Summary:
Summary Statement of Deficiencies D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on review of laboratory records to include quality control (QC) logs, proficiency testing records, personnel competencies and temperature logs, and interview with the Respiratory Supervisor, the Laboratory Director/Technical Consultant (LD/TC) failed to directly provide oversight or observe performance of daily patient Blood Gas testing for eight of eight months since the installation of the Blood Gas Analyzer on 8/1/2024. Findings Include: 1. Surveyor review of laboratory records including QC maintenance and temperature logs, proficiency testing records and personal competencies, indicated the records were being delivered to the LD/TC at an off-site office by the Respiratory Supervisor or other staff. There was no documentation of onsite oversight or involvement by the LD/TC following the installation of the Nova Stat Profile Prime CCS Blood Gas Analyzer in August 2024. 2. The Respiratory Supervisor confirmed in an interview on 4/232025 at 4:30 p.m., that the LD/TC had not physically visited the laboratory to observe or oversee routine patient testing, daily maintenance, or quality control procedures since the laboratory obtained its CLIA certificate in August 2024. 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 --