Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was completed on September 01, 2026 with the following standard level deficiencies cited. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 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 direct observation, review of the laboratory's calibration verification records, and interview with the Laboratory Director (LD), the laboratory failed to perform calibration verification on the Roche Cobas e411 analyzer at least every 6 months for 1 of 2 years (2025). Findings Included: 1) During a laboratory tour on 9/1 /2026 at 11:55 AM, one Roche Cobas e411 analyzer (Serial Number 1463-10) was observed in use. 2) Review of the laboratory's calibration verification records revealed 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 -- 'Validate LGC Maine Standards' S1 verifier testing on the Roche Cobas e411missed in 2025. Only S2 verifier testing was performed. 3) In an interview on 9/01/2026 at 10: 37 AM, the LD confirmed S1 and S2 verifier testing (Calibration Verification) are performed on March 1 and September 1 of each year, and that S1 was missed in 2025. D5783