HE3 743: Promoting Quality Management

in Health Care

1. Why We Need lt Where our health care dollars are going

2. The Systems Issue 3. What it Does

* Stakeholder benefits 0 Conclusion

William A. Levinson, P.E. 14 September 2005

Prepared by William A. Levinson, P.E., MBA

ASQ Certified Quality Engineer, Quality Manager, and Quality Auditor

Principal, Levinson Productivity Systems PC

570-824-1986 bill.levinson@ix.netcom.com

www.ct-yankee.com

Additional information on the benefits of quality management systems in health care is available in a downloadable PowerPoint presentation (about 2 megabytes) at http:ilwww.ct-yankee.comin~anfctrylhealth.ppt

Why We Need It

* Pennsylvania can no longer afford the status quo (1) Skyrocketing medical insurance

costs are making insurance unaffordable for individuals while crushing employers that provide health care benefits.

(2) Rising malpractice insurance premiums are destroying physician practices and making health care even less accessible.

(3) Health advocacy groups are petitioning the State to provide more funds for Medicaid . Even if the taxpayers could afford it, this

is like asking for more blood donors while doing nothing to stop the bleeding.

Wli$mA. Levmron. P.E. 14 5BillemOCr2005

Item (1): There is an almost-perennial controversy over Blue Cross rate increases in Northeast PA.

Item (3) "Son of Sanford," Wall Street Journal: August 23 2005 says that Medicaid now costs the country $300 billion a year and is growing 8% a year.

The health advocacy groups include the Consumer Health Coalition, PA Protection and Advocacy, and about three dozen other organizational signatories to the "No Ma Cuts" letter to Governor Rendell. Their letter to Governor Rendell reads in part, "Yet the proposed caps and Iiillits on Medicaid services will leave the most vulnerable Pennsylvanians without access to critical healthcare and at risk of institutionalization or even death. Costs will be shifted. Hospitals may be forced to close their doors. Other health care providers will bear a heavier burden. In the end, we will pay more, both in human suffering and in actual costs."

This is true but, even if the taxpayers could afford it, throwing more money at Medicaid without addressing the underlying health care quality management problem is like asking for more blood donors while leaving a bleeding wound unbandaged. HB 743 "bandages the wound" through enormous cost reductions without any reduction of services. HB 743 will in fact promote better health care for less money.

This is where our health care dollars are going

(1)30 to 60 cents of every health care dollat are wasted because of poor quality. [ I ]

I (2) About 85 percent of all malpractice is due to the systems in which doctors work. 121 I

We can no longer afford to squander 30 to 60 cents of every health care dollar on poor quality, nor can we continue to tolerate deficient or nonexistent quality management systems that cause five out of six malpractice lawsuits.

W8lilam A. Levsnsm. P.E. 3 1 14 SeptembeiZWS

Note that, as the cost of major medical insurance continues to rise, many individuals and businesses will simply stop participating, e.g. by switching to alternatives like policies with extremely high deductibles or even by doing without. The effect is to reduce the covered population, thus making the insurers' positions even worse.

[I] "Health care providers' cost of poor quality is estimated to be as high as 30-50 perccnt of the total paid for health care. For some companies the cost of employee health ~nsurance is now higher than profits" (Blanton Godfrey, 2000. "Managing Key Suppliers." Quality Digest. September, 2000, p. 20).

"The national numbers for waste in health care are between 30% and 40%; but the reality of what we've observed doing minute-by-minute observation over the last three years is closer to 60%," asserts [Cindy] Jimmerson. (Panchak, Patricia. "Lean Health Care'? It Works!" in Iridustly Week, Novernber 2003)

[2] The rule of thumb in industry is that 15 percent of all quality problems (like defects, rework, and scrap) result from workers' carelessness and negligencel and 85 percent fsom deficiencies in the systems in which they must work. Malpractice case studies suggest that the same ratio applies to health care.

We pay hospitals to make people sicker and then we

pay them to fix the damage.

Hospitals infect hundreds of thousands of patients with diseases they didn't have when they went in. . Unsanitary operating rooms [31 . Failure of staff to wash hands between

patients [4] . Handwritten prescriptions cause countless medication errors [5] * We are more careful with our money

(checks) than with prescriptions! . Mixed-up test results Blood banks cannot afford to make this error (and they don't) but hospitals and laboratories do so all the time.

Wllim A iCY#n-. P.E. 1" Septenbs. 2W5

[3] "Patients suffer as agency shields troubled hospitals," Chicago Tribune, 10 November 2002

[4] "Up to 10 percent of hospitalized patients suffer from an infection acquired while they are in the hospital. Many of these infections are transmitted via the hands of healthcare workers. ... studies have repeatedly shown that hand washing compliance rates are venerallv less than 50 percent." The Leapfrog Group, "Hospital Quality and Safety Survey." https:l/leapfrog.medstat.com/pdfiFinal.doc The role of bacteria in causing infections was discovered in the mid-191h century by Louis Pasteur and his contemporaries. The British physician Joseph Lister (for whom Listerine is named) cut infection fatalities enorlnously during the 1870s and 1880s by persuading surgeons to sterilize their equipment, hands. and clothing between operations. In other words. we are losine lives and monev to a orohleln that was identified and solved more than 120 vears ago.

