Center For Dermatology, Pllc

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: **Based on lack of Quality Assessment (QA) documentation from 2024, review of established QA policies and interview with the facility personnel, the laboratory failed to follow established policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. Findings include: 1. Patient-specific data and the final test result information for Mohs and Frozen Biopsy testing is manually transcribed by laboratory personnel into the patient's Electronic Health Record (EHR). 2. The laboratory's Quality Assessment policy states, "Our laboratory uses a QA Program which includes review/case reviews to ensure the processes were performed and documented correctly and that there were no significant errors in the processes, documentation, or diagnosis. The QA form will be attached with the Biannual Peer Review. Biannually, 5 cases will be randomly selected. Biannually up to 2 frozen sections will be pulled for review if performed. If issues noted would impact patient care, then remedial actions will be taken and documented immediately." 3. No documentation was presented for review to indicate the laboratory followed the policy referenced above to perform a biannual audit of 5 Mohs cases and 2 frozen section cases during 2024. 4. The facility personnel interviewed on 6/05/25 at 10:55 AM confirmed the laboratory failed to perform and document the QA review indicated above during 2024. 5. The laboratory performs approximately 780 tests annually under the subspecialty of Histopathology. **This is a repeat deficiency from the previous inspection conducted on 12/14/2023 D6093 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) documentation from 2024 and interview with the facility personnel, the laboratory director failed to ensure that QA programs are maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Findings include: 1. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 780. 2. The laboratory failed to provide evidence of documented QA activities from 2024. (See D5891 for specific findings) 3. The laboratory director failed to ensure that the

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 the laboratory's Mohs logs, Mohs Maps, patient slides and final test reports maintained in the patient's Electronic Medical Record (EMR), and interview with the facility personnel, the laboratory failed to ensure positive identification of patient's dermatopathology specimens from the time of collection through completion of testing and reporting of test results for one out of six patients reviewed. Findings include: 1. The laboratory performs Mohs testing and Frozen Biopsy testing under the subspecialty of Histopathology, with an annual test volume of 840. 2. The laboratory assigns a unique accession (case) number to each Mohs and Frozen Biopsy specimen. The laboratory differentiates between Mohs cases and Frozen Biopsies by utilizing the letter "M" for Mohs cases and by utilizing the letter "F" for Frozen Biopsies. 3. The laboratory failed to ensure positive identification of a patient's specimen for Frozen Biopsy testing throughout the entire test process for patient J.H. for testing performed on 12/22/21 as evidenced by: a Frozen Biopsy case being recorded in the patient log as Case: "RGM21-03". The slides, Mohs Map, and documentation reviewed in the EMR for this patient listed the case as RGF21-03. 4. The facility personnel interviewed on 12/14/23 at 10:05 AM acknowledged the laboratory failed to ensure positive identification of the patient's specimens from the time of collection through completion of testing and reporting of results, as evidenced by the specimen identification error indicated above. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) documentation, review of post-analytic QA policies, review of electronic test records and interview with the facility personnel, the laboratory failed to follow established policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. Findings include: 1. Patient-specific data and the final test result information for Mohs interpretations and Frozen Biopsy testing is manually transcribed by laboratory personnel into the patient's Electronic Health Record (EHR). 2. The laboratory's established Quality Assessment policy states, "Biannually, 5 cases will be reviewed and randomly selected. All frozen sections will be pulled for review. If any issues noted they will be documented, and

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on lack of policy for review, review of patient test reports and interview with the facility personnel, the laboratory failed to establish a policy for reporting and maintaining test reports in an electronic record system. Findings include: 1. The laboratory performs Mohs testing on patient specimens under the sub-specialty of histopathology, with an approximate annual test volume of 550. The laboratory utilizes an electronic medical record (EMR) system to maintain patient records, including Mohs test reports which are electronically signed by the physician who made the diagnosis. 2. Review of patient test report (YGM17-0192) for Mohs testing that occurred on 11/09/17 indicated the electronic operative note was not finalized and electronically signed by the physician who made the diagnosis until 12/03/17. 3. On the date of the survey, 03/13/19, no documentation was presented for review to indicate the laboratory had established policies and procedures in place for electronically signing patient test reports in a timely manner and maintaining test records in an electronic system. 4. The facility personnel confirmed that the physician who made the diagnosis did not electronically sign the operative note in a timely manner for the patient indicated above and confirmed that the laboratory did not have an established policy related to test reports and test records that are maintained electronically. 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 --