Duke Khuu Md Faad Dba Khuu Dermatology

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 Mohs surgical procedures slides on 10/26/2021 at 1:00 p. m., patient final testing reports (medical records/operative notes), slide labeling and an interview with the laboratory director, it was determined that from 05/30/2020 through 08/28/2021 for two (2) out of ten (10) random patients' testing records reviewed, the laboratory failed to follow written policies and procedures for specimen collection, labeling and Mohs surgery reports for each Mohs specimen. The findings included: 1. Review of two different patient Mohs patient slides, the unique identifiers did not match the unique identifiers found on the final patient testing reports (medical records/operative notes). Surgical Date Accession # Discrepancy 09/19/20 M20-034 Identifier (Surname) 11/21/20 M20-054 Site 2. On 10/26/2021 2:00 p.m. (survey date) the laboratory director affirmed that the unique slide identifier (Surname) for M20- 034 (09/19/2020) slides was different than the patient's final testing reports (medical records/operative notes); M20-054 (11/21/2020) for one of two slides had incorrect information on the site than the patient's final testing reports (medical records /operative notes). 3. Based on the laboratory's annual test volume declaration (08/05 /2021) the laboratory performed 100 histopathological Mohs surgical procedures tests annually. 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 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 review of 10 (ten) randomly selected patients records from 02/11/2017 to 05 /11/2019, Mohs surgical procedure documents, an interview with the laboratory director and lack of documentation of twice a year verification of the accuracy of the test or procedure, it was determined that the laboratory failed to at least twice a year verify the accuracy of the Mohs surgical procedure performed and reported for 2017, 2018. The findings included: a. On 05/21/2019 (survey date) the laboratory was unable to retrieve documentation of twice a year verification of accuracy for Mohs procedures performed and reported for the years 2017 and 2018. b. On 05/21/2019 11: 30 the laboratory director confirmed that no review of twice a year verification the accuracy of the Mohs surgical procedures were performed in 2017 and 2018. c. The laboratory testing declaration of 05/17/2019 estimated an annual Mohs surgical procedures performed 120 patient tests. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. 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 (05/21/2019) of laboratory policies and procedures, and an interview with the laboratory director it was determined that the laboratory director failed to ensure written policies and procedures were established for monitoring individuals who conduct preanalytical, analytical and postaanalytical phases of testing to assure that they are competent and maintain their competency (See D5217). -- 2 of 2 --