HB-4447, As Passed House, May 27, 2015
SUBSTITUTE FOR
HOUSE BILL NO. 4447
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
1 basis upon determining that the applicant has complied with this
2 part and rules promulgated under this part. A licensee shall
3 prominently display the license while it is in effect.
4 Sec. 6238. (1) A standard license issued under this part is
5 effective for no longer than 1 year after the date of issuance.
6 The department may issue a provisional license to an applicant
7 temporarily unable to comply with this part or the rules
8 promulgated under this part. The department may renew or extend a
9 provisional license issued under this section for not more than 1
10 year. The department may issue a temporary, nonrenewable permit
11 for not more than 90 days if additional time is needed for the
12 department to properly investigate or for the applicant to
13 undertake remedial action.
14 (2) The department shall make at least 1 visit to each
15 licensed substance use disorder program every 3 years for survey
16 and evaluation for the purpose of licensure.
17 (3) The department may waive the visit required by
18 subsection (2) if the licensed program requests a waiver and
19 submits the following:
20 (a) Evidence that it is currently fully accredited by an
21 accrediting body with expertise in the health facility type and
22 the accrediting organization is accepted by the department.
23 (b) A copy of the most recent accreditation executive
24 summary submitted to the department at least 30 days from
25 licensure renewal. Submission of an executive summary does not
26 prevent or prohibit the department from requesting the entire
27 accreditation report if the department considers it necessary.
1 (4) Accreditation information provided to the department
2 under subsection (3) is confidential, is not a public record, and
3 is not subject to court subpoena. The department shall use the
4 accreditation information only as provided in this section. The
5 department shall properly destroy the documentation after a
6 decision on the waiver request is made.
7 (5) The department shall grant a waiver under subsection (3)
8 if the accreditation report submitted is less than 3 years old
9 and there is no indication of substantial noncompliance with
10 licensure standards or of deficiencies that represent a threat to
11 public safety or patient care in the accreditation report.
12 (6) Denial of waiver request by the department is not
13 subject to appeal.
14 (7) This section does not prohibit the department from
15 conducting an inspection or citing a violation of this part
16 related to a complaint.
17 Sec. 20104. (1) "Certification" means the issuance of a
18 document by the department to a health facility or agency
19 attesting to the fact that the health facility or agency meets
20 both of the following:
21 (a) It complies with applicable statutory and regulatory
22 requirements and standards.
23 (b) It is eligible to participate as a provider of care and
24 services in a specific federal or state health program.
25 (2) "Clinical laboratory" means a facility patronized
by, or
26 at the direction of, a physician, health officer, or other person
27 authorized by law to obtain information for the diagnosis,
1 prevention, or treatment of disease or the assessment of a
2 medical condition by the microbiological, serological,
3 histological, hematological, immunohematological, biophysical,
4 cytological, pathological, or biochemical examination of
5 materials derived from the human body, except as provided in
6 section 20507.
7 (2) (3) "Consumer"
means a person who is not a provider of
8 health care as defined in section 1531(3) of title 15 of the
9 public health service act, 42 USC 300n.
10 (3) (4) "County
medical care facility" means a nursing care
11 facility, other than a hospital long-term care unit, which that
12 provides organized nursing care and medical treatment to 7 or
13 more unrelated individuals who are suffering or recovering from
14 illness, injury, or infirmity and which that is
owned by a county
15 or counties.
16 (4) (5) "Direct
access" means access to a patient or
17 resident or to a patient's or resident's property, financial
18 information, medical records, treatment information, or any other
19 identifying information.
20 (5) (6) "Freestanding
surgical outpatient facility" means a
21 facility, other than the office of a physician, dentist,
22 podiatrist, or other private practice office, offering a surgical
23 procedure and related care that in the opinion of the attending
24 physician can be safely performed without requiring overnight
25 inpatient hospital care. It Freestanding surgical outpatient
26 facility does not include a surgical outpatient facility owned by
27 and operated as part of a hospital.
1 (6) (7) "Good
moral character" means that term as defined in
2 section 1 of 1974 PA 381, MCL 338.41.
3 Sec. 20106. (1) "Health facility or agency", except as
4 provided in section 20115, means:
5 (a) An ambulance operation, aircraft transport operation,
6 nontransport prehospital life support operation, or medical first
7 response service.
8 (b) A clinical laboratory.
9 (b) (c) A
county medical care facility.
10 (c) (d) A
freestanding surgical outpatient facility.
11 (d) (e) A
health maintenance organization.
12 (e) (f) A
home for the aged.
13 (f) (g) A
hospital.
14 (g) (h) A
nursing home.
15 (h) (i) A
hospice.
16 (i) (j) A
hospice residence.
17 (j) (k) A
facility or agency listed in subdivisions (a) to
18 (h) (g) located in a university, college, or other
educational
19 institution.
20 (2) "Health maintenance organization" means that term as
21 defined in section 3501 of the insurance code of 1956, 1956 PA
22 218, MCL 500.3501.
23 (3) "Home for the aged" means a supervised personal care
24 facility, other than a hotel, adult foster care facility,
25 hospital, nursing home, or county medical care facility that
26 provides room, board, and supervised personal care to 21 or more
27 unrelated, nontransient, individuals 60 years of age or older.
1 Home for the aged includes a supervised personal care facility
2 for 20 or fewer individuals 60 years of age or older if the
3 facility is operated in conjunction with and as a distinct part
4 of a licensed nursing home. Home for the aged does not include an
5 area excluded from this definition by section 17(3) of the
6 continuing care community disclosure act, 2014 PA 448, MCL
7 554.917.
8 (4) "Hospice" means a health care program that provides a
9 coordinated set of services rendered at home or in outpatient or
10 institutional settings for individuals suffering from a disease
11 or condition with a terminal prognosis.
12 (5) "Hospital" means a facility offering inpatient,
13 overnight care, and services for observation, diagnosis, and
14 active treatment of an individual with a medical, surgical,
15 obstetric, chronic, or rehabilitative condition requiring the
16 daily direction or supervision of a physician. Hospital does not
17 include a mental health hospital licensed or operated by the
18 department of community health or a hospital operated by the
19 department of corrections.
20 (6) "Hospital long-term care unit" means a nursing care
21 facility, owned and operated by and as part of a hospital,
22 providing organized nursing care and medical treatment to 7 or
23 more unrelated individuals suffering or recovering from illness,
24 injury, or infirmity.
