Checklist, CLIA line up on COVID reporting

Anne Paxton

November 2020—It’s been well understood since the Ten Commandments that rules that appear simple in theory can be fiendishly complex or even impossible to execute. The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now: It may not be clear which rules are mandatory, desirable, or optional—and those aren’t the only sources of confusion.

Since March, much attention at the federal level has been focused on clear standards for reporting results of SARS-CoV-2 testing. But many fear that new rules to standardize reporting could require hammering a multitude of diverse square pegs into round holes.

The main points of contention and sources of confusion over the rules, as set forth June 4 in Health and Human Services reporting guidance and the CLIA regulations for COVID-19 result reporting (QSO-20-37-CLIA), have been the type, number, and format of data elements that would be required. “The initial set of requirements, the amount of data that was requested to be collected, and the uncertainty of what CMS would enforce put labs in a precarious situation,” says Raj Dash, MD, a member until last month of the CAP Board of Governors. “As the HHS guidance was originally written, it was untenable for many labs, particularly smaller labs, to comply with.”

At present, labs will be penalized only if they fail to report both positive and negative test results to their state and local public health authorities. While the June 4 guidance is required, the Centers for Medicare and Medicaid Services has said it will enforce only a few key aspects.

An eAlert announcing a checklist revision to GEN.41316 (Infectious Disease Reporting) designed to align CAP laboratory accreditation requirements with the changes in the CLIA regulations has been sent to all CAP-accredited labs, and that requirement will be the basis for any type of CAP review or audit inspection, Dr. Dash says. The new checklist requirement says that labs subject to U.S. regulations that perform testing intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 must report positive and negative results to local or state health authorities “in a standardized format and at a frequency specified by the Secretary of HHS to include all molecular, antigen, and antibody test methods used with all types of CLIA certificates.” The checklist revision to GEN.41316 is effective immediately for all laboratories.

The actions still required of laboratories are to work with their local or state public health authorities to ensure that all required COVID-19 testing results are reported and to have records available (electronic or paper) to show the reporting is occurring.

Reporting both positive and negative results breaks with established practice for infectious disease reporting, which usually requires reporting of only positive results. Since the current requirements are only part of an interim rule, the concern is that more could be forthcoming. HHS initially proposed additional standards and those may still be under consideration.

The data elements that could be required later are answers to what has been labeled ask-on-order-entry questions, such as whether the patient is symptomatic as defined by the CDC or if the patient is pregnant.

Both the interim final rule and HHS reporting guidance are sufficiently worrisome that even though HHS contends they are necessary to help it manage the pandemic, the CAP has requested publicly and in private meetings that they be rescinded.

The CAP’s concern grew when HHS issued COVID-19 reporting requirements geared to the pandemic. “The June 4 guidance included 18 ‘required’ data elements plus a huge number of others that were ‘requested,’” says Alexis B. Carter, MD, physician informaticist, pathology and laboratory medicine, Children’s Healthcare of Atlanta. “You would have been required to make every reasonable effort to report that data, and there was a deadline of August 1—but no specifics about what would be the penalties for lack of compliance.”

Moreover, she notes, “There was a lot of conflicting and contradictory information in the reporting requirements that indicated they were put together in a hurry. The federal government was asking for data we had never been asked to provide in public health reporting previously. So laboratories were confused about what they need to do.”

Then the CMS issued an interim final rule (CMS-3401-IFC) that outlined penalties for both hospitals and laboratories that did not comply with the HHS reporting requirements.

“This is a big change for CMS to do this,” Dr. Carter says, “and it would be a big change for CLIA-deemed agencies that accredit laboratories,” including the CAP, to revise their requirements to comply. The interim final rule became effective Sept. 2. But at the CAP’s request, the CMS agreed to a three-week grace period with a compliance date of Sept. 23. The CMS has told CAP leaders it is not currently enforcing the 18 data elements. However, many reporting requirements, both actual and potential, remain to be clarified.

