Centracare Laboratory Services - Albany

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure Hematology and Microbiology proficiency testing (PT) samples from two of five Hematology PT events and one of five Microbiology events reviewed from 2020 through mid 2021 were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Hematology and Microbiology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory at 11:00 a.m. on 12/22/21. 2. The laboratory performed PT in 2020 and 2021 using the American Proficiency Institute proficiency testing provider. 3. The Proficiency Testing Policy found in the Lab Test Manual indicated PT samples would be tested in the same manner as patient specimens. 4. The Blood Cell Identification (BCI), Differential (Diff), Vaginal Wet Preparation with KOH (VKP), Vaginal Wet Preparation (VA), Urine Sediment (US), and Potassium Hydroxide slide (KOH) PT samples were tested by multiple testing personnel (TP) prior to the event submission deadline for three PT events as indicated on attestation statements and handwritten result documents. See below. 2020 - Hematology 2nd event Submission deadline 07/13/20 Samples BCI-06 through BCI- 10 Diff-02 VKP-02 VA-02 US-03 and US-04 Tested by TP1 and TP3 on 07/03/20 2021 - Microbiology 2nd event Submission deadline 07/07/21 Samples KOH-03 Tested by TP1 and former TP PS on 07/01/21 2021 - Hematology 3rd event Submission deadline 11/23/21 Samples BCI-11 through BCI-15 VKP-03 VA-03 US- 05 and US-06 Tested by TP2 on 11/11/21 and TP4 on 11/09/21 5. In an interview at 1: 40 p.m. on 12/22/21, TP1 confirmed the above finding. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)