25 Sec. 20145. (1) Before contracting for and initiating a
26 construction project involving new construction, additions,
27 modernizations, or conversions of a health facility or agency
1 with a capital expenditure of $1,000,000.00 or more, a person
2 shall obtain a construction permit from the department. The
3 department shall not issue the permit under this subsection
4 unless the applicant holds a valid certificate of need if a
5 certificate of need is required for the project pursuant to under
6 part 222.
7 (2) To protect the public health, safety, and welfare, the
8 department may promulgate rules to require construction permits
9 for projects other than those described in subsection (1) and the
10 submission of plans for other construction projects to expand or
11 change service areas and services provided.
12 (3) If a construction project requires a construction permit
13 under subsection (1) or (2), but does not require a certificate
14 of need under part 222, the department shall require the
15 applicant to submit information considered necessary by the
16 department to assure that the capital expenditure for the project
17 is not a covered capital expenditure as defined in section
18 22203(9).
19 (4) If a construction project requires a construction permit
20 under subsection (1), but does not require a certificate of need
21 under part 222, the department shall require the applicant to
22 submit information on a 1-page sheet, along with the application
23 for a construction permit, consisting of all of the following:
24 (a) A short description of the reason for the project and
25 the funding source.
26 (b) A contact person for further information, including
27 address and phone number.
1 (c) The estimated resulting increase or decrease in annual
2 operating costs.
3 (d) The current governing board membership of the applicant.
4 (e) The entity, if any, that owns the applicant.
5 (5) The information filed under subsection (4) shall be made
6 publicly available by the department by the same methods used to
7 make information about certificate of need applications publicly
8 available.
9 (6) The review and approval of architectural plans and
10 narrative shall require that the proposed construction project is
11 designed and constructed in accord with applicable statutory and
12 other regulatory requirements. In performing a construction
13 permit review for a health facility or agency under this section,
14 the department shall, at a minimum, apply the standards contained
15 in the document entitled "Minimum Design Standards for Health
16 Care Facilities in Michigan" published by the department and
17 dated March 1998. July
2007. The standards are incorporated by
18 reference for purposes of this subsection. The department may
19 promulgate rules that are more stringent than the standards if
20 necessary to protect the public health, safety, and welfare.
21 (7) The department shall promulgate rules to further
22 prescribe the scope of construction projects and other
23 alterations subject to review under this section.
24 (8) The department may waive the applicability of this
25 section to a construction project or alteration if the waiver
26 will not affect the public health, safety, and welfare.
27 (9) Upon request by the person initiating a construction
1 project, the department may review and issue a construction
2 permit to a construction project that is not subject to
3 subsection (1) or (2) if the department determines that the
4 review will promote the public health, safety, and welfare.
5 (10) The department shall assess a fee for each review
6 conducted under this section. The fee is .5% of the first
7 $1,000,000.00 of capital expenditure and .85% of any amount over
8 $1,000,000.00 of capital expenditure, up to a maximum of
9 $60,000.00.
10 (11) As used in this section, "capital expenditure" means
11 that term as defined in section 22203(2), except that it capital
12 expenditure does not include the cost of equipment that is not
13 fixed equipment.
14 Sec. 20155. (1) Except as otherwise provided in this section
15 and section 20155a, the department shall make annual and other
16 visits to each health facility or agency licensed under this
17 article for the purposes of survey, evaluation, and consultation.
18 at least 1 visit to each licensed health facility or agency every
19 3 years for survey and evaluation for the purpose of licensure. A
20 visit made according to a complaint shall be unannounced. Except
21 for a county medical care facility, a home for the aged, a
22 nursing home, or a hospice residence, the department shall
23 determine whether the visits that are not made according to a
24 complaint are announced or unannounced. Beginning June 20, 2001,
25 the The department shall ensure that each newly hired
nursing
26 home surveyor, as part of his or her basic training, is assigned
27 full-time to a licensed nursing home for at least 10 days within
1 a 14-day period to observe actual operations outside of the
2 survey process before the trainee begins oversight
3 responsibilities.
4 (2) The state shall establish a process that ensures both of
5 the following:
6 (a) A newly hired nursing home surveyor shall not make
7 independent compliance decisions during his or her training
8 period.
9 (b) A nursing home surveyor shall not be assigned as a
10 member of a survey team for a nursing home in which he or she
11 received training for 1 standard survey following the training
12 received in that nursing home.
13 (3) Beginning November 1, 2012, the The department
shall
14 perform a criminal history check on all nursing home surveyors in
15 the manner provided for in section 20173a.
16 (4) A member of a survey team shall not be employed by a
17 licensed nursing home or a nursing home management company doing
18 business in this state at the time of conducting a survey under
19 this section. The department shall not assign an individual to be
20 a member of a survey team for purposes of a survey, evaluation,
21 or consultation visit at a nursing home in which he or she was an
22 employee within the preceding 3 years.
23 (5) Representatives from all nursing home provider
24 organizations and the state long-term care ombudsman or his or
25 her designee shall be invited to participate in the planning
26 process for the joint provider and surveyor training sessions.
27 The department shall include at least 1 representative from
1 nursing home provider organizations that do not own or operate a
2 nursing home representing 30 or more nursing homes statewide in
3 internal surveyor group quality assurance training provided for
4 the purpose of general clarification and interpretation of
5 existing or new regulatory requirements and expectations.
6 (6) The department shall make available online the general
7 civil service position description related to the required
8 qualifications for individual surveyors. The department shall use
9 the required qualifications to hire, educate, develop, and
10 evaluate surveyors.
11 (7) The department shall ensure that each annual survey team
12 is composed of an interdisciplinary group of professionals, 1 of
13 whom must be a registered nurse. Other members may include social
14 workers, therapists, dietitians, pharmacists, administrators,
15 physicians, sanitarians, and others who may have the expertise
16 necessary to evaluate specific aspects of nursing home operation.
17 (8) Except as otherwise provided in this section and section
18 20155a, the department shall make at least a biennial visit to
19 each licensed clinical laboratory, each nursing home, and each
20 hospice residence for the purposes of survey, evaluation, and
21 consultation. The
department shall semiannually provide for joint
22 training with nursing home surveyors and providers on at least 1
23 of the 10 most frequently issued federal citations in this state
24 during the past calendar year. The department shall develop a
25 protocol for the review of citation patterns compared to regional
26 outcomes and standards and complaints regarding the nursing home
27 survey process. The review will be included in the report
House Bill No. 4447 as amended May 27, 2015
1 required under subsection (20). Except as otherwise provided in
2 this subsection, beginning with his or her first full relicensure
3 period after June 20, 2000, each member of a department nursing
4 home survey team who is a health professional licensee under
5 article 15 shall earn not less than 50% of his or her required
6 continuing education credits, if any, in geriatric care. If a
7 member of a nursing home survey team is a pharmacist licensed
8 under article 15, he or she shall earn not less than 30% of his
9 or her required continuing education credits in geriatric care.
