Summary:
Summary Statement of Deficiencies D0000 An on-site announced CLIA initial survey was conducted at Regional Cancer Center at BHC on 03/05/24. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 patient test reports and staff interview, the laboratory failed to include the name of the laboratory location where testing was performed for 8 out of 8 (#1-#8) patient reports reviewed. Findings included: Review of eight patient final test reports (#1 to #8) dated 2/21/24, 2/22/24, 2/23/24, 2/29/24, 3/4/24, 3/5/24 (x3) revealed the laboratory location where testing was performed was not documented. On 3/5/24 at 4:30 p.m., the Administrative Director of Lab Compliance confirmed the final reports did not include the name of the laboratory where the patient testing was performed. 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 --