 

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

 

 5  The department shall consider recommendations from an advisory

 

 6  workgroup created under subsection (24) on clinical process

 

 7  guidelines. The department shall include training on new and

 

 8  revised clinical process guidelines in the joint provider and

 

 9  surveyor training sessions as those clinical process guidelines are

 

10  developed and revised.

 

11        (27) Beginning November 1, 2012, representatives

 

12  Representatives from each nursing home provider organization that

 

13  does not own or operate a nursing home representing 30 or more

 

14  nursing homes statewide and the state long-term care ombudsman or

 

15  his or her designee shall be permanent members of any clinical

 

16  advisory workgroup created under subsection (24). The department

 

17  shall issue survey certification memorandums to providers to

 

18  announce or clarify changes in the interpretation of regulations.

 

19        (28) The department shall maintain the process by which the

 

20  director of the division of nursing home monitoring or his or her

 

21  designee or the director of the division of operations or his or

 

22  her designee reviews and authorizes the issuance of a citation for

 

23  immediate jeopardy or substandard quality of care before the

 

24  statement of deficiencies is made final. The review shall be to

 

25  assure that the applicable concepts, clinical process guidelines,

 

26  and other tools contained in subsections (25) to (27) are being

 

27  used consistently, accurately, and effectively. As used in this


 1  subsection, "immediate jeopardy" and "substandard quality of care"

 

 2  mean those terms as defined by the federal centers for medicare and

 

 3  medicaid services.Centers for Medicare and Medicaid Services.

 

 4        (29) Upon availability of funds, the department shall give

 

 5  grants, awards, or other recognition to nursing homes to encourage

 

 6  the rapid implementation or maintenance of the clinical process

 

 7  guidelines adopted under subsection (25).

 

 8        (30) The department shall instruct and train the surveyors in

 

 9  the clinical process guidelines adopted under subsection (25) in

 

10  citing deficiencies.

 

11        (31) A nursing home shall post the nursing home's survey

 

12  report in a conspicuous place within the nursing home for public

 

13  review.

 

14        (32) Nothing in this amendatory act shall be construed to

 

15  limit section limits the requirements of related state and federal

 

16  law.

 

17        (33) As used in this section:

 

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

 

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

 

20  holidays.

 

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

 

22  medicaid services' Centers for Medicare and Medicaid Services' form

 

23  for the statement of deficiencies and plan of correction or a

 

24  successor form serving the same purpose.

 

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

 

26  act, 42 USC 1395 to 1395kkk.

 

27        (d) "Title XIX" means title XIX of the social security act, 42


 1  USC 1396 to 1396w-5.

 

 2        Sec. 20161. (1) The department shall assess fees and other

 

 3  assessments for health facility and agency licenses and

 

 4  certificates of need on an annual basis as provided in this

 

 5  article. Except Until October 1, 2019, except as otherwise provided

 

 6  in this article, fees and assessments shall be paid as provided in

 

 7  the following schedule:

 

 

 8             (a) Freestanding surgical

 9        outpatient facilities................$238.00 $500.00 per facility

10                                             license.

11             (b) Hospitals...................$8.28 $500.00 per facility

12                                             license and $10.00 per

13                                             licensed bed.

14             (c) Nursing homes, county

15        medical care facilities, and

16        hospital long-term care units........$2.20 $500.00 per facility

17                                             license and $5.00 per

18                                             licensed bed.

19             (d) Homes for the aged..........$6.27 per licensed bed.

20             (e) Clinical laboratories.......$475.00 per laboratory.

21             (e) Hospice agencies............$500.00 per agency license.

22             (f) Hospice residences..........$200.00 $500.00 per facility

23                                             survey; license and $20.00

$5.00

24                                             per licensed bed.

25             (g) Subject to subsection

26        (13), (11), quality assurance assessment

27        for nursing homes and hospital


 1        long-term care units.................an amount resulting

 2                                             in not more than 6%

 3                                             of total industry

 4                                             revenues.

 5             (h) Subject to subsection

 6        (14), (12), quality assurance assessment

 7        for hospitals........................at a fixed or variable

 8                                             rate that generates

 9                                             funds not more than the

10                                             maximum allowable under

11                                             the federal matching

12                                             requirements, after

13                                             consideration for the

14                                             amounts in subsection

15                                             (14)(a) (12)(a) and (i).

16             (i) Initial licensure

17        application fee for subdivisions

18        (a), (b), (c), (e), and (f)..........$2,000.00 per initial

19                                             license.

 

 

20        (2) If a hospital requests the department to conduct a

 

21  certification survey for purposes of title XVIII or title XIX of

 

22  the social security act, the hospital shall pay a license fee

 

23  surcharge of $23.00 per bed. As used in this subsection, "title

 

24  XVIII" and "title XIX" mean those terms as defined in section

 

25  20155.

 

26        (3) All of the following apply to the assessment under this

 

27  section for certificates of need:


 1        (a) The base fee for a certificate of need is $3,000.00 for

 

 2  each application. For a project requiring a projected capital

 

 3  expenditure of more than $500,000.00 but less than $4,000,000.00,

 

 4  an additional fee of $5,000.00 is added to the base fee. For a

 

 5  project requiring a projected capital expenditure of $4,000,000.00

 

 6  or more but less than $10,000,000.00, an additional fee of

 

 7  $8,000.00 is added to the base fee. For a project requiring a

 

 8  projected capital expenditure of $10,000,000.00 or more, an

 

 9  additional fee of $12,000.00 is added to the base fee.

 

10        (b) In addition to the fees under subdivision (a), the

 

11  applicant shall pay $3,000.00 for any designated complex project

 

12  including a project scheduled for comparative review or for a

 

13  consolidated licensed health facility application for acquisition

 

14  or replacement.

 

15        (c) If required by the department, the applicant shall pay

 

16  $1,000.00 for a certificate of need application that receives

 

17  expedited processing at the request of the applicant.

 

18        (d) The department shall charge a fee of $500.00 to review any

 

19  letter of intent requesting or resulting in a waiver from

 

20  certificate of need review and any amendment request to an approved

 

21  certificate of need.

 

22        (e) A health facility or agency that offers certificate of

 

23  need covered clinical services shall pay $100.00 for each

 

24  certificate of need approved covered clinical service as part of

 

25  the certificate of need annual survey at the time of submission of

 

26  the survey data.

 

27        (f) The department of community health shall use the fees


 1  collected under this subsection only to fund the certificate of

 

 2  need program. Funds remaining in the certificate of need program at

 

 3  the end of the fiscal year shall not lapse to the general fund but

 

 4  shall remain available to fund the certificate of need program in

 

 5  subsequent years.

 

 6        (4) If licensure is for more than 1 year, the fees described

 

 7  in subsection (1) are multiplied by the number of years for which

 

 8  the license is issued, and the total amount of the fees shall be

 

 9  collected in the year in which the license is issued.A license

 

10  issued under this part is effective for no longer than 1 year after

 

11  the date of issuance.

 

12        (5) Fees described in this section are payable to the

 

13  department at the time an application for a license, permit, or

 

14  certificate is submitted. If an application for a license, permit,

 

15  or certificate is denied or if a license, permit, or certificate is

 

16  revoked before its expiration date, the department shall not refund

 

17  fees paid to the department.

 

18        (6) The fee for a provisional license or temporary permit is

 

19  the same as for a license. A license may be issued at the

 

20  expiration date of a temporary permit without an additional fee for

 

21  the balance of the period for which the fee was paid if the

 

22  requirements for licensure are met.

 

23        (7) The department may charge a fee to recover the cost of

 

24  purchase or production and distribution of proficiency evaluation

 

25  samples that are supplied to clinical laboratories under section

 

26  20521(3).

 

27        (8) In addition to the fees imposed under subsection (1), a


 1  clinical laboratory shall submit a fee of $25.00 to the department

 

 2  for each reissuance during the licensure period of the clinical

 

 3  laboratory's license.

