SECOND REGULAR SESSION
93RD GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVE WASSON.
Read 1st time March 28, 2006 and copies ordered printed.
STEPHEN S. DAVIS, Chief Clerk
AN ACT
To amend chapter 324, RSMo, by adding thereto ten new sections relating to licensure of clinical laboratory science personnel, with penalty provisions.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Chapter 324, RSMo, is amended by adding thereto ten new sections, to be known as sections 324.1200, 324.1203, 324.1206, 324.1209, 324.1212, 324.1215, 324.1218, 324.1221, 324.1224, and 324.1227, to read as follows:
324.1200. Sections 324.1200 to 324.1227 shall be known and may be cited as the "Clinical Laboratory Science Practice Act".
324.1203. As used in sections 324.1200 to 324.1227, the following terms, unless otherwise indicated within the context, mean:
(1) "Approved certification examination", a competency based certification examination administered by an approved credentialing agency;
(2) "Approved credentialing agency", a national nonprofit credentialing agency approved by the board;
(3) "Board", the Missouri clinical laboratory science board;
(4) "Categorical clinical laboratory science supervisor", also known as a "categorical medical technologist", a person who supervises clinical laboratory science personnel in a specific category. A categorical clinical laboratory science supervisor shall also be licensed as a categorical clinical laboratory scientist in the same category as the personnel that he or she supervises;
(5) "Categorical clinical laboratory scientist", also known as a "categorical medical technologist", a person who is responsible for the performance, interpretation, and reporting of clinical laboratory testing in one or more categories, such as microbiology, clinical chemistry, immunology, hematology, immunohematology, molecular diagnostics, or other areas specified by the board. The categorical clinical laboratory scientist is responsible for the establishment and implementation of protocols, quality assurance, method selection and implementation, equipment selection and maintenance, and all activities related to the pre-analytical, analytical and post-analytical phases of testing in their specialty area. A categorical clinical laboratory scientist may perform all levels of testing within their categorical specialty, and may perform phlebotomy, if so qualified;
(6) "Clinical laboratory" or "laboratory", any site or location in which clinical laboratory tests or examinations are performed;
(7) "Clinical laboratory director", also known as a "diplomat in laboratory management", a person who is responsible for the technical and scientific oversight and the overall management and administration of the clinical laboratory, including the employment of personnel who are competent to collect laboratory specimens, perform test procedures, and record and report tests results promptly, accurately, and proficiently. A clinical laboratory director shall also be licensed as a clinical laboratory scientist;
(8) "Clinical laboratory science assistant", a person who is responsible for performing level 1 testing with oversight of a clinical laboratory scientist, categorical clinical laboratory scientist, clinical laboratory science consultant, clinical laboratory science director, medical laboratory director, or a state licensed physician;
(9) "Clinical laboratory science consultant", also known as a "medical laboratory consultant", a person who is an expert in the technical and scientific aspects of the laboratory and functions independently in providing laboratory related guidance to health care facilities. A clinical laboratory science consultant shall also be licensed as a clinical laboratory scientist, or if providing consulting services in only one specialty of clinical laboratory science, shall be licensed in that specialty as a categorical clinical laboratory scientist;
(10) "Clinical laboratory science educator", a person who is a faculty member of a college, university, or hospital-based educational program and provides instruction in a clinical laboratory science program approved by an accrediting agency as approved by rule by the board;
(11) "Clinical laboratory science practitioner", a clinical laboratory science director, clinical laboratory science consultant, clinical laboratory science supervisor, clinical laboratory scientist, categorical clinical laboratory science supervisor, categorical clinical laboratory scientist, clinical laboratory science technician, or clinical laboratory science assistant who performs or is responsible for clinical laboratory test procedures. The term does not include trainees, persons who perform donor screening for blood banks or plasmapheresis centers, or other persons employed by a clinical laboratory to perform clerical, personnel, or other administrative duties;
(12) "Clinical laboratory science supervisor", also known as a "medical technologist supervisor", a person who supervises clinical laboratory science personnel. A clinical laboratory science supervisor shall also be licensed as a clinical laboratory scientist;
