Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing records, a review of the quality control records and an interview with the laboratory manager, the surveyor determined the laboratory failed to rotate the testing of proficiency specimens, among all personnel who test patient specimens [Complete Blood Counts (Hematology)]. This affected 8 of 8 Hematology testing events from 2018 (Event #3), 2019 and 2020 (six events), and 2021(Event #1). The findings include: 1. A review of API proficiency testing records revealed Testing Personnel (TP) #1 signed the attestation statements for all eight Hematology testing events from 2018 (Event #3) - 2021 (Event #1). 2. The laboratory staff listed the same three qualified and trained individuals on the CMS form #209 (Laboratory Personnel Report) as on the previous survey conducted 12/19/2018. 3. At 10:55 AM on May 26, 2021, the surveyor asked the laboratory manager (also listed as TP #3) about proficiency testing rotation, inquiring if TP #1 was the only personnel who perform Hematology testing. The laboratory manager stated TP #1 was the primary testing personnel, although TP #2 was usually on-site, and assisted with laboratory testing (CBC testing), when the laboratory is busy. TP #3, the laboratory manager, usually worked another location. The laboratory manager stated the testing would be rotated. 4. A review of the quality control records, from 2019 - 2021, revealed TP #2 performed testing on the Hematology analyzer. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (b) The analytic systems quality assessment must include a review of the effectiveness of