To certify or not to certify, that is the question

2012 10 24 14 22 20 255 Oosterwijk Herman 70

The recent buzz around the new Integrating the Healthcare Enterprise (IHE) certification caused me to step back and think about the value of certification, and how it might affect -- and potentially better -- the implementation of healthcare imaging and information technology.

If you look up the definition of certification, it means "confirmation that some fact or statement is true." Therefore, it appears we are looking for an entity, supposedly unbiased and objective, to prove that a specific claim, such as a person, product, or service, or, in the case of IHE, functionality and/or interface specification, is true.

Herman Oosterwijk of OTech.Herman Oosterwijk of OTech.
Herman Oosterwijk of OTech.

Some of these certifications are well-established and accepted by the industry; for example, we have professionals who are Certified PACS Associates (CPAS) or Certified Imaging Informatics Professionals (CIIP). We have products that are "certified EMR."

Another semicertification is the U.S. Food and Drug Administration (FDA) approval process. The FDA would not want you to claim that you are "FDA-certified"; rather, a device would have received 510(k) clearance, but it is still the same process: confirming that a medical device meets certain requirements with regard to safety and effectiveness. There are also voluntary certifications such as International Organization for Standardization (ISO) 9000, and its equivalent for medical devices, ISO 13485, which certifies the presence of a quality management system.

First, a few words about certifying professionals. A healthcare imaging and IT professional can pursue quite a few certifications after he or she has completed a basic education. Universities are offering numerous certificate programs as additional training, and there are many certifications by the major hardware and software vendors (Cisco, Microsoft, Oracle). Most application software vendors offer their own certification (Epic-certified), and professional organizations such as the American Registry of Radiologic Technologists also offer certification. In addition, nonprofits such as the Healthcare Information and Management Systems Society, the PACS Administrators Registry and Certification Association, and the American Board of Imaging Informatics offer certifications as well.

In general, there is a trend among institutions as well as vendors to require their staff to be certified. In addition, there is also a trend by the states to require certifications. As an example, the Texas Legislature in the previous session actually had a bill pending that would require all healthcare technical professionals to be certified.

In addition to these trends, there have been sometimes-heated discussions about the benefits and/or requirements of being certified as a healthcare imaging and IT professional, although these seem to have calmed down and it has become accepted.

Second, with regard to certification of products and services by ISO, the FDA, and others, there is no question that this has improved the quality of the products and services offered. The FDA clearance process is not quite perfect, which is witnessed by the number of discrepancy letters that the FDA generates as a result of its site inspections, and the number of worst-case interventions resulting in recalls and closing down plants.

Many of you might recall the shortage of C-arms several years back as GE Healthcare was forced to close down its manufacturing plant (as per the press release: "FDA's most recent inspection of the Utah facility, conducted between July 31 and August 29, 2006, revealed [current good manufacturing practice (cGMP)] deficiencies, including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions.").

These products did all have FDA clearance, which shows that certification can only provide a higher level of certainty that a product meets certain specifications -- it cannot guarantee it. As a company, OTech provides FDA "mock-audits," and it is very unusual for a typical company to pass this without any minor -- or in many cases, major -- discrepancies, therefore proving the point.

I have seen similar behavior at the annual Connectathon meetings, where vendors show up to test their IHE profile implementations, and, with all good intentions, their implementations are sometimes quite far from meeting the connectivity requirements as defined by these profiles. Needless to say, Connectathon testing provides a major benefit to both the vendor and, ultimately, the user community.

However, the question that is now raised is whether or not we also need certification in addition to the testing that has taken place ever since the late 1990s. IHE USA definitely thinks it should add a certification component, as per the recent announcement to provide this as an option at the 2013 Connectathon in Chicago.

I have been fortunate to be able to participate in the Connectathon effort as a monitor for the past several years. The way this effort operates is probably best described by David Clunie in his blog on this subject: It provides "the opportunity to gather and learn and test and even experiment at the Connectathon, in a relatively informal manner that encourages iteration, improvement, and collegiality between competitors."

One item I'd like to add to this statement is that the Connectathon provides a level playing field for any vendor, regardless of its nationality, size, or perceived importance in the market.

As an example, I have watched integrations between small Asian companies that developed workstation applications and major players of PACS and imaging modalities. These small companies would never have had the chance to test their implementations against these other parties except in the field, which is definitely not the ideal test environment.

Third, I think we have started to realize that worldwide specifications such as IHE and their corresponding DICOM and HL7 standards are still subject to interpretation, especially by engineers whose primary mother language is not English. The Connectathon provides a forum for interpretation.

If certification of IHE profiles is going to be reality and replace the Connectathon, it will almost certainly use Internet-based tools. That means the end of the face-to-face interactions with monitors who are domain experts, and the iterative improvement process that has been taking place.

It will also mean that some of the profile testing will become impossible, especially when there is human (visual) interpretation required. As a case in point, how would a radiologist-monitor be judged as to whether the computer-aided detection marks match the actual findings on a mammography image in a virtual Internet-based test environment?

Furthermore, I am not sure about the additional benefit that an "ISO-based" certification process would provide, except for additional cost and effort. As experience has shown with FDA approval, unless there is an "inspection process" that actually validates the implementation in certain products, along with an enforcement process, the additional benefit of the rubber stamp might not justify throwing away the baby with the bath water.

In conclusion, I believe that certification makes sense for professionals; for medical devices as required by the FDA; for implementing quality systems, such as through ISO; and for functionality as required by the Office of the National Coordinator for Health Information Technology for EMRs. However, for IHE, I can't find any sensible reason to require certification.

Will it happen regardless? Probably, but I can only hope there will be a fair amount of discussion around the adoption of certification, and that IHE leadership will be listening to all stakeholders involved and take their concerns into account.

Herman Oosterwijk is president of OTech, a healthcare imaging and IT company specializing in EMR, PACS, DICOM, and HL7 training.

The comments and observations expressed herein do not necessarily reflect the opinions of, nor should they be construed as an endorsement or admonishment of any particular vendor, analyst, industry consultant, or consulting group.

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