Summary:
Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's verification studies performed on the ABX Micros 60 hematology analyzer in March 2025, review of patient test reports, and staff interview, the laboratory failed to have documentation of verifying 1 of 1 sets of patient normal ranges. The findings included: 1. A review of the laboratory's verification records for the ABX Micros 60 hematology analyzer (serial number: 311CS100950) performed in March 2025 determined the laboratory failed to have documentation of verifying 1 of 1 sets of patient normal ranges. 2. A review of patient test reports from December 2025 identified the laboratory had the following set of patient normal ranges in use: White Blood Cell 3.5 - 10 Red Blood Cell 3.8 - 5.8 Hemoglobin 11 - 16.5 Hematocrit 35 - 50 Mean Corpuscular Volume 80 - 97 Mean Corpuscular Hemoglobin 26.5 - 33.5 Mean Corpuscular Hemoglobin Concentration 31.5 - 35.0 Red cell distribution width 10 - 15 Mean Platelet Volume 6.5 - 11 Lymphocyte percent 17 - 48 Lymphocyte count 1.2 - 3.2 Monocyte percent 4 - 6 Monocyte count 0.3 - 0.8 Granulocyte percent 43 - 76 Granulocyte count 1.2 - 6.8 3. The laboratory stated it performed 360 tests annually. 4. The technical consultant confirmed the findings in an interview conducted on 01/14/2026 at 0930 hours in the break room. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of the laboratory's ABX Micros 60 analyzer records from March 2025 to January 2026, and staff interview, the laboratory failed to have documentation of performing 1 of 1 calibrations on the ABX Micros 60 hematology analyzer. The findings included: 1. A review of the laboratory's policy titled "Instrument Operation and Maintenance" determined: "Calibration of laboratory instruments will be every six months..." 2. A review of the laboratory's records for the ABX Micros 60 analyzer from March 2025 to January 2026 identified a calibration was performed upon installation in March 2025. No calibration had been performed since (a time lapse of 9 months). 3. The technical consultant confirmed the findings in an interview conducted on 01/14/2026 at 0900 hours in the break room. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on review of the laboratory's hematology quality control records from May 2025 to December 2025, and staff interview, the laboratory failed to have documentation of verifying 4 of 4 new lots prior to use. The findings included: 1. A review of the laboratory's ABX Minotrol 16 hematology control records from May 2025 to December 2025 determined the following lots were placed into service: Lot number: 5097 Lot number: 5153 Lot number: 5209 Lot number: 5265 2. Further review of the laboratory's quality control records determined the laboratory failed to -- 2 of 4 -- have documentation of verifying each of the 4 lots prior to placing them into service. 3. The technical consultant confirmed the findings in an interview conducted on 01/14 /2026 at 0930 hours in the break room. D5779