Information Gathering

6116 - Information Gathering (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) The technique for information gathering includes observation, interviews, and record review and these are usually performed concurrently. The information gathering process is critical in the determination of quality laboratory testing. Gather sufficient information to evaluate the laboratory’s operations without being overly intrusive or gathering excessive information. As each laboratory is unique in the services offered, the order of gathering information may be different for each survey. The timing for observing testing and the availability of staff for interview may determine the sequence of the survey. Consider the laboratory’s compliance history (including, but not limited to, deficient practices and Plans of Correction). Verify the correction of all previously cited deficiencies and continued compliance with CLIA regulations. Pay particular attention to deficiencies that the laboratory has failed to correct. Refer to enforcement requirements at 42 CFR Part 493, Subpart R, if needed.