Summary:
Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure daily quality control (QC) was performed and acceptable prior to reporting patient test results for the qualitative detection of human chorionic gonadotropin (hCG) in the subspecialty of endocrinology. Findings include: 1. Record review on 2/8/2023 of the laboratory's 'Stat Lab Serum Qualitative BhCG Quality Control and Patient Log' for June 2022 through February 8, 2023, revealed the following: a. Positive and negative Sure-Vue hCG-Stat serum controls are utilized. b. Lack of documentation of positive QC results for 3 of 3 patient testing days, specifically, 6/30/2022, 12/12/2022, and 2/6 /2023. c. Lack of documentation of negative QC results on 2/6/2023. d. Three patient results were reported on the above testing days. e. Director review and sign off with no