Hospitals Prep for Policy Change

Last year, the Centers for Medicare and Medicaid Services announced that beginning Oct. 1, Medicare will no longer reimburse medical providers for additional care resulting from some hospital-acquired infections or medical errors.

But the healthcare industry isn't waiting for fall to turn over a new leaf.

Hospitals and healthcare systems across the country are implementing programs to ensure patient safety is held to an even higher standard and that the effect of the policy change—which prohibits passing those charges on to the patient—is minimal.

Healthcare organizations are taking steps such as implementing simple checklists that halt wrong-side surgeries to outfitting surgical sponges with radio frequency identification tags—wave a wand over the patient, and the system alerts medical personnel if sponges were left inside.

"I hear people say healthcare doesn't know anything about quality, or healthcare is far behind," said Ray Zielke, ASQ's healthcare market manager. "Well, healthcare might be behind when it comes to using some tools or techniques that traditional manufacturing has used. But healthcare has always had a strong focus on quality. It's just more difficult to measure."

It's far easier to crunch the numbers that accompany a lack of quality, and it's that data—hospital errors and the fallout from them—that has the industry focused on remaining a step ahead of any disease or condition that enters the waiting room.

According to the Institute for Healthcare Improvement, unintended physical injury occurs 40,000 times each day in U.S. hospitals. Add to that the 2 million people the Centers for Disease Control and Prevention say are affected annually by surgery site infections, drug reactions and bedsores, and it's clear the healthcare industry has a multitude of reasons to deal with the issue sooner rather than later.

Addressing 'never events'

By the letter of the new law, hospitals and healthcare systems need only concern themselves with eight hospital-acquired conditions—catheter-associated urinary tract and vascular infections, pressure ulcers, objects left during surgery, air embolism, blood incompatibility, mediastinitis (chest inflamation) and falls.

That list likely will grow before too long. In fact, Medicare already plans to add three conditions next year. But healthcare organizations across the country aren't waiting for the list to lengthen before taking action. Several have already multiplied it more than three-fold to include what the National Quality Forum (NQF) calls "never events," a list of 28 extremely rare medical errors that should never happen to a patient.

"The hospitals are just trying to get ahead of the game," said Zielke. "You could give them the benefit of the doubt and say they think it's just good practice. But I think they understand that this is going to take hold."

Some in the healthcare industry began to get their arms around the issue last September, and as of March, 11 states have agreed to dismiss the costs associated with at least the eight never events on the Medicare list. But arguably the largest player to weigh in on the matter was the BlueCross BlueShield Assn.

The federation of healthcare coverage companies—which covers more than 100 million Americans—said in November it would work toward ending payment for never events. Fellow insurance provider Aetna, which covers almost 17 million people, followed suit in January by altering its hospital contract template to include language that asks hospitals to waive all costs related to never events.

The costs are nothing to sneeze at, either. Hospital-acquired infections populate a mere portion of Medicare's no-pay list, and according to the CDC, an additional $27.5 billion is spent annually as a result of these mistakes. In the majority of those cases, Medicare picks up the tab—at least until October, when instead of raking in that dough, the healthcare industry will have to leave it on the table.

"I'd love to say this is a case of hospitals understanding that there's a social contract, and there's increased transparency now, so hospitals are going to be applauded for taking on this responsibility," said Zielke. "But you could be skeptical and say this is motivated by the economic case for quality or the cost of poor quality. When there's financial incentives, things get done.

"It's the club or the carrot. In this case, it's more of a club," he continued. "When Medicare is providing 46% or 47% of your revenue, and hospitals run on a 4% or 5% margin, that can be big, big money."

-Brett Krzykowski, assistant editor


Four For After 5

Four lighthearted, laid-back sessions relating quality to everyday life are scheduled for the 2008 World Conference on Quality and Improvement, May 5-7 in Houston.

The After 5 sessions also include opportunities for conference-goers to socialize with one another. The 75-minute sessions are:

  • Design of Experiments (DoE) and Pizza: Use statistical pizza analysis DoE to replicate New York style pizza.
  • Lean for Your Life: Declutter your house with lean tools.
  • Slow Food and Quality: How continuous improvement, sustainability, farming, organic food, eating, entertaining and cooking come together.
  • Reduce Stress—Yoga at Your Desk: Learn ways to relax and regenerate with yoga stretches at work.

