Tag: Certification

Sometimes the Best Choice is the Simplest One

Screen Shot 2014-09-07 at 7.53.02 PMCMS recently announced another change to health IT policy in order to offer healthcare providers greater flexibility. But what will the unintended consequences of this latest change be?

Over the Labor Day weekend, CMS announced that the Meaningful Use Stage 2 deadline will be extended through 2016 in order to offer more options and greater flexibility to providers for the certified use of EHRs.  In the interest of full disclosure, I found the timing to be strange— a rule published over a holiday weekend seems an odd choice, particularly when it is being touted as a benefit to the industry and the impact on healthcare provider organizations and clinicians, alike, is monumental.

Unfortunately, I think the additional flexibility allotted by this rule is the latest example of the unintended consequences of health IT regulations.  In an effort to make things easier and give healthcare providers more leeway, they have, in fact, made the situation unnecessarily more complex.

Agility is not healthcare’s strong suit

It seems at this point, too many options, or waffling between them (for instance the new ICD-10 transition deadline), can be more crippling than stringent regulations, particularly when there is so much on the line.  Healthcare organizations don’t have the wherewithal to vacillate with implementations; they are wrestling with string-tight budgets and constantly shifting rules require large cultural and behavioral changes.  As a result, as Dr. John Halamka noted, health IT agendas are being constantly hijacked by regulatory changes, such as Meaningful Use and ICD-10.

It now seems that hospital administrative teams and physicians again must endure constantly shifting rules that they’ve been coping with for years under Meaningful Use.  As Dr. Ben Kanter, former CMIO of Palomar Health, so astutely noted “A computer system is a tool, just as a scalpel is a tool.  What if a surgeon’s scalpel changed every few weeks?  How is it possible to deliver good care if the primary tool you are using keeps changing on an irregular basis?”Continue reading…

The Real Problem with Board Exams-and How to Solve It

This week there’s been a debate brewing about why so many young doctors are failing their board exams. On one side John Schumann writes that young clinicians may not have the time or study habits to engage in lifelong learning, so they default to “lifelong googling.” On the other, David Shaywitz blames the tests themselves as being outmoded rites of passage administered by guild-like medical societies. He poses the question: Are young doctors failing their boards, or are we failing them?

The answer is: (C) All of the above.

I can say this with high confidence because as a young doctor-in-training who just completed my second year of medical school, I’ve become pretty good at answering test questions. Well before our White Coat Ceremonies, medical students have been honed into lean, mean, test-taking machines by a series of now-distant acronyms: AP, SAT, ACT, MCAT. Looming ahead are even more acronyms, only these are slightly longer and significantly more expensive: NBME, COMLEX, USMLE, ABIM. Even though their letters and demographics differ, what each of these acronyms share is the ability to ideologically divide a room in less time than Limbaugh.

This controversy directly results from the clear dichotomy* between the theory behind the exams and their practical consequences. In theory these exams do serve necessary and even agreeable purposes, including:

1)     Ensuring a minimum body of knowledge or skill before advancing a student to the next level in her education,

2)     Providing an “objective” measure to compare applicants in situations where demand for positions exceeds supply.

So apart from the common, albeit inconvenient, side effects that students experience (fatigue, irritability, proctalgia), what are the problems with these tests in practice? These are five of the core issues that are cited as the basis for reformations to our current examination model:

1)     Lack of objectivity. Tests are created by humans and thus are inherently biased. While they aim to assess a broad base of knowledge or skills, performance can be underestimated not due to a lack of this base but due to issues with the testing format, such as duration, question types, and scoring procedure (e.g. the SAT penalizes guessers, whereas the ACT does not). Just as our current model of clinical trial testing is antithetical to personalized medicine (What is a standard dose? Or, more puzzlingly, a standard patient?), our current model of testing does not take into account these individual differences.

Continue reading…

Early Experiences with Hospital Certification

As one of the pilot sites for CCHIT’s EHR Alternative Certification for Hospitals (EACH), I promised the industry an overview of my experience.

It’s going very well.   Here’s what has happened thus far.

1.  Recognizing that security and interoperability are some of the more challenging aspects of certification, we started with the CCHIT ONC-ATCB Certified Security Self Attestation Form to document all the details of the hashing and encryption we use to protect data in transit via the New England Healthcare Exchange Network.

Next, I had my staff prepare samples of all the interoperability messages we send to patients, providers, public health, and CMS.   Specifically, we created

CCD v.2.5 used to fulfill the Discharge summary criterion
HL7 2.51 Reportable lab
HL7 2.51 Syndromic surveillance
HL7 2.51 Immunizations
PQRI XML 2009 for hospital quality measures

We validated them with the HL7 NIST test site

and the HITSP C32 version 2.5 NIST test site.

