Test Tracking Processes: Eliminate Gaps to Reduce Risk

A pediatrics practice recently consulted MICA’s Risk Team asking, “What is our liability when patients’ parents don’t follow through with lab work or other diagnostic testing we order?” Maybe you and your practice have the same question, or a slightly different one like, “What systems can we implement to alert us to imaging/lab studies that we order but don’t receive?” At the root of these questions is the same theme: efficient, safe, and effective management of test orders and results. The topic is vitally important for patient safety and health care risk management, so here we share our guidance and recommendations.   

The Consequences of Mismanagement 

“Closed loop communication” refers to a process which ensures every test or referral order is sent, received, acknowledged/reviewed, and acted on. It starts with the patient (an order) and ends with the patient (communication of results and any follow-up or treatment plan). In contrast, failure to “close the loop” occurs when there are gaps in the process or communication breakdowns which permit patient test results to fall through the cracks before the loop/process is complete. Examples of these failures include: 

• • Patient never completed ordered test. Clinician/practice fails to notice there are no results or does not document follow-up attempts to get the patient to comply;
     
  • Lab/imaging results not logged/tracked;
     
  • Results not provided to clinician for review;
     
  • No review by clinician of results he/she received;
     
  • Results not entered in medical record;
     
  • Patient not notified of results; and/or
     
  • Patient with abnormal results not monitored through follow-up. 

Breakdowns in the management of test orders and results may compromise patient safety and expose physicians, advanced practice providers (APPs), and their practices to lawsuits and board complaints. Failures can result in missed or delayed diagnoses (collectively, “diagnostic error”). Diagnostic error has long been a leading cause of malpractice lawsuits. A study of closed claims involving diagnostic error found that the vast majority of errors occurred in the “testing and results processing” or “follow up and coordination” stages of the diagnostic process. This includes: 

• • Failure to review results,
     
  • Failure to communicate results to patients, and 
     
  • Breakdowns in coordinating and documenting follow-up testing or treatment.  

To reduce exposure, physicians, APPs, and their practices should: 

• Implement effective processes to track test/imaging results through each stage of the process until the loop is closed;
   
• Educate employees to follow these processes; and
   
• Conduct periodic assessments to identify weaknesses or gaps and implement corrections aimed at closing the communication loop. 

Patient Responsibility vs. Clinician Duty 

Some practices ask patients to sign a form acknowledging a responsibility to follow up if they don’t receive results. Although acknowledgement forms have their place, practices should be careful with wording.¹ Patients should not be cast as the ones primarily in charge of chasing results.  

While patients must assume some responsibility in the clinician-patient partnership, relying on patient follow-up in place of an effective tracking system is the wrong approach. Physicians and APPs owe a legal duty of care to their patients. In a delayed diagnosis lawsuit, a plaintiff’s attorney could credibly argue that a reasonable physician should have a reliable system in place that tracks test orders and alerts the physician when results are not timely received. In a case where the results were in the chart but not communicated to the patient or where the lab didn’t send results, a clinician who ignores his/her own systems failures and resorts to blaming the patient for lack of follow-up will likely lose credibility and appear unprofessional in the eyes of a jury or a licensing board.  

No News is Good News, NOT 

MICA recommends against the common practice of telling patients, “No news is good news” or “If you don’t hear from us, then everything is good.” Practices should notify patients of all lab and test results, whether normal or abnormal. Practices have a responsibility to implement effective processes to track receipt of results and ensure timely review by clinicians with notification to patients. 

The better practice, although clinicians and practices should avoid placing primary follow-up responsibility on patients, is to ask patients to call the practice if they don’t receive results within a specified timeframe. This instruction, if patients follow it, may help avoid catastrophic consequences of a tracking system failure where results are not communicated, and the patient is not scheduled for a follow-up appointment or does not return to the clinic until the next annual exam.  

The following scenarios, based on closed claims from CRICO (the insurer of Harvard-affiliated entities), illustrate clinician communication failures caused by tracking systems breakdowns. While we don’t have all the facts, it is possible that had the patients called for missing results, the outcomes would have been different. 

• • The PCP ordered a chest CT for a 64-year-old patient with shortness of breath and a complex medical history. The radiologist identified an incidental lung nodule and recommended close monitoring. The PCP failed to notify the patient of the results or need follow-up. The patient died 18 months later from lung cancer. 

• • A gynecologist’s biller, reviewing the chart to send to collections, discovered abnormal colposcopy results requiring follow-up that were never communicated to the patient. 

