Schweiger Dermatology, Pc

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of the Mohs Log Sheet (MLS), Test Records and interview with the Office Manager (OM), the laboratory failed to maintain an accurate information system for Histopathology tests from 7/22/24 to 8/28/24. The findings include: 1. A review of 5 entries on the MLS revealed: a) Case # 24-413 had 2 stages documented on the MLS but had 3 stages documented on the MOHS map and final report. b) Case # 24-411 had "Rt Posterior Neck" listed as the location on the Mohs Map and MLS but the Final Report had the location listed as "right central lateral neck." 2. The OM confirmed at 11:00 am on 8/28/24 the laboratory failed to maintain an accurate information system. 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 --

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 surveyor review of the Procedure Manual and interview with the Operations Manager (OM), the laboratory failed to establish a detailed procedure for Biannual Assessment (BA) from on the date of survey. The findings include: 1. The BA procedure did not include the name of the referring pathologist. 2. The BA procedure requires the Mohs map to be sent to the reviewing pathologist. 3. The BA does not list a third party to review in the instance when the referring physician results do not match the reviewing physicians results. 4. The OM confirmed on 2/1/22 at 2:15 pm that the BA procedure was not in detail. 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 --