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 interview and record review of Chemistry proficiency testing results, the laboratory failed to attain a satisfactory score of a least eighty percent (80 %) on the Creatinine certified analyte. Findings include: 1. Record review on 12/06/18 at 10:35 AM, of Chemistry Proficiency Testing Results, revealed the laboratory scored a sixty percent (60 %) in the second testing event of 2017, and all five (5) analytes for that survey were below the peer group mean, suggesting a calibration problem. The Calibration was not part of the