Summary:
Summary Statement of Deficiencies D8100 INSPECTION REQUIREMENTS CFR(s): 493.1771 Each laboratory issued a CLIA certificate must meet the requirements in 493.1773 and the specific requirements for its certificate type, as specified in 493.1775 through 493.1780. All CLIA-exempt laboratories must comply with the inspection requirements in 493.1773 and 493.1780, when applicable. This CONDITION is not met as evidenced by: Based on surveyor's direct observation and interview with the laboratory owner (LO); the laboratory failed to comply with the inspection requirements in 493.1773. (Refer to D8101). D8101 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(a) A laboratory issued a certificate must permit CMS or a CMS agent to conduct an inspection to assess the laboratory's compliance with the requirements of this part. A CLIA-exempt laboratory and a laboratory that requests, or is issued a certificate of accreditation, must permit CMS or a CMS agent to conduct validation and complaint inspections. This STANDARD is not met as evidenced by: Based on surveyor's direct observation and interview with the laboratory owner (LO); the laboratory failed to permit the scheduled Centers for Medicare & Medicaid Services (CMS) initial certification survey of the laboratory on 03/04/2024 at 9:00 a. m. Findings include: 1. Direct observation on 03/04/2024 at 9:35 a.m., revealed the LO taking photographs of the outside of CLIA # 14D2244185 - CLEAR LABS LLC, 6318 N Cicero Ave, Chicago, IL 60646. 2. Surveyor's interview with the LO on 03/04 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 -- /2024, at 9:35 a.m., confirmed the CMS survey would be completed as scheduled. 3. Direct observation on 03/04/2024, at 9:43 a.m., revealed the LO returned to his vehicle and left the laboratory. -- 2 of 2 --