A Practice Smart(TM) Feature
By: Daniel U. Smith and Valerie T. McGinty
Daniel U. Smith and Valerie T. McGinty, partners at Smith & McGinty, belong to Consumer Attorneys of California’s Amicus Committee. They represent consumers in post-trial motions, writs, and appeals. Mr. Smith is a Certified Appellate Specialist (State Bar Bd. Legal Specialization). For more information, visit www.plaintiffsappeals.com.
THE SURGICAL SAFETY CHECKLIST, launched in 2008 by the World Health Organization (WHO), is a crucial document in making the use of checklists the standard of care for surgeons. (World Health Org., Surgical Safety Checklist, http://www.safesurg.org/uploads/1/0/9/0/1090835/surgical_safety_checklist_ production.pdf.)
This checklist requires the surgical team to perform the following steps in three stages.
(1) Before anesthesia, a “time out” is required for the team to verbally confirm: the patient’s identity, the surgery site, the procedure, and patient consent; that the site is marked; that the anesthesia machine and medication check are complete; that the pulse oximeter is on the patient and functioning; whether the patient has an allergy, difficult airway, aspiration risk, or risk of blood loss greater than 500 ml.
(2) Before skin incision a “time out” is required to introduce the team members by name and role and to verbally confirm: the patient’s name, the procedure, and where the incision will be made; that antibiotic was given within the last sixty minutes; whether the procedure requires critical or non-routine steps; how long will the case take; anticipated blood loss; patient-specific concerns (to anesthesiologist);
sterility and equipment issues or other concerns (to nursing team); and that essential imaging is displayed.
(3) Before the patient leaves the operating room, a “time out” is required for the nurse to verbally confirm the name of the procedure, the count of instruments, sponges, and needles, and specimen labeling. The team addresses any equipment problems and determines key concerns for the patient’s recovery and management. Before the 2008 launch, WHO tested this surgical checklist in eight hospitals (rich and poor) around the world. This checklist reduced major complications by 36 percent, reduced deaths by 47 percent, reduced infections by almost half, and reduced the number of patients needing further surgery by 25 percent. (Gawande, p. 154.)
Yet, in 2009 only 10% of American hospitals utilized checklists. The majority of doctors and hospitals rely solely on the doctor in charge, believing that the doctors’ training and skills will prevent or correct mistakes without injury to the patient. Accordingly, in the absence of checklists, patients in the U.S. are needlessly exposed to avoidable medical errors that could be eliminated or reduced by the use of checklists.
Checklists Apply Current Medical Knowledge Uniformly
Checklists reduce errors and improve patient safety by applying current medical knowledge without requiring any increase in skill. (Gawande, p. 168.) Checklists thus solve the problem of “ineptitude” – “the knowledge exists, yet we fail to apply it correctly.” (Gawande, p. 8.) Checklists overcome the two most common reasons that providers fail to apply current medical knowledge.
First, some providers don’t learn the latest medical developments. Keeping up with some 700,000 medical journal articles yearly is not easy for busy medical practitioners. As a result, patients in the U.S. receive barely 50 percent of medically recommended therapies. (Pronovost, p. 55.) For example, antacids are known to reduce the ulcer risk from ventilation, yet a survey showed that one-half of one hospital’s ICU staff did not know this. (Gawande, p. 39.) Similarly, after research showed that the pneumococcus vaccine protects both children and adults from respiratory infections, it took doctors 17 years to provide the new treatment to half their patients. (Gawande, p. 133.) Checklists bring the standard of medical care into conformity with the latest medical knowledge by creating an up-to-date, “simple, usable, and systematic form.” (Gawande, p. 133.)
Second, some providers fail to consistently administer even those therapies they know and agree with. For example, though administering antibiotic within an hour of surgery greatly reduces the risk of infection, one hospital’s internal study showed that this recognized procedure was missed in one-third of cases. In these cases patients either got the antibiotic too soon, too late, or not at all. (Gawande, p. 98.) After a checklist was adopted and team members received authority to intervene until all checklist steps were completed, all patients got the right antibiotic at the right time. (Id., p. 100.)
Similarly, the safety steps for reducing central line infections are well known—wash hands with soap; clean the skin with antiseptic; drape the entire patient; wear mask, hat, sterile gown and gloves; and after the line is in, drape the site with a sterile dressing. Yet surveys show doctors skip at least one step 33 percent of the time. (Gawande, supra, 38.) After one hospital instituted a checklist and gave nurses authority to intervene if a doctor missed one of the steps, the ten-day line-infection rate went from 11 percent to zero, preventing eight deaths and saving $2 million in costs. (Id., p. 38-44.)
Again, using a checklist for patients on mechanical ventilators – to ensure antacid medication was administered to prevent stomach ulcers and the patient’s head was propped up 30 degrees – reduced pneumonias by 25 percent and 21 fewer patients died compared to the previous year. (Id., p. 39.)