(13) "Clinical laboratory science technician", also known as a "medical laboratory technician", a person who is responsible for the performance and reporting of clinical laboratory tests of all levels, under established and approved protocols which require limited exercise of independent judgment and that are performed with oversight of a clinical laboratory science supervisor, categorical clinical laboratory science supervisor in their specialty of license, clinical laboratory science consultant, clinical laboratory science director, medical laboratory director, or state licensed physician;
(14) "Clinical laboratory scientist", also known as a "medical technologist", a person who is responsible for the performance, interpretation, and reporting of clinical laboratory tests, including those that require the exercise of independent judgment. In addition, this person is responsible for the establishment and implementation of protocols, quality assurance, method selection and implementation, equipment selection and maintenance, and all activities related to the pre-analytical, analytical, and post-analytical phases of testing. A clinical laboratory scientist may perform all levels of testing and may perform phlebotomy, if so qualified;
(15) "Clinical laboratory test" or "laboratory test", a microbiological, serological, molecular, chemical, biological, hematological, immunological, immunohematological, biophysical, or any other test or procedure performed on material derived from or present within a human body which provides information for the diagnosis, treatment, health maintenance, or prevention of disease. Clinical laboratory testing encompasses the pre-analytical, analytical, and post-analytical phases of testing;
(16) "Department", the Missouri department of economic development;
(17) "Director", the director of the division;
(18) "Division", the division of professional registration;
(19) "Levels of testing", clinical laboratory tests categorized by rule by the board as:
(a) "Level 1 testing", low complexity testing as defined by the board;
(b) "Level 2 testing", moderate complexity testing as defined by the board; and
(c) "Level 3 testing", high complexity testing as defined by the board;
(20) "Medical laboratory director", a physician licensed in this state who is certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology, or a person possessing a doctorate degree in clinical laboratory science, who is responsible for the medical oversight of the clinical laboratory, the ongoing competence of clinical laboratory personnel, the quality of the clinical laboratory testing, and the laboratory's compliance with applicable regulations. Some of his or her duties may be delegated, but the medical laboratory director retains the responsibility that all duties are properly performed. The medical laboratory director serves as a consultant for physicians and other health care professionals and may provide diagnoses upon the examination of laboratory test results;
(21) "Phlebotomy technician", a person who is responsible for obtaining blood specimens by venipuncture or capillary puncture according to established and approved protocols and with the oversight of a clinical laboratory scientist, categorical clinical laboratory scientist, clinical laboratory science consultant, clinical laboratory science director, medical laboratory director, or a physician licensed in this state;
(22) "Point of care testing/bedside testing", clinical laboratory testing that is critical to patient care and shall be performed immediately at the patient's location. Tests which meet this definition provide clinically relevant information, which determines the patient's therapy, are limited to procedures that produce accurate data within a short period of time, meet the current standards of quality in clinical laboratory science, and comply with all standards of accrediting agencies and are approved by the board.
324.1206. Sections 324.1200 to 324.1227 shall not apply to:
(1) Licensed health care professionals whose scope of practice includes blood collection or the performance of level 1 testing. Level 2 clinical laboratory microscopy procedures shall be performed by licensed practitioners of the healing arts;
(2) Cytologists, including those persons who perform steps in the pre-analytical phase of testing;
(3) Clinical laboratory science practitioners employed by the United States government or any bureau, division, or agency thereof, while in the discharge of the employee's official duties;
(4) Clinical laboratory science practitioners engaged in teaching or research, provided that the results of any examination performed are not used in the diagnosis, treatment, health maintenance, or prevention of disease;
(5) Students or trainees enrolled in an accredited clinical laboratory science education program provided that their activities constitute a part of a designed course in the program, that the individuals are designated by title as intern, trainee, or student, and the individuals work under the direct supervision of a clinical laboratory scientist, categorical clinical laboratory scientist, or clinical laboratory science technician who is responsible for reporting test results.
