Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 MOHS logs, patient final reports from 7/6/23 to 10/5/23, and confirmed in an interview, the laboratory failed to include the testing facility address for 117 of 117 patient final reports. The findings were: 1. Review of the laboratory's MOHS logs revealed the facility had the first MOHS case on 7/6/23. 2. Review of the patient final reports from 7/6/23 to 10/5/23 revealed 117 of 117 patients final reports failed to include the testing facility address. Refer to the attachment "MOHS Patient List." 3. An interview with the laboratory director on 10/6 /23 at 10:45 am confirmed the above findings. 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 --