Summary:
Summary Statement of Deficiencies D0000 An offsite follow-up was conducted on 09/10/2026 All deficiencies have been corrected, and no new noncompliance found. The laboratory is in compliance with 42 CFR Part 493 Requirements for Clinical Laboratories. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency-testing records, the random selection of five (5) patient reports, and an interview with the Technical Consultant (TC) on September 1, 2026, it was determined that the laboratory failed to achieve at least 80 percent acceptable responses for each routine chemistry analyte during the second and third testing events of 2025. The findings included: 1. The laboratory participated in the College of American Pathologists (CAP) Proficiency Testing (PT) Program for routine chemistry testing using a VITROS CHEM (VITROS XT 3400) analyzer. According to the CAP evaluation, the laboratory received the following unsatisfactory scores: Q2- 2025: Albumin = 40% Q2- 2025: Bilirubin, total = 60% Q3- 2025: Albumin = 60% 2. On September 1, 2026, at approximately 1:00 pm, the TC confirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on August 5, 2026, stated that the laboratory performed approximately 16,000 routine chemistry tests including albumin and bilirubin, total annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --