Current through Register Vol. XLI, No. 45, November 8, 2024
Section 64-57-5 - Licensure Requirements, Duration, Renewal5.1. General. -- Applicants for licensure under this rule shall submit an application form available online at https://dhhr.wv.gov/ols/regulatory/Pages/Licensure.aspx and the following materials:5.1.a. Documentation of the applicant's qualifying education and certification or documentation of other substitute qualification as permitted by this section;5.1.b. The applicant's job description or education program description for which certification is sought by the applicant; and5.1.c. The annual licensure fee of $25 per person as authorized by W. Va. Code § 16-5J-10 and any other special circumstance fees as required by this section.5.1.d. Applicants seeking license renewal shall provide evidence of the completion of the continuing education requirements contained in subsection 5.9.5.2. Unless the applicant provides verification that he or she has met one of the substitute criteria permitted by CLIA for testing personnel, a Clinical Laboratory Practitioner - Medical Laboratory Scientist (CLP-MLS), applicant shall provide documentation to establish that he or she:5.2.a. Has earned a bachelor's degree in medical technology/medical laboratory science from an NAACLS accredited program, and has passed a national certification examination administered by a certifying agency recognized under subsection 2.1 of this rule; or5.2.b. Was previously certified as a medical laboratory technician by a certifying agency recognized under subsection 2.1; and5.2.b.1. Obtained a bachelor's degree from an accredited institution; and5.2.b.2. Has passed a national certification examination administered by a certifying agency recognized under subsection 2.1; or5.2.c. Has earned a bachelor's degree in a chemical, physical, or biological science other than medical technology/medical laboratory science from an accredited institution, and, in addition, has at least one year of pertinent full-time experience or training, or both, designed to provide him or her the skills required by CLIA with respect to the specialties or subspecialties he or she will perform.5.3. Unless the applicant provides verification that they have met one of the substitute criteria permitted by CLIA for testing personnel, a Clinical Laboratory Practitioner - Laboratory Technician (CLP-MLT) applicant shall provide documentation sufficient to establish that he or she: 5.3.a. Has earned an associate degree in medical technology/medical laboratory science from an NAACLS accredited program, and has passed a national certification examination administered by a certifying agency recognized under subsection 2.1 of this rule; or5.3.b. Has earned an associate degree from an accredited institution in a chemical, physical, or biological science other than medical technology/medical laboratory science, and, in addition, has at least one year of pertinent full-time experience, or training, or both, designed to provide him or her the skills required by CLIA with respect to the specialties or subspecialties he or she will perform; or5.3.c. Has successfully completed 60 semester hours of academic credit at an accredited institution, including at a minimum, either 24 semester hours of medical laboratory technology/medical laboratory science courses or six semester hours of chemistry, six semester hours of biology, and 12 semester hours of chemistry, biology, or medical laboratory technology/medical laboratory science, in any combination, and has at least one year of pertinent full-time experience or training, or both, designed to comply with the CLIA requirements for testing personnel. Applicants with an associate degree in medical technology/medical laboratory science are excluded from this provision.5.4. Unless the applicant provides verification that he or she has met one of the substitute criteria permitted by CLIA for testing personnel, a Clinical Laboratory Practitioner - Cytotechnologist (CLP-CT) applicant shall provide documentation to establish that he or she: 5.4.a. Has graduated from a school of cytotechnology accredited by the Commission on Accreditation of Allied Health Education Programs, or its predecessor, the Committee on Allied Health Education and Accreditation; or5.4.b. Has been certified in cytotechnology by a certifying agency approved by United States Department of Health and Human Services.5.5. Unless the applicant provides verification that her or she has met one of the substitute criteria permitted by CLIA for testing personnel, a Clinical Laboratory Practitioner - Pathologist Assistant (CLP-PA) applicant shall provide documentation to establish that he or she: 5.5.a. Has graduated from a Pathologist Assistant program accredited by NAACLS; and5.5.b. Is certified by a certifying agency enumerated in subsection 2.1 of this rule.5.6. Unless the applicant provides verification that he or she has met one of the substitute criteria permitted by CLIA for testing personnel, a Clinical Laboratory Practitioner - Histologist (CLP-H) applicant shall provide documentation to establish that he or she: 5.6.a. Meets requirements under §493.1489 of CLIA for high complexity testing personnel; and5.6.b. Has passed a national histotechnologist or histotechnician certification examination administered by a certifying agency enumerated in subsection 2.1 of this rule; or5.6.c. Has at least one year of pertinent full-time experience or training in the gross examination of human tissue specimens performed under the supervision of a pathologist, such as to provide the skills required by CLIA with respect to the specific tests that he or she will perform.5.7. Clinical Laboratory Practitioner - Point of Care Technician (CLP-POCT) applicant shall provide documentation to establish that he or she: 5.7.a. Has at least a high school diploma, a general