Allegheny County Health Department

Summary Statement of Deficiencies 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 record review and interviews with technical supervisors (TS) #2 and (TS) #3, the laboratory failed to establish and follow written policies to continually monitor, assess, and correct problems identified in the analytic systems when immunology and virology testing was performed from 05/10/2022 to the day of survey. Findings include: 1. On the day of survey, 03/06/2024, review of the laboratory's Sure-Vue Rapid plasma reagin (RPR) card test records and the Panther 2 Lab Room Temp and Humidity records revealed the laboratory failed to document the following when Immunology and Virology testing was performed from 05/10/2022 to 03/06/2024: - Lot number and expiration date of RPR antigen reagent: 12 of 12 days in May 2022, 13 of 13 days in June 2022, and 5 of 8 days in December 2022. - Temperature of RPR antigen reagent to meet the laboratory's established acceptable range (23-29 C) prior to use: 12 of 12 days in May 2022, 13 of 13 days in June 2022, and 5 of 8 days in December 2022. - Weekly verification of accuracy of Sure-Vue RPR card testing (dispensing bottle and speed check) for 5 of 5 weeks in May 2022, 4 of 4 weeks in June 2022, and 3 of 4 weeks in December 2022. -

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Premier EHEC quality control (QC) records, and interview the technical supervisor (TS) #3, the laboratory failed to document QC procedures each day of patient testing in 2020 and 2021. Findings Include: 1. The Premier EHEC package insert states, "The positive and negative controls must be used with each assay run". 2. On the day of survey, 05/10/2022 at 11:45 am, review of the Premier EHEC quality QC records revealed, the laboratory did not document QC each day of patient testing from 05/10/2020 to 05/10/2022. 3. The TS #3 confirmed the findings above on 05/10/2022 around 12:00 PM. 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: 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 lack of documentation and interview with the Technical Supervisor (TS)#4, the laboratory failed to evaluate and document the relationship between the 2 of 2 Biofire FilmArray analyzers at least twice in 2020 and 2021. Findings Include: 1. On the day of survey, 05/10/2022, the laboratory could not provide documentation for the comparison of test results between 2 of 2 Biofire FilmArray analyzers for the gastrointestinal panel twice annually from 05/10/2020 to 05/10/2022. 2. The TP#4 confirmed the finding above on 05/10/222 around 12:00 pm. -- 2 of 2 --