A Comprehensive Dermatology

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Liaison (LL), the laboratory failed to follow their procedure for annual review for 2 (2020 and 2021) of 2 years reviewed. Findings include: 1. Record review of the "Quality Assessment Policy" revealed a lack of documentation of review for 2 (2020 and 2021) of 2 years. 2. An interview on 4/21/2022 at 9:51, the LL confirmed the policy had not been reviewed and signed by the Laboratory Director for 2020 and 2021. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory liaison (LL), the laboratory failed to detect an incorrect site on the final report for 1 (20-0389B) of 13 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 -- patient reports reviewed for two years. Findings include: 1. Record review for 1 (20- 0389B) of 13 patient reports reviewed revealed the site of the procedure was incorrect on the final report as follows: i. requisition and specimen log - Posterior left scalp ii. final report - Anterior left scalp 2. During the interview on 4/22/2021 at 10:24 am, the LL confirmed the final laboratory test report in the patient's paper chart did not match the site on the paper requisition and specimen log. -- 2 of 2 --

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to retain slides for histopathology testing for 1 (Patient 19-0506) of 17 patient test records reviewed. Findings include: 1. A review of patient test records revealed Patient 19-0506 had testing performed on 6/21/19. 2. The surveyor requested slides for Patient 19-0506 on 10/1/20 at 10:33 am and they were not made available. 3. An interview on 10/1/20 at 10:33 am with the Office Manager confirmed the slides for the patient listed above were not available. 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 with the Office Manager, the laboratory failed to perform verification of accuracy testing at least twice annually for histopathology testing for 2 (September 2018 to September 2020) of 2 years reviewed. Findings 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 -- include: 1. A review of the laboratory's testing records revealed a lack of verification of accuracy testing for September 2018 to September 2020. 2. An interview on 10/1 /20 at 10:04 am with the Office Manager confirmed the laboratory did not verify the accuracy of histopathology at least twice annually for September 2018 to September 2020. 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 record review and interview with the Office Manager, the laboratory failed to ensure test results were sent to the final report destination in a timely manner for 3 (Patients 20-396, 20-414, and 19-958) of 17 patient test record reviewed. Findings include: 1. A review of the laboratory's patient test records revealed the following patients with histopathology testing ordered did not have a test report available: a. Patient 20-396 performed on 6/15/20 b. Patient 20-414 performed on 6/18/20 c. Patient 19-958 performed on 10/7/19 2. An interview on 10/1/20 at 10:37 am with the Office Manager confirmed the test reports for the patients listed above were not available. -- 2 of 2 --