CCHIT validated the PQRI XML as conforming.Continue reading…

Not So Meaningful EHR Certification

Can you buy an ONC Certified EHR, or EHR module, and discover to your chagrin that no matter how hard you try, Meaningful Use is not within reach?

While the spotlights were shining brightly on CMS and ONC as the final definitions of Meaningful Use (MU) and EHR certification criteria were being released, NIST quietly posted its (almost) final definition of EHR testing procedures for certification. The procedures still need ONC’s stamp of final approval, but it seems that this is just a formality. In the past I expressed misgivings regarding the “lightness” of the draft version of the NIST testing procedures, so naturally I was curious to see the final documents. Although some problematic procedures were simply removed from the final version, others still remain.

Thus the answer to the opening question above is a resounding Yes.

In an attempt to part ways with the heavy handed CCHIT certification model, NIST adopted a simplistic, narrowly defined set of testing procedures. Vendors, particularly small ones who never underwent CCHIT certification, will likely be happy with the latitude afforded by NIST. However, the lack of specificity may very well place unsuspecting physician buyers in a bad situation, and here is how.

  • §170.302(h) – Incorporate laboratory test results: The final ONC certification rule does not require a particular standard to be used by the EHR for receiving structured lab results. All comments submitted to ONC requesting standard specification have been rejected in the interest of flexibility. Adhering to the ONC ruling, NIST allows the EHR vendor to select any format they desire for certification purposes. A comma or pipe delimited text file will do.National reference labs, like Quest and LabCorp, as well as smaller regional labs and hospital labs, are all standardized on some minor version of the HL7 2.X standard for transmission of lab results. An EHR, or EHR module, passing ONC certification with anything but the industry accepted HL7 standards will be unable to connect to any laboratories. The “older” EHRs, which have submitted to CCHIT certification in the past, all have working HL7 lab interfaces. The concern is with brand new products, certifying for the first time.

    Assuming the EHR, or EHR module, has HL7 capabilities for lab results, there is still a major hurdle to overcome. National reference labs have long implementation queues and stringent testing and certification processes of their own. It may take 6 months or so, for a new EHR vendor to establish the first live interface with a reference lab. Any subsequent interfaces must also undergo testing and could also take months to create, depending on both vendor and lab availability of resources.

    For a physician contemplating the purchase of a particular EHR this translates into a need to obtain documented proof from both the EHR vendor and the Lab(s) that operational interfaces exist for the Laboratories used by the practice. It also requires that you factor in the additional time it will take to create your particular interface(s).

  • §170.304(b) – Electronically exchange prescription information: NIST has decided that for certification purposes, only the ability to send out a new prescription will be tested. The entire test procedure consists of generating NEWRX messages according to the SCRIPT standard and sending them to a vendor identified external system. Successful testing is decided based on the correctness of the generated message. An EHR, or EHR module, conforming to this particular test is not guaranteed to be able to satisfy the MU criterion. Not by a long shot.EHRs need to connect to the Surescripts network in order to send prescriptions electronically to pharmacies. Surescripts requires the EHR vendor to go through an arduous testing process prior to being allowed to use the network. The ability to send out new scripts is only a small part of Surescripts testing. The vendor must have the ability to also receive error response messages from Surescripts and the pharmacy, receive and respond to refill requests from the pharmacy and send renewal messages to pharmacies. Surescripts must also be satisfied that the EHR’s user interface conforms to Surescripts standards. Surescripts certification is a lengthy process and it is not unusual for it to extend well beyond eight months.

    In a nutshell, a physician aiming to become a meaningful user and collect Government incentives must ensure that the ONC certified EHR about to be purchased is also Surescripts certified. ONC certification for this core MU requirement is meaningless.

  • §170.302(d) – Maintain active medication list: The minimalistic NIST test procedure for this criterion will not affect Meaningful Use or stimulus incentives. It may, however, adversely affect patient care. This test procedure actually presumes that each time a prescription is modified, such as changing dosage or frequency, any and all previous history of said prescription is erased. For example, if a few weeks ago you prescribed Celexa 20mg and today you and the patient decide to increase the dose to 40mg, the medical record will show that the patient was started on Celexa today, and the dose is 40mg. There will be no visible trace of the 20mg regimen in the EHR.Again, “older” EHRs, having gone through CCHIT certification at some point, will probably retain correct medication histories. New EHRs and EHR modules, written to the NIST testing specifications, may not. Unlike lab interfaces and electronic prescriptions, there is no obvious third party verification to look for when shopping for an EHR. This type of problem will not be discovered by a prospective buyer until the EHR has been purchased, installed and used for some time. At that point, with histories lost, the only recourse would be to request the vendor to provide an enhancement to certified functionality.