324.1209. 1. No person shall collect, process, perform, interpret, report, or consult regarding clinical laboratory tests unless licensed under sections 324.1200 to 324.1227. The board may grant a temporary license as specified in subsection 1 of section 324.1218.
2. All persons collecting blood specimens, processing laboratory specimens, performing, interpreting, or reporting laboratory tests or consulting regarding clinical laboratory tests, or defined as a clinical laboratory practitioner on August 28, 2006, who are certified by or eligible for certification by an approved credentialing agency, and who have applied to the board on or before December 31, 2006, and have complied with all necessary requirements for such application may continue to perform the duties until the expiration of twelve months after the filing of such application, the denial of the application by the board, or the withdrawal of the application, whichever occurs first.
3. Effective December 31, 2007, no initial license shall be issued until an applicant meets all of the requirements under sections 324.1200 to 324.1227 and successfully passes an approved credentialing agency certification examination specific for the professional level of licensure sought as determined by the board.
4. Persons not meeting the requirements of an approved credentialing agency for any license described in sections 324.1200 to 324.1227 prior to August 28, 2006, shall be considered to have met the qualifications providing they have three years of acceptable experience at the professional level for which licensure is sought during the five-year period immediately prior to August 28, 2006, and submit to the board documentation of experience as approved by rule of the board.
5. As pertaining to point of care/bedside testing, an individual licensed as a clinical laboratory scientist, clinical laboratory science consultant, clinical laboratory science director, or medical laboratory director shall have the following responsibilities:
(1) Designing, conducting, or supervising the training programs for the point of care/bedside testing personnel;
(2) Supervising and monitoring the test quality assurance and quality control activities of the point of care/bedside testing program;
(3) Assisting in the selection of laboratory methodology and instrumentation for the point of care/bedside testing program;
(4) Reviewing and evaluating results of proficiency testing and recommending corrective action, if necessary, for the point of care/bedside testing program; and
(5) Monitoring the continued competence of the point of care/bedside testing personnel.
324.1212. 1. There is hereby created within the division of professional registration, the "Clinical Laboratory Science Board". The board shall assist the division in administering and enforcing the provisions of sections 324.1200 to 324.1227, and shall adopt, publish, and enforce such rules and regulations as may be considered necessary or proper for the effective administration and interpretation of the provisions of sections 324.1200 to 324.1227, and for the conduct of its business and management of its internal affairs.
2. At least ninety days before the expiration of a term of a board member, and as soon as feasible after the occurrence of a vacancy on the board for reasons other than the expiration of a term, a list of three licensed and qualified individuals shall be submitted to the director of the division of professional registration. The governor may appoint a board member to fill the vacancy from the list submitted or may appoint some other qualified, licensed clinical laboratorian.
3. The board shall approve by rule the types of certifications required for each level of licensure.
4. The board shall consist of seven members, including one public member, one practicing medical laboratory director, one practicing clinical laboratory science director, two practicing clinical laboratory scientists, one practicing clinical laboratory technician, and one clinical laboratory assistant or phlebotomy technician the first of which shall be a clinical laboratory assistant and followed by a phlebotomy technician on an ongoing rotational basis from term to term, appointed by the governor, with the advice and consent of the senate. Within ninety days after August 28, 2006, the governor shall appoint two members for a term of two years, two members for a term of three years, and three members for a term of four years. As terms of the initial members expire, the governor shall appoint successors for terms of four years. A member whose term has expired shall continue to serve on the board until such time as a replacement is appointed. Whenever a vacancy shall occur on the board by reason other than the expiration of a term of office, the governor shall appoint a successor of like qualifications for the remainder of the unexpired term. No member shall serve more than the remaining portion of a previous member's unexpired term, plus two consecutive four-year terms of the member's own thereafter. Each member of the board shall be a citizen of the United States and of the state of Missouri and, except for the first members appointed, shall be licensed under sections 324.1200 to 324.1227. In appointing members to the board, consideration shall be given to race, gender, ethnic origin, and persons from the various geographic regions of this state. No more than four members shall be from the same political party.