10 (9) The department shall make a biennial visit to each
11 hospital for survey and evaluation for the purpose of licensure.
12 Subject to subsection (12), the department may waive the biennial
13 visit required by this subsection (1) if a hospital, as
part of a
14 timely application for license renewal, health facility or
15
agency, requests a waiver and submits both
of the following as
16 applicable and if all of the requirements of subsection (11) are
17 met:
18 (a) Evidence that it is currently fully accredited by a body
19 with expertise in hospital accreditation whose hospital
20 accreditations are the
health facility or agency type and the
21 accrediting organization is accepted by the United States
22 department of health and human services Department of Health and
23
Human Services for purposes of section
1865 of part [C E] of title
24 XVIII of the social security act, 42 USC 1395bb.
25 (b) A copy of the most recent accreditation report, for
the
26 hospital or executive
summary, issued by a body described in
27 subdivision (a), and the hospital's health facility's or agency's
1 responses to the accreditation report is submitted to the
2 department at least 30 days from license renewal. Submission of
3 an executive summary does not prevent or prohibit the department
4 from requesting the entire accreditation report if the department
5 considers it necessary.
6 (c) For a nursing home, a standard federal certification
7 survey conducted within the immediately preceding 9 to 15 months
8 that shows substantial compliance or has an accepted plan of
9 correction, if applicable.
10 (10) Except as provided in subsection (14), accreditation
11 information provided to the department under subsection (9) is
12 confidential, is not a public record, and is not subject to court
13 subpoena. The department shall use the accreditation information
14 only as provided in this section and shall return the
15 accreditation information to the hospital within a reasonable
16 time properly destroy
the documentation after a decision on
the
17 waiver request is made.
18 (11) The department shall grant a waiver under subsection
19 (9) if the accreditation report submitted under subsection (9)(b)
20 is less than 2 3 years old or
the standard federal survey
21 submitted under subsection (9)(c) is less than 15 months old and
22 there is no indication of substantial noncompliance with
23 licensure standards or of deficiencies that represent a threat to
24 public safety or patient care. in the report, in complaints
25 involving the hospital, or in any other information available to
26 the department. If the
accreditation report or standard
federal
27
survey is 2 or more years too old,
the department may do 1 of the
1 following:
2 (a) Grant an extension of the hospital's current license
3 until the next accreditation survey is completed by the body
4 described in subsection (9)(a).
5 (b) Grant a waiver under subsection (9) based on the
6 accreditation report that is 2 or more years old, on condition
7 that the hospital promptly submit the next accreditation report
8 to the department.
9 (c) Deny deny the waiver request and conduct the visits
10 required under subsection (9). Denial of a waiver request by the
11 department is not subject to appeal.
12 (12) This section does not prohibit the department from
13 citing a violation of this part during a survey, conducting
14 investigations or inspections according to section 20156, or
15 conducting surveys of health facilities or agencies for the
16 purpose of complaint investigations or federal certification.
17 This section does not prohibit the bureau of fire services
18 created in section 1b of the fire prevention code, 1941 PA 207,
19 MCL 29.1b, from conducting annual surveys of hospitals, nursing
20 homes, and county medical care facilities.
21 (13) At the request of a health facility or agency, the
22 department may conduct a consultation engineering survey of a
23 health facility and provide professional advice and consultation
24 regarding health facility construction and design. A health
25 facility or agency may request a voluntary consultation survey
26 under this subsection at any time between licensure surveys. The
27 fees for a consultation engineering survey are the same as the
1 fees established for waivers under section 20161(10).20161(8).
2 (14) If the department determines that substantial
3 noncompliance with licensure standards exists or that
4 deficiencies that represent a threat to public safety or patient
5 care exist based on a review of an accreditation report submitted
6 under subsection (9)(b), the department shall prepare a written
7 summary of the substantial noncompliance or deficiencies and the
8 hospital's health
facility's or agency's response to the
9 department's determination. The department's written summary and
10 the hospital's health
facility's or agency's response are
public
11 documents.
12 (15) The department or a local health department shall
13 conduct investigations or inspections, other than inspections of
14 financial records, of a county medical care facility, home for
15 the aged, nursing home, or hospice residence without prior notice
16 to the health facility or agency. An employee of a state agency
17 charged with investigating or inspecting the health facility or
18 agency or an employee of a local health department who directly
19 or indirectly gives prior notice regarding an investigation or an
20 inspection, other than an inspection of the financial records, to
21 the health facility or agency or to an employee of the health
22 facility or agency, is guilty of a misdemeanor. Consultation
23 visits that are not for the purpose of annual or follow-up
24 inspection or survey may be announced.
25 (16) The department shall maintain a record indicating
26 whether a visit and inspection is announced or unannounced.
27 Survey findings gathered at each health facility or agency during
1 each visit and inspection, whether announced or unannounced,
2 shall be taken into account in licensure decisions.
3 (17) The department shall require periodic reports and a
4 health facility or agency shall give the department access to
5 books, records, and other documents maintained by a health
6 facility or agency to the extent necessary to carry out the
7 purpose of this article and the rules promulgated under this
8 article. The department shall not divulge or disclose the
9 contents of the patient's clinical records in a manner that
10 identifies an individual except under court order. The department
11 may copy health facility or agency records as required to
12 document findings. Surveyors shall use electronic resident
13 information, whenever available, as a source of survey-related
14 data and shall request facility assistance to access the system
15 to maximize data export.
16 (18) The department may delegate survey, evaluation, or
17 consultation functions to another state agency or to a local
18 health department qualified to perform those functions. However,
19 the The department shall not delegate survey, evaluation, or
20 consultation functions to a local health department that owns or
21 operates a hospice or hospice residence licensed under this
22 article. The delegation shall be by cost reimbursement contract
23 between the department and the state agency or local health
24 department. Survey, evaluation, or consultation functions shall
25 not be delegated to nongovernmental agencies, except as provided
26 in this section. The department may accept voluntary inspections
27 performed by an accrediting body with expertise in clinical
1 laboratory accreditation under part 205 if the accrediting body
2 utilizes forms acceptable to the department, applies the same
3 licensing standards as applied to other clinical laboratories,
4 and provides the same information and data usually filed by the
5 department's own employees when engaged in similar inspections or
6 surveys. The voluntary
inspection described in this subsection
7 shall be agreed upon by both the licensee and the department.
