Yesterday I had the opportunity to chat with several members of the executive leadership team from DNV Healthcare, the "new kid on the block" for hospital accreditationDNV was recently granted deeming authority by CMS — the first time the federales have taken such a step since recognizing the Joint Commission about 40 years ago.  (The AOA has deeming authority for osteopathic hospitals.)  I spoke with Darrel Scott, Senior Vice President, Patrick Horine, Executive Vice President – Accreditation, and Becky Wise, Chief Operating Officer, and learned more about DNV, ISO 9001, and the National Integrated Accreditation for Healthcare Organizations (NIAHO) standards. 

DNV developed its NIAHO standards for hospital accreditation, building upon both the Medicare COPs and on ISO 9001, a quality management standard that the DNV judged would enable hospitals to most effectively address — and avoid — issues such as never events.  ISO 9001 is specifically designed to address service organizations (rather than, e.g., manufacturing), and is proven as a basis for quality improvement.

In essence, NIAHO requires hospitals to implement ISO 9001 as a means to achieving compliance with the COPs.  ISO 9001 is a vehicle to implement and maintain a quality management system which ensures compliance with COPs across all hospital processes.  DNV views a "process" as being a holistic whole, cutting across traditional silos of hospital departments (such as nursing, pharmacy, IT, housekeeping, etc.) — so a process is "acute hospital inpatient care," not "radiology turnaround time."  A hospital would likely have no more than a dozen "processes" by this definition.

NIAHO standards speak to the COPs more directly. DNV is differentiating itself from the Joint Commission by observing that, for example, the JC requires that in order to meet the no-wrong-site-surgery element of the COPs, hospital employees and medical staff follow a prescribed process.  Failure to adhere to the process means a ding on a survey.  By contrast, the ISO 9001 approach requires that there be some reliable process in place to assure that no wrong-site surgeries take place, but does not prescribe the particular mechanism.  In shorthand, ISO 9001 is the "what," not the "how."  That can be a good thing or a bad thing.  DNV is clearly pitching this as a good thing: giving hospitals much greater flexibility than the Joint Commission approach.  The challenge for hospitals and their advisors is to ensure that there be either sufficient local innovation and development — or cross-pollination, or communication with other organizations — of best practices, to ensure optimum patient care in the absence of specific patient safety goals or other standards. 

ISO 9001 compliance will not require hiring of new staff; entities that are currently JC-accredited are "about 70% of the way there."  Annual visits (vs. every-three-year JC surveys) will promote more of a continuous quality improvement mindset.  In addition to the survey visits, each department in a hospital needs to be audited by another department on an annual basis.  A positive side effect of the interdepartmental audits is expected to be an overall improvement in communication across silos, leading to a reduction in errors in handoffs and otherwise.

After accrediting a couple dozen U.S. hospitals during its "out-of-town tryouts," DNV says that it is ready to ramp up and begin surveying hospitals nationwide, having engaged and trained a cadre of surveyors as employees and contractors — nearly 100 to date.   These surveyors are cross-trained both as ISO 9001 lead auditors and as generalist, clinical or life safety code surveyors.  (DNV affiliates have conducted ISO certifications of over 1,200 health care facilities worldwide.)

One potential bump in the road is state hospital licensure regulations.  In the HealthBlawger's unscientific survey of two states, hospital licensure regs require a licensure survey by state surveyors unless the hospital is Joint Commission-accredited (Joint Commission is named in the regs).  At least one of these states has expressed a reluctance to make the change to more generic language that would recognize the CMS-approved DNV accreditation in lieu of a licensure survey.  DNV's view is that these issues will not prove to be long-lived, and that state hospital associations are likely to carry the water on this one at the behest of their membership.

DNV stresses that ISO 9001 compliance is not required day one in order to obtain DNV accreditation.  There is a two-year ramp-up period to allow for hospitals to learn the ropes and come into compliance. 

One of the positive aspects of the new system highlighted by DNV is that there is no "tipping point" — no threshold number of negative findings that will edge a hospital out of compliance.  Instead, any nonconformities will require corrective action plans.  If the nonconformities are "Category 1" (i.e., more severe), the corrective action must be taken within 60 days, or the hospital moves into "jeopardy" — and risks losing accreditation.  This aspect, among others, has impressed DNV executive leadership with the value of open dialogue between hospital and survey team, made more likely given the less likely event of an operations-stopping notice of deficiencies.

DNV offers "sustainability" — DNV standards change only if COPs or ISO 9001 standards change.  This may be attractive to some hospitals, which have balked at some Joint Commission requirements/revisions in recent years.  (The MS 1.20 – Medical Staff By-Laws saga comes to mind as one example.)

Check out the DNV website for FAQs, articles, and info on full-day workshops coming up over the next month or so.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting