To reduce errors, focus on procedures, not casting blame
To reduce errors, focus on procedures, not casting blame
By Pearl S. Schaikewitz, JD, Legal Consultant, Dunwoody, GA.
As in any endeavor, human errors occur in medical practice, and these errors all too frequently lead to grievous consequences for patients. The wrong side of the brain is operated upon. The wrong leg is amputated. A fatal drug overdose is administered. Intravenous fluid is infused into a central line before its proper position is confirmed. In the past, the common response to such mistakes was to look for an individual to blame. Now, physicians, risk managers, and other health care experts are examining the root causes of these errors, attempting to develop systems, protocols, policies, and procedures that will detect these errors before a patient is injured.
Editor’s note: Human error is, of course, unavoidable. This is as true in medicine as it is in any other endeavor. Physicians who think this is not so should review the 1991 Harvard Medical Practice Study results.1 In this study, approximately 30,000 randomly selected records of patients hospitalized in the state of New York during 1984 were reviewed. The study found that approximately 1% of the hospitalizations involved adverse events caused by negligence. The researchers estimated that, during 1984, negligent care provided in New York state hospitals was responsible for 27,179 injuries, including approximately 6,895 deaths and 877 instances of "permanent and total disability."
This shift in outlook is reflected in the Sentinel Event policy established by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).2 JCAHO defines a Sentinel Event as "an unexpected occurrence or variation involving death or serious physical or psychological injury [specifically including loss of limb or function], or the risk thereof."3 Sentinel Events are reviewable, and hospitals are given an incentive to self-report limited confidentiality as to the details of the actual event. Hospitals that have a Sentinel Event are expected to complete a "root cause analysis" within 30 days, which is designed to identify the basic factors that caused the adverse outcome. Rather than seeking to assign blame to individual staff members, the stated goal is to identify potential improvements in processes or systems that could lessen the likelihood of such events in the future.4
Editor’s note: JCAHO and its Sentinel Event Policy were discussed in detail in October 1999 issue of ED Legal Letter.
The change in focus was intended to improve the quality of patient care, says Denise Bisaillon, EdD, director of training and development for the Risk Management Foundation of the Harvard Medical Institutions ("Foundation"). The Foundation’s goal is to attempt to study, quantify, and improve patient care. A report written in 1993 by Lucian L. Leape, MD, adjunct professor of health policy at the Harvard School of Public Health, found that 1 million preventable injuries and 120,000 preventable deaths occurred in hospitals across the United States in a single year. Leape says that the health care industry can devise new equipment, change existing equipment, or devise new policies, procedures, and systems to reduce the consequences of human error in health care. The principle is to develop systems and processes to make it virtually impossible for certain types of human error to go undetected and, therefore, to result in injury.
"Research shows that fewer mishaps occur when hospitals shift from a blame-oriented culture to one that seeks to design systems that will prevent future mistakes," says Bisaillon. "We look at how to set up structures to prevent the errors from occurring again."
Emergency Department Quality Study
Another key player in the movement toward redesigning systems to improve the quality of care is Troyen Brennan, MD, JD, MPH, professor of medicine at Harvard Medical School and professor of law and medicine at the Harvard School of Public Health. Brennan was the principal investigator for an emergency department quality study the Foundation conducted from 1993 through 1996.5 Six hospitals participated, and six diagnoses were targeted for improvement: chest pain, asthma, abdominal pain, hand lacerations, vaginal bleeding in the first trimester, and head trauma. Several hundred patients were interviewed and conformance with clinical guidelines was assessed. Each emergency department created its own interventions. For example, one hospital developed a new triage process. Another evaluated and changed its ambulance usage. A third renovated its space and increased its interpreter services. One hospital changed completely to electronic medical records. Another emergency department instituted repeat exams for head trauma for patients who stayed for more than 90 minutes in a waiting room.
The study found improved conformance with clinical practice guidelines after the various interventions were implemented. For instance, conformance with clinical guidelines requiring the timely completion of thrombolysis in acute myocardial infarction improved from 70% to 100%.
Changing Our Expectations of Caregivers
Bisaillon points out that the aviation industry and the military have successfully utilized error causation analysis in an effort to reduce the consequences of human error. Stephen Trosty, JD, MHA, risk management specialist for the Alternative Risk Transfer Division of Mutual Insurance Corporation of America (MICOA) in East Lansing, MI, believes it is time the health care industry subscribed to this framework as well: "We need to change our expectations of care givers. An airplane is not deemed ready for takeoff until the pilot and copilot accomplish all the tasks on a checklist. Both pilots are required to verify that each item on the [check]list has been done. The list is written because the pilots realize it would be extremely difficult to remember each item every time they take off. Yet there are no checklists for surgery, which is incredibly complex. Why not? So many things must be done before an operation. We need to orient ourselves to the mentality that surgeons and nurses should not have to memorize all of the steps. Why is patient safety in a hospital any less critical than passenger safety in an airplane?"