8 (19) If, upon investigation, the department or a state
9 agency determines that an individual licensed to practice a
10 profession in this state has violated the applicable licensure
11 statute or the rules promulgated under that statute, the
12 department, state agency, or local health department shall
13 forward the evidence it has to the appropriate licensing agency.
14 (20) The department may consolidate all information provided
15 for any report required under this section and section 20155a
16 into a single report. The department shall report to the
17 appropriations subcommittees, the senate and house of
18 representatives standing committees having jurisdiction over
19 issues involving senior citizens, and the fiscal agencies on
20 March 1 of each year on the initial and follow-up surveys
21 conducted on all nursing homes in this state. The report shall
22 include all of the following information:
23 (a) The number of surveys conducted.
24 (b) The number requiring follow-up surveys.
25 (c) The average number of citations per nursing home for the
26 most recent calendar year.
27 (d) The number of night and weekend complaints filed.
1 (e) The number of night and weekend responses to complaints
2 conducted by the department.
3 (f) The average length of time for the department to respond
4 to a complaint filed against a nursing home.
5 (g) The number and percentage of citations disputed through
6 informal dispute resolution and independent informal dispute
7 resolution.
8 (h) The number and percentage of citations overturned or
9 modified, or both.
10 (i) The review of citation patterns developed under
11 subsection (8).
12 (j) Implementation of the clinical process guidelines and
13 the impact of the guidelines on resident care.
14 (k) Information regarding the progress made on implementing
15 the administrative and electronic support structure to
16 efficiently coordinate all nursing home licensing and
17 certification functions.
18 (l) The number of annual standard surveys of nursing homes
19 that were conducted during a period of open survey or enforcement
20 cycle.
21 (m) The number of abbreviated complaint surveys that were
22 not conducted on consecutive surveyor workdays.
23 (n) The percent of all form CMS-2567 reports of findings
24 that were released to the nursing home within the 10-working-day
25 requirement.
26 (o) The percent of provider notifications of acceptance or
27 rejection of a plan of correction that were released to the
1 nursing home within the 10-working-day requirement.
2 (p) The percent of first revisits that were completed within
3 60 days from the date of survey completion.
4 (q) The percent of second revisits that were completed
5 within 85 days from the date of survey completion.
6 (r) The percent of letters of compliance notification to the
7 nursing home that were released within 10 working days of the
8 date of the completion of the revisit.
9 (s) A summary of the discussions from the meetings required
10 in subsection (24).
11 (t) The number of nursing homes that participated in a
12 recognized quality improvement program as described under section
13 20155a(3).
14 (21) The department shall report March 1 of each year to the
15 standing committees on appropriations and the standing committees
16 having jurisdiction over issues involving senior citizens in the
17 senate and the house of representatives on all of the following:
18 (a) The percentage of nursing home citations that are
19 appealed through the informal dispute resolution process.
20 (b) The number and percentage of nursing home citations that
21 are appealed and supported, amended, or deleted through the
22 informal dispute resolution process.
23 (c) A summary of the quality assurance review of the amended
24 citations and related survey retraining efforts to improve
25 consistency among surveyors and across the survey administrative
26 unit that occurred in the year being reported.
27 (22) Subject to subsection (23), a clarification work group
1 comprised of the department in consultation with a nursing home
2 resident or a member of a nursing home resident's family, nursing
3 home provider groups, the American medical directors association,
4 Medical Directors Association, the state long-term care
5 ombudsman, and the federal centers for medicare and medicaid
6 services Centers for Medicare
and Medicaid Services shall clarify
7 the following terms as those terms are used in title XVIII and
8 title XIX and applied by the department to provide more
9 consistent regulation of nursing homes in this state:
10 (a) Immediate jeopardy.
11 (b) Harm.
12 (c) Potential harm.
13 (d) Avoidable.
14 (e) Unavoidable.
15 (23) All of the following clarifications developed under
16 subsection (22) apply for purposes of subsection (22):
17 (a) Specifically, the term "immediate jeopardy" means a
18 situation in which immediate corrective action is necessary
19 because the nursing home's noncompliance with 1 or more
20 requirements of participation has caused or is likely to cause
21 serious injury, harm, impairment, or death to a resident
22 receiving care in a nursing home.
23 (b) The likelihood of immediate jeopardy is reasonably
24 higher if there is evidence of a flagrant failure by the nursing
25 home to comply with a clinical process guideline adopted under
26 subsection (25) than if the nursing home has substantially and
27 continuously complied with those guidelines. If federal
1 regulations and guidelines are not clear, and if the clinical
2 process guidelines have been recognized, a process failure giving
3 rise to an immediate jeopardy may involve an egregious widespread
4 or repeated process failure and the absence of reasonable efforts
5 to detect and prevent the process failure.
6 (c) In determining whether or not there is immediate
7 jeopardy, the survey agency should consider at least all of the
8 following:
9 (i) Whether the nursing home could reasonably have been
10 expected to know about the deficient practice and to stop it, but
11 did not stop the deficient practice.
12 (ii) Whether the nursing home could reasonably have been
13 expected to identify the deficient practice and to correct it,
14 but did not correct the deficient practice.
15 (iii) Whether the nursing home could reasonably have been
16 expected to anticipate that serious injury, serious harm,
17 impairment, or death might result from continuing the deficient
18 practice, but did not so anticipate.
19 (iv) Whether the nursing home could reasonably have been
20 expected to know that a widely accepted high-risk practice is or
21 could be problematic, but did not know.
22 (v) Whether the nursing home could reasonably have been
23 expected to detect the process problem in a more timely fashion,
24 but did not so detect.
25 (d) The existence of 1 or more of the factors described in
26 subdivision (c), and especially the existence of 3 or more of
27 those factors simultaneously, may lead to a conclusion that the
1 situation is one in which the nursing home's practice makes
2 adverse events likely to occur if immediate intervention is not
3 undertaken, and therefore constitutes immediate jeopardy. If none
4 of the factors described in subdivision (c) is present, the
5 situation may involve harm or potential harm that is not
6 immediate jeopardy.
7 (e) Specifically, "actual harm" means a negative outcome to
8 a resident that has compromised the resident's ability to
9 maintain or reach, or both, his or her highest practicable
10 physical, mental, and psychosocial well-being as defined by an
11 accurate and comprehensive resident assessment, plan of care, and
12 provision of services. Harm does not include a deficient practice
13 that only may cause or has caused limited consequences to the
14 resident.
