CME Information

Sponsored by:
NORCAL Mutual Insurance Company, a member of the NORCAL Group. The NORCAL Group of companies includes NORCAL Mutual Insurance Company, Medicus Insurance Company and FD Insurance Company.

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: March 15, 2017

Expiration Date: April 1, 2019

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

Primary care physicians, administrators and other physicians and staff who receive actionable test results.

Credit Designation Statement

NORCAL Mutual Insurance Company designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit^TM. 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.

Primary care physicians (PCPs) receive a considerable number of test results.¹ One study found that a typical PCP reviews an average of 930 pieces of chemistry/hematology data and 60 pathology/radiology reports per week.² Volume is not the only reason test result management and follow-up is complex.³ It requires multi-step data-sharing among multiple physicians, staff and patients across a variety of settings, using different manual and electronic systems.^4,5 Lurking among the voluminous test results moving through various complex systems are critical and significantly abnormal findings that require expedited follow-up. These test results may be overlooked, misunderstood or misdirected at any step along the way,¹ and delays and failures can be deadly.^3,4

One part of managing the risks associated with significantly abnormal test result management and communication is anticipating potential errors and instituting processes that make them less likely. The following collection of case studies, based on NORCAL closed claims, shows the variety of ways significantly abnormal test result follow-up failures can result in patient harm and lawsuits against physicians. Risk management strategies are provided to help PCPs, staff and administrators recognize and correct error-prone practices.

Case One

Allegation:

The physician's failure to inform the patient of her dangerously high INR contributed to her death.

A solo family practice physician (FP) monitored various patients who were receiving anticoagulation therapy with warfarin. He told these patients they would only be contacted if their INRs were outside of therapeutic range. If they were not contacted within a day or two, they could assume the results were in range. This is what the patient believed when she came in to have her blood drawn for INR levels one Thursday. The patient had comorbidities and took medications that potentiated the anticoagulating effect of warfarin, and her INR levels had varied considerably during the six months she had been on warfarin.

The following day (Friday), the FP and his staff planned to be out of the office after 1200 for continuing medical education (CME). No patients had been scheduled during this time. They did not plan to change the standard message on the office telephone, which directed callers to call the FP's cellphone number or the Emergency Department (ED) during business hours. (After business hours and on the weekends, the calls were routed to a physician who covered calls for the FP.) Consequently, anyone calling the office from 1200-1700 on that Friday would not know the office was empty. The FP planned to check his cellphone messages during breaks or following the CME training.

By 1200 Friday, the lab had determined the patient's INR was 7.6, which the lab considered "significantly abnormal." (The therapeutic range for this patient was 2.0-3.0.) The lab's policy was to communicate significantly abnormal results directly to the ordering physician. The lab technician called the FP's office line twice on Friday afternoon to report the INR, leaving messages on the cellphone both times. When the FP did not return the second message, the lab technician faxed the INR result to the office. Because no one was in the office, the faxed results were not read. The FP, who usually did not turn his phone off, forgot to turn it back on until Monday. Meanwhile, because the patient did not receive a telephone call from the FP, she assumed her INR was within therapeutic range and continued taking the warfarin as directed.

On Monday morning, the FP discovered the result and called the patient's home telephone number, but no one answered. He left a message for the patient to call the office, but was vague because he did not want to violate HIPAA. Monday evening, the patient died as a result of a massive brain hemorrhage. The patient's husband filed a lawsuit alleging the standard of care required patient notification of the INR results on Friday afternoon. He further alleged that such notification would have resulted in lifesaving intervention.

Experts believed the patient's higher risk for hemorrhage and fluctuating INR levels required the FP to be more vigilant in following up on her INR results. They were critical of his failure to communicate the INR results to the patient on Friday. This case is a good example of how easily a significantly abnormal test result can slip through the cracks when policies and procedures are lacking or ignored. Various system changes could have reduced the potential for patient injury in this case. For example, since the physician knew he was not going to be in the office on Friday, and that the INR results generally took a day and a half to return, he could have scheduled the patient earlier in the week to ensure he received the results in a time frame that allowed for prompt communication. The FP and his office staff also failed to consider the risks associated with giving callers the impression the office was open on that Friday afternoon. The lab technician would have directly contacted the patient with the INR results, had he been aware that no one was available to receive the results that Friday. Clearly, the FP's failure to check his messages from the office on Friday was a problem. Finally, the FP's practice of telling patients to expect notifications only for abnormal INR results - "no news is good news" - foreclosed an opportunity for the patient to discover the results before the injury occurred.

