Dillon Dermatology

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 record review and interviews with the Mohs Histotechnician, the laboratory failed to blindly verify the accuracy of the Mohs tissue biopsy and slide interpretation procedures at least twice annually, in the year 2019. This deficient practice had the potential to affect all patients tested in the specialty of histopathology in the year 2019. Findings Include: 1. An offsite review of the laboratory's 'Peer Review' policy and procedure found the following statement: "...Two cases from the previous year are selected and submitted for independent review..." 2. An offsite review of the laboratory's 'Peer Review' documentation for 2019 and 2020 found that only 1 case was submitted for independent review in 2019. Year Submitted Case 2019 19192 2020 20184 2020 20222 3. An interview with the Mohs Histotechnician via video phone call, on 1/14/21 at 1:00 PM, confirmed that only 1 Mohs case was submitted for independent review in 2019; thus, the lab failed to blindly verify the accuracy of the Mohs tissue biopsy and slide interpretation procedures at least twice annually, in the year 2019. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) 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 -- Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, and an interview with Mohs Histotechnician, the laboratory failed to perform, document and follow QC (quality control) procedures for the potassium hydroxide (KOH) testing performed to detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance, for 1 out of 9 patient and QC results reviewed. All patients tested in the subspecialties of mycology and parasitology had the potential to be affected. Findings Include: 1. An offsite review of the laboratory's 'Ectoparasites' and 'KOH' policy and procedure found the following statement: "...Quality Control Procedures...Test each specimen in "duplicate"..." 2. An offsite review of patient KOH and ectoparasite test results and QC found 1 out of 9 patients charts reviewed did not have QC results. Patient Test Date QC Result 1 11/01/2020 'negative' 2 10/29/2020 'negative' 3 10/26 /2020 [no result] 4 10/22/2020 'negative' 5 10/22/2020 'negative' 6 07/29/2019 'negative' 7 07/01/2019 'short hyphae...' 8 06/28/2019 'negative' 9 06/13/2019 'negative' 3. An interview with the Mohs Histotechnician, confirmed that the laboratory failed to perform, document and follow KOH and ectoparasites QC procedures for 1 out of 9 patients. -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Item I: Based on record review, the laboratory failed to review and evaluate MOHS Surgery proficiency testing results. All patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of the "Histopathology - MOHS Surgery" policy and procedure found no mention of reviewing and evaluating results from American Society for MOHS Surgery, which serves as proficiency testing. 2. Review of the 2018 and 2017 "Peer Review Results" received from the American Society for MOHS Surgery found no evidence of review and evaluation of the results. Item II: Based on record review, the laboratory failed to review and evaluate Frozen Section Biopsy proficiency testing results. All patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of the "Histopathology - Frozen Section Biopsy" policy and procedure found no mention of reviewing and evaluating results from Pinkus Dermatopathology, which serves as proficiency testing. 2. Review of the 2018 and 2017 reports received from Pinkus Dermatopathology found no evidence of review and evaluation of the results. D5787 TEST RECORDS CFR(s): 493.1283(a) 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 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 -- who performed the test(s). This STANDARD is not met as evidenced by: Based on record review, the laboratory failed to maintain a record system indicating the identity of the personnel who performed the test. All patients tested at this laboratory have the potential to be affected. Finding include: 1. A review of 2018 and 2017 "Maintenance Record for Cryostats" found no initials to indicate the identity of the personnel who performed cryostat maintenance. -- 2 of 2 --