Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 30, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on hematology document review and staff interview, the laboratory failed to perform and document maintenance as required. Findings include: 1. Review of Coulter AcT diff 2 logs revealed the laboratory failed to perform and document required instrument maintenance for 2016, 2017, and 2018 thus far. 2. An interview with the Clinical Compliance coordinator in the conference room on 1/30/18 at approximately 2:00 p.m. confirmed the laboratory failed to perform and document required hematology instrument maintenance for 2016, 2017, and 2018 thus far. 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 --