Jackson Clinic, Pa Convenient Care Medina, The

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), a review of the laboratory's College of American Pathologists (CAP) and American Proficiency Institute (API) proficiency testing (PT) records, and staff interview the laboratory failed to ensure proficiency testing samples were performed by personnel who routinely perform patient testing when Testing Person Two performed 14 of 17 PT events in 2024 and 2025. The findings include: 1. Laboratory observation on 11/17/25 at 8:10 a.m. revealed the following non-waived test systems used for patient testing: The Sysmex XN430 Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff). A microscope used for performing urine microscopy and vaginal wet prep and potassium hydroxide (KOH) testing. The Polymedco Pathfast for high-sensitivity Troponin I (hs-TnI), Fibrin Degradation Product (D-Dimer), and N- Terminal-pro B-type Natriuretic Peptide (NT-proBNP). 2. A review of the Form CMS- 209 revealed three personnel who performed patient testing. 3. A review of the laboratory's CAP PT records revealed that Testing Person Two had performed 14 of 17 PT events. 4. Technical Consultant Two confirmed the survey findings during an interview on 11/17/25 at 5:00 p.m. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency 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 -- testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's CAP and API PT records and staff interviews, one of seventeen PT Performance Evaluation reports was not retained (2025 Event One API Chemistry Core). The findings include: 1. A review of the laboratory's PT records revealed that the Performance Evaluation report was not retained for the API Chemistry Core Event One. 2. Technical Consultant Two confirmed the survey findings during an interview on 11/17/25 at 5:00 p.m. 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 laboratory observation, a review of the laboratory's testing personnel competency assessment policy, a review of testing personnel competency assessment records and staff interview, the laboratory failed to follow it's own policies and procedures for assessing testing personnel competency in 2024 and 2025. The findings include: 1. Laboratory observation on 11/17/25 at 8:10 a.m. revealed the following non-waived test systems used for patient testing: The Sysmex XN430 Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff). A microscope used for performing urine microscopy, vaginal wet prep, and potassium hydroxide (KOH) testing. The Polymedco Pathfast for high-sensitivity Troponin I (hs- TnI), Fibrin Degradation Product (D-Dimer), and N-Terminal-pro B-type Natriuretic Peptide (NT-proBNP). 2. A review of the laboratory policy for assessing testing personnel competency 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. Thereafter, competency assessment will be performed at least annually. The following six procedures will be performed for testing personnel for each test that the individual is approved to perform. 1. Directly observe test performance, including patient preparation, if applicable, specimen handling, processing and testing. 2. Monitor the recording and reporting of test results. 3. Review worksheets, QC records, PT results and preventive maintenance records. 4. Directly observe performance of instrument maintenance and function checks. 5. Assess test performance using previously analyzed testing samples. 6. Assessment of problem solving skills. Note: Technical Consultants, Technical Supervisors, and General Supervisors who are performing testing on patient specimens are also required to have competency assessment including the six procedures." 3. A review of testing personnel competency assessment records revealed that: The 2024 Annual Competency Assessment was not performed for Established Testing Person One /Technical Consultant One for any test system. The 2024 Annual Competency -- 2 of 6 -- Assessment was not performed for Established Testing Personnel Two for any test system. The 2025 Annual Competency Assessment, completed on 11/11/25 for Testing Person One/Technical Consultant One, did not include evaluation of test performance using blind testing or proficiency testing for the Sysmex XN430 CBC w /Diff instrument or the Polymedco Pathfast Cardiac Testing instrument. The 2025 Annual Competency Assessment, completed on 11/14/25 for Testing Person Two, did not include an evaluation of test performance using blind testing or proficiency testing for the CBC w/Diff performed on the Sysmex XN 430 or the Polymedco Pathfast Cardiac Testing instrument. The Six-Month Competency Assessment, completed on 09/12/25 for Testing Person Three, did not include an evaluation of test performance using blind testing or proficiency testing for any test system. The 2025 Annual Competency Assessment, completed on 11/15/25 for Testing Person Three, did not include evaluation of test performance using blind testing or proficiency testing for the Sysmex XN 430 CBC w/Diff or the Polymedco Pathfast Cardiac Testing instrument. 