Laboratory Quality Assurance

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 Site licensure program, the Office of Laboratory Quality Assurance:

  • 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