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Quality health care
- 1. Quality Health Care Practice Dr PS Deb
- 2. What is Quality? Product Services Good Perfect Satisfactory Punctual Robust Beautiful Error free
- 4. Quality? Producer or Provider User or Customer The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs (ISO)
- 5. “ the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” Quality of care
- 7. Process variation – Error (Sigma) 3.4 6 230 5 6210 4 66800 3 308,000 2 690,000 1 DPMO S
- 8. 1. Error of execution - the failure of a planned action to be completed as intended 2. Error of planning - the use of a wrong plan to achieve an aim Medical error
- 18. Evolution of Health Care Quality Regulatory Learning Management Punish Academic Quality practice Hammurabi (2100 B.C.) Standardization (1917) ACS – HSP (JCAHO: 1951 – 1980s) Hippocrates (300 B.C.) Controlled Trials (1840s) Industrial Revolution (1800 AD) Sigma, ISO, TQM
- 20. Quality Control TQM ISO Accreditation Six Sigma
- 26. The act of the granting recognition that maintains suitable standards Accreditation
- 27. Organizational Structure ACS 1913 HSP - 1917 JCAHO - 1951 JCR - 1997 JCI - 1997
- 42. WHAT HOW ACCREDITATION ISO
- 43. Capability Maturity Model (CMM) 1- Initial – Ad hoc, chaotic 2- Repeatable – tack cost, schedule, function 3 – Defined – Documented, standardized 4 – Managed 5 - Optimized
- 45. Ayubouwan
Hinweis der Redaktion
- An important phenomenon that has occurred in the business world during the past several decades has been the “Quality Revolution.” Total Quality Management (TQM) practices such as continuous improvement, benchmarking, customer satisfaction, worker empowerment, and statistical process control are widely used in business today.
- Definition: The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. Not to be mistaken for "degree of excellence" or "fitness for use" which meet only part of the definition. HyperDic.com Pride in Workmanship" -- W. Edwards Deming "Quality is fitness for use" -- J.M. Juran "Quality means best for certain customer conditions. These conditions are (a) the actual use and (b) the selling price of the product." -- Armand Feigenbaum "[Quality is] meeting or exceeding customer expectations at a cost that represents a value to them." -- H. James Harrington "When quality is viewed as being the number of products that conform to specifications, a company is already behind the eight ball" -- Rafael Aguayo "Zero defects is not good enough." -- Donald Wheeler and David Chambers "Quality should be defined as surpassing customer needs and expectations throughout the life of the product." -- Howard Gitlow and Shelley Gitlow "Quality is Free" -- Phillip Crosby The "Rest of The World" "I like the definition by Rafael, and see the definition of quality as related to customer delite." -- Dr. James R. Stewart, PE, CQA "...quality is what the customer, whether internal or external, perceives it to be." -- Frans J. C. Martins "Better than you would or could, have ever expected." -- Tony Schuster "Quality is defined as the degree to which an item or process meets or exceeds the customers' requirements and expectations." -- Thom Davis "Quality means whatever our customers want it to mean" -- John Humberstone "How close a product or service meets its design specification." -- Con Murren "Big Q relates to "cultural" issues such as TQM, quality philosophy, policy (as discussed in a thread above), things which help to engender a quality mindset. Little Q relates to product quality stuff: conformance to specifications, fitness for purpose, the TickIT guidance, as examples." -- Pete Hall "Quality is a state of mind. Difficult to explain without a long discussion but essentially a mental balance between *what you'd like and what will do*" -- Pete Hall (Number 2) "Quality is not Goodness but the conformance to requirements" -- Kwalaty@aol.com All of the definitions shown on the other pages are wonderful views of Quality. I use many of them everyday. But, still I ponder the definition of this elusive word. So here are: My Constantly Improving Definitions Level 1 Definition "Quality is derived from the inherent ability of everyone in the organization to be proud of their daily work." -- Duane A. Floyd, CQE, CQA (level 1 definition) Level 1 is my most personal and thoughtful definition of quality. Technically speaking, it only indicates where quality is derived from, not the actual meaning. I believe that the derivation gives more meaning than any group of words. Let's take a look at the important words in my definition: inherent ability People are born with the "inherent ability" to take pride. This is something that seems to be taken away at some point. I have watched the people of many companies over my 15 years in quality become very frustrated with attempting to create a quality product (or process or service or system, etc.). What was getting in the way and causing the frustration? What was taking this "inherent ability" away from the people? In a simple answer, WE DO. I am a manager in my company, so how could I dare say that WE "got in the way?" We get in each others way by failures in our abilities to interact with each other. We are often very selfish about our interactions...we do not take other people's best interest to heart...we fail to follow the "Golden Rule" (you know, "Do unto others, as you would