Lab Data is the Gold Standard

by | Mar 25, 2020 | Covid-19, Intrepid

 

As Federal, State, and local public health agencies mobilize to respond to the COVID-19 crisis, they are looking to sift through the noise of data available to them to determine how best to plan for the acute management of infected individuals. While data infrastructures across the country handle a variety of different types of data that can potentially be helpful, the single piece of data that is most useful by far is the result of approved COVID-19 testing – the lab result. No other piece of information is as timely, definitive, or specific (from a data quality and completeness standpoint) as a simple laboratory test result. Lab test results are the place where documentation of a positive COVID-19 case will originate in a definitive way – they contain demographic and geolocated information about the individual being tested, and also where that person is seeking treatment (in the form of the ordering provider for the lab test).

 

Unfortunately, this fact is a major problem for a coordinated, data-driven response to COVID-19 in the United States, given significant gaps in the sharing of lab results between key players in the US healthcare system. The implementation of electronic lab data interfaces by public health departments and key data aggregators such as Health Information Organizations (HIOs) is uneven across the national landscape. With the exception of the major reference labs like Quest Diagnostics and Labcorp, the majority of lab results delivery is still done on paper, via fax, a fact that is especially true for public health labs – which are performing the majority of COVID-19 tests to date. Related gaps and bottlenecks in the routing of lab data make it challenging for public health agencies and health care providers to gain access to accurate information on who has COVID-19 and who does not.

 

Diagnosis codes (generally in the form of ICD-10 codes), entered by health care providers into their electronic health records when they make a diagnosis, would seem to present an alternative to lab results for monitoring COVID-19 cases, due to the more universal health care focus on electronic sharing of diagnoses. However, there are three primary obstacles to this approach. First, diagnosis codes currently in use for COVID-19 range from temporary CDC guidance to use a combination of existing ICD-10 codes, to a special World Health Organization ICD-10 code that is being adopted on a region-by-region basis, since it has not gone through the official balloting process for the US healthcare system. Thankfully, an emergency update to ICD-10 with a single diagnosis code for COVID-19 was recently announced for April 1 by the CDC that should help to alleviate this problem.[1] Second, a diagnosis depends on a health care provider actually encountering an individual patient and entering a code (or a combination of codes) – diagnoses rarely if ever are automatically triggered in EHR systems based on the status of a COVID-19 test result. This means that even when they diagnoses are specific enough to be used for syndromic surveillance or other types of monitoring, they are often not timely and skew toward availability for patients that have been hospitalized. Third, many public health departments don’t have ready access to clinical diagnoses anyway, and they often don’t fully trust the data given the issues above.

 

In contrast, they do trust lab data, as it has been largely consistent for COVID-19 testing across the country and stands to be reinforced as the large reference labs come online and implement their LOINC code-sets (which look to conform to what is already in wide use).[2] Unfortunately, lab data is not as cleanly routed through the health data ecosystem as diagnoses are. This is partially due to the fact that electronic interfaces to route these data have generally not been prioritized by States and HIOs, but also due to the fact that key parts of the laboratory ecosystem remain paper-based. Most COVID-19 tests have so far been processed by public health labs, which exist either at the State or local level in most cases – although some States are much more complex and may have many more public health labs than others (New York has two, California had 32[3] listed as of 2018…all at the local or regional level). The vast majority of these labs remain paper-based, and report lab results back to the ordering provider via fax (who then keys the result into the patient’s electronic health record). In some cases, as in both California and New York, the public health labs even report test results on paper or via a secondary data entry method[4] to the public health departments responsible for tracking and managing disease outbreaks like COVID-19. This situation is partially a result of our historical underfunding of public health systems, who have not prioritized electronic laboratory results delivery.

 

Typical “Flow” of Laboratory Results Data, Public Health Labs

 

It is important to understand that in both the commercial laboratory world and also the public health laboratory world, test results are mainly intended to be delivered to the ordering provider – the individual (or facility) that actually ordered the test. Reporting to public health departments for syndromic surveillance sometimes falls on the labs themselves, and sometimes on the ordering provider – something they are supposed to do once they get back the lab result. In some cases, lab results can be sent to a “CC’ed” entity (maybe a public health lab, maybe an HIO) – but this rarely happens outside of the commercial reference labs, since public health labs often lack the resources to send out multiple copies of an individual lab result (especially if they are pushing results out via fax). So in order for public health lab test results to get to State and local public health agencies as well as to aggregators like HIOs, the data is often circuitously routed to ordering providers via fax, who then need to key the information into their EHRs for it to get picked up and reported out to other systems.

