History, Exam and Workup Problems in Diagnosis Error Claims
CME Information
Sponsored by: The NORCAL Group of companies includes NORCAL Mutual Insurance Company, along with its subsidiary companies Medicus Insurance Company, FD Insurance Company, NORCAL Specialty Insurance Company and its affiliate Preferred Physicians Medical RRG.
NORCAL Mutual Insurance Company is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
For questions, please call the Risk Management Department at 855.882.3412.
Method and Medium
To obtain CME credit, read the article then take the quiz and fill out the evaluation form. You can print or email your CME certificate from this application.
Please complete and submit the online quiz by the expiration date indicated below:
Original Release Date: August 15, 2018
Expiration Date: September 1, 2020
Learning Objectives
By reviewing medical professional liability claims and/or emerging topics in healthcare risk management, this enduring material series will support your ability to:
Assess your practice for risk exposures.
Apply risk management best practices that increase patient safety and reduce medical professional liability claims.
Target Audience
All physicians, clinicians, staff and healthcare administrators.
Credit Designation Statement
NORCAL Mutual Insurance Company designates this enduring material for a maximum of 1 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Disclosure Policy
As an ACCME accredited provider, NORCAL Mutual Insurance Company requires planners, reviewers or authors who influence or control the content of a CME activity to disclose financial relationships (of any amount) they have had with commercial interests associated with this CME activity during the year preceding publication of the content.
Any identified conflicts of interest are resolved prior to the commencement of the activity.
Disclosures
Individuals involved in the planning, reviewing or execution of this activity have indicated they have no relevant financial relationships to disclose.
Editor
Mary-Lynn Ryan, JD
Risk Management Specialist, NORCAL Mutual
Content Advisors
Sandra L. Beretta, MD
Chair, NORCAL Mutual, FD Insurance, Medicus and Preferred Physicians Medical RRG
"Decades from now, a physician in retrospective reverie about his or her career in medicine will not remember the chemistry panels, the MRI results, or even the majority of the medical scientific facts of their past practice...What they will remember…are the stories of their patients, about who they were and how they acted, and what their physical examinations showed that surprised or confirmed history-generated hypotheses."1
The topic of this month's publication was chosen because of the prevalence of history, exam and workup problems as a contributing factor in NORCAL diagnostic error claims. This contributing factor prevalence is not unique to NORCAL policyholders. A recent CRICO study found that incomplete patient assessment was a contributing factor in half of the malpractice claims in its claims database.2 The benefits of conducting an appropriate history, exam and workup go beyond managing liability risk. Fully engaging in the history and physical exam process, instead of primarily relying on technology to diagnose patients, also can reduce physician burnout.1,3,4
The case studies presented are primarily based on NORCAL closed claims. These cases illustrate the value of appropriate history, exam and workup, and why meaningful documentation is a key risk management strategy.
Family Health History
A patient history is more than an exposition of facts. When appropriately taken and recorded, it tells a story of how the patient's health has been impacted by social, environmental, hereditary and behavioral factors.1 In the short window of time patients and clinicians are together during an office encounter, the history provides a structure for creating a bond that can enhance whatever follows in the diagnostic process. Family history plays a critical role in assessing the risk of inherited medical conditions and genetic alterations, such as type 2 diabetes, coronary artery disease, Alzheimer's disease, breast cancer and colon cancer. Unfortunately, some patients are poor historians. Clinicians are not expected to be mind readers, but in some cases it may be worthwhile to evaluate whether the patient understands the importance of family and health history, and is able to complete the history form accurately. There are many reasons that patients may not correctly complete a history form. For example, a form that requires checking a box next to a family history of "cardiovascular disease" may not prompt a positive response from a patient who does not equate "heart attack" with cardiovascular disease. In the following case, the patient, who failed to inform his physician of his family history of early myocardial infarction (MI), had a sixth-grade education. He may not have accurately filled out the history form because of low health literacy.
Case One
Allegation:
The primary care physician failed to obtain an accurate family history of heart disease.
