Schweiger Dermatology Group

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), observation of staining station and interview with the Office Manager (OM), the laboratory failed to have a procedure for Hematoxyilin-Eosin (HE) staining from March 2022 to the date of the survey. The OM confirmed on 7/14/22 at 1:30 pm that the laboratory did not have a procedure for HE staining. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Laboratory Consultant (LC), the laboratory failed to follow its policies and procedures for assessing the competency of the Testing Personnel (TP) in the calendar years 2018 and 2019. The findings include: 1. The laboratory failed to evaluate: a. Direct observation of routine patient test performance. b. Performance of instrument maintenance and function checks. c. Assessment of problem solving skills. 2. There was no documentation competency was met for procedures evaluated on the CA form. 3. The LC confirmed on 7/24/19 at 12:25 pm that CA procedures were not followed. 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 Test Records (TR) and interview with the Laboratory 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 -- Consultant (LC), the laboratory failed to maintain accurate TR for Histopathology testing from 11/13/18 to 1/8/19. The findings include: 1. A review of ten patients revealed one of ten were not accurate as follows: a. Patient 18-176 had 2 stages recorded in the Accession Log (AL) but three on the Mohs Map (MM). b. Patient 18- 196 had a different diagnosis in the AL than what was recorded on the MM. c. Patient 19-01 did not have the correct stage written on the slide. 2. The LC confirmed on 7/24 /19 at 12:45 pm that the laboratory did not maintain accurate TR. -- 2 of 2 --