August 21, 2007, Introduced by Reps. Wojno, Accavitti, Gaffney, Valentine, Amos, Lemmons, Hammon, Polidori and Dean and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
(MCL 333.1101 to 333.25211) by adding section 16351 and part
187A.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
1 Sec. 16351. Fees for a person licensed or seeking licensure
2 as a medical laboratory scientist, associate medical laboratory
3 assistant, or medical laboratory assistant under part 187A are as
4 follows:
5 (a) Application processing fee.................... $ 25.00
6 (b) License fee, per year:
7 (i) Medical laboratory assistant.................. $ 25.00
8 (ii) Associate medical laboratory scientist........ $ 75.00
1 (iii) Medical laboratory scientist.................. $ 75.00
2 (c) Temporary license............................. $ 15.00
3 (d) Limited license, per year.................... $ 25.00
4 PART 187A. LABORATORY TESTING PERSONNEL
5 Sec. 18751. (1) As used in this part:
6 (a) "Accredited educational program" means a program that
7 provides instruction and experience in laboratory testing and
8 that has been approved or accredited by an accrediting agency
9 recognized by the council for higher education accreditation or
10 the United States department of education.
11 (b) "Associate medical laboratory scientist" means an
12 individual who is licensed under this article to engage in the
13 practice of laboratory testing at the associate medical
14 laboratory scientist level.
15 (c) "Client" means the individual upon whose body, body
16 fluid, or body part a laboratory test is performed.
17 (d) "Laboratory" means the site at which a laboratory test
18 is performed.
19 (e) "Laboratory director" means an individual who is
20 qualified under 42 CFR 493, subpart M, to manage and direct the
21 technical and scientific operation of a clinical laboratory,
22 including the supervision of laboratory personnel, procedures,
23 and reporting of findings. If the qualifications for a laboratory
24 director under 42 CFR 493, subpart M, are amended after the
25 effective date of the amendatory act that added this part, the
26 director of the department of community health, in cooperation
27 with the board, shall determine whether those changes are
1 congruent with this part and should apply to this section and, if
2 so, may adopt those changes by rule.
3 (f) "Laboratory test" means a biological, microbiological,
4 serological, chemical, immunohematological, hematological,
5 radiometric, cytological, biophysical, immunological,
6 histological, genetic, or other clinical or anatomic pathological
7 examination or procedure that is performed on material derived
8 from or existing in a human body that provides information for
9 the diagnosis, prevention, monitoring, or treatment of a disease
10 or impairment or assessment of a medical condition or
11 predisposition. Laboratory test does not include a waived test,
12 in vivo diagnostic imaging, noninvasive vascular diagnostic
13 studies, or the collection, handling, and preparation of a body
14 fluid or microbiology culture specimen used for a laboratory
15 test, or a test the results of which are used solely for
16 evidentiary purposes in a civil or criminal proceeding.
17 (g) "Medical laboratory assistant" means an individual who
18 is licensed under this article to engage in the practice of
19 laboratory testing at the medical laboratory assistant level.
20 (h) "Medical laboratory scientist" means an individual who
21 is licensed under this article to engage in the practice of
22 laboratory testing at the medical laboratory scientist level.
23 (i) "Perfusionist" means an individual who operates
24 extracorporeal circulation equipment for a patient whose medical
25 condition requires the support or temporary replacement of the
26 patient's cardiopulmonary-circulatory function and who satisfies
27 1 of the following:
1 (i) Has graduated from a perfusion training program approved
2 by the department and accredited by the commission on
3 accreditation of allied health education programs or its
4 successor organization and has successfully completed the
5 examination developed by the American board of cardiovascular
6 perfusion or its successor and approved by the department.
7 (ii) Has performed a minimum of 40 perfusion cases per year
8 during the 2 years immediately preceding the effective date of
9 this part.
10 (iii) Has graduated from a perfusion training program approved
11 by the department and accredited by the commission on
12 accreditation of allied health education programs or its
13 successor organization and, before successfully completing the
14 examination developed by the American board of cardiovascular
15 perfusion or its successor and approved by the department, is
16 supervised by a perfusionist who meets the requirements of either
17 subparagraph (i) or (ii).
18 (j) "Point-of-care testing" means a laboratory test
19 performed in a hospital or a freestanding surgical outpatient
20 facility licensed under article 17 that is performed on and near
21 the patient to reduce testing time or time to treatment, but does
22 not include a laboratory test performed in a laboratory described
23 in section 20507(a), (b), or (c).