have others do unto you!"). Do we not all want that? It is crucial that the "inherent ability" be reenergized and allowed to flow. How can we do this? A simple four step remedy: (1) realize that we have this "inherent ability," (2) get out of everyone else's job, (3) allow the other people of the organization to do their own job and (4) concentrate on your job! That's it, nothing harder than that! everyone We must all work together to reenergize our "inherent ability" to do quality work. Complete and utter teamwork is a necessity. Not the bogus teams that most people think of, but a true team...like a basketball team!! For the team to win, everyone on the squad must be willing to do what it takes to win. This doing what it takes may be scoring the most baskets, getting the most rebounds or it may simply be to sit on the bench and provide someone for the "stars" to practice against. All roles are important, none are more important than others. Everyone must be treated fairly by everyone else! proud Pride is one of the seven deadly sins...I do not intend this word to be defined as "prideful." Simply, it is important for each individual to feel good about the work that they complete each day. Oftentimes, people leave work with their head held low...worried that they could have performed better that day. When someone leaves work feeling this way, they have not created quality. We must create a work situation where people believe that they will leave work each day, feeling that they earned their pay...not that it was given to them. daily work Every individual in the entire world has "daily work." Obviously, the people working in any type of industry go to work each day and perform some task..but, we must also include others. Others such as the student, whose "daily work" is to attend classes and to learn; or the homemaker, who must keep the house clean and provide for others. Level 2 Definition "Quality is the totality of all customer desired attributes" -- Duane A. Floyd, CQE, CQA (level 2 definition, explained below) This statement typifies many company quality policies. I condensed our corporate quality policy down to this simple statement. It works well in dealing with customers and suppliers...it is neither too simple or too complex. This definition demands that the supplier understand the "desired attributes" of the customer...this is why many customers love this definition. What could some of the "desired attributes" be? Functionality Aesthetics Price Delivery Customer Service and many other things... Level 3 Definition "Surpass Our Customers Needs Or Wants" -- Duane A. Floyd, CQE, CQA (level 3 definition, explained below) I crafted a quality policy for my company. Many people in my company applauded the 10,000 foot view of my corporate quality policy. But, the people on the manufacturing floor found it difficult to use (like many management related policy statements). Thus, I wondered about the policy...it used many of the concepts in the statements above..."fitness for use" and "continuous improvement" for example. The down-to-earth people that I work with everyday did not understand this 10,000 foot view of quality. So, I simplified it...boiled it down to a small statement SOC it NOW This simple statement is an acronym for Surpass Our Customers Needs Or Wants. This definition helped my organization get through an ISO 9002 registration audit. It also put a very complex statement into simple, understandable, meaningful words to reach every individual in our organization. Amazingly, everyone in the organization already understood the meaning, they just needed some words to put with the meaning that they already knew!! This statement really works. It is simple, memorable and it contains the essence of a good quality policy. But, I did not feel that it reached deep enough...I honestly believed that there was a second, more personal definition of quality. Quality is something that must be lived...we need to have quality not only at work, but in our personal lives also. I use, change and grow these definitions every day. I still believe that I have not achieved the true definition of quality. The gurus try, the rest of the world tries, I try, on a daily basis, to define quality, but, I am not convinced any of us are any closer than the statement: "I know it when I see it." And, since we are still attempting to define the word, I search on............ I plan to update and change this page on a somewhat frequent basis (monthly??) as I change or think further about these definitions...so, please check back regularly. A measure of excellence. We defines quality as our ability to fulfil our customer's expectations - not only the expectations for our products, but also for all services in connection with doing business with Corning Cabelcon A/S. The total quality experience has many facets: Product quality is determined by the ability to develop products with the right construction quality i.e. functionality and reliability and by the ability to produce these products with a high and homogeneous production quality. The security of delivery is determined by the ability to deliver the product in exactly the quality and quantity and at exactly the time the customer requires. Service is determined by the ability to advise the customers in technical and commercial questions. The expectations of the customer can change currently