Novant Health Forsyth Pediatrics Union Cross

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 review of 2022, 2023, and 2024 hematology quality control records and interview with the TC (technical consultant) 8/1/24, the laboratory failed to retain manufacturer's assay sheets for each lot number of hematology control material used from 4/1/22 - 8/1/24. Findings: Review of 2022, 2023, and 2024 quality control records for the Medonic M-Series hematology analyzer revealed the laboratory failed to retain manufacturer's assay sheets for the following lot numbers of Boule Con-Diff control material for at least two years: 1. 2211231/2211232/2211233 2. 2220131 /2220132/2220133 3. 2220231/2220232/2220233 4. 2220331/2220332/2220333 5. 2220431/2220432/2220433 6. 2220531/2220532/2220533 7. 2220731/2220732 /2220733 8. 2221001/2221002/2221003 9. 2221031/2221032/2221033 10. 2230101 /2230102/2230103 11. 2230131/2230132/2230133 12. 2230331/2230332/2230333 13. 2230431/2230432/2230433 14. 2230731/2230732/2230733 15. 2231031/2231032 /2231033 16. 2231231/2231232/2231233 During interview at approximately 1:00 p. m., the TC confirmed the laboratory had not saved the hematology quality control assay sheets. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment plan, review of 2022, 2023, and 2024 quality assessment records, and interview with the TC 8/1/24, the laboratory failed to retain all quality assessment records for at least two years. Findings: Review of the laboratory's quality assessment plan revealed the plan included monitors to be completed by the laboratory on a quarterly basis and an annual assessment. Review of 2022, 2023, and 2024 quality assessment monitors revealed the following monitors were not available for review during the survey: 1. 2022 4th quarter 2. 2023 1st, 2nd, 3rd, and 4th quarters and annual assessment During interview at approximately 2:00 p. m., the TC confirmed the 2022 4th quarter and the 2023 1st, 2nd, 3rd, and 4th quarters and annual assessment records were missing. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions and review of 2022, 2023, and 2024 hematology maintenance logs 8/1/24, the laboratory failed to document required monthly maintenance for the Medonic M-Series hematology analyzer for 7 of 12 months in 2022. Findings: Review of the Medonic M-Series User's Manual "Section 8: Cleaning, Maintenance & Transport" revealed maintenance procedures to be performed daily, monthly, and every six months. Section "8.2 Monthly Cleaning" stated "This section describes the cleaning procedure to be used to secure the correct function of the instrument on a monthly basis. ..." The section included instructions for cleaning the analyzer with hypochlorite and instructions for performing the clot prevention procedure using enzymatic cleaner. Review of 2022, 2023, and 2024 Medonic M-Series maintenance logs revealed the laboratory failed to document monthly maintenance for 7 of 12 months in 2022. Monthly maintenance was not documented for the following months: February, April, May, June, July, November, December. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of MediaLab training documents, review of 2022, 2023, and 2024 bilirubin quality control records, and review of manufacturer's quality control assay sheet 8/1/24, the laboratory failed to ensure quality control was acceptable prior to reporting patient test results. Findings: Review of MediaLab "Bilirubinometer - Initial" training documents for the Reichert Unistat Bilirubinometer revealed on Slide 5 "Quality Control Two levels of control material will be processed each day prior to -- 2 of 3 -- patient testing ... Controls are processed in the same manner as patients and results recorded on the QC log. If one or both control values are outside the acceptable range, check the lot # and expiration date, remix the controls and retest. If controls continue to be out of acceptable range, call your Technical Consultant or Reichert Customer Service. Do not report patients until acceptable quality control has been obtained." Review of 2022, 2023, and 2024 bilirubin quality control records revealed the laboratory used Quantimetrix Bilirubin Control - Pediatric / Level 1 & 2 (lot #131651 /131652) from 2/1/22 - 3/31/23. Review of the manufacturer's quality control assay sheet revealed the following acceptable ranges for quality control: 1. Lot #131651 (Level 1) - 9.3 - 13.9 mg/dL (milligrams per deciliter) 2. Lot #131652 (Level 2) - 19.1 - 28.6 mg/dL Review of the laboratory's bilirubin logs revealed the following acceptable ranges for quality control which were not consistent with the ranges specified by the manufacturer: 1. Lot #131651 (Level 1) - 8.9 - 13.4 