Summary:
Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with a technical consultant, the laboratory did not retain a copy of the discontinued XS1000i procedure including the dates of initial use and discontinuance at this laboratory. Findings include: 1. Review of maintenance records for the Sysmex XS-1000i analyzer showed the laboratory discontinued use of the analyzer for patient testing as of September 22, 2021. 2. Review of the electronic copy of the XS-1000i procedure showed the procedure was retired in May 2022. 3. Interview with a technical consultant (staff B) on February 6, 2023 at 11:40 AM confirmed the laboratory had not retained a copy of the test procedure for the Sysmex XS1000i with the dates of initial use and discontinuance at this laboratory. 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 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 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 -- 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 records and interview with testing personnel, the laboratory did not perform calibration verification at least once every six months for sodium, potassium, chloride, calcium and AST (aspartate transaminase) testing on the Dimension EXL analyzer in 2022. Testing personnel did not perform one of the last two calibration verification events on the Dimension EXL within six months of the previous event. Finding include: 1. Review of calibration verification records for the Dimension EXL analyzer showed testing personnel performed calibration verification for sodium, potassium, chloride, calcium and AST on January 17, 2022 and December 21, 2022. No other records of calibration verification in 2022 were available. 2. Interview with testing personnel (staff A) on February 6, 2023, at 2:00 PM confirmed testing personnel did not perform calibration verification on the Dimension EXL within six months of the January 2022 calibration verification event. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and records and interview with testing personnel and a technical consultant, testing personnel did not follow quality control procedures and did not document the