In addition to these sessions, the three-day conference has lined up various courses, certification exams, the Team Excellence Award competition and other learning sessions at the George R. Brown Convention Center. Scheduled featured speakers include:

  • T.K. "Ken" Mattingly, the astronaut who played a key role in the return of the Apollo 13 astronauts from the near-disastrous lunar mission in 1970.
  • Gregory S. Babe, president and CEO of Bayer Corp. Material Science.
  • Patrick Townsend, author and a former Malcolm Baldrige National Quality Award examiner.
  • Michael Stanleigh, director of project and quality management at SheridanCorporate's Innovation Centre, an adult learning and training organization, and president of Business Improvement Architects, a consulting firm.
  • Glenn Walters, a consultant on quality, management and leadership issues for more than 30 years.

For more information about the sessions and the conference, visit http://wcqi.asq.org.

Who's Who in Q

Name: Sonni Williams

Residence: Wichita, KS

Education: Williams has a master's degree in HR development and a master's degree in organizational development.

Current Job: She holds several positions, including Senior Care Act program manager for the Central Plains Area Agency on Aging and quality management coordinator for Sedgwick County Department on Aging. Since 2005, she has been an adjunct faculty member at Friends University in Wichita. She teaches various courses at the college for the adult professional studies HR management program.

Introduction to quality: Academically, her introduction to quality was an organizational development course in graduate school, where she first learned about the Malcolm Baldrige National Quality Award. Professionally, she learned about quality when she obtained her current position as the quality management coordinator for Sedgwick County Department on Aging.

ASQ Activities: Williams is a member of Wichita's local chapter—Section 1307—and a member of the Government Division. She has attended three ASQ Quality Management Division conferences.

Other Activities: She was an examiner for the Kansas Award for Excellence (KAE) in 2006, and she successfully led her department through the KAE self-assessment process. The department was the first in Kansas to achieve this recognition.

Personal: Three sons: ages 16, 18 and 21.

Favorite Ways to Relax: Williams loves movies and nonfiction books on socioeconomic issues such as homelessness and the working poor. She also enjoys watching documentaries on the same topics.

Quality Quote: "The absence of quality proves its worth more than any theory or method that can be applied."


April 7, 1947

QP looks back on an event or person that made a difference in the history of quality.

Henry Ford, a pioneer of the manufacturing assembly system, died of a cerebral hemorrhage at his estate in Dearborn, MI, at age 83.

Ford founded Ford Motor Co. and was the first to mass produce cars in the early 1900s. Toyota founders, who developed the Toyota Production System and lean manufacturing, drew heavily on his writings and credit Ford with helping improve their manufacturing processes.

Quality quote: "Quality means doing it right when no one is looking."

Source: Thinkexist.com, http://thinkexist.com/quotation/quality_means_doing_it_right_when_no_one_is/146322.html.

Short Runs

ASQ'S GOVERNMENT DIVISION will host its 5th Annual Leadership Dialogue event May 8 following the World Conference for Quality and Improvement.Presenters will act as facilitators for a dialogue on how well the public sector performs compared with counterparts in the global Fortune 500 business community and the not-for-profit sector. Registration is limited to 60 participants. Visit www.asq.org/conferences/government-division-leadership/index.html for information and to register.

THE 20TH QUEST FOR EXCELLENCE of the Malcolm Baldrige National Quality Program will be held April 22-25 in Washington, DC. The conference features presentations by current and past award recipients. Visit www.quality.nist.gov/Quest_for_Excellence.htm (case sensitive) for details and registration materials.

ORGANIZERS ARE ACCEPTING applications for this year's John M. Eisenberg Patient Safety and Quality Awards, which recognize individuals and healthcare organizations. The deadline is April 14. Visit www.jointcommission.org for nomination forms and information on the award.

SHARING of CLINICAL DATA among hospitals, doctors and health plans continues to face barriers. That's because of concerns about potential loss of competitive advantage and data misuse, according to a recent study by the Center for Studying Health System Change and the National Institute for Health Care Management Foundation. Visit www.hschange.org/CONTENT/970/ (case sensitive) to view a brief on the report.

ASQ'S SERVICE QUALITY DIVISION is accepting applications for the annual A.C. Rosander scholarship award for the 2008-2009 academic year. The scholarship is open to eligible members of the Service Quality Division and their family members. The number of scholarships and the amount awarded each year is based on the number of applicants. Applicants must be enrolled at an accredited university. Applications, which include an essay, are due June 2. To download an application, visit www.asq.org/service/scholarship/index.html.


THE NUMBER OF international management system certifications that Arizona’s Pima County Regional Wastewater Reclamation Department’s conveyance division recently received simultaneously.

The department was certified to ISO 9001 (quality), ISO 14001 (environment) and OHSAS 18001 (health and safety) in February. The utility’s officials said they believe it is the first public or private enterprise in the United States to achieve this distinction.