but... Corning Cabelcon has the aim of quality persistently to fulfil these expectation and in this way keep on appearing as an innovative and competent co-operator. In connection with the above mentioned aim it is an important part of our policy to work closely together with our customers not only in connection with the development of new products but also in the development of other services e.g. agreements concerning quality or new delivery systems and in solving technical problems. As it is important that Corning Cabelcon A/S persistently develop new products and services which meet the demands of the market, it is also an important aim for the company consistently to work towards an increase of our internal quality. The higher the internal quality is the more effectively and financially we can produce our products. A high internal quality is secured by the best possible understanding for possibilities and limits in technical solutions, equipment, tools, and processes supported by education and training of all employees. As far as possible quality control is carried out as operator self control rather than central control functions on the philosophy of most responsibility for own work. We are trying to be at the leading edge of developments to use to the customers and ourselves by following the development of the cable market. It is a declared goal of Corning Cabelcon A/S that all employees have to be inform of the development of the company and the market so they have the best understanding for the new demands which are made to us. The quality control system of Corning Cabelcon A/S has to support this philosophy and in that way contribute to the business success of the company. Quality is difficult to define but easy to understand. Quality is client dependent, i.e. what is good for one may not be for other. Quality has following attributes. Good Pleasant Error free Robust Reproducible Perfect Smooth Comfortable Beautiful Quality variable Place Time period Race Religion Sex
- I was taking tea in EDR (executive dianing room) , every day there was water at different temp, milk at different and different concentration , result was tea of variable taste. When I got admitted in ward I started getting same tea with a creamer, tea bag and sugar, tea was quality tea.
- QUALITY The Quality Utilization Advisory Group accepted the following definition of quality to guide its actions and strategic health planning. "Good quality means providing patients with appropriate services in a technically competent manner, with good communication, shared decision making and cultural sensitivity." (IOM, Crossing The Quality Chasm) The definition is further expressed as six aims - safe, effective, patient-centered, timely, efficient, and equitable health care. This is how our readers define quality. (Note: these definitions are straight from our database and have not been edited."Quality itself has been defined as fundamentally relational: 'Quality is the ongoing process of building and sustaining relationships by assessing, anticipating, and fulfilling stated and implied needs.' "Even those quality definitions which are not expressly relational have an implicit relational character. Why do we try to do the right thing right, on time, every time? To build and sustain relationships. Why do we seek zero defects and conformance to requirements (or their modern counterpart, six sigma)? To build and sustain relationships. Why do we seek to structure features or characteristics of a product or service that bear on their ability to satisfy stated and implied needs? (ANSI/ASQC.) To build and sustain relationships. The focus of continuous improvement is, likewise, the building and sustaining of relationships. It would be difficult to find a realistic definition of quality that did not have, implicit within the definition, a fundamental express or implied focus of building and sustaining relationships." --from Winder, Richard E. and Judd, Daniel K., 1996, ORGANIZATIONAL ORIENTEERING: Linking Deming, Covey, and Senge in an Integrated Five Dimension Quality Model, In ASQC Seventh National Quality Management Conference Transactions. American Society for Quality. (http://www.ldri.com/articles/96orgorient.html) Quality is the customers' perception of the value of the suppliers' work output. You can not separate the process and the human factor, therefore I believe that Quality, when built into a product, generates emotions and feelings within those who have taken part in it's creation. When you have made something that you are proud of, when you have produced a product that brings smiles to your customers, then you have achieved Quality. You'll know it, they'll know it, and each of you will prosper from it. Error-free, value-added care and service that meets and/or exceeds both the needs and legitimate expectations of those served as well as those within the Medical Center. The word "Quality" represents the properties of products and/or services that are valued by the consumer. Quality is a momentary perception that occurs when something in our environment interacts with us, in the pre-intellectual awareness that comes before rational thought takes over and begins establishing order. Judgment of the resulting order is then reported as good or bad quality value. We at Navy Medicine define quality as: delivering products and services to our customers which are faster, better, cheaper and newer. There are two definitive types of "quality". Quality of design Quality of the process Whether you are in discrete manufacturing, process manufacturing or a service related industry you have design issues of usability, comfort, and tolerance of durability beyond prescribe use and identity of "status" of design quality. In this regard, you do not have the axiom of "variation is inherent..." The ability to live up to the "quality of design" is maintained by the "quality of the process" My definition of Quality is way off from the traditional concept of Quality. My definition of Quality is: "Reducing the variation around the target". That means, it is very basic that process limits are within the spec limits and process average is very close to the target. I think " Quality" concept should be AFTER the above condition. If that's so, strive should be reduce the variation of the process while maintaining the process average close to the target. All your actions aimed at the translation, transformation and realization of customer expectations , converting them to requirements, both qualitatively and quantitatively and measuring your process performance during and after the realization of these expectations and requirements . Quality is doing the right things right and is uniquely defined by each individual. A product or process that is Reliable, and that performs its intended function is said to be a quality product. The degree to which something meets or exceeds the expectations of its consumers. "Conformance to *Valid* Requirements" where to be valid, the requirements must be proven (in advance by management) to: 1) be achievable in operation 2) meet the needs of the intended user making this a universal, operational and easy-to-use definition for the quality for all outputs from any work activity or process. The definition depends on the purpose and for whom you are talking: If you talk for your customers, then it is what ever he says it is, what he expect from the product or service. If you talk to your company, to your people, then I follow the Kano Model. There are three part of Quality: 1. The Basic Q. What absolutely must be. w/o the customers is dissatisfied. 2. The Customer expected Q. achieve all and the customer is satisfied. I.e Six Sigma helps to do that. 3. The exciting Q. The customer does not know it exist, is possible. This becomes tomorrow's expectation. This is our slogan, and our policy..."Quality" is to satisfy the ever-changing needs of our customers, vendors and employees, with value added products and services emphasizing a continuous commitment to satisfaction through an ongoing process of education, communication, evaluation and constant improvement. Quality is meeting the customer's needs in a way that exceeds the customer's expectations. "Quality is nothing more or less than the perception the customer has of you, your products, and your services"! Definition of Quality: "WOW" RATIONALE: Suppose you were with your *soul mate*, *significant other* *spouse* etc. and after a relationship that person looked longingly into your eyes and said "That met the requirements!" or "There were no defects there!" or "That had all the value I wanted!" or "The degree of excellence was acceptable!. Wouldn't you rather have that person look into your eyes and say "WOW!"? SOURCE: I wish I could remember the specific phrase from the book/article, but over the years this has been my approach to the tricky question of how to define quality. "Quality is the extent to which products, services, processes, and relationships are free from defects, constraints, and items which do not add value for customers." My definition of quality is included in our textbook entitled Strategic Quality Management: A Strategic, Systems Approach to Continuous Improvement, published by Dame Publishing Company, a Division of Southwestern Publishing Company. clean, precise and flawless Quality is a perceived degree of excellence with a minimum usually set forth by the customer. Quality-The production of a commodity which conforms to standards applied to said commodity,be they mechanical standards, society's standards etc. When the customer returns and the product doesn't. When something is what you expect it to be then it is perceived as quality. Thus, quality is a fulfillment of expectation. DFN for "Today's" Quality: (Applies to all goods and services) Quality = Maximization of Perceived Value = Fulfillment of Tangible and Intangible Expectations = (Good or Service Performance + Customer Service)Attributes; Divided by Cost "Quality is the expression of human excellence." I came up with this concept at the AQC back in 1986. We used it occasionally as a motto for the old Human Resources Division Quality is... do what you have to do when you have to do it well done to satisfy your customer needs and make your product or service do what they suppose to do. Quality is the the ability of a product or service to meet a customer's expectations for that product or service. MEETS ALL CUSTOMER EXPECTATIONS The manufacture/distribution of a product/service which provides both tangible(quality product/service, low cost$$$) and intangible(customer satisfaction) value to the internal and external customer. All those planned and systemic actions required to provide adequate confidence that a product or service will satisfy given requirements Never having to say you're sorry. Consistent conformance to customer expectations There are two forms of quality, and therefore two definitions and two forms of measurement. 