Confusion reigns now over which regulatory requirements are in effect and which are tabled indefinitely because different federal agencies responsible for health regulation have advocated different proposals. “There are a lot of layers and there is a lot of information coming at folks,” says Jordan Olson, MD, division chief, clinical pathology informatics and quality, Geisinger Medical Center, Danville, Pa. “Everybody’s saying, ‘Oh, we need to do reporting,’ but then everybody has their own flavor of what exactly they want. And that’s been hard to deal with.”

The initial 18 required data elements, though they pose challenges, are comparatively clear; it’s the requested data elements that look difficult to impossible to many in the laboratory world. As Mick Scanlan, MD, chairman of the CAP Council on Accreditation and vice chair of clinical pathology at Oregon Health and Science University, says, one silo of the government—that is, HHS, or essentially the executive branch—“is asking for all this additional information that we can’t get very easily.”

While some of the requirements have been put on hold for now, more clarity would be helpful because there have been conflicting signals from different federal agencies and the White House/HHS, Dr. Carter says. “The interim final rule says we have to follow the original reporting requirements or we are subject to civil monetary penalties. But when we’ve had lectures or webinars from CMS on this topic, they’ve indicated that, at least initially, they will only look at whether we’re reporting positives and negatives.”

The data elements to go with the result reports are the problem. As Dr. Carter points out, many of the data elements mandated in the HHS reporting guidance have never been required before—for example, inclusion of the test system’s FDA unique device identifier (UDI). “I don’t know of a single lab that has done that. On top of that, the vast majority of the tests have an emergency use authorization from the FDA and don’t have a UDI.” In addition, rules such as those that require HL7 reporting format would mean changes to laboratory information system interfaces for which LIS vendors charge fees.

Also not fully appreciated is that the test results are to be reported to the public health laboratories of the individual’s residence. “We have seen patients from 27 different states outside Georgia,” Dr. Carter says. “It might be easy if all states accepted faxes but they don’t. California and Alabama, for example, require electronic entry into a portal and it takes days to get access and training for that, while Texas requires a secure file transfer protocol that takes weeks to get set up.” There could also be a serious problem of states duplicating reports, she adds, which could cloud data being used to gauge the spread of SARS-CoV-2 infection.

The concept of “ask on order,” in general, may not be as useful as intended, she believes. “Hospitals are already reporting a good bit of this data such as whether a patient is hospitalized. It isn’t clear how asking these questions at a test order level will be helpful.”

The confusion that issues like these create has led to many laboratories being unable to report, she says. “I’ve heard that only 26 percent of laboratories were doing any reporting,” amid the supply shortages and other difficulties they face.

Potential penalties for laboratories failing to report correctly are also unclear, Dr. Carter says. “CMS initially said it would strictly fine laboratories based only on whether they are reporting positives and negatives, and it did not necessarily plan to look at each data element. But when we had meetings with the local CMS branch, the message was much different. The letter of the law says we have to comply.”

The CAP began expressing concern to the CMS about reporting requirements in April or May, says Helena Duncan, CAP assistant director, public health and scientific affairs, who has been in direct contact with the federal oversight agencies about the reporting requirements.

After the CARES Act passed in March, the plan to require clinical laboratories to report positive and negative results was communicated, and the CAP believed the HHS guidance went far beyond what was in the CARES Act and would exceed laboratories’ resources, Duncan says. “Initially we wanted to talk with them about either simplifying the reporting requirements or easing the burden on laboratories by creating templates that could be integrated into the laboratory information systems so reporting would be an automated process.”

But the June 4 guidance seemed to up the requirements even further. “It was a lot more detailed and requested information beyond the lab’s control and scope, such as ask-on-order-entry questions.”

Given that SARS-CoV-2 was a new strain of the SARS virus, Duncan says, “we were supportive at first of reporting positives or negatives to better understand the prevalence of the disease. The reporting up to that time was inconsistent and we needed all the states to be reporting the same information. The June guidance just went well beyond what we felt was necessary.”