State Authority and Responsibilities
Washington's clinical laboratory licensing program is exempt from the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). Under the Medical Test Sites (MTS) licensure program:
- Issues licenses or certificates of waiver to about 3,500 test sites under the Washington State Medical Test Site licensure program;
- Conducts biennial on-site surveys of about 600 non-waived medical test sites using an outcome-oriented approach;
- Examines quality control and patient records, test performance, test reporting, management policies and quality assurance programs during on-site inspection;
- Verifies corrections of deficiencies by an on-site visit or through mail or telephone contact, depending on nature of deficiencies;
- Monitors proficiency test results for acceptable performance for about 600 licensed sites; provides consultation and technical assistance to regulated sites;
- Provides information on laboratory and healthcare issues to regulated sites and interested parties through a monthly newsletter;
- Performs complaint investigations
- Provides or facilitates training for technical personnel; and
- Manages a computer database of all medical test sites and provides information to other state agencies and federal government.
Facilities and services regulated
- Ambulatory surgical centers
- Blood banks
- Clinics
- Commercial independent laboratories
- Community clinics
- Correctional facilities
- Drug treatment centers
- End-stage renal disease
- Health clubs
- Health departments
- Home health agencies
- Hospitals
- Intermediate care facilities
- Midwives
- Migrant health centers
- Mobile units/sites
- Nursing homes
- Physician office laboratories
- Pregnancy counseling centers
- Rural health clinics
- Student health services
- Visiting nurses