Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) (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 interview with the laboratory director, the laboratory failed to include the laboratory's address on the test report for six (Patients 1-6) of six patient test reports reviewed. Findings include: 1. A review of the laboratory's Form CMS-116 listed the laboratory's suite number as 307. 2. The surveyor observed the laboratory space in suite 307 on 2/25/26 at 9:05 am. 3. A review of six patient test reports revealed the laboratory address was listed as suite 309: a. Patient 1 received testing on 09/29/2025. b. Patient 2 received testing on 10/09/2025. c. Patient 3 received testing on 11/17/2025. d. Patient 4 received testing on 12/29/2025. e. Patient 5 received testing on 01/06/2026. f. Patient 6 received testing on 02/11/2026. 4. An interview on 2/25/26 at 11:34 am with the laboratory director confirmed the address on the test report was incorrect. 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 --