Sona Dermatology

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on quality control (QC) record review and interview with the histotechnologist, the laboratory failed to ensure that staining materials were tested for intended reactivity to ensure predictable staining characteristics when performing Hematoxylin and Eosin (H&E) and Toluidine Blue (T-Blue) staining of histopathology slides (D5473); failed to ensure that the results of all H&E and T-Blue stain QC were acceptable and that all control procedures were documented prior to reporting patient results (D5481); and failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283 (D5791). D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the recertification Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- survey on 3/13/2018 for not recording the daily stain quality control, recording the staining characteristics of the Hematoxylin and Eosin stain and the Toluidine Blue stain. The

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 procedure manual and quality assurance (QA) review and interview with the laboratory director (LD), the laboratory did not ensure that proficiency testing (PT) was performed at least twice annually. Findings: 1. The procedure, "Proficiency Testing" states that "At a minimum of twice of a year, quality control proficiency testing shall be performed on slides for Toluidine Blue (T-Blue) and Hematoxylin and Eosin (H&E)." 2. A review of QA records showed that 8 slides were sent out to another doctor to evaluate for PT on 8/3/17 and 4 slides were sent out for PT on 2/14 /18; and 3. At the time of the survey, there was no documentation of PT being sent out in 2016. 3. During an interview on 3/13/18 at 12:30 PM, the LD confirmed that PT had not been performed twice a year. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the re-certification 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 -- survey on 3/30/2016 for not recording the daily stain quality control, recording the staining characteristics of the Hematoxylin and Eosin stain and the Toluidine Blue stain. The