West Virginia Code of State Rules
Title 64 - Health
64-57 - Clinical Laboratory Technican and Scientist Licensure and Certification
§64-57-5 - Licensure Requirements, Duration, Renewal.

§64-57-5. Licensure Requirements, Duration, Renewal.

5.1. General. - Applicants for licensure as a clinical laboratory practitioner - medical laboratory scientist, a clinical laboratory practitioner - laboratory technician, a clinical laboratory practitioner - cytotechnologist, or a clinical laboratory practitioner - point of care technician shall submit to the Secretary:

5.1.a. A completed application form supplied by the Secretary with documentation required by this rule;

5.1.b. Documentation of the applicant’s competency in the specialties or subspecialties of laboratory tests for which the applicant has been trained and is currently competent to perform. If the applicant is currently employed as a clinical laboratory practitioner, the documentation shall consist of a statement obtained from and signed by the applicant’s laboratory director which identifies these specialties or subspecialties of laboratory tests. The evaluation of competency shall include consideration of the applicant's performance in any proficiency testing programs. If the applicant is not currently employed as a clinical laboratory practitioner, the documentation shall be adequate to identify and verify the specialty or specialties of laboratory tests for which the applicant has been trained and has previously performed; and

5.1.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 outlined in subsection 5.9. of this section.

5.1.d. For the renewal of a license, evidence of the completion of the continuing education requirements contained in subdivision 5.7.a.

5.2. Clinical Laboratory Practitioner – Medical Laboratory Scientist (CLP-MLS). - A person seeking licensure as a clinical laboratory practitioner – medical laboratory scientist shall, at the time of application for initial licensure as a clinical laboratory practitioner – medical laboratory scientist, apply for a license on the form provided by the Secretary and submit documentation to establish that he or she:

5.2.a. Has earned a bachelor’s degree in medical technology/medical laboratory science from an accredited institution, and has passed a national certification examination administered by a certifying agency recognized under subsection 2.1 of this rule; or

5.2.b. 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 (1) year of pertinent full-time experience or training, or both, designed to provide him or her the following with respect to the specialties or subspecialties he or she will perform:

5.2.b.1. The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens;

5.2.b.2. The skills required for implementing all standard laboratory procedures;

5.2.b.3. The skills required for performing each test method and for proper instrument use;

5.2.b.4. The skills required for performing preventive maintenance, trouble shooting and calibration procedures related to each test performed;

5.2.b.5. A working knowledge of reagent stability and storage;

5.2.b.6. The skills required to implement the quality control policies and procedures of the laboratory;

5.2.b.7. An awareness of the factors that influence test results; and

5.2.b.8. The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results; or

5.2.c. Passed a proficiency examination for technologists given by the U.S. Department of Health and Human Services (HHS) between March 1, 1986 and December 31, 1987; or

5.2.d. On or before April 24, 1995, was:

5.2.d.1. Qualified under 42 CFR 493.1489(b)(5)(i); and

5.2.d.2. Performing high complexity testing.

5.2.e. Was licensed as a CLP-MT immediately preceding the effective date of this rule series, and has complied with all of the applicable requirements of paragraphs 5.1.a through 5.1.d.

5.3. Clinical Laboratory Practitioner - Laboratory Technician (CLP-MLT). - A person seeking licensure as a clinical laboratory practitioner - laboratory technician shall, at the time of application for initial licensure as a clinical laboratory practitioner - laboratory technician apply on the form provided by the Secretary, and submit documentation sufficient to establish that he or she:

5.3.a. Has earned an associate degree in medical technology/medical laboratory science from an accredited institution, and has passed a national certification examination administered by a certifying agency recognized under subsection 2.1 of this rule; or

5.3.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 (1) year of pertinent full-time experience, or training, or both, designed to provide him or her the following with respect to the specialties or subspecialties he or she will perform:

5.3.b.1. The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens;

5.3.b.2. The skills required for implementing all standard laboratory procedures;

5.3.b.3. The skills required for performing each test method and for proper instrument use;

5.3.b.4. The skills required for performing preventive maintenance, trouble shooting and calibration procedures related to each test performed;

5.3.b.5. A working knowledge of reagent stability and storage;

5.3.b.6. The skills required to implement the quality control policies and procedures of the laboratory;

5.3.b.7. An awareness of the factors that influence test results; and

5.3.b.8. The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results; or

5.3.c. Has successfully completed sixty (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 6 semester hours of chemistry, 6 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 (1) year of pertinent full-time experience or training, or both, designed to comply with the requirements of paragraphs 5.3.b.1 through 5.3.b.8 of this rule. Applicants with an associate’s degree in medical technology/medical laboratory science are excluded from this provision; or

5.3.d. On or before April 24, 1995, be a high school graduate or equivalent and have either:

5.3.d.1. Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA or other organization approved by HHS; or

5.3.d.2 Successfully completed an official US military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).; or

5.3.e On or before July 7, 1989, was performing, at least, moderate complexity tasks in a clinical laboratory.

