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 surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records and interviews technical consultant (TC) and testing personnel (TP), it was determined that the laboratory failed to attain at least 80 percent of the acceptable response from one out of three testing events resulting to an unsatisfactory performance in the Hemoglobin (Hgb) analyte during the first event in 2025 (Q1-2025) under Hematology specialty. The findings include: 1. The laboratory was enrolled in the API PT program and received an unsatisfactory score of 60% for the Hgb analayte in Q1-2025. The result as followed: Sample Reported Grading Range HEM-01 *9.5 8.5 - 9.3 HEM-02 15.8 14.5 - 15.8 HEM-03 5.8 5.2 - 5.8 HEM- 04 *13.8 12.5 - 13.7 HEM-05 11.6 10.6 - 11.6 2. The TC and TP affirmed by interviews on April 1, 2026, at approximately 1:05 p.m. that the laboratory obtained the PT unsatisfactory scores as mentioned in statement #1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 14,400 patient samples annually for Hematology specialty that included the Hemoglobin analyte. . 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 surveyor's review of the laboratory's proficiency testing documentation and interviews with the technical consultant and testing personnel on April 1, 2026, this deficiency is herein cited for the laboratory director due to failure to ensure that proficiency testing samples were tested as required under Subpart H of this part. The findings include: 1. The laboratory obtained an unsatisfactory score for the Hemoglobin analyte in one out of three testing events for 2025 in Hematology specialty. See D2121 . -- 2 of 2 --