 

 4        (7) (9) The cost of licensure activities shall be supported by

 

 5  license fees.

 

 6        (8) (10) The application fee for a waiver under section 21564

 

 7  is $200.00 plus $40.00 per hour for the professional services and

 

 8  travel expenses directly related to processing the application. The

 

 9  travel expenses shall be calculated in accordance with the state

 

10  standardized travel regulations of the department of technology,

 

11  management, and budget in effect at the time of the travel.

 

12        (9) (11) An applicant for licensure or renewal of licensure

 

13  under part 209 shall pay the applicable fees set forth in part 209.

 

14        (10) (12) Except as otherwise provided in this section, the

 

15  fees and assessments collected under this section shall be

 

16  deposited in the state treasury, to the credit of the general fund.

 

17  The department may use the unreserved fund balance in fees and

 

18  assessments for the criminal history check program required under

 

19  this article.

 

20        (11) (13) The quality assurance assessment collected under

 

21  subsection (1)(g) and all federal matching funds attributed to that

 

22  assessment shall be used only for the following purposes and under

 

23  the following specific circumstances:

 

24        (a) The quality assurance assessment and all federal matching

 

25  funds attributed to that assessment shall be used to finance

 

26  medicaid Medicaid nursing home reimbursement payments. Only

 

27  licensed nursing homes and hospital long-term care units that are


 1  assessed the quality assurance assessment and participate in the

 

 2  medicaid Medicaid program are eligible for increased per diem

 

 3  medicaid Medicaid reimbursement rates under this subdivision. A

 

 4  nursing home or long-term care unit that is assessed the quality

 

 5  assurance assessment and that does not pay the assessment required

 

 6  under subsection (1)(g) in accordance with subdivision (c)(i) or in

 

 7  accordance with a written payment agreement with the state shall

 

 8  not receive the increased per diem medicaid Medicaid reimbursement

 

 9  rates under this subdivision until all of its outstanding quality

 

10  assurance assessments and any penalties assessed pursuant to under

 

11  subdivision (f) have been paid in full. Nothing in this This

 

12  subdivision shall be construed to does not authorize or require the

 

13  department to overspend tax revenue in violation of the management

 

14  and budget act, 1984 PA 431, MCL 18.1101 to 18.1594.

 

15        (b) Except as otherwise provided under subdivision (c),

 

16  beginning October 1, 2005, the quality assurance assessment is

 

17  based on the total number of patient days of care each nursing home

 

18  and hospital long-term care unit provided to nonmedicare non-

 

19  Medicare patients within the immediately preceding year and shall

 

20  be assessed at a uniform rate on October 1, 2005 and subsequently

 

21  on October 1 of each following year, and is payable on a quarterly

 

22  basis, the first payment due 90 days after the date the assessment

 

23  is assessed.

 

24        (c) Within 30 days after September 30, 2005, the department

 

25  shall submit an application to the federal centers for medicare and

 

26  medicaid services Centers for Medicare and Medicaid Services to

 

27  request a waiver pursuant according to 42 CFR 433.68(e) to


 1  implement this subdivision as follows:

 

 2        (i) If the waiver is approved, the quality assurance

 

 3  assessment rate for a nursing home or hospital long-term care unit

 

 4  with less than 40 licensed beds or with the maximum number, or more

 

 5  than the maximum number, of licensed beds necessary to secure

 

 6  federal approval of the application is $2.00 per nonmedicare non-

 

 7  Medicare patient day of care provided within the immediately

 

 8  preceding year or a rate as otherwise altered on the application

 

 9  for the waiver to obtain federal approval. If the waiver is

 

10  approved, for all other nursing homes and long-term care units the

 

11  quality assurance assessment rate is to be calculated by dividing

 

12  the total statewide maximum allowable assessment permitted under

 

13  subsection (1)(g) less the total amount to be paid by the nursing

 

14  homes and long-term care units with less than 40 or with the

 

15  maximum number, or more than the maximum number, of licensed beds

 

16  necessary to secure federal approval of the application by the

 

17  total number of nonmedicare non-Medicare patient days of care

 

18  provided within the immediately preceding year by those nursing

 

19  homes and long-term care units with more than 39, but less than the

 

20  maximum number of licensed beds necessary to secure federal

 

21  approval. The quality assurance assessment, as provided under this

 

22  subparagraph, shall be assessed in the first quarter after federal

 

23  approval of the waiver and shall be subsequently assessed on

 

24  October 1 of each following year, and is payable on a quarterly

 

25  basis, the first payment due 90 days after the date the assessment

 

26  is assessed.