 

Reference labs like Quest Diagnostics and LabCorp, on the other hand, often send their results to the ordering provider electronically, and are in some geographies CC’ing HIOs on lab results. While these and other reference labs are still working on implementation of COVID-19 testing, their entry into the space will vastly increase the degree to which electronic lab results for COVID-19 testing are being delivered to both providers and HIOs, in places where an electronic results delivery connection already exists.

Typical “Flow” of Laboratory Results data, Reference Labs

 

The key gap, even with the reference labs, is that HIOs and public health departments are not always on the CC “List” for lab results originating from the reference labs – impeding their ability to utilize this extremely valuable data resource to manage the COVID-19 crisis. In cases where they are, such as in Indiana[5] and New York, HIOs are playing a significant public health role as a de-facto repository of COVID-19 test results, or in the Indiana case, as a centralized alerting service that triggers when a new positive result comes in. But in places where they are not (e.g. many parts of California) they may only be doing so on a comparatively small scale.

 

While we cannot go back in time and fix this issue, we can work to remedy it in the present. HIOs, States, labs and public health agencies should all be building and enhancing current lab data interfaces now. Focusing on less high-fidelity data like diagnosis codes or admit, discharge, transfer data just because it is currently available is not a substitute for getting access to the gold standard for COVID-19 cases. Models like Indiana’s already exist for integrating this information more broadly, and should be replicated wherever possible.

 

[1] Centers for Disease Control and Prevention, March 2020: https://www.cdc.gov/nchs/data/icd/Announcement-New-ICD-code-for-coronavirus-3-18-2020.pdf

[2] LOINC Codes: 31208-2, 75325-1, 94309-2

[3] California Association of Public Health Laboratory Directors, May 2018: http://websites.networksolutions.com/share/scrapbook/74/745076/Laboratory_Listing_Report.pdf

[4] These systems are often a basic web portal that require some degree of demographic information to be entered along with a positive test result LOINC code. They do not transmit a copy of the lab result in any kind of structured, encoded data format and are often very light on the level of information that is required in order to actually submit a case.

[5] Raths, David “Some HIEs Stepping Up to Play Key Role in COVID-19 Response,” March 2020: https://www.hcinnovationgroup.com/interoperability-hie/health-information-exchange-hie/article/21130588/some-hies-stepping-up-to-play-key-role-in-covid19-response

The Calm Before The Storm

by | Mar 24, 2020 | Covid-19, Intrepid

The coronavirus has unleashed a series of paradoxes into our lives. We show solidarity by staying apart, with the belief that young people meeting for brunch endanger elders in rest homes. We cease gathering around dinner tables, while hiking trails are packed not with seekers of solitude but with seekers of social connection (for as long as parks stay open). Waiters have lost their jobs, grocery-store clerks serve on the front lines, and there is no traffic on the Bay Bridge.

It is shocking how quickly we have adjusted to this new normal. At Intrepid Ascent, we’re as connected to each other as ever before even though no one has been in the office for two weeks. Most people I know are having more conversations with family and friends, gathering for virtual chats and checking in through an expanding circle of group texts. People are finding ways to help each other navigate dramatically altered times.

Amid these revolutions in daily life, there’s an eerie sense of calm before the storm in health care. Yes, the planners are busy planning and needed space and equipment are being considered, counted, ordered, set aside. But at least here in California, Emergency Departments and Urgent Care centers are relatively quiet. A large medical center nearby has actually emptied out, keeping doctors and patients at home and as healthy as possible in anticipation of the coming waves of very sick people needing intensive care. And many potential patients are themselves reluctant to visit health care settings, which are perceived to be hot-spots for COVID-19.

So we’re rationing health care, both consciously and unconsciously, on a vast scale in response to the crisis. Not yet in terms of which lives to save with a respirator or bed in the ICU, but in terms of who gets tested and receives sustained professional attention. Given the botched testing regime in the US to date, people with COVID-19 symptoms who do not seem to require immediate intensive care are told that while they probably have the virus, they will not be tested, nor will their contacts be traced. They should stay home and follow the guidelines, no matter how many others they live with or how porous the quarantine.

