Forefront Dermatology, Sc Dba Arizona

Summary Statement of Deficiencies 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 review of patient test reports, review of

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 lack of accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2018. Findings include: 1. No documentation was presented for review during the survey to indicate that the laboratory verified the accuracy of Mohs testing at least twice annually during 2018. 2. The facility personnel confirmed that the laboratory failed to verify the accuracy of Mohs testing at least twice annually during 2018. 3. The laboratory's approximate annual test volume under the sub-specialty of Histopathology is 500. **This is a repeat deficiency from the previous survey conducted on 02/22/2018 and the previous survey conducted on 01/21/2016. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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 accuracy verification documentation and interview with the facility personnel, the laboratory failed to verify the accuracy of dermatopathology testing at least twice annually during 2016 and 2017. Findings include: 1. The laboratory performs patient testing under the sub-specialty of Histopathology, with an approximate annual test volume of 3,000. 2. On the date of the survey, February 22, 2018, the laboratory presented documentation of accuracy verification for Mohs cases that were performed by the laboratory in 2016 and 2017. The facility personnel stated that the laboratory performed the accuracy verification procedure during each respective year, however the original documenation could not be located. The accuracy verification documentation presented for review during the survey for both years (2016 and 2017) was sent for verification by the laboratory in late 2017 and the results were not returned until January 2018. 3. The facility personnel stated that the accuracy verification for Mohs testing was performed for 2016 and 2017 during each respective year but the original documentation could not be located. ** This is a repeat deficiency from the previous survey conducted on 01/21/2016. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of