After not receiving any medical care for many years, a 56-year-old sedentary, overweight, pack-a-day smoker presented to a primary care physician (PCP) as a new patient. His reason for the visit was persistent pain in his left arm radiating from his shoulder into his bicep, and tingling in his fingers. He did not recall anything precipitating the pain. The PCP diagnosed musculoskeletal pain and prescribed ibuprofen. One week following the examination, the patient died of an MI. His family members filed a malpractice lawsuit against the physician alleging his failure to obtain an accurate history resulted in the misdiagnosis.
Poor documentation and conflicting testimony from the deceased patient's family members complicated the defense of this case. The patient did not tell the physician that his maternal grandmother and uncle had both suffered MIs in their late 40s, and apparently did not adequately describe his pain, since his family members testified that the patient had chest and left arm pain so severe that it interfered with his sleep and that he suffered from shortness of breath on exertion. Why the patient failed to reveal the severity of his symptoms and the family history of MI was never discovered. The patient's siblings had discussed together the fact that MIs at an early age seemed to run in their family. They could think of no reason why their brother failed to indicate this history, other than he had misunderstood the health history form or had simply forgotten to indicate it.
Although many clinicians and staff are capable of taking family histories, inaccurate and incomplete information provided by patients can lead to misleading conclusions.5,6 Consider the following strategies:
Educate patients about the importance of adequately reporting family medical history and the history of symptoms.
Have patients complete the history form at home.
Suggest that patients contact family members to provide the most accurate family health history.
Review patient responses on health history forms to determine whether anything important is missing based on the symptoms being described or the examination taking place.
Use this opportunity to prompt conversation, create a bond and delve deeper into relevant aspects of the patient's history.
Analyze your health history form to determine whether it is written in plain layperson language and at an appropriate comprehension level.
For general health literacy education, NORCAL policyholders can access the NORCAL CME webinar entitled "Health Literacy: Making Patients Safer Through Understanding" in MyACCOUNT.
Analyze your health history form to determine whether changes would increase the chance of identifying patients who are at high risk of hereditary disease based on their family medical history.
Family History Tools for Patients
A variety of online family history resources for patients are available, for example:
Genetics Home Reference: Why is it important to know my family medical history? U.S. National Library of Medicine
Available at: ghr.nlm.nih.gov/... (accessed 6/20/2018)
Family Medical History Patient Video
American Medical Association
Available at: ama-assn.org/... (free registration required) (accessed 6/20/2018)
A Guide to Family Health History
Geisinger Genomic Medicine Institute Available at: geisinger.org/... (accessed 6/20/2018)
The Surgeon General's Family Health History Initiative
Available at: hhs.gov/familyhistory (accessed 6/20/2018)
Family History Sample Form
American Medical Association
Available at: ama-assn.org/... (accessed 6/20/2018)
History of Symptoms
The workup of patients presenting with cardiovascular disease symptoms requires focused history taking and careful physical examination. In the following case, the physician overlooked ominous symptoms due to the patient's apparent low risk of heart disease.
Case Two
Allegation:
The physician failed to obtain an adequate history of the patient's symptoms.
On March 25, a 50-year-old female patient, who, before this time, had been healthy and rarely made appointments outside of a yearly physical, made an appointment with her family practice physician (FP) because her lungs ached when she worked out at the gym. She had no family history of heart disease and was otherwise very low risk. She explained she had a cold for the last two weeks, which seemed to be resolving. The FP listened to her lungs and documented "crackles" in the base of her lungs. His differential diagnosis included allergies and bronchitis. He recommended over-the-counter allergy medication as a first course and, if that did not work, to start using the antibiotics he prescribed.
The medications were not resolving the patient's chest discomfort, so she returned to the FP on April 9. However, she now described epigastric pain. The FP diagnosed GERD, and ordered an upper GI and blood tests. The upper GI was normal, but the blood test showed H. pylori, which the FP determined was the cause of the epigastric pain. He prescribed a Prevpac®. On April 17, the patient called to report her symptoms were worse on the Prevpac®. The FP encouraged her to continue with the medication.
On April 26, the patient called the FP in unbearable pain and asked about going to the hospital. The FP instead told the patient to come into the office immediately. At this appointment, the patient reported her epigastric pain went up and down during the day with no apparent triggers other than physical exertion. She revealed that epigastric pain associated with jogging had preceded the lung burning she originally reported. The FP told the patient that the Prevpac® was probably causing her pain, but since there were only two days left on the prescription, to continue taking it. The FP then ordered an abdominal ultrasound to rule out gallbladder disease. On April 27, the patient had the ultrasound, which was normal. That evening, she collapsed at home and could not be revived. Autopsy showed a blocked proximal left anterior descending coronary artery was the cause of death.
