Will New Medicare Rules Lead to Better Health Care Quality?

The cost of poor quality in health care ranges from 30 to 60 cents of every health care dollar. Until recently, however, there have been few financial consequences for health care providers’ failure to address the underlying root causes. This article describes Medicare’s new policy of not paying for preventable medical errors and complications, and how this may drive implementation of quality management systems in health care.

Quality management systems (QMS) and health care
As long ago as 2001, the Automotive Industry Action Group cited the possible role of ISO 9001 in reducing medical costs while saving thousands of lives. There’s little doubt that ISO-compliant systems would have prevented the following medical errors.

In 2002, a cancer patient received a tenfold overdose of the blood thinner Warfarin, which resulted in an eventually fatal cerebral hemorrhage. A common term for this is “death by decimal,” which involves a patient getting 10 times or one tenth what the doctor prescribed. We’re more careful with our money than we are with medications, because we write out the dollar amount on checks to prevent exactly this kind of error.

“Death by decimal” is a well-known problem, and it’s easy to envision an auditor asking a pharmacy what procedures exist to prevent it. The idea of programming a computerized physician order entry (CPOE) system to detect misplaced decimals is meanwhile obvious. The Leapfrog Group provides more information about CPOEs.

ISO 9001 also calls for product and information traceability, which would have easily prevented at least two medical tragedies. Jessica Santillan was killed and two sets of transplant organs were wasted, because the first set she was given had Type A blood, and she was Type O. Everybody in the supply chain assumed that somebody had checked the organs’ blood type against the patient. Anybody could have done it, but nobody did it. The American Red Cross already uses the necessary procedures in its blood donor program, which means that methods for assuring organ compatibility should be available off the shelf.

The same traceability issue allegedly caused the death of Jeanella Aranda, along with one of those malpractice suits about which the medical community is always complaining:

The lawsuit alleges that doctors mistakenly gave Jeanella Aranda a liver transplant from her father instead of from her mother. The mother and child had type O blood; the father is type A. A laboratory that performed the blood typing for Jeanella and her parents mixed up the blood types of the parents and incorrectly identified the father as a suitable donor of a partial liver.” (from “Another Fatal Transplant Error? Lawsuit: Baby Given Liver That Didn’t Match Her Blood Type.” CBS News, March 12, 2003.)

Test and inspection data don’t get mixed up in an ISO-compliant factory, so there’s no excuse for this kind of mistake in a medical laboratory. It may be contended, in fact, that anywhere from 80 to 85 percent of all malpractice cases result not from individual doctors’ negligence, but from deficiencies in the system in which they work. This is the usual proportion for problems in other work environments, and examination of publicly reported medical mistakes supports this conclusion.

Why is the health care sector not using effective quality systems?
Implementation of ISO 9001 or a comparable system by health care providers is an obvious solution to these kinds of problems. Furthermore, the AIAG, American Society for Quality, and other organizations have even done part of the health care providers’ work for them. In 2001, they published International Workshop Agreement 1 (IWA‑1), a health care-specific modification of ISO 9001. Few health care providers have, however, attempted to implement it. As explained by Goodman: “Research by John Wennberg and his colleagues at Dartmouth Medical School suggest that if everyone in America went to the Mayo Clinic, our annual health-care bill would be 25 percent lower (more than $500 billion!), and the average quality of care would improve. If everyone got care at Intermountain Healthcare in Salt Lake City, our health-care costs would be lowered by one-third.”

Why are these examples of efficient, high-quality care not being replicated all across the country? High-quality, low-cost care is not financially rewarding. Indeed, hospitals and doctors can make more money providing inefficient, mediocre care.

The difference between health care providers and factories is therefore the overriding financial incentives. A factory that ships nonconforming work not only doesn’t get paid, it risks losing future orders unless it completes a corrective action report (CAR) that shows the measures that it has put into place to prevent the same problem from happening again. The CAR is, in turn, based on the standard closed-loop corrective-action cycle, of which Ford Motor Co.’s team-oriented problem-solving, eight disciplines (TOPS‑8D) and Six Sigma’s define, measure, analyze, improve, control (DMAIC) are but two examples. ISO 9001, in fact, requires that a closed-loop corrective-action system be in place.

In contrast, a hospital that gives a patient methicillin-resistant staphylococcus auraeus (MRSA), e.g., through staff members who don’t wash their hands between patients, suffers no penalty for endangering a patients’ lives and increasing their length of stay. The hospital is, in fact, rewarded because it can bill the patient or insurer for a longer stay.

