News & Events

Patients in peril?

Good story, that is, accurate descriptions of what happens on the ground in hospitals, to employees who whistleblow, to how The Joint Commission works, to the scrutiny given hospital mergers (or not) and to the fact that CMS has withheld only $20 million of the $150 billion it has paid to hospitals as a result of hospital-acquired infections, for which hospitals can be penalized financially.

So hospitals have only had to pay back .00013 of the money they were paid for infections brought about by their own system problems.

Patients in peril?


Sunday, February 27, 2011 Two recent reports found issues at University Hospital that could affect patient safety. But a disconnect between regulators means many safety concerns like these are not shared with other agencies — or with the public.

Food and Drug Administration

An image from the Food and Drug Administration’s 2008 report on University Hospital (Missouri) shows a knife handle that was packaged for reuse with rust visible on the handle. The FDA report contains several images showing items that were not properly sterilized or were reused despite being meant for single use.

Rusty drill bits. Several rusty knife handles. Single-use surgical towels used to soak up blood and other body fluids, then reused to wrap “sterile” surgical trays.
Those were among the findings at University Hospital during eight days of inspections by a Food and Drug Administration investigator between May and July 2008.

Two and a half years later, an inspection of the hospital by the Department of Health and Senior Services for the Center for Medicare and Medicaid Services (CMS) made similar finds: Residue and debris on instruments in sterile surgical containers. Orthopedic instruments with bone or cement on them. A sterile processing technician washing dirty surgical instruments with gloves on, then opening a door and answering a phone without removing the soiled, wet gloves.

The lengthy report from CMS dated Nov. 5 concluded “the cumulative effect of these systemic practices has the potential to affect all patients in the hospital.”

But three weeks before CMS inspectors began an unannounced, five-day visit to University Hospital, officials from the Joint Commission on Accreditation of Healthcare Organizations were on site to review the merger between University Hospital and the Women’s & Children’s Hospital, previously known as Columbia Regional.

On Nov. 10 — five days after CMS determined MU Health Care was not in compliance with standards of infection control and was in jeopardy of losing the ability to collect federal Medicare funds — the Joint Commission issued a report awarding the hospital full accreditation.

In fact, the Joint Commission granted its gold seal of approval, meaning the hospital meets or exceeds national standards in most areas.

In light of the divergent accounts, patient advocacy groups wonder why the reporting agencies don’t share reports with one another. Even MU Health Care administrators have said there appears to be a disconnect among regulatory agencies. [note: TJC is not a regulatory agency]

“I don’t think there is a real good system for sharing that kind of information,” said Becky Miller, director of the Missouri Center for Patient Safety. “I think there’s a long way to go to open up those communication lines.”

MU Health Care executives disagreed with several findings from both reports. MU Health spokeswoman Jo Ann Wait pointed out 18 months passed between the FDA’s inspection and that report’s release.

“No patients were harmed or in immediate jeopardy or they wouldn’t have waited 18 months to get back to us,” Wait said. She said the hospital was not asked to respond to the findings, but MU Health officials voluntarily sent a copy of their internal “FDA Action Plan” to the federal agency.

Through a Freedom of Information Act request, the Tribune obtained more than 400 pages of documents — including the hospital’s action plan — listed as attachments or exhibits to the 24-page FDA report. Wait said hospital administrators have not seen those documents.

“That’s part of the disconnect,” Wait said. “We’re not playing with the same deck of cards.”

The Affordable Care Act, which aims to reform the nation’s health care system, targets that disconnect to some degree. What patient safety advocates particularly like, however, are the new, phased-in reporting requirements that will require all hospitals and surgery centers to report hospital-acquired or health care-acquired infections.

Sharing information would go a long way toward improving hospital-acquired infection rates, said Lucian Leape, co-founder of the National Patient Safety Foundation. “Information from reporting systems … is seldom used by regulators to improve safety,” he said.

It seems clear the regulators aren’t sharing information. FDA spokesman Christopher Kelly said his agency’s reports are “sometimes” shared with sister agencies, but he could not disclose which reports are shared. CMS regional director Judy Baker said officials in her agency are addressing the communication gap internally.

And the Joint Commission learned about the latest CMS inspection and report from MU Health Care CEO Jim Ross. “They were surprised,” Ross said during an interview last month. “They hadn’t seen it.”

The Joint Commission is not a federal regulator. Hospitals voluntarily choose to go through the agency’s accreditation process, and there is no law requiring other agencies to share their reports.

