


Patient Safety
Developing a Culture of Safety in the Veterans Health Administration
Red Flags for Patient Mental Health Warning Signs
Patient Safety Policy Lexington, KY 1999
VA National Center for Patient Safety ¾ Ensuring Correct Surgery Directive
The Ensuring Correct Surgery Directive is NCPS’ most recent safety initiative. Wrong site, wrong patient and wrong implant procedures are relatively uncommon adverse events but often devastating when they occur. The initiative offers a simple, straight-forward, five-step process to avoid adverse surgical events.
Developed by NCPS, the VA instituted this field-tested program on Jan. 1, 2003. The directive is just one example of how the VA is achieving or exceeding the Joint Commission on Accreditation of Healthcare Organization’s 2003 patient safety goals.
The 2001 VA rate for incorrect surgical procedures was approximately one in 25,000 to one in 30,000. By comparison, the private sector medical community has reported incidents ranging from one in 15,000 to one in 20,000. Regardless of the relatively low frequency of occurrence, this is an important issue in patient safety.
NCPS fosters a “systems approach” to develop health care solutions, based on prevention, not punishment. Only by viewing the health care continuum as a system can truly meaningful improvements be made.
NCPS uses Root Cause Analysis (RCA) to study problems in patient safety. The goal of RCA is to find out what happened, why it happened and what can be done to prevent it from happening again. This directive exemplifies a system developed using data gathered by RCA that can improve health care at VA facilities nationwide.
An analysis using RCA showed problems were more complex than just determining left- verses right-side surgery. These categories were noted: 44% were left-right mix-ups on the correct patient; 36% were wrong patient; 14% were wrong implant or wrong procedure on the correct patient; 7% were wrong site (not left-right on correct patient).
Wrong site surgery is more likely to occur when the communication system involved in identifying the correct procedure is too complex or does not involve the patient. It usually is a failure to have a system in place to adequately review the medical record or to assure that patients have not been accidentally switched due to misidentification.
The Ensuring Correct Surgery Directive is based on straight-forward communications, using both written and verbal methods. The five-step system involves the patient and the operating team. It identifies and specifies information and procedures critical to ensuring a correct surgical procedure.
The directive was pilot-tested at ten VA medical centers in the summer of 2002. The sites reported that implementing the steps would be effective without being unduly arduous.
VA employees participating in this mandatory program include the surgeon – to include the attending surgeon(s) and/or residents - nurses, the anesthesia provider, and other health care professionals involved in the surgery. Patients are strongly encouraged to participate in all phases as appropriate.


Two Basic Questions about the new VHA Directive 2004-028, Ensuring Correct Surgery and Invasive Procedures
Updated June 28, 2004, Contact: Noel Eldridge
1) How does Directive 2004-028 differ from the rescinded Directive 2002-070? Directive 2004-028 is designed to fully conform to the JCAHO Universal Protocol for Correct Site Surgery (UP), it applies to out-of-operating room (OR) invasive procedures (in addition to in-OR procedures) and provides a specific list of invasive procedures to which it applies, and it addresses various issues that have arisen since Directive 2002-070 was implemented in January 2003. Like 2002-070, it was pilot-tested at VAMCs (9) prior to presentation to the Under Secretary for Health for approval.
2) How does Directive 2004-028 differ from the JCAHO Universal Protocol for Correct Site Surgery? Directive 2004-028 is designed to conform fully to the JCAHO UP. But it differs from the JCAHO UP in two general and important ways: 1) it is more specific than the JCAHO UP, and 2) its requirements go beyond those of the JCAHO UP in some ways. These are explained below.
DIRECTIVE 2004-028 MORE SPECIFIC
· The patient identification process is more specific: it requires that a patient be asked to state their name and birth date or full SSN at a particular point in the pre-operative sequence of events and that specific documents be cross-checked.
· Attachment E contains a specific list of invasive procedures that are covered by the Directive. Procedures performed in the OR, out of the OR, or in either setting, are included.
· The different requirements for operating rooms and settings other than operating rooms are described separately in Attachments A, B, C, and D.
DIRECTIVE 2004-028 GOES BEYOND THE JCAHO UNIVERSAL PROTOCOL
· The requirements of the informed consent process are specified and the ability of a conscientiously implemented informed consent process to contribute to the prevention of adverse events is emphasized.
· The JCAHO UP excludes many sites and procedures (e.g., those on the midline and single organ procedures) from the requirement to be marked, whereas 2004-028 requires that virtually all sites on the exterior of the body be marked. (2004-028 details a JCAHO-approved option to substitute a special-purpose wristband in cases that are sometimes difficult or awkward to mark.)
· A specific step is included, prior to the start of the procedure, which requires practitioners to check imaging data that will be used to confirm the site. The JCAHO UP does not contain this step.
· A sample of a local policy that can be copied and adapted for use at a VAMC is included as Attachment F. A simplifying flowchart is included as Attachment H.
This page was last updated on 10/05/2007 12:44 PM
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In the event that you have a Veterans Administration medical malpractice claim, you should immediately seek representation from an attorney who is experienced with litigating medical malpractice cases against the Veterans Administration or the VA.
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