Certification and Quality

Modern Healthcare Online (article available to subscribers only, March 12, 2007 Issue)

I think it’s been true in the manufacturing world that quality certifications, such as ISO-9001, aren’t necessarily predictors of world-class quality. I’ve seen it be far too easy for bad factories to get ISO certification. Companies play the game, they put together their binders, they coach their employees how to pass the certification, and their sole ISO focus is getting that certificate (as opposed to using the methodology to actually drive improvement).

The same dynamic is often true in healthcare, not surprisingly, maybe. Hospital labs have regular certification cycles with the same common dysfunctions as ISO.

Modern Healthcare magazine writes about the “Joint Commission” accreditation for hospitals and how some recent quality problems have occurred in accredited hospitals, including Walter Reed and West Texas Hospital (a specialty hospital where employees had to, on 15 occasions, call 911 to get patients moved to other hospitals for emergency care).

Dennis O’Leary, President of the Joint Commission says:

O’Leary defended the value of his organization’s accreditation, but acknowledged that the process has its limits. “Accreditation is not a warranty that any organization is perfect,” he said.

True. The burden isn’t on any certification or accreditation organization. Quality is an ongoing process that is management’s/administration’s burden. As a customer/patient, don’t take quality/safety for granted just because all of the right certification tickets have been punched.

We can’t expect outside inspectors to catch every systemic process problem, as the article explains:

At Walter Reed, the problems may be linked to the accreditation process’ focus on clinical areas. Dean Samet, director of regulatory compliance services at consultancy Smith Seckman Reid and a former Joint Commission associate director, said it wouldn’t be uncommon for a building like the one affiliated with Walter Reed to not be included on the survey list. Whether any of the Army hospital’s staff mentioned the building’s condition during the overall accreditation survey is unclear—but also unlikely. “To be quite honest, the staff normally wouldn’t be airing their problem areas” to surveyors, Samet said.

Typically, Joint Commission surveyors focus first on the main clinical areas, such as inpatient and ambulatory-care settings, Samet said. “Time permitting, they may try to do a random sampling of some of the other areas,” he added. “But that’s only time permitting.”

Ticking off the checklist, Samet said that surveyors need to focus on emergency management, sentinel event alerts, compliance with the National Patient Safety Goals and, at the base level, the ever-changing Joint Commission standards. “That typically keeps surveyors pretty busy,” he said.

Of course employees aren’t going to bring up problem areas. When the management focus is on “pass the inspection,” speaking up in the name of solving a problem would probably only bring punishment down on yourself. Employees should be bringing those issues up to management first, ideally. And, ideally, management should be helping address those issues independent of any inspections/certifications.

Paul Keckley, executive director of the Deloitte Center for Health Solutions, Washington, noted that it’s generally accepted that Walter Reed’s problems are on its ambulatory side while the Joint Commission is more geared toward assessing acute care, but that the Joint Commission is probably getting “a spotlight it deserves” and that—at times—it “has been its own worst enemy.”

What these scandals illustrate is that “you can do all the right things to get accredited, yet there can be systemic problems in your organization,” Keckley said. “I think (the Joint Commission) made a couple changes that are significant in the past 18 months. That said, I still don’t think the Joint Commission is as significant a force in quality and safety as it should be.”

What are your experiences with certification and quality, in manufacturing or other industries? Do people just try to “pass the test” or use it for real improvement?

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Mark Graban's passion is creating a better, safer, more cost effective healthcare system for patients and better workplaces for all. Mark is a consultant, author, and speaker in the "Lean healthcare" methodology. He is author of the Shingo Award-winning books Lean Hospitals and Healthcare Kaizen, as well as The Executive Guide to Healthcare Kaizen. His most recent project is an eBook titled Practicing Lean that benefits the Louise H. Batz Patient Safety Foundation, where Mark is a board member. Mark is also the VP of Improvement & Innovation Services for the technology company KaiNexus.

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3 Comments on "Certification and Quality"

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  1. Rob says:

    I believe that the ethos behind ISO9001 is totally correct. Just look at the principles it is based on:

    . Focus on your customers
    . Provide leadership
    . Involve your people
    . Use a process approach
    . Identify interrelated processes and manage them as a system.
    . Encourage continual improvement
    . Get the facts before you decide
    . Work with your suppliers

    Really it is no different to poor lean implementation. Focus on lean tools will bring some benefits but we all know that’s not the whole story. Same with ISO9001, focus on gaining a certificate and you may well get it but not much else.

    Rob

  2. LeanPrinter says:

    Ditto Rob’s comments, above. What’s that saying, “you are what you tolerate?”

    My first experience with an ISO-9001 certified supplier was back in the mid-90’s. We were having signficant quality issues with their products, both in severity and frequency. It turns out that they had made a process change without informing us and our lines were shutting down several times because of it. A call to their Sales Rep only resulted in getting the “well, we’re ISO certified now” response, as if that excused the problem. I called the President of the Company and told him a) his products had become garbage b) his sales rep should be fired and c) ever since they became ISO certified they were more focused on their paperwork and not on their product. Since we were a very large customer they quickly corrected the problem.

    The 2nd was when my own company was undergoing a 9002 maintenance audit. Let’s just just I was less than impressed with the auditor and, by extension, the audit firm. We were a $40MM plus operation, 165 employees, 150,000 sq ft, and operated 24/7. The auditor was done in 4 hours, and that included an hour lunch! There was no preparation, no pre-audit meeting, and no post-audit discussion of findings because there were none!?!

    I know there had to be at least one finding, because we were suspicious about the registrar to begin with (they had lost a number of their senior auditors) and the lack of pre-audit preparation gave us more reason to be concerned, so we had planted a non-calibrated measurement device for a non-critical component in a very conspicous place and he never looked at it. All this guy wanted was a free lunch and to get on to his next “assignment”.

    Needless to say we dropped that registrar shortly afterward and signed on with a new firm to conduct our 9000:2000 recertification, one that I’m happy (?) to say crawls up one side and down the other, and them inside out and back again.

    The fly-by-night registrars and auditors out there are making a mockery of the entire process, but as long as there are clients out there who only care about a piece of paper this little scam will continue to grow. It devalues the certification of the truly well-run companies out there, because a customer who has been burned by a supplier with a sham certification will now have doubts about the well run company’s certification – after all they’re both “certified”.

  3. Dave Haagsma MBA,MT(ASCP) says:

    After 7 years working in a hospital lab and experiencing annual CAP surveys I can say that they are much more intensive than an ISO Audit. After leaving the hospital environment, I became a Lead Internal Auditor for a Distribution company. My inspections which I modeled after the CAP inspection turned up many more defects than the ISO audit trail would ever uncover. <><>The blanket statement made in the second paragraph disparages the efforts made by the Laboratory Professionals in this county over the last fifty years. We have always been at the forefront of improving quality through peer reviews, check samples and annual inspections. For the lab six sigma is unacceptable as every result must be correct.

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