Skin Clinic, The

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/17/2021. The findings were reviewed with the histotechnician at the conclusion of the survey. The laboratory was found in compliance with a standard-level deficiency cited. 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 a review of patient test reports and interview with the histotechnician, the laboratory failed to ensure test reports reflected accurate patient information for 2 of 12 patient reports. Findings include: (1) On 11/17/2021, the surveyor reviewed 12 patient test reports and identified the reports did not accurately reflect the following information: (a) Report #1 - A MOHS procedure was performed with the results reported on 01/05/2021: (i) The patient's MOHS pathology number on the report (D20MOHS-002) did not match the patient's slide (D21MOHS-002). (b) Report #2 - A MOHS procedure was performed with the results reported on 01/18/2021: (i) The patient's MOHS pathology number on the report (DOF21-004) did not match the patient's slide (D21MOHS-004). (2) The surveyor reviewed the reports with the histotechnician. The histotechnician stated on 11/17/2020 11:40 am the 2 patient reports did not reflect accurate information as indicated above. 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 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 09/25/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the histotechnician at the conclusion of the survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, policy and procedure, and interview with the histotechnician, the laboratory failed to follow its policy and procedure for