4. Technical Consultant Two confirmed the survey findings during an interview on 11/17/25 at 5:00 p.m. 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 a review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and staff interview, the laboratory failed to evaluate PT results that were not graded by the PT program for four of ten PT events with ungraded scores from 2024 and 2025. The findings include: 1. A review of the laboratory's CAP PT records revealed the following ungraded scores that were not evaluated to determine the accuracy of the laboratory's performance: 2025 Event One- Hematology with Automated White Blood Cell Differential (FH(-A)-Educational Challenge for Immature Granulocyte percent and Immature Granulocyte absolute count for sample numbers FH9-01, FH9-02, FH9-03, FH9-04, and FH9-05. 2025 Event Two-Hematology with Automated White Blood Cell Differential (FH9-B)- Educational Challenge for Immature Granulocyte percent and Immature Granulocyte absolute count for sample numbers FH9-06, FH9-07, FH9-08, FH9-09, and FH9-10. 2025 Event One-Blood Cell Identification-(BCP-A)-Educational Challenges for sample numbers BCP-06, BCP-07, BCP-08, BCP-09, BCP-10 2025 Event Two-Blood Cell Identification-(BCP-B)Educational Challenges for sample numbers BCP-16, BCP-17, BCP-18, BCP-19, BCP-20. 2. Technical Consultant Two confirmed the survey findings during an interview on 11/17/25 at 5:00 p.m. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. -- 3 of 6 -- This STANDARD is not met as evidenced by: CITATION ONE: Based on laboratory observation, a review of the laboratory procedure manual, lack of documentation, and staff interview, the laboratory failed to follow the procedure for performing biannual centrifuge checks for the centrifuge timer and Revolutions Per Minute (RPMs) in 2024 and 2025. The findings include: 1. Laboratory observation on 11/17/25 at 8:10 a.m. revealed a centrifuge used to spin down urine samples to prepare for microscopic examination. 2. A review of the laboratory procedure titled "MISCELLANEOUS LAB MAINTENANCE" revealed that the centrifuge timer and RPMs were to be checked biannually. 3. There was no documentation that the function checks had been completed biannually in 2024 or 2025. 4. The Regional Quality Assurance Manager confirmed the survey findings during an interview on 11/17/25 at 1:10 p.m. CITATION TWO: Based on laboratory observation, a review of the laboratory procedure manual, a review of the available calibration verification documents and staff interview, the laboratory failed to perform six-month calibration verification for analytes performed on the Polymedco Pathfast instrument when due in 2024 and 2025. The findings include: 1. Laboratory observation on 11/17/25 at 8:10 a.m. revealed the Polymedco Pathfast used for high- sensitivity Troponin I (hs-TnI), Fibrin Degradation Product (D-Dimer), and N- Terminal-pro B-type Natriuretic Peptide (NT-proBNP). 2. A review of the laboratory procedure for the Polymedco Pathfast revealed that calibration verification for the analytes would be performed every six months. 3. A review of calibration verification documents revealed that calibration verification was not performed when due in October 2024, and no calibration verification was performed in 2025 for the previous Troponin I assay, D-Dimer, or NT-pro-BNP assays. 4. The Regional Quality Assurance manager confirmed the survey findings during an interview on 11/17/25 at 1:30 p.m. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of reagent and quality control (QC) records, lack of records, patient test records, and staff interviews, the laboratory failed to monitor QC for accuracy and precision over time for the Troponin I and N-terminal- pro-B-type natriuretic peptide (NT-proBNP) tests performed on the Polymedco Pathfast instrument (Refer to D5441) and failed to maintain records of QC ranges and statistical parameters for the Troponin I and NT-proBNP (Refer to D5469). D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, lack of documentation, review of reagent and quality control records, patient test records, and staff interviews, the laboratory failed to monitor complete blood count with automated white blood cell differential (CBC w/diff) quality