Summary:
Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the quality assessment (QA) plan, the QA records and interview with the laboratory liaison, the laboratory failed to follow the QA plan for complete blood count (CBC) quality control (QC) review process, in 2018 and 2019. The findings include: 1) Observation of the laboratory on July 3, 2019 at 9:50 a.m. revealed the Medonic CBC instrument, serial number 22514, in use for patient CBC testing. 2) Review of the QA plan revealed, "At the end of each month the clinic will email the monthly quality control summary page for that month to include all three levels of controls and the kit insert containing the limits and ranges to the technical consultant. The TC will review the quality control records, noting any problems or issues that may need