Summary:
Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting System (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, as well as interview with the Technical Consultant (TC), the laboratory failed to perform, document, and retain remedial action for unacceptable subspecialty and analyte testing event scores. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Routine Chemistry Subspecialty: 2023 Second Event = 50% 2. Creatinine Kinase (CK), Total Test Analyte: 2023 Second Event = 0% b. A review of the PT scores from API (2023) summary reports confirmed the above test event findings. c. There was no documentation of