81R6033 YDB-D

By: Lucio S.B. No. 775

A BILL TO BE ENTITLED

AN ACT

relating to the licensing and regulation of clinical laboratory science professionals; providing penalties.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION 1. Subtitle M, Title 3, Occupations Code, is amended by adding Chapter 703 to read as follows:

CHAPTER 703. CLINICAL LABORATORY SCIENCE PROFESSIONALS

SUBCHAPTER A. GENERAL PROVISIONS

Sec. 703.001. SHORT TITLE. This chapter may be cited as the Clinical Laboratory Science Practice Act.

Sec. 703.002. PUBLIC POLICY; LEGISLATIVE PURPOSE. (a) The legislature declares as a policy of this state that:

(1) the practice of clinical laboratory science by health care professionals affects the public health, safety, and welfare and is subject to control and regulation in the public interest; and

(2) clinical laboratories and clinical laboratory science professionals provide essential services to health care professionals by furnishing vital information that may be used in the diagnosis, prevention, and treatment of diseases or impairment and the assessment of human health.

(b) The purpose of this chapter is to ensure better protection of the public health by:

(1) requiring minimum qualifications for clinical laboratory science professionals; and

(2) ensuring that clinical laboratory tests are performed with the highest degree of professional competency by individuals engaged in providing the services in this state.

Sec. 703.003. DEFINITIONS. In this chapter:

(1) "Advisory board" means the Clinical Laboratory Science Advisory Board.

(2) "Categorical clinical laboratory scientist" means an individual licensed under this chapter to perform clinical laboratory scientist services in one major practice area of a laboratory.

(3) "Clinical laboratory" means a facility in which a clinical laboratory test is performed.

(4) "Clinical laboratory science professional" means an individual licensed under this chapter to practice clinical laboratory science.

(5) "Clinical laboratory scientist" means an individual licensed under this chapter to perform clinical laboratory scientist services. The term includes a medical technologist.

(6) "Clinical laboratory scientist services" means:

(A) the performance of clinical laboratory tests;

(B) the establishment and implementation of protocols, quality assessment, method development and selection, equipment selection and maintenance, and all activities related to the pre-analytic, analytic, and post-analytic phases of clinical laboratory testing; and

(C) the direction, supervision, consultation, education, and performance of research functions related to clinical laboratory testing.

(7) "Clinical laboratory specialist in cytogenetics" means an individual licensed under this chapter to perform cytogenetic testing, including culturing, harvesting, staining, microscopy, and chromosome analysis, and to direct, supervise, consult, educate, and perform research functions related to clinical laboratory testing.

(8) "Clinical laboratory specialist in histocompatibility" means an individual licensed under this chapter to perform histocompatibility testing by molecular and serological techniques and to direct, supervise, consult, educate, and perform research functions related to clinical laboratory testing.

(9) "Clinical laboratory specialist in molecular biology" means an individual licensed under this chapter to perform each aspect of molecular analysis, including recombinant DNA technology, polymerase chain reaction, and hybridization techniques and to direct, supervise, consult, educate, and perform research functions related to clinical laboratory testing.

(10) "Clinical laboratory technician" means an individual licensed under this chapter to perform clinical laboratory technician services. The term includes a medical laboratory technician.

(11) "Clinical laboratory technician services" means the performance of clinical laboratory tests in accordance with established and approved protocols that require the limited exercise of independent judgment and are performed under the supervision of a clinical laboratory scientist, laboratory supervisor, or laboratory director.

(12) "Clinical laboratory test" means a microbiological, serological, chemical, biological, hematological, immunological, immunohematological, radiobioassay, cytochemical, cytobiological, or biophysical test or procedure performed on material derived from or existing in a human body that provides information for the diagnosis, prevention, or monitoring of a disease or impairment or assessment of a clinical condition. The term includes the pre-analytic, analytic, and post-analytic phases of testing.

(13) "Commissioner" means the commissioner of state health services.

(14) "Department" means the Department of State Health Services.

(15) "Executive commissioner" means the executive commissioner of the Health and Human Services Commission.

(16) "Point-of-care testing" means analytical patient testing activities provided at a health care facility but performed outside the central medical laboratory facilities that do not require permanent dedicated space, including testing using analytical instruments at a temporary patient care location.

(17) "Practice of clinical laboratory science" means practice by an individual who manages, supervises, educates, consults, researches, or performs clinical laboratory testing or technical procedures in a clinical laboratory. The term does not include the activities of a licensed physician or of a person performing only clerical duties or other duties not directly related to the performance of clinical laboratory testing.