 

27        (ii) If the waiver is approved, continuing care retirement


 1  centers are exempt from the quality assurance assessment if the

 

 2  continuing care retirement center requires each center resident to

 

 3  provide an initial life interest payment of $150,000.00, on

 

 4  average, per resident to ensure payment for that resident's

 

 5  residency and services and the continuing care retirement center

 

 6  utilizes all of the initial life interest payment before the

 

 7  resident becomes eligible for medical assistance under the state's

 

 8  medicaid Medicaid plan. As used in this subparagraph, "continuing

 

 9  care retirement center" means a nursing care facility that provides

 

10  independent living services, assisted living services, and nursing

 

11  care and medical treatment services, in a campus-like setting that

 

12  has shared facilities or common areas, or both.

 

13        (d) Beginning May 10, 2002, the department of community health

 

14  shall increase the per diem nursing home medicaid Medicaid

 

15  reimbursement rates for the balance of that year. For each

 

16  subsequent year in which the quality assurance assessment is

 

17  assessed and collected, the department of community health shall

 

18  maintain the medicaid Medicaid nursing home reimbursement payment

 

19  increase financed by the quality assurance assessment.

 

20        (e) The department of community health shall implement this

 

21  section in a manner that complies with federal requirements

 

22  necessary to assure ensure that the quality assurance assessment

 

23  qualifies for federal matching funds.

 

24        (f) If a nursing home or a hospital long-term care unit fails

 

25  to pay the assessment required by subsection (1)(g), the department

 

26  of community health may assess the nursing home or hospital long-

 

27  term care unit a penalty of 5% of the assessment for each month


 1  that the assessment and penalty are not paid up to a maximum of 50%

 

 2  of the assessment. The department of community health may also

 

 3  refer for collection to the department of treasury past due amounts

 

 4  consistent with section 13 of 1941 PA 122, MCL 205.13.

 

 5        (g) The medicaid Medicaid nursing home quality assurance

 

 6  assessment fund is established in the state treasury. The

 

 7  department of community health shall deposit the revenue raised

 

 8  through the quality assurance assessment with the state treasurer

 

 9  for deposit in the medicaid Medicaid nursing home quality assurance

 

10  assessment fund.

 

11        (h) The department of community health shall not implement

 

12  this subsection in a manner that conflicts with 42 USC 1396b(w).

 

13        (i) The quality assurance assessment collected under

 

14  subsection (1)(g) shall be prorated on a quarterly basis for any

 

15  licensed beds added to or subtracted from a nursing home or

 

16  hospital long-term care unit since the immediately preceding July

 

17  1. Any adjustments in payments are due on the next quarterly

 

18  installment due date.

 

19        (j) In each fiscal year governed by this subsection, medicaid

 

20  Medicaid reimbursement rates shall not be reduced below the

 

21  medicaid Medicaid reimbursement rates in effect on April 1, 2002 as

 

22  a direct result of the quality assurance assessment collected under

 

23  subsection (1)(g).

 

24        (k) The state retention amount of the quality assurance

 

25  assessment collected pursuant to under subsection (1)(g) shall be

 

26  equal to 13.2% of the federal funds generated by the nursing homes

 

27  and hospital long-term care units quality assurance assessment,


 1  including the state retention amount. The state retention amount

 

 2  shall be appropriated each fiscal year to the department of

 

 3  community health to support medicaid Medicaid expenditures for

 

 4  long-term care services. These funds shall offset an identical

 

 5  amount of general fund/general purpose revenue originally

 

 6  appropriated for that purpose.

