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New surgical safety checklist to reduce deaths and complications

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“Doctor, the sponge count is incorrect.” “No, it’s not.” “Doctor, a lap sponge is missing.” “That’s impossible.” “Doctor, we have verified that the sponge count is incorrect.” “Oh,(expletive deleted)!”

The World Health Organization (WHO) has estimated that 500,000 surgical deaths and complications which occur worldwide every year can be prevented. In October 2007, WHO launched its first “Safe Surgery Saves Lives” campaign, co-sponsored by the Harvard School of Public Health (HSPH) and led by Atul Gawande, M.D., a surgical oncologist and Associate Professor of Health Policy and Management at HSPH. The study was based on the theory that a one-page surgery checklist developed in consultation with international experts in surgery, anesthesiology, nursing and patient safety would prevent errors and omissions in the Operating Room. The initiative included 3,955 patients in eight hospitals in eight cities worldwide (Seattle, Washington; Toronto, Canada; New Delhi, India; Amman, Jordan; Auckland, New Zealand; Manila, Philippines; Ifakara, Tanzania; and London, England).

The study demonstrated that the use of this low-cost, low-tech risk management tool significantly decreased mortality and morbidity associated with surgery. It has been estimated that approximately one-half of all Operating Room complications are preventable. The annual cost savings from the prevention of major complications in the United States has been anticipated to be between $15 billion and $25 billion per year. Encouraged by these figures, the Institute for Healthcare Improvement (IHI) and WHO initiated the “Sprint” challenge: To have every hospital in the country utilize the surgical safety checklist with at least one surgical team by April 1, 2009.

The WHO surgical safety checklist procedure requires an oral verification process in the Operating Room by the patient, surgeon, circulating nurse, anesthesiologist, and all other members of the surgical team. The process occurs at three distinct phases: before induction of anesthesia, before the skin incision is made, and before the patient leaves the Operating Room. The critical items confirmed during each phase of the checklist process are to be documented in tick boxes provided on the form, which includes verification of the correct patient, correct procedure, correct site, patient allergies, estimated blood loss, prophylactic antibiotic administration, all instruments, needles and surgical sponges are accounted for, and specimens are properly labeled for the laboratory.

Sounds efficient, effective and easy, but those of us who have actually been there know better than to consider this checklist the only key to avoiding negligence in this venue. Critical barriers to widespread adoption of the surgical checklist can include physician attitudes as well as a lack of appropriate surgical team implementation measures. In fact, successful implementation will require a monumental culture change in many Operating Rooms. Highly-trained surgeons, anesthesiologists, and surgical staff members take justifiable pride in the quality of care they provide and high standards they follow in their clinical practice. However, it is essential for the entire Operating Room culture to support and expect that compliance with a standardized surgical checklist is for the best interest of the patient and not a questioning of individual competency. Realistically, a leveling of the surgical team hierarchy must occur along with a positive commitment to the process - every time for every patient. The structured oral format by the entire surgical team of reviewing and verifying the surgical plan of care needs to transpire as routinely as the pre-flight aviation checklist pilots complete prior to take-off. The time required to accomplish the three-stage verification process would be minimal, but it would require some significant changes in routine to entirely incorporate it into the work flow of most Operating Rooms.

An additional consideration is the actual documentation of the checklist that is performed for each surgical procedure. As an experienced Operating Room nurse and manager, I have seen patients sign incorrect surgical consent forms and allow themselves to be incorrectly marked for the planned procedure, observed surgical staff refusing to perform the required double-verifications of sponge, needle, and instrument counts, found nurses documenting patient safety measures that were not actually performed, and discovered surgeons injecting medications that were not labeled on the sterile surgical field. As part of the patient’s chart, will evidence of the checklist work for or against a plaintiff/defendant’s case?

The creation and promotion of the checklist is supported by the Association of periOperative Registered Nurses (AORN) and the Joint Commission (several of the items are consistent with its current required protocol). Ireland, Jordan, the United Kingdom and the Philippines have already established nationwide programs to accelerate implementation of the surgical checklist.

Ideally, these changes in procedure will bring about broader changes in clinical performance and standards of care that will optimize patient safety. Bad things can happen even when no malpractice or negligence is involved, of course. But to paraphrase James Reason, a world expert on human error, this surgical checklist can be an opportunity to transform “human as hazard” to “human as hero.” We shall see and time will tell.

Stephanie Johannsen, RN, BSN, MSHA, CLNC, has over 20 years of experience in the health care industry. Her expertise includes the areas of hospital administration, managed care at HMO’s and insurance companies, drug and device clinical trials, FDA drug and device recalls, and over 10 years of experience as a perioperative registered nurse and OR manager. For more information and/or comprehensive expert service with your next medical-related case, contact: Johannsen Legal Nurse Consultants, 619-876-2371, snjohannsen@aol.com.

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