When such a diagnosis of COVID-19, whether remote or in person, is entered into an individual’s electronic health record, it will be coded in a manner that can be shared and communicated widely beginning April 1, thanks to an unprecedented update to diagnostic codes (which otherwise occurs on on annual basis, in October). Nevertheless, as our post on lab data explains, there is a disconnect between clinical and public health databases, and a diagnosis alone will not usually trigger public health to count an individual as an official COVID-19 case. Public health agencies are relying on positive lab test results for that, and we’re not testing nearly enough. So, in this very basic way – knowing who has the virus and who doesn’t – we’re in a fog. Thankfully, bright spots are emerging with the creative use of software tools by front-line staff to assess risk factors for COVID-19 and to coordinate services for vulnerable populations such as the homeless; and the engines of Silicon Valley innovation are revving up.

As the coming storm crashes into our imperfectly prepared institutions, we will need all of the tests, N95 masks, hospital and ICU beds, respirators, courageous medical staff, brilliant data scientists, and enlightened policymakers we can find. But also resilience, empathy, and ingenuity from the rest of us. Staying home and watching Netflix will not be enough. In Wuhan, in addition to aggressive testing and other measures to track and isolate the virus, “many people idled by the lockdowns stepped up to act as fever checkers, contact tracers, hospital construction workers, food deliverers, even babysitters for the children of first responders.”* An outbreak of common spirit is evident all around us, and I am confident that as the challenge deepens, so will the response. Let’s get ready.

*McNeil Jr., Donald G. “The Virus Can be Stopped, but Only With Harsh Steps, Experts Say,” The New York Times. March 22, 2020.

 

 

Coronavirus: Health-IT Information and Resources

by | Mar 24, 2020 | Covid-19, Intrepid

Intrepid Ascent is updating this blog with health IT and data management dynamics of the COVID-19 response (e.g. the importance of lab data, recent state and federal waivers on data privacy, the role of data sharing networks, emerging IT-enabled care coordination use cases) and additional resources.

Coding the Coronavirus

by | Mar 3, 2020 | Covid-19, Intrepid

Note: CDC has released an emergency update announcing that there will be a single ICD-10 code for COVID-19 as of April 1, much earlier than the annual ICD-10 updates in October as stated below. The announcement is here. All relevant IT systems should be prepared to update to this new code and staff should be trained to use it. This change will increase the reliability of diagnoses data as an important counterpoint to lab data (see our post above, “Lab Data is the Gold Standard.”

As developments over the past several days have made clear, monitoring and addressing the coronavirus effectively will require consistent documentation of cases as they emerge, and accurate sharing of this information across organizations and IT systems. To this end, the CDC’s National Center for Health Statistics has announced that it will implement a new ICD-10-CM diagnosis code for the 2019 Novel Coronavirus (COVID-19), effective with the next update on October 1. 

In the meantime, the CDC released interim guidance for the coding of encounters related to coronavirus. We recommend that you confirm that your ICD-10 code sets include the codes in this interim CDC guidance, and that you begin relevant staff training on documenting COVID-19 in accordance with these guidelines as soon as possible. Local public health authorities may issue further notices and requirements in the days ahead, so be on the lookout for those as well.

In addition to accurate public health reporting, accurate health information exchange among providers and labs will be critical for communities to stay ahead of COVID-19 through effective treatment of individuals, coordination across organizations, and population monitoring.

Coding scenarios covered in the CDC interim guidance include:

  • Pneumonia case confirmed as due to COVID-19
  • Acute bronchitis confirmed as due to COVID-19
  • A case with COVID-19 documented as being associated with a lower respiratory infection, not otherwise specified or an acute respiratory infection, not otherwise specified
  • Acute respiratory distress syndrome developed in conjunction with the COVID-19
  • Cases where there is a concern about a possible exposure to COVID-19, but this is ruled out after evaluation
  • Cases where there is actual exposure to someone who is confirmed to have COVID-19

Thanks to the courageous front-line health care and public health workforce responding to the virus, and to everyone else supporting them with the information, training, and tools necessary for them to succeed – for all of our benefit.