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 the review of the laboratory's 1 of 1 patient test report and interview with the Technical supervisor (TS), the laboratory failed to include the address of the laboratory location where Immunology testing was performed and the date on the test report when patient specific results were reported from 11/22/2024 to the day of survey. Findings Include: 1. On the day of survey, 12/17/2024 at 10:09 am, review of 1 of 1 patient test report revealed, the report did not list the test report date and address of the laboratory where Immunology testing (Rheumatoid factor/3: RF IgA, RF IgG, RF IgM) was performed on 11/22/2024. 2. The location of the laboratory is Rheumatology Specialty Center (1717 Langhorne Newtown Road, Suite 101 Langhorne PA 19047) but Rheumatic Disease Associates LTD (2360 Maryland Road Willow Grove PA 19090) was listed on the final report. 3. The laboratory reported 30 patient results from 11/22/2024 to 12/17/2024. 4. The TS confirmed the findings above on 12/17/2024 at 10:17 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 --