ISO 9000 and patient safety

[Bill Levinson]

I found this forum by searching for discussions of Pennsylvania's Blue Cross surplus. I am working with a legislator to protect the interests of Blue Cross ratepayers (http://www.hersheyphilbin.com/news/hpa/101404.html, I was the one who advocated rebating the surplus to the customers or using it to hold down premiums), and also to get the state's hospitals to implement quality management systems that conform to the international ISO 9000 standard that is already used in industry.

The basic idea is that MOST (the rule of thumb is 85%) malpractice and medical error comes not from the people (doctors and RNs) but from the system in which they work. Adoption of ISO 9000 would therefore suppress up to 85% of all malpractice and fix the state's malpractice crisis very quickly. It also would reduce the cost of health care 30 to 60 percent because this is the estimate of the cost of poor quality in health care.

We have run this idea by the Pennsylvania Medical Society, local hospitals, and also Blue Cross but it has mostly gone in one ear and out the other. The doctors are demanding caps on malpractice awards (instead of accepting the idea that the system in which they work causes most of the malpractice, and doing something to fix it). Blue Cross has been advised repeatedly to use its immense purchasing power to encourage, or even require, the hospitals with which it does business to implement ISO 9000. In one ear and out the other, while it recently asked the insurance commission for a rate increase (which we managed to get shot down).

Hopefully the nursing profession will get behind this initiative, noting that it will make nurses' jobs easier and less stressful (I will reply to the thread about "learning from mistakes"). Also, by reducing the waste of poor quality, it will reduce patient costs while leaving more money for nurse and physician salaries.

A few hospitals have implemented ISO 9000 and achieved results with it, including higher profitability, higher patient satisfaction, and lower staff turnover. The Automotive Industry Action Group (AIAG) wants hospitals to do this because it will reduce the enormous costs that the automakers are incurring for health care-- while keeping their workers healthier.

Now here is a question; do you feel that you do a lot of walking during the work day? The Henry and Clara Ford Hospital (built around 1920 using Ford's industrial efficiency principles) was designed to minimize the walking that nurses had to do, thus allowing them to spend more time with patients.

[danu3]

I am a prenursing student. Before this, I worked in engineering for close to 20 years and on the side I am an ISO 9000 internal auditor.

In my opinion, I don't think the health care system needs ISO 9000 because it has something that is many many times tougher - JACHO. For example, ISO 9000 standard only has 7 pages and JACHO has a lot more than 7 pages.

Furthermore, if a hospital or an agency is into TQM or any of the continuous improvement stuff, it will do a lot better than passing ISO 9000.

In engineering, the only reason high quality companies went with ISO 9000 is because their customers wants it - thinking that haveing a ISO 9000 sticker means quality (that is not true). Companies with high quality think ISO 9000 is a joke in many cases because their standard is way tougher.

Take the actual auditing for example, I'll take a ISO 9000 audit anyday then a JACHO audit.

What ISO 9000 does gurantee to some extend is that you have consistent quality (it can be a consistent bad quality)and that you can look at their records in your contract to see what level of quality they have.

If a hospital passes ISO 9000 and fail JACHO, I would not put my worst enemy in that hospital personally.

Also I've seen enough incidents being an internal ISO 9000 auditor on the side to know one can really messed up the quality of a company if implemented wrong (goes from bad quality to even worst quality) and it is easy to implement it wrong. What it will create is even more paper works, paper works that are down right silly just to meet the standard. And Healtcare have enough paper work already.

-Dan

[Bill Levinson]

In engineering, the only reason high quality companies went with ISO 9000 is because their customers wants it - thinking that haveing a ISO 9000 sticker means quality (that is not true). Companies with high quality think ISO 9000 is a joke in many cases because their standard is way tougher.

You are absolutely right about many companies' motivation for getting ISO 9000. They think it is a costly annoyance they "have" to comply with because their customers want them to have it. And that is exactly what they get: a costly annoyance that does not improve their quality. This is because they let the system slide until about a month before the audit, and then there is a last-minute scramble to get ready for the audit. Their system therefore never delivers the benefits that an ISO 9000-compliant system is supposed to deliver.

When used properly, though, ISO 9000 is a moneymaker (despite the registration costs) because it provides a framework for developing and improving a quality management system that will prevent problems and reduce costs.

Take the actual auditing for example, I'll take a ISO 9000 audit anyday then a JACHO audit.

What ISO 9000 does gurantee to some extend is that you have consistent quality (it can be a consistent bad quality)and that you can look at their records in your contract to see what level of quality they have.

Not any more. ISO 9000 now requires you to define quality, and also to assure it. If the quality is bad, it can't be allowed to get to the customer ("segregation of noncomforming product"). Furthermore, there must be closed-loop corrective action on serious quality problems; not doing corrective action is itself an ISO 9000 nonconformance.

If a hospital passes ISO 9000 and fail JACHO, I would not put my worst enemy in that hospital personally.

Also I've seen enough incidents being an internal ISO 9000 auditor on the side to know one can really messed up the quality of a company if implemented wrong (goes from bad quality to even worst quality) and it is easy to implement it wrong. What it will create is even more paper works, paper works that are down right silly just to meet the standard. And Healtcare have enough paper work already.

-Dan

Your experience might have been with a company that is merely trying to "get the certificate" as opposed to using ISO 9000 as it is meant to be used. This was doubtlessly frustrating to you as an auditor, and I am sure management's attitude pervaded the entire organization. (Speaking of which, management commitment and leadership also are aspects of the ISO 9000 standard.)

As for the relative merits of ISO 9000 and JCAHO, I'm pretty sure that the nurses who are discussing "mistakes" in the thread https://allnurses.com/forums/showthread.php?t=79485 work in JCAHO-compliant hospitals. But the mistakes still happened. And I can cite the provisions of an ISO 9000-compliant system that would have prevented them.

What really bothers me about that thread is that nurses are blaming themselves (and are being blamed) for things that are really the fault of deficient quality systems-- and it is quite evident from their stories that JCAHO isn't doing what ISO 9000 can do.