(18) "Trainee" means an individual who has not fulfilled the educational requirements to take an approved nationally recognized certification examination or who is in the process of obtaining full-time comprehensive experience under supervision.

(19) "Waived test" means a simple laboratory examination or procedure that, under the United States Food and Drug Administration's interpretation of the Clinical Laboratory Improvement Amendments (42 C.F.R. Part 493), employs a simple and accurate methodology that renders the likelihood of erroneous results negligible or poses no reasonable risk of harm to the patient if performed incorrectly.

Sec. 703.004. EXEMPTIONS. This chapter does not apply to:

(1) an individual licensed under the laws of this state and engaged in health care services within the scope of the license holder's licensed practice;

(2) an individual engaged in the practice of clinical laboratory science in the employ of the federal government or a federal bureau, division, or agency and in the discharge of the employee's official duties;

(3) an individual engaged in the practice of clinical laboratory science and engaged exclusively in research, provided that the results of an examination performed are not used in health maintenance, diagnosis, or treatment of disease;

(4) a student or trainee enrolled in a clinical laboratory science education program, provided that:

(A) the activities constitute a part of a planned course in the program;

(B) the individual is designated by title as an intern, trainee, or student; and

(C) the individual works directly under an individual licensed by this state to practice clinical laboratory science or an individual exempt from this chapter under Subdivision (3);

(5) an individual solely performing waived or provider-performed microscopy tests under the Clinical Laboratory Improvement Amendments (42 C.F.R. Part 493); or

(6) an individual performing tests categorized under the Clinical Laboratory Improvement Amendments (42 C.F.R. Part 493) as non-waived point-of-care testing, but only if the acute care facility complies with the following requirements:

(A) in the laboratory, a clinical laboratory scientist or individual who qualifies as a laboratory director under the Clinical Laboratory Improvement Amendments (42 C.F.R. Part 493) is responsible for:

(i) designing and providing or supervising the training programs for the point-of-care testing personnel;

(ii) supervising and monitoring the quality assurance and quality control activities of the testing site;

(iii) assisting in the selection of technology;

(iv) reviewing the results of proficiency testing and recommending corrective action, if necessary; and

(v) monitoring the continued competency of the testing personnel; and

(B) processes are in place at the facility and are acceptable to the department to ensure and document the continued competency of the point-of-care testing personnel.

Sec. 703.005. APPLICATION OF SUNSET ACT. The Clinical Laboratory Science Advisory Board is subject to Chapter 325, Government Code (Texas Sunset Act). Unless continued in existence as provided by that chapter, the advisory board is abolished and this chapter expires September 1, 2021.

[Sections 703.006-703.050 reserved for expansion]

SUBCHAPTER B. EXECUTIVE COMMISSIONER, COMMISSIONER, AND

DEPARTMENT POWERS AND DUTIES

Sec. 703.051. RULES. (a) The executive commissioner shall adopt rules necessary to administer this chapter, including rules on:

(1) the qualifications for licensure under each category of clinical laboratory science professional;

(2) the renewal of licensure;

(3) standards of professional conduct for each category of clinical laboratory science professional;

(4) authorization or approval of nationally recognized, validated, criterion-based certification examinations for clinical laboratory science professionals; and

(5) criteria for the continuing education of clinical laboratory science professionals as required for license renewal.

(b) The executive commissioner by rule shall prescribe the activities that may be performed by each category of license holder under this chapter.

Sec. 703.052. FEES. The commissioner shall establish and collect reasonable and necessary fees in amounts sufficient to cover the costs of administering this chapter.

Sec. 703.053. DEPARTMENT POWERS AND DUTIES. (a) The department may authorize disbursements necessary to implement this chapter, including disbursements for office expenses, equipment costs, and other necessary facilities.

(b) The department may examine any criminal conviction, guilty plea, or deferred adjudication of an applicant for issuance or renewal of a license, including by obtaining any criminal history record information permitted by law.

Sec. 703.054. PERSONNEL. The department may employ personnel necessary to administer this chapter.

Sec. 703.055. REGISTRY OF LICENSE HOLDERS. (a) The department shall maintain a registry of the name and addresses of each individual licensed under this chapter and each individual whose license has been suspended or revoked in the preceding year.

(b) The department shall post the registry on the department's Internet website and make copies of the registry available to the public on request.

