New Rules for Electronic Health Records

What began as an incentive program in 2009 to coax providers into making the switch from paper to electronic records is quickly trading the carrot for the stick. In 2014, the federal government will ramp up the pressure on providers to embrace electronic health records (EHR) with the second stage of meaningful use guidelines, requiring many hospitals and physician offices to meet tough new standards or face payment cuts beginning in 2015.

A number of new requirements under stage 2 meaningful use will impact labs, both directly and indirectly. For providers moving onto this stage, at least 30% of lab orders must now be entered into the EHR through computerized physician order entry (CPOE), and 55% of orders must be received electronically in a structured data format. Hospitals and physicians also must be measured by quality metrics that rely on lab data. For example, physicians will report the number of patients with controlled diabetes using HbA1c results. Providers must also show patient engagement by demonstrating that patients actively download or transmit their electronically accessed health information.

According to laboratorians who have studied the stage 2 meaningful use requirements, this phase of the government's push for EHRs will require labs to adjust to a whole new perspective on what it means to order tests, report results, and grapple with patient engagement. With hospitals and physicians rushing to comply with the new requirements, now is the time for laboratorians to tackle these issues head-on, according to Walter Henricks, MD, medical director of the Center for Pathology Informatics at the Cleveland Clinic. "For laboratories to be successful in an environment of increasing EHR use, I believe there must first be a recognition and acceptance on the part of laboratory leaders that addressing EHR-related laboratory information management issues is a part of laboratory administration now, whether they like it or not," Henricks said. "Such issues are now on par with compliance, accreditation, and other elements of quality management we accept as essential to running a lab."

What Could Go Wrong?

In some ways, the drive for adoption of EHRs is a story about the rest of medicine catching up to the lab. The first commercial laboratory information systems (LIS) arrived in 1982, replacing innumerable steps of tedious manual work. Next came electronic ordering via hospital information systems in the mid-1990s. Now, as EHRs erase what's left of the paper boundary and give lab information a new life outside the LIS, laboratorians are finding that it's easy to lose control of their information once it is whisked off into the hum of the hospital's servers.

"What happens to laboratory information in the EHR goes far beyond the technical transmission aspect: it's about how information is displayed, orders generated, and data captured for new purposes," explained Henricks. "It used to be that the laboratory designed its requisitions and reports. Not any longer. Now the computer screen is the requisition and the report, and the laboratory has to find new ways to influence that and to ensure patient care and laboratory operations are not compromised."

As providers gear up to meet the government's meaningful use deadlines, laboratorians will not be too surprised that EHR vendors have priorities other than laboratory information handling. Even multi-million dollar EHRs in large hospital systems arrive with design features that lead to all kinds of unintended consequences, Henricks noted. For example, the EHR's CPOE may have a definition of a test that does not match the lab's, resulting in the physician ordering one test and the lab performing a different one. In addition, certain elements of lab reports such as interpretive comments or notes on a hemolyzed specimen may be hidden on poorly-designed EHR displays, or a test menu might be too crowded on the screen such that physicians can't find what they need.

"This is why I emphasize that laboratorians have to get outside the lab," Henricks said. "They're not going to come looking for you—unless there is a problem and the lab is blamed, even though the lab might have had nothing to do with it. If there is any kind of problem with ordering or results in the EHR, they're going to come to the lab first, so we need to get out ahead of these issues. Engagement is key, and with engagement, you build credibility."

All of these EHR changes will take place with the threat of potentially painful cuts to hospital reimbursement for those that can't make the grade. The penalties for providers who do not meaningfully use EHRs are applied based on performance 2 years prior and begin as early as 2015 with a 1% payment adjustment. For physicians, 2014 is their last chance to adopt EHRs before penalties are applied to those who do not demonstrate their first year of meaningful use by October 1. In the case of hospitals, many that have already demonstrated meaningful use in stage 1 must now move along to stage 2 in order to retain their incentive payments and avoid penalties (See Box, below).

Physicians will want their investment in EHRs to pay off when it comes to the lab, even if they're late adopters and behind schedule for stage 2, Henricks noted. "A lot of physician offices and group practices were still happy with faxes or paper reporting. But as soon as they invest in an EHR, they'll expect results to be provided electronically. Already, many labs are facing higher expectations for electronic exchange, even though it was not overtly mandated in stage 1," Henricks said.

At the Cleveland Clinic, Henricks represents the lab on a physicians advisory group for the EHR and leads the organization's Center for Pathology Informatics. But smaller labs can tackle the EHR issue, too, he said. "Laboratories will have to plan strategically and designate time, resources, and staff for this. Does that mean everyone has to be an EHR expert? No. But someone in the laboratory needs to be aware. Usually a lab has at least one person who really knows the LIS and supports it. That expertise can be cultivated as a natural extension to get involved in EHR-related issues because it draws on many of the same skills: test definitions, interface testing, validation, change control, and the like," said Hendricks.

What Is a Lab Report?

Laboratorians also face frustration with an expanding number of quasi-official lab reports, as EHRs manipulate and display lab information in countless ways that the lab can't predict or control—a concern both for physicians, and now, for patients who must be able to access their records.

These unofficial reports are a particularly sensitive issue given that, unlike some other areas of medicine, labs are held to a high standard for their reports under CLIA regulations, including containing elements such as reference ranges, units of measure, and contact information for the laboratory. The Centers for Medicare and Medicaid Services (CMS) has explained in updated CLIA interpretive guidelines that an official lab report is essentially the first time results arrive at the authorized provider. After this point, the lab's legal responsibilities end. But most laboratorians are not satisfied to turn a blind eye to subsequent displays of lab results in the EHR.

These rogue reports were the subject of a CLN Patient Safety Focus article in April 2013 in which Patient Safety Focus Editorial Board member Corinne Fantz, PhD, interviewed two experts who urged labs to be more proactive (CLN April 2013).

One of those experts, Alexis Carter, MD, told CLN she remains concerned for labs as they grapple with rules under stage 2 meaningful use that require patient engagement. "I continue to make the case that the CLIA requirements for lab reports are there for patient safety reasons," Carter said. "I have had a lot of people tell me that they don't see why some of the EHR reports should comply with CLIA if they're not the ‘official report.' But if you're handing it to a patient, how can it not be an official lab report?" Carter is director of pathology informatics at Emory University School of Medicine in Atlanta.

Similar concerns arise when it comes to ordering tests. Generally, EHRs group tests together based on the patient's diagnosis or some other principle into order sets. At Emory, Carter addresses this issue by making sure that the lab reviews all lab orders in CPOE order sets prior to their implementation. Fantz, formerly a faculty member at Emory but now the director of lab development at LabSource in Greenville, S.C., recalled that the initial CPOE order sets at Emory had some problems that could have led to improper utilization. Many of these had been developed primarily from paper order sets. Some panels, pre-checked and set as the default, called for tests to be ordered every day of the week, which may not have been necessary. In other instances, tests were missing from order sets that laboratorians believed physicians would need, a case of underutilization.

"We were not just looking to cut tests out of their order set, but aiming for completeness," Fantz said. "Often members of the same department would have different ideas about how often, for example, to order tests, so we had to get consensus from practitioners, using guidelines if there were any for their practice, and examining the literature whenever possible."

Building consensus among clinicians for lab order sets isn't always straightforward. "Some departments knew just what they wanted, but others wanted just about every choice available, thinking that if someone wanted to order a test, they would have the freedom to choose what they needed," Fantz said. "But the problem with just putting everything in the order set is that people will click on a test reflexively, thinking, ‘oh, maybe I should order that, too.' It becomes more of a general laboratory menu than a specific order set. On the other hand, the lab doesn't always know what is in the best interest of the patient in every situation. So you need that collaboration with clinicians and clinical teams."

Implementing Clinical Decision Support

Another meaningful use requirement that will draw on lab information is clinical decision support (CDS). Under stage 2, physicians and hospitals must implement five CDS interventions, in which the EHR "intelligently" filters and organizes contextually appropriate patient information to enhance care. Such decision support applications will invariably rely on lab results.

Many of these CDS interventions will also be based on clinical quality measures (CQM), which have been changed significantly to adapt to the electronic environment of EHRs and rely more heavily on lab information. Quality measures for healthcare are not new. However, with the progression of meaningful use, measures that depended on paper reports and billing data from insurance companies have been updated to better fit new workflows and data sources in the EHR. The quality measures will draw directly from hospitals' and physicians' EHRs, noted Lauren Fifield, senior health policy advisor at EHR developer Practice Fusion, the fastest growing EHR for physician offices in the country, in part due to its web-based, free model. Labs, billers, imaging centers, and other third parties pay to access the software provided to physicians to better facilitate integrations and workflows and other entities pay to advertise within the application.

"Most of the quality measures for meaningful use and the other programs have been retooled to better fit an EHR workflow," Fifield said. "This is relevant for labs, because now that some of the measures have been changed to fit the electronic setting, the use of electronic lab results has become incredibly important. With an electronic results interface, providers are able to let the EHR calculate almost automatically whether a certain quality measure has been achieved." CQMs will likely become even more critical in the future, as Medicare seeks to leverage such data in its self-proclaimed pursuit of paying for value rather than quantity, Fifield added.

Laboratorians experienced with EHRs advised caution when it comes to interfaces. "It's essential to validate your interfaces and check the data," Carter said. "Despite a vendor's best efforts, data can become garbled across interfaces, especially if it is free text or changes in decimal places. I've seen a situation where the decimal point was changed in one system, and it caused creatinine values to be multiplied by a factor of ten when it crossed the interface."These same problems come into play when it comes to sharing data with patients.

"Often patient portals don't look anything like what the lab sees or what the physicians see in the EHR," Fantz said. "Labs really have to get a handle on where the information that the lab is generating is going and get a seat at the table to review these displays. Otherwise it's really difficult to address problems you don't know exist."

Adapting to Structured Data

When it comes to the actual transmission of lab data itself, labs operating in a stage 2 environment may have significant work to do in the LIS. Stage 2 rules require that at least 55% of lab results be incorporated in the EHR as structured data. Under the certification standards for EHR software, this means that lab results must have standardized codes associated with them so that other EHRs can more easily interpret and display them. For labs, the government chose a standard called Logical Observation Identifiers Names and Codes (LOINC). LOINC codes identify and structure the content of an electronic message containing a lab result, such as the analyte and unit of measure.

Software is available to help labs layer LOINC codes into their LIS, but this process still requires plenty of attention from laboratorians, Carter noted. "Coding for LOINC is not for the faint of heart," she said. "There is a lot of flexibility in how you could code something."

Fifield believes that once labs get over the hurdle of updating their LIS with LOINC, they'll be glad they have such a standard. "Oftentimes standards don't get as much praise, as they're a less exciting element of any given program, but if you consider that a majority of providers will be using technology in which they receive lab results in structured form, that's really good news for labs," she said. "It will lead to better utility of lab results in the health system, and I think it would be a relief to lab providers to be able to point to a standard and say, this is how we will deliver results."

Public Health Reporting

For hospitals, stage 2 meaningful use will also require electronic transmission of reportable laboratory results, a requirement Henricks believes many hospitals may delegate to the lab itself. "This is one area where the hospital may want to rely on the laboratory directly," Henricks said. "Some LISs increasingly are certified as EHR modules. So the two basic choices are that hospitals report these lab results from EHRs to public health agencies, or they use a certified module in the LIS to report results and just let labs handle it on their own."

Reportable lab results vary by state, but include West Nile virus, novel influenza strains, malaria, tuberculosis, and other more common infectious diseases such as hepatitis C (CDC website). If a state public health agency does not yet accept electronic reports, hospitals can skip this requirement. According to the Centers for Disease Control and Prevention, including reportable laboratory results in meaningful use will have many benefits, such as speed, less manual data entry and errors, and more complete information.

An Opportunity for the Lab

Experts say labs face an uphill battle to ensure their voice is heard and their expertise put to use in the quickly evolving realm of EHRs. But forward-thinking laboratorians will also have a chance to benefit from hospitals' and physicians' needs as meaningful use requirements get tougher, according to Fifield.

"I think laboratories can be opportunistic here. They have an opening to help providers optimize and really get the full benefit from their EHR investment by making electronic lab ordering available, partnering with health IT companies to make information available to patients, and enhancing providers' workflows," she said. "I think that labs could really make their brand by pushing ahead of meaningful use and bringing even more benefit to providers."

Fifield also urged that labs not count on the government to offer any compromises on the progress of the program. Some physician groups and health systems lobbied CMS asking for an easier transition to and delay of stage 2, but Fifield doesn't expect the agency to budge. However, due to the fact that 2014 could mark a payment adjustment for providers who are just beginning to comply with meaningful use, the government might offer extra time to get started, Fifield explained. "That's the only suggestion that's on the table that's really feasible," she said. "Other suggestions include relaxing standards and requirements, but I don't think those are realistic. It would create more complexity, and this is not a program where we need more complexity. And the agency does not want to slow the program down."

Looking ahead to meaningful use stage 3, which CMS has slated for 2016, the good news is that laboratorians will have more of a say on some of the requirements for EHR reports. Carter and other lab experts are serving on an advisory team for the Office of the National Coordinator for Health Information Technology, working on adding requirements for CLIA compliance to the certification process for EHRs.