Public Health Lab City Of Philadelphia

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 review of laboratory temperature records, lack of documentation and interview with the Quality Officer, the laboratory failed to monitor and document temperatures to ensure proper storage of reagents and test system operating conditions were met for instrumentation used to perform hematology, chemistry, immunology and microbiology examinations for 242 of 852 days from 09/07/2022 to 12/31/2024. Findings include: 1. On the day of survey, 02/26/2025 at 1:31 pm, review of the laboratory's temperature logs revealed the laboratory failed to monitor and document the following temperatures for 242 of 852 days from 09/07/2022 to 12/31/2024: - refrigerator temperature (laboratory's acceptable range 2 to 8 degrees Celsius) - freezer temperature (laboratory's acceptable range -13 to -31 degrees Celsius) - room temperature (laboratory's acceptable range 15 to 30 degrees Celsius) 2. The hours of laboratory testing are Monday-Friday 07:00 am to 07:00 pm (CMS 116). The laboratory could not provide documentation of temperatures taken on days the laboratory was closed. 3. The Quality Officer confirmed the above findings on 02/26 /25 at 1:40 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 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 American Proficiency Institute (API) proficiency testing (PT) records and interview with the Quality Assuarance Officer (QA), the laboratory failed to verify the accuracy for 1 of 4 Mycobacteriology Culture Susceptibilites in 2021. Findings Include: 1. On the day of survey, 09/07/2022 at 10:11 am, review of 2021 API proficiency testing records revealed that the laboratory did not verify the accuracy for the following analytes that were not graded by the proficiency testing agency: - API 2021 Mycobacteriology 1st Event: Mycobacteriology Culture Susceptibility Testing for Pyrazinamide was not graded due to lack of particpants. 2. The QA Officer confirmed the findings above on 09/07/2022 around 03:00 pm. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Quality Assurance Officer (QA), the laboratory failed to document the evaluation and verification activities for 2 of 3 events of Chemistry 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 -- Core and 1 of 3 events of Microbiology for the Unacceptable Proficiency Testing (PT) for 2021. Findings Include: 1. On the day of survey, 09/07/2022 at 10:11 am, a review of API proficiency testing records revealed that the laboratory received an unacceptable grade for the following PT events. - 50% on API 2021 1st event Chemistry Core: PSA Testing Abbott Architect i2000SR. - 80% on API 2021 2nd event Chemistry Core: LDL Cholesterol (measured) (mg/dL). - 80% on API 2021 1st event Microbiology Core: Gram Stain. 2. The laboratory failed to provide documentation of the evaluation and verification activities for the above PT events. 3. The QA Officer confirmed the findings above on 09/07/2022 at 03:10 PM. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of the ALCOR iSED analyzer validation records and interview with the Technical Supervisor (TS)#3, the Laboratory Director (LD) failed to approve the performance specification procedures used to determine the accuracy and precision for the Erythrocyte Sedimentation Rate (ESR) testing performed on the ALCOR iSED before reporting patient test results from April 2022 to the date of survey. Findings Include: 1. On the day of survey, 09/07/2022 at 11:00 am, review of the ALCOR iSED validation records revealed that the LD did not review and approve the validation studies for the ALCOR iSED performed on 04/07/2022. 2. The TS#3 confirmed the findings above on 09/07/2022 around 3:00 p.m. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 review of Bactec MGIT 960 daily maintenance QC log sheets and interview with Testing Personnel #4 (TP#4), the laboratory failed to record the temperatures of the Bactec MGIT 960 for 32 of 169 days reviewed from January 2020 to August 2020. Findings include: 1. The Bactec MGIT 960 daily maintenance QC log sheet states: - "Perform daily, except on weekends and holidays." - "Perform even if no testing is being performed that day." 2. On the date of survey 11/12/2020, review of the Bactec MGIT 960 daily maintenance QC log sheet revealed, the laboratory did not document temperatures for the following days from January 2020 to August 2020: - 1 of 22 days in March 2020. - 3 of 22 days in April 2020. - 1 of 20 days in May 2020. - 3 of 21 days in June 2020. - 16 of 23 days in July 2020. - 8 of 21 days in August 2020. 