Summary:
Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(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 American Proficiency Institute (API) proficiency testing (PT) records, the CASPER 0155D report, and an interview with the technical consultant (TC) on June 3, 2026, it was determined that the laboratory failed to achieve at least 80 percent acceptable responses for the White Blood Cell (WBC) Differential analyte during the third PT event in 2025 (Q3-2025) under the Hematology specialty. The findings include: 1. Review of the laboratory's API PT records showed that the laboratory received an unsatisfactory score of 20% for the WBC Differential analyte in the Q3-2025 event. This result was further verified through the CASPER 0155D report. 2. The TC confirmed by an interview on June 3, 2026, at approximately 10:20 a.m. that the laboratory obtained the PT unsatisfactory score as mentioned in statement #1. 3. According to the testing declaration form (Lab- 144) submitted on the day of the survey, the laboratory tested and reported approximately 4,214 patient sample results annually for Hematology specialty that included the WBC Differential analyte. . D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on the surveyors' review of the laboratory's quality control (QC) documentation, policy and procedure, eight patient records dated from 07/16/2025 to 01/28/2026, and interviews with the technical consultant (TC) and testing personnel (TP) on June 3, 2026, it was determined that the laboratory failed to perform QC prior to patient testing on October 30, 2025. The findings include: 1. Review of the laboratory's QC documentation and policies and procedures showed that QC must be performed and acceptable prior to patient testing. This was not followed specifically on October 30, 2025 for the Vitamin D test. 2. The surveyors reviewed eight patient records dated from 07/16/2025 to 01/28/2026 and found one record (Accession #25302012) in which Vitamin D test was performed outside the QC validity on October 30, 2025. 3. Further review of patient record for Vitamin D tested on October 30, 2025, showed that a total of 10 patient samples-including the accession identified during the record review-were tested beyond QC validity. a. The QC for Vitamin D was performed on October 29, 2025 at 11:14 a.m. for level 1 and at 11:18 a.m. for level 3. b. The next QC performed for Vitamin D was on October 30, 2025 at 6:12 p. m. for level 1 and at 6:17 p.m. for level 3. c. The records performed on October 30, 2025 are as followed: Accession | Time Tested - | - 25302013 | 1:44 p.m. 25302014 | 1: 48 p.m. 25302015 | 1:51 p.m. 25302016 | 1:52 p.m. 25302001 | 2:03 p.m. 25302008 | 2:06 p.m. 25302009 | 2:10 p.m. 25302010 | 2:13 p.m. 25302011 | 2:15 p.m. 25302012 | 2:17 p.m. 4. The TC and TP confirmed in an interview on June 3, 2026, at approximately 11:30 a.m., that the 10 patient samples tested on October 30, 2025, were performed beyond QC validity and that no repeat testing or