Ob/Gyn Associates Of Erie

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at OB/GYN Associates of Erie on 6/15/2023 by the Pennsylvania Department of Health (PA DOH). The laboratory was surveyed under 42 CFR Part 493 CLIA Requirements. Specific deficiencies cites are as follows: 1. On the date of the survey, 06/15/2023 at 12:14 PM, interview with the Technical Supervisor (TS) revealed the laboratory failed to meet the following conditions for multiple laboratories operating at the same location with different CLIA certificates and using the same personnel and equipment from 8 /18/2021 to the date of the survey: -Quality control (QC) was not ran independently for each CLIA certificate and failed to show that each laboratory is operating independently. QC records indicate that QC was only performed to asses testing for 1 CLIA certificate for the following: - 1 of 1 Abbott Alinity i - 1 of 1 Sysmex XP-300 - 1 of 1 Cepheid GeneXpert - 1 of 1 DiaSorin XL 2. The TS confirmed these findings on 6/15/23 around 2:00 PM 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 documention and interview with the Technical Supervisor (TS), the laboratory failed to establish a procedure for competency assessments for 5 of 5 testing personnel (TP) who performed testing on the Cepheid GeneXpert. Findings include: 1. On the day of the survey, 06/15/2023 at 8:58 PM, the laboratory could not provide competency assessment for 5 of 5 TP for each category of tests performed on the Cepheid GeneXpert from 8/18/2021 to the date of the survey. 2. The TS confirmed the findings above on 06/15/2023 around 02:00 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 3 -- 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 College of American Pathologists (CAP) proficiency testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to verify the accuracy for 1 of 3 Hematology PT results in 2022, 1 of 3 Special Immunology PT results in 2022, 1 of 3 Urinalysis and Microscopy PT results in 2022, and 1 of 1 Special Immunology PT results in 2023. Findings Include: 1. On the day of survey, 06/15/2023 at 10:45 AM, review of 2022 CAP proficiency testing records revealed that the laboratory did not verify the accuracy for the following analyte that was given an unacceptable grade: - CAP 2022 Hematology 1st event - MPV (FH-13) was unacceptable 2. On the day of survey, 06/15/2023 at 10:45 AM, review of 2022 CAP proficiency testing records revealed that the laboratory did not verify the accuracy for the following analytes that was not graded by the proficiency testing agency: - CAP 2022 Special Immunology 2st event - Anti-thyroglobulin and Anti- thyroid (S2-10) was not graded - CAP 2022 Urinalysis and Microscopy 2nd event - Specific Gravity (CHEM 02 and CHEM 03) was not graded - CAP 2023 Special Immunology 1st event - Anti-thyroglobulin and Anti-thyroid (S2-03) was not graded 3. The TS confirmed the findings above on 06/15/23 around 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 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 lack of documentation and interview with the Technical Supervisor (TS), the laboratory failed to evaluate, twice a year, the relationship between test results for 3 of 3 Affirm VP analyzers from 08/18/2021 to the day of the survey. Findings include: 1. On the day of the survey, 06/15/2023 at 12:03 am, the laboratory could not provide documentation of the biannual comparison of test results between 3 of 3 Affirm VP analyzers for Candida species, Gardnerella Vaginosis, and Trichomonas Vaginosis performed from 8/18/2021 to the date of the survey. 2. The laboratory performed 938 Candida species, Gardnerella Vaginosis, and Trichomonas Vaginosis tests in 2022. 3. TP #1 confirmed the finding above on 6/15/2023 at 3:00 PM. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, -- 2 of 3 -- 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 the review of Patient Test Report and interview with Technical Supervisor (TS), the laboratory failed to include on test reports the Emergency Use Authorizations (EUA) disclaimer regarding COVID-19 testing from 8/18/2021 to the date of survey. Finding Include: 1. On the day of survey, 06/15/23, a review of some test reports (1 of 1) revealed the test reports did not include the disclaimer regarding the Emergency Use Authorizations (EUA) for COVD-19 testing. 2. The TS confirmed the findings above on 06/15/2023 around 2:00 PM. -- 3 of 3 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on observation and interview with the technical Supervisor (TS), the laboratory failed to perform maintenance on 3 of 3 Fisher Scientific Thermometers from 08/18 /2019 to the day of survey. Findings include: 1. On the day of survey, 08/18/2021, observation of the laboratory revealed, 3 of 3 Fisher Scientific Thermometers were due for maintenance on 10/18/2014: - Room temperature thermometer - s/n: 122594842. - Refrigerator temperature thermometer - s/n: 122594688. - Freezer temperature thermometer - s/n: 122594710. 2. The laboratory could not provide a thermometer maintenance procedure policy . 3. The TS confirmed the findings about on 08/18/2021 around 3:00 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 laboratory's validation records and interview with the technical supervisor (TS), the laboratory director (LD) failed to ensure performance specification procedures used are adequate to determine the accuracy and precision 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 -- for the SARS - CoV-2 testing performed on the Cepheid GeneXpert System and the Architect ci 4100 before reporting patient test results in 2021. Findings Include: 1. On the days of survey 08/18/2021, a review of the Cepheid GeneXpert System and the Architect ci 4100 validation records revealed the following was not assessed before reporting patient test results in 2021: The Cepheid GeneXpert System - SARS - CoV- 2 Molecular testing: - did not state performance specifications for accuracy and precision. - Validation was not signed by laboratory director. The Architect ci 4100- SARS - CoV-2 Antibody testing: -Validation was not signed by laboratory director. 2. The TS confirmed the findings above on 08/18/2021 around 2:15 p.m. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, review of personnel competency assessment records and interview with the technical supervisor (TS), the TS failed to perform competency assessment for 4 of 4 TP performing urine sedimentation and semen analysis microscopic examinations in 2020 and 2021. Findings Include: 1. On the day of survey, 08/18/2021, a review of TP competency assessment records revealed, 4 of 4 TP performing the following tests were not assessed for competency in 2020 and 2021: - Semen analysis microscopic examinations. - Urine sedimentation microscopic examinations. 2. The TS confirmed the findings above on 08/18/2021 around 1:50 pm. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competency assessment records and interview with the technical supervisor (TS), the TS failed to assess the test performance for 2 of 4 TP through external proficiency testing samples or internal blind testing samples for all tests performed in the departments of Chemistry, Hematology, Immunology, Microbiology, Immunohematology and Urinalysis in 2019 and 2020. Findings Include: 1. On the day of survey, 08/18/2021, review of TP competency assessment records revealed, 2 of 4 TP were not assessed for test performance through external proficiency testing samples or internal blind testing samples for all testing performed in the departments of Chemistry, Hematology, Immunology, Microbiology, Immunohematology and Urinalysis in 2019 and 2020. 2. The TS confirmed the finding above on 08/18/2021 around 2:00 pm. -- 2 of 2 --