The literature contains many other dramatic examples where checklists improved patient safety. (E.g., Alex B. Haynes et al., A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population, 360 New Eng. J. Med. 491 (2009) [surgical checklists reduced deaths of post-surgical patients by almost half]; Peter J. Pronovost et al., An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU, 355 New Eng. J. Med. 2725, 2726 (2006) [a five-step checklist caused catheter-related bloodstream infections to decrease by almost 66 percent, a decrease that was sustained over an eighteen-month period]; Eefje N. de Vries et al., Effect of a Comprehensive Surgical Safety System on Patient Outcomes, 363 New Eng. J. Med. 1928, 1928 (2010) [surgical checklist reduced post-surgical complications from 15.4 percent to 10.6 percent of patients and reduced in-hospital mortality from 1.5 percent to 0.8 percent].)
Medical Errors Kill 44,000 to 98,000 Yearly
The need for checklists is apparent from studies suggesting that national annual deaths from medical errors range from 44,000 to 98,000. (Linda T. Kohn, et al., To Err is Human: Building a Safer Health System, p. 1 (National Academy Press, 1999).) This national mortality rate from medical errors exceeds deaths from motor vehicle accidents (43,458), breast cancer (42,297) or AIDS (15,516). (See David Costa, Human Error: An Inevitable Part of Healthcare, or a Better Future?, Respiratory Therapy, June-July 2008, p. 9 [medical error is the eighth-leading cause of American deaths].)
A New York City study suggests that the national rate of medically-induced death rates equal three jumbo-jet crashes every other day. (Lucian L. Leape et al., Error in Medicine, 272 J. Am. Med. Ass’n 1851, 1851 (1994).)
A “Toxic Culture” Fosters Errors by Resisting Checklists
Avoidable medical errors persist because a “toxic culture” vests sole control for patient safety in the doctor, resisting the checklist that would require the entire care team to promote patient safety. (Pronovost, p. 41.) In this “toxic culture,” the supposed guarantee of patient safety is a highly-trained doctor with “the right stuff.” (Gawande, p. 161.) “Doctors often think they are infallible, communication between doctors and nurses is poor, and accountability is virtually nonexistent.” (Pronovost, p. 36.) Surgeons resist checklists, according to Dr. Pronovost, in the false belief that “we don’t make mistakes.” (Id., p. 53.)
In this toxic culture where the surgeon exercises total control, other members of the care team with valuable knowledge and suggestions for patient safety are ignored or intimidated into silence. Indeed, one study of significant liability claims and errors showed that in nearly 90 percent of cases, one member of the care team knew something was wrong but either kept silent or was ignored. (Id., p. 81.)
That this toxic culture resists standardized solutions such as checklists is exemplified by one surgeon’s admission that “[s]urgeons … rely on themselves for success or failure. They are the captains of their ships. They do not need or want to rely on … another person ….” (P. Ruggieri, “Confessions of a Surgeon” (2012) p. 9.) “I am a surgeon. I am all-powerful. I can do anything ….” (Id., p. 116.) “The operating room is a sacred place, where I rule and have sovereign power.” (Id., p. 122.) “I want to be in total control of events during an operation, relying, if possible, only on myself.” (Id., p. 140-141.)
This toxic culture breeds errors. For example, when a surgical patient developed a potentially fatal allergic reaction to the surgeon’s latex gloves, the surgeon repeatedly rejected the anesthesiologist’s multiple requests to change his gloves until the hospital president was called. (Pronovost, p. 73-77.) Similarly, when an ICU nurse told a surgeon that his post-op patient could not safely be transferred to an overwhelmed ICU, the nurse was berated by the surgeon and the administration. (Id., p. 86-88.) Also, though shaving of surgical sites breaks the skin barrier and so encourages infection, some surgeons refuse to abandon the now-forbidden practice, smuggling their own razors into the surgical suite. (Id., p. 70-72.)
As these examples show, some doctors fear that using checklists will limit their freedom and control. Indeed, Dr. Ruggieri admitted his negative reaction to the surgery checklist’s first “time out.” When the team verbally verified who the patient is, who the surgeon is, what procedure was – e.g., thoracotomy (an open-chest procedure with a huge front-to-back wound) or thoracoscopy (videoscope procedure requiring a quarter-inch incision) (Gawande, p. 109) – and on what side of the patient, Dr. Ruggieri “compl[ied] with it because I have no choice. … I have reluctantly embraced the team concept [because] I have no choice. Deep down, my raw instincts as a surgeon do not embrace being on a team. … I went into surgery so I could rely on my own instincts and skills, not the team’s. As a surgeon, I consider myself a loner. … I do not look kindly on putting my patient’s life in the hands of a ‘team.’” (Ruggieri, p. 250, emphasis added.)
Attorneys suing doctors and hospitals will want to investigate whether the defendant doctor(s) or hospital suffered from this “toxic culture” that resists the use of checklists.
Checklists have become the standard of care due to their effectiveness in reducing medical errors and improving patient safety without requiring any increase in skill. Hence, plaintiffs’ attorneys should direct discovery and their evidence at trial to proving that a substantial factor in causing the plaintiffs’ injury was the defendants’ negligent failure to use a checklist.
© 2012 Consumer Attorneys of California. Reprinted with permission from CAOC Forum magazine, May/June 2012.
The information in this article is provide for informational purposes only and with the understanding that the author is not engaged in rendering legal, accounting, tax or other professional advice or services. The discussion is not intended as legal advice and cannot be relied on for any purpose without independent research and the services of a qualified professional.
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