Trosty also notes that pilots, unlike surgeons, are required to take a certain number of hours off between flights: "If it isn’t safe to fly a plane without sleep, why is it safe to perform surgery? We know that the reflexes and senses are significantly diminished by lack of sleep. Yet [the medical] profession thinks nothing of permitting surgeons to operate after having been awake for as much as 36 or 48 hours."
Education in the New Millennium
Bisaillon adds that the military has long used simulation in its aviation training. Harvard is now following suit in medicine on an investigational basis. "Simulation involves recreating actual cases or compilations of cases. A mannequin is hooked up to a sophisticated computer and receives data to simulate a real patient. As the event unfolds, the medical team is observed to see whether they share information that comes in, as well as how the leadership develops in that team. We get a real sense of what is going on in the OR."
The simulation is videotaped, and physician educators review the tape with the team. "People are profoundly moved by the experience. They appreciate getting feedback in a safe environment," Bisaillon says. She explains that Harvard has already done this with anesthesia teams, and is preparing to do so with emergency department teams. The researchers will attempt to determine whether the staff’s interactions are different after simulation training.
One process they intend to study is how a technician communicates a lab report to the attending physician, according to Bisaillon. They will observe whether the technician is too overwhelmed or intimidated to interrupt the attending physician to pass along the information.
An $18.7 Million Error
A misstep in the transmission of a radiology report had disastrous consequences in a case involving a woman who suffered cardiac arrest and profound brain damage because IV fluid was infused into a misplaced central venous line.6 The patient underwent an exploratory laparotomy in May 1996 to investigate the etiology of her abdominal pain. Prior to, or during, the surgical procedure, the anesthesiologist inserted a central venous catheter, apparently inadvertently extending the tip through the right atrium. A chest x-ray, revealing the catheter tip’s misplacement, had been taken within 30 minutes of the insertion of the catheter. Hospital procedure required that the radiologist read the x-ray on a stat basis and report the results to the patient’s nurse who was, in turn, supposed to contact the appropriate physician to, if necessary, adjust the catheter position. In addition, hospital protocol prohibited the nurses from infusing fluids through the central line until they had verified that the line was correctly placed.
Unfortunately, the infusion of fluids was apparently begun with the catheter tip in the patient’s pericardial sac. Either the x-ray was not read, the report was not properly given to the nurse, or the nurse received the report but did not call the physician. Whatever the cause, or causes, the infusion was begun prematurely and it was not until the patient’s blood pressure had dropped that the catheter tip was eventually pulled back. Three hours later, the patient suffered a cardiac arrest. An echocardiogram, performed during the resuscitation, showed a pericardial effusion causing pericardial tamponade. A pericardiocentesis revealed fluid consistent with the intravenous fluid that had been infusing. The cardiac arrest caused severe brain damage and the patient required around-the-clock care. The plaintiff won a verdict in excess of $17.7 million. In addition, during jury deliberations, a settlement was reached with one of the physicians for the malpractice policy limit of $1 million. The total recovery was $18,774,000.
Lana N. Bracewell, RN, risk manager for Largo Medical Center in Largo, FL, questioned the hospital’s policy requiring radiology technicians to call the nurses with radiology reports. "Why would the results be called in to the nurses when the facility already had a protocol in place that required a doctor’s intervention? When the nurse received the information, policy required her to notify the surgeon, who was supposed to come in and reposition the line. If the policy were changed to require the radiologist to call the physician, the hospital would have avoided the question of whether the nurse received a call and notified the doctor. Adding the extra step seemed to create opportunities for human error."
On-Call Specialists and Discharge Instructions
One recurrent problem in emergency departments is persuading on-call specialists to come in and see patients, Trosty says. "The increase in managed care and prepaid plans has created this situation. On-call specialists are increasingly reluctant to come in because managed care plans are refusing to pay them. The plans often decide [in retrospect] that the patient did not have an emergency and could have waited a few days to see a specialist."
Those delays are having disastrous effects, and in some cases, leading to numerous lawsuits, according to Trosty. The American and California medical associations are conducting focus groups to try and determine a course of action to resolve this issue. Trosty also notes that many hospitals have medical staff bylaws, rules, and regulations governing staff privileges which require on-call physicians to come in when called. "The problem is that most hospitals which have the rule do not enforce it. It’s difficult to make doctors come in when they aren’t getting paid for it."
