Spotlight Case

1. Spotlight Case Delay in Treatment: Failure to Contact Patient Leads to Significant Complications

2. Source and Credits • This presentation is based on the February 2013AHRQ WebM&M Spotlight Case • See the full article at http://webmm.ahrq.gov • CME credit is available • Commentary by: David W. Shapiro, MD, JD, Editor, Professional Liability Newsletter • Editor, AHRQ WebM&M: Robert Wachter, MD • Spotlight Editor: Bradley A. Sharpe, MD • Managing Editor: Erin Hartman, MS

3. Objectives At the conclusion of this educational activity, participants should be able to: • Know that failure to properly act on abnormal test results is a significant patient safety issue • Appreciate that failing to contact a patient about abnormal test results is a source of successful malpractice claims • Describe the legal standard applied to failure to contact a patient about test results that require follow-up action • List some steps that might reduce the harm from failure to act on abnormal test results

4. Case: Failure to Contact A 21-year-old woman presented to the emergency department (ED) with heavy vaginal bleeding. She was admitted to the obstetrics and gynecology (OB/GYN) service for management. She received a blood transfusion and Depo-Provera injection (a hormone to stop the bleeding) and was discharged home the next day. As part of the evaluation, a chlamydia test was performed in the ED. This test returned positive the day after the patient was discharged.

5. Case: Failure to Contact (2) Per standard protocol, the positive laboratory result was sent through the electronic medical record (EMR) to a nurse in the OB/GYN clinic. She followed standard procedure and tried to call the patient using the contact number in the EMR. No one answered, and the nurse called again on each of the next 4 days, but there continued to be no answer. She notified her clinic supervisor who noted the result, but made no further attempts to contact the patient. 5

6. Case: Failure to Contact (3) One week later, the patient went to the radiology department for an ultrasound scheduled during the initial hospitalization. The ultrasound technician did not notice the abnormal test result or that the chlamydia infection had not been treated.The next day, a different OB/GYN clinic nurse tried to call the patient with the ultrasound results, and again no one answered. She sent a letter by mail to the patient with both the ultrasound and chlamydia results. 6

7. Case: Failure to Contact (4) The patient received the letter and came to the clinic 2 weeks later (26 days after initial presentation), where she received appropriate antibiotics for the chlamydia infection (a single dose of azithromycin). Despite this treatment, she developed fevers and abdominal pain and presented to the ED. She was diagnosed with chlamydial pyosalpinx (infection of the fallopian tubes) and peritonitis. 7

8. Case: Failure to Contact (5) This severe form of chlamydial infection likely developed due to delay in treatment.The patient was admitted for intravenous antibiotics and was discharged 3 days later. She was expected to make a full recovery, although there is some risk of long-term complications including infertility and chronic pelvic pain. 8

9. Background • Arriving at an accurate diagnosis often involves many steps in a complex system, and errors can occur at any step along the way • Errors can happen in the final step—the clinician and patient executing a treatment plan • That is what occurred in this case

10. Follow-up Errors • A number of high-profile cases have occurred in which test results were not acted on • The death of a prominent physician’s daughter from cervical cancer years after an abnormal PAP smear was not properly followed up • The Rory Staunton case in New York City where abnormal test results were reported after a 12-year-old boy left the ED, and he died of a serious infection See Notes for references.

11. Malpractice Implications • The parents of Rory Staunton have engaged a medical malpractice lawyer • In response to similar cases of missed diagnoses, the federal Mammography Quality Standards Act has long required facilities that perform mammograms to send a summary of the written report “directly to the patient in terms easily understood by a lay person” See Notes for reference.

12. Following up Test Results • The process of appropriately following up test results has flaws • Often results are not seen or acted on • May be system pressures • See related AHRQ WebM&M commentary • One study of primary care practices showed 6.8% of errors in the testing process involved failure to inform the patient of the result See Notes for references.

13. Following up Test Results (2) • Particularly difficult after patient has left ED or inpatient unit • In one study of three particular tests in an ED, results were available after the patient had left 33% to 75% of the time See Notes for reference.

14. Providing Results Directly to Patients • Health care systems are increasingly providing test results directly to patients • Some EMRs allow patients to access results after their physician releases them • Proposed federal regulations would require laboratories to release test results directly to patients if requested See Notes for references.

15. Malpractice and Test Results • One study found that delays in diagnosis are the fastest-growing type of malpractice claim • ¼ of these claims concern failure to follow up test results • There are a number of common scenarios in the malpractice system: • Radiograph findings in the ED that are missed and discovered later when the film is read by the radiologist • Outpatient biopsies or imaging studies that are indicative of cancer and not pursued See Notes for reference.

16. Standard of Care • In general, malpractice “standard of care” might be described as what a typical, similar health care provider or institution would or should do in the same circumstances • Determined on case-by-case basis by unique juries deciding cases involving unique facts • What can reasonably be expected will depend on details of the clinical situation, the patient, and the means available to reach the patient

17. Standard of Care (2) • Can take a common-sense approach • Effort that must be expended should be proportionate to importance of contacting the patient (i.e., the harm that could result should the patient not be reached) • An immediate, life-threatening medical problem requires an immediate strong effort to reach the patient • A result that would not cause appreciable harm if unaddressed for weeks requires much less effort and urgency

18. What Means Should Be Used to Reach a Patient? • Any readily available means should be used • To date, no malpractice cases have addressed the Internet as a means of contact specifically • Whatever is done should be documented in the medical record: to communicate to others what has been done and to provide written or electronic documentation in case the failure to contact becomes the subject of a lawsuit

19. Patient’s Responsibility • From a legal perspective, patients also have a duty to participate in appropriate follow up • There are no specific rules or guidelines; determination is made on a case-by-case basis

20. Suggested Steps • Engage patients in following up on test results • Educate them about tests and their importance • Obtain or verify contact information • Ideally more than one contact method and each time a patient is seen

21. Suggested Steps (2) 3) Customize approach depending on patient • For example, consider holding some patients in an ED until all important test results expected within a reasonable time are returned and reviewed • Use an EMR to provide an alert when the patient needs to be contacted • Develop and improve tracking systems to be sure results are reviewed and acted on 21

22. Take-Home Points • A significant number of abnormal test results from outpatient, inpatient, and ED areas are not properly acted on. • Failing to contact a patient about abnormal test results that require follow up is a clear error that can result in a successful malpractice claim.

23. Take-Home Points (2) • The malpractice standard of care requires an effort to contact patients about abnormal test results that is proportionate to the harm that might occur without proper follow up. • Two steps that could reduce the harm from failure to contact patients about abnormal test results are engaging patients in following up on pending tests and routinely obtaining or verifying contact information.