Auburn Pediatric And Adult Medicine

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to ensure the Laboratory Director signed the attestation statements for six of fifteen events reviewed in 2020 through 2023. The findings include: 1. A review of the API PT records revealed the no signature by the Laboratory Director (or designee) on attestation statements for the following surveys: a) 2020 Microbiology 3rd Event. b) 2020 Hematology 3rd Event. c) 2022 Hematology 1st Event. d) 2022 Hematology 2nd Event. e) 2022 Hematology 3rd Event. f) 2022 Microbiology 1st Event. 2. During an interview on March 28, 2023, at 11:12 PM, Testing Personnel #1 confirmed the above findings. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a review of the refrigerator and freezer temperature records, the Cell Dyn 18+ Quality Control (QC) package insert, the Filmarray Biofire QC package insert, and an interview with Testing Personnel #1, the Laboratory failed to ensure QC material was stored within the manufacturer's acceptable limits. Refrigerator temperatures were below acceptable ranges for six out of twelve months in 2022, and freezer temperatures were higher than acceptable ranges since the previous survey on 2 /5/2020 to the current survey on 3/28/2023. The findings include: 1. A review of the temperature records revealed the refrigerator in which the Cell Dyn+ Hematology Controls were stored were below the manufacturer's acceptable limits (less than 2 degrees Celsius) from April through September 2022. 2. A review of the Cell Dyn 18+ Control package insert revealed, "Cell Dyn 18+ controls should be tightly capped and stored at 2-10 degrees Celsius." 3. A review of the freezer temperature records revealed: a) Temperatures for the freezer in which the Filmarray Biofire Gastrointestinal (GI) controls were stored were above the manufacturer's acceptable limits since the previous survey on 2/5/2020 to the current survey on 3/28/2023. b) The laboratory's "acceptable ranges" of 3-8 degrees Fahrenheit do not reflect manufacturer's storage requirements for the Filmarray GI control Panel. 4. A review of the Filmarray Biofire GI controls package insert revealed, "Filmarray GI control Panel M238 should be stored frozen (-25 degrees Celsius to -15 degrees Celsius)". 5. During an interview on March 28th, 2023, at 1:03 PM, Testing Personnel #1 confirmed the above findings. D5781

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Abbott Cell Dyn Emerald Hematology analyzer calibration records, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to verify the accuracy of the 2/13/2018 calibration by performing quality controls (QC) before resuming patient testing. This affected one of three calibrations performed in 2018. The findings include: 1. A review of the Abbott Cell Dyn Emerald Hematology analyzer records from the 2/13/2018 calibration performed at 1:21 PM, revealed the testing personnel failed to verify the accuracy of the calibration by running QC afterwards. 2. A further review of the Hematology records revealed QC was only run in the early morning. 3. During an interview and review of the records on 2/5/2020 at 11:38 AM, the Technical Consultant confirmed testing personnel should run QC after a calibration, and ensure the results are acceptable before running patient samples. The surveyor then asked if any patient CBC's (Complete Blood Counts) were performed after 1:21 PM on 2/13/2018; the Technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Consultant checked the records, and stated two CBC's were performed on patients after the calibration on the above date. Thus, the above noted findings were confirmed. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of patient results reports and an interview with the Technical Consultant and the Testing Personnel, the laboratory failed to ensure the name and address of the laboratory performing the testing was included on the reports. The findings include: 1. On 2/5/2019 at 2:05 PM, the Technical Consultant and the Testing Personnel were asked about the post-analytical process in the facility. Upon the surveyor's request, the Technical Consultant provided a final report of a patient's results. 2. A review of the Film Array Respiratory Panel 2 Report revealed no name and address of the laboratory performing the tests on the report. These tests had been performed on-site since the previous survey. 3. As the interview continued on 2/5 /2019 at 2:15 PM, the surveyor reviewed the report with the Technical Consultant and Testing Personnel (TP) #5, who stated the Biofire Technician set up the testing platform and report; TP #5 further stated the laboratory was unable to modify the report. The surveyor explained the name and address of the laboratory performing the testing were required parameters on the report, and the laboratory must implement a mechanism to ensure this information was included. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D0000 This laboratory was determined to be in substantial compliance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor 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 --