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: The laboratory failed to cooperate with the inspection process, resulting in the failure to complete the survey process due to a hostile environment. (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 observation of the laboratory, interview with medical assistant number 2 and the technical consultant, the laboratory failed to cooperate with the inspection process, resulting in the failure to complete the survey process due to a hostile environment. The findings include: 1) Observation of the laboratory on February 21, 2018 at 12:10 p.m. revealed a complete blood count instrument and test kits in use for patient testing. 2) Interview on February 21, 2018 at 12:20 pm and 12:35 pm with medical assistant number 2 resulted in the medical assistant number 2 not being cooperative 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 -- with the survey interviews creating an unstable and hostile environment. 3) Interview on February 21, 2018 at 12:50 p.m. with the technical consultant confirmed that the medical assistant number 2's unstable and hostile response was unprovoked by the inspection process. -- 2 of 2 --