24 (k) "Practice of laboratory testing at the medical
25 laboratory assistant level" means 1 or more of the following:
26 (i) Performing a laboratory test pursuant to established
27 protocols.
1 (ii) Comparing patient data to reference ranges established
2 or approved by the laboratory director or a medical laboratory
3 scientist.
4 (iii) Applying arithmetic or algebraic calculations according
5 to protocols.
6 (iv) Performing automated tests in a manner requiring
7 complete reliance on laboratory instruments for calibrations,
8 calculations, and analyses.
9 (l) "Practice of laboratory testing at the associate medical
10 laboratory scientist level" means the practice of laboratory
11 testing at the medical laboratory assistant level and any of the
12 following:
13 (i) Performing a laboratory test pursuant to criteria
14 established or approved by the laboratory director or a medical
15 laboratory scientist.
16 (ii) Evaluating data pursuant to criteria established or
17 approved by the laboratory director or a medical laboratory
18 scientist.
19 (iii) Arithmetical, mathematical, or statistical manipulation
20 of numbers according to protocol.
21 (iv) Identifying a direct cause of improper test performance
22 and correcting that cause according to strategies established by
23 the laboratory director or a medical laboratory scientist.
24 (m) "Practice of laboratory testing at the medical
25 laboratory scientist level" means the practice of laboratory
26 testing at the medical laboratory assistant level, the practice
27 of laboratory testing at the associate medical laboratory
1 scientist level, and any of the following:
2 (i) Decision making that employs advanced knowledge of
3 pathophysiology, cytopathology laboratory methods, or laboratory
4 instrumentation, and that does not employ predetermined criteria.
5 (ii) Establishing criteria for decision making in laboratory
6 testing.
7 (iii) Validating laboratory test data.
8 (iv) Establishing procedures for reporting results.
9 (v) Selecting appropriate calculation methods in the absence
10 of established guidelines.
11 (vi) Without preset strategies, identifying causes of
12 improper test performance and determining alternative means of
13 obtaining correct test performance or solutions to problems
14 created by incorrect test performance.
15 (n) "Protocol" means information prepared or approved by the
16 laboratory director or a medical laboratory scientist that
17 provides a step-by-step description of the manner in which a
18 laboratory test is to be performed.
19 (o) "Waived test" means a laboratory examination or
20 procedure that meets the criteria established under the
21 provisions of 42 CFR 493 and is approved by the board. If the
22 criteria and designation of waived tests under 42 CFR 493 are
23 amended after the effective date of the amendatory act that added
24 this part, the director of the department of community health, in
25 cooperation with the board, shall determine whether those changes
26 are congruent with this part and should apply to this section
27 and, if so, may adopt those changes by rule.
1 (2) In addition to the definitions in this part, article 1
2 contains general definitions and principles of construction
3 applicable to all articles in this code and part 161 contains
4 definitions applicable to this part.
5 Sec. 18753. (1) Beginning 1 year after the effective date of
6 this part, a person shall not engage in laboratory testing at the
7 medical laboratory scientist, associate medical laboratory
8 scientist, or medical laboratory assistant level or use the
9 titles "medical laboratory scientist", "associate medical
10 laboratory scientist", "medical laboratory assistant", "M.L.S.",
11 "A.M.L.S.", and "M.L.A.", or similar words that indicate that the
12 individual is a laboratory scientist or assistant unless that
13 person is licensed or otherwise authorized by this article.
14 (2) A licensee shall not perform any acts, tasks, or
15 functions included within his or her respective level of practice
16 unless he or she is trained to perform such acts, tests, or
17 functions.
18 Sec. 18755. (1) The department may grant a limited license
19 to an individual to practice laboratory testing at the medical
20 laboratory scientist, associate medical laboratory scientist, or
21 medical laboratory assistant level. A limited license to practice
22 laboratory testing at any level under this part shall require
23 that the individual has successfully completed the educational
24 requirements required under section 18761 for that level. An
25 individual who holds a limited license under this section shall
26 provide a laboratory test service only under the supervision of
27 an individual licensed, at an equivalent level or higher, or an
1 individual who is licensed as a physician under part 170 or 175.
2 (2) A limited license to practice laboratory testing at the
3 medical laboratory scientist or associate medical laboratory
4 scientist level issued under this section is effective for not
5 more than 4 years from the date of issuance. A limited license to
6 practice laboratory testing at the medical laboratory assistant
7 level issued under this section is effective for not more than 2
8 years from the date of issuance.
