Summary:
Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the written quality procedure, interview with the laboratory manager, and the lab supervisor, the laboratory failed to maintain meeting minutes that were documented during lab huddles. Findings: 1. The laboratory personnel started routine quality huddles in August 2020. 2. The meeting minutes were documented by the lab supervisor in August 2020. 3. During the interview with the lab supervisor he stated that the huddle meeting minutes were discarded. 4. The laboratory manager and lab supervisor confirmed that huddle meeting minutes were not maintained to ensure the quality of lab performance. 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 coagulation package insert, interview with the lab manager, and the testing person (TP), the laboratory failed to follow the package insert when performing the coagulation INR verification. Findings: 1. The laboratory performs coagulation testing on the Sysmex CS 2500. 2. The TP stated that he performs the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- INR calculation when the reagent lot number changes. 3. The TP performed the INR manual calculation verification on 3/7/2022 with the incorrect ISI number. 4. The coagulation package insert states that the ISI number for the CS 2500 is 1.05. 5. The TP used 1.08 to perform the INR manual calculation verification on 3/7/2022. 6. The TP stated that he was not aware that the ISI number he used for INR verification was incorrect because the calculated values were within the normal ranges. 7. The TP confirmed that the ISI number used for the INR manual calculation verification was not the correct number stated in the manufacturer package insert. 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: A. Based on review of temperature records and interview with the lead technologist, the laboratory failed to document accurate temperature values to ensure the laboratory's established criteria of acceptability. Findings: 1. The laboratory room temperature record for the month of January 2021 had temperature values and dates that were written over multiple times and was not legible. 2. Testing personnel did not document room temperatures each day patient testing was performed in January 2121. 3. The lead tech confirmed that the laboratory did not document accurate temperature values to ensure the laboratory's established criteria of acceptability. B. Based on review of temperature logs, interview the lab manager, and the testing person (TP), the laboratory failed to document room temperatures each day of patient testing when performing blood gases. Findings: 1. The laboratory performs blood gas testing on the Gem analyzer. 2. The lab manger stated that analyzer cartridges are stored in materials management once they are delivered at the loading dock. 3. The lab manager stated that cartridges are stored in the materials management area until needed for testing. 4. The manufacturers manual states that analyzer cartridges can be stored between 15- 25C. 5. The lab was not documenting the storage area temperature each day of patient testing. 6. The lab manger and the TP confirmed that room temperatures were not documented each day of patient testing when performing blood gases. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of maintenance records, interview with the lab manger, and the lead technologist, the laboratory failed to document accurate values for the chemistry analyzer. Findings: 1. The laboratory performs chemistry testing on the Dimensions -- 2 of 7 -- chemistry analyzer. 2. The laboratory performed system checks when performing maintenance procedures on the analyzer. 3. The documented values on the maintenance log for January 2121 had multiple write overs by lab staff and was not legible. 4. The lead tech confirmed that the laboratory did not document accurate system check values when performing chemistry maintenance procedures. D5783