Jackson Clinic, Pa North Convenient Care, The

Summary Statement of Deficiencies 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 observations of the laboratory, review of quality control (QC) records, and staff interview, the laboratory failed to retain the "MC ENTRY CARD" that comes in each box of reagent for the PATHFAST instrument resulting in the laboratory not being able to tie the box lot number (as printed on the control data sheet), and corresponding QC ranges, to the lot number on the QC printouts. The findings include: 1. Observation of the laboratory on 08/16/23 at 8:40 am revealed the Polymedco PATHFAST instrument in use for patient testing for Troponin I, B-Type Natriuretic Peptide (NT-ProBNP), and Fibrin Degradation Product (D-Dimer). 2. Observation of a box of test cartridge reagents on 08/16/23 at 1:30 pm revealed the following: Each box of reagent comes with a "MC ENTRY CARD" that has a unique lot number and expiration date which is scanned when setting up new lot numbers of reagent in the instrument. The box also comes with a control data sheet that includes lot specific QC ranges and references the Lot # that is on the outside of the box, which is different from the lot number on the MC ENTRY CARD. The lot number from the MC ENTRY CARD was not included on the manufacturer's control data sheet. 3. Review of quality control records for the Troponin I and NT-ProBNP performed on 05 /05/23 revealed the following: The reagent lot number from the MC ENTRY card was printed on each of the QC printouts. The box lot number that is included on the control data sheet was not captured on the QC printouts. Troponin I QC revealed the use of reagent lot # 1102405654 on the QC printouts. The corresponding MC ENTRY CARD was not retained with the Control Range Data Sheet. NT-proBNP QC revealed the use of reagent lot # 1062407628. The MC ENTRY CARD was not retained with 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 -- the Control Range Data Sheet. 4. Interview with technical consultant number one on 08/16/23 at 3:30 pm confirmed the laboratory failed to retain the MC ENTRY CARD that comes in each box of PATHFAST reagents, resulting in the laboratory not being able to tie the box lot number (and appropriate QC ranges) to the lot number (as scanned from the MC ENTRY CARD) on the QC instrument printouts. He confirmed there was no process in place to tie the reagent lot number on the MC ENTRY CARD to the box lot number and corresponding QC values on the control data sheet. 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 review of the laboratory's testing personnel policy, testing personnel (TP) competency assessment records, patient test reports and staff interview, the laboratory policy for competency assessment was not followed when two of two established TP did not have annual competency assessments in 2022, and the competency forms in use did not include all six elements for each test performed by the TP in 2021, 2022, and 2023. The findings include: 1. Review of the laboratory's testing personnel policy revealed that TP competency assessments would be performed annually during the first year and then annually thereafter. It also indicated that the six required procedures would be included for each test the individual is approved to perform. 2. Review of personnel records revealed the following: a. No competency assessments were performed for testing personnel numbers one and two in 2022 (two of two established TP). b. The competency assessment forms in use did not include the following: Direct observation and record review was not included for manual differential. Direct observation and record review was not included for Potassium Hydroxide (KOH). Monitoring of test result recording and reporting did not specify which test(s). Blind testing did not specify which test(s). Assessment of problem solving skills did not specify which test(s). c. Competency assessments were performed using these forms in 2021, 2022, and 2023. d. The problem solving tests used for the 2023 competency for testing person number one were not graded. 3. Review of patient test reports revealed patient testing for manual differential performed 08/16/21 (patient 6152902), 09/16/22 (patient 99677318), and 08/15/23 (patient 99772098); KOH performed 09/04/21 (patient 3421112), 04/04/22 (patient 22045469), and 03/21/23 (patient 100163460). 4. Interview with technical consultant number one on 08/16/23 at 3:30 pm confirmed the laboratory did not follow its' own policy for competency assessment when competency assessments were not performed for TP numbers one and two in 2022, it failed to include all six elements for each test performed in 2021, 2022, and 2023, and the problem solving tests for TP number one for 2023 was not graded. He also confirmed the competency did not include direct observation and record review for manual differential and KOH in 2021, 2022, and 2023 with patient testing performed. 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 -- 2 of 3 -- 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 observation of the laboratory, review of manufacturers' operator's manual, lack of records, and staff interview, the laboratory failed to monitor humidity in the area where the Sysmex KX-21N Complete Blood Count with automated white blood cell differential (CBC w/Diff) instrument and the PASTFAST chemistry instrument were in use. The findings include: 1. Observation of the laboratory on 08/16/23 at 8: 40 am revealed the Sysmex KX-21N (serial #F2734) in use for performing patient testing for CBC w/Diff and the PathFast instrument (serial # 1906D3548) in use for performing patient testing for Troponin I, B-type Natriuretic Peptide (BNP), and Fibrin Degradation Product (D-Dimer). No device for monitoring of humidity was observed in the laboratory. 