W. Va. Code R. § 64-57-1

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 64-57-1 - General

1.1. Scope. -- This legislative rule sets forth standards and procedures for the licensing of 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. -- April 4, 2022.

1.4. Effective Date. -- May 1, 2022.

1.5 Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2027.

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

1.6.a. Clinical laboratory practitioners who perform non-waived clinical laboratory tests as defined by 42 CFR 493.17 of the Clinical Laboratory Improvement Amendments of 1988 (CLIA); and

1.6.b. Clinical laboratory consultants, directors, supervisors, or testing personnel who perform non-waived testing or manipulate and report data obtained from laboratories 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 and Prevention 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) - (e);

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;

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

1.6.c.5. An individual employed as a clinical laboratory practitioner in an agency or organization exempt from licensure in accordance with W. Va. Code § 16-5j-7;

1.6.c.6. A medical doctor, doctor of osteopathy, or podiatrist licensed to practice that profession in West Virginia;

1.6.c.7. A doctor of philosophy performing laboratory testing within the scope of his or her degree and board certification;

1.6.c.8. An individual performing laboratory testing for a CLIA-exempt laboratory;

1.6.c.9. An individual solely performing forensic laboratory testing; or

1.6.c.10. An individual solely performing drug testing for a laboratory certified by the Substance Abuse and Mental Health Services Administration;

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

W. Va. Code R. § 64-57-1