Electronic Archival and Compliance System for a Point-of-Care Instrument Not Connected to the Hospital Information System

Maintaining sufficient records to demonstrate regulatory compliance can be laborious and time-consuming for point-of-care (POC) instruments not connected to central hospital information systems. The cardiac catheterization labs at Dartmouth-Hitchcock Medical Center have several AVOXimeter 1000E oximeters that are used regularly to diagnose intracardiac and great-vessel shunts. Multiple blood samples are typically drawn from each patient, and each oximeter can store up to 100 readings in nonvolatile memory. The data stored in the oximeter's memory consist of both patient data and quality control (QC) readings. Consequently, it was necessary for a POC coordinator to visit the cath labs regularly and manually transcribe or print out the QC readings to maintain proof of regulatory compliance, and to show that QC procedures were performed at specified intervals. Therefore, the authors developed a software interface that enables the POC coordinator to upload the oximeter's stored data to a personal computer for review and electronic archival. The interface required modifying the oximeter's software and writing a program for the computer receiving the data from the oximeter's serial port (RS-232C). The program, called OxyReview, enables a POC coordinator to (1) establish serial communications with the AVOXimeter 1000E, (2) query the oximeter to determine which software version the oximeter is using, (3) find out how many readings are stored in the oximeter's memory, (4) upload a user-specified number of readings, (5) review the transferred data on the computer monitor, and (6) store the transferred data on hard disk in a format that can be read by spreadsheet programs such as Excel. If the oximeter is using software version vE.1.1 or later, OxyReview automatically segregates QC readings from patient data. The AVOXimeter sends each reading in a format based on ASTM standard 1381-91 along with a checksum that OxyReview compares with its own checksum to verify the validity of transferred data. Each reading on a patient sample consists of a sample number, operator and patient identifiers, oxyhemoglobin saturation, total hemoglobin concentration, a time/date stamp, and an optional label for the anatomic site from which the blood sample was drawn (eg, aorta, right ventricle, pulmonary artery, etc.). OxyReview runs under most recent versions of Windows. The authors' experience at Dartmouth-Hitchcock Medical Center indicates that this type of interface to a personal computer provides a paperless archive that is clinically useful to the cath laboratory staff and makes it easier for the POC coordinator to demonstrate regulatory compliance.