 

 7        (l) Beginning October 1, 2015, 2019, the department shall no

 

 8  longer assess or collect the quality assurance assessment or apply

 

 9  for federal matching funds. The quality assurance assessment

 

10  collected under subsection (1)(g) shall no longer be assessed or

 

11  collected after September 30, 2011, in the event that the quality

 

12  assurance assessment is not eligible for federal matching funds.

 

13  Any portion of the quality assurance assessment collected from a

 

14  nursing home or hospital long-term care unit that is not eligible

 

15  for federal matching funds shall be returned to the nursing home or

 

16  hospital long-term care unit.

 

17        (12) (14) The quality assurance dedication is an earmarked

 

18  assessment collected under subsection (1)(h). That assessment and

 

19  all federal matching funds attributed to that assessment shall be

 

20  used only for the following purpose and under the following

 

21  specific circumstances:

 

22        (a) To maintain the increased medicaid Medicaid reimbursement

 

23  rate increases as provided for in subdivision (c).

 

24        (b) The quality assurance assessment shall be assessed on all

 

25  net patient revenue, before deduction of expenses, less medicare

 

26  Medicare net revenue, as reported in the most recently available

 

27  medicare Medicare cost report and is payable on a quarterly basis,


 1  the first payment due 90 days after the date the assessment is

 

 2  assessed. As used in this subdivision, "medicare "Medicare net

 

 3  revenue" includes medicare Medicare payments and amounts collected

 

 4  for coinsurance and deductibles.

 

 5        (c) Beginning October 1, 2002, the department of community

 

 6  health shall increase the hospital medicaid Medicaid reimbursement

 

 7  rates for the balance of that year. For each subsequent year in

 

 8  which the quality assurance assessment is assessed and collected,

 

 9  the department of community health shall maintain the hospital

 

10  medicaid Medicaid reimbursement rate increase financed by the

 

11  quality assurance assessments.

 

12        (d) The department of community health shall implement this

 

13  section in a manner that complies with federal requirements

 

14  necessary to assure ensure that the quality assurance assessment

 

15  qualifies for federal matching funds.

 

16        (e) If a hospital fails to pay the assessment required by

 

17  subsection (1)(h), the department of community health may assess

 

18  the hospital a penalty of 5% of the assessment for each month that

 

19  the assessment and penalty are not paid up to a maximum of 50% of

 

20  the assessment. The department of community health may also refer

 

21  for collection to the department of treasury past due amounts

 

22  consistent with section 13 of 1941 PA 122, MCL 205.13.

 

23        (f) The hospital quality assurance assessment fund is

 

24  established in the state treasury. The department of community

 

25  health shall deposit the revenue raised through the quality

 

26  assurance assessment with the state treasurer for deposit in the

 

27  hospital quality assurance assessment fund.


 1        (g) In each fiscal year governed by this subsection, the

 

 2  quality assurance assessment shall only be collected and expended

 

 3  if medicaid Medicaid hospital inpatient DRG and outpatient

 

 4  reimbursement rates and disproportionate share hospital and

 

 5  graduate medical education payments are not below the level of

 

 6  rates and payments in effect on April 1, 2002 as a direct result of

 

 7  the quality assurance assessment collected under subsection (1)(h),

 

 8  except as provided in subdivision (h).

 

 9        (h) The quality assurance assessment collected under

 

10  subsection (1)(h) shall no longer be assessed or collected after

 

11  September 30, 2011 in the event that the quality assurance

 

12  assessment is not eligible for federal matching funds. Any portion

 

13  of the quality assurance assessment collected from a hospital that

 

14  is not eligible for federal matching funds shall be returned to the

 

15  hospital.

 

16        (i) The state retention amount of the quality assurance

 

17  assessment collected pursuant to under subsection (1)(h) shall be

 

18  equal to 13.2% of the federal funds generated by the hospital

 

19  quality assurance assessment, including the state retention amount.

