INSCYTE Corporation
	2 Berkeley Street, Suite 403, Toronto, Ontario, Canada M5A 2W3 Tel: 416-594-9393 Fax: 416-594-2420

QC/QA Report

Since May of 1999, CytoBase has operated a Quality Control/Quality Assurance Program with the objective to ensure the data registered in the database are of the highest quality and specifically that the data are complete and technically and syntactically correct. This includes the identification of issues or problems, execution of corrective actions and development of processes to prevent their occurrence.

A number of projects have been undertaken in the past few months from analysis of required fields to the expansion of existing audit logs. A few of these items are briefly discussed below.

• CytoBase requires a data set consisting of mandatory, strongly recommended and preferred fields to be submitted as components of each report. If a report is missing one of several mandatory fields, the report will be rejected. As well, the data submitted by the laboratory must be analyzed to ensure the fields contain plausible values. Currently, CytoBase requires the specimen date (date specimen was received in the laboratory) and diagnosis date (date of final diagnosis) of all reports. Upon analysis of the specimen date field, implausible specimen dates were identified. Instead, the diagnosis date had been inserted into the field. The difference in the time between the specimen date and the diagnosis date ranges from a few days to over a month. This error will cause a minor discrepancy in the generation of the statistics for the CytoBase Report. As well, there will be discrepancies in the generation of follow-up letters, as the specimen date is used to determine when the patient is overdue for follow-up. The laboratories have been notified of this issue and are in the process of changing their submission programs.
• By the end of 1999, all laboratories were submitting reports to CytoBase via an updated registration program. This new registration program improved the submission process to CytoBase by providing the laboratories with the following opportunities:
  • Submission of reports to CytoBase in a simplified format. In the past, reports were submitted to CytoBase in a standard format known as Health Level Seven or HL7. An alternate format was created to ease the burden of the HL7 formatting for the laboratories. The laboratories now have the option to submit reports in standard HL7 or in an abbreviated format referred to as the CytoBase Short Form Format.
  • Receipt of data through new submission software, TransMed EDI. This software provides more concise audit logs on report registration, queries and rejections.
  TransMed EDI provides a secure mode to transfer data over the internet, thus increasing the speed of report acknowledgements and query responses to the laboratories. Responses are usually returned to the laboratory in less than a minute. The previous submission utility program required a longer response time, as registration and acknowledgement of batch reports were transmitted by telephone. The audit logs in TransMed have greatly improved the ability to search through registered cases.
• The Technical summary on page 13 identifies that there are 3,556,431 reports registered in the database. The total number of reports identified in Cumulative Database - Diagnosis Distribution by Age and Class (page 14) is 3,349,132. This discrepancy arises from the fact that some cases could not be grouped into the main categories of the Diagnosis Distribution table.