Novant Health Forsyth Pediatrics Kernersville

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 2020, 2021, and 2022 API (American Proficiency Institute) proficiency testing records and interview with the TC (technical consultant) 11/15/22, the laboratory failed to review and evaluate all proficiency testing results. Findings: 1. The laboratory failed to evaluate the following ungraded results: a. 2020 hematology 3rd event - ungraded urine sediment identification sample US-06; b. 2021 hematology 3rd event - ungraded wet prep/KOH (potassium hydroxide) sample VKP-03. 2. The laboratory failed to evaluate a 50% score for urine colony count on the 2020 microbiology 2nd event. 3. The laboratory failed to review and evaluate results for the 2021 hematology 2nd event. Results for the 2021 hematology 2nd event were not available in the laboratory's proficiency testing records at the time of the survey. During interview at approximately 9:35 a.m., the TC confirmed that there was no documentation of evaluation for the ungraded, unacceptable, and missing results. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. 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 review of 2020, 2021, and 2022 media quality control records and interview with the TC (technical consultant) 11/15/22, the laboratory failed to document visual inspection of each new lot number of Uricult media for 6 of 9 lot numbers used during 2020, 2021, and 2022. Review of 2020, 2021, and 2022 Uricult quality control records revealed the laboratory utilized a "MEDIA CHECK-IN LOG" and documented visual inspection for 3 of 9 lot numbers of Uricult media received. There was no documentation of visual inspection for the other 6 lot numbers of Uricult media used by the laboratory during 2020, 2021, and 2022. During interview at approximately 12: 30 p.m., the TC confirmed the laboratory had not documented visual inspection of each new lot number of Uricult media. She stated they thought it was acceptable to save the manufacturer's documentation of quality control for each lot number and they did not realize documentation of the visual inspection was required. 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 review of the laboratory's quality assessment plan and review of 2020, 2021, and 2022 quality assessment monitors 11/15/22, the laboratory director failed to ensure the quality assessment program was maintained to assure the quality of the laboratory services offered. Findings: The laboratory's "Quality Assessment Plan" consists of monitors to be completed on a quarterly basis and a year-end annual assessment. The "Quality Assessment Plan" states "... V. PROCESSES / PROGRAM COMPONENTS Quality Assessment Activities ... 4. Testing personnel, the Laboratory Director, Technical Consultant and Clinic Administrator shall review and sign the completed monitors. ..." Review of 2020, 2021, and 2022 quality assessment monitors revealed many of the monitors for 2020 and 2021 had not been signed by all personnel required to review them. Examples: 1. 2020 - 1st and 2nd quarter monitors and year-end annual assessment signed by the testing personnel who completed the monitors, but not signed by the laboratory director, the technical consultant, or the clinic administrator. 2. 2021 - 1st quarter monitor signed by the testing personnel who completed the monitor, but not by the laboratory director, the technical consultant, or the clinic administrator. 2nd, 3rd, and 4th quarter monitors signed by the testing personnel who completed the monitor and the technical consultant, but not by the laboratory director or the clinic administrator. -- 2 of 2 --

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 review of 2020 and 2021 API(American Proficiency Institute) proficiency testing results 5/14/21, the laboratory failed to successfully participate in proficiency testing for HCT(hematocrit) for two consecutive testing events. See the deficiency cited at D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 API (American Proficiency Institute) proficiency testing results 5/14/21, the laboratory failed to successfully participate in proficiency testing for HCT(hematocrit) in two consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory provided unacceptable responses for 3 of 5 samples, resulting in a score of 40% for HCT on the 2020 Hematology 3rd event. 2. Desk review of CMS Casper report 155D and 2021 API Proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for HCT on the 2021 Hematology 1st 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 (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 API (American Proficiency Institute) proficiency testing results 5/14/21, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. 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 (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 API (American Proficiency Institute) proficiency testing results 5/14/21, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory provided unacceptable responses for 3 of 5 samples, resulting in a score of 40% for HCT on the 2020 Hematology 3rd event. 2. -- 2 of 3 -- Desk review of CMS Casper report 155D and 2021 API Proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for HCT on the 2021 Hematology 1st event. -- 3 of 3 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2017, 2018, and 2019 API (American Proficiency Institute) proficiency testing records, and interview with TP (testing personnel) 11/15/19, the laboratory failed to test proficiency samples in the same manner as patient specimens are routinely tested. The laboratory's "In-House Critical Values" policy states "All Critical values shall be repeated and then reported to the ordering physician or the person responsible for that patient. ..." Review of 2017, 2018, and 2019 API proficiency testing records revealed the laboratory failed to test proficiency samples in the same manner as patient specimens are routinely tested. Examples: 1. 2017 3rd event hematology - sample HEM-13 had a critical value for WBC (white blood cell count), and sample HEM-15 had critical values for WBC and hemoglobin. There was no documentation that the samples were retested to confirm the critical values. 2. 2018 1st event hematology - sample HEM-01 had critical values for WBC and hemoglobin, and samples HEM-03 and HEM-04 had critical values for WBC. There was no documentation that the samples were retested to confirm the critical values. 3. 2018 2nd event hematology - sample HEM-06 had a critical value for WBC, and sample HEM-08 had critical values for WBC and hemoglobin. There was no documentation that the samples were 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 -- retested to confirm the critical values. 4. 2018 3rd event hematology - samples HEM- 11 and HEM-13 had critical values for WBC, and sample HEM-15 had critical values for WBC and hemoglobin. There was no documentation that the samples were retested to confirm the critical values. 5. 2019 1st event hematology - sample HEM-02 had critical values for WBC and hemoglobin. There was no documentation that the sample was retested to confirm the critical values. 6. 2019 2nd event hematology - sample HEM-10 had critical values for WBC and hemoglobin. There was no documentation that the sample was retested to confirm the critical values. During interview at approximately 10:30 a.m., TP #1 stated that patient specimens with panic values are retested to confirm, so proficiency samples should be treated the same way. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of 2017, 2018, and 2019 API (American Proficiency Institute) proficiency testing records and interview with TP (testing personnel) 11/15/19, the laboratory failed to ensure TP signed the attestation statements to indicate who tested each sample. Review of 2017, 2018, and 2019 API proficiency testing records revealed attestation statements for the 2017 3rd, the 2018 1st, 2nd, and 3rd, and the 2019 1st hematology test events did not indicate which TP tested the vaginal wet prep, KOH (potassium hydroxide) prep, and urine sediment samples. During interview at approximately 10:40 a.m., TP #1 stated she is the only TP who performs those tests. She confirmed she performed the testing but did not sign the attestation statements. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the 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 11/15/19 and the deficiency cited at D6065, the laboratory failed to verify that 1 of 15 testing personnel (TP #6) 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 -- 2 of 3 -- 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 11/15/19 and interview with the TC (technical consultant) 11/15/19, the laboratory failed to verify that 1 of 15 testing personnel (TP #6) met the minimum education requirements for performing moderate complexity testing. Review of personnel records for TP #6 revealed there were no education credentials available for review. During interview at approximately 3:30 p.m., the TC stated TP #6 was asked to bring in her education credentials prior to the survey but had not brought them in yet. -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --