West Virginia Code of State Rules
Title 64 - Health
64-57 - Clinical Laboratory Technican and Scientist Licensure and Certification
§64-57-1 - General.

§64-57-1. General.

1.1. Scope. - This legislative rule sets forth standards and procedures for the licensing of laboratory technicians and medical laboratory scientists as clinical laboratory practitioners and establishes penalties for the use of unlicensed persons to perform the work of clinical laboratory practitioners by health care facilities.

1.2. Authority. - W. Va. Code §§16-1-4, 16-1-11 and 16-5J-10.

1.3. Filing Date. - May 22, 2017

1.4. Effective Date. - June 1, 2017

1.5 Sunset Provision. - This rule shall terminate and have no further force or effect on June 1, 2022.

1.6. Applicability. - Except as otherwise provided in this rule, this rule applies to:

1.6.a. Clinical laboratory practitioners employed as such in West Virginia who perform non-waived clinical laboratory tests as defined in section 42 CFR 493.17 of the Clinical Laboratory Improvement Amendment of 1988 (CLIA-88), including individuals employed as clinical laboratory practitioners in agencies or organizations exempted from licensure as a laboratory under the provisions of W. Va. Code§16-5J-7; and

1.6.b. Clinical laboratory consultants, directors, and supervisors in West Virginia.

1.6.c. This rule does not apply to:

1.6.c.1. Any individual who performs only laboratory tests published in the Federal Register as waived under CLIA by the Centers for Disease Control under the provisions of § 42 CFR 493.17;

1.6.c.2. Any physician, dentist, nurse practitioner, nurse midwife or physician assistant, licensed within this State working within the scope of his or her professional license, who performs only provider-performed microscopy procedures as found at § 42 CFR 493.19 (a) - (d);

1.6.c.3. Any respiratory care provider licensed within the state providing diagnostic testing within the scope of his or her professional license who performs moderate complexity testing as defined by CLIA, pursuant to 42 CFR 493.17; or

1.6.c.4. Any individual who performs laboratory tests only on himself or herself or members of his or her family.

1.7. Enforcement. - This rule is enforced by the Secretary of the West Virginia Department of Health And Human Resources.

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