5. Each member of the board shall receive as compensation an amount set by the board and shall be reimbursed for necessary and actual expenses incurred in the performance of the member's official duties. The board may appoint, employ, and fix the compensation of a legal counsel and board personnel. The division shall provide all staff for the board.
6. The board shall hold an annual meeting at which it shall elect for a one-year term from its membership a chairperson and a secretary who shall also be treasurer. The board may hold such additional meetings as may be required in the performance of its duties, provided that notice of every meeting shall be given to each member at least three days prior to the date of the meeting. A majority of the board, including at least one officer, shall constitute a quorum for the conducting of business.
7. The board shall adopt and revise such rules and regulations as may be necessary to enable it to carry into effect the provisions of sections 324.1200 to 324.1227. Any rule or portion of a rule, as that term is defined in section 536.010, RSMo, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536, RSMo, and, if applicable, section 536.028, RSMo. This section and chapter 536, RSMo, are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536, RSMo, to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2006, shall be invalid and void.
8. The board shall prescribe by rule minimum standards for organizations that provide continuing education programs for license renewal for clinical laboratory personnel.
9. The board shall designate as "approved" such programs as meet the requirements of the standards and the division shall annually publish a list of such programs.
10. The board shall by rule designate the number of hours and type of continuing education required for the renewal of each license level, if the approved credentialing agency did not require continuing education for certification renewal.
11. The board shall keep a record of all proceedings.
12. The governor may remove a board member for misconduct, incompetence, neglect of the member's official duties, or for cause.
13. The public member shall be at the time of the person's appointment a resident of this state for a minimum of one year and a registered voter, a person who is not and never has been licensed under sections 324.1200 to 324.1227 or the spouse of such a person, and a person who does not have and never has had a material financial interest in either the providing of the professional services regulated under sections 324.1200 to 324.1227 or an activity or organization directly related to any profession licensed or regulated under sections 324.1200 to 324.1227. The duties of the public member shall not include the determination of approved credentialing agencies or the approval of organizations that offer continuing education programs for clinical laboratory personnel or any other technical decision making.
14. Members of the board shall not be personally liable, either jointly or separately, for any act or acts committed in the performance of their official duties as board members.
324.1215. The board shall review the certification by the approved credentialing agency and shall determine by rule the level of license to issue and shall recommend, if applicable, to the department the issuance of such a license. The following levels of licenses shall be issued, and a person may qualify for and be issued several licenses dependent on the applicant's certifications and the board's recommendation:
(1) Clinical laboratory science director: minimum educational requirement shall be a baccalaureate degree;
(2) Clinical laboratory science consultant: minimum educational requirement shall be a baccalaureate degree;
(3) Clinical laboratory science supervisor: minimum educational requirement shall be a baccalaureate degree;
(4) Clinical laboratory scientist: minimum educational requirement shall be a baccalaureate degree;
(5) Categorical clinical laboratory science supervisor: the laboratory specialty shall be specified on the license; minimum educational requirement shall be a baccalaureate degree;
(6) Categorical clinical laboratory scientist: the laboratory specialty shall be specified on the license; minimum educational requirement shall be a baccalaureate degree;
(7) Clinical laboratory science technician: minimum educational requirement shall be an associate's degree;
(8) Clinical laboratory science assistant: minimum educational requirement shall be a high school diploma or a GED;
(9) Phlebotomy technician: minimal educational requirement shall be a high school diploma or a GED.
324.1218. 1. Licensure applicants who qualify by education, experience, or training but have not taken or passed an approved credentialing agency's certification examination may be granted a temporary license by the board, upon submission of proof to the board from the credentialing agency of acceptance to sit for the certification exam, that will allow that person to engage in the practice of clinical laboratory science at the appropriate level. The temporary license will be valid for twelve months and can be renewed once upon failure to pass an approved certification examination.
2. Internationally trained licensure applicants must have their transcripts evaluated by a transcript evaluation agency acceptable to the board and submitted directly to a board-approved credentialing agency. The evaluation shall indicate that the applicant's education is equivalent to that which is required for licensure of United States graduates at the level of licensure sought. Upon submission of proof to the board of acceptance to sit for the certification examination from the credentialing agency, the person may apply for a temporary license in the corresponding category.
