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Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events for Syphilis Serology, constituting unsuccessful PT performance. (See D2074) 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 -- D2074 SYPHILIS SEROLOGY CFR(s): 493.835(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Syphilis Serology, resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, Syphilis Serology, as follows: 2019 Q2 2020 Q1 Syphilis Serology 60% 60% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for Syphilis Serology. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For Syphilis Serology, the laboratory repeatedly failed to achieve satisfactory performance in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2074) -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory test records for ten (10) randomly selected patients results from 07/07/2017 to 02/07/2019, proficiency testing (PT) result reports, and interview with the laboratory supervisor, it was determined that the laboratory failed to enroll and participate in a proficiency testing (PT) program that meets the criteria in subpart H of 42 CFR part 493 and is approved by HHS. The findings included: a. The laboratory performed bacteriology, routine chemistry, endocrinology, toxicology and hematology testing which is in the list of subpart I of 42 CFR part 493 using the BD Probe Tec ET, Beckman DxC, UniCel DxC, Access II and Sysmex CA series, Coulter UniCel DxH analyzers. b. The laboratory failed to show evidence of enroll in a PT program for bacteriology, routine chemistry, endocrinology, toxicology and hematology testing events using a CMS approved PT program for the first event (Q- 1), 2017 and third event (Q-3), 2018 (which meets the criteria in subpart H of 42 CFR part 493). The laboratory analyzed and reported bacteriology, routine chemistry, endocrinology, toxicology (therapeutic drugs) and hematology (complete blood count (CBCD) and PT/PTT) patient test results during the approximate time of non- enrollment in a proficiency testing (PT) program; the PT 1st event (Q-1), 2017 for routine chemistry, endocrinology, toxicology and hematology and bacteriology and 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 -- 3rd event (Q-3), 2 018 for (C. trachomatis and N. gonorrhoeae) analytes. c. The laboratory supervisor confirmed 04/11/2017 13:00 (survey date) that patient test results were reported for the PT 1st event (Q-1), 2017 for routine chemistry, endocrinology, toxicology and hematology and bacteriology and 3rd event (Q-3), 2 018 for (C. trachomatis and N. gonorrhoeae) analytes yet the laboratory was not enrolled in an accredited PT program. d. The laboratory annual testing declaration (04 /11/2019) estimated the bacteriology, routine chemistry and endocrinology, toxicology and hematology estimated the total test volume as 2,360,501. D2099 ENDOCRINOLOGY CFR(s): 493.843(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 API (American Proficiency Institute) proficiency reports (PT), review of ten (10) randomly selected patient result records from 07/07/2017 to 02/07/2019, proficiency testing (PT) results and interview with the laboratory technical supervisor, the laboratory failed to attain a score of at least 80 percent for thyroxine (TY). The findings included: a. API second event (Q-2) 2018 the laboratory received a proficiency testing score of 0% for the thyroxine (TY) analyte performed on the Beckman Access analyzer. Sample Reported Result Expected Result CH-06 18.6 12.1 - 18.3 CH-07 8.7 5.5 - 8.3 CH-08 12.3 7.6 - 11.5 CH-09 18.5 11.6 - 17.5 CH-10 24.6 13.4 - 20.3 c. The technical supervisor confirmed on 04/11/2019 15:00 (Survey date) that the laboratory had failed to attain a proficiency score of at least 80 percent for thyroxine (TY). D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review and the lack of documentation of enrollment in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS, and interview with the laboratory supervisor, it was determined that the laboratory director failed to ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the bacteriology, routine chemistry, endocrinology, toxicology and hematology analytes testing performed. (See D-2000) -- 2 of 2 --