Ashley Medical Center

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to perform two levels of quality control (QC) 3 of 5 patient testing days (01/03, 01/11, and 01/20) for free thyroxine (FT4) and 3 of 11 patient testing days (01/06, 01/07, 01 /11) for hemoglobin A1C (HgbA1C) in January 2022. The laboratory performed four FT4 and seven HgbA1C patient tests on the days in January when the laboratory performed only one level of QC. Findings include: 1. Review of the January 2022 QC results for analytes on the Ortho Vitros 5600 chemistry analyzer occurred on 04/27 /22. The laboratory performed one level of QC for FT4 on 01/03, 01/11, and 01/20. The laboratory performed one level of QC for HgbA1C on 01/06, 01/07, and 01/11. 2. During interview at 12:10 p.m. on 04/27/22, the laboratory supervisor (#1) stated the laboratory should perform two levels of QC on days when the laboratory tests patient specimens and confirmed the laboratory performed one level of QC for FT4 on 01/03, 01/11, and 01/20 and for HgbA1C on 01/06, 01/07, and 01/11 in January 2022. 3. The undated policy "Quality Control Processing, Reviewing,

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to twice annually verify the accuracy of 1 of 1 non-regulated microscopy analyte (urine sediment) in 2019. The laboratory performed approximately 330 urine sediment patient tests in 2019. Findings include: 1. Reviewed at approximately 11:00 a.m. on 11 /23/20, the laboratory's test menu listed urine sediment microscopy available for patient testing. 2. Reviewed at approximately 11:00 a.m. on 11/23/20, the 2019 proficiency testing records indicated the laboratory did not participate in proficiency testing for urine sediment microscopy. 3. Upon request on 11/23/20, the laboratory failed to provide evidence of twice annual accuracy verification for urine sediment microscopy in 2019. 4. During interview at 12:30 p.m. on 11/23/20, the laboratory manager (Personnel #1) confirmed the laboratory performed urine sediment microscopy patient testing and did not twice annually verify the accuracy in 2019. 5. Reviewed at 4:30 p.m. on 11/23/20, the policy "Proficiency Testing (PT) / (3) Sets Performed/Year," dated 08-2006, stated, ". . . (3) Five (5) PT samples are sent for each analyte done in the laboratory. . . ." 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 --