Summary:
Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's quality assessment policy, review of 2019 and 2020 laboratory records, and interview with GS (general supervisor) #2 on 11/2/20 and the Corporate Director of Laboratory Service on 11/4/20, the laboratory failed to have effective mechanisms in place to identify and correct problems and prevent their recurrence. Findings: The laboratory's "Quality Management Program" (GEN 8) states on page 11 "Monitoring and Assessment ... 1. Internal assessments may include evaluation of quality indicators, targeted audits of a single process, or system audits. A. Quality indicators are specific performance measurements designed to monitor one or more processes during a defined time period. The indicators are useful for evaluating service demands, production, and process stability. B. QA Compliance /Regulatory Coordinator or designees perform system and single process audits on an on-going basis (monthly, quarterly, and annually). C. Safety Improvement Reports (SIR) are completed thru the hospital Quality and Patient Safety software for incidents and events. SIRs are reviewed through the hospital and corporate Quality Councils. 2. Laboratory assessments and regulatory audits provide a review of policies and practices to ensure safe and appropriate processes. Audits are based on measurable, predetermined performance criteria. Audit