15 (f) For purposes of subdivision (e), in determining whether
16 a negative outcome is of limited consequence, if the "state
17 operations manual" or "the guidance to surveyors" published by
18 the federal centers for medicare and medicaid services Centers
19 for Medicare and Medicaid Services does not provide specific
20 guidance, the department may consider whether most people in
21 similar circumstances would feel that the damage was of such
22 short duration or impact as to be inconsequential or trivial. In
23 such a case, the consequence of a negative outcome may be
24 considered more limited if it occurs in the context of overall
25 procedural consistency with an accepted clinical process
26 guideline adopted under subsection (25), as compared to a
27 substantial inconsistency with or variance from the guideline.
1 (g) For purposes of subdivision (e), if the publications
2 described in subdivision (f) do not provide specific guidance,
3 the department may consider the degree of a nursing home's
4 adherence to a clinical process guideline adopted under
5 subsection (25) in considering whether the degree of compromise
6 and future risk to the resident constitutes actual harm. The risk
7 of significant compromise to the resident may be considered
8 greater in the context of substantial deviation from the
9 guidelines than in the case of overall adherence.
10 (h) To improve consistency and to avoid disputes over
11 avoidable and unavoidable negative outcomes, nursing homes and
12 survey agencies must have a common understanding of accepted
13 process guidelines and of the circumstances under which it can
14 reasonably be said that certain actions or inactions will lead to
15 avoidable negative outcomes. If the "state operations manual" or
16 "the guidance to surveyors" published by the federal centers
for
17 medicare and medicaid services Centers for Medicare and Medicaid
18 Services is not specific, a nursing home's overall documentation
19 of adherence to a clinical process guideline with a process
20 indicator adopted under subsection (25) is relevant information
21 in considering whether a negative outcome was avoidable or
22 unavoidable and may be considered in the application of that
23 term.
24 (24) The department shall conduct a quarterly meeting and
25 invite appropriate stakeholders. Appropriate stakeholders shall
26 include at least 1 representative from each nursing home provider
27 organization that does not own or operate a nursing home
1 representing 30 or more nursing homes statewide, the state long-
2 term care ombudsman or his or her designee, and any other
3 clinical experts. Individuals who participate in these quarterly
4 meetings, in conjunction with the department, may designate
5 advisory workgroups to develop recommendations on the discussion
6 topics that should include, at a minimum, all of the following:
7 (a) Opportunities for enhanced promotion of nursing home
8 performance, including, but not limited to, programs that
9 encourage and reward providers that strive for excellence.
10 (b) Seeking quality improvement to the survey and
11 enforcement process, including clarifications to process-related
12 policies and protocols that include, but are not limited to, all
13 of the following:
14 (i) Improving the surveyors' quality and preparedness.
15 (ii) Enhanced communication between regulators, surveyors,
16 providers, and consumers.
17 (iii) Ensuring fair enforcement and dispute resolution by
18 identifying methods or strategies that may resolve identified
19 problems or concerns.
20 (c) Promoting transparency across provider and surveyor
21 communities, including, but not limited to, all of the following:
22 (i) Applying regulations in a consistent manner and
23 evaluating changes that have been implemented to resolve
24 identified problems and concerns.
25 (ii) Providing consumers with information regarding changes
26 in policy and interpretation.
27 (iii) Identifying positive and negative trends and factors
1 contributing to those trends in the areas of resident care,
2 deficient practices, and enforcement.
3 (d) Clinical process guidelines.
4 (25) Subject to subsection (27), the department shall
5 develop and adopt clinical process guidelines. The department
6 shall establish and adopt clinical process guidelines and
7 compliance protocols with outcome measures for all of the
8 following areas and for other topics where the department
9 determines that clarification will benefit providers and
10 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
2 develop and implement clinical process guidelines for topics that
3 have not been developed from the list in subsection (25) and
4 other topics identified as a result of the meetings required in
5 subsection (24). The department shall consider recommendations
6 from an advisory workgroup created under subsection (24) on
7 clinical process guidelines. The department shall include
8 training on new and revised clinical process guidelines in the
9 joint provider and surveyor training sessions as those clinical
10 process guidelines are 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
department director of the division
of nursing home monitoring or
21 his or her designee or the director of the division of operations
22 or his or her designee reviews
and authorizes the issuance of a
23 citation for immediate jeopardy or substandard quality of care
24 before the statement of deficiencies is made final. The review
25 shall be to assure that the applicable concepts, clinical process
26 guidelines, and other tools contained in subsections (25) to (27)
27 are being used consistently, accurately, and effectively. As used
1 in this subsection, "immediate jeopardy" and "substandard quality
2 of care" mean those terms as defined by the federal centers for
3 medicare and medicaid services.Centers for Medicare and Medicaid
4 Services.
5 (29) Upon availability of funds, the department shall give
6 grants, awards, or other recognition to nursing homes to
7 encourage the rapid implementation or maintenance of the clinical
8 process guidelines adopted under subsection (25).
9 (30) The department shall instruct and train the surveyors
10 in the clinical process guidelines adopted under subsection (25)
11 in citing deficiencies.
12 (31) A nursing home shall post the nursing home's survey
13 report in a conspicuous place within the nursing home for public
14 review.
15 (32) Nothing in this amendatory act shall be construed to
16 limit section limits the requirements of related state and
17 federal law.
18 (33) As used in this section:
19 (a) "Consecutive days" means calendar days, but does not
20 include Saturday, Sunday, or state- or federally-recognized
21 holidays.
22 (b) "Form CMS-2567" means the federal centers for
medicare
23 and medicaid services' Centers
for Medicare and Medicaid
24 Services' form for the statement of deficiencies and plan of
25 correction or a successor form serving the same purpose.
26 (c) "Title XVIII" means title XVIII of the social security
27 act, 42 USC 1395 to 1395kkk.
1 (d) "Title XIX" means title XIX of the social security act,
2 42 USC 1396 to 1396w-5.
3 Sec. 20161. (1) The department shall assess fees and other
4 assessments for health facility and agency licenses and
5 certificates of need on an annual basis as provided in this
6 article. Except Until
October 1, 2019, except as otherwise
7 provided in this article, fees and assessments shall be paid as
8 provided in the following schedule:
9 (a) Freestanding surgical
10 outpatient
facilities................$238.00 $500.00 per facility
11 license.
12
(b) Hospitals...................$8.28 $500.00 per facility
13 license and $10.00 per
14 licensed bed.
15 (c) Nursing homes, county
16 medical care facilities, and
17 hospital
long-term care units........$2.20 $500.00 per facility
18 license and $3.00 per
19 licensed bed over 100
20 licensed beds.
21 (d) Homes for the aged..........$6.27 per licensed bed.
