Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the General Supervisor (GS), the surveyor determined the laboratory failed to ensure proficiency testing samples were tested the same number of times that it routinely tests patient samples. This was noted on four out of seven Hematology events reviewed from 2022 to 2024. The findings include: 1. A review of API attestation statements and PT instrument printouts revealed two Testing Personnel were performing the same PT samples for the following events. a) 2023 Hematology 3rd Event b) 2024 Hematology 1st Event c) 2024 Hematology 2nd Event d) 2024 Hematology 3rd Event 2. The GS confirmed the above findings during the exit conference on 02-28-2025 at 1:30 PM. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. 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 a review of the Hematology Quality Control (QC) records and an interview with the General Supervisor (GS), the laboratory failed to implement a mechanism for monitoring shifts and trends of test performance over time. The failure commenced from the date when patient testing began, 04-10-2024 through the date of the current survey, 02-28-2025. The findings include: 1. A review of the Medonic M-Series QC records revealed only the daily QC data from the instrument were retained from 2024- 2025. No evidence of Levey Jennings charts or peer group comparison data from Medonic was available for review at the time of survey. 2. During the exit conference on 02-28-2025 at 1:30 PM, the GS confirmed the above findings. -- 2 of 2 --