Summary:
Summary Statement of Deficiencies D0000 An announced validation survey was performed on 08/04/2023. The laboratory was found to be in compliance with CLIA regulations found at 42 CFR 493.1 through 493.1780. 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: Based on review of the laboratory's American Proficiency Institute (API) profiency testing records for 2022 and 2023 and confirmed interview, the laboratory failed to establish a mechanism to document patient remedial action for any unacceptable analyte proficiency testing (PT) score for one of five PT events reviewed. Findings included: 1. A review of the laboratory's American Proficiecncy Institute (API) proficiency testing for 2023 indicated the facility failed to attain a satisfactory score for proBNP (B-type natriuretic peptide) for the 2023 Chemistry 1st event. Four out of five samples received an unsatisfactory score, which resulted in a score of 20% (percent) on the first event of 2023. The failure to attain an individual score of at least 80% is unsatisfactory performance. CM-01 Lab result 126 pg/mL (API acceptable range 127-195 pg/mL) CM-02 Lab result 6863 pg/mL (API acceptable range 7043- 9155 pg/mL) CM-03 Lab result 1608 pg/mL (API acceptable range 1674 - 2612 pg /mL) CM-05 Lab result 120 pg/mL (API acceptable range 126-194 pg/mL) 2. Review of the