22 (e) Clinical laboratories.......$475.00 per laboratory.
23 (e) Hospice agencies............$500.00 per agency license.
24
(f) Hospice residences..........$200.00 $500.00 per
25
facility survey; license
26
and $20.00 $5.00
per
27 licensed bed.
28 (g) Subject to subsection
1 (13), (11), quality assurance assessment
2 for nursing homes and hospital
3 long-term care units.................an amount resulting
4 in not more than 6%
5 of total industry
6 revenues.
7 (h) Subject to subsection
8 (14), (12), quality assurance assessment
9 for hospitals........................at a fixed or variable
10 rate that generates
11 funds not more than the
12 maximum allowable under
13 the federal matching
14 requirements, after
15 consideration for the
16 amounts in subsection
17
(14)(a) (12)(a) and (i).
18 (i) Initial licensure
19 application fee for subdivisions
20 (a), (b), (c), (e), and (f)..........$2,000.00 per initial
21 license.
22 (2) If a hospital requests the department to conduct a
23 certification survey for purposes of title XVIII or title XIX of
24 the social security act, the hospital shall pay a license fee
25 surcharge of $23.00 per bed. As used in this subsection, "title
26 XVIII" and "title XIX" mean those terms as defined in section
27 20155.
28 (3) All of the following apply to the assessment under this
1 section for certificates of need:
2 (a) The base fee for a certificate of need is $3,000.00 for
3 each application. For a project requiring a projected capital
4 expenditure of more than $500,000.00 but less than $4,000,000.00,
5 an additional fee of $5,000.00 is added to the base fee. For a
6 project requiring a projected capital expenditure of
7 $4,000,000.00 or more but less than $10,000,000.00, an additional
8 fee of $8,000.00 is added to the base fee. For a project
9 requiring a projected capital expenditure of $10,000,000.00 or
10 more, an additional fee of $12,000.00 is added to the base fee.
11 (b) In addition to the fees under subdivision (a), the
12 applicant shall pay $3,000.00 for any designated complex project
13 including a project scheduled for comparative review or for a
14 consolidated licensed health facility application for acquisition
15 or replacement.
16 (c) If required by the department, the applicant shall pay
17 $1,000.00 for a certificate of need application that receives
18 expedited processing at the request of the applicant.
19 (d) The department shall charge a fee of $500.00 to review
20 any letter of intent requesting or resulting in a waiver from
21 certificate of need review and any amendment request to an
22 approved certificate of need.
23 (e) A health facility or agency that offers certificate of
24 need covered clinical services shall pay $100.00 for each
25 certificate of need approved covered clinical service as part of
26 the certificate of need annual survey at the time of submission
27 of the survey data.
1 (f) The department of community health shall use the fees
2 collected under this subsection only to fund the certificate of
3 need program. Funds remaining in the certificate of need program
4 at the end of the fiscal year shall not lapse to the general fund
5 but shall remain available to fund the certificate of need
6 program in subsequent years.
7 (4) If licensure is for more than 1 year, the fees described
8 in subsection (1) are multiplied by the number of years for which
9 the license is issued, and the total amount of the fees shall be
10 collected in the year in which the license is issued.A license
11 issued under this part is effective for no longer than 1 year
12 after the date of issuance.
13 (5) Fees described in this section are payable to the
14 department at the time an application for a license, permit, or
15 certificate is submitted. If an application for a license,
16 permit, or certificate is denied or if a license, permit, or
17 certificate is revoked before its expiration date, the department
18 shall not refund fees paid to the department.
19 (6) The fee for a provisional license or temporary permit is
20 the same as for a license. A license may be issued at the
21 expiration date of a temporary permit without an additional fee
22 for the balance of the period for which the fee was paid if the
23 requirements for licensure are met.
24 (7) The department may charge a fee to recover the cost of
25 purchase or production and distribution of proficiency evaluation
26 samples that are supplied to clinical laboratories under section
27 20521(3).
1 (8) In addition to the fees imposed under subsection (1), a
2 clinical laboratory shall submit a fee of $25.00 to the
3 department for each reissuance during the licensure period of the
4 clinical laboratory's license.
5 (7) (9) The
cost of licensure activities shall be supported
6 by license fees.
7 (8) (10) The
application fee for a waiver under section
8 21564 is $200.00 plus $40.00 per hour for the professional
9 services and travel expenses directly related to processing the
10 application. The travel expenses shall be calculated in
11 accordance with the state standardized travel regulations of the
12 department of technology, management, and budget in effect at the
13 time of the travel.
14 (9) (11) An
applicant for licensure or renewal of licensure
15 under part 209 shall pay the applicable fees set forth in part
16 209.
17 (10) (12) Except
as otherwise provided in this section, the
18 fees and assessments collected under this section shall be
19 deposited in the state treasury, to the credit of the general
20 fund. The department may use the unreserved fund balance in fees
21 and assessments for the criminal history check program required
22 under this article.
23 (11) (13) The
quality assurance assessment collected under
24 subsection (1)(g) and all federal matching funds attributed to
25 that assessment shall be used only for the following purposes and
26 under the following specific circumstances:
27 (a) The quality assurance assessment and all federal
1 matching funds attributed to that assessment shall be used to
2 finance medicaid Medicaid
nursing home reimbursement payments.
3 Only licensed nursing homes and hospital long-term care units
4 that are assessed the quality assurance assessment and
5 participate in the medicaid Medicaid program are
eligible for
6 increased per diem medicaid Medicaid reimbursement rates
under
7 this subdivision. A nursing home or long-term care unit that is
8 assessed the quality assurance assessment and that does not pay
9 the assessment required under subsection (1)(g) in accordance
10 with subdivision (c)(i) or in accordance with a written payment
11 agreement with the state shall not receive the increased per diem
12 medicaid Medicaid reimbursement rates under this subdivision
13 until all of its outstanding quality assurance assessments and
14 any penalties assessed pursuant to under subdivision
(f) have
15 been paid in full. Nothing in this This subdivision
shall be
16 construed to does not
authorize or require the department to
17 overspend tax revenue in violation of the management and budget
18 act, 1984 PA 431, MCL 18.1101 to 18.1594.
19 (b) Except as otherwise provided under subdivision (c),
20 beginning October 1, 2005, the quality assurance assessment is
21 based on the total number of patient days of care each nursing
22 home and hospital long-term care unit provided to nonmedicare
23 non-Medicare patients within the immediately preceding year and
24 shall be assessed at a uniform rate on October 1, 2005 and
25 subsequently on October 1 of each following year, and is payable
26 on a quarterly basis, the first payment due 90 days after the
27 date the assessment is assessed.