(51 Comp~rtex Physician Entry Order (CPEO) systems. "Assures that prescribers enter hospital medication orders via a computer system that includes decision supuort software to reduce ~rescribine errors." https:llleapfrog.medstat.co~n/pdfiFinal.doc

"Death by decimal" (as described on Oprah Winfrey's "Outrageous Medical Mistakes" show) occurs when a patient gets, for example, ten milligrams of a drug instead of one milligram. This kills 7000 to 10,000 people a year. "Make No Mistakes: High-tech tools transfom~ hospital medication practices," APICS Magazine, March 2005, p.40, adds, "Shockingly, almost one in iive medication doses administered in U.S. hospitals is given in emor; according to a recent American Medical Association 'Archives of Internal Medicine' study."

We are more careful with money than with medicine. We write out the dollar amount on checks (e.g. "eighty-one dollars and 21/100n) but a typical handwritten prescription

might call for 1 0 mg QD, QD is actual shorthand for "per day" and the selected font is more legible than many doctors' handwriting.

We even pay hospitals to kill us

* Our health care "system" kills more people than automobile accidents and violent crime put together.

* HealthGrades reports that medical mistakes of all kinds kill 195,000 annually. [6]

Equivalent to a daily jumbo jet crash Equivalent to a weekly 911 1 terrorist attack Even lower estimates are comparable to American fatalities in the Second Worldwar. [7] . Prescription errors alone kill 25,000 [8]

Yiilllam 4. iWm6m. P.E. 14 5e01embn 2006

hseaction=mod&modtype=conte~~t&modact=Media-PressRelease-Detail&&pressjd= 135

In-Hospital Dealhs from Rledical Errors at 195,000 per Year, HealthG1.ades9 Study Finds

Lakewood, Colo. (July 27,2004) -"An average of 195,000 people in the U.S. died due to potentially preventable. in-hospital medical errors in each of the years 2000,2001 and 2002, according to a new study of 37 million patient recol-ds thal was released today by HealthGrades, the healthcare quality company."

"Of the total 323,993 deaths among Medicare patients in those years who developed one or more patient-safety incidents. 253,864, or 81 percent, of these deaths were directly attributable to the [patient safety] incident(s)."

"One in every four Medicare patients who were hospitalized from 2000 to 2002 and experienced a patient-safety incident died."

[7] The Institute of Medicine reported in November 1999 that 44,000 to 98,000 hospital patients die every year from avoidable mistakes (Shapiro, 2000,50). Crago (2000) cites the same estimate and adds Harvard School of Public Health adjunct professor Lucian Leape's estimate of 120,000 deaths a year from all medicai mistakes. 98,000 deaths a year is comparable to annual American co~nbat losses in World War 11, and more than automobile accidents and violent crime put together.

Crago, Michael G. 2000. "Patient Safety, Six Sigma. and IS0 9000 Quality Management." Otrnlity Digest, November 2000. -

Shapiro, Joseph P. "Taking the mistakes out of medicine." U. S. ATews and WOI-Id Repol-i, 15 July 2000, 50-66

[8] "Message to physicians: Better read than dead." 2000. W'ilkes-Bnl-re Times Leudel-. 25 October 2000.

More of what our health care dollars are buying:

Jessica Santillan was killed and two donated heart-lung sets were wasted because the first organs had type A blood and Jessica was Type 0. . This may also have cost the life of a patient

with Type A blood whom the first healt-lung set might have saved.

* Jeanella Aranda was killed and her father underwent unnecessary surgery because of mixed-up test results.

"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 0 blood; the father is type A." This sort of thing might be contributing to higher malpractice premiums.

Wlliam A. Levinson P.E 14 September 2W5

Re: Jeanella Aranda http:/lwww.cbsnews.com/stones/2003/03/13iliealthln~ain5438 14.shtmt "A laboratory that performed the blood typing for Jeanella and her parents mixed up the blood t s e s of the parents and incorrectly identified the father as a suitable donor of a partial liver." (The article explains that a living donor can donate part of his or liver, which regenerates.)

""...An exhaustive review of the care Jeanella received at our hospital has been conducted, and Children's believes it acted appropriately, based on the informatioiz provided to us by arz external labor-atory," the hospital's statement read in part." [emphasis is mine]

The internationally-recognized IS0 9000 standard for quality management systems requires assurance that external suppliers (such as medical laboratories) are capable of providing the necessary quality. This kind of mistake happens rarely if ever with blood donations because of the very stringent traceability methods that blood banks use. The procedures exist and there is no excuse for not using them.

See also http:llwww.duke1nednews.org/ne~~sia~~cle.php?id=6419

I

I Why did this happen?

