SUNQUEST APPLICATION INTERFACING
Received Nov 23, 2009 · Event occurred Oct 19, 2009
Report 2029302-2009-00004 · MDR key 1555872
Device
Manufacturer
Sunquest Info SystemsProduct problems
- Application Program Problem
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT HAS BEEN REPORTED THAT AN OUTBOUND PHLEBOTOMY POINT OF CARE (POC) INTERFACE IS COMBINING PT ORDERS INAPPROPRIATELY UNDER THE FOLLOWING CIRCUMSTANCES: WHEN THE FIRST ORDER ALPHABETICALLY IN THE BATTERY OF TESTS DOES NOT QUALIFY TO CROSS THE POC INTERFACE, SUCH AS BILL ONLY TEST, BATCH MODE MUST BE TURNED OFF ON THE PHLEBOTOMY POC INTERFACE, NOTE: THIS IS A HARD CODED FEATURE ASSOCIATED WITH THE INTERFACE SPECIFICATIONS. THERE MUST BE MULTIPLE PATIENTS THAT QUALIFY FOR THE DOWNLOAD TO THE OUTBOUND POC ENTRY INTERFACE. NOTE: THERE ARE A TOTAL OF NINE (9) SITES POTENTIALLY AFFECTED. SUNQUEST HAS DISCONTINUED INSTALLING THE PHLEBOTOMY POC INTERFACE AND NO FURTHER CLIENTS CAN BE AFFECTED.
Additional Manufacturer Narrative
THIS ISSUE WAS REPORTED BY THE SITE WHEN IT WAS NOTICED THE POC PHLEBOTOMY SPECIMEN LABEL CONTAINED PT DEMOGRAPHIC INFO FROM ONE PT AND SUNQUEST DISPLAYED PT DEMOGRAPHIC INFO FROM ANOTHER PT. IF THE TECHNOLOGIST PROCEEDS TO PROCESS AND ACCEPT THE RESULTS THAT CONTAIN MISMATCHED PT DEMOGRAPHICS, INCORRECT RESULTS WOULD APPEAR ON A PT REPORT OR INQUIRY. SUNQUEST APPLICATION INTERFACING HAS CORRECTED THE PROBLEM AND WILL BE CONTACTING EACH AFFECTED FACILITY (9 TOTAL) TO SCHEDULE INSTALLING THE SOFTWARE CORRECTION. EXAMPLE PRECONDITIONS: PT A HAS THE FOLLOWING ORDER IN SUNQUEST M123: CBC. PT B HAS THE FOLLOWING ORDERS IN SUNQUEST M456: BILL, LYTES. THE POINT OF CARE (POC) INTERFACE MAY INAPPROPRIATELY COMBINE THE ORDERS FOR PATIENTS A AND B, SENDING ONLY PT B WITH THE COMBINED ORDERS IN THE FOLLOWING FORMAT: PT B: M123: CBC, M456: LYTES. NOTE: ACCESSION M456 CONTAINS A BILL ONLY TEST WHOSE TEST CODE IS ALPHABETICALLY FIRST IN THE LIST OF ORDERS. HOWEVER, THE BILL ONLY TEST DOES NOT QUALIFY TO DOWNLOAD TO THE POC DEVICE. PT A'S ORDER (CBC) IS NOT SENT ACROSS THE PHLEBOTOMY POC INTERFACE AND REMAINS UNCHANGED IN SUNQUEST. PHLEBOTOMIST COLLECTS THE SPECIMENS USING THE POC LABELS FOR PT B. PHLEBOTOMIST UPLOADS THE COLLECT DATE/TIME MODIFICATIONS BACK TO SUNQUEST FOR PT B. NOTE: A MESSAGE (2051) IS WRITTEN TO THE POC INBOUND INTERFACE ERROR LOG INDICATING THE COLLECT DATE/TIME HAS NOT BEEN ACCEPTED FOR PT B. IN SUNQUEST, PT B HAD NO CBC ON FILE FOR ACCESSION NUMBER M123. THE TECHNOLOGIST PERFORMS THE TESTING ON THE CBC ON PT B. RESULTING APPLICATIONS WILL DISPLAY THE PT DEMOGRAPHICS FOR PT A AND NOT PT B WITH THE EXCEPTION OF AUTOFILING. NOTE: IF THE CBC RESULTS ARE ACCEPTED, THE RESULTS ARE FILED TO PT A. NOTE: SPECIMEN RECEIPT APPLICATIONS, ORDER RECEIPT MODIFICATION (ORM) OR COLLECTION LIST VERIFY ((B)(4)), SHOULD BE USED TO CROSS-REFERENCE THE PT DEMOGRAPHICS BETWEEN THE POC CONTAINER LABEL AND SUNQUEST PRIOR TO RESULTING. TYPE OF EVAL PERFORMED METHOD: COMPUTER SOFTWARE PROGRAM CORE EVALUATED.
Remedial action
- Modification/Adjustment