Laboratory Associates Of Erie Llc

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 assess 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 documentation 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 test 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 2 -- 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, 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. -- 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 a review of temperature records and communication via email with the technical consultant (TC), the laboratory failed to provide separate temperature records for the laboratory from September 2019 to October 2021. Findings Include: 1. There are two CLIA certified laboratories (CLIA #39D2135920 and CLIA #39D0679874) located at the same address, using the same instruments with the same testing personnel. 2. Via email communication with the TC on September 23, 2021, the surveyor requested room, refrigerator and freezer temperature records from 2/4 /2020, 9/16/2020 and 8/18/202 for each laboratory by September 30, 2021. 3. The laboratory provided the following temperature records, that were reviewed during the onsite inspection for CLIA #39D0679874 on 8/8/2021. - 2020 refrigerator temperature chart. - 2020 micro Incubator temperature chart. - 2020 room temperature chart. - 2020 Group B Streptococcal (GBS) incubator temperature. - 2021 room temperature chart. - 2021 GBS incubator temperature. - 2021 freezer temperature chart. 4. The lab could not provide separate temperature records for CLIA #39D2135920. 5. The TC confirmed on 10/04/2021 at 11:48 am, temperatures were recorded during either laboratory's operating hours and temperatures were not documented separately for each laboratory. 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 -- 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 review of maintenance records and communication via email with the technical consultant, the laboratory failed to provide separate maintenance records for the laboratory from September 2019 to October 2021. Findings Include: 1. There are two CLIA certified laboratories (CLIA #39D2135920 and CLIA #39D0679874) located at the same address, using the same instruments with the same testing personnel. 2. Via email communication with the TC on September 23, 2021, the surveyor requested maintenance records from 2/4/2020, 9/16/2020 and 8/18/202 for each laboratory by September 30, 2021. 3. The laboratory provided maintenance records for the following analyzers, which were reviewed during the onsite inspection for CLIA #39D0679874 on 8/8/2021: - Sysmex XP 301. - Roche Cobas 4800. - DiaSorin Liaison X. - Cepheid GeneXpert. - Abbott Architect ci4100. 4. The laboratory could not provide separate maintenance records for CLIA #39D2135920. 5. The TC confirmed the findings above on 10/04/2021 at 11:48 am. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of laboratory records and communication via email with the technical consultant (TC), the laboratory failed to provide separate calibration records for the Abbott Architect ci4100 and the Sysmex XP 301 systems in use from September 2019 to October 2021. Findings Include: 1. There are two CLIA certified laboratories (CLIA #39D2135920 and CLIA #39D0679874) located at the same -- 2 of 3 -- address, using the same instruments with the same testing personnel. 2. Via email communication with the TC on September 23, 2021, the surveyor requested the laboratory to provide calibration records for the Abbott Architect ci4100 and the Sysmex XP 301 systems for each laboratory by September 30, 2021. 3. The laboratory provided calibration records for the Abbott Architect ci4100 and the Sysmex XP 301 systems, that were reviewed during the onsite inspection of CLIA #39D0679874 on 08 /08/2021. 4. The laboratory could not provide separate calibration records for the Abbott Architect ci4100 and the Sysmex XP 301 records for CLIA #39D2135920. 5. The TC confirmed the findings above on 10/04/2021 at 11:48 am. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory records and communication via email with the technical consultant (TC), the laboratory failed to provide separate quality control (QC) records for all tests performed in the laboratory from September 2019 to October 2021. Findings Include: 1. There are two CIA certificated laboratories (CLIA #39D2135920 and CLIA #39D0679874) located at the same address, using the same instruments with the same testing personnel. 2. Via email communication with the TC on September 23, 2021, the surveyor requested QC records from 07/07/2020, 09/16 /2020, 4/5/2021 and 07/16/2021 for each laboratory by September 30, 2021. 3. The laboratory provided the following test QC records that were reviewed for CLIA #39D0679874 during the CLIA inspection on 8/8/2021: - Abbott Architect ci4100. - Diasorin XL. - Affirm VP. - Manual differential. - Sysmex xp-301. - Consult Diagnostics Serum hcg. - Bacteriology Media. - Roche Cobas 4800. - Cepheid GeneXpert. 4. The laboratory could not provide separate QC records for CLIA #39D2135920. 5. The TC confirmed the findings above on 10/04/2021 at 11:48 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory records and communication via email with the technical consultant (TC), the laboratory director failed to documents all quality assessment (QA) records separately in laboratory from September 2019 to October 2021. Findings Include: 1. There are two CLIA certificated laboratories (CLIA #39D2135920 and CLIA #39D0679874) located at the same address, using the same instruments with the same testing personnel. 2. Via email communication with the TC on September 23, 2021, the surveyor requested for QA records to be sent by September 30, 2021. 3. Based on the documents provided by the TC, the surveyor could not differentiate the QA records of CLIA #39D2135920 from CLIA# 39D0679874. 4. The TC confirmed the finding above on 10/04/2021 at 11:48 am. -- 3 of 3 --