“We would like to have the survey reports from CMS,” said Patricia Kurtz, director of federal relations for the Joint Commission. FDA reports don’t usually end up with Joint Commission inspectors. “We would like to receive those because those are part of our oversight fabric.”

Some CMS regional offices are “very good” about providing the reports, she said. “Some regions are not so good,” she said. “Some regions are horrible.”

At the very least, the CMS and FDA inspection reports would be “very beneficial to the Joint Commission,” she said, and could help target the commission’s surveys of hospitals.

Kurtz said Joint Commission inspectors review more than a thousand requirements for accreditation.

“I’m surprised that we did not pick up these issues that the two federal bodies picked up,” she said.

Elizabeth Eaken Zhani, media relations manager for the Joint Commission, said the agency can issue a “requirement for improvement” from the hospital. University Hospital has not received such a request for the FDA or CMS reports.

Carey Smith, MU Health’s manager of regulatory affairs, said all complaints made by patients, employees and the regulatory agencies are taken seriously.

“We’re always looking for ways to improve,” he said, noting complaints often generate a task force or work group to address concerns.

Hospital administrators continue to insist there was no evidence the hospital has an infection-control problem. In fact, data show MU Health, as well as Boone Hospital Center and Truman Memorial Veterans Hospital, are all doing as well or better than other hospitals across the nation in controlling infections.

“My wife actually had surgery here after this report,” Ross said in the January interview, referring to the CMS report. “Our reputation about patient safety is everything.” [his wife—not HIM!]

Les Hall, MU Health’s chief medical officer, provided information to show the hospital’s rate of staph infections has declined dramatically each year since 2002. Hall also pointed out the health system had implemented corrective action on all the CMS findings, even though Ross said his administrative team did not agree with all the findings.

For instance, Ross said, his team agreed some casters on medical equipment wheels were rusty, but he said that did not affect patient health and “outcomes,” such as infection rates and hospital readmissions. The report also detailed findings of food on the floor and in the corners of food preparation areas.

Ross called some of the CMS observations “awfully granular.”

Even though MU Health officials disagreed with several of the CMS findings, hospital staff responded with a massive deep-cleaning of the hospital in December. Some 120 employees worked overtime or volunteered to help housekeeping staff with the cleaning effort. An additional 25 housekeeping crew members were hired as a result of the CMS inspection.

The voluntary action plan in response to the 2008 FDA report, while not agreeing with most of the specific findings, called for discarding old instruments and instruments with rust or debris and removing instruments that could be mistaken for single-use devices. The plan also outlined improvements in record-keeping, training for employees in the sterile processing department and improved tracking of equipment repairs and maintenance.

Wait said MU Health spends some $4.6 million annually to support specific efforts to boost health care quality.

Hall pointed out University Hospital, in particular, treats “the sickest of the sick,” because patients are often transferred there from other hospitals. Those patients often already have compromised immune systems and are at a higher risk for complications or infection.

Marcia Patrick, director of infection prevention and control for MultiCare Health System in Tacoma, Wash., agreed hospital patients are already more vulnerable to certain infections because of pre-existing conditions such as diabetes, malnutrition or dirty wounds. “That makes it very hard to prevent infections,” she said.

Patrick, who is a board member with the Association for Professionals in Infection Control and Epidemiology Inc., or APIC, said it’s not good enough, though, for a hospital to say it is “average” in terms of infection control.

“Hospitals say, ‘Look, we’re doing really well. We don’t have a bunch of infections. We’re better than the national average,’ ” she said. “Average is nothing to brag about. Average isn’t good enough, especially in the area of infection control. We’re all aiming for zero.”

As for the scathing inspection reports from the Food and Drug Administration in 2008 and the Centers for Medicare and Medicaid Services in 2010, hospital administrators point to the CMS finding that the complaint that initiated the November inspection was “unsubstantiated with related deficiencies.” Ross and Hall insisted patients were not harmed even by the “related deficiencies” in poor housekeeping and sterilization.

Even so, FDA and CMS each pointed to deficiencies that resulted in “dirty” surgical instruments in 2008 and 2010. Both reports also pointed out a lack of documented tracking of instruments, miscommunication between supervisors and staff, and similar issues that apparently allowed the deficiencies to persist.

“It does sound like there are system problems, and hopefully those have been addressed,” Patrick said.