Physicians who reviewed this case were not supportive of the FP's management of the patient. Although the patient was at extremely low risk for heart disease, the FP did not obtain an adequate history of her lung symptoms or epigastric pain with physical exertion. The reviewers believed the FP needed to clarify what the patient meant by these symptoms, and discover if any other activities brought on the pain. Even without the extra information, the burning sensation in the patient's chest (lungs) warranted a referral for a stress test.
Furthermore, the H. pylori finding initially supported the treatment for GERD, but when medications had no effect, and the upper GI revealed no reflux, the FP should have considered other causes of the patient's epigastric pain, based on the severity of her complaints. Experts believed the FP was understandably influenced by the patient's low cardiac risk profile, but this did not excuse his failure to obtain a more thorough history of her symptoms associated with exertion.
Consider the following recommendations:
Ensure history-taking and physical exam strategies are appropriate for patients who present with chest pain or other symptoms that may signal heart disease, particularly an impending MI.
Improve cardiac exam skills. Various resources are available; for example:
The Stanford Medicine 25 educational videos on cardiac second heart sounds, neck vein examination and wave forms and precordial movements in the cardiac exam Available at: stanfordmedicine25... (accessed 6/30/2018)
John Hopkins C.A.R.D. Murmurlab Available at: murmurquiz.org/ (accessed 6/30/2018)
Audit history and physical forms being used for patients who present with symptoms of heart disease by using cardiovascular disease clinical guidelines; for example:
American Heart Association Heart Failure Guidelines Toolkit Available at: www.heart.org/... (accessed 6/30/2018)
The Argument for Refreshing Physical Examination Skills
Various studies indicate that diagnostic failures frequently involve physical exam inadequacies.i For many diseases - Parkinson's disease, shingles, drug rashes, pericarditis - diagnosis is based on observation and examination, not a test.ii The strategy of using a careful exam to guide workup has many benefits.i While it's not necessary or even possible to do a complete physical exam at every patient appointment, a brief, thoughtful exam can help physicians bond with patients and enhance communication.i A cursory exam can indicate disinterest,i which may not rise to the level of malpractice but can contribute to a patient's decision to file a lawsuit if the treatment outcome is poor.iii
Stanford Medicine 25
Online bedside exam skill video sessions for students and practicing clinicians Available at: stanfordmedicine25.stanford.edu/... (accessed 6/30/2018)
Society of Bedside Medicine (SBM)
"The purpose of SBM is to foster a culture of bedside medicine through deliberate practice and teaching, and by encouraging innovation in education and research on the role of the clinical encounter in 21st century medicine." Available at: bedsidemedicine.org/ (accessed 6/30/2018)
Medical Clinics of North America - May 2018 issue
Contains 14 articles related to bedside medicine and the physical exam
Available at: medical.theclinics.com/... (accessed 6/30/2018)
Resources
i. Durkin M. Bringing medicine back to the bedside. ACP Internist. 2018. Available at: acpinternist.org/...
ii. Boodman SG. Patients Lose When Doctors Can't Do Good Physical Exams. Kaiser Health News. 2014. Available at: khn.org/news/...
iii. Clark BW, Derakhshan A, Desai SV. Diagnostic Errors and the Bedside Clinical Examination. Medical Clinics of North America. 2018;102(3):453-464.
Documentation of History, Exam and Workup
What is - and more often is not - documented in the patient record is often a pivotal factor in a medical liability lawsuit. In most of the case studies in this article, the absence of documentation about history, exam or workup complicated the defense of the malpractice claim. Defendant physicians rarely have an independent memory of the details of the office visits at issue in a lawsuit. Without adequate documentation, there can be little evidence to rebut plaintiffs' claims that history, physical and workup were insufficient.
Case Three
Allegation:
The patient's physical exam remained unchanged in the record over time, raising questions as to its accuracy.
