Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 review of the laboratory's written Individualized Quality Control Plan (IQCP), review of quality control, calibration, and patient test records for the MeMed Key analyzer from 8/16/2024 through 7/1/2025, and interview with the technical consultant on 7/24/2025 at 4:55 p.m., the laboratory failed to follow its written IQCP for performing external quality control after two calibrations, of twelve calibrations reviewed, when a total of six patient bacterial vaginosis results were reported. Findings include: 1. Review of the laboratory's written IQCP for bacterial vaginosis testing on the MeMed Key analyzer revealed the Quality Control Plan of the IQCP stated that external controls should be run after calibration, which is done every twenty-eight days. 2. Review of QC and calibration records for the MeMed Key analyzer from 8/16/2024 through 7/1/2025 revealed no external control results on the MeMed control printouts from 4/7/2025 until 6/4/2025, with calibrations performed on 5/1/2025 and 5/31/2025, two of twelve calibrations performed during the twelve months reviewed. 3. Patient test printouts for the MeMed Key analyzer from 8/16 /2024 through 7/1/2025 revealed the following six patient bacterial vaginosis results were reported from 5/1/2025 through 5/31/2025: 5/01/2025--Patient #285823 5/02 /2025--Patient #180901 5/07/2025--Patient #346993 5/16/2025--Patient #348794 5/25 /2025--Patient #122782 5/31/2025--Patient #203711 4. In an interview on 7/24/2025 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 -- at 4:55 p.m., the technical consultant confirmed the external controls were not performed after the calibration on 5/1/2025, and external controls were not performed after the calibration on 5/31/2025 until 6/4/2025. -- 2 of 2 --