Case Two

Allegation:

Failure to promptly follow up on abnormal lab values resulted in permanent injuries.

An eight-year-old patient presented to a pediatrician for a well-child exam. The patient's clinical presentation was unremarkable and she had no complaints. The pediatrician ordered routine labs. One of the values was significantly abnormal, but not technically critical, according to the laboratory's results notification policy. Had it been critical, the laboratory would have directly communicated the result to the pediatrician. The value was not highlighted on the faxed lab report that arrived in the pediatrician's office two days later, although the normal range was listed next to it, indicating that it was abnormal. According to office policy, when a patient's values from routine labs were out of range, but not designated as critical (which would be immediately referred to the pediatrician), a receptionist contacted the patient's parent and set up an appointment to repeat the test, which occurred in this case.

A few days before the scheduled appointment to repeat the test, the child presented to the ED in critical condition. She sustained permanent injuries. The parents filed a lawsuit alleging the pediatrician's failure to promptly advise them of the abnormal laboratory value resulted in delayed diagnosis and treatment.

Overwhelming volumes of test result data can negatively impact patient safety.1 Consider the following strategies:1,3 Carefully consider the tests you order based on each patient's clinical presentation, symptoms and needs. Review the results of the tests you order. Establish strategies for communicating different categories of results (e.g., critical, significantly abnormal, abnormal, normal). Establish time frames for delivering different categories of results to patients (e.g., critical results should be immediately and directly communicated to patients.) Do not overly rely on laboratory definitions of critical values. Individualize critical values for patients. For example, a patient with kidney disease whose normal potassium level is above normal will have a different critical level than an average patient. Document review of the results and plans for follow-up or treatment. Document efforts to communicate and actual communication of results to patients. Even if ordering a test is not required by the standard of care, once you order the tests you have to respond appropriately to the results.

Do You Have an Effective "Tickler System"?

Evidence of absent or poor follow-up systems can be used to support negligence allegations and to shed a generally negative light on the defendant physician during malpractice litigation. There are a variety of ways to ensure patients receive test results in a timely fashion. Consider the following recommendations:*

• Utilize the tracking and follow-up capabilities in an electronic medical record system to their full capacities.
• Ask the laboratory/radiologist/pathologist how long it will take to provide results and use this time frame when developing a follow-up system.
• When ordering tests, tell patients approximately how long it will take to obtain results and advise them to call by an appropriate date if they have not been advised of the results.
  • Requesting the patient's involvement in follow-up should enhance, not replace, an office "tickler system."

• For manual tracking, consider implementing the following:
  • Place copies of all ordered tests in a designated file.
  • Monitor this file regularly to ensure that all ordered tests have been completed and that you have received the results.
• Contact patients and/or consultants and/or the facility conducting the test to determine the reason for delayed tests or missing test results.
• Utilize a tracking mechanism to compare all tests ordered with the corresponding results.
• Document follow-up communication in the medical record.
• Audit communication processes to ensure compliance with reporting procedures and the timeliness of abnormal test result follow-up.

Resources
*Singh H, Vij MS. Eight Recommendations for Policies for Communicating Abnormal Test Results. Jt Comm J Qual Patient Saf. 2010 May;36(5):226-32. Available at: www.jointcommissionjournal.com... (accessed 1/24/2017).

Case Three

Allegation:

Delayed diagnosis and treatment, due to failure to promptly communicate abnormal results to the patient, caused the patient's injuries.

