Summary:
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 Quality Control (QC) records for the Diatron Abacus 3 Hematology analyzer, patient data log, and an interview with the Technical Consultant (TC), the laboratory failed to ensure QC was within acceptable range before releasing patient results. This affected three of six months reviewed. The findings include: 1. A review of the QC records for the Diatron Abacus 3 Hematology analyzer revealed only one level of control was acceptable on 10/3/2017 and 1/22 /2018. The records revealed on 12/23/2017, there was no acceptable QC within range to report patient results. 2. A review of the patient data log revealed the following: a. on 10/3/2017 one patient Complete Blood Count (CBC) was performed. b. on 12/13 /2017 two patients CBC'S were performed. c. on 1/22/2018 two patients were CBC'S performed. 3. In an interview conducted on 2/22/2018 at 11:19 AM, the TC confirmed no patient testing should be performed when QC is not within the established acceptable range. TC also reviewed the records and confirmed two levels or more were not within acceptable range for the dates listed above. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor 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 --