3. TP#4 confirmed the findings above on 11/12/2020 at 11:12 a.m. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of the Iris ichem VELOCITY Urine Chemistry System maintenance cards, Iris ichem VELOCITY Urine Chemistry System maintenance records and interview with the Testing personnel (TP #1), the laboratory failed to perform and document quarterly (3 of 4) maintenance for the Iris Ichem VELOCITY Urine Chemistry System in 2019. Findings include: 1. The Iris Ichem VELOCITY Urine Chemistry System maintenance cards state, "Quarterly maintenance, run iChem Velocity CalChek reflectance Strips". 2. On the day of survey, 11/12/2020, review of Iris ichem VELOCITY Urine Chemistry System maintenance records revealed, quarterly maintenance of the iChem Velocity CalChek reflectance Strips were performed 3 of 4 times in 2019. -The laboratory performed and documented maintenance for the iChem Velocity CalChek reflectance Strips on 04/09/2019, 09/23 /2019 and on 12/19/2019. 3. TP #1 confirmed the findings above on 11/12/2020 at 12: 35 p.m.. 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 quality control records and interview with Technical Supervisor (TS) #3, the laboratory failed to perform a negative and positive controls, each day of patient testing for the Meridian Bioscience Illumigene Herpes simplex virus (HSV) 1 & 2 and the Meridian Bioscience Illumigene Bordetella pertussis/parapertussis testing performed from 09/26/2018 to the day of survey. Findings include: 1. On the day of survey, 11/12/2020, review of the Meridian Bioscience Illumigene HSV 1&2 and the Meridian Bioscience Illumigene Bordetella pertussis/parapertussis quality control records revealed, that laboratory did not perform a positive and negative controls each day of patient testing for HSV 1 & 2 and Bordetella pertussis/parapertussis testing performed from 09/26/2018 to 11/12/2020. 2. From (9/26/2018 to 6/25/19) 290 tests were analyzed on the Meridian Bioscience Illumigene for HSV 1&2. 3. From (6/26/19 to 11/12/2020) the follow volume of tests were analyzed on the Meridian Bioscience Illumigene: - HSV 1&2: 530 - Bordetella pertussis/parapertussis: 1 4. TS #3 confirmed the findings above on 11/12/2020 around 1:45 pm. D5785

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on Surveyor review of Proficiency Testing (PT) records, Laboratory PT exception investigation forms, and interview with the Administrative Scientist and Biosafety Outreach Quality Officer at the time of survey, the laboratory failed to monitor and assess the American Proficiency Institute (API) 2017 (2nd event) and 2018 (1st event) Chemistry PT unsuccessful performances and correct the problems. Findings include: 1. The American Proficiency Institute (API) PT 2017 2nd event and 2018 1st event revealed the following unsuccessful performances: - 2017 Chemistry - Miscellaneous - 2nd event -- Luteinizing Hormone (LH)- 33% -- Testosterone - 0% - 2018 Chemistry - Miscellaneous - 1st event -- Luteinizing Hormone - 67% -- Testosterone - 67% 2. A review of the laboratory PT exception investigation forms revealed the following: - 2017 Chemistry 2nd event PT results with a LH unsatisfactory score of 33% and Testosterone 0% were received 12/17/17. The PT performance was not reviewed to correct the problem until 9/24/18, two days before the recertification inspection. The PT exception investigation forms reviewed at the time of survey did not indicate the action taken to correct this unsatisfactory PT performance. - 2018 chemistry 1st event PT results recorded another unsatisfactory performance for the same analytes, with a LH unsatisfactory score of 67% and Testosterone 67%. These results were received 5/31/18. The PT performance was not reviewed until 9/25/18, a day before the recertification survey. The PT exception investigation forms reviewed at the time of survey did not indicate the action taken to correct this unsatisfactory PT performance. 3. The forms were signed by the Quality Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Assurance Officer, Operations Director on 9/25/18 and Laboratory Director (Medical Director) on 9/26/18. 4. 400 patient specimens were tested for LH (2017 - 2018) 5. 200 patient specimens were tested for Testosterone (2017 - 2018) 6. The Administrative Scientist, Biosafety Outreach Quality Officer, Operations Director and laboratory Director confirmed the findings at the exit interview on 9/26/18 around 2: 20 pm. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)