scope:

This guideline is intended for use by referring laboratories seeking a broad spectrum of services, a limited number of esoteric examinations, consultative services, or a backup service provider for examinations performed by the referring laboratory. This guideline provides recommendations for periodically evaluating the services provided by the referral laboratory. This guideline can also be used by referral laboratories to assist in understanding the qualification, selection, and evaluation process and what might be expected by them from a referring laboratory. The recommendations in this guideline include activities necessary to meet international and national published requirements for referral laboratories.

The recommendations in this guideline are not meant as the only way to qualify, select, and evaluate referral laboratories. Referring laboratories can modify the suggested criteria, with the caveat not to delete criteria that reflect applicable regulatory and accreditation requirements for medical laboratories.^2-13

¹ CLSI. A Quality Management System Model for Laboratory Services. 5th ed. CLSI guideline QMS01. Wayne, PA: Clinical and Laboratory Standards Institute; 2019.

² ISO. Quality management systems - Requirements. ISO 9001. Geneva, Switzerland: International Organization for Standardization; 2015.

³ ISO/IEC. General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025. Geneva, Switzerland: International Organization for Standardization; 2017.

⁴ ISO. Medical laboratories - Requirements for quality and competence. ISO 15189. Geneva, Switzerland: International Organization for Standardization; 2012.

⁵ Centers for Medicare & Medicaid Services, US Department of Health and Human Services. Part 493-Laboratory Requirements: Clinical Laboratory Improvement Amendments of 1988 (Codified at 42 CFR §493). Office of the Federal Register; published annually.

⁶ US Food and Drug Administration, US Department of Health and Human Services. Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals (Codified at 21 CFR §211). Office of the Federal Register; published annually.

⁷ US Food and Drug Administration, US Department of Health and Human Services. Part 610-General Biological Products Standards (Codified at 21 CFR §610). Office of the Federal Register; published annually.

⁸ US Food and Drug Administration, US Department of Health and Human Services. Part 58-Good Laboratory Practice for Nonclinical Laboratory Studies (Codified at 21 CFR §58, Subparts B through J). Office of the Federal Register; published annually.

⁹ The Joint Commission. Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing. Oakbrook, IL: Joint Commission Resources; published annually.

¹⁰ CAP. CAP Accreditation Checklists. Northfield, IL: College of American Pathologists; published annually.

¹¹ COLA. Laboratory Accreditation Manual. Columbia, MD: COLA; 2017.

¹² IQMH, Centre for Accreditation. IQMH Accreditation Requirements and Guidance Information. Version 7.1. Toronto, Canada: Institute for Quality Management in Healthcare; 2017.

¹³ AABB. Standards for Blood Banks and Transfusion Services. 31st ed. Bethesda, MD: AABB; 2018.