St Vincent Morrilton Rural Health Clinic

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, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature of one of two refrigerators in which reagents with storage temperature requirements were stored on each day of operation. Findings follow: A) During a tour of the laboratory on 3/22/22 at 09:15 AM two refrigerators containing items with a refrigerated temperature storage requirement were observed. B) During a review of the laboratory's temperature records it was noted that temperature records for only one refrigerator were presented. C) During a tour of the laboratory on 3/22/22 at 11:15 AM, nine boxes of Abbott Afinion Hemoglobin A1C lot # 10214933 expiration date 2023-11-15 with a storage temperature requirement of 2 to 8 degrees C. were observed in one of two refrigerators present in the laboratory. D) Upon request, the laboratory could not present the temperature records for the refrigerator in which the reagents identified above were stored,. E) In an interview on 3/22/22 at 11:15 AM the laboratory staff member, identified as number four on the CMS 209 form, stated that the daily temperature of the refrigerator in which the Afinion reagents were stored had not been monitored and recorded.. 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 that the laboratory had 50 BD Na Citrate blood collection tubes available for use that exceeded their date of expiration. Findings follow: A. During a tour of the laboratory on 7/17/19 at approximately 11:15 AM , the surveyor observed 50 BD 4.5 ml. Na Citrate, lot # B1806346, with an expiration date of 2019-06-12 in a storage cabinet in the laboratory. B. In an interview on 7/17/19 at approximately 11:30 PM, the laboratory director identified as number 2 on the CMS 209 form confirmed that the tubes identified above had exceeded their expiration date and were available for use. 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 --