Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of laboratory testing records, lack of documentation and interview with testing personnel (TP) #2; the laboratory failed to retain complete blood count quality control (QC) testing records for one of five days of patient testing reviewed. Findings include: 1. A review of quality control testing records revealed the laboratory failed to have complete blood count QC testing records for the Sysmex XP- 300 analyzer used for patient testing on 11/15/2024. 2. Interview with TP #2 on 03/24 /2026, at 08:15 am, confirmed the laboratory did not have the QC records for 11/15 /2024. The paper records had been destroyed after having liquid spilled on them. TP #2 was unable to access the QC data from that time frame on the analyzer. 3. Review of patient testing records revealed that one patient had complete blood count testing completed on 11/15/2024. Patient Record Number: 46281 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)