education development certificate (GED), or an equivalent approved by the State department of education;5.7.b. Is employed in a clinical laboratory which holds a CLIA certificate other than a certificate of waiver; and5.7.c. Written verification from the laboratory director that the applicant has had training designed to provide the skills required by CLIA with respect to the specific tests he or she will perform.5.7.d. In the event that a person licensed as a clinical laboratory practitioner - point of care technician is to perform tests in addition to those which he or she is licensed to perform, he or she shall submit to the secretary documentation of training related to the additional tests in the skills, knowledge, and awareness consistent with the requirements of this subsection.5.8. A Clinical Laboratory Practitioner - Trainee (CLP-T) applicant shall provide documentation to establish that he or she:5.8.a. Is employed in a clinical laboratory which holds a CLIA certificate other than a certificate of waiver; and meets one of the following qualifications: 5.8.a.1. Has earned an associate degree from an accredited institution in medical technology/medical laboratory science but has not met requirements for national certification; or5.8.a.2. Has earned an associate degree from an accredited institution in a chemical, physical, or biological science other than medical technology/medical laboratory science and has less than one year of prior non-waived laboratory experience; or5.8.a.3. Has successfully completed 60 semester hours of academic credit at an accredited institution, including at a minimum, either 24 semester hours of medical laboratory technology/medical laboratory science courses or six semester hours of chemistry, six semester hours of biology, and 12 semester hours of chemistry, biology, or medical laboratory technology/medical laboratory science, in any combination and has less than one year of prior non-waived laboratory experience; or5.8.a.4. Has earned a bachelor's degree in medical technology/medical laboratory science from an accredited institution but has not met requirements for national certification; or5.8.a.5. Has earned a bachelor's degree in a chemical, physical, or biological science other than medical technology/medical laboratory science from an accredited institution and has less than one year of prior non-waived laboratory experience; or5.8.a.6. Is enrolled in a clinical laboratory technology/science training program that is accredited by the National Accrediting Agency for Clinical Laboratory Science (NAACLS); and5.8.b. Written verification by the laboratory director or program director which states that the applicant will have training designed to provide the skills required by CLIA with respect to the specific tests he or she will perform.5.8.c. The trainee license is designed to provide applicants meeting the qualifications in this section the ability to obtain clinical training or experience until such time he or she qualifies for full licensure as a CLP-MLS, CLP-MLT, CLP-CT, OR CLP-PA.5.8.d. Trainees licensed under paragraphs 5.8.a.2., 5.8.a.3., or 5.8.a.5. of this rule may qualify for a full license upon completion of one year of training/experience and submission of the "verification of competency" document, to be completed by the laboratory director or a designee.5.8.e. Trainees licensed under paragraphs 5.8.a.1., 5.8.a.4., or 5.8.a.6. of this rule are expected to obtain the required national certification within one year of obtaining the trainee license, and any application for renewal without national certification shall provide documentation of attempts to become certified.5.8.f. A trainee license may be renewed no more than twice and shall be issued at the discretion of the secretary. A person may not be licensed as a trainee for more than three years.5.9. An applicant for renewal of either a current or an expired license shall submit the application, information and licensure fee required by subsection 5.1. of this rule and evidence that the applicant has completed at least 10 continuing education hours of activities commensurate with the level of complexity of testing the individual performs from a program or programs approved by the secretary, since the issuance of his or her current or expired license, as applicable. Acceptable continuing educational activities include, but are not limited to lectures, seminars, workshops, formal classes, in-service programs, or correspondence courses.5.10. Term of License. -- A clinical laboratory practitioner license expires one year after the date it was issued. In the case of a license which has lapsed or been inactive for five years the individual shall comply with the requirements for issuance of an original license as described in subsection 5.1. of this section.5.11. Fees applicable to requests for licenses under special circumstances: Additional fees shall be charged for the following:5.11.a. A late fee of $10 per license for licensee renewal requests that are postmarked after the application due date but before the license has lapsed.5.11.b. A fee of $20 for a replacement license.5.11.c. A fee of $20 for reinstatement of a lapsed license.5.11.d. An "emergency" issuance fee of $35 for processing and issuance of a license requested by the licensee or management to be issued within a 24-hour turn-around time.5.11.e. A penalty of $100 shall be assessed to any testing personnel found to be unlicensed or whose license has lapsed during the CLIA survey process as a violation of CLIA personnel requirements.5.11.f. A fee of $10 for issuing an official licensure source verification.5.11.g. A special handling fee of $10 per license processing for practitioner license mailed directly to laboratory management in lieu of the licensee home address.5.11.h. A fee of $35 for payments returned due to non-sufficient funds.