Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory Qualigen Individualized Quality Control Plan (IQCP), calibration and quality control (QC) records, and confirmed in interview, the laboratory failed to follow their own policy for performing quality control following calibration for six of twelve calibrations performed in 2024. Findings Included: 1. During a tour of the laboratory on 06/18/2024 at 11:15 AM, the surveyor observed one Qualigen Immunoassay analyzer (Serial Number: 02187) currently in use for patient testosterone testing. 2. Review of laboratory's Qualigen testosterone IQCP (Approved by the Laboratory Director on 02/2024) revealed the following: "Quality Control Plan ...QC is still performed at the time of opening a new shipment of FastPacks, after calibration or maintenance, if improper storage is suspected, or a patient test result appears to be questionable." Further review of the IQCP revealed the following: "If QC results are in range, and the overall risk of the lab is manageable, QC frequency is reduced to once per week and after each calibration." 3. Review of calibration and QC records revealed the following days calibrations were performed on the Qualigen FastPack testosterone analyte, and QC was not documented following calibration in 2024: Calibration performed on: a. 02/23 /2024; No testosterone QC documented b. 03/11/2024; No testosterone QC documented c. 03/19/2024; No testosterone QC documented d. 04/03/2024; No Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- testosterone QC documented e. 05/24/2024; No testosterone QC documented f. 06/07 /2024; No testosterone QC documented The surveyor requested QC documentation for the above days calibrations were performed on 06/18/2024 at 11:45 AM, and none were provided. 4. In an interview on 06/18/2024 at 12:05 PM, the laboratory owner confirmed the laboratory failed to follow their own policy for performing quality control following calibration for six of twelve calibrations performed in 2024. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory Qualigen FastPack Testosterone verification study, and confirmed in interview, the laboratory failed to have documentation of verifying its patient population reference range for one of one analyte performed in 2024. Findings Included: 1. During a tour of the laboratory on 06 /18/2024 at 11:15 AM, the surveyor observed one Qualigen Immunoassay analyzer (Serial Number: 02187) currently in use for patient testosterone testing. 2. Review of laboratory Qualigen FastPack Testosterone verification study performed in January 2024 revealed the following: "Installation and Method Validation Method validation is performed for each test being used per system serial number and consists of the following: ...Identifying your Reference Ranges In this step you are identifying the reference range that is appropriate for your patient population." Directly under this statement was a provided table with the header, "Your Reference (Normal) Ranges". The table had no documentation for the laboratory's reference range. The surveyor requested documentation of the laboratory verifying its patient population reference range on 06/18/2024 at 11:48 AM, and none was provided. 3. In an interview on 06/18 /2024 at 12:05 PM, the laboratory owner confirmed the laboratory failed to have documentation of verifying its patient population reference range for one of one analyte performed in 2024. D5779