Summary:
Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on a lack of policy and/or procedure provided by the laboratory and interview with the laboratory personnel, the laboratory failed to have a specific policy and/or procedure in place that indicated how the laboratory monitors and assesses the accuracy of test results from manually entered results and results sent from interfaced instruments to the LIS and EMR. Findings include: 1. The laboratory did provide the surveyor with documentation that indicated some monthly checks were in place, but there was no policy and/or procedure in place that indicated the specifics of the accuracy checks including how often the checks would be performed and what specific information was being assessed. 2. The laboratory personnel acknowledged that there was no specific policy and/or procedure in place that addressed the accuracy checks indicated above. 3. The laboratory's annual test volume is approximately 15,731. 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 --