Sec. 703.056. CONSUMER INTEREST INFORMATION. (a) The department shall prepare information of consumer interest describing:

(1) the functions performed by the department under this chapter; and

(2) the rights of a consumer affected by this chapter.

(b) The information must describe the procedure by which a consumer complaint is filed with and resolved by the department.

(c) The department shall make the information available to the public.

[Sections 703.057-703.100 reserved for expansion]

SUBCHAPTER C. CLINICAL LABORATORY SCIENCE ADVISORY BOARD

Sec. 703.101. ADVISORY BOARD. (a) The Clinical Laboratory Science Advisory Board is an advisory body to the department and executive commissioner.

(b) The advisory board consists of seven members appointed by the governor as follows:

(1) four members who are licensed clinical laboratory science professionals, with at least one who is not a physician laboratory director and at least one who is a clinical laboratory scientist;

(2) one member who is a physician certified by the American Board of Pathology, the American Board of Osteopathic Pathology, or another certification board the department determines has certification requirements at least as stringent as those of the American Board of Pathology or the American Board of Osteopathic Pathology;

(3) one member who is a physician and is not a laboratory director or pathologist; and

(4) one public member.

(c) The governor may make appointments to the advisory board from lists submitted by organizations of clinical laboratory science professionals and organizations of physician pathologists.

(d) Chapter 2110, Government Code, does not apply to the advisory board.

Sec. 703.102. TERMS; VACANCIES. (a) Members serve staggered three-year terms and until their successors are appointed and qualified.

(b) A vacancy shall be filled for the remainder of the unexpired term in the same manner as an original appointment.

(c) A member may not serve more than two consecutive terms.

Sec. 703.103. PUBLIC MEMBER ELIGIBILITY. A member who represents the public may not be:

(1) an officer, director, or employee of an individual regulated under this chapter;

(2) an individual required to register as a lobbyist under Chapter 305, Government Code; or

(3) an individual related to an individual described by Subdivision (1) or (2) within the second degree by affinity or consanguinity.

Sec. 703.104. COMPENSATION; REIMBURSEMENT. A member of the advisory board serves without compensation. If authorized by the commissioner, an advisory board member is entitled to reimbursement for actual and necessary expenses incurred in performing the functions of the advisory board, subject to the General Appropriations Act.

Sec. 703.105. MEETINGS. The advisory board shall meet twice annually and may meet at other times at the call of the commissioner.

Sec. 703.106. ADVISORY BOARD DUTIES. The advisory board shall provide advice and recommendations to the department and executive commissioner on technical matters relevant to the administration and enforcement of this chapter, including examination approval, licensing standards and qualifications, renewal requirements, standards of professional conduct, and continuing education requirements.

[Sections 703.107-703.150 reserved for expansion]

SUBCHAPTER D. LICENSE REQUIREMENTS

Sec. 703.151. LICENSE REQUIRED. (a) Except as provided by Section 703.004, an individual may not perform or offer to perform clinical laboratory tests or represent that the individual is a clinical laboratory science professional unless the individual holds an appropriate license issued under this chapter.

(b) The executive commissioner by rule may establish the qualifications and licensing requirements for additional categories of clinical laboratory license professionals as the executive commissioner determines necessary to protect the public health and safety.

Sec. 703.152. APPLICATION REQUIREMENTS. (a) An applicant for a license under this chapter must:

(1) submit to the department a completed application on a form prescribed by the commissioner;

(2) submit to the department any other information required by department rule;

(3) demonstrate to the satisfaction of the commissioner the qualifications required by this chapter and department rule;

(4) demonstrate the applicant's honesty, trustworthiness, and integrity; and

(5) pay the application fee.

(b) The department shall issue the appropriate license to each individual who meets the qualifications required by this chapter and department rule.

(c) The department may conduct an examination of any criminal conviction of an applicant, including obtaining any criminal history record information permitted by law.

Sec. 703.153. CLINICAL LABORATORY SCIENTIST. An applicant for a clinical laboratory scientist license must:

(1) hold a baccalaureate degree from a regionally accredited college or university;

(2) have successfully completed the clinical laboratory experience or training required by department rule;

(3) be certified by a nationally recognized certification organization approved by the executive commissioner;

(4) pay the application fee and license fee; and

(5) comply with any other requirements established by department rule.

Sec. 703.154. CATEGORICAL CLINICAL LABORATORY SCIENTIST. An applicant for a categorical clinical laboratory scientist license must:

(1) hold a baccalaureate degree from a regionally accredited college or university;

(2) have successfully completed the clinical laboratory experience or training required by department rule;

(3) be certified by a nationally recognized certification organization approved by the executive commissioner;

(4) pay the application fee and license fee; and

(5) comply with any other requirements established by department rule.

