Maryland General

January 2006

Across the US, laboratorians are growing pale. Many of them will no longer know the exact date of their inspection. But will "surprise" inpections improve quality?

• But that's different!
• The issue becomes enforcement, but quality is not enforceable!
• So what's the answer?
• References

The January 2006 issue of Clinical Lab News highlights the upcoming changes in the laboratory inspection process – that the specific dates of an inspection will NOT be announced. That change in the inspection process is the outcome or solution enacted in response to the Maryland General Laboratory problems that we have been discussing on this website for the last year [1].

Unannounced inspections may strike fear in the hearts of laboratories, but fear has not been demonstrated to be effective for quality improvement. As we have pointed out before, one of Deming’s principles of quality management is to remove fear from the workplace [2]. Fear keeps problems hidden, rather than contributing to remedies and improvements.

In this same first week of January 2006, we have also seen some hard facts that unannounced inspections don’t work, as evidenced by the tragic deaths of 12 coalminers at the Sago Mine in West Virginia. That particularly coal mine WAS subject to unannounced inspections and had a long list of violations. According to the Washington Post, “in the past two years, the mine was cited 273 times for safety violations, of which about a third were classified as ‘significant and substantial’…” [3]

Unfortunately, that list of violations did not effect the improvements that were needed. The mine kept operating in spite of the violations.

But that’s different!

Certainly, coal mining is different from laboratory testing in healthcare, but the two situations have some interesting similarities.

• There is a rising cost of energy which places pressure on business to keep costs down. The Sago Mine is a small mine in West Virginia where the expenses of deep mining are much higher than the costs of surface mining in Wyoming. Small mines like Sago can now make money only if costs can be contained. Healthcare is also under economic press to contain costs. The Maryland General problem could be attributed most directly to the effort to contain laboratory costs and maximize billing for tests that could generate more revenue.
  
• New business organizations take over old operations with the idea that they know better how to run these operations and can make money through improved efficiency. The Sago Mine was just purchased by a new company two months ago, so many of the violations were on record as occurring with the older owner. Nonetheless, the mining operation continued in spite of the known problems. Remember that Maryland General was under the operation of the University of Maryland Health System, which had many other operations that competed for administrative attention and priority. It was only when the laboratory problem blew up that the administration started to pay attention. The same will be true with Sago Mine. Tragically, the problems will get fixed now that 12 miners have been killed.
  
• The inspection process and procedures were part of government oversight by the Labor Department’s Mine Safety and Health Administration (MSHA). The government therefore knew that these problems existed, that the regulatory rules were being violated, but took no action other than to provide the citations. Likewise for Maryland General, the regulatory bodies performed their duties as charged, issuing citations, but taking no actions to correct the problems. Remember that the hospital and laboratory were inspected by the State of Maryland, CMS, CAP, and JCAHO. There were citations, but nothing serious enough to shut down the laboratory and/or the hospital.

The issue becomes enforcement, but quality is not enforceable!

It’s not an issue of whether or not unannounced inspections will identify problems. Of course they will! The issue is what to do when problems are identified, which becomes an issue of enforcement. The Sago mine had 68 citations in 2004, which more than tripled to 208 citations in 2005. But most of the fines for the citations were between $60 and $440, despite the repeated violations. The total of all the fines reached only $24,000, even though the maximum single fine can be $60,000.[4] One might speculate that the company that owned Sago mines chose to pay financial penalties rather than make the necessary improvements simply because it was cheaper.

Quality is not enforceable in today’s free enterprise marketplace. Supposedly the customers will decide and quality will emerge as a market force if it is sufficiently important. The difficulty with that assumption is that healthcare customers are not readily able to evaluate the quality of services, particularly laboratory services. Sure, they can tell whether they had to wait before getting their blood drawn, whether the acquisition process was quick and painless, but beyond that they can’t tell whether the testing process is being correctly performed and whether quality is adequately controlled. Not even the physician can tell about the correctness and adequacy of the testing process. Thus, the customer-centered enforcement of free-market principles does not work in laboratory testing or, on a larger scale, in healthcare in general.

So what’s the answer?

Inspections are useful if they are accepted as audits that are performed for the benefit of the laboratory, not for the purpose of issuing citations that get the laboratory in trouble. As inspections become a more strict regulatory tool, rather than a voluntary audit, they become less useful for improving quality.

Unfortunately, the regulatory process co-opts the quality process. Compliance with regulations and inspection or accreditation guidelines takes the place of doing what’s right to manage quality. That doesn’t mean you can’t manage quality and be in compliance, rather it means that being in compliance doesn’t equate to providing quality testing services.

Given that quality cannot be effectively enforced in healthcare through market forces, that leaves professionals with the responsibility to assure quality in the services they manage and deliver. That also means that we need professional leadership at the top of the healthcare organization, not business managers. We must assert our professional responsibilities for delivering quality services to our patients! We must assert our professional interests through management and leadership responsibilities and positions! We must acquire the business and management skills to complement our technical skills! We must emerge as the advocates, leaders, and managers of quality for our patients.

References

1. Westgard JO. Hearings on untruth and unquality. I. Cracks in the healthcare quality system.
2. Westgard JO, Westgard SA. Hearings on untruth and unquality. IV. Inadequate inspections.
3. Warrick J. Safety Violations Have Piled Up at Coal Mine. Washington Post online, Washingtonpost.com, January 5, 2006. Accessed January 5, 2006.
4. Klein R. Democrats asking Congress to review safety, enforcement. Boston Globe online, Boston.com, January 5, 2006. Accessed January 5, 2006.

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.