Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Northeast Urologic Surgery, PC laboratory on 09/12/2024 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 interview the laboratory did not run external quality control (QC) in the subspecialites of Bacteriology each day of patient testing. Findings include: 1. Record review of Quality Control (QC) for the Quant Studio 3 Microbiology PCR analyzer revealed QC was run once a week, not every day of patient testing. 2. Staff interview on 09/12/2024 at 11:00AM: Testing personnel stated "we run QC on the Quant Studio 3 each week." 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 --