Another important component of malpractice prevention is providing the patient with clear discharge instructions, adds Gregory L. Henry, MD, FACEP, past president of ACEP, chair of ASHRM’s Emergency Medicine Task Force, and clinical professor of emergency medicine at the University of Michigan in Ann Arbor. "Any discharge instructions which are not time and action specific do not help the patient," Henry points out. "What is the meaning of see your doctor if not better?’ Does that mean a month, or a year? If the instructions say see Dr. Smith in 24 hours for a re-exam,’ that’s pretty clear. If we do not specify a time and an action for follow-up care, then the patient is sent off into the medical wilderness." Instructions should specify a referral doctor with a phone number, Henry adds.
To illustrate his point, Henry relates a case involving a patient who went into renal failure three years after a trip to the emergency department. His blood pressure was elevated at the time of his emergency department visit. The patient sued the hospital because the physician did not tell him to have his blood pressure rechecked. The patient’s current physician maintains that if his blood pressure had been treated, he would not have developed renal failure. "The systems solution lies with the discharge instructions. They should say that any abnormal vital sign must be rechecked. Either repeat it in the ER or have the patient follow-up with his own physician. Nothing acutely has to be done about that elevated blood pressure [usually], but over time, it can lead to renal problems."
A case that illustrates the dilemma of the emergency department physician in securing the services of the on-call specialist is Cone v. National Emergency Services, Inc.7 The plaintiff was born on March 30, 1979, with an undescended testicle on the right side. This physical problem was first addressed on May 21, 1979, by Dr. Lee Gary Ensley, a Decatur, IL, urologist. Dr. Ensley took no action at that time, hoping that the testicle would descend naturally. He next saw the boy on April 11, 1980, at which time he thought he could feel the testicle high in the inguinal canal.
However, a year later, on April 13, 1981, Dr. Ensley could not palpate the testicle and decided to perform exploratory surgery. It was Dr. Ensley’s hope to locate the testicle and, if it was not atrophic, bring it down into the scrotum. That was not to be the case. He performed the surgery in July 1981, and the testicle was removed.
Over the next 10 years, the boy experienced intermittent pain in the abdomen and groin. On Sunday, Nov. 24, 1991, he awoke from a nap with a stomach ache and began vomiting. His mother sent him to bed, assuming that he had the flu. His symptoms worsened. At 2:45 a.m., his mother took him to the Bayne-Jones Army Community Hospital Emergency Room at Fort Polk, LA. He was seen by an emergency department physician provided by National Emergency Services (NES), pursuant to NES’s contract with the Army. It was determined that at least 8-9 hours had elapsed between the initial onset of symptoms and the emergency department visit.
During the exam, the physician was able to determine that the patient’s pain was coming from the boy’s remaining testicle on the left side. During the exam, the pain was so severe that the child allowed the physician to touch the testicle but not to manipulate it. After the exam, the physician asked the staff to contact the on-call urologist, who was found to be unavailable. He then asked for the on-call surgeon, who was also unavailable. Still concerned that he needed to consult with a urologist, the physician personally made calls to various regional hospitals in a fruitless attempt to find a urologist. The physician never informed the child’s parents that a specialist was required immediately. Nor did he advise them that he was looking for the on-call urologist.
The physician testified that the only two significant diagnoses in his differential, given his limited examination, were acute epididymitis and torsion of the testicle. Without a urology consultation, he opted to pursue treatment for acute epididymitis. He did not attempt to detorse the testicle manually, or otherwise address the possibility of torsion. When questioned concerning his instructions to the child’s parents, the physician said that he "may have" told the parents that they needed to return immediately the next morning to see the urologist, but he could not testify definitively that he had done so. Upon discharge he had prescribed antibiotics and analgesics.
When the child still could not walk normally on Tuesday, his mother called a urologist, who admitted him to a hospital and performed a testicular scan which suggested testicular torsion. The urologist took the child to the operating room immediately where he found that the testicle was torsed 120 degrees. Upon detorsion of the testicle, it appeared to regain color and perfusion.
Follow up visits in December and January indicated that the testicle would likely survive. Unfortunately, however, the testicle was found to be atrophying on April 27, 1992. A serum testosterone level test showed that the testicle was not producing testosterone and was no longer functional. As of the time of the trial, at the age of 18, the plaintiff was receiving biweekly testosterone replacement therapy by injection.
At trial, an emergency department physician testified that the defendant physician had breached the applicable standard of care by not adequately pursuing the possible diagnosis of testicular torsion. He testified that the physician should have ordered additional tests and immediately consulted with a urologist. The defendant physician did not "seriously dispute" that he erred in his diagnosis or that he had failed to inform the parents of the possible ramifications of testicular torsion.8 He also admitted that he did not tell the parents that time was essential in treating testicular torsion, believing at the time that the diagnosis was acute epididymitis.
