Transcript ISO 9000 quality management system.

Quality Management:
Solving the Nation's
Health Care Crisis
(1) The Problem
(2) The Root Cause: lack of a
systems perspective in medicine
•
Doctors' obsolete paradigms
(3) Introducing ISO 9000 and IWA-1
•
Application examples
(4) Others that are doing it
(5) Recommendation: Encourage or
require health care providers to
register to the ISO 9000 standard
for quality management systems.
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(1) The Problem
•
The entire country is suffering from a
worsening health care crisis.
(1) Rising health care costs that are increasingly
more difficult to pay
(2) Rising malpractice insurance costs
The Opportunity
Health care: 40
?: 30
WASTE: 30
(1) 30 to 60 cents of every health care dollar
are wasted because of poor quality. [1]
Dr.: 15
SYSTEM: 85
(2) About 85 percent of all malpractice is due
to the systems in which doctors work. [2]
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Health Insurance
Premiums Now Pay For:
• Unhygienic hospital conditions that cause
thousands of preventable infections.
• Failure to keep operating rooms clean [3]
• Failure of staff to wash hands between
patients [4]
• Medication errors caused by handwritten
prescriptions [5]
• "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.
• A no-brainer under any decent quality system
• Mixed-up test results
• ISO 9000 requires traceability; see also blood
banks that cannot afford to make this error.
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JCAHO Accreditation
Not Enough?
• "Using a voluntary system of reporting, the Joint
Commission vastly underestimates the number of
avoidable patient deaths. The organization, for
instance, documents just 12 cases of preventable
hospital-borne infections since 1995. The Tribune
found about 75,000 such deaths in just one year,
a figure supported by state and government files.
Joint Commission officials acknowledge
substantial inaccuracies in their records."
• The article adds that the Joint Commission often
does not change a hospital's accreditation even
when there is strong evidence that patient care
has been compromised.
• The article also says that nurses told a surveyor
that a Minnesota hospital used the "Potemkin
Village" approach to JCAHO audits. It bought new
linens for its empty beds, and returned them after
the JCAHO survey.
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JCAHO's Response
• JCAHO's response to the Chicago
Tribune article suggests that it does not
understand the problem:
• "Resource constraints and staffing shortages
create patient safety vulnerabilities and force
even conscientious health care professionals,
in some circumstances, to forego basic
necessities such as handwashing in order to
meet urgent patient care needs. It is problems
such as these that set the stage for the types
of serious and deplorable outbreaks of
nosocomial (hospital acquired) infections
portrayed in the Tribune article."
• JCAHO states the problem but does not assert
that "lack of staffing" is never accepted as an
excuse for skipping operations like quality
testing in industry, much less life safety-critical
ones like hygiene in hospitals.
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(2) The Root Cause
• Why are medical costs, which were
relatively affordable several decades
ago, now spiraling out of control?
Except for the most serious and
complex cases, a single physician was
usually in charge of each patient's care.
The doctor with the little black bag still
made house calls.
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A Typical Health Care "System"
of the Early 20th Century
This health care system was very simple
and straightforward, and it was hard for
much to go wrong with it.
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A Small Part of Today's
Health Care System
Laboratory
Diagnostics
• Information Systems
• Pharmacy
• Nursing
• Maintenance
• Instrument calibration
Interdependent teams
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The Doctors' Paradigm
Much of the medical
community still
seems to think that
doctors work in this
kind of system 
• "I am a conscientious and competent
doctor so why do I need a quality
management system?"
• A health care system of the kind
illustrated (only in part, by the way)
in the previous slide cannot be run
like a single-practitioner doctor's
office of the mid-twentieth century!
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Industry went through
the same transition!
A typical business of the
early 19th century. The
blacksmith was
completely responsible
for making the horseshoe
and fitting it to the horse.
The skilled tradesman
had total control over the
process that created his
product or service.
The doctor with his little
black bag was in similar
control of the process
that delivered health
care to his patient.
