Tools, Technologies and Training for Healthcare Laboratories

Part IV. Inadequate Inspections

August 2004

One of the most dramatic revelations of the Maryland General Hospital scandal was the failure of inspections to uncover the problems in the lab. How did the inspections fail, and can new inspection regimes solve this?

Hear, Hear, Hear! Hearings on untruth and unquality!
Part IV. Inadequate Inspections

with Sten Westgard, MS

Of the many shocks revealed by the Maryland General Scandal, the failure of inspections was one of the most dramatic. Despite passing a CAP inspection and achieving accreditation with distinction (meaning doing more than just the bare CLIA minimums), the laboratory continued to report HIV and hepatitis tests when QC results showed the tests might be invalid. In fact, there was a long list of bad practices that continued for at least 14 months, despite the accreditation and inspection process. Why didn't inspections at both the state and national levels catch the problems?

What went wrong with the inspections?

In congressional testimony, it was pointed out that one shortcoming of laboratory inspections is that they are announced in advance, so that laboratories know when the inspectors are going to arrive. In many laboratories, the weeks prior to an inspection are hectic times as people try to get everything in order while also doing their normal daily work. Particular attention is paid to getting documents and records ready for review, which includes QC policies, procedures, and results.

Those documents and records are supposed to show the typical laboratory practices and procedures, but apparently they don’t. Instead, inspectors usually get a glimpse of the laboratory under the best possible light, rather than a true picture of the normal operation of the laboratory. Appearances at the time of inspection do not necessarily represent the reality of what goes on in a laboratory on a daily basis!

Finally, during the congressional hearing, it was noted that the inspections are often performed by private organizations that are “deemed” to meet or exceed the government requirements. Some of these organizations employ full time inspectors and others employ volunteers or “peers” who may be from neighboring institutions. The training and objectivity of the inspectors themselves are critical, but questionable.

What proposals have been made to improve inspections?

Based on the failure of the inspection process, it has been proposed that inspections should be unannounced. In addition, there should be an opportunity for laboratory workers to speak directly with the inspectors under the condition of confidentiality. In effect, “whistle-blower” protection is needed if workers are to reveal what is really happening in a laboratory. That need was clearly documented in the MGH situation, where lab workers were intimidated by laboratory managers. If workers feel the threat of losing their job, they will remain silent while inspectors go through the laboratory.

By changing the inspection process from announced to unannounced and adding the condition for confidential comments from workers, the accrediting agencies are acknowledging that there is, in fact, a problem that goes beyond just the Maryland General Hospital laboratory. Professional accreditation processes, whose historical purpose have been educational, are not well-suited for the regulatory application. The assumption of the professional model is that professionals do their best to achieve a high level of quality. The inspection checklists provide the current guidelines for the best practices, procedures, and processes for achieving quality. Professionals do their best to implement those guidelines. The inspection itself is to identify areas for improvement and to provide educational support. Today’s cost-driven healthcare environment and compliance-driven management violate the basic premises of the professional accreditation model, which is the trust that the practitioner is doing her best to follow best practices, rather than doing the least that is necessary to be in compliance with minimum requirements.

But now the trust is gone and the need for surprise inspections shouldn’t come as a surprise! In our compliance oriented healthcare industry, inspectors are going to have to crack down. There will be a more adversarial relationship between the inspector and the laboratory. That will hardly encourage laboratory managers or analysts to come forward with information about the real workings of the laboratory.

What is fundamentally wrong with inspections?

The third of Deming's famous 14 points advises us to “Cease dependence on mass inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place” [1986]. Deming stressed that inspections occur too late to improve quality, and as such, increasing the number of inspections only consumes more money and effort. He quoted Harold Dodge, “You cannot inspect quality into a product.” You have to build quality in from the beginning.

Unannounced inspections also fail to address the problem with worker intimidation. If the climate of a laboratory intimidates workers into silence on a daily basis, they will be unprepared to step forward during an unannounced inspection. “Whistle blowing” is not for the timid and unprepared. It requires careful deliberation to make a stand and express yourself.

In fact, one might even say that the inspection process works on the basis of fear and intimidation. The fear of a surprise inspection is supposed to motivate laboratories to improve their practices and at assure the quality of laboratory testing. But, making the inspection process more fearful and adversarial is not likely to assure quality. Remember Deming’s 8th point, which is to “drive out fear, so that everyone may work effectively for the company.” Fear does not motivate laboratory workers to increase quality beyond the bare minimum. Fear just motivates us to not get caught in violation of the rules. We all know that the fear of a speeding ticket by itself does not require us to be good drivers; it merely motivates us to avoid speeding. Likewise, fear only motivates us to avoid deficiencies in complying with regulations, by whatever means accomplish that purpose!

Is there any solution?

New technology, such as radar detectors for inspectors, would provide the simplest solution for today’s compliance-focused healthcare industry. With the advent of embeddable chips, the industry could lobby for a bill that requires inspectors to be detectable. There’s a better chance of that happening than any real effort to implement quality systems that will guarantee the quality of laboratory testing.

The problem is that quality work requires a quality workplace and a quality of life for the workers. That’s not possible today! Clinical Laboratory Scientists are some of the hardest-worked employees in the healthcare industry. They are also some of the most under-paid, given the amount of education and technical expertise that their profession requires. Their schedules are often brutal, due to the need for round the clock testing, staff reductions due to cost-cutting in their institutions, which is further complicated by the high turnover rate and further exacerbated by the general shortage of available workers. Because of this poor compensation and work climate, students are fleeing the profession, making it harder and harder on those who remain.

To this overburdened profession, we now seem to be adding an additional weight. Now they are the ones we expect to blow the whistle. They are often the lowest rung on the ladder, but we are expecting them to have higher moral values than their bosses. It seems strange that we are holding the bench level workers more responsible than their management. But this seems like a typical trait of the post-Enron business climate and is demonstrated by our own government in the Abu Ghraib prison scandal.

Quality is a management problem and can only be solved by changes in management. And it has to begin right at the top!

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.