1 (c) Within 30 days after September 30, 2005, the department
2 shall submit an application to the federal centers for medicare
3 and medicaid services Centers
for Medicare and Medicaid Services
4 to request a waiver pursuant according to 42 CFR
433.68(e) to
5 implement this subdivision as follows:
6 (i) If the waiver is approved, the quality assurance
7 assessment rate for a nursing home or hospital long-term care
8 unit with less than 40 licensed beds or with the maximum number,
9 or more than the maximum number, of licensed beds necessary to
10 secure federal approval of the application is $2.00 per
11 nonmedicare non-Medicare
patient day of care provided within the
12 immediately preceding year or a rate as otherwise altered on the
13 application for the waiver to obtain federal approval. If the
14 waiver is approved, for all other nursing homes and long-term
15 care units the quality assurance assessment rate is to be
16 calculated by dividing the total statewide maximum allowable
17 assessment permitted under subsection (1)(g) less the total
18 amount to be paid by the nursing homes and long-term care units
19 with less than 40 or with the maximum number, or more than the
20 maximum number, of licensed beds necessary to secure federal
21 approval of the application by the total number of nonmedicare
22 non-Medicare patient days of care provided within the immediately
23 preceding year by those nursing homes and long-term care units
24 with more than 39, but less than the maximum number of licensed
25 beds necessary to secure federal approval. The quality assurance
26 assessment, as provided under this subparagraph, shall be
27 assessed in the first quarter after federal approval of the
1 waiver and shall be subsequently assessed on October 1 of each
2 following year, and is payable on a quarterly basis, the first
3 payment due 90 days after the date the assessment is assessed.
4 (ii) If the waiver is approved, continuing care retirement
5 centers are exempt from the quality assurance assessment if the
6 continuing care retirement center requires each center resident
7 to provide an initial life interest payment of $150,000.00, on
8 average, per resident to ensure payment for that resident's
9 residency and services and the continuing care retirement center
10 utilizes all of the initial life interest payment before the
11 resident becomes eligible for medical assistance under the
12 state's medicaid Medicaid
plan. As used in this subparagraph,
13 "continuing care retirement center" means a nursing care facility
14 that provides independent living services, assisted living
15 services, and nursing care and medical treatment services, in a
16 campus-like setting that has shared facilities or common areas,
17 or both.
18 (d) Beginning May 10, 2002, the department of community
19 health shall increase the
per diem nursing home medicaid Medicaid
20 reimbursement rates for the balance of that year. For each
21 subsequent year in which the quality assurance assessment is
22 assessed and collected, the department of community health shall
23 maintain the medicaid Medicaid
nursing home reimbursement payment
24 increase financed by the quality assurance assessment.
25 (e) The department of community health shall implement
this
26 section in a manner that complies with federal requirements
27 necessary to assure ensure
that the quality assurance assessment
1 qualifies for federal matching funds.
2 (f) If a nursing home or a hospital long-term care unit
3 fails to pay the assessment required by subsection (1)(g), the
4 department of community health may assess the nursing home or
5 hospital long-term care unit a penalty of 5% of the assessment
6 for each month that the assessment and penalty are not paid up to
7 a maximum of 50% of the assessment. The department of community
8 health may also refer for
collection to the department of
9 treasury past due amounts consistent with section 13 of 1941 PA
10 122, MCL 205.13.
11 (g) The medicaid Medicaid
nursing home quality assurance
12 assessment fund is established in the state treasury. The
13 department of community health shall deposit the revenue raised
14 through the quality assurance assessment with the state treasurer
15 for deposit in the medicaid Medicaid nursing home
quality
16 assurance assessment fund.
17 (h) The department of community health shall not implement
18 this subsection in a manner that conflicts with 42 USC 1396b(w).
19 (i) The quality assurance assessment collected under
20 subsection (1)(g) shall be prorated on a quarterly basis for any
21 licensed beds added to or subtracted from a nursing home or
22 hospital long-term care unit since the immediately preceding July
23 1. Any adjustments in payments are due on the next quarterly
24 installment due date.
25 (j) In each fiscal year governed by this subsection,
26 medicaid Medicaid reimbursement rates shall not be reduced below
27 the medicaid Medicaid
reimbursement rates in effect on April
1,
1 2002 as a direct result of the quality assurance assessment
2 collected under subsection (1)(g).
3 (k) The state retention amount of the quality assurance
4 assessment collected pursuant to under subsection (1)(g)
shall be
5 equal to 13.2% of the federal funds generated by the nursing
6 homes and hospital long-term care units quality assurance
7 assessment, including the state retention amount. The state
8 retention amount shall be appropriated each fiscal year to the
9 department of community health to support medicaid Medicaid
10 expenditures for long-term care services. These funds shall
11 offset an identical amount of general fund/general purpose
12 revenue originally appropriated for that purpose.
13 (l) Beginning October 1, 2015,
2019, the department shall no
14 longer assess or collect the quality assurance assessment or
15 apply for federal matching funds. The quality assurance
16 assessment collected under subsection (1)(g) shall no longer be
17 assessed or collected after September 30, 2011, in the event that
18 the quality assurance assessment is not eligible for federal
19 matching funds. Any portion of the quality assurance assessment
20 collected from a nursing home or hospital long-term care unit
21 that is not eligible for federal matching funds shall be returned
22 to the nursing home or hospital long-term care unit.
23 (12) (14) The
quality assurance dedication is an earmarked
24 assessment collected under subsection (1)(h). That assessment and
25 all federal matching funds attributed to that assessment shall be
26 used only for the following purpose and under the following
27 specific circumstances:
1 (a) To maintain the increased medicaid Medicaid
2 reimbursement rate increases as provided for in subdivision (c).
3 (b) The quality assurance assessment shall be assessed on
4 all net patient revenue, before deduction of expenses, less
5 medicare Medicare net revenue, as reported in the most recently
6 available medicare Medicare
cost report and is payable on a
7 quarterly basis, the first payment due 90 days after the date the
8 assessment is assessed. As used in this subdivision, "medicare
9
"Medicare net revenue"
includes medicare Medicare
payments and
10 amounts collected for coinsurance and deductibles.
11 (c) Beginning October 1, 2002, the department of community
12 health shall increase the
hospital medicaid Medicaid
13 reimbursement rates for the balance of that year. For each
14 subsequent year in which the quality assurance assessment is
15 assessed and collected, the department of community health shall
16 maintain the hospital medicaid Medicaid reimbursement rate
17 increase financed by the quality assurance assessments.
