Biomedical Engineering Reference
In-Depth Information
11.1 Introduction
In the mid-1990s, the University of Pittsburgh conducted a
major study of functional requirements for record-keeping,
called the Electronic Records Project.
1
Reporting on
this project, and specifi cally describing records, Wendy Duff
stated: “[Records] are created in the fi rst instance to
control or direct an organization and to help orient staff to a
common goal or purpose.”
2
That is, records serve the
purpose of controlling and directing the organization.
She continues:
They have residual value because they document the
outcomes of the directing and controlling activities and
because they provide evidence of an organization's
rights as well as its obligations to its staff and society.
For records to fulfi ll these roles, they must be readable,
understandable, and trustworthy.
3
There are two main audiences for record-keeping: operational
staff and various quality auditors. The operational perspective
is typically proactive, while the auditor's perspective is
typically retroactive. There are also other audiences,
including the training unit itself.
Operational staff includes employees (the trainees) and
their supervisors. Both employees and supervisors are
interested in the trainees' currency in their individual training
plans (ITPs), for purposes of work assignments. At the
beginning of each shift, the supervisor wants to know if the
employees on this shift are trained to the current versions of
each and every standard operating procedure (SOP) that is
listed in the ITP, that will be executed during that shift. The
supervisor reviews the employees' training histories (i.e., the
summary of the training records). Then the supervisor makes