9 (3) In addition to the grounds for discipline and sanctions
10 prescribed under sections 16221 and 16226, the board shall review
11 the supervision of an individual licensed under this section at
12 least once annually and may recommend to the department the
13 revocation or suspension of a limited license if the board
14 determines that the individual to whom that limited license is
15 issued lacks adequate supervision.
16 Sec. 18757. This part does not apply to the following:
17 (a) An individual who is enrolled in an accredited
18 educational program, if the laboratory testing performed by that
19 individual is part of a course of study within the accredited
20 educational program.
21 (b) An individual engaged in teaching or research, if the
22 results of each laboratory test performed by that individual are
23 not used in diagnosis, prevention, monitoring, or treatment of a
24 disease or impairment or assessment of a medical condition or
25 predisposition.
26 (c) A licensed or statutorily recognized member of any other
27 profession who practices his or her profession as authorized by
1 law, if that individual does not hold himself or herself out to
2 the public as a medical laboratory scientist, associate medical
3 laboratory scientist, or medical laboratory assistant licensed
4 under this article.
5 (d) An individual performing point-of-care testing if both
6 of the following requirements are met:
7 (i) The facility in which the point-of-care testing is
8 performed is under the direction of a medical laboratory
9 scientist who is responsible for all of the following:
10 (A) Designing and providing or supervising the training
11 programs for individuals who perform point-of-care testing in the
12 hospital or freestanding surgical outpatient facility.
13 (B) Supervising and monitoring the quality assurance and
14 quality control activities of the laboratory.
15 (C) Assisting in the selection of technology for the point-
16 of-care testing.
17 (D) Monitoring the continued competency of individuals
18 performing point-of-care testing.
19 (E) Reviewing the results of proficiency testing of
20 individuals performing point-of-care testing and recommending
21 corrective action, if necessary.
22 (ii) The facility in which the point-of-care testing is
23 performed has procedures that ensure and document the continued
24 competency of individuals who perform point-of-care testing and
25 that are approved by the board.
26 (e) A perfusionist performing laboratory testing for
27 extracorporeal functions including, but not limited to, those
1 functions necessary for the support, treatment, measurement, or
2 supplementation of the cardiopulmonary or circulatory system of a
3 patient, as long as he or she is trained to perform that act,
4 task, or function.
5 (f) An individual who performs laboratory testing as
6 described in subdivision (e) while engaged in the practice of
7 perfusion as a student in a perfusion training program approved
8 by the department and accredited by the commission on
9 accreditation of allied health education programs or its
10 successor organization, if during the performance of laboratory
11 testing the individual is under the direct physical supervision
12 of a perfusionist who meets the requirements of section
13 18751(i)(i) or (ii).
14 (g) A respiratory care practitioner licensed under this
15 article who performs laboratory testing while engaged in the
16 practice of respiratory care.
17 (h) An individual who only performs waived tests.
18 Sec. 18759. (1) The Michigan board of laboratory testing is
19 created within the department. The board shall comply with part
20 161 and shall consist of the following 7 members:
21 (a) Five members who are licensed under this part.
22 (b) Two public members.
23 (2) The board members appointed under subsection (1)(a)
24 shall have among them anatomical and clinical pathological
25 testing experience and shall meet the requirements of section
26 16135(2).
27 (3) The terms of office of individual members of the board
1 created under this part, except those appointed to fill
2 vacancies, expire 4 years after appointment on December 31 of the
3 year in which the term expires.
4 (4) The board shall submit rules to implement this part for
5 public hearing pursuant to the administrative procedures act of
6 1969 within 180 days after the effective date of this part.
7 Sec. 18761. (1) Except as otherwise provided under section
8 18763, the department shall require an individual seeking
9 licensure under this part to meet the respective requirements
10 before the department decides to issue a license under this part:
11 (a) To engage in the practice of laboratory testing at the
12 medical laboratory assistant level to an individual who the board
13 determines has sufficient knowledge essential to the safe and
14 competent practice of his or her profession and who has
15 successfully completed high school or its equivalent and either
16 of the following:
17 (i) An accredited educational program approved by the board
18 including, but not limited to, programs at the medical laboratory
19 assistant level or at an equivalent level that is approved by the
20 board.
