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 the Refractometer Quality Control Log/Zero Calibration, Procedure Urine Specific Gravity by Refractometer, and an interview with Laboratory Administration and Testing Personnel #1, the laboratory failed to document the actual value of the controls and calibration run each day of patient testing. This was noted from May 2019 to June 2021. The findings include: 1. A review of the Refractometer Quality Control Log/Zero Calibration revealed three levels of quality control and a zero calibration (Deionized water) were run each day of patient testing, but the value of each control and calibrations were not documented. A check mark was used to state the control was in range, the acceptable ranges are documented on the form. 2. A review of the Procedure Urine Specific Gravity by Refractometer revealed under 6.5 Documentation "Record all Calibration and Quality Control results (failed and successful) manually or electronically..." 3. During an interview on 07/15/2021 at 1: 30 PM, Laboratory Administration and Testing Personnel #1 confirmed they do not document the value of each control and calibration. 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 --