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 AcT diff 2 Hematology analyzer, patient data log, policy and procedure manual, and an interview with Testing Personnel (TP) #1, the laboratory failed to ensure QC was within acceptable range before releasing patient results for one day in August and November of 2017. The findings include: 1. A review of the QC records for the AcT Diff 2 Hematology analyzer revealed only one level of control was acceptable on 8/15/2017 and 11/8 /2017. 2. A review of the patient data log revealed the following: a. On 8/15/2017, 11 patient Complete Blood Counts (CBC'S) were performed. b. On 11/8/2017, 17 patient CBC'S were performed. 3. The policy entitled Quality Assurance Program under QC indicated: "Values should be within the performance range limits stated by the manufacturer of the assayed value for each of the tests before any patient results are reported, and results will not be reported if more than one value falls out side this range..." 4. In an interview conducted on 5/24/2018 at 12:06 PM, TP #1 reviewed the QC records with the surveyor and confirmed that only one level of QC was within range on the above mentioned dates. TP #1 also reviewed the patient data logs and confirmed patient testing occurred on the two days, when only one level of quality control was acceptable. 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 --