I Every health care worker involved knew the importance of matching the patient's and the donor organ's blood types. * Anybody could have done it and

Everybody doubtlessly assumed that Somebody had done it. When something is Everybody's job, though, Nobody usually does it- and in the systems in which these people worked, it was Everybody's and therefore Nobody's job.

"...technical specifications may not in themselves guarantee that a customer's requirements will be consistently met, if there happen to be any deficiencies in the specifications or in the organizational system to design and produce the product or service."

William A. Levinson, P.E 14 September 2005

Reference for quoted material: 1987 I S 0 9000 standard. I S 0 9000's focus is on the organizational system that delivers the product or service, which is in this case health care.

The Systems Issue

A Typical Health Care "System" of the Early 20th Century

The physician usually had total control over the patient's care. This health care system was very simple and it was hard for much to go wrong with it.

William A. Levinson, P.E 14 Seplernber 2005

As shown by some of the black bag's contents, the doctor was in co~nplete control of the diagnosis and even administration of the medications that appear in the picture. The basic idea is that the doctor was the only person to izaizdle the black bag, i.e. the system. This made it far more difficult for a systenl-related error to occur.

I I i

A Small Part of Today's Health Care System

William A. Levinson. P.E. 14 September 2005

The picture only barely bcgins to illustrate the true complexity of a 21St-century health care system, in which even the smallest piece of information (like a laboratory test result) may pass through several handlers.

The operating room picture underscores the concept that the patient's welfare is far from under the surgeon's direct control. The surgeon's activities are partially at the mercy of his assistants (shown), the people and laboratories that provide him with information like X-rays to guide the surgery (not shown), and even the people who are responsible for cleaning the operating room and sterilizing the instruments (not shown). If the patient suffers a postoperative infection, of course, the surgeon will doubtlessly be among the first to be named in a lawsuit. This is why physicians should welcome the introduction of quality management systems but they are slow in understanding their importance.

The Problem: Summary Modern physicians work in a system of interacting processes and activities over which neither they nor any other single person has control.

Any breakdown in this system can harm the patient (and cause a malpractice lawsuit) even if the doctor does nothing wrong.

The medical community is largely unable or unwilling to recognize this problem.

William A. Levinson. P.E 14 September 2005

I I

The Solution: A Systems Perspective How do factories assure product quality when no individual craft worker has control over or responsibility for the work?

Primitive quality control: inspectors sat at the end of the assembly line and sorted the good pieces from the bad ones. Turn of the 20th century: Scientific Management, introduced by Frederick Winslow Taylor. Early 20th century: Henry Ford's lean manufacturing system included error- proofing and similar controls to make sure the job was done right the first time.

1980s: Introduction of the !SO 9000 quality management standard. Automotive QS-9000 and lSO/TS 16949:2002 (similar to IS0 9000)

William A. Levinson, P.E 14 September 2005

Heilry Ford's production system is better known today as the Toyota production system. Taiichi Ohno admits opmly that he got the idea from Henry Ford, and the key elements of the TPS are very evident in the books that Henry Ford and Samuel Crowther wrote during the 1920s.

Part suppliers must be registered to QS-9000 (to be superseded by ISOITS 16949:2002) as a condition of selling to auto manufacturers! -3 Health insurers and Medicare could require health care providers to register to IS0 9000,' IWA-I. IWA-1 stands for International Workshop Agreement, a modification of IS0 9000 that the American Society for Quality and the ,4utomotive Industry Action Group tailored specifically to health care.

HB 7'43 encourages health care providers to implement

quality management systems

HB 743 uses the basic concept of the existing PennSAFE program.

Employers that implement qualifying employee safety committees get discounts on their workers' compensation insurance premiums. Fewer workplace accidents + fewer worker's compensation claims.

* HB 743 provides a 20% malpractice insurance discount to health care providers that implement quality management systems that are approved by the Department of Health. * Remember that about 85 percent of all

malpractice is system-related.

William A. Levinson, P.E. 14 September 2005

HB 743 does not, however, prescribe a specific quality management system standard like IS0 9000:2000. If the appropriate standards change (as IS0 9000 has done at least twice since its inception), the Department of Health can update the set of qualifying standards without thc need for further legislation.

Stakeholders 6 Everyone wins with HB 743

Patients @ Lower health care costs

Less chance of being harmed

* Physicians Fewer malpractice suits -3 lower malpractice insurance premiums

Hospitals and Clinics * Lower costs + higher staff pay and profits

Insurers (e.g. Blue Cross) Lower costs .3 lower premiums -9 more customers

Employers Lower benefit costs

* Pennsylvania Lower Medicaid costs

William A. Levinson. P.E. 14 September 2005

Conclusion

We can no longer afford the status quo.

Waste of 30 to 60 cents of every health care dollar Up to 85% preventable malpractice

* HB 743, the first-of-its-kind legislation in the country, addresses our health care system's disease- deficient or nonexistent quality management systems- instead of its symptoms.

HB 743 goes beyond fixing Pennsylvania's health care crisis; it sets an example for other states and the Federal government as well.

William A. Levinson, P.E. 14 September 2005