The Jackson Clinic, Pa-Midtown

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review from the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and the laboratory's College of American Pathologists (CAP) 2025 Proficiency Testing (PT) records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in PT for the analyte automated White Blood Cell differential (WBC Diff). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CASPER 0155 report and the laboratory's CAP PT records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the WBC Diff analyte for two consecutive testing events. The findings include: 1. A review of the CASPER 0155 report revealed the following results: A score of 0% for the WBC Diff analyte for 2025 Event Two A score of 60% for the WBC Diff analyte for 2025 Event Three. 2. A review of the laboratory's CAP PT records confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the laboratory's CAP 2025 PT records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the laboratory's CAP 2025 PT records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on direct observation, a review of quality controls (QC) files, the laboratory procedure manual, and staff interview, the laboratory's QC procedure for the Polymedco Pathfast instrument did not match the QC protocol that the laboratory followed. The findings include: 1. Laboratory observation on 04/04/25 at 10:30 a.m. revealed the following control vials used for performing QC on the Polymedco Pathfast instrument for Troponin I, NTproBNP and D-Dimer assays: Biorad Liquichek Cardiac Marker Level 1 (Lot number 1003121), Level 1C (Lot number 1003116), and Level 3 (Lot number 1003123). Biorad Liquichek D-Dimer Level 1 (Lot number 74441) and Level L (Lot 74444). 2. A review of QC files in the Orchard LIS revealed that the control files for Troponin I were Levels 1C and Level 3, the control files for NTproBNP were Level 1 and Level 3, and the control files for D- Dimer were Level 1 and Level L. 3. A review of the laboratory's Pathfast procedure revealed that controls used for Troponin I were Level 1 and Level 1C, NTproBNP controls were Level 1 and Level 3, and D-Dimer controls were Level 1 and Level 2. 4. The laboratory director confirmed by phone interview on 04/09/25 at 1:45 p.m. that the laboratory's QC procedure for the Pathfast instrument was inconsistent with the 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 -- control protocol used in the laboratory as recommended by the manufacturer. Word Key: D-Dimer = Fibrin degradation product NTproBNP=N-terminal pro hormone B- type natriuretic peptide (NTproBNP) LIS=Laboratory Information System D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (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 materials must be defined and available. (d)(10)(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. (d)(10)(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. This STANDARD is not met as evidenced by: Based on direct observation, review of Biorad Quality Control (QC) package inserts, lack of QC ranges, review of laboratory QC records, review of manufacturer control data assay sheets, review of a patient activity log, and staff interview, the laboratory failed to verify the QC ranges and QC lot numbers used for the Troponin I and N- terminal pro hormone B-type natriuretic peptide (NTproBNP) assays when QC lot numbers and reagent box lot numbers changed. The findings include: 1. Laboratory observation on 04/04/25 at 10:30 a.m. revealed the following control vials used for performing QC on the Polymedco Pathfast instrument for Troponin I, NTproBNP and D-Dimer assays: Biorad Liquichek Cardiac Marker Level 1 (Lot number 1003121), Level 1C (Lot number 1003116), and Level 3 (Lot number 1003123). Biorad Liquichek D-Dimer Level 1 (Lot number 74441) and Level L (Lot 74444). 2. A review of the Biorad Cardiac Marker LT package inserts revealed the following: Level 3 (Lot 1003123) for Troponin I revealed no QC ranges. The comment code stated "The reagent kit manufacturer requests that you refer to LSI MEDIENCE PATHFAST reagent kit's CONTROL DATA SHEETS for assignment of values." Level 1 (Lot 1003121) for NTproBNP revealed no QC ranges. The comment code stated "The reagent kit manufacturer requests that you refer to LSI MEDIENCE PATHFAST reagent kit's CONTROL DATA SHEETS for assignment of values." Level 3 (Lot 1003123) for NTproBNP revealed no QC ranges. The comment code stated "The reagent kit manufacturer requests that you refer to LSI MEDIENCE PATHFAST reagent kit's CONTROL DATA SHEETS for assignment of values." 3. A review of the Pathfast Control Data Sheets on the survey date (04/04/25) revealed analyte QC ranges were not provided for the following: Troponin reagent lot 1102602800 for the Cardiac Marker Level 3 - lot number 1003123. NTproBNP reagent lot 1062602771 for the Cardiac Marker Level 1 (lot number 1003121) or Level 3 (lot number 1003123). 4. A review of the laboratory records revealed the following: The NTproBNP Level 1 lot number was set up as 1003111 in the Orchard LIS; the observed lot number was 1003121 (see finding one). The Level 1 QC lot number 1003121 was potentially put into use on 03/05/25. The NTproBNP and Troponin I Level 3 QC lot number was set up as 1003113 in the Orchard LIS; the observed lot number was 1003123 (see finding one). The Level 3 QC lot 1003123 was potentially put into use on 03/03/25 for both assays. 5. The laboratory requested the control data sheets for the affected reagent lots on the survey date. A review of the manufacturer control data sheets obtained on the survey date and the QC ranges used -- 2 of 3 -- by the laboratory revealed the laboratory used ranges that were not consistent with the manufacturer's ranges as follows: Troponin I Level 3-The QC range for Level 3 (lot number 1003123) was 10.1 - 18.7 ng/mL. The QC range in the Orchard LIS was 13.4 - 24.9 ng/mL. NTproBNP Level 1-The QC range for Level 1 (Lot 1003121) was 143- 265 pg/mL. The QC range in the Orchard LIS was 140 - 260 pg/mL. NTproBNP Level 3-The QC range for Level 3 (Lot 1003123) was 5278 - 9802 pg/mL. The QC range in the Orchard LIS was 5159 - 9581 pg/mL. 6. A review of a patient activity log covering the period from the last onsite survey on 02/11/25 to 04/09/25 (date of revisit) revealed that the laboratory had not tested any patients. 7. The lead testing person and technical consultant confirmed during an interview on 04/04/25 at 12:30 p. m. that the laboratory failed to manage QC lot number changes and changes in QC ranges when reagent box lot numbers changed. They also confirmed that with each box lot of reagent, the control ranges for both Troponin I and NTproBNP changed, and the laboratory had not acquired the correct control datasheet from the manufacturer to ensure the correct QC ranges were used for the evaluation of QC data. Word Key: LIS=Laboratory Information System pg/mL=picograms/milliliter ng /mL=nanograms/milliliter -- 3 of 3 --

Summary Statement of Deficiencies D0000 During an initial certification survey on 02/11/25, the laboratory was found out of compliance with the following conditions: 493.1250 Condition: Analytic systems. 493. 1415 Condition: Laboratories performing moderate complexity testing; clinical consultant. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on laboratory observation, a review of laboratory procedures, lack of documentation, a review of a patient activity log and patient test reports, and staff interview, the laboratory failed to ensure the procedure for the Polymedco Pathfast instrument included the normal range for each test performed, the reportable range for the N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) assay, and calibration procedures for each test performed (Refer to D5403), failed to verify the manufacturer performance specifications for three of four non-waived Food and Drug Administration (FDA) approved test systems (Refer to D5421), and failed to establish performance specifications for two of two textbook procedures (Refer to D5423). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test 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 -- 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)