Checklist, CLIA line up on COVID reporting

Typically, Dr. Scanlan says, when a state public health agency tracks influenza or tuberculosis cases, only positive cultures are reported. “That’s the structure that’s been in place forever,” he says. “And the focus of the state public health laboratories is on contact tracing,” which is why they are interested only in positives. “Here, the government wants more data about the infection’s spread and what’s going on, so that’s why they are requiring all this excessive data.”

One reason both positive and negative test results began to appear necessary to the CMS was the difficulty of identifying COVID-19 hotspots, he explains. “Some locations had 100 percent positivity, which was not believable.”

The data elements to be required may not be capped at 18. Requirements mentioned by the CDC have 24 elements, including the test platform on which the test was performed, Dr. Scanlan says.

He worries about the impact of the penalties labs could face for noncompliance with the rules. “On the first day of noncompliance, you’re fined $1,000, and then $500 per day.” Accreditation issues have also arisen related to the reporting requirements, he says, one of which is how to deal with labs if they don’t comply. “We do need to report noncompliant labs to CMS if they are not reporting. And we can discover that through a live inspection, through a complaint, or by other means.” To encourage compliance, the CAP accreditation program has developed a paper insert for the inspection packet to help laboratory inspectors focus on the issues around COVID, which include such areas as safety.

From Dr. Dash’s perspective at Duke University Health System, the HHS guidance has been challenging because there are two sets of requirements, one for the hospital and one for the laboratory.

“The laboratory is focused on COVID-19 testing”—the DNA, antibody, and antigen tests. “On the hospital side, it contains aggregated diagnostic testing data but also reflects other elements of the hospital, such as pharmaceuticals and availability of ICU beds, that would be outside the purview of the laboratory. So it requires close coordination to ensure that we’re leveraging the same data sources, not skipping a segment of the population or a certain set of orders, and that the numbers jibe across the health system where you have multiple hospitals, multiple clinics, and testing occurring at patients’ bedside or in some samples traveling to a central lab and being tested there. Those results all need to be aggregated daily and sent to the government agencies, which include our county, our state, and the CDC as well.”

The speed with which data had to be provided was also difficult. “If there are data elements the White House feels it’s important to collect, they want to start collecting them right away, not wait months for implementation as you would normally for bringing a change into an information system.” The normal procedure, Dr. Dash notes, would involve a regimented process for identifying requirements, building the system, validating the platform, bringing it into production, and having another round of evaluation and metrics after it’s gone live. “That’s not the same cadence with which labs have been asked to respond in the COVID-19 setting.”

But it’s also been unclear which elements are most important, what is required and enforced, and what is optional. “We can make assumptions about what the data is going to be used for, and sometimes we scratch our heads on why they’re asking about one data element but ignoring others.”

Epic has created a user community to let customers crowdsource answers to questions and resolve ambiguities. For example, for an answer to the question about pregnancy, “they would go out to the EMR and if they were able to find a recent pregnancy test, they would answer yes to questions that they knew were yes, as a default, although the provider would be able to change the answer. So at least the provider wouldn’t have to check the chart and fill in the value.”

The mandate from the agency is for laboratories to fill out the answer as best they can. But since “unknown” is one of the answer options, Dr. Dash says, “it’s very easy for a provider or reference lab to just put ‘unknown’ for all the responses simply because it would be a great deal of work, or onerous, to collect the data and validate that the answers are accurate.” Some reference labs have created a new specification to get the answers at the time the order was placed, but others may be hard-coding the word “unknown” into those responses, he says. Duke has devoted a lot of time and effort to meeting the reporting requirements. “We are fully compliant. But not everyone has access to our resources. So the regulations ask that you do the best you can, and I think that’s where we are today.”

Supply chain limitations and thus the need for labs to use multiple platforms means a lot of IT infrastructure, he says. “We’ve had to create a mechanism whereby the microbiology lab and their staff can take a sample, decide that day they have more reagent in a particular instrument and run the test on that instrument, then the next day run it on a different platform that needs to work with the same order. That requires IT expertise and effort to move specimens around across different platforms and have the LIS recognize where results from different instruments need to be paired together for the right patient.”

