Gastroenterology Consultants

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 surveyor review of the Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy of Histopathology testing twice annually in the calendar 2020. The OM confirmed on 9/7 /21 at 10:00 am that the laboratory did not perform BA for Histopathology testing twice in 2020. 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 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) and interview with the Office Staff (OS) and on phone with the Laboratory Director, the laboratory failed to follow Section III, Subject: "Pathology laboratory Performance Improvement Plan" Title: 'Resposibility' procedure from 11/1/16 to the date of survey. The finding includes: 1. The PM stated 'A report received from another outside laboratory' but the laboratory did not receive any reports from another outside laboratory in the calendar year 2017 and 2018. 2. The OS confirmed on 11/19/18 at 10:15 am that the PM was not followed. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require