1. OBJECTIVE quality is the degree of compliance of a process or its outcome with a predetermined set of criteria, which are presumed essential to the ultimate value it provides. Example: proper formulation of a medication. 2. SUBJECTIVE quality is the level of perceived value reported by the person who benefits from a process or its outcome. It may subsume various intermediate quality measures, both objective and subjective. Example: pain relief provided by a medication. Satisfy or exceed customer expectations at the minimum possible cost Quality is to reach the costumer needs at low rates (costs) to the company and achieving employee satisfaction. Quality is an ever evolving perception by the customer of the value provided by a product. It is not a static perception that never changes but a fluid process that changes as a product matures (innovation) and other alternatives (competition) are made available as a basis of comparison. Example: Just as the Model T was once thought of as a quality product, by today's standards, it is perceived by the customer as no longer fit for use as a general purpose item. The product (a car) has evolved to something beyond the Model T both because of innovation and satisfying customer demand. Crosby, Deming, Juran provide us a foundation. Drucker then builds on the foundation to refer to products that a market accepts as value and is willing to pay for it. To the quality department responsible for testing the product; quality (value) is awareness of defects and getting fixes or workarounds for customers To the company that produces the product, quality (value) is measured by profit, forecasted opportunities and customer satisfaction. To the companies that purchase the product, quality (value)is ease of use, performance and solving the business problem at hand. Every definition has apparent "holes" in it, as Scott Paton often points out, but the bottom line is: once a customer has purchased your product do you get return business/referrals or do they look somewhere else ? obtaining customers is easier than maintain them. My definition starts with Deming's: "Variation is the enemy of Quality";(and I add) "Uniformity is the enemy of Knowledge". Given current status vis a vis expectations this couplet provides us a sense of direction. My definition appeared in "Last Word" in your October issue. Essentially it boiled down to "Attention to Detail", I have been collecting definitions for awhile: Quality is neither mind nor matter, but a third entity independent of the two, even though Quality cannot be defined, you know what it is. (Persig, 1974) Quality is fitness for use. (Juran, 1974) Quality means conformance to requirements. (Crosby, 1979) [Quality is] a system of means to economically produce goods or services which satisfy customers' requirements. (Japanese Industrial Standards Committee, 1981) Quality refers to the amounts of the unpriced attributes contained in each unit of the priced attribute. (Leffler, 1982) Quality means best for certain conditions...(a) the actual use and (b) the selling price. (Feigenbaum, 1983) [Quality] means that the organization's culture is defined by and supports the constant attainment of customer satisfaction through an integrated system of tools, techniques, and training. (Sashkin & Kiser, 1993) Quality is Job #1. Quality First. Quality, It's a Way of Life. Quality Is Our Most Important Product. Quality is a degree of excellence... (Webster) Quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy given needs. (American Society for Quality) Quality, an inherent or distinguishing characteristic, a degree or grade of excellence. (American Heritage Dictionary, 1996) All aspects/features of a product (a good or a service) that bears on its ability to satisfy fitness for use, safety, and effectiveness. (this is the FDA's medical device regulations def'n of quality--and a pretty good one at that, as long as Juran's fitness for use is also defined and the word "grade" is defined close by to avoid excellence being used as a quality definition, e.g., Holiday Inn is a lower grade but not necessarily lower quality than Hyatt Hotel. We need to weed out the definitions of quality that accidentally incur the notion of grade or excellence, since those can be purposefully set at a reduced level for pricing advantages without harm to quality (e.g., Honda Accord EX versus LX). "That we shall get the right product to the right place at the right time while exceeding our customers expectations". Shorewood Packaging is a company dedicated to providing high quality, cost effective packaging products and services that satisfy customer requirements in a timely manner while achieving our profit, growth and leadership objective in selected markets. Leadership in quality can only be accomplished by ongoing improvements and through the active participation of all employees. QUALITY IS EVERYONE'S RESPONSIBILITY! Working without hassles Quality is unobtrusively meeting the needs of the customer. Quality means providing customer with innovative products or services characteristics/attributes and defects free which provide fitness for use. "Fitness for use" which I believe is