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The Transition to
Organized Factories
• Toward the middle and end of the 19th
century, the individual craftsman was
superseded by systems of workers,
equipment, and information systems.
• No individual had control over the
entire job, so no one could be
responsible for it.
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The Systems
Perspective
• How did factories assure product quality
when no individual craft worker had
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 errorproofing and similar controls to make sure the
job was done right the first time.
• 1980s: Introduction of the ISO 9000
quality management system.
• Automotive QS-9000 and ISO/TS 16949:2002
(similar to ISO 9000)
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Taking Industrial
Methods to the Hospital
• "The same kind of management which
permits a factory to give the fullest
service will permit a hospital to give the
fullest service, and at a price so low as to
be within the reach of everyone" (Henry
Ford, My Life and Work).
• "In the ordinary hospital the nurses must make
many useless steps. More of their time is
spent in walking than in caring for the patient.
This hospital is designed to save steps. just
as in the factories we have tried to eliminate
the necessity for waste motion, so have we
also tried to eliminate waste motion in the
hospital" (also from My Life and Work).
• "It is simply a matter of transferring those
precision methods, so well established in
the Ford shops, into hospital work"
(Norwood, Ford: Men and Methods).
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(3) Introducing ISO 9000
• Health care providers (such as
hospitals and medical laboratories)
need state-of-the-art quality
management systems because:
• "…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."
• Emphasis is mine. The indicated concept
cannot possibly be overemphasized.
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What Is ISO 9000?
•
•
ISO 9000 is an internationallyrecognized standard for quality
management systems.
Registration to ISO 9000 (awarded by
various internationally-recognized and
independent registrars) requires:
(1) Implementation of a quality management
system (QMS) that meets the standard's
requirements.
•
A hierarchy of documented procedures for all
processes and activities in the organization.
(2) Performance of all operations and activities
according to the procedures that are in place
to satisfy the standard.
•
"Say what you do and do what you say."
(3) Confirmation of the above by a third-party
(independent of the customer or supplier)
auditor, who acts for the registrar.
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ISO 9000 and IWA-1
• IWA-1 (International Workshop
Agreement), "Quality Management
Systems: Guidelines for process
improvements in health service
organizations."
• Based on the internationally-recognized ISO
9000 quality management standard
• A joint project of the Automotive Industry
Action Group (AIAG), the American Society for
Quality's Healthcare Division, Standards
Council of Canada, and CSA.
• Purpose: "The goal of this document is to aid
in the development or improvement of a
fundamental quality management system for
health service organizations that provides for
continuous improvement, emphasizing error
prevention, the reduction of variation and
organizational waste, e.g. non-value added
activities."
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ISO 9000 Applications
• A woman underwent an unnecessary
double mastectomy because her test
results were mixed with those of another
woman. "I had my breasts amputated
because a doctor didn't take the time to
check the signature on my paperwork
with the signature on my biopsy slide.
Every day I'm reminded of this mistake.
Every day, every moment of my day"
(Oprah Winfrey's "Outrageous Medical
Mistakes").
• This could not have happened in an ISO
9000-compliant system, which requires
traceability of test and inspection results.
Failsafe traceability procedures, such as those
used by blood banks, already exist!
• Who paid for the unnecessary operation plus
the legal damages???
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Organ Donation Errors
• Jessica Santillan was killed (and two
donated heart-lung sets were wasted)
because the first organs had type A blood
and Jessica was Type O.
• Everybody assumed that Somebody had
checked the blood type match. Anybody could
have done it but Nobody did it?  Should be
impossible under an ISO 9000-compliant
system.
• 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 O blood; the father
is type A."
• (And the doctors wonder why their malpractice
premiums are so high.)
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Didn't Joseph Lister tell us about
this more than 130 years ago?
