Health IT Standards Committee: Clinical Operations group seeks specificity in standards

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During the Health IT Standards Committee meeting on Feb. 24 in Washington, D.C., the Clinical Operations Workgroup sought to gather comments on proposed recommendations on implementation specifications for content exchange, vocabulary and code set standards for the Interim Final Rule (IFR) of meaningful use.

A single implementation guide was proposed regarding the NCPDP SCRIPT, a standard for e-prescribing, HL7 version 2, the standard for the exchange, integration and retrieval of EHRs and HL7 Clinical Document Architecture, the standard for the specification of the encoding and structuring of clinical documents.

Because minimal or broad implementation guides are being considered in the final rule, rather than more finite guidelines, committee member John Halamka of Harvard Medical School in Boston, noted that the workgroup could not come to a consensus on this topic.

“One of the things we discussed in our workgroup was having a singular implementation guide that is fully specific and removes all the optionality as a minimum requirement,” explained Halamka. “Either, we provide implementation specificity – or we provide a family [of standards], and that seems to offer us the capacity to evolve pretty rapidly.”

Pointing out a need for a balance between under- and over-specified implementation guidelines, committee member Christopher Ross of the MinuteClinic in Minneapolis, said “[i]f we are not careful, having a family of underspecified issues or implementation guidelines that are not required is not going to achieve the kinds of goals many of us hope this opportunity can afford.”

The creation of specified guidelines may present the opportunity to improve quality and safety of healthcare, and even reduce its costs, said Ross, who warned that these opportunities will not materialize in the absence of clarity and specificity about interoperability.

Noting that the committee must find some process for allowing standards to grow and adapt, while needing to separate this from the way that hospitals and practices achieve their business goals and the committee’s goals for quality and safety, Wes Rishel of Gartner in Stamford, Conn., said: “There is no interoperability without a very detailed specifications.”

Seeking a middle ground between these two standpoints, Jodi Daniel, director of the Office of Policy and Research at the Office of the National Coordinator for Health IT (ONC) noted the "limitations on what we can adopt and allow for in building-in flexibility.”

In addition, creating versions of the standards, as well as timelines for implementation of the versions, were discussed by the committee, as a way to help practices that may be lagging behind in the implementation process.

“What we should be regulating is the desired outcome, and not the process of getting there,” said committee member David McCallie, Jr., of Cerner in Kansas City, Mo.

Another issue in which the committee requested clarification regarding the rule of what is required inside the EHR versus required only for interoperability at the borders.

The Clinical Operations Workgroup recommended a minimum vocabulary subset requirement for interfaces to be mandated in certification and/or testing--an idea in which many committee members were in agreement.

“I would speak very strongly that we normalize at the borders and allow a lot of creativity and expensiveness with what you can do within your own system because that’s what we have to provide; patient safety the ability to always say what we need to say clinically to take the best care of the patients,” offered committee member Stanley M. Huff of Intermountain Healthcare in Salt Lake City.

“Our business is only at the borders, and not inside the organizations,” agreed Carol Diamond of the Markle Foundation in New York City.

The discussion of the initial standards, implementation specifications, and certification criteria for EHRs varied among committee members and McCallie noted that people still remain undecided regarding the right mechanism for allowing change over time.

“I think we are in complete agreement within our workgroup that you need to get to that complete level of specificity to insure interoperability to achieve meaningful use objectives,” concluded Chair of the Clinical Operations Workgroup Jamie Ferguson. “The question that I think we are struggling with here is how to achieve that level of specificity through regulations versus other means.”