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 the CMS - 116 form received on 08/31 /2021; 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 the CMS - 116 form received on 08/31 /2021; the laboratory failed to be operational for the Centers for Medicare & Medicaid Services (CMS) initial certification / complaint survey of CARE CLINICAL LAB, INC. on 03/25/2024, at 9:00 a.m. Findings include: 1. Review of the CMS - 116 form received on 08/31/2021 revealed the hours of operation as 9:00 a.m. - 5:00 p.m., Monday through Saturday for CLIA # 14D2234507 - CARE CLINICAL LAB, INC. 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 -- 2. Direct observation on Monday 03/25/2024, at 9:20 a.m., of the facility location marked as CLIA # 14D2234507 - CARE CLINICAL LAB, INC, 4055 OAKTON STREET, SKOKIE, IL 60076 revealed the location was closed and the surveyor was unable to enter the building. 3. Surveyor's direct observation revealed two documents adhered to the front entry doorway that read: a) "FedEx Express - We missed you. Date: 3-7 Door tag number: DT1062 7141 9498" b) "Violation Citation Complaint Administrative Court Copy - The Village of Skokie, A Municipal Corporation, Versus Respondent (Named Below), Now Comes by the Under-signed and States: Respondent: Care Clinical Lab, Inc. Address: 4055 Oakton St. Skokie, IL 60076 On Day Of Week: Friday, 3/8/24 Approx.: 11:00 a.m. Did and Then Violate Section: 86- 43 44 86-7 - Waste is not held in dumpster with lid closed. Lake Shore Waste has suspended service due to lack of payment. Posted on property: March 11th, 2024, at 11:05 a.m.". 4. On 03/25/2024, at 9:20 a.m., surveyor's direct observation through the front entry doorway revealed the facility to be empty and non - operational. -- 2 of 2 --