A 50-year-old male patient was seen by a nurse practitioner (NP) at a community clinic 11 times between September and December 2014 for severe back, shoulder and sacroiliac pain. The NP prescribed pain medications, assuming the pain was being caused by a muscle strain. However, it turned out that the patient had osteomyelitis, which ultimately required the replacement of three vertebrae and resulted in permanent disability.
There were a number of problematic issues in this case, including the NP's failure to order x-rays and refer the patient to a specialist. According to experts, as the patient developed more serious symptoms, a more detailed diagnostic workup was required. The medical record documentation further complicated the defense. The NP's electronic health record (EHR) system provided "documentation by exception" templates (also referred to as "exploding notes"). This allowed the NP to pull up an office visit template and then check boxes indicating normal or abnormal values or observations. When the NP checked "normal," an examination note in paragraph form was generated in the EHR. This resulted in office visit notes that appeared extensive, but that did not change much from visit to visit. The NP explained that the notes were similar because the patient's symptoms had changed so subtly that it was hard to express the changes in the record. Unfortunately, when the NP added "free form" examination documentation into the EHR, it was not always consistent with the templated content.
Case Four
Allegation:
Failure to diagnose pneumonia resulted in the patient's death.
A 65-year-old female patient presented to an urgent care center. She reported to the medical assistant (MA) that she had had a headache, vomiting and a productive cough for the past week. The MA recorded the patient's blood pressure at 92/60 and a normal temperature. The only entries the physician made in the record were a check mark on the pulmonary exam box and the word "rales" right next to it. She also prescribed cough syrup. The patient died three days later from bilateral pneumonia, with related septic shock, leukopenia and metabolic acidosis. The patient's husband filed a wrongful death lawsuit based on the physician's failure to diagnose and treat the patient's pneumonia.
Experts felt that the physician's treatment of the patient did not meet the standard of care because there was no evidence in the medical record that she had completed an appropriate history, exam and workup. The documentation of the patient visit lacked any evidence of:
Measuring and recording the patient's pulse and respiratory rate
Taking a history
Examining the patient's ears, throat or nose
Auscultating the patient's chest
Questioning the patient about respiratory symptoms with exertion, presence of hemoptysis, fever, chest pain and diarrhea
Obtaining a complete blood count and serum chemistries
Obtaining a chest x-ray
- Documentation of History, Exam and Workup
In many claims with documentation inadequacies, physician credibility versus patient credibility becomes the crux of litigation. Lack of documentation often is advantageous to plaintiffs in professional liability lawsuits because juries tend to believe that "if it wasn't documented, it wasn't done." Therefore, consider the following strategies:
Clinicians/Staff
When a patient presents with a complaint that requires a diagnostic process, document history, exam and workup completely and accurately. The documentation should include:
Reason for the encounter
Relevant health risk factors
Family health history
History of the present illness
Physical examination findings
Vital signs (e.g., blood pressure, pulse, respirations, temperature, as appropriate) and weight
Risk assessment process
Differential diagnoses
The plan of care and the reasoning behind it
Include treatments, tests, assessments, medications and referrals.
The patient's progress - including response to treatment, change in treatment, change in diagnosis and patient noncompliance
Instructions for follow-up
If your EHR system carries information forward, uses "exploding notes," "documentation by exception" (DBE) templates or templates that "blow in text," review the final version of the office visit note to ensure that it accurately reflects findings associated with the particular encounter.
If some parts of a form are not applicable to a particular patient situation, note "not applicable" or "not examined" on that individual form in the area(s) not used.
Administrators
Audit medical record entries on a regular basis.
Evaluate physician usage of templates, forms and checklists. If physicians are routinely skipping sections or marking sections "not applicable," consider modifying or redesigning the template, form or checklist.
Bias in History and Workup
There are various causes of inaccurate data collection during patient history taking and exams. Patients may not accurately report their health history, symptoms or family history. Physicians may be influenced in their workup decisions by various non-clinical issues, including the patient's ability to pay, the discomfort or inconvenience of the test or the patient not fitting a disease demographic. The following two cases illustrate how physician bias during history taking can negatively affect workup and result in misdiagnosis.
Case Five7
Allegation:
The surgeon failed to give appropriate weight to the option of BRCA mutation testing during the informed consent discussion for bilateral mastectomy and oophorectomy due to the patient's perceived inability to pay for it.
The patient, a 34-year-old woman on Medicaid, was referred to a surgeon because of suspected BRCA mutation based on her family history of cancer. She reported bilateral breast pain, nipple discharge and a growing, painful lump in her right breast. Mammograms indicated fibrocystic breasts and biopsies were negative for malignancy. Unbeknownst to the referring physician and surgeon, her reported family history of cancer was inaccurate:
Patient's Reported Family History of Cancer
Patient's Actual Family History of Cancer
Mother had bilateral breast cancer at age 26.
Mother had breast cancer in the right breast at age 26, but chose bilateral mastectomy.
Mother had ovarian cancer at age 38.
Mother had cervical cancer.
Sister had ovarian cancer at age 26.
Sister had cervical cancer.
Based on her reported family history of cancer, the surgeon concluded the patient was at high risk for breast and ovarian cancer due to the possibility that she had a BRCA mutation. During informed consent discussions, the surgeon explained the risks and benefits of three alternatives for the patient: tamoxifen, genetic testing for a BRCA mutation, and bilateral mastectomy and oophorectomy. The patient was primarily swayed in her decision making by information the surgeon provided about the negative side effects of tamoxifen; the likelihood that genetic testing would not be covered by her health insurance; and the likelihood that bilateral mastectomy and oophorectomy would significantly reduce her risk of cancer and would be covered by insurance. The patient was anxious about developing breast or ovarian cancer and concluded that bilateral mastectomy and oophorectomy were her best options. Following surgery, her recovery was long and complicated. No cancer was found in the tissues of her breasts or ovaries. She later sued the surgeon, alleging he negligently discouraged her from undergoing genetic testing due to her inability to pay for it and that failure to verify her family cancer history or BRCA mutation status prior to recommending surgery was a breach of the standard of care.
During trial, the patient's expert testified that the surgeon had deviated from the standard of care by failing to verify the patient's hereditary breast and ovarian cancer (HBOC) risk prior to recommending and performing double mastectomy and oophorectomy. Unfortunately for the patient, she had her facts wrong. The physician admitted that given the patient's actual family history of cancer, she did not meet the clinical guideline criteria for prophylactic double mastectomy and oophorectomy. Furthermore, genetic testing would have revealed that she did not have a BRCA mutation.
Resist the urge to discourage workup options that may seem unaffordable.
Involve ancillary staff (e.g., social workers) with specialized knowledge and training about appropriate resources for testing patients who may not be able to afford it.
If a patient refuses a recommended test, inform the patient of the following:
Reasons for the recommended test
Expected benefit of the recommended test
Alternatives to the recommended test
Risks of not undergoing the recommended test or pursuing alternatives
Use of a form is optional, but it can be used as a checklist during the informed refusal process to ensure that risks and alternatives are not overlooked. Forms also enhance documentation of the process.
In addition to a "Refusal of Treatment" form, document the process in the patient's medical record. Documentation should include the following:
Information given to the patient during the informed refusal process, including referral to a safety net healthcare organization or other resource that may provide financial assistance for the recommended testing
Efforts to confirm the patient's understanding of the risks
Carefully consider whether going forward without recommended workup complies with the standard of care.
Case Six
Allegation:
The patient's constellation of symptoms indicated she had AIDS, but she was never tested for HIV.
The patient was a married, 50-year-old elementary school teacher with grown children. In February 2013, she presented to her physician complaining of a rash on her legs and trunk that had been slowly progressing for about a year. The physician noted several purple macules on her lower trunk, feet and ankles in varying sizes, which were not tender to palpation. The physician believed the rash was a reaction to one of the patient's medications, which he discontinued. He advised her that it could take several months for the rash to resolve.
Over the course of the next year, the physician treated the patient for various other conditions: a persistent dry cough (attributed to bronchitis or seasonal allergies), a yeast infection in her groin area (attributed to increased exercise), oral thrush (attributed to a steroid prescription), night sweats (attributed to menopause) and fatigue (attributed to sleep apnea). He treated all of these conditions as independent of each other. The rash was never noted again in the patient record.
