Summary:
Summary Statement of Deficiencies 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 the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records and an interview+ with the office manager (OM), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Total Bilirubin, Magnesium and Triglycerides analytes. The findings include: 1. The surveyor reviewed the PT records wherein API reported an unsatisfactory score of the following: a. Total Bilirubin, first event of 2023 (Q1-2023) Sample Reported Expected CH-01 0.4 0.0 - 0.8 CH-02 0.1 0.0 - 0.4 CH-03 *4.9 3.0 - 4.6 CH-04 1.3 0.7 - 1.5 CH-05 *3.3 2.0 - 3.2 b. Magnesium, first event of 2024 (Q1-2024) Sample Reported Expected CH-01 *2.2 1.0 - 1.7 CH-02 4.6 2.7 - 4.7 CH-03 3.9 2.2 - 3.9 CH-04 *2.3 1.2 - 2.1 CH-05 >4.8 3.5 - 6.0 c. Triglycerides, third event of 2025 (Q3-2025) Sample Reported Expected CH-11 *164 117 - 160 CH-12 267 202 - 275 CH-13 *119 84 - 115 CH-14 178 134 - 183 CH-15 205 151 - 206 Legend: * = unsatisfactory score 2. The OM affirmed by an interview on December 4, 2025, at approximately 9:40 a.m. that the laboratory obtained the unsatisfactory PT scores for Total Bilirubin, Magnesium and Triglycerides analytes mentioned in statement #1. 3. The accuracy and reliability of patient test reported cannot be determined. 4. According to the laboratory's testing declaration form (Lab- 144) submitted on the day of the survey, the laboratory performed approximately 80,665 patient test samples annually for Routine Chemistry including the Total Bilirubin, Magnesium and Triglycerides analytes during the time the laboratory received an unsatisfactory proficiency testing scores. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing (PT) records and an interview with the office manager (OM) on December 4, 2025; the laboratory failed to perform/document a