Summary:
Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 record review and staff interview, the laboratory failed to investigate and take remedial action when unacceptable Proficiency Testing (PT) results were obtained in the specialty of Chemistry. Findings include: 1. Record review on 08/01 /2024 of the laboratory's 'Comparative Evaluation 2024 Chemistry - Core - 2nd Event' report from the American Proficiency Institute (API) revealed the following survey with an unacceptable result for Total Iron for 2 out of 5 PT samples: Event Sample ID Score 2nd Event CH-07and CH-09 Unacceptable 2. Record review on 08/01/2024 of the laboratory's 'API Proficiency Testing Performance Evaluation, Performance Review and