Summary:
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 observation of the Point of Care refrigerators, review of manufacturer's Procedure Manual for the i-Stat System instructions, TempTrak Sensor temperature record review, point of care testing records for the OR/COR during August 2018, and interview with the Laboratory Supervisor determined the laboratory failed to ensure the refrigerator in the Surgery Suite was monitored to ensure the stored reagents were maintained according to manufacturer's instructions in 2018. The findings include: 1. On a routine tour of the Point of Care testing sites on September 11, 2018, at 3:30 PM, observation of the Surgery(OR)/Cardiac Surgery(COR) refrigerator revealed three thermometers: (1) the inside refrigerator thermometer reading of 2.0Centigrade (C), (2) the inside laboratory thermometer reading between 1.5C - 2.0C and (3) the TempTrak Sensor reading of 1.6C . 2. Review of the manufacturer's Procedure Manual for the i-Stat System instructions revealed "Store the main supply of cartridges at a temperature between 2 and 8C. Do not allow cartridges to freeze". 3. Review of the TempTrak Sensor temperature records revealed the OR/COR refrigerator read 1.6C at 3:30 PM on September 11, 2018 and was outside acceptable limits for the entire day. Review of the TempTrac Sensor temperatures for the month of August 2018 revealed that the OR/COR refrigerator was below the manufacturer's acceptable limits of 2C - 8C for 893 of the 1269 readings taken from August 16, 2018, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- at 10:15AM to August 28, 2018, at 10:45AM, with temperatures ranging from 1.9C to -1.6C . 4. Review of the point of care testing records for the OR/COR revealed 163 of the 704 patients tested in August 2018 were resulted between August 16 and August 28, 2018. 5. Interview with the Laboratory Supervisor on September 11, 2018, at 4:00 PM confirmed the OR/COR refrigerator contained the CG8+, ACT, E3+ i-Stat cartridges and the CLOTtrac HR controls used for patient testing in the OR and COR. The Laboratory Supervisor confirmed that the refrigerator temperature was outside the manufacturer's acceptable limits for the storage of the reagents on September 11, 2018, and below the manufacturer's acceptable limits from August 16 at 10:00AM to August 28, 2018, at 10:45 AM with temperatures ranging from 1.9C to -1.6C and 163 patients were tested and reported. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the Point of Care whole blood glucose (WBG) testing areas, review of WBG patient testing records, and interview with the Laboratory Supervisor determined the point of care testing personnel failed to ensure the WBG controls are not used when they have exceeded their expiration dates in 2018. The findings include: 1. On a routine tour of the Point of Care WBG testing sites on September 11, 2018, at 2:00 PM revealed that the WBG controls in the Cath Lab expired on September 9, 2018, and were still in use for patient testing. Review of the Hospital Outpatient Diagnostic(HOPD) WBG testing site revealed the WBG controls expired on August 7, 2018 and were still in use for patient testing. 2. Review of the WBG patient testing records on September 12, 2018, at 8:45 AM with the Laboratory Supervisor revealed patient testing was performed for one patient on September 10, 2018 in the Cath Lab and for three patients on August 7, 2018, in HOPD by the point of care testing personnel. 3. Interview with the Laboratory Supervisor on September 11, 2018, at 3:00 PM confirmed the WBG Controls used for patient testing in the Cath Lab expired on September 9, 2018, with one patient tested and reported on September 10, 2018, and the WBG controls used for patient testing in HOPD expired August 7, 2018, with three patients tested and reported on August 7, 2018. D5785