Summary:
Summary Statement of Deficiencies D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on record review and staff interview on 02/20/2018, the laboratory failed to run two levels of quality control material each day of patient testing for reticulocyte and spinal fluid cell counts. Findings include: Review of the policy and procedure manual on 02/20/18, failed to reveal an established quality control plan for reticulocyte counts and spinal fluid cell counts. The Technical Consultant acknowledged in an interview at 12:50 PM on 02/20/2018, the laboratory failed to establish a quality control program to include acceptable parameters appropriate for the performance of the reticulocyte and spinal fluid cell counts. 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 --