Schweiger Dermatology, Pc

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 (SS) and interview with the Office Manager (OM), the laboratory failed to follow the PM for Hematoxyilin-Eosin (HE) staining from 2/3/22 to the date of the survey. The findings include: 1. The PM stated step 10 "10 seconds Eosin" but the SS had 95% alcohol 2. The PM steted step 11 "10 seconds 100 alcohol" but the SS had Eosin. 3. The PM stated step 12 "10 seconds 100 alcohol" but the SS had 95% alcohol. 4. The PM stated step 13 "10 seconds 100 alcohol" but the SS had 95% alcohol. 5. The OM confirmed on 5/21/24 at 10:30 am that the laboratory did not follow the PM. D5781

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 office Manager (OM) the laboratory failed to follow its policies and procedures for assessing the competency of TP who perform Histopathology testing at the date of survey. The findings include: 1. The CA was not performed on one out of one TP in the calendar years, 2020, and 2021. 2. The laboratory CA policy stated that testing personnel are evaluated annually. 3. The OM confirmed on 2/3/22 at 10:20 am the laboratory did not follow the CA procedure. 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 --