Ascension St John Medical Center Picu

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/29/2020. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the point of care lead at the conclusion of the survey. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records, procedure manual, and interview with the point of care lead, the laboratory failed to ensure the demonstrated reportable ranges were utilized for a new test method. Findings include: (1) On 10/29/2020 at 10:00 am, the point of care lead stated the following to the surveyor: (a) The laboratory performed pH, pCO2, pO2, Sodium, Potassium, Glucose, Ionized Calcium, Hemoglobin, and Hematocrit testing using the CG8+ cartridge and the iSTAT 1 analyzer; (b) A new iSTAT 1 handheld analyzer (serial number 335887) was put into use on 04/05/2019. (2) The surveyor reviewed the performance specification records for the new analyzer and identified the following for the reportable ranges for pO2 and Potassium: (a) pO2 - The laboratory had demonstrated a reportable range of 13-401 mm Hg; (b) Potassium - The laboratory had demonstrated a reportable range of 2.3-7.7 mmol/L. (3) The surveyor then requested documentation to verify the reportable ranges that were being utilized by the laboratory. The following was identified: (a) pO2 - The laboratory was using a reportable range of 15-426 mm Hg; (b) Potassium - 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 2 -- laboratory was using a reportable range of 2.0-8.2 mmol/L. (4) The surveyor reviewed the findings with the point of care lead, who stated on 10/29/2020 at 12:30 pm, the laboratory was not using the reportable ranges for pO2 and Potassium that had been demonstrated by the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the point of care coordinator/technical consultant and the point of care technician at the conclusion of the survey. 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 a review of records, manufacturer's instructions, and interview with the point of care coordinator/technical consultant, the laboratory failed to ensure analyzers were stored as required by the manufacturer. Findings include: (1) At the beginning of the survey, the point of care coordinator/technical consultant stated the following to the surveyor: (a) Sodium, Potassium, Ionized Calcium, Glucose, Total CO2, Hematocrit, Hemoglobin, pH, PCO2, PO2 were performed on the Abbott iSTAT analyzer. (2) Later during the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer's required the operating temperature be maintained as follows: (a) Abbott iSTAT must be within the range of 18-30 degrees Celsius (3) The surveyor reviewed laboratory temperature records from December 2016 through April 2018 and identified the following for 2 of 17 months: (a) August 2016 - 4 of 31 temperature readings were not documented (days 14,16,18,19); (b) November 2016 - 2 of 30 temperature readings 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 -- were not documented (days 25,27). (4) The surveyor reviewed the records with the point of care coordinator/technical consultant who stated the temperatures of the laboratory had not been documented as indicated above. -- 2 of 2 --