actually one of Dr. Juran's definitions. While it is simple in words the subtleties and nuances of its meaning is rather profound. For example a well made ice box at the turn of this century (i.e., 1900s) was an exciting invention but refrigeration was more fit for use. Yet, if the modern refrigerator can't maintain the proper temperature it is not quality, because it is not fit for the use it it intended. All that being said, I work in government, specifically a environmental regulatory agency dependent on highly technical and scientific information. Many refuse to believe that quality, by anyone's definition, does not fit in with how government works. I believe that until it does then government will continue to lose the respect of "we the people". Having numerous customers in various different industries, "Quality" can mean different things to each Customer. To satisfy every customer "Quality Requirement" it simply comes down to "Conformance to Customer Specified Requirements". Exceeding the customer's product or service expectations by delighting them. "Quality" is achieved by meeting or exceeding established process guidelines so that, regardless of the type of industry, a consistent outcome can be predicted. "Peace of Mind" Quality is conformance to specified requirement & is never an accident Quality goes beyond customer expectations. Usually customers define the expectations or requirements based on what they know about the product or service and they do not take into consideration what they do not know about it (the error that does not exist cannot be missed should be part of the requirements). Quality today is a moving target because we ask for new requirements when something goes wrong and this is wrong. What is not part of the product or service, should be taken into consideration when Quality is defined. I have to go along with Philip Crosby in defining quality as conformance to requirements. As a customer, there are certain things(requirements) that you expect in a product or service. When those things are not there then the customer is not satisfied and unhappy. Webster's definition of quality as "the degree of excellence which a thing possesses" is way to vague. Excellence is another term that is hard to define. My boss loves to scuba dive. Recently he went on a deep dive of of the coast of Mexico. He also loves to collect watches. He had purchased an expensive Rolex divers watch. At a certain depth it leaked and was useless. He had to resurface and go back to using the old Timex that was deemed to be considerably less excellent or "quality". If the product or service does what the supplier says it will do and what the customer wants it to do, then it is a "quality" product or service. That's meeting requirements. Thank you for the opportunity to share my thoughts on this always subject. I look forward to reading the results. Best value for the money Our customers and competition define our quality status. When we can keep and acquire new customers/business, that shows an overall picture of our how well we are doing with the quality of our products. Comments & Complaints from customers are the measuring system. Continuously improving upon our practices helps us to stay "in" with the competition. Quality is in the eyes of the beholder. And in a business environment, the beholder is always the customer or client. In other words, quality is whatever the customer says it is. My definition of Quality is production satisfactory to the customer and making a profit for the manufacturer. Quality Control is all the means by which the frequency of defects is reduced. It includes quality planning, quality measuring and quality analysis. A product or service that surpasses all requirements and endeavors beyond expectations. QUALITY IS MEETING CUSTOMER REQUIREMENTS AT LOWER COST WITH BUILT IN PREVENTIVE ACTIONS IN THE PROCESSES AND EMPLOYEE/MANAGEMENT INVOLVEMENT ENSURING THE BEST PRODUCT TO THE CUSTOMER/END USER WITH JIT DELIVERY. Quality simply means delivering to the customer what they expected. Thus, for example, if a product: - has the right configuration/features, - does what it's supposed to do, - is reliable, - is delivered on-time, and - is well-supported, then . . . . . . it's a quality product! 1. WOW! 2. Doing the right thing right, every time from the first time. 3. Working according to five elements: a. Quality leadership b. The customer is in the center c. personal responsibility d. measurement & improvement e. Infrastructure The inherent features possessed by a product or service. Quality, like truth is in the mind of believer. To define it is to misunderstand the infinite possibilities we are capable of achieving. There is no universal definition. Robert Pirsig went crazy trying to define it in his famous book; Zen and the Art of Motorcycle Maintenance. There will always be rule-based thinkers who will attempt to regulate and proceduralize the rest of us who know there is no such thing as the right answer, only that which works for each of us. Quality is being: Creative, Innovative, Fluid and Forthright Quality is a customer perception of the value received for the price paid for the attributes of a product or service as they related to its fit, form, or function. A degree of excellence. "The ability of a company to identify their customers' requirements, then meet or exceed their expectations to the mutual benefit and satisfaction of both organizations." Quality is doing right things right. It is customer orientation, innovation, teamwork, and everyone's responsibility. Quality is a "system" which produces a product, service, information or delivery, on target with minimal variance which meet or exceeds the customers needs, now and in the future. The reason that Deming (and thousands of others) "dance around a definition of quality" is that quality cannot be defined in principle. 