Allegheny County Health Department

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and interview with the technical supervisor (TS) #3, the laboratory failed to evaluate and verify the accuracy of the PT results not graded by the PT agency for 14 of 17 CAP PT testing events performed from 3/6/2024 to 3/12 /2026. Findings: 1. On the day of survey, 3/12/2026 at 10:50 am, review of the laboratory's CAP PT results revealed the laboratory failed to verify the accuracy of PT results not graded by the PT agency for the following 14 of 17 CAP PT testing events performed from 3/6/2024 to 3/12/2026: a. CAP: Laboratory Preparedness: 5 of 6 events in 2024 and 2025 b. CAP: Parasitology: 3 of 3 events in 2025 c. CAP: Monkey Pox: 2 of 2 events in 2025 d. CAP: Nucleic Acid Amplification Respiratory Limited: 1 of 3 events in 2025. e. CAP: Infectious Disease Respiratory Panel: 3 of 3 testing events in 2025. 2. TS #3 confirmed the finding above on 3/12/2026 at 3:45 pm. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures and interview with the Laboratory Director, (LD), the laboratory failed to ensure that 1 of 1 laboratory procedures used for Virology and Bacteriology testing were approved, signed and dated by the current LD for 2 of 2 years from 03/06/2024 to day of survey. Findings include: 1. On the day of survey, 03/12/2026 at 09:30 am, review of the laboratory procedure manual used for Virology and bacteriology testing revealed the laboratory failed to ensure the following procedures were approved, signed, and dated by the current LD for 2 of 2 years from 03/06/2024 to 03/12/2026: - Aptima Combo 2 assay for Chamydia Trachomatis/ Niessera Gonherrra - General Bacteriology Procedure - Rapid Identification Procdure 2. The laboratory performed 17,483 bacteriology and virology tests in 2025 (CMS 116, estimated annual volume, dated 03/12/2026). 3. The LD confirmed the above findings on 03/12/2026 at 04:00 pm. 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: A. Based on lack of documentation, and interview with Technical Supervisor (TS) #2, the laboratory failed to monitor room temperature and humidity to ensure proper storage of reagents and specimens, on weekends and holidays for 208 out of 730 days from 03/006/2024 to 3/12/2026. Findings include: 1. On the day of survey, 3/12/2026 at 1:30 pm, review of the laboratory's temperature records revealed the laboratory failed to monitor and document room temperature and humidity to ensure proper storage of reagents and specimens were maintained for 208 of 730 days from 3/06 /2024 to 3/12/2026 when the laboratory was closed. 2. The following reagents were not monitored for proper storage and monitoring: Hologic Panther/Fusion system: - Aptima Combo 2 Assay Kit (Reagent box 1: 2-8 degrees Celsius; Reagent box 2: 15- 30 degrees Celsius) Biofire Torch: -FilmArray GI Panel (Kit and patient sample storage 15-25 degrees Celsius) Diasorin Liaison: -XL Murex HBsAg Confirmatory (2- 8 degrees Celsius) -XL Murex HCV Ab (Kit and patient sample storage 2-8 degrees Celsius) BioRad Geenius System: -HIV Confirmatory Kit (2-30 degrees Celsius) Gold Standard AIX-1000 -RPR (Kit and patient sample storage conditions 2-8 degrees Celsius) 2. The laboratory performed 17,483 total tests/examinations in 2025 (CMS 116, estimated annual volume, dated 03/02/2026). 3. TS #2 confirmed the findings above on 3/12/2026 at 2:00 pm. B. Based on observation in the laboratory, lack of documentation, and interview with technical supervisor (TS) #3, the laboratory failed to monitor daily temperatures and humidity to ensure proper operating conditions were met for 5 of 5 Olympus BX43 microscopes and 1 of 1 Olympus DP72 microscope from 3/6/2024 to 3/12/2026. 1. The manufacturer acceptable temperature and humidity range for the microscopes are as follows: - Olympus BX43 requirements: temperature 5C to 40C and humidity up to 80% Relative Humidity - Olympus DP72 requirements: temperature 10C to 35C and humidity 20% to 85% -- 2 of 6 -- Relative Humidity 2. On the day of the survey, 3/12/2026 at 12:00 pm, the laboratory failed to provide temperature and relative humidity documentation to ensure proper operating conditions were met for 5 of 5 Olympus BX43 microscopes and 1 of 1 Olympus DP72 microscope from 3/6/2024 to 3/12/2026. 3. The laboratory performed 17,483 total tests/examinations in 2025 (CMS 116, estimated annual volume, dated 03 /02/2026). 4. TS #3 confirmed the findings above on 3/12/2026 at 12:45 pm. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with Technical Supervisor (TS) #3, the laboratory failed to label 1 of 1 container used to aliquot reagents with the pertinent information required for proper use from 3/6/2024 to 3/12/2026. Findings include: 1. On the day of survey, 3/12/2026 at 2:30 pm, during the laboratory tour, observation of the laboratory revealed 1 of 1 container used to aliquot reagents (saline) were not properly labeled with the following when immunology examinations were performed from 3/6/2024 to 3/12/2026: - Storage requirements - Preparation and expiration dates 2. The laboratory performed 7,010 immunology examinations in 2025 (CMS 116, estimated volume, dated 03/02/2026). 3. The LD confirmed the findings above on 03/12/2026 at 4:00 pm. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of procedures, maintenance records, and interview with Technical Supervisor (TS) #2, the laboratory failed to perform and document maintenance checks as defined by the manufacturer for the Hologic Panther used for immunology examinations for 10 of 24 months from 3/6/2024 to 3/12/2026. Findings include: 1. On the day of survey, 3/12/2026 at 11:30 am, review of the laboratory's maintenance records revealed the laboratory failed to perform and document the manufacturer recommended daily, weekly and monthly maintenance checks for the Hologic Panther used for immunology examinations for 10 of 24 months (March through December 2024) from 3/6/2024 to 3/12/2026. 2. TS #2 confirmed the findings above on 3/12 /2026 at 2:00 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 -- 3 of 6 -- have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with the laboratory director (LD), the laboratory failed to evaluate twice a year the relationship between test results using different methodologies for immunology, virology, and syphilis examinations for 2 of 2 years from 3/6/2024 to 3/12/2026. Findings include: 1. On the day of the survey, 3 /12/2026 at 1:10 pm, the laboratory failed to provide documentation for the evaluation performed twice a year to monitor and evaluate the relationship between the following methodologies used for immunology, virology, and syphllis examinations for 2 of 2 years from 3/6/2024 to 3/12/2026: - Manual vs Automated Rapid Plasma Reagin - Herpes Simplex Virus 1 and 2, Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, Hepatitis C Virus on 2 of 2 Hologic Panthers - Gastrointestinal Panel on 2 of 2 BioMerieux Biofire Torch - Measles PCR, Monkey Pox PCR, Influenza viruses and Covid on 2 of 2 Quant Studio 2. The LD confirmed the findings above on 3/12/2026 at 3:30 pm. D5781

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 --