Sierra Medical Group Inc

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing records reports and interview with the testing personnel (TP); it was determined that the laboratory failed to verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance. The findings included: 1. The AAB reported an artificial 100% proficiency score for the Cardiac Markers/ Isoenzymes: Troponin I for the first event of 2019 (Q1-2019) and the third event of 2019 (Q3-2019) as follow: a. (Q1-2019) Specimen Reported Intended 1 # 8.81 3.18 - 5.3 2 0.33 0 - 0.35 3 ? 15.82 6.63 - 11.05 4 #43.33 13.04 - 21.74 5 #4.95 1.55 - 2.59 Note: True score for Troponin I should have been 20%. b. (Q3-2019) Specimen Reported Intended 1 0.24 0 - 0.32 2 #32.56 13.02 - 21.7 3 # 6.13 3.5 - 5.84 4 #13.88 7.95 - 13.25 5 #3.05 1.58 - 2.63 Note: True score for Troponin I should have been 20%. c. The AAB has the following footnotes: ? = This score may not truly evaluate performance for these specimens which were not graded because of a lack of participant's consensus. # = this method was not grade due to an insufficient number of peer respondents. No appropriate default grouping was available. The listed ranges should provide a reasonable guide to your performance. However exercise caution in evaluating your results. 3. The testing personnel confirmed on 03/03/2021 that the laboratory received the above artificial 100% scores and that the laboratory did not have a

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on request, review of random patient sampling test orders, and interview with the technical consultant, it was determined that the laboratory failed to have a written or electronic request for patient testing from an authorized person. The findings included: a. For one (1) out of six (6) random patient test results reviewed covering period from 7/29/2016 to 7/27/2018, one (1) patient was analyzed and reported for Complete Blood Count (CBC) without a test order from an authorized person. b. The technical consultant affirmed (10/1/2018, 1645) that the laboratory has no documentation to show for a written or electronic request for the above patient test results from an authorized person. 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 review and the lack of documentation for quality control (QC) performance, random patient sampling test results reviewed, and interview with the technical 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 -- consultant, it was determined that the laboratory failed to at least once a day patient specimens are assayed or examined perform the each quantitative procedure, include two control materials of different concentrations. The findings included. a. Based on the laboratory's annual testing volume submitted for 2017-2018 for Troponin analyte, the laboratory analyzed and reported 21 tests. b. The technical consultant affirmed (10 /1/2018, 1330) that the laboratory has no documentation to show of QC performance for Troponin analytes. c. For one (1) out of six (6) random patient test results reviewed from 7/21/2016 to 7/27/2018, one (1) patient had an order for CBC that was analyzed and reported without the QC materials analyzed and performed. d. The technical consultant affirmed (10/1/2018, 1330) that the laboratory has no documentation to show of QC performance for CBC analytes. 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 review and the lack of documentation for quality control (QC) performance, random patient sampling test results reviewed, and interview with the technical consultant, it was determined that the laboratory failed to at least once a day patient specimens are assayed or examined perform the each quantitative procedure, include two control materials of different concentrations. The findings included a. The laboratory analyzed and reported thirteen (13) Troponin analytes from 10/2017 to 10 /2018 with no documentation of QC performed. b. For one (1) out of six (6) random patient test results reviewed from 7/21/2016 to 7/27/2018, one (1) patient had an order for CBC that was analyzed and reported without the QC materials analyzed and performed. c. The technical consultant affirmed (10/1/2018, 1645) that the laboratory has no documentation to show of QC performance for Troponin and CBC analytes. -- 2 of 2 --