Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: ================================== Based on review of 5 of 5 patient test records, pre-survey review of the Centers for Medicare System (CMS) 2567 form and interview with the Quality manager determined the final patient records failed to contain the name and address of the laboratory from 2017-18. The findings include: 1. Review of 5 of 5 patient test records dated 2/15/17, 11/29/17, 5/23/18, 6/13/18, 7/11 /18 revealed missing the name and address of the laboratory in 2017 and 2018. 2. Pre- survey review of the CMS-2567 form revealed a past deficiency in which the laboratory failed to list the name and address of the laboratory in 2014 on patient test records. 3. An interview with the Quality manager at approximately 3:00 p.m. July 25, 2018 confirmed the final patient records did not contain the name and address of the laboratory from 2017 and 2018. ================================== D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on a review of the Quality Assurance (QA) policy, pre-survey review of the 2014