1. Quality has no essence. To understand the implication of this point, ask yourself: Why would it be odd to conduct a survey of the meaning of the word bachelor? The answer is that the essence of the word bachelor, i.e., a man not yet married, is totally contained within the word. Quality contains no such essence. A dictionary definition such as "the degree of excellence a thing possesses" begs a slew of other questions. 2. Quality is abstract. Thinkers and writers have been trying to tackle big abstract words like knowledge and beauty for thousands of words. Why should quality be open to an absolute definition in a way that other abstract words are not? 3. The distinction between quality and quantity has become blurred. We once distinguished between quantity, that which could be measured and quality, that which could only be judged. Now quality, as far as the quality industry is concerned, is all about measurement. So what word do we have for that which cannot be measured? Has the idea of simply judging quality totally disappeared? The result of this inability to define quality is that most definitions will bear a resemblance to one another but none of them will be THE definition. In the face of this barrier, what are organizations to do? Rather than fruitlessly wrestling with a definition, they would be better off simply identifying what they want the world to look like once quality is better, e.g., the ratio of defects to opportunities will be improving, customers will be coming back and saying, unprompted, how much they value the product or service. The point is not to define quality but to produce it. And we can produce it even without a definition! 1. "Quality is variability." Shewart 2. "Quality is predictability." Deming 3. "Quality is a conformance to requirements." Crosby 4. "Quality is a fitness for use." Juran 5. "Quality is the customer's opinion." Feigenbaum For references, call me on (703)360-9134. Henry Kling Quality is complete satisfaction (Performance, Appearance & Longevity) at the lowest possible cost. At Crescent Drilling & Production, Inc., we define Quality as, "the pursuit of excellence." To always be reaching for a higher goal. Quality is performance excellence as viewed by all stakeholders. This is a Baldrige influenced definition and has profound implications. We know that meeting end user needs relative to competitors is good but not enough. We must also meet societal, producer, owner and supplier needs. Further, these needs reflect future as well as present needs. Our smaller world requires this system view of quality. Quality is meeting customer expectations. Your quality level shows the gap between your company and your dreams. closer you are you know the meaning better.... Quality is meeting the "stated" and "implied" needs of the customer. It is by Quality a customer can be satisfied, delighted and be retained for mutual benefit. "Face is the index of mind" , "Quality is the index of a product or service". Quality is not something extraordinary. It is something ordinary extraordinarily well. "...When who comes back is the client, not the product..." la bonne réponse à une demande a good answer to a demand Providing product and service features which are free of deficiencies that create value for your customers and stakeholders. I like the old standard definition of quality: Quality is meeting or exceeding your customers' expectations. My simple definition follows me around no matter where I am, work, home, pleasure, etc. NO SURPRISES!! If you really think about what goes on in your life, this works. Reduction in variation. The customers definition of Quality is the only one that counts. The totality of features and characteristics of a product or service that bears on its ability to satisfy given needs. QUALITY IS NOT ACHIEVED BY DOING DIFFERENT THINGS. IT IS ACHIEVED BY DOING THINGS DIFFERENTLY. Quality medical care may be defined as that care which may reasonably be expected to lead to an optimal outcome, and must include care which educates patients about their personal responsibility for their health, prevents illnesses when possible, and utilizes appropriate modalities to diagnose and treat disease. Quality medical care is dependent on the interaction between those who provide care and those who receive care. Quality care should produce optimal health outcomes in the most cost effective manner and result in high patient satisfaction. The AAFP believes quality care is comprised of the following elements: (a) Produces optimal improvement in the patient's physiological status, physical function, emotional and intellectual performance, and comfort at the earliest time possible consistent with the patient's best interests; (b) Emphasizes health promotion, disease and disability prevention, and early detection and treatment of such conditions; (c) Is provided in a timely manner without undue delay