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We’ve done many columns, listed below, on serious patient injuries occurring when significant test or imaging findings are not promptly conveyed to responsible physicians or to patients. There are many reasons, related to both human factors and system issues, that significant results “fall through the cracks”. Responsibility to ensure closing the loop is the responsibility of the ordering physician, the radiologist/imager (or lab for lab test results), the physician primarily responsible for management of the patient, and the patient him/herself.
We’ve described systems that need to be put into place to help avoid such failures. Physicians ordering a test or imaging study need to have some sort of tickler mechanism that alerts them when results of a test or study have not been received within a specified time frame. Especially problematic is when the ordering physician is different from the physician primarily responsible for management of the patient. Such vulnerability is often seen when patients are hospitalized or seen in an emergency department (ED) and the formal report of that study is not yet available when the patient is discharged. Systems must be put in place to alert the next care physician that there is a “pending” test result so that that physician can appropriately follow up.
Patients also have a responsibility. After all, it is their health and well-being that is at risk. We always counsel patients that “no news is not good news” and that they should always discuss with their physician how test results will be communicated to them and that they need to contact the physician if they have not heard from him/her within a reasonable time.
Lastly, the radiologist or other imager (or the lab in the case of lab testing) has a responsibility to make sure the presence of any significant finding gets communicated to the responsible physician and, ultimately, the patient. Failure to communicate significant findings is also a factor in a large percentage of malpractice claims against radiologists.
To address the latter issue, Pennsylvania has passed a new law, the “Patient Test Result Information Act” (Pennsylvania General Assembly 2018), that will go into effect in December 2019. The act requires that the patient be directly notified within 20 days when a diagnostic imaging exam is performed that identifies a “significant abnormality” may exist. “Significant abnormality” is defined as one that “would cause a reasonably prudent person to seek additional or follow-up medical care within three months.” The law was actually passed in 2018 but implementation was delayed until December 2019 in order to give hospitals and imaging practices time to implement systems to facilitate compliance.
Here’s what the “Patient Test Result Information Act” (Pennsylvania General Assembly 2018) says:
“When, in the judgment of the entity performing a diagnostic imaging service, a significant abnormality may exist, the entity performing the diagnostic imaging service shall directly notify the patient or the patient's designee by providing notice that the entity has completed a review of the test performed on the patient and has sent results to the health care practitioner who ordered the diagnostic imaging service. The notice shall include all of the following:
(1) The name of the ordering health care practitioner.
(2) The date the test was performed.
(3) The date the results were sent to the ordering health care practitioner.
(4) The following statements:
‘You are receiving this notice as a result of a determination by your diagnostic imaging service that further discussions of your test results are warranted and would be beneficial to you.’
‘The complete results of your test or tests have been or will be sent to the health care practitioner that ordered the test or tests. It is recommended that you contact your health care practitioner to discuss your results as soon as possible.’
(5) The contact information necessary for the patient to obtain a full report.
(b) Exceptions.- The following shall be exempted from the requirements of subsection (a):
(1) Routine obstetrical ultrasounds used to monitor the development of a fetus.
(2) Diagnostic imaging services performed on a patient who is being treated on an inpatient basis or in an emergency room.
(3) Diagnostic radiographs.”
Apparently, a separate notice is not required if the patient was told of the result at the time of the visit or if the patient was given a copy of the report during the visit.
Note that the act specifically exempts 2 scenarios we mentioned above as significant vulnerabilities – patients admitted to hospitals or seen in the ED. It also exempts “diagnostic radiographs” from the notification requirement. We don’t know why the latter would be exempted since one of the most common scenarios is an X-ray ordered looking for pneumonia may yield a significant unrelated finding.
While it is critical that patients be informed about significant findings on imaging studies, imagine yourself (as a patient) getting such a notice by mail! You’d probably panic! Therefore, many imaging practices will contact and discuss with the physician responsible for management of the patient, then delay for several days sending out the notice to the patient (so sufficient time has elapsed for the patient’s physician to discuss the findings with the patient).
A recent article in the Journal of the American College of Radiology (Mittl 2019) discusses how imaging practices in Pennsylvania are complying with the new law. Some organizations or groups are using a “hard-stop” approach. That means the imager, when dictating his/her report, would indicate whether a patient notification is required. Some include a sentence at the end of the report that then gets incorporated into an automated letter of notification to the patient. Yet others use standardized language within the report to flag cases that require a letter to the patient.
Flagging significant findings that merit follow up and tracking for that follow up can be difficult, given that sometimes items can appear in different fields in electronic medical records. One article (Farrington 2019) discusses use of AI (artificial intelligence) and NLP (natural language program) or machine learning to identify these items in different parts of the EMR.