She said it was probably easy for inspectors to find problems because they were tipped off “and went in there with laser vision.”

Hal Williamson, vice chancellor for the University of Missouri Health System, said CMS inspectors combined to spend 312 hours on site. “They had a lot of stuff to work with,” he said.

Williamson said he did not necessarily agree with all the findings and was puzzled about why CMS made the report public before giving MU Health Care an opportunity to respond with a plan of corrective action. CMS officials said it was unusual for that to happen.

Without the tip from former sterile processing technician Sam Backues, neither the regulatory agencies nor the public would have known about the problems. Backues, who was the only certified sterile processing technician on his shift — and who was identified by his immediate supervisor as a possible trainer for other technicians — notified the FDA about the problems in May 2008. Backues also made contacts that led to the CMS inspection in November.

Hall said hospital policy encourages employees to “speak up,” especially in the area of infection control.

“He did raise the issue when he was employed here,” Ross said. The hospital’s infection control department conducted an internal investigation and “did not substantiate his complaint.”

Backues worked the fourth and final stage of the sterilization process. He cited faulty washing and drying machines as the main reason instruments were still embedded with bone or tissue when they reached his station.

“There was literally blood running out of the” surgical “tray when it came out of the washer, and it was cold,” Backues said. He provided several copies of work orders for the department’s equipment. The FDA report noted the equipment problems.

He filed a complaint with FDA on May 1, 2008, claiming the sterile processing department was routinely reprocessing devices meant to be used only once. The other claim that caught FDA’s attention was his observation of “dirty” orthopedic implant parts that had been sterilized.

Backues recalled the visit from FDA inspector Monique Brooks. Brooks asked technicians whether single-use devices were being reprocessed. Other staff members said that was not occurring. However, Backues not only confirmed it, he also told Brooks where to find the devices. Her subsequent report confirmed his claim.

Within an hour of his on-site conversation with Brooks, Backues said, he was summoned to the office of Director of Surgery Mark Jackson “to talk about my employment with the university.”

University officials have not responded to that claim. Brooks’ report includes affidavits from at least two other employees who feared retaliation if they spoke out about the sterile processing department. Brooks also noted that concern in her report.

The discussion between Backues and his supervisors took place two weeks later, with a union representative joining the meeting on behalf of Backues. He eventually transferred to other areas of employment within the university system. He voluntarily left in January 2009.

Backues also made the complaint that led to the CMS inspection.

“As far as direct observations, he has not been here on-site in the last two and a half years,” Ross said last month.

Actually, Backues next worked as an independent contractor providing courier services for Guardian Medical Logistics in Columbia. In August, he delivered used vaginal speculums and other instruments from MU Health’s Smiley Lane clinic to the hospital’s sterile processing department. Backues said he was instructed to take instruments through the “clean,” or sterile, side of the department.

“I knew then nothing had changed with management’s attitude toward cleanliness,” he said. “They were still running dirty.”

He phoned in a complaint to the hospital’s infection control department that day. By then, he also had a copy of the 2008 FDA report, which he circulated to local media and other parties, including the attorney general’s office.

Backues said he was contacted by state Department of Health and Senior Services officials to get more information. At that point, Backues filed an official complaint, which led to the CMS review in November.

Hospitals want the public to keep the reports in the context of the overall work they do. Every day, about 120 surgical procedures are done in Columbia’s three hospitals. In the vast majority of cases, nothing goes wrong.

Finding information about the cases that go wrong can be cumbersome, and scant details are available. For instance, a national tracking service shows some 6,000 medical malpractice reports in Missouri since 1990. The list includes 4,158 medical doctors, 696 osteopaths and 604 dentists. But no names or other identification are listed. Another report lists thousands more “adverse action reports” by licensing agencies against nurses, athletic trainers, chiropractors, pharmacists, professional counselors and social workers, speech pathologists and doctors.

Discipline reports are often available online from the licensing agencies, but without knowing which names to look for, matching those reports with the national database is virtually impossible.

When it comes to information related to preventable medical errors — including hospital infections — the public is usually in the dark. Until now. Health care reform legislation has established a timetable for meeting infection reporting requirements.

“Most hospitals already have this information,” said Lisa McGiffert of Consumers Union, “but if they never put it together for the public in a meaningful way, it might as well not be there.”

Lawmakers passed the Missouri Hospital Infection Control Act of 2004 that required hospitals to report their rates of specific infections, but patients must know how to navigate specific websites to find the information. MU Health officials said this week their patient safety data will soon be on the university’s website.