(1) The Chicago Tribune reported that, in early 1997,
dozens of patients at Bridgeport Medical Center
in Connecticut were suffering hospital-borne
infections. As many as 20 percent of open-heart
surgery patients contracted antibiotic-resistant
diseases. "Dust and flies littered the operating
room during surgeries, according to internal
hospital records obtained by the Tribune." A
surprise inspection by state public health
investigators found numerous violations of
infection control procedures, "such as failure by
surgical assistants to wash hands."
(2) "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 generally less than 50
percent."
• WHO PAYS FOR THE CONSEQUENCES?
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Inadvertent Needle Sticks
and Bloodborne Pathogens
• "'Can't' rather than 'don't'" was the
safety policy at Henry Ford's River
Rouge plant.
• Instead of telling nurses, "don't stick
yourself with a needle you have just
used on a patient," you fix the
hypodermic or IV device so the nurse
can't stick herself with the needle.
• Too expensive? Not when compared to
HIV/AIDS or hepatitis.
• Caps that are attached to the syringe
and can be placed over the needle
achieve this objective.
• Spring-loaded finger-stick devices that
retract the needle instantly and
permanently after use are another
example of "can't rather than don't."
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Prescription Errors
• Handwritten prescriptions kill about
25,000 people a year. (Again, who pays
for the consequences?)
• Handwritten instructions are not allowed under
ISO 9000. "Little sticky notes with work
instructions stuck to documents or machinery
won't cut it" (Bakker).
• The Leapfrog Group advocates Computer
Physician Entry Order (CPEO) systems.
"Assures that prescribers* enter hospital
medication orders via a computer system that
includes decision support software to reduce
prescribing errors."
• Verbal order readback is a routine practice in
the Armed Forces. This means that the person
who receives a verbal instruction repeats it
back to the person who gave it to assure that
there was no confusion. "Verbal (including
telephone orders) should be recorded
whenever possible and immediately read back
to the prescriber"
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"Death by Decimal"
• Oprah Winfrey's "Outrageous Medical
Mistakes" uses the phrase "death by
decimal," which kills seven to ten
thousand people a year.
• Presumably out of the 25,000 total.
• E.g. a patient gets 10 milligrams instead of 1.0
milligram.
• A total no-brainer and 100% preventable!
• We are more careful with our money than
many doctors are with their prescriptions. We
write, for example, "Twenty dollars and
30/100" on a check and it is impossible to
mistake this for anything else.
• 100% preventable by a CPEO system.
• Even preventable by requiring the pharmacist
to reject any prescription whose quantity is
ambiguous.
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Causes of Medication
Errors
• "most medication errors occur as a
result of multiple, compounding events
rather than from a single act by a single
individual. Medication errors invariably
represent the collapse of a faulty
system, not a faulty human being."
• Reasons cited include: "Failed
communication: handwriting and oral
communications, especially over the
telephone, drugs with similar names, missing
or misplaced zeroes and decimal points,
confusion between metric and apothecary
systems of measure, use of nonstandard
abbreviations (TABLE 1), ambiguous or
incomplete orders."
• The above problems are completely avoidable
under a decent quality management system.
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Avoidance of
Prescription Errors
• Procedure at Citizens General Hospital in
New Kensington, Pennsylvania
• A robot reads bar-coded prescriptions and
retrieves the medications.
• Medications go into individual bar-coded bags.
• Prior to administering the drug, the nurse
scans both the bag and the patient's barcoded wristband to assure that they match.
• Anesthesiology
• The anesthesiologist announces the name
and dose of each drug she administers, along
with the patient's weight. Another (specific)
member of the operating team should be
responsible for double-checking the activity.
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Closed-Loop Corrective
Action Systems
•
•
Closed-loop corrective action
systems are mandatory centerpieces of
ISO 9000-compliant systems.
If there is a quality nonconformance
(such as a medical mistake), the health
care organization is required to:
(1) Define the problem (e.g. prescription error,
wrong-site surgery)
(2) Identify the root cause
•
This does not mean blaming the personnel.
(3) Identify and implement a permanent solution.
•
Telling people to be "more careful" isn't one.
