Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with the Clinical Coordinator (CC), the Laboratory Director (or designee) failed to sign the PT attestation statements for the specialty in Hematology. This was noted for two of six events reviewed in 2024 through 2026. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director (or designee) on attestation statements for the following surveys: a) 2025 Hematology 3rd Event (M3), b) 2026 Hematology 1st Event (M1). 2. During an interview on 4-7-26, at 1:13 PM, the CC confirmed the above findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of the Hematology Quality Control (QC) records, and an interview with the Clinical Coordinator (CC), the laboratory used expired QC reagent on the Medonic Hematology analyzer. The surveyor noted the laboratory utilized expired QC 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 -- for one day of patient testing in January 2026. The findings include: 1. A review of the Hematology QC records revealed the QC performed on 1/13/2026 expired prior to patient testing. 2. During an interview on 4-7-26, at 2:15 PM, the CC confirmed the above findings. 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 a review of the Hematology calibration records and an interview with Testing Personnel #2, the Laboratory failed to perform calibrations on the Medonic Hematology analyzer every six months as per the interview with TP#2. The laboratory failed to perform one of one calibration due in 2026. The findings include: 1. A review of the Hematology calibration records revealed the Medonic was last calibrated on 7/31/2025. There was no documentation of a calibration performed the first half of 2026. 2. During an interview on 4-7-26, at 2:17 PM, Testing Personnel #2 confirmed the calibration is performed every 6 months and the calibration due in January 2026 was not performed. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Hematology Quality Control (QC) records, patient log, and an interview with the Clinical Coordinator (CC), the Laboratory failed to ensure the Medonic Hematology QC was within the manufacturer's acceptable ranges prior to patient testing. This was noted for 3 days of 8 months reviewed in 2024 through 2026. The findings include: 1. A review of the QC records for the Medonic Hematology analyzer revealed the following: a) 7-22-25 all 3 levels of QC were not acceptable; 13 patients were performed, b) 7-24-25 all 3 levels of QC were not acceptable; 16 patients were performed, c) 7-29-25 QC levels 2 and 3 were not acceptable; 10 patients were performed. 2. During an interview on 4-7-26 at 2:15 PM, the CC confirmed QC was out for those 3 days. D5781