control (QC) for accuracy and precision over time (Refer to D5441 Citation One), failed to monitor QC for accuracy and precision over time for the cross-linked fibrin degradation product Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (D-Dimer) performed on the Polymedco Pathfast instrument (Refer to D5441, Citation Two), failed to maintain records of QC ranges and statistical parameters for the D-Dimer assay (Refer to D5469), and failed to follow the quality assessment plan for the CBC w/diff testing performed on the Sysmex XN 430 (Refer to D5791). D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: CITATION NUMBER ONE: Based on observation of the laboratory, review of quality control records, lack of documentation, and staff interview, the laboratory failed to monitor CBC w/Diff quality control for accuracy and precision over time in 2023 and 2024. The findings include: 1. Observation of the laboratory on 04/15/24 at 8:25 a.m. revealed the Sysmex XN 430 (serial number 11245) used for performing patient testing for CBC w/diff. 2. The laboratory failed to provide documentation of QC records and reviews that included monitoring for accuracy and precision over time for three of three months reviewed - March 2023 (lot 3041), September 2023 (lot 3209), and February 2024 (lot 4012). 3. The technical consultant confirmed the survey findings during the interview on 04/15/24 at 4:30 p.m. He further confirmed the laboratory failed to document review of reports that monitored shifts and trends from February 2023 to the survey date on 04/15/24. CITATION NUMBER TWO: Based on observation of the laboratory, review of quality control records, lack of records, and staff interview, the laboratory failed to monitor quality control for accuracy and precision over time for the tests performed on the Polymedco Pathfast instrument in 2023 and 2024. 1. Observation of the laboratory on 04/15/24 at 8:25 a.m. revealed the Polymedco Pathfast instrument (serial number 161002851) used for performing patient testing for D-Dimer, Troponin I, and NT-proBNP. 2. The laboratory failed to provide documentation that QC data was monitored for accuracy and precision over time for any of the three tests. The months reviewed included April 2023, November 2023, and January 2024. 3. The technical consultant confirmed the survey findings during an interview on 04/15/24 at 4:30 p.m. He further stated the laboratory had not printed any reports in 2023 or 2024 that included monitoring of QC over time. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control -- 2 of 4 -- materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, staff interview, review of reagent and quality control (QC) records, lack of documentation, patient test records, interview with the technical consultant, and staff interview via phone, the laboratory failed to maintain records of the mean and standard deviation (statistical parameters) entered in the Polymedco Pathfast instrument for the D-Dimer, Troponin I and NT-proBNP analytes in 2023 and 2024, with approximately 61 D-Dimer tests, 250 Troponin I, and 220 NT- proBNP tests performed annually. The findings include: 1. Observation of the laboratory on 04/15/24 at 8:25 a.m. revealed the Polymedco Pathfast instrument used for performing patient testing for D-Dimer, Troponin I, and. NT proBNP. The observed lot number on the box of Troponin I reagent was B374; the lot number of the reagent inside the box and the MC entry card (used to scan the reagent lot number into the instrument) was 1102504744. 2. During an interview on 04/15/24 at 3 p.m. the lead testing person and the technical consultant described the following: Each box of reagent for D-Dimer, Troponin I and NT proBNP has a four-digit "Box" lot number. The reagent cartridges contained within the box have a different lot number from the box lot number. Each box also has an MC Entry Card with the reagent lot number. When the lab starts using the reagent lot, the information from the MC entry card is scanned into the instrument. It does not include the box lot number. Each Troponin I and NT Pro-BNP reagent box includes a control package insert that lists lot numbers of Biorad controls and the corresponding control ranges. The control ranges are specific to the 'box' lot number. The reagent lot number is not included on the control datasheet. The laboratory keeps a reagent log that only includes the 'box' lot number. The corresponding 'reagent' lot number is not included in the records. The box lot number does not print on the instrument printout for either patients or QC. The QC ranges used by the laboratory are maintained in the Polymedco Pathfast instrument. 