Cleveland County Health Department

Summary Statement of Deficiencies 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 policies and procedures, review of personnel records, and interview with TC (technical consultant) #2 on 3/18/25, the laboratory failed to follow their policy for evaluating the competency of testing personnel and failed to document the performance of a technical consultant competency evaluation for TC #2. Findings: Review of the laboratory's "Training/Orientation of Laboratory Personnel and Competency Assessment for Testing Personnel" policy revealed "... PROCEDURE: ...4. Competency assessments will include: a. Direct observation of routine test performance including preparation, handling, processing and testing. ... d. Direct observation of performance of instrument maintenance. ..." Review of personnel records for TC #2 revealed TC #1 had signed off on the technical competency evaluations for TC #2 performed in 2023 and 2024. The evaluation for 2023 was performed 4/28/23, and TC #1 signed off 8/16/23. The evaluation for 2024 was performed 4/30/24, and TC #1 signed off 5/2/24. During interview at approximately 11:55 a.m., TC #2 confirmed that TC #1 had not been onsite during the evaluations to directly observe her routine test performance or the performance of maintenance. TC #2 also confirmed she had not been evaluated for her TC duties. 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 --

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 2020 and 2021 QC(quality control) records and the absence of documentation 2/3/22, the laboratory failed to retain all required DCA Vantage Microalbumin and Creatinine quality control records. Findings: Review of 2020 and 2021 DCA Vantage Microalbumin and Creatinine QC records revealed the laboratory failed to retain copies of the Siemens DCA Systems Microalbumin/Creatinine Control Assay cards with the quality control material acceptable ranges and expiration dates for the following lot numbers: 1. Microalbumin/Creatinine low/high control lot # 0055, unknown expiration date; 2. Microalbumin/Creatinine low/high control lot # 0056, expiration date 9/21(obtained during survey from manufacturer); 3. Microalbumin/Creatinine low/high control lot # 0057, expiration date 3/22(obtained during survey from manufacturer); 4. Microalbumin/Creatinine low/high control lot # 0059, expiration date 1/23(obtained during survey from manufacturer). D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: 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 -- Based on observation and review of gram stain QC(quality control) and patient records 2/3/22,the laboratory failed to discard gram stain reagent that had exceeded the expiration date and was used for patient testing. Findings: During tour of laboratory at approximately 9:20 am, the surveyor observed one bottle of BD BBL Gram Crystal Violet reagent,( lot #0140192, expiration date: 12/31/21), located in the gram stain area and in use. Review of gram stain QC records revealed QC was performed weekly from 1/5/22 to 2/2/22 with the expired Gram Crystal Violet reagent. Review of patient records revealed approximately 15 patients were tested with the expired Gram Crystal Violet reagent from 1/3/22 to 1/26/22. -- 2 of 2 --