The physician argued that his misdiagnosis did not cause any injury because the testicle had been fully torsed for 8-9 hours before he had examined the child. However, according to the urologist who performed the surgery, the testicle was only torsed 120 degrees, while full torsion is 540 degrees. In addition, the urologist testified that proper treatment would have been to attempt to manually reduce the torsion "to preserve a portion of the window of opportunity during preparation for surgery."9
The jury returned a $5.5 million verdict, assigning 90% of the fault to the physician and 10% to NES. The award was affirmed on appeal.
Commentary: The emergency physician made extensive efforts to consult with a urologist in the middle of the night, but this did not garner him any sympathy with the jury. Once he made the judgment that testicular torsion was possible, the standard of care required him to persist until he was successful.
Discharge Instructions: A Software Solution
Curtis Birchall, MD, who has been board certified in emergency medicine since 1977 and is president of Curtis Software, in Akron, Ohio, knows that the best discharge instructions are not written in the middle of the night. In addition to other computer programs that address various systems problems in emergency departments, he has developed computer-generated discharge instructions. "The sheet lists the patient’s name, physician, reasons for treatment in the emergency department, final diagnosis, and a preprogrammed set of instructions written at the eighth-grade level for every imaginable diagnosis. It clearly delineates the course the illness is expected to take, what the treatment should accomplish, and how to follow-up if the treatment is unsuccessful." Birchall believes the instructions he has developed have resulted in better patient education and a decrease in malpractice risk. "They make me feel better because I know I am giving coherent home-going instructions to these patients." The program has been utilized successfully in various Ohio hospitals since 1990, he says.
Tracking Patients Through the ED
Trosty points out another predicament that commonly plagues emergency departments — losing track of patients. "Large emergency departments are extremely busy places, and tracking patients is a growing concern. Time is a critical factor, and it is essential to make certain that patients receive treatment within a time frame required by the standard of care."
"The physician may be seeing 15 patients at once, and each patient may have three or four lab tests out. It is tough to monitor it all using a paper system with no cues built in as to when the lab tests come back. The patient may sit around for hours, perhaps with internal bleeding, or a heart attack, or some other preventable problem, while the physician did not know that the lab tests were back, indicating that the patient had a serious condition warranting admission," Birchall adds.
Trosty believes that Birchall has developed software that significantly enhances the ability to track and update the status of patients within the emergency department. Called the Proclaim S.T.A.T. (Systematic Triage and Tracking) System, it is designed to monitor and track the flow of patients and their treatment in the emergency department or a physician’s office, Birchall says. The program is in its final testing stages, and is expected to be released in the spring.
The software is used to enter orders and to display all the results of laboratory tests, medications, and treatments. Birchall describes how the system works when a patient arrives: "First, the patient is registered on the software. The patient is then triaged, and either left in a waiting area or placed into a treatment room, depending on the severity of the case. While in the triage area, the patient’s pertinent medical history is entered into the software, so that all of the practitioners can view the patient’s record. They access the system using their password."
Birchall adds that the patient’s allergies, current medications, and chief complaint are all viewable on the screen. The time the patient arrived is entered, and the practitioner can see how long the patient has been waiting. The practitioner initials the patient’s record to indicate that he or she is going to be that patient’s treating physician. The physician can then order medications and treatments, as well as dictate a history and physical directly into the system. Voice recognition technology is used, so using a keyboard or mouse is not necessary. The patient’s electronic record can then be sent either to a referring physician or a central data bank held in the emergency department, Birchall says. It could also be downloaded onto the hospital’s mainframe computer, if it has the capability of maintaining electronic records.
Tracking Laboratory Tests
Birchall’s software also addresses the problem of getting the correct results on the correct chart when the physician has ordered the same lab test on multiple patients. "The software documents when the test was ordered, the indication for ordering the test, and the test results. The program allows the laboratory to send the information directly to the electronic medical record. It requires the physician to acknowledge the fact that he [or she] has seen this lab result. A time and date stamp is placed on that physician acknowledgment as the laboratory report, EKG, or x-ray is interpreted."
The program accomplishes this by means of a series of different colors on the screen in blocks, similar to the blocks of color on a slot machine, Birchall says. "The patient’s name appears on the screen, and next to it are a series of blocks, one indicating lab, one indicating x-ray, and one indicating medication. When an order is placed, the three-letter initial, such as EKG or CBC, appears in a red block under the column labeled Lab’ next to the patient’s name. That red block changes to yellow once the lab acknowledges receipt of the order. When the result comes back, the block changes to a flashing green, indicating that the physician needs to take some action."
"Next, the physician touches acknowledge’ on the screen, the box stops flashing, and he [or she] can see the lab results. The physician can then dictate an interpretation of the lab results directly into the chart." With this system, the physician does not mistakenly discharge a patient before all of the labs, x-rays, and EKGs are back and interpreted, Birchall says. Contrast this with a paper system. "At the time of dictation and final patient disposition, one might find out that the last lab test, for instance, never came back, and the patient was sent home. If the patient had a heart condition, that one lab test may be the pivotal piece of information that may have warranted admission."
