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 record review and staff interview, the laboratory failed to include the correct name and address of the laboratory where the test was performed in the specialty of Histopathology. Findings Include: 1. Record review on 2/9/2024 of the final patient test report for patient #1, dated 1/15/2024, revealed the report contained documentation that the professional component was performed at Derm ASAP, 500 Congress Street, Suite B1, Quincy, MA 02169. 2. Staff Interview on 2/9/2024 at 10:30 AM with the Testing Personnel (TP) who performed the test revealed: a. The test was actually performed at Derm DX New England, 1380 Soldiers Field Road, Suite 3800, Brighton, MA 02135. b. The TP is also the Laboratory Director at Derm DX New England- noted in 2a above. c. The TP reads the slides at Derm DX New England noted in 2a above, but results and reports under the laboratory referenced in 1 above. d. The TP stated, "I am paid by ID of Quincy directly for the slides I read for them at Derm DX New England and It is only a few non-medicare patients a week." 3. The laboratory performs 2,500 tests annually in the specialty of Histopathology. 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 --