Arkansas Gastroenterology

Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based upon review of personnel records, lack of documentation, and interview it was determined that the laboratory director failed to specify in writing the examinations and procedures that personnel are authorized to perform for two of two testing personnel for which records were presented. Findings follow: A. Review of personnel records did not include authorization to perform testing signed by the current laboratory director. B. Upon request, the laboratory was unable to provide a written authorization to perform procedures signed by the laboratory director for two of two testing personnel. B. In an interview on 3/27/25 at 10:18am the laboratory director confirmed there were no written authorizations to perform testing, signed by the laboratory director. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observations made during a tour of the laboratory, review of manufacturer's instruction manual, review of the laboratory's temperature and humidity records, and interviews with staff, it was determined the laboratory humidity was below the manufacturer's requirement for the laboratory's Tissue-Tek DRS 2000 Slide Stainer and Sakura Tissue-Tek TEC 5. Survey findings include: A) During a tour of the laboratory on 7/7/2023 at 11:30 a.m., Tissue-Tek DRS 2000 Slide Stainer and Sakura Tissue-Tek TEC 5 was observed in the main laboratory. B) Review of the manufacturer's instruction manual for Tissue-Tek DRS 2000 Slide Stainer and Sakura Tissue-Tek TEC 5 normal operating humidity range is 30%-85%. C) Review of the Laboratory Temperature Log revealed conditions of operating requirement listed as "Room Temp 55-80F and Room Humidity 10%-80%". D) Review of the laboratory's room temperature and humidity log for January, February, March, April, September, October, November, and December of 2022 revealed 93 days humidity below 30%. E) Review of the laboratory's room temperature and humidity log for January, February, March, April, and May of 2023 revealed 39 days humidity below 30%. F) In an interview on 7/7/2023 at 12:49 p.m. the laboratory staff member (# 2 on the CMS 209 form) confirmed that the Tissue-Tek DRS 2000 Slide Stainer and Sakura Tissue-Tek TEC 5 was in use 132 days below 30% humidity. 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 D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Through a review of six randomly selected patient pathology reports and interviews with laboratory staff, it was determined that six of six pathology reports failed to include the name of the laboratory where gross examinations were performed. Survey findings include: A. Through a review of six randomly selected patient pathology reports, which included gross description performed by Arkansas Gastroenterology, it was determined that six of six test reports failed to include the name of the laboratory. B. In an interview, at 11:30 on 4/14/2021, laboratory employee #1 (as listed on the form CMS-209), confirmed that Arkansas Gastroenterology did the gross description but the pathology reports had a laboratory name other than Arkansas Gastroenterology. 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 --