Mercy Clinic Convenient Care Rogers Ave

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 observation, lack of documentation and interview it was determined the laboratory failed to monitor room temperature in one of two rooms in which supplies with storage temperature requirement were stored. Findings follow: A) During a tour of the laboratory on 02/12/20 at approximately 02:30 PM, 400 BD SST Blood Collection Tubes Lot # 9108634, expiration date 2020-4-30 and 300 BD EDTA Blood Collection Tubes Lot # 9095756 expiration date 2020-8-31 all with a storage temperature requirement of 4 degrees C. to 25 degrees C. were observed stored in a storage room separate from the laboratory . B) Upon request, the laboratory was unable to provide records of room temperature in the separate storage room. C) In an interview on 02/12/20 at approximately 02:30 PM, the laboratory staff member, identified as number three on the CMS 209 form, stated that the laboratory did not monitor the room temperature in the storage room identified above. 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 D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Through review of the Casper 155D report, proficiency testing documentation and interview it was determined that the laboratory failed to report proficiency testing results to CMS on two of two 2018 proficiency testing events reviewed. Findings follow: A. Review of Casper 155D reports for Mercy Clinic Urgent Care - Fort Smith, CLIA # 2139193, revealed that the laboratory did not appear on the report. B. Review of the API Hematology/Coagulation proficiency testing reports for 2018 event number one and 2018 event number two revealed that the laboratory was registered with the proficiency testing agency as " Mercy Clinic Urgent Care Fort Smith, 6801 Rogers Avenue, Fort Smith, Arkansas, CLIA # 04D0469289". CLIA # 04D0469289 was the number assigned to a laboratory at the same location that was terminated in November 2017. C. In an interview on August 2, 2018at approximately 12:00 Noon the technical consultant identified as number 2 on the CMS 209 report confirmed that when the proficiency testing service was ordered for 2018 the CLIA number was not changed to the new CLIA number for the laboratory. 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 --