Editor’s note: The inadvertent discharge of patients before all ordered laboratory test results have been reviewed is a potential disaster. This software provides a method of avoiding this dangerous situation. For physicians who dictate their records, it is important to always dictate the record before the patient leaves the department. This gives the physician an opportunity to review all the test results and to ensure that all test results have been received.
Results Never Reviewed — A $724,800 verdict
In Fadle v. Mueller,10 a 60-year-old man presented to the emergency department on Oct. 8, 1995, at 12:20 a.m. with difficulty breathing, chest pain, and diarrhea. He had a history of Type II diabetes and hypertension. A nurse ordered and did an EKG, and the results showed T-wave inversions and possible ST-segment elevation. The EKG results were not placed in the patient’s chart, and the physician on duty never saw them or the EKG. A chest x-ray was taken, which the physician interpreted as showing a left-sided pneumonia. The radiologist, who reviewed the films the next morning, saw bilateral abnormalities suggesting congestive heart failure. This was reported to the emergency department before noon that day. The physician on duty, not the original physician, disagreed with the radiologist’s interpretation. After reviewing the original physician’s notes, without personally examining the patient, he concurred with the original emergency physician’s assessment that the patient had pneumonia and could be treated on an outpatient basis. Like the first emergency physician, he did not see the EKG or its report. The patient collapsed and died in the parking lot of his apartment building less than 24 hours after he was discharged. The first physician testified that he did not know who had ordered the EKG, and he didn’t think the patient needed one when he came in. Both physicians were found negligent, and the patient’s estate was awarded $724,800.
Commentary: Birchall thinks his software’s visual cueing system can reduce the risk of this type of human error. "A flashing green block on the computer screen with EKG’ in it is difficult to ignore. And the patient cannot be discharged from the system until all the flashing green boxes have been dealt with and acknowledged. Moreover, EKGs can be electronically entered into, and retained by, the software. It is just a matter of docking the EKG machine to the software port, and downloading the EKG into the software. If downloading the results is a routine function of the emergency department nurse, then the physician has no recourse but to push the button and look at the EKG. The patient cannot be discharged until all of the boxes are solid green, indicating that all of the tests have been completed, come back, and acknowledged by the physician, with a time and date stamp."
Editor’s note: It is crucial that the results of every ancillary study ordered be reviewed before the patient leaves the department. This includes tests, like the EKG in the case summarized above, that are "ordered" and done by nurses or ancillary personnel. A necessary exception is laboratory results which are not reported on a STAT basis. In those cases, a meticulous follow-up process must be designed that will ensure that, when these results are returned, they are reviewed and appropriately acted upon.
X-rays Never Viewed
Another system concern arises with x-rays taken in the emergency department, Henry points out. He recalls a case involving a woman who hit her chest in an automobile accident. "The emergency room physician examined the film and did not see much. The radiologist thought he might have spotted a little infiltrate, but there were no broken ribs and no pneumothorax. From a trauma standpoint, the film was normal. The ER physician sent it to the family doctor, who put it in the patient’s chart without looking at it."
Two years later the patient developed lung cancer. The thoracic surgeon reviewed the old film and concluded that the carcinoma had been visible two years earlier. "How did the chest x-ray report get filed with no one looking at it? Before a report is filed in a patient’s chart, all positive results should be put on the physician’s desk, and he [or she] should be required to initial them. This report was not initialed; it was merely filed in the chart. We do not know what the physician would have done with an infiltrate, but normally, you would let the patient know that an abnormality appeared on the x-ray and you need to reread it."
Editor’s note: Similar cases were discussed in the July 1999 issue of ED Legal Letter.
High-Risk Complaints
Birchall says that another feature of the software is to flag high-risk complaints or symptom/sign combinations. "For example, a headache, temperature, and stiff neck are often associated with meningitis, which is frequently a litigation-producing complaint. The system can be configured so that when this chief complaint is entered, it will flash. The system can suggest a therapy, diagnostic tests, and a course of treatment. Similarly, cues for the physician can come up in the dictation template, indicating that perhaps certain tests might be warranted." These cues are not entered into the patient’s record; they merely appear as reminders to the physician. In the case of a patient who presents with chest pain, the system might ask whether the enzymes came back negative, or whether two EKGs were performed. It might ask whether the patient was admitted, or whether adequate follow-up was successfully put together for the patient, Birchall says.
