Summary:
Summary Statement of Deficiencies 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 a review of Quality Control Procedures, the Oxicom Individualized Quality Control Plan (IQCP), the Oxicom quality control (QC) log sheets, and an interview with the technical consultant, the laboratory did not follow their written procedure and IQCP to perform two levels of liquid controls weekly for six (6) of thirty-four (34) weeks in 2022. Findings: 1. Policy #1203, Quality Control Measures for Laboratory Services, states "The Oxicom 3000 will be checked weekly with the Liquid Control samples. All liquid readings will be recorded on the Oxicom QC worksheet." 2. The Oxicom 3000/O2Sats IQCP states External Liquid Quality Controls will be performed weekly. 3. The Oxicom QC logsheets were missing QC documentation for the weeks 1 /7/22, 01/31/2022, 02/14/2022, 03/07/2022, 04/18/2022, 07/04/2022. 4. The technical consultant confirmed these findings by interview on 8/22/22 at 15:00. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --