1. Medical and/or System Error
Wrong Medication Prescription—No Injury
Mr. Brown, a 65-year-old retired professor, had been seeing his internal medicine physician for control of his hypertension for the past five years. He had historically been prescribed Norvasc, but his BP readings were consistently around 140/92. His internist decided to prescribe Lotrel to see if Mr. Brown’s hypertension would be better controlled. He wrote the prescription and asked Mr. Brown to return for a follow-up appointment in a month. As the physician reviewed Mr. Brown’s chart the evening of the appointment, he realized that he had written a prescription for Norvasc—not Lotrel.
“Mr. Brown, I realized that I wrote a prescription for the same medication you have been on for several years. As I explained, I wanted to try something different to see if we can better control your blood pressure. So, I will call in the correct prescription. Just tell me which pharmacy you are going to.”
The physician decided that since Mr. Brown had been on this medication for years and nothing bad had happened, he would just wait to see the patient at his next appointment. And, frankly, it was not a big deal; the patient was very well educated and should be able to figure out the prescription was wrong. This was really an example of no disclosure needed at all.
Wrong Immunization Administered to Child in Physician Office
Reprinted with permission of AHRQ WebM&M: Gallagher TH, Levinson W. The wrong shot: error disclosure. AHRQ WebM&M (online journal: http://webmm.ahrq.gov). June 2004. Available at: www.webmm.ahrq.gov/case.aspx?caseID=64.
A 10-year-old child from India presented to his pediatrician’s office for a school physical. The child had no past medical history, was in excellent health, and all immunizations were up to date with the exception of hepatitis B. The physician discussed the issues around vaccination with the patient’s father and obtained consent. The nurse drew up the vaccine and the physician administered it. After administration, the physician went to record the lot number and discovered that a dose of vaccine for hepatitis A had been given instead of hepatitis B.
Without hesitation, the physician informed the father that the wrong vaccine had mistakenly been given to the boy. He explained the usual indications for hepatitis A vaccination and emphasized that this vaccine would not bring any harm to the boy and may even protect him from illness in the future. He suggested that the boy still receive the hepatitis B vaccine.
The father became extremely angry. He refused to allow further vaccination and proceeded to report the incident to the clinic administrator.
The father might have been less angry had he learned that, as a result of this error, such vaccines were now being stored in separate and clearly labeled spots in the physician’s office. Furthermore, the need to tell the family about an error’s cause and prevention may stimulate the physician to think more critically about why the error happened and to develop a robust prevention plan, thereby enhancing the quality of future care. Determining exactly how an error happened and formulating a plan for preventing recurrences can be especially challenging in the outpatient setting, where the resources to conduct formal error analyses may be absent.
To illustrate effective and ineffective disclosure communications, The Doctors Company has added the following examples to this case.
The physician asked himself, “Why say anything? No one will ever know; I will get him back in the office within the next few weeks for a ‘booster.’”
The physician stated, “Don’t worry—this is really not a big deal. But I have to tell you—you can’t even trust your nurse these days!”
Failure to Monitor Gentamicin Levels
After several weeks of taking gentamicin prescribed for endocarditis, a 37-year-old house painter returned to his family practice physician complaining of dizziness and hearing loss. The physician quickly realized that she intended to order lab work to check peak and trough levels of the antibiotic when her patient returned for his post-hospital check two days after hospital discharge. The patient’s appointment was canceled and rescheduled twice, first due to the physician’s schedule conflicts and then due to the patient’s request. As a result of the schedule changes, her patient may now have gentamicin toxicity and could suffer permanent hearing loss and vestibular dysfunction.
“Mr. Gray, in looking over your chart I realized that I never got the blood work to monitor the antibiotic, and I’m concerned that your dizziness and hearing loss are signs of toxic levels. We’ll stop the medication now, and I need to have you report to the lab immediately so we can check your blood levels. We’ll also need to do some additional testing today. I will look into why this testing didn’t happen as it should have, and we’ll have a chance to talk about that at your next visit. Right now we need to get a handle on your dizziness and hearing loss.”
“Mr. Gray, if you hadn’t moved your last appointment, we could have gotten the blood work in time. Now I’m worried that you could have permanent hearing loss and dizziness due to drug toxicity.”
Error During Breast Augmentation Surgery
A patient from State A presented for breast augmentation with a plastic surgeon in State B. She was self-employed with no insurance and pre-paid all fees. The procedure was completed without incident, and the patient returned to her home state. Two days after the procedure, the surgical nurse notified the surgeon that the saline implants purchased by the patient were not implanted. Rather, the “sample” implants, which are utilized during surgery to determine the proper level and size for the final implants, were not removed at the time of the surgery. The actual implants were discovered in the surgical suite. Though not optimal, the sample implants can remain in the patient indefinitely if needed. The patient had not yet been notified of the event. Furthermore, at the time of the surgery, the patient expressed her need to return to work right away.
“I failed to place the final/permanent implants during your surgery. The nurse notified me two days after your surgery that I left the sample implants in. I’m sorry you have to go through this, and this is what I suggest....” (Continue with a discussion of her choices with risks, benefits, and alternatives clearly discussed and documented.)
Nothing needed—no harm done. Why upset the patient?
“I need to tell you something that happened during surgery. The nurse called me a couple of days ago and admitted she failed to place the permanent implants on the surgical field where they were supposed to be. I’m sorry you have to go through this. I can take you back to surgery and make sure we have a different nurse there.”
“I just found out that the wrong implants were used during your surgery. It was some sort of mix-up at the hospital, and I think they’re straightening it out.”
Pediatric Case Communication Failure
A six-year-old female patient was injured in the face while playing in a soccer game. The parents of the child brought her to their pediatrician’s office that day. Since the pediatrician’s schedule was fully booked, the certified nurse practitioner (CNP) saw the patient. She diagnosed the child’s nose as broken and requiring surgery. She documented this in the record. This multispecialty pediatric office included a pediatric plastic surgeon who would perform the surgery. The parents were directed to the surgery scheduler within the office.
One week later, a local plastic surgeon called the pediatrician’s office to inform her that he had performed surgery on the patient and that the procedure was complicated, with a less than satisfactory result. The child would probably need more surgery. He went on to say that the parents had gone to the local Emergency Department (ED), and the hospital plastic surgeon had been consulted after they were offered a 10-day delayed surgery through the multispecialty office.
The pediatrician discussed the situation with her staff and discovered that, based on the CNP’s vague note, the surgery scheduler had scheduled the patient 10 days later as an elective case.
“Upon reviewing your daughter’s chart and investigating the matter, I determined that there was a delay in scheduling surgery. The surgery scheduler did not verify the urgency of the surgery, and I should have seen your daughter during the visit. I would like to see her as soon as possible to determine how best to proceed if you are comfortable with my doing so. I am sorry this happened.”
“Upon reviewing your daughter’s chart, I determined that there was a failure to communicate within my office, which caused a delay in scheduling the surgery. I will work with you to get the best result for your daughter.”
“I just cannot keep good help these days.”
“Your daughter can get her nose done when she is older and more appreciative.”
“Sometimes things happen. We will try to work things out.”
Failure to Follow Up on Incidental Radiology Findings
A 57-year-old real estate agent consulted her internal medicine physician for abdominal swelling. She had been seen for three clinic visits a year earlier due to right lower quadrant discomfort and had been referred to gynecology for consultation at that time. No reason for the discomfort had been identified, and the patient decided to “live with it.” Now, MRI results indicated metastatic disease involving multiple sites in the abdomen, with unknown primary. As she scanned through her patient’s prior chart notes, the physician found a pelvic radiology final report from the prior year that noted an incidental finding of a 2 cm opacity in the right lobe of the liver that could represent a benign hepatic cyst but additional radiology studies were recommended to rule out malignancy.
“Mrs. Teal, I know that you have had more bad news than anyone ought to hear in a day, but I have found something else I need to tell you about. When I looked through your office record just now, I found a radiology report from last year indicating a spot on your liver that should have prompted more tests to rule out cancer. No radiology reports are supposed to be filed in a chart unless I see them and write my initials on the report. This report does not have my initials, so our system here in the office didn’t work. I understand that you might feel very upset with me and my office and wish to transfer your care to another doctor. If you begin to feel that way, please let me know and I’ll do everything in my power to make the transfer as quick and smooth as possible. Please know that I am so sorry for what has happened. I want to do everything I can to help you and your family deal with this situation, and I hope you will let me do that.”
This was an incidental finding. I’m sure I got a verbal report that there were no pelvic abnormalities. How was I supposed to know about a final report with an incidental finding if my staff filed it away? Anyway, the gynecologist I referred her to should have requested and reviewed any reports. I’m not going to say anything and maybe the problem will never surface.
Wrong Dosage of Insulin
Reprinted with permission of AHRQ WebM&M: Weingart SN. It’s all in the syringe. AHRQ WebM&M (online journal: http://webmm.ahrq.gov). August 2006. Available at: www.webmm.ahrq.gov/case.aspx?caseID=133.
A 33-year-old man with type II diabetes presented to his physician’s office to discuss his diabetes management. The patient admitted not taking his medications or checking his blood sugars regularly. In the office, his blood sugar was 335 mg/dL, so the nurse practitioner (NP) ordered 6 units of regular insulin to administer.
After the medical assistant brought the insulin and syringe, the NP prepared the medication and injected the insulin. Immediately after the injection, the NP discovered that a tuberculin syringe was used instead of an insulin syringe. As a result of the error, the patient inadvertently received 60 units of insulin rather than 6 units. The patient was given orange juice and a sandwich, and his blood sugars were closely monitored for four hours with no significant events.
To illustrate effective and ineffective disclosure communications, The Doctors Company has added the following examples to this case.
The NP immediately reported this to the physician.
The physician immediately went to the treatment room to check on the patient, who ended up staying there for four hours. The physician and the NP sat down with the patient and the family and explained what happened without placing blame on anyone. Additionally, the physician stated, “We are not exactly sure why this happened, but we are going to investigate and find out so this won’t happen again. Please don’t hesitate to call me at any time during the next few days if there is a problem. Here is the way to contact me after hours.”
The physician immediately went to the treatment room to check on the patient, who ended up staying for four hours. He stated, “You’re going to be fine. I knew that your failing to check your blood sugars regularly was going to result in something like this. We had to make sure to get your blood sugar down very quickly!”
2. Known Risk/Complication or Unforeseeable Event
Ms. Mauve was seen in her surgeon’s office one week after a mastectomy of the left breast. Surgery had been uneventful, and she had been discharged 24 hours postoperatively. When the surgeon entered the treatment room, he noticed that the wound was reddened and swollen. The surgeon didn’t seem to take notice, so Ms. Mauve mentioned that she was concerned about her increasing pain and that the wound seemed to be getting redder and redder. The surgeon asked the tech to take Ms. Mauve’s temperature, which was 100.7. The surgeon told Ms. Mauve to get the prescription filled for antibiotics and see him back in the office in a week.
“Ms. Mauve, you may remember that when we discussed your surgery, I mentioned that an infection sometimes occurs after surgery. However, surgery is not always followed by an infection, and certainly, both the hospital team and I try to make sure this kind of thing doesn’t happen. This is something that we have to quickly treat and make sure it doesn’t get worse. Even though we can’t prevent all infections, we try to keep the incidence as low as possible, and I’ll let the hospital know as well since they track infection rates too.”
“No, you shouldn’t worry. This is to be expected in surgeries like yours—removing cancer can cause these symptoms.” The surgeon then asked the office nurse to make sure the patient makes a follow-up appointment but also told the nurse to avoid mentioning the word “infection.” After all, he saved this woman’s life, and a post-op infection is not a big deal.
A 48-year-old male patient, weighing 350 pounds, presented for a laparoscopic gastric bypass. The patient had diabetes, hypertension, and chronic low back pain. The patient was evaluated by a multidisciplinary team. After an adequate informed consent was obtained, the patient had a gastric bypass done at a local community hospital that had a proven track record in bariatric surgery.
Initially, the patient did well postoperatively. Six months after surgery, he had lost 75 pounds. The patient then reported diarrhea, abdominal pain, and nausea. The patient was very upset over these symptoms and the disruption in his life.
“This is one of those problems that sometimes occurs in patients who have had bariatric surgery. We discussed this prior to your surgery. I know this is very frustrating and scary for you, but there are several things we can do to manage the problem. I will refer you to a dietitian to help you select foods that will minimize the symptoms. There are some medications that may be helpful as well.” The surgeon then arranged for the office RN to coordinate these follow-up appointments. He introduced the patient to the RN and told him that if he had any questions, he should call either him (the surgeon) or the RN.
“This is one of the complications of the surgery that I told you about at our preoperative appointment. We discussed in detail the possibility of this. You are going to have to live with it.”
Communication with Family Following Outpatient Suicide
A 36-year-old newly married woman presented for depression and anxiety. She reportedly had a history of depression. Her job was cited as a recent stressor due to increased work demands and a difficult boss. She was unable to quit her job because of financial constraints. She acknowledged having some transient suicidal ideation without a defined plan.
The patient was treated with Wellbutrin and Xanax, which were somewhat helpful. After her inpatient mental health benefits were exhausted, the patient was treated in a day-treatment program and then seen as an outpatient with psychotherapy and medication. She continued to be depressed with occasional suicidal ideation. The patient did not have the money for further inpatient psychiatric care. Her in-laws agreed to keep in close contact with the patient during this time. The patient agreed not to harm herself and promised to call the psychiatrist if she was in a crisis.
The patient had plans to go to the mountains with her husband for the weekend. She was at home packing while her husband was at work. When she failed to answer the phone, her husband came home to find that she had hung herself in the garage. The paramedics responded and took the patient to the hospital. The patient subsequently died.
The psychiatrist expressed regret over the loss of the patient and offered consultation to help with the grieving process. He offered to arrange for clergy to be with the family. He let the family know that he would be following up with them in a week.
The psychiatrist grilled the in-laws and husband about when they last had contact with the patient and what was said. The conversation seemed more like a psychiatric assessment of the family. (This may raise feelings of guilt in the family.)
The psychiatrist expressed his sorrow but then withdrew from the family.
Life-Threatening Allergic Reaction to Medication
Three days after starting his patient on Bactrim for recurrent urinary tract infections, a urologist is notified by the Intensive Care Unit at his local hospital that his patient was admitted for toxic epidermal necrolysis and would be airlifted to the regional burn unit for treatment. Six weeks later, after learning that his patient was home and continuing to recover, the urologist called his patient at home.
“Mr. Sienna, I was so sorry to hear about the terrible ordeal you have been through. When you are up to it, I’d like to see you in my office to make sure that I answer any questions you may have and to discuss a plan for dealing with your chronic bladder infections. I wish we could tell ahead of time which patients might have an extreme reaction like this, but now that we know you have a sulfa allergy, we need to make sure that you are never exposed to this medicine again.”
“Mr. Sienna, I’m so sorry this happened to you, and we’re going to make sure it never happens again by putting flags on your chart and in the computer so you’ll never get sulfa again. Please accept our apologies that this happened to you. We are terribly, terribly sorry.” (Nothing is conveyed to frame this event as a newly identified allergy, and no patient education is initiated about steps to prevent a future exposure. The patient later contacts the urologist’s office about compensating him for any post-insurance balance on his medical bills because of the “error.”)
The urologist hung up the phone before the patient answered and removed the patient’s name from the rotary schedule alert, believing that it would be better to let the patient initiate contact.
Pregnancy after Sterilization Procedure
Several months after her sterilization procedure, a patient reported to her gynecologist with a positive home pregnancy test. The gynecologist confirmed pregnancy status and arranged for his partner to perform a requested termination of pregnancy and laparoscopic sterilization revision. Following the repeat laparoscopic procedure, his partner reported that he replaced the Hulka clip used in the original sterilization (which had slipped and no longer compressed/occluded the fallopian tube).
“Before we proceed with the second procedure, we need to review the pros and cons of each sterilization method. Because you are in your twenties, you opted for the more reversible method of clip compression. As you recall from the consent process on that first procedure, the trade-off for reversibility is a higher risk of pregnancy, especially in younger women who have more resilient tissue that pushes back against the clip. Now that you’ve faced that pregnancy risk once, do you still wish to choose the more reversible method, or do you want to consider a more permanent tubal procedure?”
The first gynecologist, convinced that he was taking appropriate steps to apologize, wrote the patient a letter detailing his regret for his error that caused her the emotional trauma of a pregnancy termination and additional time lost from work. The patient and her husband contacted a lawyer, and the gynecologist’s professional liability insurance carrier quickly initiated a settlement offer. In this case, the plaintiffs’ attorney would not need to secure an expert witness to review the case and testify. The gynecologist had provided expert testimony against himself with his admission-of-liability letter.
3. Unexplained Change in Patient Status or New Diagnosis of Late-Stage Disease
Hindsight Bias on Chest X-ray
A 62-year-old woman with a persistent cough consulted her primary care provider. A chest radiograph was ordered that revealed a suspicious nodule in the left lower lobe. Upon comparison with a film taken 18 months earlier during a resolving pneumonia that was interpreted by a radiologist at a competing freestanding radiology clinic, the current radiologist believed that he could see signs of the nodule within the infiltrate on the earlier film. The radiologist called the primary care provider with a verbal report.
Effective Immediate Disclosure
“Mrs. Green, your chest x-ray shows a nodule that we need to have evaluated further with some additional tests to make sure it’s not cancer. In cases like this, the radiologists also go back to review any films taken in the past few years and make comparisons. When they are done with reviewing those films, I’ll make sure to go over their findings with you. In the meantime, let’s talk about the tests you need and how to schedule them.”
Ineffective Immediate Disclosure
“Mrs. Green, you’ve got a mass on your chest x-ray that might be cancer and it looks like the radiologist missed it 18 months ago when you had pneumonia. It probably won’t make any difference in your treatment or the outcome anyway.”
The radiologist who read the earlier resolving pneumonia film obtained a blind review by three other board certified radiologists, and none identified a nodule in the resolving infiltrate on the earlier film.
Patient Found Deceased in Bed after Discharge from ED
A 52-year-old contractor reported to his local Emergency Department with abdominal pain on a Sunday afternoon. The initial workup indicated a possible partial bowel obstruction, and the patient boarded in the ED for a total of 11 hours during his initial evaluation and subsequent consultations. Eventually, the pain resolved and the patient was discharged to home with a follow-up visit scheduled with his internist in two weeks. The patient’s wife called the internist’s office the next morning to say that her husband died during the night.
Effective Immediate Disclosure
“Mrs. Black, I don’t know why your husband died, but I think it is important for all of us to understand what happened. I can’t imagine how difficult this is for you. Would you be willing to consent to an autopsy? Then, when you are ready, I would like to meet with you and your family. I will go over everything we learn from the autopsy as well as the case review.”
Ineffective Immediate Disclosure
“Mrs. Black, I know you must be angry, and I can’t explain why we couldn’t get a surgeon to take your husband to the operating room. He must have perforated his bowel, but there’s nothing we can do about it now.”
The family agreed to a postmortem examination that revealed a new inferior myocardial infarction. The patient had been treated for several years with beta-blocker and calcium channel blocker medication for unstable angina, and review indicated that he had skipped two doses due to nausea and abdominal pain prior to arriving at the hospital and had missed two more doses while being evaluated in the Emergency Department.
Intrauterine Fetal Demise
Eleven days after an amniocentesis study, a 41-year-old primigravida patient with a history of extensive infertility treatment to achieve this pregnancy reported for her routine prenatal exam, and the fetal heart tone could not be found. An ultrasound study confirmed the absence of fetal heart activity.
“I am so sorry to tell you that the baby died. We will know more about what might have caused or contributed to the baby’s death when the placenta and baby are examined after birth. We may also find explanation in the amniocentesis report when it comes in. When you are ready, we can review everything we find out. For now, we’ll need to discuss the treatment choices to deal with the situation, but first I want to know how we can help you. Is there anyone we can call to be with you?”
“This was one of the risks of amniocentesis. You can’t have it both ways, you know. Finding out the information from amniocentesis requires taking some risk, and unfortunately you got burned. Don’t worry. There’s still time to get you another try at a successful pregnancy.”
“I am so very sorry that you lost the baby. I worried that the Maternal Fetal Medicine group was trying to pack in too many amniocentesis patients each day. I sure hope that didn’t contribute to this tragedy.”
Case review indicated that the fetus died from chromosomal abnormalities. Although the parents indicated they were impressed by the studies and reports reviewed, they continued to believe that the amniocentesis caused the baby’s intrauterine death and discontinued care with the involved providers.
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.