 

20  The state retention percentage shall be applied proportionately to

 

21  each hospital quality assurance assessment program to determine the

 

22  retention amount for each program. The state retention amount shall

 

23  be appropriated each fiscal year to the department of community

 

24  health to support medicaid Medicaid expenditures for hospital

 

25  services and therapy. These funds shall offset an identical amount

 

26  of general fund/general purpose revenue originally appropriated for

 

27  that purpose.


 1        (13) (15) The quality assurance assessment provided for under

 

 2  this section is a tax that is levied on a health facility or

 

 3  agency.

 

 4        (14) (16) As used in this section, "medicaid" "Medicaid" means

 

 5  that term as defined in section 22207.

 

 6        Sec. 20501. (1) As used in this part, : "laboratory" means a

 

 7  facility for the biological, microbiological, serological,

 

 8  chemical, immunohematological, hematological, biophysical,

 

 9  cytological, pathological, or other examination of materials

 

10  derived from the human body for the purpose of providing

 

11  information for the diagnosis, prevention, or treatment of any

 

12  disease or impairment of, or the assessment of the health of, human

 

13  beings.

 

14        (a) "Laboratory director" means the individual responsible for

 

15  administration of the technical and scientific operation of a

 

16  clinical laboratory, including the supervision of procedures and

 

17  reporting of findings.

 

18        (b) "Owner" means a person who owns and controls a clinical

 

19  laboratory.

 

20        (2) In addition, article 1 contains general definitions and

 

21  principles of construction applicable to all articles in this code.

 

22  and part 201 contains definitions applicable to this part.

 

23        Sec. 20521. (1) The owner, laboratory director, and governing

 

24  body of a clinical laboratory are responsible for the operation of

 

25  the clinical laboratory.

 

26        (2) The laboratory director is responsible for the making and

 

27  keeping of an accurate record for each specimen examined and


 1  procedure followed.

 

 2        (3) A clinical laboratory shall analyze test samples submitted

 

 3  by the department and report to the department on the results of

 

 4  the analyses, except that proficiency evaluation programs of

 

 5  recognized professional organizations may be acceptable to the

 

 6  department in lieu thereof. The analyses and reports may be

 

 7  considered by the department in taking action under section 20165

 

 8  or 20525. Only a physician, dentist, or other person authorized by

 

 9  law can order a laboratory test that has been classified by the

 

10  Food and Drug Administration as moderate or high complexity. A

 

11  laboratory test that is classified by the Food and Drug

 

12  Administration as waived does not require an order.

 

13        Sec. 20551. (1) A laboratory or other place where live

 

14  bacteria, fungi, mycoplasma, parasites, viruses, or other

 

15  microorganisms of a pathogenic nature are handled, cultivated,

 

16  sold, given away, or shipped from or to or where recombinant

 

17  deoxyribonucleic acid research is done shall be registered with the

 

18  department, and a registration number shall be issued to each place

 

19  registered. An application for a registration number shall be made

 

20  by the person in charge of the laboratory or other place where the

 

21  pathogens are handled or where recombinant deoxyribonucleic acid

 

22  research is done. The registration number is valid for 1 year and

 

23  may be renewed upon application to the department.

 

24        (2) A clinical laboratory licensed in microbiology under

 

25  sections 20501 to 20525 is registered for purposes of this section

 

26  and section 20552, and its license number shall be used as its

 

27  registration number.


 1        (2) (3) As used in sections 20551 this section and section

 

 2  20552, "handled", "cultivated", or "shipped" does not include the

 

 3  collection of specimens, the initial inoculation of specimens into

 

 4  transport media or culture media, or the shipment to registered

 

 5  laboratories, but does include any additional work performed on

 

 6  cultivated pathogenic microorganisms or any recombinant

 

 7  deoxyribonucleic acid research is done.

 

 8        Enacting section 1. Sections 20511, 20515, and 20525 of the

 

 9  public health code, 1978 PA 368, MCL 333.20511, 333.20515, and

 

10  333.20525, are repealed.

 

11        Enacting section 2. This amendatory act takes effect 90 days

 

12  after the date it is enacted into law.