Adult & Pediatric Dermatology, Pc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Adult & Pediatric Dermatology, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 record review and interview the laboratory failed to assess postanalytic systems quality assessment activities as evidenced by the following: a) A review of the laboratory's preanalytical monitoring for calendar years 2020 and 2021 showed that the lab had policies and procedures for monitoring post analytic problems. Histotechnician number 6 was asked for a total of corrected reports for calendar year 2021. She replied that it was approximately 300. The following list of corrected reports include but are not limited to the following problems: 1. Case number ADP21- 17728 - corrected report for body site location. 2. Case number DA21-9529 - corrected report for grossing site. 3. Case number ADP21-25397 - corrected report for office procedure. 4. Case number ADP21-24637 - corrected report for two specimens on the same patient where biopsy sites were switched. 5. Case number ADP21-10017 - corrected report for date of service. However, there was no ongoing assessment of these problems to identify trends or patterns that needed to be addressed and corrected. b) The Histotechnician confirmed in an interview on 3/15/22 at 10:40 AM that corrected reports data was not being compiled in order to track trends or patterns that needed to be addressed and corrected. c) The laboratory performs approximately 90,000 histopathology 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 D0000 A CLIA recertification survey was conducted for the Adult & Pediatric Dermatology, P.C. laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review interview and interview, the technical supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: a) Review of the CMS 209 Laboratory Personnel Report on 3/16/17 showed that there were four (4) new histotechnicians hired and performing tissue grossing since the last CLIA recertification survey on 1/5/18. Three (3) of the four new histotechnicians had been working for over a year. b) Review of personnel competencies for calendar years 2018 and 2019 revealed that there was no documentation of semiannual competency evaluations for one (1) of the three (3) new testing personnel who had been working for over a year. c) Histotechnician number 2 confirmed in an interview on 1/10/20 at 8: 55 AM that no semiannual competency evaluations had been performed on the one (1) new histotechnician. 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 D0000 A CLIA recertification survey was conducted for the Adult & Pediatric Dermatology, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 interview, the laboratory failed to follow policies and procedures for twice annual verification of testing it performs that is not included in subpart I of this part as evidenced by the following: A review of the laboratory's polices for histopathology skin slide case reviews for accuracy of diagnoses stated that the laboratory, "performs biannually intra/inter reliability test of 10 randomly selected cases...". A review of histopathology skin slide case reviews performed in calendar year 2016 and 2017 revealed that skin slide case reviews for accuracy verification were not performed semiannually in calendar year 2016. Record review revealed that a 10 case review was performed, for cases chosen between January and June of 2016, on 6/8/16. For cases chosen between July and December of 2016 the case reviews were not performed until 6/13/17. The histotechnician interviewed on 1/5/18 at 10:20 AM confirmed that twice annual accuracy verification for histopathology cases had not been performed twice annually during calendar year 2016. 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 --