Apls Services Llc D/B/A Clear Diagnostics

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at APLS Services LLC dba Clear Diagnostics on 06/30/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Supervisor failed to perform an initial and 6 month competency assessment for one testing person (TP #A) of seven TP (#A - #G). Findings included: The owner stated during an interview on 06/30/2025 at 10:30 a.m. that TP #A's date of hired was 08/2023. Competency assessments for TP #A were reviewed. An initial and 6 month competency were not present. Interview with the owner at 11:15 a.m. on 06/30/2025 confirmed the initial and 6 month competencies were not present. 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 D0000 An unannounced complaint survey, #2022001509, was conducted on 03/15/22 at APLS Services LLC dba Clear Diagnostics. The facility was in compliance with 42 CFR 493, Requirement for clinical laboratories. 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 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 the Laboratory Owner the laboratory failed to perform competency evaluations on 1 out of 1 Pathologist (Testing Person #B) who reads Histopathology slides. Findings Included: Review of competency evaluations revealed no competency evaluation for Testing Person #B. Interview on 02 /14/19 at 10:34 AM the Laboratory Owner confirmed that there were no competency evaluations done on Testing Person #B. 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 --