Medication Errors
Medication errors present another enormous problem for emergency departments and hospitals. Cases involving fatal iatrogenic overdoses frequently make headlines, as exemplified by a 1997 New York Times Magazine article about the death of a 2-month-old boy at a Houston hospital on Aug. 2, 1996. As the article indicates, the infant’s parents brought him to the hospital’s outpatient clinic for a checkup.11 Physicians detected a ventricular septal defect and early signs of congestive heart failure. According to the doctors, his long-term prognosis was good. The physicians informed the parents that either the defect would likely correct itself, or surgery could be performed in about a year.
Because of the early signs of congestive heart failure, admission was advised to start the infant on digoxin. The attending physician discussed the digoxin dose with the resident and the appropriate dose was calculated in micrograms and then converted to milligrams. After calculating the dose together, and double-checking their math, they determined that the proper dose was 0.09 milligrams of intravenous digoxin. The resident then wrote the order. Unfortunately, "[w]ith a slip of the pen that would prove fatal, the resident ordered 0.9 milligrams of digoxin rather than 0.09.12 The fatal cascade of errors was thereby set in motion.
The attending physician scanned the list of orders written by the resident and did not detect the error. A copy was faxed to the pharmacy. The pharmacist on duty questioned the dosage and paged the resident and then "put the order on top of the pharmacy’s coffeepot, site of the unofficial important’ pile." Unbeknownst to the pharmacist, the resident had left for the day and never received the page. Later, the pharmacy received a backup copy of the order, and this time a technician filled it as written. The technician then set the order and the vial containing exactly 0.9 milligrams of digoxin on the counter for the pharmacist to double-check. The pharmacist "double-checked" the technician’s work by verifying that the dosage on the prescription matched the dosage in the vial. Unfortunately, the pharmacist did not remember questioning the dosage earlier, and the medication was sent to the pediatric unit.
When a floor nurse read the dosage on the vial, she thought it was incorrect and asked an on-call resident to check it. "The resident took out a calculator, redid the math and came up with .09, the correct dose. Looking from the calculator to the vial, the resident saw a 0’ and 9’ on both and did not notice the difference in the decimal point.
The nurse then asked a second nurse to verify that the order in the chart was the same as the label on the vial. It, of course, was. "At 9:35 p.m., a troubled nurse gave Jose Martinez a dose of Digoxin that was 10 times what was intended." Less than 30 minutes later, while drinking a bottle, the child began to vomit. The nurse immediately called for Digibind, but it was too late to save the infant.
Editor’s note: I recommend this article to all readers. In analyzing the causes of this tragedy, the author describes the combination of multiple errors that had to occur for this medication error to go undetected. As in many, if not most cases like this, a single error is not the cause of the catastrophe. Rather, a number of errors must occur in combination. The solution lies in developing processes that will detect human error when it occurs, so as to prevent the adverse consequences to the patient.
Another incident mentioned in The New York Times article involved Betsy Lehman, a 39-year-old mother of two and a health columnist for The Boston Globe who died on Dec. 3, 1994, at the Dana Farber Cancer Institute in Boston ("Institute").13 Ms. Lehman was a patient, enrolled in an experimental breast cancer treatment protocol that was designed to test the efficacy and safety of high doses of cyclophosphamide. She was admitted for her third round of chemotherapy on Nov. 14. On that day, the third-year clinical fellow responsible for her treatment, who had been on the service only two weeks, wrote down the incorrect dosage. The proper protocol dose was 4000 mg/m2 (a total dose of 6520 mg), to be infused over four days a daily dose of 1630 mg. Instead, the order was written as a daily dose of 4000 mg/m2 (i.e., four times the planned dosage). The pharmacists, who were supposed to compare the drug order to the research protocol, did not identify the unusually high dose as an error.14 The drug was also administered to another patient, who suffered severe toxicity, but survived.
On Feb. 13, 1995, an assistant data manager at the Institute discovered the error as she entered data from the trial into a computer. The Institute suspended the clinical privileges of two of the treating physicians and placed them on administrative duty. Two committee investigations into the matter found structural deficiencies in the Institute’s requirements for research protocols, in its clinical procedures, in its pharmacy’s procedures and technology, and in its quality assurance program. The Institute took extensive corrective actions, including revising and expanding its quality improvement program; instituting and intensifying executive leadership training; and instituting an interdisciplinary, collaborative approach to quality improvement.15
Commentary: Medication errors can result from a variety of problems: miscalculation of dosage, storing containers that look alike too near each other, insufficient nurse training, and calibrating a machine incorrectly, etc. Trosty offers suggestions for reducing error: "Pharmaceutical companies can be asked not to assign similar names to medications and to regulate the shapes or colors of containers. That makes it more difficult to mix up the medications. Moreover, the trend in the administration of medication is toward the use of self-regulating mechanisms. Equipment can be designed in a way that will make it almost impossible for certain types of errors to occur. Machines can be set and calibrated to provide the medication in certain time frames, and to be compatible only with the use of specific medications or classes of medication."