Sec. 703.155. CLINICAL LABORATORY TECHNICIAN. An applicant for a clinical laboratory technician license must:

(1) hold at least an associate degree from a regionally accredited college or university;

(2) have successfully completed the clinical laboratory experience or training required by department rule;

(3) be certified by a nationally recognized certification organization approved by the executive commissioner;

(4) pay the application fee and license fee; and

(5) comply with any other requirements established by department rule.

Sec. 703.156. CLINICAL LABORATORY SPECIALIST IN MOLECULAR BIOLOGY. An applicant for a clinical laboratory specialist in molecular biology license must:

(1) hold a baccalaureate degree from a regionally accredited college or university;

(2) have successfully completed the clinical laboratory experience or training required by department rule;

(3) be certified by a nationally recognized certification organization approved by the executive commissioner;

(4) pay the application fee and license fee; and

(5) comply with any other requirements established by department rule.

Sec. 703.157. CLINICAL LABORATORY SPECIALIST IN CYTOGENETICS. An applicant for a clinical laboratory specialist in cytogenetics license must:

(1) hold a baccalaureate degree from a regionally accredited college or university;

(2) have successfully completed the clinical laboratory experience or training required by department rule;

(3) be certified by a nationally recognized certification organization approved by the executive commissioner;

(4) pay the application fee and license fee; and

(5) comply with any other requirements established by department rule.

Sec. 703.158. CLINICAL LABORATORY SPECIALIST IN HISTOCOMPATIBILITY. An applicant for a clinical laboratory specialist in histocompatibility license must:

(1) hold a baccalaureate degree from a regionally accredited college or university;

(2) have successfully completed the clinical laboratory experience or training required by department rule;

(3) be certified by a nationally recognized certification organization approved by the executive commissioner;

(4) pay the application fee and license fee; and

(5) comply with any other requirements established by department rule.

Sec. 703.159. TEMPORARY LICENSE. (a) The executive commissioner by rule may establish a procedure for issuance of temporary licenses to individuals otherwise qualified under this chapter who intend to engage in the practice of clinical laboratory science in this state for a limited period not to exceed one year.

(b) Unless otherwise noted on the license, a temporary license is valid until the first anniversary of the date of issuance and may be renewed once at the discretion of the commissioner.

Sec. 703.160. PROVISIONAL LICENSE. The department may issue a provisional license under this chapter to an applicant who holds a license in another state, submits a proper application, and pays the required fees if the department determines that the applicant is licensed in a state in which the requirements for issuance of the license are at least as stringent as the requirements under this chapter and department rule.

Sec. 703.161. LICENSE RENEWAL. (a) A license issued under this chapter expires on the second anniversary of the date of issuance.

(b) A license holder may renew the license by paying the required renewal fee and:

(1) successfully completing at least 10 hours each year of continuing education courses, clinics, lectures, training programs, seminars, or other programs related to clinical laboratory practice that are approved or accepted by the department; or

(2) successfully completing recertification by a national certifying organization recognized by the department that mandates at least 10 hours each year of continuing education for recertification.

(c) The executive commissioner by rule may require additional evidence of competency to practice clinical laboratory science as the executive commissioner considers reasonably appropriate as a prerequisite to the renewal of any license under this chapter if the requirements are:

(1) uniformly applied;

(2) reasonably related to the measurement of qualification, performance, or competence; and

(3) desirable and necessary for the protection of the public health.

[Sections 703.162-703.200 reserved for expansion]

SUBCHAPTER E. LICENSE DENIAL AND DISCIPLINARY ACTION

Sec. 703.201. GROUNDS FOR DISCIPLINARY ACTION. The department may refuse to issue or renew, revoke, or suspend a license, place on probation, censure, or reprimand a license holder, or take any other disciplinary action, including the imposition of a civil penalty under Section 703.202 or the imposition of an administrative penalty under Section 703.204, the department considers appropriate for:

(1) a material misstatement in furnishing information to the department;

(2) a violation or negligent or intentional disregard of this chapter or a rule adopted under this chapter;

(3) a conviction for any crime under the laws of the United States or any state of the United States that is a felony or a misdemeanor, an essential element of which is dishonesty, or of any crime that is directly related to the practice of the profession;

(4) a misrepresentation made to obtain a license;