Clinicians and practices should note that telling patients to call for expected results not received is purely a safety valve measure. It is an opportunity to avoid patient harm due to a tracking system failure. If the patient doesn’t call for results and, for example, there is a delayed cancer diagnosis due to a tracking system breakdown, it likely would not be an effective defense in trial or before a licensing board to blame the injured or dead patient for not following up for results.  

Applying Informed Refusal to Closing the Loop 

Sometimes results never arrive because the patient never completed the ordered test. There are multiple reasons why patients don’t complete tests including: 

• • Financial concerns,
     
  • Insurance barriers, and
     
  • Scheduling or travel difficulties related to child-care arrangements, transportation issues, and other personal reasons. 

In these instances, clinicians sometimes ask whether they could still be sued for delayed diagnosis if it was the patient who caused the delay by not timely getting the test.  The answer is likely, yes, especially if the patient lacks an understanding of what a particular test is or why their physician or APP ordered it. 

Providing sufficient, easily understandable patient education at the time the test is ordered, and documenting it, can reduce exposure to this type of claim. This process is much like documenting informed refusal because it involves educating the patient about the risks and consequences of not timely completing the recommended test. You can use this approach even though the patient is not “refusing” to complete the test.  

Documentation reflecting that the patient received education in patient-friendly terms about the importance of the test goes a long way towards weakening the claim, “I couldn’t schedule the test because… I am a fulltime caretaker for my mother/I didn’t have anyone to watch my kids. If only I had known it was necessary for a timely diagnosis of my illness, I would have figured out a way to get the test. Now I have inoperable cancer.”  

MICA’s The Vital Importance of Documenting Informed Refusal Conversations provides more details about how to have and document these conversations with patients and family.  

Evaluating and Improving Tracking Processes: Resources and Points to Remember 

The Agency for Healthcare Research and Quality offers a toolkit for mapping and analyzing your current tracking process to identify where improvement activities are needed. It also includes a patient handout template in English/Spanish that clinicians can use to reinforce information provided during the visit concerning the test purpose and/or results. 

In addition, consider the following tips when optimizing your process. 

Evaluate your patient education process/documentation and consider:  

• • The teach-back method can be helpful in monitoring whether patients understand what you told them about why you are ordering the test. 
     
  • Chart audits may reveal a need for more thorough documentation of these conversations to reflect the information provided by the clinician. Sometimes, it can be helpful to ask yourself whether your note would convey to a jury the information you covered with the patient.
     
  • Consider developing handouts that patients can take home explaining the purpose and importance of certain tests you regularly order and when/how results will be communicated. 
     
  • Forms should be relatively short and written around the 6th grade reading level to ensure ease of understanding for all patients. 

When evaluating your tracking processes, consider: 

• • If, when the test is ordered, you schedule a follow-up appointment to discuss results, make sure your tickler system will alert you if a patient later cancels or no-shows for the appointment. This may be as simple as keeping a list of daily cancels/no-shows and developing processes to ensure patients are contacted and rescheduled.
     
  • Take advantage of your EHR’s capabilities. Work with your vendor and IT to determine what reports you can run to track orders that still need results, orders where results have been received but not communicated, etc.
     
  • Errors can occur even in automated electronic processes. Conduct periodic monitoring to decrease the risk that such errors go unnoticed. 
     
  • If your EHR’s tracking capabilities are inadequate, manual processes must be developed and implemented to close the gaps. This may be as simple as a log where all test orders are entered and columns for each stage of the process are checked off as completed.
     
  • Systems to ensure that clinicians receive and review results are crucial. If your EHR does not support this, some practices put a stamp on all results where clinicians can initial after completing their review and communication. Filing does not occur without this. 
     
  • In case of extended clinician illness or vacation, systems should be in place that notify a backup clinician of the need to address results awaiting review and follow-up. 

When evaluating your results communication processes, consider: 

• • Many patients still do not/cannot access portals. Avoid using portal messages or email alone to communicate results requiring follow-up action.
     
  • If calling to notify a patient of abnormal results, a clinician should call rather than unlicensed staff who will be unable to answer patient questions.
     
  • The number and method of attempts to contact a patient depends on the results being communicated and the need for follow-up. Dangerously high or low lab results may require multiple phone calls or even reaching out to another physician of record in the chart to see if they are in current contact with the patient. Communicating the need for follow up of a potentially terminal pathology result requires continued follow up by every method possible.
     
  • All communications/attempts should be adequately documented at the time they occur. Chart audits can identify a need for improvement.
     
  • After results communication, it is important to have a system in place to ensure necessary follow-up appointments are made and kept. 

 

^{[1] MICA’s Risk Team consultants are always happy to review your forms and offer feedback and suggestions. Contact us at rm_info@mica-insurance.com or 800-705-0538.}