3. Review of reagent and QC records for the Troponin I and NT-ProBNP reagent revealed the following: QC printouts from 04/10/23, 11/07/23, and 01/22/24 did not include the Box lot number. The QC printouts from 04/10/23 did not include the QC lot number for either of the two levels of Biorad controls. The "MC Entry Card" included the reagent lot, but not the four-digit 'Box lot.' The laboratory's reagent log included the box lot but not the reagent lot. The QC printouts did not include the four- digit lot number from the reagent box and could not be matched to the appropriate QC ranges. 4. The laboratory failed to provide records of the quality control ranges including the mean and standard deviation (statistical parameters) used for each 'Box' lot and corresponding 'Reagent' lot of Troponin I and NT-ProBNP box/reagent. Records of the QC lot numbers and QC ranges entered in the Pathfast instrument were not maintained for D-Dimer, NT-proBNP, and Troponin I QC performed on 04/10/23. Records of QC ranges entered into the Pathfast instrument were not maintained for D- Dimer, N-proBNP and Troponin I QC performed on 11/07/23 or 01/22/24. 5. Review of patient records revealed testing for D-Dimer, Troponin I, and NT-proBNP performed on 04/10/23 for lab accession # 23046576, on 11/7/23 for lab accession number 23141212 and on 01/22/24 for lab accession # 24008093. 6. The technical consultant confirmed the survey findings during interview on 04/15/24 at 4:30 p.m. 7. -- 3 of 4 -- The laboratory liaison stated during interview on 04/25/24 at 4:45 p.m. that the laboratory performed an average of 61 D-Dimer tests, 250 Troponin I tests and 220 NT-proBNP testing annually. 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 observation of the laboratory, review of the laboratory procedure manual, lack of documentation, and staff interview, the laboratory failed to follow the quality assessment (QA) plan for the Sysmex XN 430 CBC w/Diff when it did not review the required monthly reports beginning February 2023 to the date of the survey on 04/15 /24. This was previously cited on the survey conducted on 11/08/22, and compliance was not maintained. The findings include: 1. Observation of the laboratory on 04/15 /24 at 8:25 a.m. revealed the Sysmex XN 430 (serial number 11245) used for performing patient testing for CBC w/diff. 2. Review of the laboratory procedure for the Sysmex XN 430 revealed that the following QA reports were to be reviewed monthly: Insight IQAP, Exception Report, Summary Report, Continuous Calibration Verification Certificate, and Detailed Daily Verification Report. 3. The laboratory failed to provide documentation of monthly review for the Exception Report, Summary Report, Continuous Calibration Verification Certificate, or Detailed Daily Verification from February 2023 to the survey date on 04/15/24. 4. During an interview on 04/15/24 at 4:30 p.m., the technical consultant confirmed that the laboratory failed to follow the QA plan for reviewing the required monthly reports from February 2023 to the survey date on 04/15/24. He further confirmed the laboratory failed to maintain compliance with the previous

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with the technical consultant, the laboratory failed to review proficiency testing and evaluate the laboratory's results for two of sixteen events reviewed. The findings include: 1. Review of the laboratory's CAP proficiency testing results revealed the following events had not reviewed: Hematology 2021 event three Cardiac Markers 2021 event three 2. Interview with the technical consultant on 11/08/22 at 6 pm confirmed the laboratory failed to review and evaluate proficiency testing results for two of sixteen events reviewed from 2021 and 2022. 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 consultant, the laboratory failed to evaluate the accuracy of non-graded proficiency testing scores in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 2021 and 2022 for six of ten surveys that included non-graded PT scores. The findings include: 1. Review of the laboratory's proficiency testing records revealed the following events with non-graded scores that had not been evaluated for accuracy: 2021 event three--Hematology 2022 event one--Hematology 2022 event two-- Hematology 2021 event three--Cardiac Markers 2022 event one---Cardiac Markers 2022 event three--Cardiac Markers 2. Interview with the technical consultant on 11/08 /22 at 6 pm confirmed the laboratory failed to evaluate the accuracy of non-graded PT scores in 2021 and 2022 for six of ten events with non-graded scores. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of