324.1221. The board shall recognize a valid license issued by another state, provided that the requirements under which that license was issued are equivalent to, or exceed the standards required under sections 324.1200 to 324.1227.
324.1224. 1. Applications for licensure in clinical laboratory science shall be in writing, submitted to the board on forms provided by the division, and furnished to the applicant. The application shall contain a copy of the applicant's certification, the applicant's statements showing the applicant's education and experience, and such other information as the board may require. Each application shall contain a statement that it is made under oath or affirmation and that the information contained therein is true and correct to the best knowledge and belief of the applicant, subject to the penalties provided for the making of a false affidavit or declaration. Appropriate fees shall accompany each application.
2. The board by rule shall establish fees to be paid for application, licensing and renewal, reinstatement, and record making and recordkeeping by the division. The board may also establish by rule a delinquency fee. The board shall establish fees that are adequate to ensure the continued operation of the board and to fund the proportionate expenses incurred by the division in carrying out its licensure and other related responsibilities under sections 324.1200 to 324.1227. Fees shall be based on departmental estimates of the revenue required to implement sections 324.1200 to 324.1227 and the provisions of law with respect to the regulation of clinical laboratory personnel.
3. Upon receipt of a nonrefundable, initial application fee and payment of any license fees, the division shall issue a license for the appropriate level as a clinical laboratory science director, clinical laboratory science consultant, clinical laboratory science supervisor, clinical laboratory scientist, categorical clinical laboratory science supervisor, categorical clinical laboratory scientist, clinical laboratory science technician, clinical laboratory science assistant, or phlebotomy technician to a person who meets the qualifications specified under sections 324.1200 to 324.1227 and the rules and regulations promulgated thereunder.
4. Persons requesting certification in more than one level of licensure shall receive one license, which shall list each level of licensure granted, and in the case of categorical clinical laboratory scientists, the laboratory specialty for which the license may be valid.
5. A license issued under sections 324.1200 to 324.1227 shall expire in two years. The board by rule may permit renewal less frequently than every two years and may set license fees accordingly. The division shall mail a renewal notice to the last known address of each licensee prior to the renewal date. The license of any person who fails to pay the required fee, fails to provide documentation of required certification or documentation of required continuing education, or fails to provide the board with any information required for renewal within sixty days after the expiration of such license shall be automatically cancelled without notice or further proceedings unless the person has made application for inactive status, or failure to pay the renewal fee shall result in a nonvalid license. The license shall be reinstated if, within two years of the renewal date, the applicant submits the required documentation, including continuing education requirements and pays the applicable fees as approved by the board.
6. The board shall prescribe by rule the continuing education requirements for renewal of each level of license, if a person licensed under sections 324.1200 to 324.1227 asks to be placed on inactive status, provided such person does not practice clinical laboratory science during such a period that the person is on inactive status. If the person desires to maintain such license on an inactive status and in order to avoid lapsing of such license, the person shall pay the required fee as established by the board for maintaining an inactive license. An inactive license shall be renewed biennially, or less frequently if specified by rule by the board. The board may reactivate an inactive license. The board shall prescribe by rule the continuing education requirements necessary as a condition of license reactivation and demonstrated continuing competence.
7. Each person possessing a clinical laboratory personnel license shall display the license in a prominent location in the laboratory workplace.
8. Duplicate licenses for persons practicing in more than one location, or a duplicate license to replace any license lost, destroyed, or mutilated may be issued subject to the rules of the board and upon payment of a fee established by rule by the board.
9. There is hereby created in the state treasury the "Clinical Laboratory Science Fund", which shall consist of money collected under sections 324.1200 to 324.1227. The state treasurer shall be custodian of the fund and shall approve disbursements from the fund in accordance with sections 30.170 and 30.180, RSMo. Upon appropriation, money in the fund shall be used solely for the administration of sections 324.1200 to 324.1227. Notwithstanding the provisions of section 33.080, RSMo, to the contrary, any moneys remaining in the fund at the end of the biennium shall not revert to the credit of the general revenue fund. The state treasurer shall invest moneys in the fund in the same manner as other funds are invested. Any interest and moneys earned on such investments shall be credited to the fund.
324.1227. 1. The board may refuse to issue or renew any license for one or any combination of reasons stated in this section. The board shall notify the applicant in writing of the reasons for the refusal and shall advise the applicant of the right to file a complaint with the administrative hearing commission.
2. The board may cause a complaint to be filed with the administrative hearing commission against the holder of any license or any person who has failed to renew or has surrendered the person's license that may include, but not be limited to, any one or any combination of the following causes:
(1) Use of fraud, deception, misrepresentation, or bribery in securing a license under sections 324.1200 to 324.1227;
(2) Impersonation of any person holding a license or allowing any person to use his or her license or diploma from any school;
(3) Disciplinary action against the holder of a license by another state, territory, federal agency, or country upon grounds for which revocation or suspension is authorized in this state;
(4) Issuance of a license based upon a material mistake of fact;
(5) The person has been adjudicated and found guilty, or entered a plea of guilty or nolo contendere, in a criminal prosecution under the laws of any state or the United States for any offense reasonably related to the qualifications, functions, or duties of the person who is regulated, for any offense involving an essential element of fraud, dishonesty, or act of violence, or for any offense involving moral turpitude, elderly abuse, or child abuse, regardless of whether or not a sentence is imposed;
(6) Demonstrating professional incompetence, misconduct, gross negligence, fraud, misrepresentation, or dishonesty in the performance of specimen collection, processing or performance of clinical laboratory testing, or erroneous reporting;
(7) Failing, within sixty days, to provide information in response to a written request made by the board;
(8) Directly or indirectly giving to or receiving from any person, firm, corporation, partnership, or association any fee, commission, rebate, or other form of compensation for any professional services not actually rendered;
(9) Finding by the board that the licensee, after having his or her license placed on probationary status, has violated the terms of probation;
(10) Willfully making or filing false records or reports in his practice including but not limited to false records filed with state agencies or departments;
(11) Violating any standard of professional conduct adopted by the board;
(12) Engaging in dishonorable, unethical, or unprofessional conduct of a character likely to deceive, defraud, or harm the public;
(13) Jeopardizing patient safety by providing professional services while mentally incompetent or under the influence of alcohol, a narcotic, or a controlled substance that is in excess of therapeutic amounts or without valid medical indication;
(14) Directly or indirectly contracting to perform clinical laboratory tests in a manner which offers or implies an offer of rebate, fee-splitting inducements or arrangements, or other remuneration;
(15) Aiding or assisting another individual in violating any provision of sections 324.1200 to 324.1227, or any rule adopted thereunder;
(16) Violation of the drug laws or rules and regulations of this state, any other state, or the federal government.
3. After the filing of such a complaint, the proceedings shall be conducted in accordance with the provisions of chapter 621, RSMo. Upon a finding of the administrative hearing commission that the grounds provided in subsection 2 of this section for disciplinary action are met, the board may, singly or in combination, censure or place the person named in the complaint on probation on such terms and conditions as the board deems appropriate for a period not to exceed five years, or may suspend, for a period not to exceed three years, or revoke the license.
4. A person whose license has been revoked shall wait one year from the date of revocation to apply for relicensure. Relicensure shall be at the discretion of the board after compliance with all the requirements of sections 324.1200 to 324.1227 relative to the licensing of an applicant for the first time.
5. The board may notify the proper licensing authority of any other state concerning the final disciplinary action determined by the board against any person holding a license granted by another state.
6. Any person, organization, association, or corporation who reports or provides information to the board of clinical laboratory science under sections 324.1200 to 324.1227, and who does so in good faith, shall not be subject to an action for civil damages as a result thereof.
7. Any person who violates the provisions of sections 324.1200 to 324.1227 is guilty of a class A misdemeanor and, upon conviction, shall be punished as provided by law.
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