2. Review of the manufacturers' operator's manuals revealed the following humidity requirements: Sysmex KX-21N CBC instrument = 30 - 85% PATHFAST Instrument = 20 - 80% Relative Humidity 3. There were no records for humidity monitoring. 4. Interview with technical consultant number two on 08/16/23 at 3:30 pm confirmed the laboratory did not monitor the humidity in the area where the Sysmex KX-21N CBC instrument and the PATHFAST chemistry instrument were in use. -- 3 of 3 --

Summary Statement of Deficiencies 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: The laboratory failed to maintain satisfactory participation in two consecutive proficiency testing (PT) events for the cell identification analyte, resulting in the first unsuccessful PT occurrence for the cell identification analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(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. 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 -- This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2020 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the Cell Identification analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory Cell Identification scores: 2020 Event two = 60% 2020 Event three = 0% 2. Review of the laboratory's 2020 PT event two hematology evaluation report revealed sample numbers BCP-13 and BCP-15 scored as unacceptable resulting in a score of 60% for the cell identification analyte. 3. Review of the 2020 PT event three hematology evaluation report revealed a score of 0% for cell identification due to "Results for this kit were not received," resulting in the first unsuccessful PT occurrence for the Cell Identification analyte. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the validation studies performed for the Alere Triage meter (serial # 00046321) and interview with the technical consultant, the laboratory failed to perform studies for verification of manufacturer's performance specifications for precision and reportable range for the Alere Triage Meter in 2018. The findings include: 1. Review of the validation studies performed in March 2018 for the Alere Triage meter (serial number 00046321) revealed no studies were available for verification of manufacturer's performance specifications for precision and reportable range. 2. Interview with the technical consultant on June 13, 2018 at 1pm confirmed that the validation studies performed for the Alere Triage meter (serial # 00046321) did not include studies for precision and reportable range. The laboratory reports D- dimer, CKMB, myoglobin, and troponin on this instrument and began reporting patients on April 1, 2018 with approximately 50 patients reported since installation of the meter. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's procedure for the Alere Triage meter, the laboratory's procedure manual, the Food and Drug Administration (FDA) database for test complexity, interview with the instrument manufacturer technical services, patient test reports and the laboratory's quality control records for the Triage meter, and interview with the technical consultant the laboratory failed to perform two levels of control each day of patient testing for the CKMB, myoglobin and troponin analytes in 2016, 2017, and 2018. The findings include: 1. Observation of the laboratory on June 13, 2018 at 9:00 am revealed the Alere Triage meter in use for patient testing. 2. Review of the laboratory's procedure for the Alere Triage meter revealed the following: The meter is used for performing CKMB, myoglobin, and troponin. The control frequency is every 30 days and when a new lot number of a kit is opened. 3. Review of the laboratory's procedure manual revealed there was no individualized quality control plan (IQCP) in place for the reduced frequency of quality control for the Alere Triage meter for the CKMB, myoglobin, and troponin analytes. 4. Review of the FDA database for test complexity revealed that the CKMB, myoglobin and troponin analytes performed on the Alere Triage meter are moderately complex tests. 5. Interview via phone on June 15, 2018 at 2:30 pm with the manufacturer's technical services confirmed that the tests for CK- MB, myoglobin and troponin-I performed on the Triage meter are moderately complex. 6. Review of patient number thirteen test report and quality control for the months of June and July 2016 revealed CK-MB, myoglobin and troponin patient testing reported on 07.26.2016 with quality control last performed on 06.23.2016. 7. Review of patient number ten test report and quality control for the months of April and May 2017 revealed patient testing performed on 5.2.17 with quality control last performed on 04.13.17. 8. Interview with the technical consultant on June 13, 2018 at 4:00 pm confirmed the laboratory reports patient testing for CK-MB, myoglobin and troponin using the Alere Triage meter, follows the laboratory's procedure for quality control frequency, does not perform two levels of quality control each day of patient testing, and does not have an IQCP in place for reduced frequency of quality control in 2016, 2017, and 2018. -- 2 of 2 --