Central Arkansas Gastroenterology

Summary Statement of Deficiencies D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Through a review of the laboratory procedure titled "Formaldehyde Precautions", lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to ensure employees were protected from chemical hazards of formaldehyde usage. Survey findings follow: A. The Formaldehyde Precautions procedure states, "All Pathology Department personnel shall be monitored either by badges or an environmental safety company on a yearly based...A permanent record of all results shall be kept in the office of the Laboratory Supervisor." Under the section titled "Exposure Monitoring" the procedure states, "A sampling is conducted to determine both the 8-hour time weighted average (TWA) exposures and the short term exposures of each job classification. Monitoring shall be conducted whenever a process, equipment, or personnel change occurs that may alter exposure." Under the "Recordkeeping" section of the procedure, it sates, "The following records shall be maintained: Personnel exposure measurements for a minimum of 30 years; Medical surveillance records for a minimum of 30 years; and respirator fit testing." B. At 9:55 a.m. on 2/20/2020 the surveyor requested documentation of formaldehyde exposure monitoring but none was presented to the surveyor for review. C. In an interview, at 9: 55 a.m. on 2/20/2020, laboratory employee #1 (as listed on the form CMS-209) stated that she was unaware of the need for formaldehyde monitoring and that there was no documentation. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observation and interview it was determined supplies that had exceeded their date of expiration were available for use. Findings follow: A. During a tour of the laboratory on 03/15/18 at approximately 11:00 AM, one of one bottle of Hydrochloric Acid lot number 9307 with an expiration date of November 2011 and one of one bottle of buffered formalin lot number 263451 and an expiration date of July 2017 was observed in the flammables storage cabinet. B. In an interview 0n 03/15/18 at approximately 11:00 AM the testing personnel identified as number 1 on the CMS 209 form confirmed that the chemicals had exceeded their expiration date and were available for use. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must 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. 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 -- 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 none of one testing personnel identified on the CMS 209 form. Findings follow: A. Upon review, personnel files for testing personnel identified as numbers one on the CMS 209 form did not contain written authorization by the laboratory director to perform procedures and examinations. B. Upon request, the laboratory was unable to provide written authorization by the laboratory director to perform procedures and examinations for testing personnel identified as number one on the CMS 209 form. C. In an interview on March 15, 2018 at approximately 1030, the testing personnel identified as number 1 on the CMS 209 form confirmed that no written authorization to perform procedures or examinations was present and indicated a lack of knowledge of the requirement. -- 2 of 2 --