“University of Missouri Health Care is committed to providing our patients with the safest, highest-quality, most-satisfying care possible and to transparency in sharing our quality data with the public,” the university said in an e-mail response to a series of questions. “Recognizing that this information needs to be understandable and user-friendly, we are in the process of developing our own Web site for reporting this information.”

Herb Kuhn, president of the Missouri Hospital Association, agreed hospitals should do a better job of making their data understandable.

“It’s kind of like the airline industry. We don’t hear about all the near-misses and activities,” said Kuhn, a former deputy administrator for CMS. “You don’t want to create a chilling atmosphere.”

He also pointed to a recent study that showed CMS has withheld only $20 million of $150 billion paid to hospitals as a result of hospital-acquired infections.

“I think a lot of people were surprised,” Kuhn said. “The number of incidents that occur is quite small.”

He quickly added: “Each and every one of them should never, ever happen.”

Reach Jodie Jackson Jr. at 573-815-1713 or e-mail

Hospital infections seen as ‘winnable battle’

Prevention is an increasing focus.


Sunday, February 27, 2011 To get an indication of the national magnitude of hospital- or health care-acquired infections (HAIs) consider the short list of “winnable battles” championed by Thomas Frieden, director of the Centers for Disease Control and Prevention.

Missouri Department of Health and Senior Services

The list includes reducing death and disease caused by tobacco; reducing new HIV infections; taking steps to drive down motor vehicle injuries; promoting nutrition and physical activity to stem the tide of obesity; improving public health through food safety; preventing teen pregnancy — and eliminating preventable health care-associated infections.

“There has been a big increase in focus on infection prevention,” said Marcia Patrick, director of infection prevention and control at MultiCare Health System in Tacoma, Wash. “That’s wonderful. That’s where we want to go.”

Patrick also is a board member for the Association for Professionals in Infection Control and Epidemiology Inc., an international organization with its sights set on infection and disease.

Officials at Columbia’s hospital systems say their facilities have internal infection-tracking methods and are committed to following CDC guidelines for reducing HAIs.

Boone Hospital Center staff members wear a name badge that lists the hospital’s “10 Standards of Excellence.” At the top of the list is “patient safety.”

“Patient safety and infection control are central to our hospital’s mission of improving the health of the people in the communities we serve,” Boone Hospital media relations specialist Jacob Luecke said. “We take this mission very seriously and focus a great deal of time and resources on ensuring our patients’ safety.”

But Luecke said Boone Hospital does not publicly disclose its internal tracking of safety measures.

“I can tell you that we measure widely, set the bar high and expect improvement each year,” he said. “Our most recent results show we are among the top achievers in this regard.”

University of Missouri Health Care has had its Office of Clinical Effectiveness since 1997. MU Health spokeswoman Jo Ann Wait said the office has “the singular purpose of improving the quality and safety of patient care” in the hospital’s system.

Wait said the hospital’s infection rates, which are publicly reported for surgical site and bloodstream infections, “provide strong evidence of the effectiveness of our patient safety and infection control practices.”

MU Health and Boone Hospital have new patient care towers under construction. Hospital officials said the additional rooms will enhance safety by allowing more private rooms, which control the spread of infections.

Even with increased focus on HAIs, nearly one in every 20 people who get hospital treatment — up to 2 million people a year — get an infection as the result of treatment. As many as 99,000 will die. The CDC estimates the cost to the health care system is between $35 billion to $45 billion annually.

The Agency for Healthcare Research and Quality reported an 8 percent increase in bloodstream infections over the past year. The agency estimated that more than 30,000 people die from bloodstream infections they get from being in the hospital.

Surgical sites, central lines, catheters, intravenous lines and wound care are common avenues for carrying infection. But the vast majority of HAIs are caused and spread by the most common instrument used in hospitals — the human hand.

In addition to hand hygiene and quality-checked sterile processing methods, providing surgical patients with antibiotics before surgery is an important anti-HAI measure.

A November report by the Joint Commission for Accreditation of Healthcare showed that University Hospital met or exceeded national standards in almost all performance categories. Still, the report, which is based on statistics collected from March 2009 to April 2010, showed the hospital lagged behind national averages in some areas. Seventy-three percent of patients received the appropriate medication for colon and large intestine surgery, versus the national average of 89 percent, and 82 percent of adult pneumonia patients were given antibiotics within six hours of arriving at the hospital, versus the national average of 95 percent.