The results of a third-party audit were the catalyst for the utility’s management commitment to attaining the three certifications. “We just decided it would be more efficient to prepare for all three at once,” said Edward Collette, environmental and safety manager, who served as leadership representative for the project.

The department contracted with Business Enterprise Mapping to help it develop a business management system and prepare for the certifications. For the audit, TÜV SÜD America Inc., a global certification organization, assigned six independent auditors, two for each certification.

“We serve more than a million citizens over a 370-square-mile service area,” said John Warner, deputy director of the department. “One of our main objectives was to improve their opinion of our service. Certification and the process improvements we made go a long way toward doing that.”

Checklist Ruling Overturned

Following outcry over limits placed on a quality improvement initiative at a group of Michigan hospitals, a federal healthcare agency has reversed its own decision and allowed the intensive care project to continue, clearing its way to spread to other states.

Less than two months after Johns Hopkins University was told to tap the brakes on the project, the Office for Human Research Protections (OHRP) changed its ruling—even going as far as encouraging hospitals nationwide to adopt the program.

“We do not want to stand in the way of quality improvement activities that pose minimal risks to subjects,” said Ivor Pritchard, acting director of OHRP, a part of the Department of Health and Human Services (HHS).

At the center of the controversy was a simple, five-item checklist developed in 2004 to ensure that proper precautions are taken to prevent hospital-acquired, catheter-related infections. A red flag was raised to OHRP late last year that the comprehensive five-step
program should be classified as medical research on human subjects. That meant the program should trigger safeguards similar to those taken when patients are given experimental drugs in a clinical trial or are subjected to experimental procedures.

Slotting the checklist program in this category of research and experimentation also required any participating hospital to get the OK from its institution review board and secure written permission from each patient affected by the activity.

Some said the added bureaucracy would stifle this continuous quality improvement process and perhaps slow similar initiatives.

“Thousands of hospitals nationwide, including a great many here in New York, are engaged in developing and implementing new techniques to reduce infections and improve the quality of care,” Daniel Sisto, president of the Healthcare Assn. of New York State, said before OHRP reversed its decision. “This absurd determination has the potential to halt many of these efforts and stands in blatant conflict with the national imperative to enhance patient safety.”

In Michigan, the checklists continued, but the data collection based on the lists stopped in January until each participating hospital’s institutional review board could approve the activity. Seven weeks later, OHRP changed its ruling.

Simple but effective

The program was spearheaded by Peter J. Pronovost, a physician/researcher at Johns Hopkins. He had essentially boiled down a
64-page federal document on controlling hospital-acquired infections into five simple steps.

The findings from the 18-month study were published in the New England Journal of Medicine in December 2006. The checklist resulted in a remarkable drop in catheter-related infections at John Hopkins and 108 intensive care units in Michigan: the rate fell from 4% to zero, saving an estimated 1,500 lives and nearly $200 million. The program itself cost $500,000.

About half of intensive-care patients receive these catheters—80,000 a year become infected and 28,000 die. The economic cost is estimated to be $2.3 billion.

The publicity generated from the study has sparked interest from hospitals in California, New Jersey, New York, Rhode Island, Tennessee and Washington. Spain is seeking to adopt the program nationwide, and the World Health Organization is looking to take it global.

After contacting Johns Hopkins and the Michigan group of hospitals that participated in the project in mid-February, OHRP reversed its stance and offered new guidance for future quality improvement research that poses minimal risk to human subjects, such as the Johns Hopkins checklist project.

“HHS regulations provide great flexibility and should not have inhibited this activity. The regulations are designed to protect human subjects,” OHRP’s Pritchard said.

Beyond catheters

Authorities have said that checklists could easily be expanded to improve the safety of other hospital procedures, including surgery, anesthesia and the treatment of patients with heart disease, diabetes and pulmonary diseases like asthma, in which certain approaches to care have been scientifically established as most effective, but are still often neglected.

HHS is reviewing the rules related to evidence-based quality improvement activities and when the OHRP policies apply.

Douglas B. Dotan, chair of ASQ’s Healthcare Division, called the ruling “a positive step toward clarifying” the OHRP stance on such activities, but he’s concerned about possible problems in the future.

“We would like to be able to assure healthcare quality and patient safety advocates that their initiatives are not still at risk of running afoul of the regulations,” Dotan wrote in a letter to OHRP.

Mark Edmund, associate editor

Sources used for this report include: the New Yorker, the St. Louis Post-Dispatch and the New York Times.

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