Summary:
Summary Statement of Deficiencies D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(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-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on patient test records review, quality control records review, and interview with staff, the laboratory failed to ensure they performed two levels of quality control prior to testing patient samples following a complete change of Piccolo test reagents for 1 of 11 test cartridge lot number changes reviewed. The laboratory performed approximately 3 to 5 CMP tests per day using a serum specimen. Findings include: 1. Patient test records included documentation the laboratory used lot number 9251BB7 for patient 65460 on 10/02/2019. 2. Quality control records included documentation the laboratory performed quality control for lot number 9251BB7 on 10/04/2019. 3. In an interview conducted on 01/16/2019 at approximately 12:30 P.M. staff stated they were unaware they performed quality control after they testing patient samples. D5783