Jhu Bloomberg School Of Public Health

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: Based on review of the manufacturer's instructions for use (IFU), review of temperature records, and interview with the technical supervisor (TS), the laboratory failed to monitor the humidity in the laboratory where the flow cytometer was located. Findings: 1. The laboratory used a FACSCanto II flow cytometer for patient testing. 2. The manufacturer's IFU (23-20269-00 09/2019) stated an operating relative humidity of "20-80% (noncondensing)." 3. There were no humidity records available. 4. During the survey on 04/24/2023 at 1:10 PM, the TS confirmed that the laboratory was not monitoring humidity in the laboratory where the flow cytometer was located. 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 D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's product inserts, final patient report and interview with the technical supervisor, the laboratory failed to follow the manufacturer's instructions for establishing their own normal reference range for the patient population they are testing. Findings: 1. The manufacturer's product inserts for BD Tritest CD3/CD4/CD45 and BD Tritest CD3/CD8/CD45 were reviewed. Both product inserts are dated 5/2014. Section 9. Limitations for both inserts state: Laboratories must establish their own normal reference ranges for the BD Tritest CD3 /CD4/CD45 and CD3/CD8/CD45 reagent parameters that can be affected by gender of patient, age of patient, and preparative technique ... Reference ranges provided are for information only. 2. The final report provided by the laboratory for T-HELPER Cells, Number and Percent and T-SUPPRESSOR Cells, Number and Percent provided a value but did not include a reference range for the evaluation of each test result. 3. During the survey on 08/24/2021 at 11:00 PM the, technical supervisor confirmed that the normal patient reference range was not available on the final report. 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 --