Jackson Clinic Pa South, The

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 observation of the laboratory, review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), laboratory procedure, laboratory personnel records, lack of records, final patient test reports, and staff interviews, the laboratory failed to follow the testing personnel (TP) competency assessment policy for two of two new TP reviewed in 2024. The findings include: 1. An observation of the laboratory on 03 /27/2025 at 9:30 am revealed the following used for patient testing: Sysmex XP300 (Serial B3614) instrument used for Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff) patient testing. Polymedco Pathfast (Serial 1906D3546) instrument used for Troponin I, N-terminal B-Type Natriuretic Peptide (NTproBNP), and fibrin degradation (D-dimer) patient testing. Microscope used for urine microscopy, vaginal wet prep, and manual White Blood Cell Differential (WBC Diff) patient testing. 2. A review of Form CMS-209 revealed two new testing personnel (TP three and TP four) since the previous survey, conducted on 01/23/2024. 3. A review of the laboratory Quality Assessment procedure in section six titled "Personnel Assessment" revealed that "The Technical Consultant, Technical Supervisor, and/or General Supervisor will evaluate and document competency of personnel responsible for testing at least semiannually during the first year the individual tests patient specimens." The "Aspect of Care: Training" section revealed that "Each technical position will have specified job duties and a checklist to ensure each duty or performance level is attained before releasing the employee from the department training program. The written result/checklist of the training will be filed 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 -- in the individual's personnel file". 4. A review of the laboratory personnel records revealed the following: TP three: Documentation of training and semiannual competency assessments was not available for any test system for 2024 on the survey date (03/27/2025). TP four: Documentation of training and semiannual competency assessments was not available for any test system for 2024 on the survey date (03/27 /2025). 5. A review of final patient test reports revealed the following: TP three reported urine microscopy test results on patient 5560420 on 07/29/2024 at 9:42 am. TP four reported urine microscopy test results on patient 157073 on 06/03/2024 at 12: 04 pm. 6. An interview with the laboratory technical consultant on 03/27/2025 at 3:00 pm confirmed that the laboratory failed to follow the laboratory procedure in 2024 when TPs three and four performed patient testing and did not have documented training or semiannual competency assessments. Word Key: CLIA- Clinical Laboratory Improvement Amendments 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of records, review of the final patient test report, and staff interviews, the laboratory failed to compare the White Blood Cell Differential (WBC Diff) performed using automated and manual methods in 2024. The findings include: 1. Observation of the laboratory on 03/27/2025 at 9:30 am revealed the following: Sysmex XP300 (Serial B3614) instrument used for automated WBC Diff patient testing. Microscope and stain used for manual WBC Diff patient testing. 2. Documentation for the WBC Diff performed by the automated method compared to the manual method in 2024 was not available on the survey date (03/27 /2025). 3. A review of final patient test reports revealed the following: Automated WBC Diff reported for patient 2173375 on 04/12/2024 at 8:22 am. Manual WBC Diff reported for patient 4583530 on 09/09/2024 at 1:00 pm. 4. A telephone interview with the laboratory technical consultant on 03/31/2025 at 4:35 pm confirmed the survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records and staff interview, the testing personnel and/or lab director/designee failed to sign two of fifteen PT attestation statements from 2022 and 2023. The findings include: 1. Review of the laboratory's 2022 and 2023 PT attestation statements revealed the following: The lab director/designee and testing person failed to sign Chemistry 2022 event three. The lab director/designee failed to sign Chemistry 2023 event three. 2. During an interview on 01/23/24 at 3:45 pm, the technical consultant confirmed the testing person and/or the lab director/designee failed to sign the PT attestation statements for Chemistry event three in 2022 and Chemistry event three in 2023 (two of fifteen events reviewed). D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologists (CAP) PT records, lack of procedure, and interview with the technical consultant, the laboratory failed to test PT samples the same number of times it routinely tests patient samples 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 -- for three of fifteen events reviewed from 2022 and 2023. The findings include: 1. Review of the laboratory's proficiency testing records for Hematology revealed the laboratory performed PT samples multiple times for three of three Hematology events in 2023 as follows: 2023 event one-performed three times for all five samples 2023 event two-performed three times for all five samples 2023 event three-performed two times for all five samples 2. Review of the laboratory procedure manual revealed no requirement to re-test every patient CBC sample. 3. During an interview with the technical consultant on 01/23/24 at 3:45 pm, the technical consultant confirmed the laboratory failed to test proficiency testing samples the same number of times it routinely tests patient samples for three of fifteen PT events reviewed from 2022 and 2023. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's Complete Blood Count (CBC) quality control (QC) records, lack of documentation, and staff interview, the laboratory failed to retain QC limits in use for seven of seven parent lots of CBC QC in 2022 and 2023. The findings include: 1. Observation of the laboratory on 01/23 /24 at 8:45 am revealed the Sysmex XP 300 (serial #B3614) instrument used for patient testing for CBC with automated White Blood Cell differential (CBC w/Diff). 2. Review of the laboratory's CBC w/Diff quality control records revealed the following: Lot 2109 used from 07/01/22 to 07/22/22, Lot 2193 used from 07/25/22 to 10/14/22, lot 2277 used from 10/17/22 to 01/06/23, lot 2361 used from 01/09/23 to 03 /31/23, lot 3080 used from 04/03/23 to 06/21/23, lot 3164 used from 06/23/23 to 09/19 /23, lot 3248 used from 09/20/23 to 12/08/23. Each 'parent' lot contained three sub- lots (Low, Normal and High level) (3 levels per parent lot). 3. The laboratory was asked to provide documentation of the QC ranges used for each of the lot numbers. QC range documentation could not be provided. 4. During an interview on 01/23/24 at 3:45 pm, the technical consultant confirmed the laboratory failed to retain records of QC ranges used in 2022 and 2023 for seven of seven parent CBC QC lots (21 of 21 lots). 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)

Summary Statement of Deficiencies D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (E) The laboratory director must-- (E)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the verification of performance specification records, the complete blood count patient testing records and interview with the laboratory director, the laboratory director failed to review and approve the complete blood count instrument verification records prior to patient testing in 2018. The findings include: 1) Observation of the laboratory on December 5, 2018 at 1:30 p. m. revealed the pocH-100i XP-300 serial number B3614 complete blood count instrument in use for patient testing. 2) Review of the verification of performance specification records revealed the pocH-100i XP-300 installation date January 9, 2018. The incorrect serial number B3416 on the verification of performance specification paperwork was signed for approval by the laboratory director on January 25, 2018. 3) Review of the complete blood count patient testing records revealed patient testing began on January 18, 2018, with the new pocH-100 XP-300 serial number B3614 complete blood count instrument. 4) Interview on December 5, 2018 at 2:30 p.m. with the laboratory director confirmed the new pocH-100i XP-300 serial number B3614 complete blood count instrument was installed January 9, 2018, patient testing began January 18, 2018. 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 --