Columbus Health Department Laboratory

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 record review, and an interview with the Technical Supervisor (TS) #5, the laboratory failed to establish and follow a written policy and procedure to assess competency of the Clinical Consultant (CC), TS, Technical Consultant (TC), and the General Supervisor (GS) as specified in the personnel requirements in subpart M. All patients tested at this laboratory had the potential to be affected. Findings Include: 1. Review of the laboratory's CMS-209 Personnel Report form, approved and signed by the Lab Director on 02/26/2021, found one individual that fulfilled the role of the CC, five individuals that fulfilled the role of TS, six individuals that fulfilled the role of TC, and 7 individuals that fulfilled the role of GS. 2. Review of the laboratory's Competency Assessment policy and procedure failed to find a policy and procedure for assessing the competency of the CC, TS, TC and GS based on the regulatory responsibility of that role, at a frequency determined by the laboratory. 3. Review of the laboratory's Competency Assessment documentation, failed to find evidence that the CC, TS, GS and TC were assessed for competency, based on the regulatory responsibility of that role, at a frequency determined by the laboratory. 4. An interview with the TS #5, on 03/31/2021 at 2:31 PM, confirmed that the lab did not have a policy, procedure, or documentation for assessing the competency based on the regulatory responsibility of those roles, at a frequency determined by the laboratory. 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 D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, and an interview with the Technical Supervisor (TS), the laboratory failed to follow written policies and procedures for the Quantiferon TB Gold Plus specimen processing. This deficient practice had the potential to affect all samples tested using the Quantiferon TB Gold Plus test system. Findings Include: 1. Review of the laboratory's "Specimen Collection for Quantiferon - TB Gold Plus" policy and procedure, approved, signed, and dated by the Laboratory Director on 05/15/2019, found the following statements: "Handling Conditions: 5. Incubate the QFT-Plus Blood Collection Tubes UPRIGHT at 37 C +/- 1 C for 16 to 24 hours." "Post-incubation of blood collection tubes and harvesting of plasma" * Plasma samples can be stored in centrifuged QFT-Plus Blood Collection Tubes for up to 28 days at 2 C to 8 C. Or harvested harvested plasma samples can be stored for up to 28 days at 2 C to 8 C." 2. The surveyor requested documentation of Quantiferon TB Gold Plus specimen incubation times, plasma sample and harvested plasma sample refrigerated storage dates and times. The TS #1 stated a white board attached to the incubator was used to record times but was erased daily and no date and times were recorded for the refrigerated stored samples. The interview occurred on 06/19/2019 at 2:30 PM. C = degrees Celsius 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 --