Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of patient slides for Mohs cases reviewed during the survey and interview with the facility personnel on 10/21/25 at 10:25 AM, the laboratory failed to label 1 out of 3 patient's slides with the correct anatomic site on one out of three Mohs cases reviewed during the survey. Findings include: 1. The laboratory performs Mohs and Frozen biopsy testing under the subspecialty of Histopathology, with an annual reported test volume of 1,000. 2. Review of three Mohs slides for case# PTM25-361 indicated one out of the three slides was labeled with the incorrect site, nasal infratip. The Mohs log, operative note, Mohs map and other 2 slides for this case listed the site as 'mid occipital scalp'. 3. The laboratory failed to ensure positive identification of a patient's specimen from the time of collection through the completion of testing and reporting of results for the case indicated above. 4. The facility personnel interviewed on 10/21/25 at 10:25 AM acknowledged that the laboratory personnel labeled one out of three slides with the incorrect anatomic site on case# PTM25-361. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of dermatopathology test procedures, review of patient test reports maintained in the electronic health record (EHR)and interview with the facility personnel on 10/21/25 at 11:15 AM, the laboratory failed to follow test reporting procedures for one out of two frozen biopsies reviewed during the survey. Findings include: 1. The laboratory's established test procedure "Laboratory Frozen Section Processing Policy & Procedure" states, "Test results and findings from frozen sections will be documented in the patient record and communicated to the ordering provider in a timely manner." 2. The laboratory failed to document one out of two frozen biopsy test reports (PT25-FBX-05) in the patient's EHR. 3. Interview with the facility personnel on 10/21/25 at 11:15 AM confirmed the laboratory failed to follow the procedure for test reporting in the patient's EHR for frozen biopsy# PT25-FBX-05. 4. The laboratory results approximately 1,000 histopathology patient tests annually. D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of Mohs test results maintained in the Electronic Health Record (EHR) and interview with the facility personnel on 10/21/25 at 10:15 AM, the laboratory failed to establish a policy and procedure to ensure test results and other patient-specific data are accurately and reliably entered into the EHR and electronically signed by the physician who made the diagnosis in a timely manner, and the laboratory failed to ensure 1 out of 3 Mohs test reports were electronically signed by the physician who made the diagnosis in a timely manner. Findings include: 1. Patient-specific data and the final test result information for Mohs is manually transcribed by laboratory personnel into the patient's EHR. The physician who issued the diagnosis must electronically sign the operative note in the EHR to finalize the Mohs test report. 2. The laboratory failed to provide evidence of an established policy and procedure for electronically signing the Mohs test report maintained in the patient's EHR in a timely manner. 3. One out of three Mohs test reports (PTM24-493) reviewed in the EHR was not electronically signed by the physician who made the diagnosis in a timely manner. The Mohs testing occurred on 11/05/24 and the Mohs test report maintained in the EHR was not electronically signed by the physician who made the diagnosis until 12/23/24. 4. The facility personnel interviewed on 10/21/25 at 10:15 AM confirmed the laboratory failed to provide evidence of an established policy and procedure to ensure timely signing of pathology test reports maintained in the EHR, and the facility personnel acknowledged the electronic test report for Mohs case# PTM24-493 was not electronically signed by the physician who issued the diagnosis in a timely manner. 5. The laboratory performs testing under the subspecialty of Histopathology with a reported annual test volume of 1,000. -- 2 of 2 --