Description of Event or Problem · 1
ON SEPTEMBER 25, 1998, A.L.I REC'D A REPORT FROM THE OBSTETRICS DEPT INDICATING THAT A.L.I'S ULTRAPACS PRODUCT CTS 110 "DIAGNOSTIC REPORTING CLIENT SOFTWARE" VERSION V1.20 DOES NOT RECALCULATE THE EXPECTED DATE OF DELIVERY (EDD) FIELD ON THEIR OBSTETRICS FORMS FOR SINGLE, TWINS, AND TRIPLETS WHEN THE FOLLOWING SEQUENCE IS EXECUTED: 1. A FORM IS OPENED, INFO IS ENTERED INTO MULTIPLE FIELDS USED IN THE CALCULATION OF THE EDD FIELD, AND THE FORM IS SAVED, 2. THE FORM IS RE-OPENED AND A CHANGE IS MADE TO ANY FIELDS USED IN THE CALCULATION OF THE EDD FIELD VALUE. HOWEVER, A CLINICALLY SIMILAR VALUE, THE GESTATIONAL AGE (WHICH IS NEXT TO THE EDD ON THE FORMS), IS RECALCULATED. A.L.I WAS ABLE TO REPRODUCE THE PROBLEM IN THE EDD FIELD UNDER THE REPORTED CONDITIONS. A.L.I ALSO DETERMINED THAT ANY CALCULATED DATE FIELD WOULD NOT BE RECALCULATED IF A COMPLETED FORM WAS RE-OPENED AND THE DATA USED IN THE CALCULATION OF THE DATE FIELD WAS MODIFIED. A REVIEW OF THE CLINICAL SITES THAT WERE USING CRS 110 V1.20 WAS CONDUCTED. IT WAS DETERMINED THAT TWO SITES WERE USING FORMS THAT CONTAINED CALCULATED DATE FIELDS. THESE TWO CLINICAL SITES WERE INFORMED ABOUT THE CONDITIONS UNDER WHICH THE PROBLEM OCCURS AND WERE INSTRUCTED HOW TO MANUALLY CAUSE A RECALCULATION OF A CALCULATED DATE FIELD. THEY WERE ALSO INFORMED THAT THEIR SOFTWARE WOULD BE UPDATED TO ELIMINATE THE PROBLEM. MODIFICATIONS TO THE SOFTWARE PROGRAM TO CORRECT THE PROBELM WERE PRODUCED ON OCTOBER 5, 1998 (VERSION V1.21). ON DECEMBER 8, 1998 IT WAS DISCOVERED THAT VERSION V1.21 HAD NOT BEEN RELEASED TO A.L.I SUPPORT SERVICES TO UPDATE THE IDENTIFIED CLINICAL SITES AND HAD NOT BEEN RELEASED TO ALI ASSEMBLY AND INSTALLATION FOR INCLUSION IN NEW INSTALLATIONS. A REVIEW OF ALL CLINICAL SITES USING CRS 110 (35 IN TOTAL) WAS CONDUCTED AGAIN BY INDIVIDUALLY CONTACTING EACH CLINICAL SITE BY PHONE. IT WAS DETERMINED THAT THERE WAS CURRENTLY FIVE SITES USING FORMS THAT CONTAINED CALCULATED DATE FIELDS. THE OTHER THIRTY SITES WERE NOT USING FORMS CONTAINING CALCULATED DATE FIELDS OR HAD NOT YET IMPLEMENTED USE OF THE PRODUCT. BETWEEN DECEMBER 15 AND 17 AND ON DECEMBER 22, 1998 EACH OF THE FIVE IDENTIFIED SITES WAS UPDATED WITH VERSION V1.21. THE OTHER CLINICAL SITES THAT ARE NOT USING FORMS WITH CALCULATED DATE FIELDS ARE IN THE PROCESS OF BEING UPDATED WITH THE VERSION 1.21. THIS PROCESS WILL BE COMPLETED BY MARCH 21, 1999. THE REMAINING CLINCIAL SITES THAT ARE NOT YET USING THE PRODUCT HAVE HAD THE SOFTWARE PROGRAM TURNED OFF (THE SOFTWARE CAN ONLY BE TURNED ON BY ALI). THESE SITES WILL BE UPDATED WITH VERSION V1.21 BY MARCH 12, 1999. AN ANALYSER PROGRAM WAS RUN ON THE CLINICAL DATABASES AT EACH OF THE FIVE IDENTIFIED CLINICAL SITES TO IDENTIFY PT REPORTS WHERE THE EXISTING VALUE IN A FORM'S CALCULATED DATE FIELD DID NOT MATCH THE RECALCULATED VALUE FOR THAT FIELD. EACH PT REPORT SINCE THE FIRST VERSION OF CRS 110 WAS INSTALLED AT THE CLINICAL SITE WAS EXAMINED BY THE ANALYSER PROGRAM (THE EARLIEST INSTALLATION OF CRS 110 AT A CLINICAL SITE WAS IN AUGUST 1998). LISTS IDENTIFYING THESE PT REPORTS, THE NAMES OF AFFECTED DATE FIELD(S), ITS CURRENT VALUE AND ITS CORRECT RECALCULATED VALUE WERE PREPARED AND FAXED TO EACH CLINICAL SITE ON DECEMBER 23, 1998. BECAUSE THE ANALYZER PROGRAM HAD NO WAY OF DISCERNING WHETHER THE DATE FIELD VALUE WAS PURPOSELY MODIFIED BY A USER, EACH SITE WAS REQUESTED TO REVIEW EACH IDENTIFIED PT REPORT TO DETERMINE THE CLINICAL SIGNIFICANCE OF THE DATE DIFFERENCES AND TO REPORT THE RESULTS TO ALI. BY JANUARY 21, 1999, ALI HAD REC'D REVIEW INFO FROM EACH OF THE FIVE IDENTIFIED CLINICAL SITES. NO CASES WERE FOUND WHERE THE DATE DEVIATION WAS CONSIDERED BY THE SITE TO BE OF CLINICAL SIGNIFICANCE. THE CLINICAL SITE REPORTED THAT THEY HAD PRODUCED ADDENDUM REPORTS AS THEY DEEMED NECESSARY.