Little Rock Pediatric Clinic

Summary Statement of Deficiencies D5783

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 a review of the temperature logs for 2020 and 2021, lack of documentation and interviews with staff, it was determined the laboratory failed to monitor and document room temperatures, refrigerator temperatures and humidity conditions that are essential for the proper storage of reagents and supplies. Survey findings follow: A. A review of the laboratory temperature logs revealed the temperature ranges: Refrigerator range 2-8 degrees Celsius: Room Temperature Range 18-25 degrees Celsius and Humidity 0-80%." B. A review of the refrigerator temperatures for January- December 2020 (twelve of twelve months) revealed the laboratory failed to monitor and document refrigerator temeratures and humidity on three of thirty-one days in March; one of thirty days in April and one of thirty days in September. C. A review of the refrigerator temperatures for January- December 2021 (twelve of twelve months) revealed the laboratory failed to monitor and document refrigerator temperatures and humidity on one of thirty-one days in March; two of thirty days in April and two of thirty-one days in August. D. In an interview on 1/26/2022 at 10:30, the technical consultant confirmed the laboratory failed to monitor or document room temperature and humidity on the days mentioned. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Through a review of the Quality Assessment Plan, Proficiency Testing (PT) records for 2018 and 2019, Survey exception reports and interviews with staff, it was determined the Laboratory failed to prevent the recurrence of problems in the General Laboratory Systems. As evidenced by: A. A review of the Laboratory's Quality Assessment Plan for Proficiency Testing revealed: "Each proficiency report generated by a PT program must be reviewed, dated and signed by laboratory director or technical consultant. Any unacceptable result will be investigated and the

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --