Summary:
Summary Statement of Deficiencies D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(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-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon interview with TP#1 (Testing Personnel) on 2/22/24, the laboratory failed to prepare LC/MS (liquid chromatography/mass spectrometry) quality control and calibration materials from different standard stock solutions. Findings: During interview at approximately 1:35 p.m., TP#1 stated that both quality control and calibration materials are prepared from the same standard stock solution. 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 --