Jefferson Pediatric Clinic

Summary Statement of Deficiencies D0000 A Certification survey was performed at Jefferson Pediatric Clinic, CLIA ID 19D0457919, on April 24, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation by surveyor, review of the laboratory's policies, calibration 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 -- records, and interview with personnel, the laboratory failed to perform calibration procedures on the Sysmex XN-330 utilized for Complete Blood Count (CBC) testing at least once every six (6) months in 2022. Findings: 1. Observation by surveyor during the laboratory tour on April 24, 2024 at 1:27 pm revealed the laboratory utilizes the Sysmex XN-330 for CBC testing. 2. Review of the laboratory's CBC policies under the "Calibration Procedures" section revealed "Calibrate at least once every six months. Keep calibration printouts (Reproducibility Summary Report, Carryover Summary Report, and Calibration Summary Report) for at least 2 years." 3. Review of the laboratory's calibration records revealed the laboratory did not have documentation of performance, due in October 2022. The "Certificate of Calibration" report for April 8, 2022 stated the certificate's expiration date was October 7, 2022. 4. In interview on April 24, 2024 at 4:03 pm, the Testing Personnel stated the calibration report listed one performance in 2022, April. The Testing Personnel confirmed the laboratory did have documentation of performance of calibration procedures in October 2022. 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 review of the laboratory's policies, records, and interview with personnel, the laboratory failed to perform quality assessment procedures monthly per laboratory policy in 2023 and January 2024 through March 2024. Findings: 1. Review of the laboratory's "Quality Assessment" policy revealed "The Monthly QA Checklist is our means of ongoing assessment which helps evaluate how well our polices and procedures are working, and minimizes the possibility of recurrent problems. Quality assessment activities are comprehensive and are documented monthly by the technical consultant and reviewed by the Medical Director. Once a month, complete the Monthly QA Checklist, including the chart review portion. If an item is marked 'no,' then action (and documentation of action taken) is needed. Action to take involves determining why a quality measure was not taken." 2. Review of the laboratory's records revealed the laboratory did not have documentation of performance of the "Monthly QA Checklist" for 2023 and January 2024 through March 2024. 3. In interview on April 24, 2024 at 4:30 pm, the Laboratory Director stated he does not use the Monthly QA Checklist. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on observation by surveyor, review of records, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5439. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that a quality assessment (QA) program was maintained to assure the quality of laboratory services provided. Refer to D5791. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification survey was performed on July 27, 2022 at Jefferson Pediatric Clinic, CLIA ID # 19D0457919. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to perform an assessment for one (1) of six (6) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing" policy under the "Troubleshooting Failed and 'Not Graded' PT Results" section revealed "If any PT test sample result is graded as 'Unacceptable' or 'Fail,' take action to identify and correct the problem, even if the overall event received a passing grade. Document all troubleshooting actions on the PT Event Report." 2. Review of the laboratory's 2020 (2nd and 3rd Events), 2021, and 2022 (1st Event) PT results from the College of American Pathologists (CAP) revealed the following "Unacceptable" PT result: a) 2021 FH9-C Hematology Auto Differential: Sample FH 9-12, "Unacceptable" 3. Review of the laboratory's PT records revealed the laboratory did not have documentation of an assessment performed for the identified "Unacceptable" sample. 4. In interview on July 27, 2022 at 2:00 pm the Laboratory Director confirmed the laboratory did not take any further action for the "unacceptable" PT result. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially 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 -- available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with personnel, the laboratory failed to perform annual preventative maintenance for 2020 and 2021 as required. Findings: 1. Review of the laboratory's calibration certificates revealed the laboratory failed to have documentation of annual preventative maintenance for 2020 and 2021 for the following equipment: a) Microscope b) Centrifuge c) Refrigerator Thermometer d) Freezer Thermometer e) Back-up Thermometer 2. In interview on July 27, 2022 at 2:52 pm, the Testing Personnel stated the laboratory did not have documentation of annual preventative maintenance for the identified equipment for 2021. 3. In interview on July 27, 2022 at 4:52 pm, the Laboratory Director confirmed the laboratory did not have documentation of annual preventative maintenance for the identified equipment for 2020. D5785

Summary Statement of Deficiencies D0000 A Certification Survey was performed on March 13, 2020 at Jefferson Pediatric Clinic, CLIA ID # 19D0457919. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not include the following: a) Written instructions related to actions to take for Complete Blood Count (CBC) flags on the Sysmex CBC analyzer. b)