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To ensure that the public receives accurate and reliable clinical laboratory services and test results by monitoring and evaluating medical test sites for compliance with minimum standards of quality assurance for clinical laboratory testing.

The federal Clinical Laboratory Improvement Amendments (CLIA), which requires certification of all sites performing clinical laboratory testing, was passed in 1988. Prior to 1988, the only laboratories that were regulated were those that did interstate testing, or independent laboratories and hospitals that wanted Medicare reimbursement. CLIA changed the picture dramatically by including all sites where testing was being performed, such as doctor's offices, clinics, health departments, etc.

The legislature passed the Medical Test Site (MTS) Licensure law (Chapter 70.42 RCW) in May 1989 to allow the state to regulate clinical laboratory testing. The rules to implement the law (Chapter 246-338 WAC) were adopted in October 1990.

In September 1992 the federal regulations to implement CLIA became effective. CLIA allowed equivalent State programs to apply for exemption from Federal regulation. Washington State applied for exemption in October 1992. In October 1993, Washington became the first state to have its clinical laboratory licensure program judged by the Federal Health and Human Services Centers for Medicare and Medicaid Services (CMS) as equivalent to CLIA and was granted an exemption. This exemption from CLIA retains the regulatory activity at the state level, rather than federal, where it is more accessible and responsive to local needs.

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 approximately 2,600 test sites under the Washington State Medical Test Site licensure program;

• Conducts biennial on-site surveys of approximately 600 non-waived medical test sites utilizing 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 approximately 600 licensed sites;

• Provides consultation and technical assistance to regulated sites;

• Provides information on laboratory and health care 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.

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Facilities and Services Regulated

• Ambulatory Surgical Centers

• Blood Banks

• Clinics

• Commercial Independent Laboratories

• Community Clinics

• Correctional Facilities

• Drug Treatment Centers

• End Stage Renal Disease Centers

• 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

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           Seattle Office Phone Number:   206.418.5600
           Seattle Office Fax Number:   206.418.5505

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DOH Home | Access Washington | Privacy Notice | Disclaimer/Copyright Information

Washington State Department of Health
Facility Services Licensing
P.O. Box 47852
Olympia, WA 98504-7852
Phone: (360) 236-2905
Fax: (360) 236-2901 

Last Update : 11/09/2007 02:37 PM
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