Duke Neal Medical, Llc

Summary Statement of Deficiencies D0000 A Special focus survey was performed at Duke Neal Medical, LLC-CLIA ID 19D0689175 on November 8, 2021. Duke Neal Medical, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1100 CONDITION: Facility Administration 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's test menu and interview with personnel, the laboratory failed to report one hundred eight (108) SARS COV-2 results to the state as required. Findings: 1. Review of the laboratory's test menu revealed the laboratory utilized the BD Veritor System for SARS COV-2 testing with an annual volume of 108. 2. In interview on November 8, 2021 at 10:05 am, laboratory personnel 1 stated the laboratory began utilizing the BD Veritor System for SARS COV-2 testing on October 1, 2020. 3. In further interview on November 8, 2021 at 10:13 am, laboratory personnel 2 stated no results (positive or negative) have been reported to the state. D3031 RETENTION REQUIREMENTS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 random selection of patient test records, patient microscope slides, and interview with personnel, the laboratory failed to retain technical reports for at least two (2) years as required for four (4) of nine (9) patients reviewed. Findings: 1. Review of random selection of patient test records and microscope slides from 2019, 2020, and 2021 revealed in 2020 slides are labeled with the patient's name and accession number from a technical report that is generated from the laboratory that performs the technical (processing) of patient samples. 2. Further review of random selection of patient test records revealed the laboratory did not retain copies of the technical reports for the following four (4) patients: Patient ID: IRJO0000 Patient ID: WARO0003 Patient ID: MUAU0000 Patient ID: JOMC0030 3. In interview on November 8, 2021 at 11:52 am, laboratory personnel 1 stated the technical reports for patient samples prior to March 2021 were destroyed by the hurricane in August 2021. Laboratory personnel 1 stated the laboratory kept paper copies of the technical reports. 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 polices, proficiency testing records, and interview with personnel, the laboratory failed to perform an assessment for one (1) of eight (8) proficiency testing (PT) events per laboratory policy. Findings: 1. Review of the laboratory's "Quality Assurance for Testing Personnel Histopathology and KOH" policy under the "KOH" section revealed "Three times a year a CLIA approved lab sends the testing personnel a KOH skin prep to read. If the findings are ever inconsistent with the testing personnel's findings it will be discussed with testing personnel and retested if deemed necessary. Any corrections will be noted on a

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Duke Neal Medical, LLC-CLIA ID 19D0689175 on November 8, 2021. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's test menu and interview with personnel, the laboratory failed to report one hundred eight (108) SARS COV-2 results to the state as required. Findings: 1. Review of the laboratory's test menu revealed the laboratory utilized the BD Veritor System for SARS COV-2 testing with an annual volume of 108. 2. In interview on November 8, 2021 at 10:05 am, laboratory personnel 1 stated the laboratory began utilizing the BD Veritor System for SARS COV-2 testing on October 1, 2020. 3. In further interview on November 8, 2021 at 10:13 am, laboratory personnel 2 stated no results (positive or negative) have been reported to the state. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 random selection of patient test records, patient microscope slides, and interview with personnel, the laboratory failed to retain technical reports for at least two (2) years as required for four (4) of nine (9) patients reviewed. Findings: 1. Review of random selection of patient test records and microscope slides from 2019, 2020, and 2021 revealed in 2020 slides are labeled with the patient's name and accession number from a technical report that is generated from the laboratory that performs the technical (processing) of patient samples. 2. Further review of random selection of patient test records revealed the laboratory did not retain copies of the technical reports for the following four (4) patients: Patient ID: IRJO0000 Patient ID: WARO0003 Patient ID: MUAU0000 Patient ID: JOMC0030 3. In interview on November 8, 2021 at 11:52 am, laboratory personnel 1 stated the technical reports for patient samples prior to March 2021 were destroyed by the hurricane in August 2021. Laboratory personnel 1 stated the laboratory kept paper copies of the technical reports. 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 polices, proficiency testing records, and interview with personnel, the laboratory failed to perform an assessment for one (1) of eight (8) proficiency testing (PT) events per laboratory policy. Findings: 1. Review of the laboratory's "Quality Assurance for Testing Personnel Histopathology and KOH" policy under the "KOH" section revealed "Three times a year a CLIA approved lab sends the testing personnel a KOH skin prep to read. If the findings are ever inconsistent with the testing personnel's findings it will be discussed with testing personnel and retested if deemed necessary. Any corrections will be noted on a

Summary Statement of Deficiencies D0000 A Certification Survey was performed on March 13, 2019 at SLMA Dermatology, CLIA ID # 19D0689175. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to follow their established competency assessment policy. Findings: 1. Review of the laboratory's CMS 209 (Laboratory Personnel Report) revealed the Laboratory Director and Personnel 2 serve as testing personnel for KOH testing. 2. In interview on March 13, 2019 at 1:30 pm, Personnel 3 stated Personnel 2 was hired September 2017. 3. Review of the laboratory's "Quality Assurance Manual" under the"Personnel Assessment" section revealed "If the laboratory has employees, the Laboratory Director will use personal observation to perform an ongoing evaluation of all employees of the Laboratory to ensure competence in job performance." 4. Review of the laboratory's "Risk Assessment Worksheet" for KOH under "Testing Personnel" section revealed "Must meet 6 CLIA elements of competency assessment." 5. Review of the laboratory's "Quality Control Plan Worksheet" for KOH under "Training Competency Assessment" section revealed "annually successfully meet all six CLIA Elements for Competency Assessment." 6. Review of personnel records for Personnel 2 revealed the laboratory did not have documentation of performance of a competency assessment at least semi-annually during the first year (due March 2018). 7. In interview on March 13, 2019 at approximately 2:00 pm, Personnel 3 stated the Laboratory Director did not perform a competency assessment for Personnel 2. 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 -- 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 establish a written policy for verification of the accuracy of histopathology test performance. Findings: 1. In interview on March 13, 2019 at approximately 3:00 pm, Personnel 3 stated quarterly Quality Assurance (QA) is performed, where another dermatologist reviews the Laboratory Director's cases. 2. Review of the laboratory's policy and procedure manual and QA records revealed the laboratory did not have a written policy/procedure for verification of the accuracy of histopathology, including acceptability criteria and a