(5) a violation of any standard of professional conduct adopted by the executive commissioner;

(6) dishonorable, unethical, or unprofessional conduct of a character likely to deceive, defraud, or harm the public;

(7) the provision of professional services while mentally incompetent or under the influence of alcohol, a narcotic, or a controlled dangerous substance that is in excess of therapeutic amounts or without valid medical indication;

(8) directly or indirectly contracting to perform clinical laboratory tests in a manner that offers or implies an offer of rebate, fee-splitting inducements or arrangements, or other remuneration;

(9) aiding or assisting another individual in violating any provision of this chapter or a rule adopted under this chapter; or

(10) a misrepresentation with regard to the existence or category of license or other certification or professional qualification held in connection with any employment application.

Sec. 703.202. CIVIL PENALTY. (a) A person who violates this chapter or a rule adopted under this chapter is liable to this state for a civil penalty of not more than $500 for each violation.

(b) The amount of the penalty shall be based on:

(1) the seriousness of the violation;

(2) the history of previous violations;

(3) the amount necessary to deter a future violation; and

(4) any other matter that justice may require.

(c) The attorney general may sue to collect a civil penalty under this section. In the suit the attorney general may recover, on behalf of the state, the reasonable expenses incurred in obtaining the penalty, including investigation and court costs, reasonable attorney's fees, witness fees, and other expenses.

Sec. 703.203. HEARINGS; ADMINISTRATIVE PROCEDURE. (a) If the department proposes to deny a license or take disciplinary action against a license holder, the license holder is entitled to a hearing.

(b) The proceedings relating to a license denial and disciplinary action by the department under this chapter are governed by Chapter 2001, Government Code. A hearing under this chapter may be conducted by a hearings officer designated by the commission.

Sec. 703.204. ADMINISTRATIVE PENALTY. (a) The commissioner may impose an administrative penalty on an individual licensed under this chapter who violates this chapter or a rule or order adopted under this chapter.

(b) The amount of the penalty may not exceed $500. Each day a violation continues or occurs is a separate violation for the purpose of imposing a penalty. The amount shall be based on:

(1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation;

(2) the economic harm caused by the violation;

(3) the history of previous violations;

(4) the amount necessary to deter a future violation;

(5) efforts to correct the violation; and

(6) any other matter that justice may require.

(c) The individual may stay enforcement during the time the order is under judicial review if the individual pays the penalty to the court clerk or files a supersedeas bond with the court in the amount of the penalty. An individual who cannot afford to pay the penalty or file the bond may stay enforcement by filing an affidavit in the manner required by the Texas Rules of Civil Procedure for a party who cannot afford to file security for costs, except that the department may contest the affidavit as provided by those rules.

(d) A proceeding to impose an administrative penalty is subject to Chapter 2001, Government Code.

SECTION 2. As soon as possible after the effective date of this Act, the governor shall appoint the members of the Clinical Laboratory Science Advisory Board in accordance with Chapter 703, Occupations Code, as added by this Act. In making the initial appointments, the governor shall designate:

(1) three members, including a pathologist member, a nonphysician laboratory director member, and a clinical laboratory scientist member, for terms expiring February 1, 2013;

(2) two members, including the public member and a nonpathologist physician member, for terms expiring February 1, 2012; and

(3) two members for terms expiring February 1, 2011.

SECTION 3. As soon as possible after the effective date of this Act, the executive commissioner of the Health and Human Services Commission shall adopt the rules, standards, procedures, and fees necessary to implement Chapter 703, Occupations Code, as added by this Act, and Section 5 of this Act.

SECTION 4. Notwithstanding Chapter 703, Occupations Code, as added by this Act, an individual engaged in the practice of clinical laboratory science is not required to hold a license under that chapter to engage in the practice of clinical laboratory science before September 1, 2011.

SECTION 5. Notwithstanding Chapter 703, Occupations Code, as added by this Act, the Department of State Health Services shall issue a license to a qualified applicant under this section who:

(1) applies for a license under this section not later than September 1, 2011;

(2) submits to the department the information required by department rule;

(3) submits to the department the job description of the position the applicant most recently performed and a sworn statement by the applicant's employer attesting to the applicant's job description;

(4) has at least three years of acceptable experience, in the preceding five years, in the applicable practice of clinical laboratory science;

(5) is certified by or eligible for certification by a nationally recognized certification agency approved by the department; and

(6) pays the application and licensing fee.

SECTION 6. This Act takes effect September 1, 2009.