Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Through a review of Quality Assessment Plan for Proficiency's testing, Proficiency Testing (PT) records for 2018, American Proficiency Institute (API) performance review logs, lack of documentation as well as interviews with staff, it was determined the Laboratory failed to prevent the recurrence of problems in the General Laboratory Systems. As evidenced by: A. The laboratory performs Activated Clotting Times (ACT) on the HEMOCHRON Analyzer. B. A review of the Laboratory's Quality Assessment Plan for Proficiency Testing revealed: "All results will be checked for accuracy. Any wrong or unacceptable result will be investigated to determine the cause of the failed result to reduce the likelihood of a recurrence of the problem in future surveys. Documentation of this process will take place on the Proficiency testing error report/