Summary:
Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor observation of equipment in the laboratory and interview with the technical consultant, the laboratory did not assay two control materials of different concentrations when performing nine of nine specific gravity tests with a refractometer from January through March 2023. Findings include: 1. Observation of equipment in the laboratory on April 18, 2023 at 10:30 AM revealed a refractometer available for use. 2. Interview with the technical consultant on April 18, 2023 at 10:30 AM confirmed the laboratory used the refractometer for specific gravity testing of urine. Further interview revealed nine specific gravity tests were performed with the refractometer from January to March 2023 and confirmed the laboratory did not test two control materials of different concentrations prior to testing patient samples each day of 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 --