Summary:
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 laboratory records and the laboratory policy, and interview with laboratory personnel, it was determined that the laboratory failed to at least twice annually verify the accuracy of Mohs procedures in 2019. Findings included: 1. For Mohs procedures performed by Testing Person-2 (KH) in 2019 : laboratory records documented histopathology slides for 4 out of 4 cases performed on 8/05/19, 9/09/19, 11/04/19, and 12/02/19, were not verified for accuracy until the following calendar year on 12/23/20. 2. Laboratory personnel affirmed (6/23/21 at 3:30 PM) the aforementioned dates in the records; and thus, the failure to verify the accuracy of the Mohs procedures at least twice annually in 2019. 3. The laboratory's written policy for verifying the accuracy of the Mohs procedures failed to specify completion within the same calendar year as the date of service of the Mohs procedure. 4. The reliability and quality of Mohs procedures performed by Testing Person-2 in 2019 could not be assured when accuracy was not verified at least twice annually in 2019. Examples selected for this survey are as follows: Date of service Mohs # 3/18/19 19-135, 19-136 7/18/19 19-313 with FBX, 19-316 5. Based on the stated annual test volume (CMS116, 6/22/21), the laboratory performed 2,300 Mohs procedures annually. . D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. 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 -- This STANDARD is not met as evidenced by: Based on CLIA survey findings on 6/23/21 at 3:30PM, the Laboratory Director is herein cited for deficient practice in ensuring that quality assessment programs are maintained to identify failures as they occur. Findings included: 1. Under the Laboratory Director's administration and oversight, the laboratory failed to monitor for activities verifying the accuracy of Mohs procedures at least twice within the calendar year and identify failures as they occur. -- 2 of 2 --