The patchwork of methods and instruments can be difficult to coordinate into one smooth reporting system, even theoretically, Dr. Dash says. “You have the county, the state, CDC, FEMA sometimes, ultimately CMS now, and HHS receiving data and it’s unclear what the level of data integrity is,” especially when there is a high risk for duplication of results where results are being reported interstate. It’s unclear how those issues are being resolved, he says.

“It’s just not possible for every health care organization to report to every state agency,” Dr. Dash says. The state agencies should be the ones doing the coordinating among themselves so that there is one clean data set for every lab that exists in a particular state, in his view.

“If I were a data scientist,” he says, “I would have very little confidence in the data that’s being aggregated nationally, because of the disparities inherent in the ambiguous reporting requirements.”

These reporting issues are unprecedented, Dr. Dash notes. “There’s never been a pandemic of the scale of COVID-19 and in 20 years I’ve never been in a position of having to go to such extraordinary efforts to provide the level of testing needed on a daily basis for our patients. And with this level of complexity, the public health reporting complexities are magnified.”

The CAP has been working with the federal agencies to clarify the reporting requirements, Dr. Carter says, and continues to believe that the requirements should be rescinded based on the level of confusion and difficulty. For now, Dr. Carter says, “Laboratory directors need to know what the requirements are in their state and whether or not their state department of public health is reporting to outside states, because if not, it’s the laboratories’ responsibility to do it. And they should be aware there are civil monetary penalties attached to noncompliance.”

The CAP has also been working on its comments in response to the interim final rule (due Nov. 2), which support reporting only the positive and negative data elements to public health labs, Duncan says. The CAP believes that “we should focus on the public health labs, ensure that they can accept the information, and then have the clinical labs report the data to the public health labs.”

“We continue to ask CMS and CDC to rescind the June 4 guidance document until they can implement a workable solution that is not sort of piecemeal. I think they’re very wedded to the document, and they are encouraging people still to try to comply with the guidance.”

But, she adds, “we haven’t seen or heard that HHS is going to take action; they don’t have a mechanism to enforce the 18 data elements. We know CMS can do an inspection or survey based on a complaint and assess if a laboratory is reporting, but they’re not making a special trip to do this. So our interpretation—what we’re advising labs—is that this is what CMS is requiring and what you must comply with. But labs will only be subject to enforcement action if they don’t report positive and negative results.”

Although the CDC has said that a lot of labs are compliant, Duncan says, “we don’t know if they are referring to one data element or 18.”

“We’ve been trying to educate our members to make sure they understand, and we report on this regularly in our advocacy newsletter and update our FAQs so they are aware of changes.” Labs are encouraged to report as many data elements as they can but to focus on reporting positive and negative results. “Some states have told people they won’t be able to accept this data until December. But you still have to have documentation that you attempted to submit results to the public health department, even if they won’t accept it,” Duncan says.

Her advice to labs: “Do your best in reporting and documenting your efforts to report, and if you have any issues, contact the CAP advocacy office because we’re interested in hearing about any problems or issues you are having.”

If the penalties had not been included in the agencies’ rules, says Dr. Olson of Geisinger, fewer people would be reporting as many data elements. In addition, “If the guidance were clearer about which items are truly required versus requested versus optional, we probably wouldn’t be doing as much reporting. But because there’s so much confusion, at Geisinger we’ve gone with a conservative approach to say we’ll try to report everything they’ve asked for, which has been very hard to accommodate.”

At Geisinger, this has meant spending several hundred hours of IT analyst time trying to get this reporting set up and tested. But Dr. Olson doesn’t see a way around the effort and the expense. “I would love it if HHS or CMS would change the requirements. I’m not sure if that’s a realistic expectation, though, at this point.”

Anne Paxton is a writer and attorney in Seattle.