The Farrington article also notes corrupt speech files often cause incorrect dictation. We’ve previously discussed problems with voice dictation software in radiology (see our Patient Safety Tips of the Week October 4, 2011 “Radiology Report Errors and Speech Recognition Software” and July 24, 2018 “More on Speech Recognition Software Errors”).
But, besides needing such a process to flag reports that require patient notification, imagers face other challenges in communicating the need for follow up to the responsible parties. One problem encountered too frequently is inability to correctly identify the physician responsible for management of the patient. Sometimes the ordering physician is different from the physician responsible for management of the patient (it might be a covering physician or a physician rotating through an outpatient clinic). In other cases, the name of the wrong physician is entered into the radiology IT system. Another problem we’ve seen in some hospital electronic medical record systems is that the number of physician ID fields is limited and sometimes the field for the patient’s PCP (primary care physician) gets used for other purposes. The other problem, of course, is when the patient changes PCP’s and the systems are not updated to reflect the change. Therefore, it is always wise to ask the patient at the time they register for the imaging study who is their responsible physician and to whom they want reports to be sent. (But please see our October 13, 2009 Patient Safety Tip of the Week “Slipping Through the Cracks” in which we cite a paper (Singh 2009) that demonstrated dual alerts (those sent to both the referring physician and the primary care physician) were twice as likely to go unacknowledged.)
Organizations and practices also need to determine how to notify patients of the significant findings. Apparently, the notice may be delivered to the patient using any one of the following methods, as long as it is acceptable to the patient (HAP USA 2018):
- US Postal Service mail
- “Automatic Alert” from the practice’s EHR that a notice has been posted to the patient’s electronic health record
- Directly to the patient at the time of service, so long as the patient acknowledges the receipt of the results and signs the medical record.
Thus, it would make sense to, at the time of patient registration for the imaging study, notify the patient of the new law’s requirement, and ask them not only which physicians they want the report sent to, but also what method they themselves prefer if such notification is necessary.
But, note that we do not recommend faxing the reports to patients. We highlighted the surprising continued role faxes still play in healthcare and the problems associated with them in our January 16, 2018 Patient Safety Tip of the Week “Just the Fax, Ma’am” and the several other columns listed below. The risk of violating patient privacy is too great. Not only does it risk having a relative or coworker read the letter, but the last thing you want is your faxed letter erroneously going to a local supermarket or other unintended phone number!
Then there is the problem of tracking whether the patient actually gets appropriate follow up. Some radiology IT systems help track whether a patient has had a recommended follow up. But those may not find instances where such follow ups were done at a facility outside their own organization(s). In other cases, the findings may have been discussed by the responsible physician and the patient, but the decision was made, for whatever reason, not to pursue follow up. The radiology practice would have no way of knowing that. For example, an imaging practice in the Northeast might look for follow up on a patient who happens to be a “snowbird”, wintering in Florida. That patient may well have had the recommended follow up in Florida but records of that follow up may not be available to the Northeast imaging practice.
We are cautiously optimistic that the new Pennsylvania law will reduce the number of cases of serious findings “slipping through the cracks”. Measuring its impact may be difficult. Probably the only way to do this will be to look at malpractice claims and that may not provide an accurate picture. We would also be on the alert for potential unintended consequences. We’re also concerned that the exemptions for patients hospitalized or seen in the ED and those for plain radiographs will leave unaffected areas we see as especially vulnerable.
The new Pennsylvania law is a start. Imagers are but one of several persons who must be responsible for ensuring adequate tracking and follow up of studies ordered and/or done on patients. See our prior columns, listed below, for comments on what each person should be doing to avoid “slipping through the cracks”.
See also our other columns on communicating significant results:
See our prior columns on problems related to use of fax in healthcare:
June 19, 2012 “More Problems with Faxed Orders”
January 16, 2018 “Just the Fax, Ma’am”
September 2018 “ECRI Institute Partnership: Closing the Loop”
January 2019 “Still Faxing?”
Pennsylvania General Assembly. PATIENT TEST RESULT INFORMATION ACT – ENACTMENT. Act of Oct. 24, 2018, P.L. 719, No. 112 Cl. 35
Mittl GS. Hill PA, Cook TS, et al. Ensuring Patient Follow-up of Significant Abnormalities Under Pennsylvania Act 112. Journal of the American College of Radiology 2019; Published online: September 28, 2019
Farrington R. How to protect your practice from missed follow-ups. AuntMinnie.com 2019; October 7, 2019
Singh H, Thomas EJ, Mani S, et al. Timely Follow-up of Abnormal Diagnostic Imaging Test Results in an Outpatient Setting. Arch Intern Med. 2009; 169(17): 1578-1586
HAP USA (Healthcare Administrative Partners). Pennsylvania’s “Patient Test Result Information Act”. HAP USA 2018; December 21, 2018
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