In April 2014, the patient was treated in the hospital for pneumonia and pleurisy. In July 2014, she was admitted to the hospital for shortness of breath. She reported having felt "feverish" for several months. The admitting physician thought her symptoms were consistent with new onset congestive heart failure. Instead, she was diagnosed with pneumocystic pneumonia. Her rash was biopsied, which resulted in a diagnosis of Kaposi sarcoma. Based on these diagnoses and a low CD4 count, she was diagnosed with late-stage AIDS. During the hospital admission she experienced multiple organ failure and died. Her family filed a lawsuit, alleging the physician should have referred the patient to a dermatologist for the rash and tested her for HIV.
The physician never considered AIDS because the patient lived in an area with low HIV infection rates and did not fit an AIDS patient profile. What the physician did not know, and the patient did not offer, is that she had a long period of infidelity during a service mission trip to Haiti in 2003. Her HIV infection probably occurred during this period.
The physician did not consider Kaposi sarcoma when he examined the patient's rash; although, based on descriptions, experts believed it was more consistent with Kaposi sarcoma than it was with a drug-related rash. Experts believed it was appropriate to discontinue the suspected medication to see if the rash dissipated over time; however, the standard of care was breached when the physician failed to determine whether the rash had resolved.
Furthermore, experts believed that the physician should have recommended an HIV test based on the totality of the patient's symptoms. Unfortunately, all of her symptoms were worked up independently and in a manner that tended to confirm the physician's assumptions of more benign causes. It was also noted that none of the symptoms entirely resolved with treatment, which should have prompted further work-up until a definitive diagnosis could be made. If the physician had explored whether an underlying infectious process was causing the patient's various symptoms, he might have ordered tests necessary for the correct diagnosis.
In many claims, the failure to diagnose and treat the patient's illness could have been avoided if the physician had pursued a more complete workup. Consider the following strategies:2
Support workup with patient data collected from the patient history and physical.
When a patient's symptoms do not respond to treatment or recur:
Ask yourself: "what else might this be?" or "what is the worst possible diagnosis for a patient with these symptoms?"
Re-read the medical history and other chart notes.
Re-examine and re-question the patient.
Consider different diagnostic tests.
Consider the totality of the patient's comorbidities and disease processes.
Refer to specialists.
Use clinical guidelines and algorithms.
Keep unresolved symptoms on the patient's problem list.
When workup takes an extended amount of time, educate patients about why it is taking so long.
Acknowledge uncertainty in difficult cases and seek input from colleagues, EHR diagnosis-support tools and other reference materials.
Do not overly bend diagnostic criteria to meet a patient's symptoms.
Document your analysis.
In a busy practice it can be difficult to find the time necessary to complete and document an appropriate history, physical and workup, but claims data show how critically important this aspect of patient care can be. The history and exam portions of a patient encounter can improve physician-patient rapport, which not only increases patient safety and reduces liability risk, but also can bring some of the joy back to the practice of medicine for those clinicians who are suffering from burnout.
The NORCAL documents referenced in this article, along with many other Risk Management Resource documents and past editions of the Claims Rx, are available in the Risk Solutions area of MyACCOUNT, or by policyholder request at 855.882.3412.
Henderson MC, Tierney LM, Jr., Smetana GW. eds. The Patient History: An Evidence-Based Approach to Differential Diagnosis New York, NY: McGraw-Hill; 2012.
Hoffman J. The Risk of an Incomplete Patient Assessment. CRICO website. 2018. Available at: www.rmf.harvard.edu/... (accessed 6/30/2018).
An Emphasis on the Bedside May Prevent Physician Burnout. Stanford Medicine website. 2018. Available at:
stanfordmedicine25.stanford.edu/... (accessed 6/30/2018).
Minkove J. A Mission to Reinvigorate Bedside Medicine. Johns Hopkins Medicine website. 2018. Available at:
hopkinsmedicine.org/... (accessed 6/30/2018).
Murff HJ, Greevy RA, Syngal S: The comprehensiveness of family cancer history assessments in primary care. Community Genet. 2007;10:174–180. (accessed 6/30/2018).
Berg AO, et al. National Institutes of Health State-of-the-Science Conference statement: family history and improving health. Ann Intern Med. 2009;151:872–877.
Case study based on Downey v. Dunnington, 384 Ill. App.3d 350, 895 N.E.2d 271 (2008). Minor factual changes have been made to enhance the case as a risk management tool. The entire opinion can be found at: state.il.us/...
(accessed 6/30/2018).
2018