Dmc Dermatology & Mohs Llc - Green Valley

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the policy and procedure, lack of accuracy verification documentation for Mohs and Frozen Biopsy testing and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2022 and 2023. Findings include: 1. A review of the established Proficiency Testing policy and procedure states: 1. For Mohs Surgeons: a) Peer review of slides every 6 months by one Mohs surgeon of other Mohs surgeon's slides b) External review of slides by a Pathologist) c) Both Mohs surgeons are Board-Certified in Mohs Dermatologic Surgery. Both surgeons participate in the American Board of Dermatology's Maintenance of Certification Program that requires answering questions on a quarterly basis." 2.. No documentation was presented for review to indicate the laboratory verified the accuracy of dermatopathology testing (performed in conjunction with the Mohs procedure) at least twice annually during 2022 and 2023. 3. No documentation was presented for review to indicate the laboratory verified the accuracy of Frozen Biopsy testing at least twice annually during 2022 and 2023. 4. The facility personnel interviewed on 11/20/24 at 12:15 PM confirmed the laboratory failed to verify the accuracy of dermatopathology and Frozen Biopsy testing at least twice annually during 2022 and 2023. 5. The laboratory began patient testing on 6/10/22 with a reported annual test volume of 750 in the subspecialty of Histopathology. D5787 TEST RECORDS CFR(s): 493.1283(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on lack of patient test records for Mohs testing, review of the Mohs log and interview with the facility personnel, (A) the laboratory failed to maintain a copy of the Mohs map for one out of four patient records reviewed; and (B) one out of four Mohs maps reviewed contained an incorrect case number. Findings include: 1. The laboratory began Mohs testing on 6/10/22 under the subspecialty of Histopathology, with an annual reported test volume of 750. A1. The laboratory utilizes an Electronic Medical Record (EMR) system to maintain Mohs test results, including the Mohs map. A2. One out of four Mohs patient test records reviewed during the survey was missing the Mohs map. The Mohs map was not scanned into the patient's EMR and the facility personnel could not produce evidence of the map during the survey (Case # MGV24-48 performed on 3/25/24). A3. The facility personnel interviewed on 11/20 /24 at 11:40 AM confirmed the laboratory failed to maintain a copy of the Mohs map for the case indicated above. B1. One out of four Mohs maps reviewed during the survey contained an incorrect case number. The case number provided on the Mohs map was "GV24-144." This case number was inconsistent with the Mohs log, Final operative report, and slides reviewed which listed the case number as "MGV24-144." B2. The facility personnel interviewed on 11/20/24 at 11:50 AM confirmed the the laboratory documented the incorrect case number on the Mohs map indicated above. D5801 TEST REPORT CFR(s): 493.1291(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 patient test results maintained in the Electronic Health Record (EHR) and interview with the facility personnel the laboratory failed to have a system in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (entered manually) to final report destination, in a timely manner. 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 EHR. 2. No documentation was presented for review during the survey conducted on 11//20/24 to indicate the laboratory has a system in place to ensure the accuracy of patient-specific data and patient test results that are manually entered into the EMR. 3. The testing personnel interviewed on 11/20/2024 at 12:20 PM confirmed the laboratory failed to have a system in place to verify the -- 2 of 4 -- accuracy of patient-specific data and patient test results that are manually entered into the EMR. 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 review of patient test reports and interview with the facility personnel, (A) three out of four test reports reviewed failed to include the correct facility address where the testing was performed; and (B) one out of four Mohs test reports reviewed during the survey failed to include the correct number of stages on the final report. Findings include: 1. The laboratory performs testing in conjunction with Mohs surgery and Frozen Biopsy testing under the subspecialty of Histopathology on with an annual reported test volume of 750. The laboratory began patient testing on 6/10 /22. A1. Three out of four test reports reviewed during the survey. failed to include the correct laboratory name where the testing was performed. The facility address listed on the test reports reviewed indicated: "4715 E. Camp Lowell Dr. Tucson, AZ 85712" and the laboratory address listed in the CLIA Federal Database for CLIA# 03D2132603 is "120 W. Calle De Las Tiendes, Green Valley, AZ 85614." The affected case numbers are: MGV23-08 from 8/21/23, MGV24-48 from 3/22/24, and MGV24-144 from 10/25/24. A2. The facilty personnel interviewed on 11/20/24 at 11: 30 AM confirmed the name of the laboratory where the testing was performed was incorrect on the final test reports listed above reviewed during the survey. B1. It is the practice of the laboratory to maintain the Mohs test report (Mohs operative report and Mohs map) in an electronic record system. The total number of stages is documented on the test report (operative note) and is maintained in the EHR and on the Mohs map. B2. One out of four Mohs test reports (case# MGV23-08) reviewed in the EHR during the survey failed to include the correct number of stages on the final report. The Mohs log, Mohs map (noted as "clear" at Stage 4), and slides indicated the case had four stages. The Mohs operative report maintained in the EHR listed Stages I, II, III, and II on the final report. B3. The facility personnel interviewed on 11/20/24 at 11:30 AM confirmed the Mohs operative report for the patient indicated above failed to include the correct number of stages performed. 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: -- 3 of 4 -- Based on lack of quality assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to establish QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the postanalytic systems specified in 493.1291. Findings include: 1. No QA documentation was provided for review during the survey conducted on 11/20/2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. 2. The testing personnel interviewed on 11/20/2024 at 1:00 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified with the postanalytic systems. -- 4 of 4 --