Tuesday, June 23, 2020

Determining COVID-19 Status in an EMR

Hi to my fellow CMIOs, CNIOs, #HealthIT friends, and other Clinical Informatics professionals,

For most of us, the last few months have been very busy. At no point during my medical education did I ever think we would all be working one day in the middle of a global, 1918-style pandemic.  And yet, here we are. For my fellow healthcare workers, I hope you and your families are all safe and healthy.

While there continues to be national debate about how best to manage our global crisis, there seems to be one thing most experts agree on - Having good data is key to planning and public health decision-making. 

So as a Clinical Informaticist with a background in public health and epidemiology, I'm always especially interested in the national (public) discussion about total numbers
  • How many people have been infected with the SARS-2-Novel Coronavirus?
  • How many people have active infections with the SARS-2-Novel Coronavirus? 
  • Of those infected - how many display symptoms of COVID-19? How long after infection with the SARS-2-Novel Coronavirus, and for what duration?
  • Of those infected - how many have COVID-19 illness that progresses to severe illness and/or death (case fatality rate)? How long after infection?
And yet, with all of these questions, here's one I find the most puzzling

"Q : How do you know if a patient has COVID?"

While this might seem like an easy question (A: read the chart!), in reality - it's anything but simple

It's tempting to just look in a chart for "COVID" or "COVID-19", but it's important to consider that the virus is actually called the "Novel SARS-Covariant-2 RNA virus".
  • "Novel SARS-Covariant-2 RNA virus" = The new coronavirus that actually infects people, reproduces inside their cells, and may/may not cause symptomatic disease.
  • "COVID-19" = The constellation of symptoms that are caused by the Novel SARS-Covariant-2 RNA virus
So it's entirely possible to :
  • be infected with the Novel SARS-Covariant-2 RNA Virus, with NO SYMPTOMS OR
  • be infected with the Novel SARS-Covariant-2 RNA Virus, with symptoms of COVID-19 disease. 
  • assume that patients with symptoms of COVID-19 disease should be tested for the Novel SARS-Covariant-2 RNA Virus, to determine if that is the cause of their disease symptoms.
And so when someone asks, "Q : How do you know if a patient has COVID?", it's first important to distinguish : 
  • "Did you mean how many people are CURRENTLY Infected with the Novel SARS-Covariant-2 RNA Virus?" OR
  • "Did you mean how many people total have been Infected with the Novel SARS-Covariant-2 RNA Virus, since the beginning of the outbreak?" OR
  • "Did you mean how many people infected with the Novel SARS-Covariant-2 RNA Virus have developed symptoms of COVID-19 disease?"
Always remember, when reporting data, especially to researchers or regulatory agencies - it's very important to first make sure you know exactly what is being asked

