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. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the testing personnel, staff B, the laboratory did not retain the current lot and expiration date for the hematology reagent stain pack on the Hematek 3000 slide stainer. Findings include: 1. Review of the "Hematek 3000 Slide Stainer Reagent Log" showed stain lot number 1678 with an expiration date of September 15, 2021, was opened on January 28, 2021. Further review showed no documentation on the log for additional lots after the expiration date of September 15, 2021. 2. Review of the "Hematek Stainer Maintenance" log showed the reagent stain pack was changed on September 2, 2021, and April 4, 2022. Further review showed no documentation of the reagent stain pack lot number associated with the changing of the reagent stain pack. 3. Interview with the staff B on December 15, 2022, at 1:27 PM confirmed the laboratory did not retain the current lot and expiration date for the hematology reagent stain pack on the Hematek 3000 slide stainer. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of calibration verification and patient records and interview with a technical consultant, staff A, the laboratory did not perform calibration verification every six months for the Beckman AU480 chemistry analyzer in 2021 and 2022. Findings include: 1. Review of the calibration verification records for the Beckman AU480 chemistry analyzer showed calibration verification performed on October 5, 2021, and May 2, 2022. Further review showed no additional documentation of calibration verification between those dates when calibration verification was due on April 5, 2022. 2. Review of patient testing records between April 5, 2022, and May 2, 2022, showed 961 chemistry tests were performed. 3. Interview with staff A on December 15, 2022, at 1:20 PM confirmed the laboratory did not perform calibration verification every six months for the Beckman AU480 chemistry analyzer in 2021 and 2022. -- 2 of 2 --