Shasta County Public Health Lab

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 in the specialty of Bacteriology constituting unsuccessful PT performance. (See D2020) 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 -- D2020 BACTERIOLOGY CFR(s): 493.823(a) 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 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, Bacteriology, resulting in an "initial" (first) unsuccessful performance. 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 Bacteriology, as follows: 2022 Q3 2023 Q1 Bacteriology 63% 0% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performances for the same analyte or test in two out of three consecutive PT resulted in an unsuccessful performance for the analyte, Bacteriology. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing High Complexity Testing: Laboratory Director was not met. The laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: For the analyte Bacteriology, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance (D2016 and D2020) -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for parallel instrument testing and an interview with the laboratory director (LD) on 3/9/22 between 9:00 a. m. and 12:00 p.m, it was determined that there was not documentation for parallel testing in 2020 for two instruments. Findings include: 1. On 3/9/22, an inspection was conducted between 9:00 a.m. and 12:00 p.m. 2. During a review of the laboratory documentation to support parallel testing (parallel testing is required each year when two instruments are used to report results for the same analyte), it was noted that there was not parallel testing data for the two Applied Biosystem 7500 (ABI) devices in 2020. 3. The LD recognized the above results. 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 D2020 BACTERIOLOGY CFR(s): 493.823(a) 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 2018 laboratory proficiency testing records, AAB (American Association of Bioanalysts) Bacteriology proficiency testing reports, and patients test results; and interview with Technical Supervisor-2 (Testing Person-3), it was determined that the laboratory failed to attain overall scores of at least 80%, constituting unsatisfactory performances in the culture and identification of Bacteria. Findings included: a. Event 1/ 2018: The laboratory reported incorrect responses (*) for a score of 50%, as follows: # Lab result Intended ----------------------------------------------------- 2 Gram positive * Group A Strep / Gram negative 3 Klebsiella Staph epidermidis pneumonia * 5 Neisseria sp, NOS * (no Neisseria) b. Event 3/ 2018: The laboratory reported incorrect responses (*) for a score of 40%, as follows: # Lab result ----------------------- 1 E. coli * 4 Shigella flexneri * 5 Klebsiella pneumoniae * c. The laboratory

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on request, and the lack of documentation for performance specifications of two (2) Applied Biosystems 7500 instruments Serial Number (SN) # 275030181 and SN # 275030936 acquired in 2016, random patient test results, and interview with the technical consultant, it was determined that the laboratory failed to perform verification of performance specification studies for the above instruments. The findings included: a. The laboratory lacks the documentation for verification performance specifications for the two (2) Applied Biosystems 7500. b. For two (2) out of eight (8) random patient test results reviewed covering period from 1/4/2016 to 11/27/2017, the laboratory analyzed and reported two (2) patients; one had ordered for Bordetella pertussis test and one had ordered for Influenza test which results may be affected by the lack of instrument's performance specification studies. c. The technical consultant affirmed (1/11/2018, 1230PM), that the laboratory has no documentation to show for its instruments verification of performance. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or 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 -- instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on request, and the lack of documentation for comparison of two (2) Applied Biosystems 7500 instruments Serial Number (SN) # 275030181 and SN # 275030936 acquired in 2016, review of the laboratory's policy and procedure manual, random patient test results, and interview with the technical consultant, it was determined that the laboratory failed to perform comparison studies for the above instruments. The findings included: a. Review of the laboratory's policy and procedure stated that: "Chapter 11. Comparison of Test Results. A. Comparison of Test Results. Conduct parallel studies to compare test methods or instruments." b. For two (2) out of eight (8) random patient test results reviewed covering period from 1/4/2016 to 11/27/2017, the laboratory analyzed and reported two (2) patients; one had ordered for Bordetella pertussis test and one had ordered for Influenza test which results may be affected by the lack of instrument's comparison studies. c. The technical consultant affirmed (1/11 /2018, 1230PM), that the laboratory has no documentation to show for its instruments comparison studies. -- 2 of 2 --