Summary:
Summary Statement of Deficiencies 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory (lab) written hematology quality control procedure did not ensure reliable evaluation of quality control test results. Findings: 1. The laboratory performs patient testing on an automated hematology analyzer ("Sysmex XS-1000i") and tests 3 levels of external quality control reagents each day of use (low, normal and high quality control reagents); 2. The laboratory written procedure states that the lab verify that all parameters fall within established limits or within the package assay range prior to patient testing; 3. The monthly quality control reported on the "Instrument ID: XS-1000i^74497" printouts for lots 92670804 and 92670805, from November 1, 2019 to November 27, 2019 showed that the "LL" lower limit for every analyte (including but not limited to red blood cell count, hemoglobin, hematocrit and platelet) for both the low and normal external controls was zero and the upper limits for the target means did not agree with the manufacturers stated ranges; 4. During interview with the technical consultant, in the afternoon on the day of survey, the technical consultant stated that the lab did not use the manufacturer's stated ranges, but instead used patient moving averages. In an e- 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 -- mail dated January 24, 2020 the technical consultant referred to establishing patient moving averages, but also stated the lab does not use patient moving averages. This was the explanation given for not entering the manufacturer's stated ranges onto the external quality control record; and 5. There was no documentation that the lab investigated why the manufacturer's stated ranges were not entered correctly on the external quality control record and how patient moving averages or the XM (X-bar M) is used for quality control evaluation when the written procedure states that the "... lab does not use the Xm function..." -- 2 of 2 --