The Outcome-Oriented Survey Process (OOSP)

6101 - The Outcome-Oriented Survey Process (OOSP) (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The outcome-oriented survey process (OOSP) is intended to direct the surveyor to those requirements that will most effectively and efficiently assess the laboratory’s ability to provide accurate, reliable, and timely clinical laboratory test results. In the OOSP the surveyor reviews and assesses the overall functioning of the laboratory and evaluates the laboratory’s ability to perform quality testing; that is, the surveyor evaluates the laboratory’s quality system. The quality system requirements in the Introduction to Subpart K and the General Laboratory, Preanalytic, Analytic, and Postanalytic Quality Assessment requirements are appropriate guides for the surveyor to organize the review. In the OOSP, the emphasis is placed on the laboratory’s quality system as well as the structures and processes throughout the entire testing process that contribute to quality test results. The surveyor selects a cross-section of information from all aspects of the laboratory’s operation for review to assess the laboratory’s ability to produce quality results. The surveyor reviews the cross-section of information to verify that the laboratory has established and implemented appropriate ongoing mechanisms for monitoring its practices and identifying and resolving problems effectively. If the findings from the review of the laboratory’s ongoing mechanisms for ensuring quality test results are sufficient to make the determination of compliance and if the evaluation does not warrant a more in-depth review, the surveyor concludes the survey and proceeds to the exit conference (see section 6126). NOTE: Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, includes guidelines and instructions for the listed regulatory requirements and encompasses all types of laboratory facilities. Surveyors should take care, therefore, to only cite to the portions of this document that are applicable to the laboratory operations and the complexity of testing performed and are regulatory in nature. Guidelines and instructions are not to be cited.