Background
Minnesota Hospital Association (MHA) and the Minnesota
Department of Health (MDH) have reviewed
data from the adverse health event
reporting system and have noted a
cluster of wrong invasive procedures
that have resulted from failure to
identify incorrect information in
source documents used in
pre-operative verification.
Recommendation
MHA and MDH recommend
that facilities revisit the source
documents and verification procedures
that are used to schedule procedures,
complete informed consent documents,
and perform pre-operative verification. While
research is inconclusive regarding
best practices for use of source documents
and verification, the following
suggestions should be considered in developing processes within your organization:
-
Discussions with local and
national experts have suggested
facilities consider
“5
Rights of Verification” — the procedure to
be performed is verified against:
- Provider’s
surgical/procedure order;
- Radiology and
pathology reports — if relevant to
procedure;
- Informed consent documentation;
o Patient’s
understanding of the procedure to be performed;
- Diagnostic imaging (properly labeled, displayed and viewed along with the
radiologist’s report).
- There are other documents that could be included
in this list of source documents such
as the provider’s pre-procedure note.
- If there is a discrepancy in any of the
source documents, the history and
physical diagnosis and plan can be utilized to help in the reconciliation process.
- While
efforts should be made to improve
the accuracy of the operating room/procedure
room schedule, the schedule should
not be used as a source for verification of patient or procedure.
- Analysis performed by David Marx,
Outcome Engineering LLC, estimates
that assigning one person to perform verification using a single source document, e.g. the informed consent document,
results in a failure rate of 1 in
1,000 procedures. Adding a second person to perform an independent verification using two source documents,
e.g. surgical order and history and physical, decreases the failure rate to 1
in 100,000 procedures. A third independent verification using three source documents decreases the failure rate to 1 in 1 million.
- Independent
documents should be used wherever
possible rather than using one source document that is also the basis for
subsequent documents. Relying on dependent sources of information could allow for an error to be carried through the process.
- A
pre-procedure checklist detailing the verification of multiple source documents
by independent reviewers should be completed
prior to any invasive procedure. The procedure
should not proceed until the checklist is complete and
reconciled.
- The
organization’s policy and checklists related
to pre-procedure verification should
include a clear description of who is
responsible for verifying the procedure against each of the sources of information, along with a clear process and
assignment of responsibility for reconciling discrepancies among any of the information sources prior to the procedure.
- The
policy should require not only that relevant imaging
be available prior to the procedure, but also that it be viewed, along with the radiologist’s
report, as part of the pre-procedure verification process.
For
more information on the Patient Safety Registry,
adverse health event reporting or this alert, contact Julie Apold, MHA director of patient safety, at japold@mnhospitals.org or (651) 641-1121 or toll-free
at (800) 462-5393