Public Health Law Map - Beta 5 - Medical and Public Health Law Site

traditional sense. Fetal heart monitors perform accurately and reliably within the
constraints of what they measure. Devices that are unreliable or otherwise directly
dangerous to patients will be the target of primary litigation against the device
manufacturer. Pure secondary liability is an issue for otherwise safe and well-
engineered devices. Secondary liability becomes a problem when the device in
question documents previously undocumented behavior indicating negligence on the
part of the medical care providers, records data with ambiguous interpretations,
and/or inappropriately leads to changes in medical care supervision, staffing, or
patient contact because of reliance on the device.
a) Filtering Data
The first problem, documentation of previously undocumented behavior, is
common to all recording instruments. Medical record systems that depend on
people to record events, either on paper or computer, are highly filtered.
Sometimes this filtering is conscious and intentional, as when personnel attempt to
cover up an error by not entering incriminating information into the medical chart.
In the worst case, there may even be attempts to change previous entries. This
intentional distortion of data, however, is assumed to be relatively infrequent. Most
commonly the filtering is unconscious and unintentional. It may occur because the
recorder’s memory fades between rendering the care or making the observations
and recording them in the medical record. In many situations, it occurs because the
nurses do not make their primary entries into the medical record.
While generally discouraged by protocols on medical records management, off-
chart records are commonly used by nurses to keep track of things to do,
medications given, and patient observations. These temporary records allow the
nurses to batch- enter data into medical records rather than keep contemporaneous
records. This allows two stages of filtering: first the information is compressed into
a minimal temporary record, and then that minimal record is expanded into the
permanent chart record. Such filtering makes it easy to transform an item
accidentally from the to-do list to the done list without the task’s actually being
performed. It also gives the filter an extra chance to remove nonconforming
information.
Filters are defined by what they exclude. Human clinical filters tend to exclude
things that do not easily fit into the expectations associated with the care of a given
patient. This should not be seen as an act of deception or even of carelessness. It is
more a smoothing of data that tends to obscure anomalies. The smoothing is aided
by the limited amount of information that can be recorded by periodic observations
recorded in essentially narrative format. The end result of this process of smoothing
and filtering is a medical record that is more often characterized by what it does not
contain than by what it does document. This is borne out in litigation where records
are usually incriminating because they fail to record what was allegedly done.
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