A laboratory offered a primary care clinic a free trial to use its electronic laboratory results reporting system. The system provided the physician users with access to all of their patients' laboratory results on a portal and also automatically printed partial results on a designated printer in the physician's office as they became available and a final report when all of the patient's results were complete. The new system also provided a way to integrate previously faxed laboratory results into the primary care office's electronic health record (EHR) system. (Integration was not part of the free trial.) The office manager accepted the offer. During the trial, physicians had various ways to access test results: The office continued to receive final reports by fax, and physicians had access to the portal and the partial and final reports printed out at the designated printer.

A few physicians in the practice refused to use the new system. They requested staff to only notify them when a final laboratory report was received by fax. One Friday, a series of partial laboratory results for one of the physician's patients came through the designated printer. Some were significantly abnormal. As directed, staff held the partial results in the patient's file. The complete report was faxed to the office the following Monday. The physician, noting the significantly abnormal results, attempted to contact the patient to advise him to go to the ED, but the patient had already sustained injuries from his untreated condition. The patient's wife sued the physician and the clinic, alleging delayed diagnosis and treatment caused the patient's injury.

The defense of the physician was significantly complicated by his failure to respond to the abnormal partial results. Experts believed the patient could have avoided injury if his treatment had started two days earlier. The physician's rejection of the new process, and the fact that the abnormal results would not have been available to him had the clinic stayed with the faxed final results system, did not excuse his failure to promptly respond to the partial results.

It is important for offices to have a way to respond to test result abnormalities whenever they are delivered. Changes in processes relating to retrieving test results and promptly communicating those results to patients require careful planning, implementation and assessment.⁸ Consider the following recommendations:⁶

• Implement test result communication policies that reflect feedback from clinicians and staff.
• Before making changes to test result communication processes, obtain buy-in from physicians and staff who will be using the new processes.
  • Involve clinicians and staff in changes to test result processing and communication policies and procedures.
  • Plan for the accommodation of physicians and staff who are slow adapters.

• On a regular basis assess the safety of your test result communication and follow-up system.
• Conduct a safety analysis prior to instituting a new system.
  • Consider using the various SAFER tools available at: www.healthit.gov/safer/guide/sg008 (accessed 1/23/2017).

Case Four

Allegation:

The physician's failure to convince the patient to seek urgent treatment contributed to her death.

A 75-year-old patient with multiple health conditions and early-stage dementia was hospitalized after a fall. During her week-long hospitalization, she was diagnosed with atrial fibrillation and was started on warfarin. She was discharged after a week in the hospital. Two days after discharge, the patient was examined by her long-term FP. He noted that her atrial fibrillation had converted spontaneously and told her to stop taking the warfarin. At her two-week follow-up, she admitted she had not stopped taking warfarin. The FP again told her to stop, and ordered INR levels. The lab report indicated the patient's INR was 17.5. He called the patient and told her to go immediately to the ED because of her dangerously elevated INR. The patient refused. She died the next day. The patient's family sued the FP, alleging his negligent management of the patient's anticoagulation caused her death.

Case Five

Allegation:

Failure to diagnose and treat meningococcal sepsis and meningitis resulted in brain damage.

On a Wednesday at 1700 a patient presented to the ED complaining of fever, chills, vomiting, diarrhea, sore throat, dizziness, body aches, headache and petechial rash. Initial laboratory results included an elevated white blood cell count with a shift to the left, and a low platelet count. The ED physician diagnosed gastroenteritis, dehydration and thrombocytopenia. The patient did not have a PCP; therefore, the patient was admitted to the family practice service and the on-call FP. On Thursday morning, the FP made rounds at the hospital and saw the patient at 0930. The FP concluded that the patient could be discharged. He invited the patient to follow up at his family practice group, but the patient indicated he would most likely pick a practice closer to his home for primary care.

By Friday morning, the patient's blood cultures had grown a colony of gram-negative diplococci. A laboratory technician called and faxed the results to the family practice group. Staff at the group had not set up a chart for the patient because the FP had reported the patient would establish care at a different practice. The person who took the call told the laboratory technician that she had no record of the patient and made no further effort to route the results to one of the FPs in the practice.