To help answer the question, "Q: Does this patient have COVID?", there are a surprising number of different places you might look in a medical record : 
  1. The Chief Complaint, (e.g. "cc: COVID symptoms" or "cc: Fever, Respiratory Symptoms" or "cc: Suspected COVID" or "cc: Suspected Pneumonia") - This gives you some insight about what type of symptoms the patient might have had on arrival. 
  2. The History of Present Illness (e.g. "75M with recent travel to country with high COVID activity and recent exposure to known COVID patient (8d ago), who now presents with home temp of 103 and worsening shortness of breath x1 day.") - This helps further establish the likelihood of COVID-19 disease, but may not always be conclusive.
  3. The Review of Systems (e.g. "+Fever, +Chills, +Cough, +Worsening exertional dyspnea, +Weakness") - Again, like the History of Present Illness, this is suggestive, but not conclusive of disease.
  4. The Vital Signs (e.g. "HR=120, BP=100/60, O2sat=75% on RA") - This also helps build the case that the patient has COVID-19 disease symptoms, especially the low O2 sat, which has been a hallmark of disease in patients with severe symptoms. But keep in mind : Normal vitals do not exclude disease
  5. The Radiology (e.g. Chest X-ray or CT Scan showing bilateral ground glass opacities, CT Angio showing pulmonary embolism, or ultrasounds showing DVT/VTE) - This further helps establish clinical suspicion of COVID-19 disease and SARS-CoV-2 RNA Virus Infection - But is not confirmatory
  6. The Routine Labwork (e.g. Lymphopenia, elevated Ferritin, elevated D-Dimer, Renal Insufficiency, Transaminitis) - This pattern helps establish suspicion of SARS-CoV-2 Infection and possibly COVID-19 disease, but is not confirmatory.
  7. The Diagnostic Labwork - Nasal Swabs (e.g. Positive SARS-CoV-2 RNA PCR Nasal Swab) - This is helpful and confirmatory, to determine if your patient has COVID-19 disease symptoms caused by the Novel SARS-2-CoV RNA Virus - But remember that most nasal testing, as of this post, is only about 90% sensitive. So about 1 in 10 people with a negative result may in fact actually have the disease. (As of this writing, I'm not entirely sure if this refers to testing patients WITH symptoms, or testing patients WITHOUT symptoms - If you have a good answer to this, please feel free to comment below!)
  8. The Diagnostic Labwork - Antibody Serologies (e.g. Positive IgG antibodies to the SARS-CoV-2 RNA virus) - This can help determine a prior infection, provided the patient has enough time and immune response to develop antibodies. (I'm not sure if anyone has good data on timeframes for developing antibodies - If you have a good answer to this, please feel free to comment below!Presuming the test is a reliable one, having antibodies suggests that the patient was at least exposed to the virus. Not having antibodies is not as helpful diagnostically. 
  9. The Admission Diagnosis (e.g. "Respiratory Symptoms" or "Pneumonia" or possibly "COVID-19") - This can be very helpful, and it is a required data field in most hospital admissions. If the clinical suspicion from the initial workup is high enough, and there is maybe even laboratory confirmation of SARS-2-CoV RNA Virus infection, it's possible this might list "COVID-19disease as an admission diagnosis. Keep in mind that during most hospitalizations, often because of the incomplete information on admission, the admission diagnosis is not as accurate as the discharge diagnosis. (E.g. Some doctors might not be willing to call it "COVID-19 disease" until the laboratory confirmation has returned.)
  10. The Discharge Diagnosis (e.g. "COVID-19" or "Suspected COVID-19" or "Suspected SARS CoV-2") - This can also be very helpful, and is also a required data field in most hospital discharges. Remember that because of the additional data obtained during a hospitalization, the discharge diagnosis is usually more accurate than the admission diagnosis
  11. The Active Problem List (e.g. "COVID-19" or "Suspected COVID-19" or "Confirmed COVID-19") - This can be very helpful, since doctors usually have to manually add it to the list - So if it's there, it usually means a doctor had enough clinical suspicion and laboratory confirmation to label the patient as having COVID-19 disease. Keep in mind that some doctors might not put it in the active problem list, and instead put it in their progress notes. 
  12. The ASSESSMENT/PLAN on the Admission H&P, Daily Progress Notes, and Discharge Summary (e.g. "Assessment : Patient with COVID-19 disease, hospital day #2, improving steadily." or "Plan : COVID-19 - Continue current therapy") - This can also be very helpful, since the Admission H&P, Daily Progress Notes, and Discharge Summary are usually the most intimate notes that doctors write in a chart. Depending on the clinical information available when they were were written, they might not confirm COVID-19 disease until later in the hospitalization.
  13. The Death Certificate (e.g. "Primary Cause of Death = Cardiopulmonary arrest, Secondary Cause of Death = COVID-19 Disease, Tertiary Cause of Death = Novel SARS-CoV-2 Infection) - This would be an ideal source of data and mortality, but this can be dependent on the time of death - Death immediately on arrival may not have the symptoms/laboratory confirmation/clinical information available as a death after several days of hospitalization and data gathering. (It may also be dependent on what exactly a doctor writes on the death certificate, e.g. "COVID-19 disease" or "Suspected COVID-19 disease" or "Confirmed COVID-19 disease" or "Novel SARS-CoV-2 Pneumonia"
What does this analysis suggest? That determining a patient's Novel SARS-CoV-2 Infection status or COVID-19 disease status in a medical record (electronic or paper) is not as easy and straightforward as one might imagine. And so, writing data reports for local or national reporting purposes is not easy

If that's true, then how do you develop accurate reports for local and federal reporting purposes? It takes work, but here are a few suggestions I wanted to share : 
  • Before you develop any reports, make sure you familiarize yourself with the different elements of a medical record, and work closely with clinical staff to develop those reports.
  • Try to avoid using a single data point as your source-of-truth.
  • Work closely with your clinical staff to help regularly review and validate your reports.
  • Maintain open discussions about these issues with your report writers, your clinical staff, your legal/compliance team, and your HIM team. 
  • In the absence of manual chart reviews - it would be helpful if software vendors could look at algorithms and artificial intelligence to help review all of these data sources and make a predictive analysis that could be used for reporting purposes.
I hope this helps you better understand the complexities of reporting on both Novel SARS-CoV-2 RNA Virus infections and COVID-19 disease. If you have any tips or tricks you'd like to share, please feel free to leave in the comments section below!

Remember, the information in this blog above is for educational purposes only - Your mileage may vary. If you have any reporting tips or tricks you'd like to share, feel free to leave in the comments section below!


Db said...

Thanks for the informative EHR walkthrough (as well as clinical)!

Sgermanmd said...

Dirk, excellent summary-as always.

Unknown said...

Thanks for sharing. The diagnosis code in the first position on the claim form drives a lot from the billing perspective (waiving out of pocket costs), particularly for commercial carriers.

Great summary on how complex this stuff can get.