(4) Make the new method the standard for the
process in question, e.g. by updating work
instructions and procedures.
•
Can also apply to near-misses.
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Continuous Improvement
and Supplier Development
• This means that price increases from
suppliers (e.g. hospitals and laboratories)
are always questioned and that, in fact,
continuous cost reductions are
demanded from them. Correctable
inefficiencies are simply not paid for.
• Polaroid's Zero Based Pricing (ZBP)
policy: "The first step is for a Polaroid
buyer to ask the supplier to fork over data
on its unit costs. …Buyers are not to
accept cost increases as justification
for a price rise. Instead, at that point,
Polaroid people visit the supplier's plant
and offer tips on how to contain costs"
(Schonberger, 1986, 157).
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More on Supplier
Development
• The C.R. Wilson Body Company quoted
the Ford Motor Company a price of $152
per body, which Henry Ford refused to
pay. Instead, with guidance from Ford's
production chief Charles Sorensen,
• "The man finally consented to try to
manufacture at exactly one half his former
price. Then, for the first time in his life, he
began to learn how to do business. He had to
raise wages, for he had to have first-class
men. Under the pressure of necessity, he
found he could make cost reductions here,
there, and everywhere, and the upshot of it
was that he made more money out of the
low price than he had ever made out of the
high price, and his workmen have received
a higher wage."
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(4) Others Doing It
(1) American Legion Hospital in Crowley,
Louisiana (the first hospital in the United
States to attain an ISO 9000 certificate)
1305 Crowley Rayne Hwy, Crowley,
Louisiana 70526 337-783-3222
(2) Leelanau Memorial Health Center in
Northport Michigan. Note the "ISO 9001
Certified" notice on their Web site!
(3) Memorial Medical Center of West
Michigan in Ludington Michigan
•
Why Memorial Medical Center Flies the ISO Flag.
"ISO 9002 is a rigorous set of procedures
designed to ensure consistently repeatable quality
in an organization’s operations and is used
worldwide by both manufacturing and service
companies."
(4) Quest Diagnostics
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Involvement of the
Automotive Industry
• Why are the automakers interested in
health care system reform?
• Rising costs of health benefits for autoworkers
and retirees are making the automakers
"HMOs on wheels." Employer-paid health
insurance is now the most expensive
"purchased component" of all vehicles.
• A similar issue is faced by employers that buy
health insurance for their employers.
• The automakers' precedent: QS 9000
• The automotive industry has for many years
required that parts suppliers register to the QS
9000 standard for quality management
systems. Goals include:
• Higher quality of delivered products
• Lower costs of poor quality (the cost of doing it
over because it wasn't done right up front).
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(5) Recommendation
•
Major buyers of health care services like
insurers, Medicare, Medicaid, and the
auto makers can use their immense
purchasing power to encourage or even
require the hospitals that serve their
patients to register to ISO 9000 (or its
IWA-1 healthcare version).
(1) Give hospitals a deadline by which they
must register to ISO 9000 if they want to
continue to be eligible to treat patients.
•
Educate hospitals about the benefits of ISO
9000 to their patients, staff, and (if for-profit)
stockholders. Suppression of the costs of poor
quality leaves more money for everyone.
(2) Designate ISO 9000-registered hospitals as
"preferred providers," at which patients will
have lower copayments and/or deductibles.
The idea is that these hospitals waste less
money on poor quality and inefficiency, and
will provide higher-quality care.
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Benefits
• Benefits for all health care stakeholders:
• Patients: Lower (30-60%) health care costs
and higher quality of care.
• Doctors: Enormous (up to 85%) reduction in
malpractice rates, thus eliminating the state's
malpractice insurance crisis.
• Hospitals: higher profits if for-profit, and more
money available for staff salaries. This will
help recruit and retain more nurses.
• Benefits for insurance providers:
• Ability to offer lower premiums, thus
increasing customer satisfaction and attracting
more customers— the same way Henry Ford
increased his market share through
continuous price reductions.
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