Summary:
Summary Statement of Deficiencies D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) PT (Proficiency Testing) records as well as interview with the Laboratory Supervisor (LS), the laboratory failed to document attestation that PT samples were tested in the same manner as patient specimens. FINDINGS: 1. There was no documentation of AAB-MLE Testing Personnel (TP) and Laboratory Director (LD) attestation for the following PT events: a. 2022 Third Event. b. 2023 First, Second, and Third Events. c. 2024 First, Second, and Third Events. d. 2025 First and Second Events. 2. The LS confirmed the findings on October 7, 2025, at approximately 4:30 P.M. D2020 BACTERIOLOGY CFR(s): 493.823(a) 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Based on review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and AAB-MLE PT summary reports, as well as interview with the LS, the laboratory failed to achieve satisfactory performance (80% or greater) for the bacteriology test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory score: a. Bacteriology Test Analyte: 2025 Second Event = 60% b. A review of the PT scores from AAB-MLE (2025) confirmed the above findings. 2. The LS informed the surveyor that the laboratory failed to enter two of the five total sample PT results prior to submission. 3. The LS confirmed the findings on October 7, 2025, at approximately 4:30 P.M. D2026 BACTERIOLOGY CFR(s): 493.823(d) (d)(1) For any unsatisfactory 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) 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 Standard Operating Procedures (SOPs), CASPER 0155D and AAB-MLE PT summary reports, lack of