Dixie Dermatology

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: _ Based on a review of laboratory records and an interview with testing personnel, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the general laboratory systems. _ The findings include: 1. A review of laboratory records showed no documentation of quality assessment activities. 2. The laboratory lacked a system to monitor and assess 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 quality assessment records review, lack of documentation, and interview with the office manager, the laboratory failed to verify 1 of 2 tests performed, histopathology Mohs' Micrographic frozen section test accuracy at least twice annually for 1 of 2 years reviewed, (2019). The laboratory performed approximately 35 frozen section cases per year with 1 to 2 stages (biopsy) collected. Findings include: 1. Quality assessment records review failed to include documentation the laboratory verified test accuracy twice annually in 2019. 2. In an interview conducted on 02/12/2021 at approximately 10:30 A.M., the office manager stated there was a change in the office manager in 2019 and the quality assessment program time table was not followed. THIS IS A REPEAT DEFICIENCY. D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on patient test records review, laboraotry procedure manual review, lack of 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 -- documentation, and interview with staff, the qualified person failed to sign one of 11 Mohs maps as required. The laboratory performed approximately 35 Mohs frozen section histopathology cases per year. Findings include: 1. Patient test records for Mohs case #30 collected on 04/02/2019 failed to include the final diagnosis and signature of the qualified board certified dermatologist on the Mohs Map as stated in the laboratory procedure. 2. In an interview on 02/12/2021 at approximately 10:15 A. M. the laboratory manager confirmed the Mohs map failed to include that the specimen was free of tumor after the first stage. -- 2 of 2 --

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 quality assessment records review, lack of documentation and interview with staff, the laboratory failed to verify potassium hydroxide (KOH) testing at least twice annually in 2017 and 2018. The laboratory tested approximately 50 tests per year. Findings include: 1. Quality assessment records reviewed failed to include documentation the laboratory verified KOH test accuracy at least twice annually in 2017 or 2018. 2. In an interview on 01/10/2019 at approximately 8:30 A.M. the laboratory manager stated they did not record twice annual KOH test test accuracy verification. 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 --