Wait said MU Health officials were working to address those statistics.

Other factors that increase the risk of an HAI include: age, disease history or underlying disease, inadequate nutrition, compromised immunity and trauma.

Any unnatural intrusion of the body can introduce infection. For instance, the respiratory tract has a number of defense mechanisms to protect the body: saliva, the cough and gag reflex, and the cilia lining the respiratory tract. An endotracheal tube — a temporary breathing tube to keep the airway open — bypasses those defenses. Another example of a medical procedure that bypasses the body’s natural defenses is a needle-stick that can introduce a variety of blood-borne pathogens.

Some of the more common — and potentially lethal — types of health care-associated infections that must be reported to state and federal regulators include:

  • Central line-associated bloodstream infection (CLABSI). A central line is a tube that health care providers place in a large vein in the neck, chest or arm to give fluids, blood or medications or to do certain medical tests quickly. When germs enter the bloodstream via a central line, a variety of complications can occur. A CLABSI is the most expensive health care-associated infection to treat and heal.
  • Surgical site infection (SSI). Sometimes an infection occurs after surgery in the part of the body where the surgery took place. SSIs are sometimes nothing more than superficial infections of the skin. Other SSIs are more serious and can involve tissues, organs or implanted material, such as orthopedic parts for shoulder, knee and hip surgeries.
  • Catheter-associated urinary tract infections (CAUTI). A catheter is a tube inserted into the bladder to drain urine. These infections can affect the bladder and the kidneys when a catheter carries germs into the urinary system. A CAUTI is considered the least expensive health care-associated infection, adding an average of an extra $1,000 to the patient’s bill.
  • Ventilator-associated pneumonia (VAP). Hospitals report data called “head of bed” to show what percentage of patients on ventilators have the head of their bed elevated at least 30 degrees. That seemingly simple measure is seen as the main safeguard against VAP, which is a lung infection that develops in a person who is on a ventilator.


Health care consumers who want to find the infection rates for Missouri hospitals won’t find how often “superbugs” — those drug-resistant bacteria — or similar germs make patients sick. The rates of infections caused by antibiotic-resistant organisms are not collected for public reporting by the Department of Health and Senior Services.

That decision makes patient safety advocates take notice. “It takes resources” — manpower — for a hospital to track and report every infection, Patrick said. “You can’t do it if you don’t have the bodies.”

The “superbugs” include:

  • Methicillin-resistant staphylococcus aureus, or MRSA, a common germ that can cause serious infections and pneumonia. MRSA is resistant to many of the antibiotics that are used to treat other staph infections.
  • Clostridium difficile, or C. diff. This bacterium can occur as a result of prolonged use of antibiotics during health care treatment. C. diff infections cause diarrhea and more serious intestinal conditions such as colitis. Contaminated surfaces and spores of the germ can cause C. diff to spread quickly throughout a health care facility.


Helen Haskell is a mother-turned-activist whose campaign has led most hospitals to ensure that patients and their families have the right to consult with a senior physician rather than an intern or a resident doctor. She advocates for more transparency in medical error and infection reporting and encourages patients to be more of a participant in their care than a spectator.

“There are so many questions that patients ought to ask. You’re in a very vulnerable position” as a patient under the care of a doctor. “You’re asking someone to do something very serious that you don’t know anything about. You have to trust them.”

Haskell, the founder of Mothers Against Medical Error, insists that patients and their families check the background of doctors and hospitals before getting treatment. She founded MAME 10 years ago after a series of preventable medical errors at a South Carolina hospital led to the death of her 15-year-old son, Lewis Blackman.

Health care-acquired infections are usually considered “no pay events” by CMS, so there’s an added financial incentive to hospitals for reducing or eliminating the infections. “No pay events” are not the same as “never events,” which are surgical mistakes and errors in medical tests or medication. A series of “never events” killed Lewis Blackman.

The National Quality Forum, a Washington, D.C.-based not-for-profit group, has developed a list of “never events” — 27 incidents, such as wrong-site surgery, that should never happen in health care.

The list includes surgery performed on the wrong body part, surgery performed on the wrong patient, infant discharged to the wrong person, patient suicide, patient death or serious disability associated with a medication error, patient death or serious disability associated with a burn or a fall associated with medical treatment, abduction of a patient, and sexual assault.

Reach Jodie Jackson Jr. at 573-815-1713 or e-mail