Professional Gastroenterology Associates

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 the microscope and interview with the Laboratory Director (LD) , the laboratory failed to follow the procedure to "Maintain Equipment" from July 2019 to the date of survey. The finding includes: 1. The PM stated to perform preventive maintenance annually but there was no evidence of preventative maintenance performed since July 2018. 2. The LD confirmed on 5/20/21 at 11:00 am that the laboratory did not follow the PM. 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 D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to document the reaction of the Immunohistochemical Stains (IS) for positive and negative reactivity from 10/25/16 to the date of the survey. The LD confirmed on 10/10/18 at 10:25 am that IS were not checked for positive and negative reactivity. 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 --