Trosty adds that many chemotherapeutic drugs and agents have a higher toxicity level, and a higher potential to cause adverse side effects than other drugs. For example, some of them can cause significant burning or sloughing if they touch the patient’s skin. The staff who administer them need to be appropriately trained and educated.
Birchall’s software addresses the dreaded double dosing problem, he says. "When medications are administered, the practitioner documents the time, the dosage, route of administration, the reason for the medication, and the patient’s response. Once the nurse places her initials on the medication order, it is held as pending until it is completed, and no one else can touch it."
Heed Seemingly Minor Incidents
Schopp v. Our Lady of the Lake Hospital, Inc. involved the potential consequences of failing to follow-up on seemingly minor incidents.16 At 3:30 a.m. on Aug. 2, 1993, a 75-year-old arthritic woman stumbled and fell in her bathroom during the night, hitting the right side of her head. She could not get up and lay on the floor until 8 a.m., when her home health aide arrived. An ambulance was summoned, and the woman was taken to the hospital. The emergency room physician on duty found her to be awake and alert but in significant pain, primarily from a bruise to her left elbow. She also had a bruise around her right eye. The physician ordered x-rays of her elbow and skull. The x-rays were negative, but after consulting with her internist, the physician admitted her for overnight observation. Soon afterward, an x-ray technician came to the physician "kind of scared" and stated that she and another technician had "dropped a plate" on the patient’s face while taking the skull x-ray. She was aware she should file an incident report in response to such an event.
The second technician testified that he was adjusting the x-ray tube while the first technician was positioning the cassette and the patient’s head. He saw the cassette begin to fall and caught it at the same time it hit the patient’s head. He said that the cassette "barely tapped her on the head." The first technician testified that she aligned the patient’s head while the other technician centered the cassette and she did not see the cassette fall. The technicians stated that the cartridge fell only about 2 mm. The second technician testified that when he took the patient back to the ER, he told the patient’s friend that the cartridge had "bumped" the patient, and that the patient and her friend should tell the physician if she had any pain. The patient told friends who had accompanied her to the emergency department that the technicians had been "cutting up" when the female technician let the cartridge slip, a claim denied by the technicians. At this time, one of the patient’s friends observed an ecchymosis on the left side of the patient’s forehead. Apparently no one told the emergency physician about the ecchymosis.
The day after the patient was admitted, her internist received a "panic call" from an "absolutely terrified" nurse. She told the internist about the x-ray incident, and related that the patient had an injury to the head and an excruciating headache. The internist ordered a CT scan and went to see the patient about an hour later. She showed him where the cartridge had hit her and he noted swelling and edema in the area. The CT scan revealed a large subdural hematoma, located precisely where the patient said the cartridge had hit her. A craniotomy was performed to evacuate the hema-toma, but the patient died on Aug. 16.
The patient’s two sons sued the hospital, alleging negligence by the technicians caused their mother’s death. The hospital denied the allegation, claiming that the patient’s fall at home had caused the hematoma that led to her death. The neurosurgeon who evacuated the hematoma, who was also the hospital’s chief of staff, supported the hospital’s position, opining that the patient had sustained a contrecoup injury. He believed that the cartridge would have had to have been dropped from the ceiling to cause the sizable hematoma the patient had. Another neurosurgeon testified that to create enough force to cause the hematoma, the cassette would have to have fallen at least a meter. Despite this expert testimony for the defense, the jury found for the plaintiffs, awarding damages for pain and suffering plus $100,000 to the sons. The verdict was affirmed on appeal.
Commentary: An incident report and investigation were clearly in order here, especially in light of the fact that the technicians gave contradictory accounts of the incident, both of which were contradicted by the patient’s account to her friends. Filing an incident report allows the risk management department to get a better sense of what transpired and to identify the issues that need to be addressed from a quality or risk perspective. Another reason for filing incident reports is that, if this type of event happens often enough and could potentially be prevented by a design modification, organizations such as the National Patient Safety Foundation can bring it to the manufacturer’s attention with an eye toward redesigning the system to reduce the possibility of future incidents.
The court’s recap of the evidence implied that the second technician may have feared negative repercussions from filling out an incident report. Staff members need to be educated to understand the concept that an incident report is not a punitive measure and will not be viewed as such (and the hospital needs to follow through and treat incident reports in that manner). The decision to fill out an incident report should not be made by a consensus of the staff involved. Rather, if any one employee believes one is necessary, it should be completed.
It is also important to note that when two employees of the defendant give conflicting testimony at trial, as was the situation in this case, the defendant may lose all credibility and the jury is much more likely to adopt the plaintiff’s version of the facts.