mg/dL 2. Lot #131652 (Level 2) - 18.3 - 27.4 mg/dL Review of the laboratory's bilirubin logs revealed Level 1 control values were outside the manufacturer's acceptable limits on 9 days of testing (3/29/22, 3/31/22, 4/1/22, 4/4/22, 4/6/22, 7/20/22, 2/20/23, 2/21/23, and 3/3/23), and Level 2 control values were outside the manufacturer's acceptable limits on 3 days of testing (2/20/23, 2/21/23, and 3/3/23). -- 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: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2022 API (American Proficiency Institute) proficiency testing results 7/5/23, the laboratory failed to successfully participate in proficiency testing for Total Bilirubin and failed to achieve satisfactory performance for the subspecialty of Routine Chemistry on two consecutive testing events. See the deficiency cited at D2097. D2097 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2022 API proficiency testing results 7/5/23, the laboratory failed to successfully participate in proficiency testing for Total Bilirubin and failed to achieve satisfactory performance for the subspecialty of Routine Chemistry on two consecutive testing events. Findings: Desk review of CMS Casper reports 153D and 155D and 2022 API proficiency testing results revealed: 1. The laboratory failed to participate and received a score of 0% for Total Bilirubin, resulting in an overall score of 0% for Routine Chemistry on the 2022 API Chemistry Core 2nd event. 2. The laboratory failed to participate and received a score of 0% for Total Bilirubin, resulting in an overall score of 0% for Routine Chemistry on the 2022 API Chemistry Core 3rd event. 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 desk review of CMS Casper reports 153D and 155D and desk review of 2022 API proficiency testing results 7/5/23, the laboratory director failed to provide overall management and direction to ensure successful participation in proficiency testing. See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2022 API proficiency testing results 7/5/23, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: Desk review of CMS Casper reports 153D and 155D and 2022 API proficiency testing results revealed: 1. The laboratory failed to participate and received a score of 0% for Total Bilirubin, resulting in an overall score of 0% for Routine Chemistry on the 2022 API Chemistry Core 2nd event. 2. The laboratory failed to participate and -- 2 of 3 -- received a score of 0% for Total Bilirubin, resulting in an overall score of 0% for Routine Chemistry on the 2022 API Chemistry Core 3rd event. -- 3 of 3 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the TC (technical consultant) 8/13/19, the TC failed to perform and document competency evaluations for 3 of 11 testing personnel (TP #3, TP #5, TP #8) at least semiannually during the first year. Findings: 1. Review of personnel records revealed TP #3 was trained on the Medonic hematology analyzer in February 2018. Competency evaluations were documented for TP #3 in March 2019 and May 2019. 2. Review of personnel records revealed TP #5 was trained on the Medonic hematology analyzer in February 2018. Two competency evaluations were documented for TP #5 in March 2019 - one was labeled as a six month competency, and the other was labeled as an annual competency. 3. Review of personnel records revealed TP #8 was trained on the Medonic hematology analyzer in February 2018. Two competency evaluations were documented for TP #8 in March 2019 - one was labeled as a six month competency, and the other was labeled as an annual competency. During interview at approximately 3:00 p.m., the TC confirmed that semiannual (six month) competencies were performed late for TP #3, TP #5, and TP #8 by the previous TC. She stated she was unsure why the competencies were late. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet 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 2 -- qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel records 8/13/19 and the deficiency cited at D6065, the laboratory failed to verify that 1 of 11 testing personnel (TP #4) met the minimum education requirements for performing moderate complexity testing. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the TC (technical consultant) 8/13/19, the laboratory failed to verify that 1 of 11 testing personnel (TP #4) met the minimum education requirements for performing moderate complexity testing. Review of personnel records revealed there were no education credentials on file for TP #4. During interview at approximately 2:20 p.m., the TC stated TP #4 had been asked to provide her high school diploma and she was unsure why it was not available. -- 2 of 2 --