Summary:
Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interviews with the Laboratory Director (LD) and the Compliance Officer, the laboratory failed to document quality control (QC) for interpretive biochemical testing procedures each day of patient testing. All 2,472 patients tested from 04/07/2023 through 07/27/2023 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's policies and procedures failed to find a protocol for documenting QC of interpretive biochemical testing procedures each day of patient testing. 2. Review of the laboratory's testing data from 04/07/2023 through 07/27/2023 failed to find any evidence that QC of interpretive biochemical testing procedures was documented each day of patient testing. 3. The surveyor requested QC documentation of interpretive biochemical patient test procedures each day of patient testing. 4. Interviews with the LD and the Compliance Officer, on 07/29/2023 at 12:56 PM, confirmed that the laboratory failed to document QC of interpretive biochemical testing procedures each day of patient testing. 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 --