Uc San Diego Health -

Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and interviews with the laboratory director (LD) and technical consultants (TCs); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Hematology on the first event of 2025 (Q1-2025). The findings include: 1. The CAP PT program reported an overall unsatisfactory score of 63% for the specialty of Hematology in the Q1-2025 event. This was affected by the following scores: a. White blood cell automated differential count = 60% b. Red blood cell count = 60% c. Hematocrit = 60% d. Hemoglobin = 60% e. Platelets = 60% 2. The LD and TCs affirmed by interviews on October 22, 2025, at approximately 9:20 a.m. that the laboratory received the overall unsatisfactory score for the specialty of Hematology as mentioned in statement #1. 3. According to the testing declaration form (Lab-144) submitted at the time of survey, the laboratory performed and reported 3,948 patient tests in the specialty of Hematology annually including the time when the unsatisfactory PT scores were obtained. The reliability and quality of Hematology results reported could not be assured. 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 proficiency testing documentation for the first event of 2025 and interviews with the laboratory director and technical consultants; 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. See. D2122 -- 2 of 2 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(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 review of first quarter (Q1-2017) of the College of American Pathologists (CAP) proficiency testing records, CMS Casper 0096D report, random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event. The findings included: a. Q1-2017 CAP reported a 0% score for Hematology proficiency testing. b. For seven (7) out of seven (7) random patient sampling test results reviewed covering period from 9/9 /2016 to 9/27/2018, the laboratory analyzed and reported Complete Blood Count (CBC) tests during the approximate period where in the laboratory received the unsatisfactory proficiency testing score of 0%. c. The technical consultant confirmed (12/18/2018, 1430), that the laboratory received the above unsatisfactory proficiency testing score. 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 --