5.3.f. Was licensed as a CLP-MLT immediately preceding the effective date of this rule series and has complied with all of the applicable requirements of paragraphs 5.1.a through 5.1.d.

5.4. Clinical Laboratory Practitioner - Cytotechnologist (CLP-CT). - A person seeking licensure as a clinical laboratory practitioner - cytotechnologist shall, at the time of application for initial licensure as a clinical laboratory practitioner - cytotechnologist, apply for licensure on the form provided by the Secretary and submit 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; or

5.4.b Has been certified in cytotechnology by a certifying agency approved by United States Department of Health and Human Services.

5.5. Clinical Laboratory Practitioner - Point of Care Technician (CLP-POCT). -

5.5.a. A person seeking licensure as a clinical laboratory practitioner - point of care technician shall, at the time of application for initial licensure as a clinical laboratory practitioner - point of care technician, apply on the form provided by the Secretary, and submit documentation to establish that he or she:

5.5.a.1. Has at least a high school diploma, a general education development certificate (GED), or an equivalent approved by the State department of education;

5.5.a.2. Is employed in a clinical laboratory which holds a CLIA certificate other than a certificate of waiver; and

5.5.a.3. Submits with the application a statement obtained from and signed by his or her laboratory director which states that the applicant has had training designed to provide him or her the following with respect to the specific tests he or she will perform:

5.5.a.3.A. The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens;

5.5.a.3.B. The skills required for implementing all standard laboratory procedures;

5.5.a.3.C. The skills required for performing each test method and for proper instrument use;

5.5.a.3.D. The skills required for performing preventive maintenance, trouble shooting and calibration procedures related to each test performed;

5.5.a.3.E. A working knowledge of reagent stability and storage;

5.5.a.3.F. The skills required to implement the quality control policies and procedures of the laboratory;

5.5.a.3.G. An awareness of the factors that influence test results; and

5.5.a.3.H. The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.

5.5.b. 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 as required by subparagraphs 5.5.a.3.A. through 5.5.a.3.H. of this subsection.

5.6. Initial License. - If an applicant complies with subsection 5.1 of this section, the Secretary shall grant licensure as follows:

5.6.a. A clinical laboratory practitioner - scientist license to an applicant who complies with the requirements of subsection 5.2 of this section;

5.6.b. A clinical laboratory practitioner - technician license to an applicant who complies with the requirements of subsection 5.3 of this section;

5.6.c. A clinical laboratory practitioner - cytotechnologist license to an applicant who complies with the requirements of Subsection 5.4 of this section; or

5.6.d. A clinical laboratory practitioner - point of care technician license to an applicant who complies with the requirements of Subsection 5.5 of this section.

5.7. Renewal License.

5.7.a. 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 ten (10) contact hours (one (1) continuing education unit) of educational 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, activities such as: lectures, seminars, workshops, formal classes, in-service programs or correspondence courses.

5.7.b. The Secretary shall renew a license if the applicant submits the licensure fee, a completed application form and otherwise is in compliance with the requirements of this rule.

5.8. Term of License. - A clinical laboratory practitioner license expires one (1) year after the date it was issued.

5.8.a. A license which has lapsed or been inactive for more than five years may not be reinstated through renewal.

5.8.b. 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.

5.9. Fees applicable to requests for licenses under special circumstances: - Additional fees shall be charged for the following:

5.9.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.

5.9.b. A fee of $20 for a replacement license.

5.9.c A $20 fee for reinstatement of a lapsed license.

5.9.d. A same-day “emergency” issuance fee of $35 for processing and issuance of license requested by the licensee or management to be issued within a 24 hour turn-around time.

5.9.e. A state licensure penalty of $100 per non-licensed or lapsed licensed testing personnel found during the CLIA survey process for non- compliance with federal CLIA-88 Personnel Requirements, 42 CFR 493.1489 or 493.1423, failure to possess a current license issued by the state.

5.9.f. A $10 fee for issuing an official licensure source verification on paper as opposed to using the electronic verification system available online at www.wvdhhr.org/labservices at no charge. In the event that the electronic system is non-functional, no charge will be applied for a paper verification.

5.9.g. A special handling fee of $10 per license processing for practitioner license (s) mailed to laboratory management in lieu of the licensee home address.

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