Summary:
Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of quality control documentation for November 2021, February 2022, and April 2022, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to establish statistical parameters for acceptable quality control for Hematology. Survey findings include: A. The surveyor reviewed hematology quality control documentation for November 2021, February 2022, and April 2022, The surveyor requested data used for calculating the acceptable ranges in use for quality control evaluation. None was provided. B. In an interview, at 1:47 p.m. on 6/21/2022, laboratory employee #1 (as listed on the form CMS-209) stated that the calculation of acceptable quality control ranges was not available. D5783