Summary:
Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (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 interview with the Laboratory Director (LD), the laboratory failed to ensure the QC established for microscopic urinalysis examinations included all urine sediment components reported from January 2023 to the day of survey. Findings include: 1. On the day of survey, 05/14 /2024 at, approximately, 11:00 am, the laboratory failed to provide Quality Control reports for the following 5 of 21 reportable Urine sediment analytes: - Squamous epithelial cells - Transitional epithelial cells - Mucus - Yeast - Granular Cast 2. The laboratory reported 154 urine microscopic examinations from January 2023 until day of survey. 3. The LD confirmed the above findings on 5/14/2024 at, approximately, 11:00 am. 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 --