These are just the most obvious problems. Generally speaking, the test procedures are so narrowly defined that recording such things as who modifies allergies, vital signs, medications or problem lists, or when these were modified, or why, are not a requirement for passing the tests. Presumably, these are all recorded in the audit logs, but there is no specific inspection of the logs and anyway clinicians are not going to consult audit logs on a routine basis. Many other test procedures are of similarly superficial nature, suggesting that NIST is not attempting to certify a product as much as it is trying to certify a technology framework which could be ultimately used to build a meaningful product.

Bottom Line: Physicians need to understand, and ONC needs to clarify, that although required by CMS, ONC EHR certification does not guarantee availability of all EHR features and functionalities required to achieve Meaningful Use.

Margalit Gur-Arie blogs frequently at her website, On Healthcare Technology. She was COO at GenesysMD (Purkinje), an HIT company focusing on web based EHR/PMS and billing services for physicians. Prior to GenesysMD, Margalit was Director of Product Management at Essence/Purkinje and HIT Consultant for SSM Healthcare, a large non-profit hospital organization.

Final EHR Certification Rule Announced By ONC

This week David Blumenthal, Steve Posnack and Carol Bean of the ONC announced the publication of the final (albeit temporary) EHR certification rule.  The actual publication date in the Federal Register will be June 24. (Here is the display copy of the EHR Certification Rule; a permanent rule will be forthcoming later this year.)

The technical standards were glossed over on a conference call with ONC this afternoon; the focus, instead, was on getting testing and certification rolling.  Organizations or consortia may apply for recognition as testing and/or certification organizations as soon as the rule is published; the goal is to have these entities approved by the end of the summer, so as to keep this train moving.  Notably, CCHIT will have to apply, along with everyone else, and CCHIT-certified EHRs are not grandfathered (despite the requests of many commenters.)Continue reading…

EMR Ratings: How Relevant Is CCHIT Certification In the HITECH Era?

For nearly four years, the Certification Commission for Health Information Technology (CCHIT) has been the lone entity recognized by the federal government to certify electronic health record systems. Since being named a recognized certifying body by Health and Human Services (HHS) in 2006, CCHIT has awarded certifications to nearly 200 EHR software products based on CCHIT’s standards of functionality, interoperability, usability and security.

However, CCHIT’s role in the EHR market is changing. The Office of the National Coordinator of Health IT (ONC) and the Center for Medicare & Medicaid Services (CMS) announced in early March 2010 that they would name more than one organization to certify EHR software, countering previous claims that CCHIT would become the sole certifying body. The certification requirements are in accordance with 2009’s Health Information Technology for Economic and Clinical Health (HITECH) Act.

As this news swirled around, one doctor called Software Advice and asked: “Is CCHIT dead?

Dead? No. But it appears that the organization’s influence is waning.

Continue reading…

Why Rush Vendor Certification of EHR Technologies?

A surprise move by ONC/HHS indicates the wheels may be falling off health IT reform at about the same rate they’ve fallen off Democrats’ broader health reforms.

David Blumenthal and his staff have unveiled two separate plans to test and certify EHR technology products and services. We don’t think this is a good idea. We’ve supported the purpose and spirit of the ARRA/HITECH incentive programs, and believe ONC’s/HHS’ re-definition of EHR technology puts it on a trajectory to improve the quality and efficiency of health care in the U.S. But this recently-announced two-stage EHR technology certification plan bears all the marks of a hastily drawn up blueprint that, if rushed into production, could easily collapse of its own bureaucratic weight.

The new Proposed Rule puts vendors through the wringer, twice. As defined by ONC, vendors with “complete EHRs” and those with “EHR modules” will have to find an “ONC-approved testing and certification body” (ONC-ATCB) that will take them through a “temporary certification program” from now until end of 2011. Then in 2012, under a “permanent certification program,” they’ll have to switch over to a National Voluntary Laboratory Accreditation Program (NVLAP)-accredited testing body for testing, after which they must seek an “ONC-approved certification body” (ONC-ACB, not to be confused with ONC-ATCB) that can provide certification. The ONC-ATCB will be accredited by ONC, but the ONC-ACBs will be accredited by an “ONC-approved accreditor” (ONC-AA).Continue reading…

Certification versus Meaningful Use


Recently, clinicians have asked me “why should I implement my organization’s preferred EHR when I’ve found a less expensive vendor that promises meaningful use?”

This illustrates a basic misunderstanding of the difference between Certification and Meaningful Use.

The certification process will be codified in a December 2009 Notice of Proposed Rulekmaking (NPRM) and will define the process for certifying electronic health records including modular and open source approaches. (The Standards for data exchange will be codified in a December 2009 Interim Final Rule and become law immediately.) We know that ONC will specify certification criteria and that NIST will oversee certification conformance testing which will be performed by multiple organizations. However, we will not have the final certification criteria or the defined process until Spring after a period of comment on the NPRM.Continue reading…