18 (d) The department of community health shall implement
this
19 section in a manner that complies with federal requirements
20 necessary to assure ensure
that the quality assurance assessment
21 qualifies for federal matching funds.
22 (e) If a hospital fails to pay the assessment required by
23 subsection (1)(h), the department of community health may assess
24 the hospital a penalty of 5% of the assessment for each month
25 that the assessment and penalty are not paid up to a maximum of
26 50% of the assessment. The department of community health may
27 also refer for collection to the department of treasury past due
House Bill No. 4447 as amended May 27, 2015
1 amounts consistent with section 13 of 1941 PA 122, MCL 205.13.
2 (f) The hospital quality assurance assessment fund is
3 established in the state treasury. The department of community
4 health shall deposit the
revenue raised through the quality
5 assurance assessment with the state treasurer for deposit in the
6 hospital quality assurance assessment fund.
7 (g) In each fiscal year governed by this subsection, the
8 quality assurance assessment shall only be collected and expended
9 if medicaid Medicaid
hospital inpatient DRG and outpatient
10 reimbursement rates and disproportionate share hospital and
11 graduate medical education payments are not below the level of
12 rates and payments in effect on April 1, 2002 as a direct result
13 of the quality assurance assessment collected under subsection
14 (1)(h), except as provided in subdivision (h).
15 (h) The quality assurance assessment collected under
16 subsection (1)(h) shall no longer be assessed or collected after
17 September 30, 2011 in the event that the quality assurance
18 assessment is not eligible for federal matching funds. Any
19 portion of the quality assurance assessment collected from a
20 hospital that is not eligible for federal matching funds shall be
21 returned to the hospital.
22 (i) The state retention amount of the quality assurance
23 assessment collected pursuant to under subsection (1)(h)
shall be
24 equal to 13.2% of the federal funds generated by the hospital
25 quality assurance assessment, including the state retention
26 amount. [In the fiscal year ending September 30, 2016, there is a 1-time
additional retention amount of up to $92,856,100.00.] The state retention
percentage shall be applied
27 proportionately to each hospital quality assurance assessment
House Bill No. 4447 as amended May 27, 2015
1 program to determine the retention amount for each program. The
2 state retention amount shall be appropriated each fiscal year to
3 the department of community health to support medicaid Medicaid
4 expenditures for hospital services and therapy. These funds shall
5 offset an identical amount of general fund/general purpose
6 revenue originally appropriated for that purpose.
[(13) The department may establish a quality assurance assessment to increase ambulance reimbursement as follows:
(a) The quality assurance assessment authorized under this subsection shall be used to provide reimbursement to Medicaid ambulance providers. The department may promulgate rules to provide the structure of the quality assurance assessment authorized under this subsection and the level of the assessment.
(b) The department shall implement this subsection in a manner that complies with federal requirements necessary to ensure that the quality assurance assessment qualifies for federal matching funds.
(c) The total annual collections by the department under this subsection shall not exceed $6,000,000.00.
(d) The quality assurance assessment authorized under this subsection shall not be collected after October 1, 2018. The quality assurance assessment authorized under this subsection shall no longer be collected or assessed if the quality assurance assessment authorized under this subsection is not eligible for federal matching funds.]
7 (14)] (15)
The quality assurance assessment
provided for
8 under this section is a tax that is levied on a health facility
9 or agency.
10 (15)] (16)
As used in this section, "medicaid"
"Medicaid"
11 means that term as defined in section 22207.
12 Sec. 20501. (1) As used in this part, :
"laboratory" means
a
13 facility for the biological, microbiological, serological,
14 chemical, immunohematological, hematological, biophysical,
15 cytological, pathological, or other examination of materials
16 derived from the human body for the purpose of providing
17 information for the diagnosis, prevention, or treatment of any
18 disease or impairment of, or the assessment of the health of,
19 human beings.
20 (a) "Laboratory director" means the individual
responsible
21 for administration of the technical and scientific operation of a
22 clinical laboratory, including the supervision of procedures and
23 reporting of findings.
24 (b) "Owner" means a person who owns and controls a
clinical
25 laboratory.
26 (2) In addition, article 1 contains general definitions and
27 principles of construction applicable to all articles in this
1 code. and part 201 contains definitions applicable to
this part.
2 Sec. 20521. (1) The owner, laboratory director, and
3 governing body of a clinical laboratory are responsible for the
4 operation of the clinical laboratory.
5 (2) The laboratory director is responsible for the making
6 and keeping of an accurate record for each specimen examined and
7 procedure followed.
8 (3) A clinical laboratory shall analyze test samples
9 submitted by the department and report to the department on the
10 results of the analyses, except that proficiency evaluation
11 programs of recognized professional organizations may be
12 acceptable to the department in lieu thereof. The analyses and
13 reports may be considered by the department in taking action
14 under section 20165 or 20525.Only a physician, dentist, or other
15 person authorized by law can order a laboratory test that has
16 been classified by the Food and Drug Administration as moderate
17 or high complexity. A laboratory test that is classified by the
18 Food and Drug Administration as waived does not require an order.
19 Sec. 20551. (1) A laboratory or other place where live
20 bacteria, fungi, mycoplasma, parasites, viruses, or other
21 microorganisms of a pathogenic nature are handled, cultivated,
22 sold, given away, or shipped from or to or where recombinant
23 deoxyribonucleic acid research is done shall be registered with
24 the department, and a registration number shall be issued to each
25 place registered. An application for a registration number shall
26 be made by the person in charge of the laboratory or other place
27 where the pathogens are handled or where recombinant
House Bill No. 4447 as amended May 27, 2015
1 deoxyribonucleic acid research is done. The registration number
2 is valid for 1 year and may be renewed upon application to the
3 department.
4 (2) A clinical laboratory licensed in microbiology under
5 sections 20501 to 20525 is registered for purposes of this
6 section and section 20552, and its license number shall be used
7 as its registration number.
8 (2) (3) As
used in sections 20551 this
section and section
9 20552, "handled", "cultivated", or "shipped" does not include the
10 collection of specimens, the initial inoculation of specimens
11 into transport media or culture media, or the shipment to
12 registered laboratories, but does include any additional work
13 performed on cultivated pathogenic microorganisms or any
14 recombinant deoxyribonucleic acid research is done.
15 Enacting section 1. Sections 20511, 20515, and 20525 of the
16 public health code, 1978 PA 368, MCL 333.20511, 333.20515, and
17 333.20525, are repealed.
18 [Enacting section 2. This amendatory act takes effect October 1,
19 2015. ]