Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Global Care Medical Group, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. . D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to fully evaluate competency of the staff through review of proficiency testing records as evidenced by the following: a) A review of proficiency testing records for calendar years 2021 and 2022 (six testing events) revealed that the technical consultant had documented a review of proficiency testing results. However for unsatisfactory analyte scores obtained (Urine drug screen - first testing event of 2021, Calcium and High Density Lipoprotein - 2nd testing event of 2021) the reviews did not indicate the interpretation or remedial action in response to the unsatisfactory scores obtained. b) The technical consultant confirmed in an interview on 3/15/23 at 8:49 AM that the remedial action or interpretation for the unsatisfactory proficiency testing results indicated above had not been addressed but not documented. 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 --