Pittsburgh Retrovirus Laboratory

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Manager (LM), the laboratory failed to monitor and document room humidity to ensure operating conditions were met for 1 of 1 BD FACSCANTO II used to perform flow cytometry testing from 03/05/2024 to 12/10/2025. Findings include: 1. The manufacturers operating environment specifications stated the following: BD FACSCanto II Flow Cytometer: maximum 20-80 % relative humidity. 2. On the day of the survey, 12/10 /2025, the laboratory failed to provide documentation for the monitoring of room humidity to ensure operating conditions were met for the following instruments used to perform flow cytometry ( Immunology) testing from 03/05/2024 to 12/10/2025: - 1 of 1 BD FACSCanto II (s/n: V96100288) 3. The laboratory performed 240 Flow cytometry tests in 2024 (CMS 116, estimated annual volume, dated 12/09/2025). 4. The LM confirmed the above findings on 12/10/2025 at 09:30am. D5805 TEST REPORT CFR(s): 493.1291(c) 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 -- (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the Laboratory Manager (LM), the laboratory failed to include the address of the location where flow cytometry testing was performed on 2 of 2 patient test reports reviewed from 03/05 /2024 to the date of the survey. Findings include: 1. On the day of survey, 11/10/2025 at 9:45 am, review of 2 of 2 patient test reports revealed the laboratory failed to ensure the addition of the address of the laboratory where flow cytometery (Immunology) testing was performed from 03/05/2024 until 12/10/2025. 2. The laboratory performed 240 flow cytometery tests in 2024 (CMS 116, estimated annual volume, dated 12/09 /2025). 3. The LM confirmed the above findings on 12/10/2025 at 09:35 am. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Manager (LM), the laboratory failed to follow a procedure to assess the competency of 1 of 1 technical supervisor (TS) and 1 of 2 general supervisor (GS) for their supervisory responsibilities in 2023. Findings include: 1. On the day of survey, 3/5/2024 at 10:06 am, the laboratory failed to provide competency assessment records for 1 of 1 TS (CMS 209 personnel #2) and 1 of 2 GS (CMS 209 personnel #2) for their supervisory responsibilities in 2023. 2. LM confirmed the findings above on 3/5/2024 at 10:58am. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with testing personnel (TP) #2, the laboratory failed to ensure that reagents and supplies used for CD4/CD8 T cell flow cytometry examinations had not exceeded their expiration date from 02/23/2023 to the date of the survey. Findings Include: 1. On the date of the survey, 03/05/2024 at 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 -- 10:48 am, during the laboratory tour the surveyor observed that the following 3 of 3 boxes of reagents used for CD4/CD8 T cell flow cytometry examinations performed on the BD FACS Canto II were expired: - 1 box BD FacsClean (on instrument BD FACS Canto II) expired 2-23-2023 - 2 boxes BD FacsClean (in storage) expired 2-23- 2023 2. TP #2 confirmed the findings above on 03/05/2024 at 10:48 am. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) Proficiency Testing (PT) records and interview with the Laboratory Manager (LM), the laboratory failed to test 6 of 6 CAP PT Immunology (flow cytometry) samples with the laboratory's regular patient workload by personnel who routinely performed the testing in the laboratory in 2020, 2021 and 2022. Findings include: 1. On the day of survey 04/14 /2022 at 01:25 pm., review of the attestation statements revealed, that 6 of 6 CAP PT samples in 2020 (event 2 and event 3), 2021 (event 1, event 2, and event 3), and 2022 (event 1) were tested by Testing Personnel #1. Testing Personnel# 2 and # 3 who routinely performed patient testing in 2020, 2021 and 2022 did not take part in the PT testing. 2. The Laboratory Manager confirmed the finding above on 04/14/2022 at 02: 30 pm. 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 No Tags No deficiency details available. 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 --