The famous surgeon Joseph Lister convinced the medical world of the need for antiseptic hygiene more than 130 years ago. Modern hospitals would probably be more interested in implementing the modern versions of Lister’s methods if there were serious financial consequences for hospital-acquired infections. Thanks to a new Medicare policy, this will soon be the case.

Medicare’s new policy should drive change
In a significant policy change, Bush administration officials say that Medicare will no longer pay the extra costs of treating preventable errors, injuries, and infections that occur in hospitals, a move they say could save lives and millions of dollars. (Pear, Robert. 2007. “Medicare Says It Won’t Cover Hospital Errors.” New York Times online, August 19, 2007 )

The eight conditions include injuries from patient falls, pressure ulcers, urinary-tract infections, vascular-catheter-associated infections and mediastinitis, an infection following heart surgery. Also included are so-called never events, meaning they never should happen: objects left in the body during surgery, air embolisms, and blood incompatibility. (Zhang, Jane. 2007. “Medicare to Stop Paying For Some Hospital Errors.” Wall Street Journal, August 20, 2007; Page B2)

Money is the language of upper management, and hospital administrators should react exactly like other executives who are faced with the prospect of enormous financial losses for poor quality. In addition, Medicare has set a precedent that private-sector insurers can and should imitate. Furthermore, Medicare rules should inform patients that hospital-acquired infections, ventilator-acquired pneumonia, pressure sores, and so on aren’t things that just happen. Instead of paying hospital fees and insurance copayments without question, affected patients will be more likely to call the nearest personal-injury lawyer. This will be yet another incentive for hospital administrators to make sure these things don’t "just happen” in the future, and the following section shows why they should never happen.

Preventable—so-called “never”—events
Joseph Lister’s contemporaries thought that post-operative infections "just happened” and that nothing could be done about them. Theories bordered on superstitions that involved mysterious "miasms” in the air, or even spontaneous generation of bacterial life in open wounds. It took considerable work to persuade doctors that the tiny organisms they could see under microscopes were responsible, and that antiseptics such as phenol could prevent infections by killing the organisms. The events for which Medicare will no longer pay don’t "just happen,” either.

1. Patient Falls

• Beds with load sensors can detect when a disoriented patient is trying to get out of bed. There are also beds that can lower themselves almost to the floor, thus reducing the chance of significant injury if the patient rolls out.

2. Hospital-acquired infections

• These are largely preventable by hand washing, as recommended by Lister and the Hungarian physician Ignaz Semmelweis. Placement of hand-washing stations in each patient’s room facilitates compliance, and antiseptic gels that require no rinsing make them easy to use.
• The concept of making compliance easy and convenient has been around since the 1930s if not earlier. A waste container was available within seven steps of any position at the Ford Motor Co.’s River Rouge plant, so employees always threw garbage into the containers instead of onto the floor. Disney theme parks now use the same method to keep themselves clean. If the equipment, whether for waste disposal or hand-washing, is always close at hand, people tend to use it.

3. Vascular-catheter infections

• The Institute for Healthcare Improvement prescribes a central line “bundle,” or combination of equipment and procedures, to prevent vascular-catheter infections: “The ‘central line bundle’ has five components: hand hygiene, maximal barrier precautions, chlorhexidine skin antisepsis, optimal catheter site selection, …and daily review of line necessity with prompt removal of unnecessary lines.”

4. Pressure ulcers

• The IHI estimates that the cost to treat each pressure ulcer ranges from $500 to $40,000. Most are preventable.

5. Ventilator-acquired pneumonia

• Medicare doesn’t list this as an event for which it will not pay, but the IHI shows how to prevent it. "The ’ventilator bundle’ includes four components: elevation of the head of the bed to between 30 and 45 degrees, daily ’sedation vacation’ and daily assessment of readiness to extubate [remove the tube], peptic ulcer disease (PUD) prophylaxis, and deep vein thrombosis (DVT) prophylaxis (unless contraindicated). The first two components are directed at preventing VAP and the latter two components at preventing other complications associated with mechanical ventilation.”
• The IHI reference adds that health care providers don’t implement the above recommendation routinely or reliably.

That these preventable complications and similar ones still “just happen” in hospitals underscores the observation that health care providers’ quality systems are often seriously deficient. Few quality improvements can succeed without the active support of upper management and, until recently, there have been no significant financial incentives for hospital administrators to provide such support. Now that Medicare will no longer pay for many avoidable complications, upper management support should be forthcoming.

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