Medical Group Lancaster

Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview with the testing personnel (TP); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent in Hematology Monocyte counts for the third event of 2019 (Q3-2019) which is unsatisfactory performance. The findings included: 1. On the date of the survey March 2, 2021 at approximately 11:00 a.m. based on review of the PT scores, the laboratory obtained for Hematology Monocyte automated count by Horiba ABX Micros Instrument for Q3-2019 and overall score of 40% as follow: Q3-2019 Monocyte Overall score 40%: Sample Reported Expected Score 11 4.7 5.0 - 9.9 U 12 33.3 10.7 - 36.5 A 13 10.8 4.8 - 10.1 U 14 4.6 1.9 - 4.5 U 15 33.6 11.1 - 35.8 A A = Acceptable U = Unacceptable 2. The TP affirmed on 03/02/2021 at approximately 12:00 pm the laboratory obtained the PT scores in 1. 3. According to the laboratory testing declaration submitted on the day of the survey (03/02/2021) for the years 2019-2020, the laboratory analyzed and reported approximately 3,650 (quarterly) WBC counts with differentials including Monocytes during the time the laboratory received an unsatisfactory PT performance score. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. 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 -- This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing reports and interview with the testing personnel (TP); it was determined that the laboratory failed to return proficiency testing results for Hematology for the second quarter event for 2020 (Q2-2020) to the proficiency testing program within the time frame specified by the program which is unsatisfactory performance and results in a score of zero (0). The findings included: 1. The AAB proficiency agency reported to CMS for Q2-2020 an unsatisfactory score of 0% for Cell ID or WBC Diff, RBC, HCT (non-waived), Hemoglobin (non-waived), WBC, and platelets failure to submit results within the time frame specified by the program. 2. The TP affirmed on March 2, 2021 at approximately 11:30 a.m. that the AAB Hematology proficiency score for Q-2 2020 of zero (0%) was obtained. 3. Based on the laboratory's annual test volume declaration on 03/02/2021 the laboratory analyzed and reported approximately 3,650 Hematology tests during the time the PT results were unsatisfactory. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the second quarter of 2020 of the American Association of Bioanalysts proficiency testing records, random patient test results, and interview with the testing person, it was determined that the laboratory director failed to ensure that results are returned within the timeframes established by the proficiency testing program. See D 2127. -- 2 of 2 --

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 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 for Troponin analyte. The findings included a. Based on the laboratory's annual testing volume submitted for 2017-2018 forTroponin analyte, the laboratory analyzed and reported 13 tests. b. The technical consultant affirmed (10/1/2018, 1330) that the laboratory has no documentation to show of QC performance for Troponin 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: 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 -- 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. Based on the laboratory's annual testing volume submitted for 2017-2018 for Troponin analyte, the laboratory analyzed and reported 13 tests. b. The technical consultant affirmed (10 /1/2018, 1330) that the laboratory has no documentation to show of QC performance for Routine Chemistry testing. -- 2 of 2 --