On Friday night, the patient collapsed at home and was taken back to the ED by ambulance. By the time he was examined, he was comatose. Meningitis was confirmed by a spinal tap. Lifesaving efforts succeeded; however, the patient suffered permanent brain damage requiring around-the-clock nursing care. His wife brought a lawsuit against the ED physician, the FP, his group, and the hospital, alleging failure to diagnose and treat meningococcal sepsis and meningitis.

According to experts who reviewed this case, a duty of care was established toward the patient when he was admitted to the on-call FP and he examined the patient. That duty of care included responding to the critical results that were delivered to the office on Friday, after the patient's discharge from the hospital. Even though the patient had expressed a desire to establish outpatient care with another physician, the FP had no verification that was actually done. It would be unlikely that the patient had time to do so between his discharge from the hospital and the time the critical result was reported to the FP's office. At the very least, the FP had an obligation to find out if the patient had established care elsewhere and to notify either (or both) the patient and the other physician of the critical result.

When multiple clinicians are co-managing a patient, responsibility for test result follow-up may be ambiguous.¹² In addition, patients who are assigned to on-call physicians can easily fall through the cracks after discharge from the hospital. Test result processing policies and procedures can help staff and clinicians appropriately handle unusual circumstances. Consider the following strategies:

Administrators

• Create policies and procedures that clearly describe responsibility for test result follow-up and communication.
  • Ensure clinicians and staff understand their responsibilities pursuant to the policy through training and evaluation.
• Ensure that your office has effective telephone call policies and protocols for responding to critical, significantly abnormal and unexpected test result reporting.
  • Encourage staff to seek physician input when telephone calls require clinical judgment.
• Ensure patients who establish a relationship with the group through the ED or hospital admission are accounted for in the practice's follow-up processes.

Physicians

• If you accept a patient into your service at the hospital while serving on-call, ensure your practice accounts for the patient in the office follow-up system.
• If you believe you have relinquished control of a patient's management to another physician, confirm and document it.
• When you receive a report that includes an actionable finding that demands prompt follow-up and treatment, determine who is coordinating follow-up and treatment.
  • If someone else is coordinating care, confirm that the patient or the treating physician has been informed of the finding.
• Document conversations with other physicians about follow-up responsibilities and with patients about follow-up needs.

Case Six

Allegation:

Failure to discover abnormal lab results prior to preoperative evaluation caused the patient's death.

A surgeon scheduled a 60-year-old male patient for surgery on April 10 for a bleeding peptic ulcer. On April 6, preoperative labs ordered by the surgeon revealed a significantly elevated platelet count. On April 7, the surgeon faxed the lab results to the patient's FP. On April 8, a nurse from the hospital called the FP and asked her to evaluate the patient for surgery. The FP misunderstood the nurse and believed the patient was scheduled for surgery on that day - she believed it was an urgent request. The FP pulled the patient's records up in the office EHR and saw nothing concerning. Assuming preoperative labs had been done and that the labs had not yet arrived at her office, the FP asked the nurse if the patient's labs are normal. The nurse stated the labs were normal and the FP indicated that the patient was medically stable to undergo surgery. The anesthesiologist relied on the FP's statement to determine the patient was an appropriate candidate for anesthesia. Following surgery, while still on the operating table, the patient coded and could not be revived. Autopsy indicated he died as a result of disseminated intravascular coagulation (DIC) and platelet thrombosis.

Many weeks later, the FP learned the patient had died following surgery. She reviewed the EHR again to see if she had missed something. She then realized that the preoperative labs had been faxed to her office by the surgeon April 7, but she had not been aware of them because they had not yet been scanned into the EHR. The patient's family sued the surgeon, FP, anesthesiologist and hospital, alleging the patient should not have undergone surgery with the severe case of thrombocytosis.

Data overload and the necessary, yet time-consuming nature of test result follow-up can put physicians under the kind of stress that increases the risk of adverse events. Policies and procedures for significantly abnormal test result follow-up must be fail-safe in order to manage the risks of a missed or delayed diagnosis. Prompt follow-up often requires the coordinated effort of many different staff members and clinicians in various locations, who communicate using different methodologies. Every person in the communication chain can contribute to a successful patient outcome or can cause a patient injury. Therefore, it is important to use redundant systems that create the best chance of a successful outcome.