21 (ii) One year of full-time laboratory experience within the
22 3-year period immediately preceding the date of application in a
23 laboratory activity approved by the board and under the
24 supervision of a medical laboratory scientist, an associate
25 medical laboratory scientist, a medical laboratory assistant, or
26 an individual who is licensed as a physician under part 170 or
27 175.
1 (b) To engage in the practice of laboratory testing at the
2 associate medical laboratory scientist level to an individual who
3 the board determines has sufficient knowledge essential to the
4 safe and competent practice of his or her profession and who has
5 successfully completed or attained an associate's degree from an
6 accredited college or university approved by the board, including
7 course work approved by the board, and 1 or more of the
8 following:
9 (i) An accredited educational program approved by the board,
10 including, but not limited to, programs at the associate medical
11 laboratory scientist level.
12 (ii) Two years of full-time laboratory experience attained
13 within the 3 years immediately preceding the date of application
14 in a laboratory activity approved by the board and under the
15 supervision of a medical laboratory scientist, an associate
16 medical laboratory scientist, or an individual who is licensed as
17 a physician under part 170 or 175.
18 (c) To engage in the practice of laboratory testing at the
19 medical laboratory scientist level to an individual who the board
20 determines has sufficient knowledge essential to the safe and
21 competent practice of his or her profession and who has
22 successfully completed or attained a baccalaureate degree from an
23 accredited college or university approved by the board, including
24 course work approved by the board, and 1 or more of the
25 following:
26 (i) An accredited educational program approved by the board
27 including, but not limited to, programs at the medical laboratory
1 scientist level.
2 (ii) Two years of full-time laboratory experience attained
3 within the 4-year period immediately preceding the date of
4 application in a laboratory activity approved by the board and
5 under the supervision of a medical laboratory scientist or an
6 individual who is licensed as a physician under part 170 or 175.
7 (2) The department may accept a person's certification by a
8 national organization approved by the board as evidence that the
9 person has sufficient knowledge essential to the safe and
10 competent practice of his or her profession. The board shall not
11 accept certification of a person as described in this subsection
12 unless the certifying national organization requires successful
13 passage of a competency based examination validated by that
14 organization.
15 Sec. 18763. (1) Notwithstanding section 18761, the
16 department shall issue a license at the appropriate level to a
17 person who applies for licensure at that level within 1 year
18 after the effective date of this part if that person satisfies
19 either of the following:
20 (a) Is trained in laboratory testing at the level for which
21 he or she is seeking licensure and is certified by a national
22 certifying agency approved by the board.
23 (b) Has engaged in the practice of laboratory testing in a
24 laboratory at the level for which he or she is seeking licensure
25 on a consistent basis during the 2 years immediately preceding
26 his or her application for licensure.
27 (2) The department shall require each individual who applies
1 for renewal of a license granted under this section to meet
2 applicable continuing education requirements of section 18765.
3 Sec. 18765. (1) In addition to the requirements of part 161,
4 the department shall require a medical laboratory scientist or
5 associate medical laboratory scientist seeking renewal of a
6 license to furnish evidence of either of the following:
7 (a) The licensee's successful completion, during the 3 years
8 immediately preceding application for renewal, of at least 30
9 clock hours of continuing education courses, clinics, lectures,
10 training programs, seminars, or other programs related to
11 laboratory testing that are approved by the board.
12 (b) Proof of recertification by a national certification
13 agency approved by the board.
14 (2) The department shall require a medical laboratory
15 assistant seeking renewal of a license to furnish evidence of
16 either of the following:
17 (a) That person's successful completion, during the 3 years
18 immediately preceding application for renewal, of at least 10
19 clock hours of continuing education courses, clinics, lectures,
20 training programs, seminars, or other programs approved by the
21 board.
22 (b) Proof of recertification by a national certifying agency
23 approved by the board.
24 Sec. 18767. A license issued under this part is effective
25 for 3 years.
26 Sec. 18771. A communication between a licensee and a client
27 and a client's laboratory test results are confidential and shall
1 not be disclosed to a third party by the licensee without the
2 consent of the client or except as otherwise provided by law. For
3 purposes of this section, "third party" does not include a health
4 care professional licensed under this article who requested the
5 laboratory test on behalf of the client, a health care carrier,
6 or a third party payer.
7 Sec. 18773. This part does not require new or additional
8 third party reimbursement or mandated worker's compensation
9 benefits for services rendered by an individual licensed under
10 this part.