Another concern in this case is that, by failing to immediately inform the emergency physician of the mishap, the technicians may have significantly reduced the chances for a positive intervention. The emergency physician might have re-examined the patient, ordered a CT scan, or ordered closer observation, possibly preventing the unfortunate outcome.
Policies for Residents: A $7.5 Million Award
Another ongoing concern for hospitals involves residents who do not fully understand policies specifying when they must call in the attending physician or chief resident. One such case involved a young woman who was injured in a motor vehicle accident in May 1994.17 After emergency treatment at the scene, the unconscious patient was transported to the hospital by helicopter. She was admitted to the ICU and placed on a ventilator. Several days later, her attending physician, who was the director of surgical education, performed a tracheostomy. A third-year surgical resident performed the procedure under the attending’s supervision. A few days later, the patient began to bleed from the tracheostomy site. The resident examined her, but after running several tests, decided not to call the attending physician or chief resident for assistance. Within a few hours of his examination, the patient, who had a tracheoinnominate fistula, began to hemorrhage. This resulted in a cardiac arrest from which she ultimately was resuscitated. Unfortunately, she suffered permanent anoxic encephalopathy.
The patient’s parents sued the physicians and the hospitals. When the case was tried, all defendants had settled except the hospital that employed the resident. The jury found for the plaintiffs, holding the resident 85% liable and the nurse caring for the patient at the time 15% liable. The jury verdict was for $9.5 million, and judgment was ultimately entered against the hospital for $7.5 million. The court of appeals affirmed.
Commentary: In retrospect, one wonders whether this resident took on the management of a situation that was too complex for him to handle without assistance. If the hospital did not have in place policies indicating what circumstances required residents to consult with more senior residents or their attending, it should have. In addition, hospitals must ensure that all residents are aware of the policies and adhere to them.
Summary
As these cases point out, human error is possible in all facets of medical care: communication, clinical judgment, medication dosage, and administration, etc. As hospitals conduct systems and process analyses to determine the factors involved in those errors, they are learning that the mistakes rarely involve a single individual. More frequently it is a flaw in a system, process, protocol, or policy and procedure that ultimately causes the disaster. This realization will hopefully lead to the demise of the blame-oriented culture and an increased focus on education and prevention. A cooperative approach to handling adverse outcomes will continue to improve the quality of patient care, both in the emergency department and throughout the hospital.
References
1. Troyen A. Brennan et al., "Incidence of Adverse Events and Negligence in Hospitalized Patients," N Engl J Med 1991; 324 (6):370.
2. JCAHO, "Sentinel Event Policy and Procedures," revised Oct. 1, 1998.
3. Id.
4. Id.
5. Improving Quality Measures: Harvard ED Quality Study: Forum Commentary, Vol. 18, No. 2, July 1997, Risk Management Foundation of the Harvard Medical Institutions.
6. Jennison v. Providence St. Vincent’s Medical Center, Multnomah County (OR) District Court, Case No. 9701-00543 (1999).
7. 1999 WL 110860 (La.App. 3 Cir., No. 98-257) (March 3, 1999).
8. Id.
9. Id.
10. Arlington County (MD) Circuit Court, Case No. 97462 (1999).
11. Belkin L. Getting Past Blame: How Can We Save the Next Victim. The New York Times Magazine, June 15, 1997;28.
12. Id.
13. See also, Ayash v. Dana Farber Cancer Institute, 46 Mass.App. 384, 706 N.E.316 (1999) (corollary case).
14. Reaching New Heights: ASHRM 1999 Annual Conference and Exhibition; Session Materials, Book 1; 451-457, 473.
15. The New York Times Magazine, June 15, 1997;(6)34. Reaching New Heights: ASHRM 1999 Annual Conference and Exhibition Session Materials, Book 1; 451-457.
16. 1999 WL 486667 (La.App.) (1999).
17. St. Joseph Hospital v. Wolff, 1999 WL 644726 (Tex.App., 1999).
Physician CME Questions
5. Root cause analysis is designed to:
a. identify system causes of the Sentinel Event.
b. determine the culpability of individuals.
c. improve patient care.
d. both a and c are correct.
26. Discharge instructions should
a. be time specific (e.g., "Recheck if not completely better in two days.").
b. be action specific (e.g., "If pain recurs, return to emergency department.").
c. when appropriate (almost always), specify a referral doctor with his or her telephone number.
d. all of the above.
27. Software may be designed to:
a. track patients in the department.
b. alert physicians of high-risk combinations of symptoms.
c. alert physicians that an ancillary test has not been noted prior to discharge.
d. all of the above.
28. Incident reports are:
a. just bureaucratic paperwork.
b. important risk management tools.
c. necessary only if all individuals involved believe they are necessary.
d. none of the above.
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