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 review of quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12: 00 pm on 08/25/2021, the laboratory failed to perform a negative and positive control at least each day of patient testing for respiratory syncytial virus (RSV) testing for one out of six days of patient testing (08/17/2021) in August 2021. The findings include: 1. The laboratory's RSV testing policy stated that the laboratory would perform a negative and positive control each day of patient testing. 2. Patient A had RSV testing performed on 08/17/2021. 3. Review of the laboratory's RSV testing log indicated that the laboratory did not document a positive and negative control on 08/17/2021. 4. At the time of the survey, personnel identifier #1 confirmed that the laboratory did not have RSV QC records for testing performed on 08/17/2021. 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 --