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 surveyors' review of the laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing documentation and interviews with the technical consultant (TC) and laboratory assistant (LA) on May 7, 2026, the laboratory failed to attain at least 80 percent of the acceptable responses for the Inorganic Phosphorus analyte for the first event of 2026 (Q1-2026). The findings include: 1. The surveyors reviewed the laboratory's policy and procedure and the API proficiency testing documentation and found that the laboratory obtained an unsatisfactory score of 60 percent for the Inorganic Phosphorus analyte for the Q1- 2026 event. 2. The TC and LA stated in an interview on May 7, 2026, at approximately 10:33 a.m. that laboratory obtained an unsatisfactory score for Routine Chemistry for the Inorganic Phosphorus analyte for the Q1-2026 event. 3. According to the laboratory's testing declaration form (Lab-144) submitted at the time of survey, the laboratory performed and reported approximately 15 samples annually including the time when the laboratory obtained the unsatisfactory scores for Inorganic Phosphorus. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on the surveyors' review of the laboratory's policy and procedure, proficiency testing documentation and interviews with the technical consultant and laboratory assistant on May 7, 2026, the laboratory director is herein cited for the unsatisfactory score of 60 percent in Routine Chemistry for the Inorganic Phosphorus analyte in the first event of 2026. See D2087 -- 2 of 2 --