Summary:
Summary Statement of Deficiencies D0000 The validation survey was performed on 09/09/2026. Standard-level deficiencies were 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 a review of records and interview with the Director of Laboratory Services, the laboratory failed to perform calibration verification procedures at least once every six months for one of two Qualigen Fastpack Ip System analyzers during the review period of January 2025 through the current date. Findings include: (1) On 09/09/2026 at 10:30 am, the Director of Laboratory Services stated the laboratory performed Testosterone, Prostate Specific Antigen (PSA), and Sex Hormone Binding Globulin 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 -- (SHBG) testing using the Qualigen Fastpack Ip System analyzer serial number 0574; (2) A review of calibration records from January 2025 through the current date identified no calibration verification had been performed at least once every six months as follows: (a) Testosterone - not performed prior to 08/14/2025; (b) PSA - not performed prior to 08/12/2025; (c) SHBG - not performed prior to 08/11/2025. (3) The records were reviewed with the Director of Laboratory Services who stated on 09 /09/2026 at 03:10 pm, calibration verification procedures had not been performed every six months as stated above. -- 2 of 2 --