in initiation of care, inappropriate curtailment or discontinuity, or unnecessary prolongation of such care; (d) Seeks to achieve the patient's informed cooperation and participation in decisions about care with respect for the cultural and ethical diversity of the population served; (e) Is based on accepted principles of medical science and proficient use of appropriate technological and professional resources; (f) Is provided with sensitivity to the stress and anxiety that illness can generate and with concern for the patient's overall welfare; (g) Uses technology and other resources efficiently to achieve the desired treatment goal; (h) Is sufficiently documented in the patient's medical record to enable continuity of care and peer evaluation; (i) Recognizes that in every patient's life there comes a time when the best care is no longer an attempt to prolong life, but instead, efforts must be directed toward maintenance of dignity, allowing comfort, and preparation of the patient and family for impending death. (1987) (1998) AAFP (american Academy of family physician) Can Quality of Care Be Defined? Quality of care can be defined as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. That definition, formulated by a committee to design a quality strategy for the Medicare program, has been widely accepted and has proved to be a powerful tool in the formulation of practical approaches to quality assessment and improvement. Several ideas in the definition deserve elaboration. The term health services refers to a wide array of services that affect health, including those for physical and mental illnesses. Furthermore, the definition applies to many types of health care practitioners (physicians, nurses, dentists, therapists, and various other health professionals) and to all settings of care (from hospitals and nursing homes to physicians' offices, community sites, and even private homes). Including both populations and individuals draws attention to the different perspectives that need to be addressed. On the one hand, we are concerned with the quality of care that individual plans and clinicians deliver. On the other hand, we must direct attention to the quality of care across the entire system. In particular, we must ask whether all parts of the population have access to needed and appropriate services and whether health status is improving. The phrase desired health outcomes highlights the crucial link between how care is provided and its effects on health. It underscores the importance of being mindful of people's well-being and welfare and of keeping patients and their families well informed about alternative health care interventions and their expected outcomes. Current professional knowledge emphasizes that health professionals must stay abreast of the dynamic knowledge base in their professions and take responsibility for explaining to their patients the processes and expected outcomes of care.
- Health care and other industries To fully comprehend the IOM’s findings, compare health care’s quality statistics with those of other industries. To compete in world-class markets, manufacturing and service industries must operate with quality systems capability in the range of 5-6 Sigma—that is, between 230 and 3.4 defects per million opportunities. According to recent studies, the quality capability of the systems derived from Figure 1’s Columns 1 and 2 in health care today range from 2 Sigma to 4 Sigma. That translates to somewhere between 308,000 defects per million —the number of cardiac patients who would benefit from aspirin administration daily, but who don’t receive it—and 6,210 defects per million—the current rate for hospital medication ordering and administration practices. The only known health care exception to these startling numbers is anesthesia mortality. Through a unique effort combining the knowledge of committed anesthesiologists and pervasive use of virtually foolproof equipment, anesthesia mortality presently approaches 6 Sigma. Column 3 and the future This huge health care "Sigma gap" sets the stage for a genuine quality revolution in health care. And the earliest skirmishes of the revolution are already under way. Columns 1 and 2 remained impenetrable to the quality methods of Column 3’s management science until 1987. Then, some pioneering It is time for health care to mature as a true,value-adding industry. physicians, hospitals and other health care organizations combined with quality experts from manufacturing and service industries to launch an ambitious experimental introduction of Column 3 management practices. This experiment was a definitive success, proving that management science-based techniques could duplicate in health care exactly what it had done in all other industries.4 With proof that process improvement can simultaneously improve quality and lower cost, the continuous quality improvement wave in health care was under way. Organizations spent millions on continuous improvement processes, realizing impressive results and some failures. But the wave passed by. Modern quality management science failed to take hold in a critical mass of health care organizations. Most that experimented with Column 3 reverted to the more familiar practices of Columns 1 and 2. And they unwittingly locked their institutions into the 2-4 Sigma quality capability of today’s health care system. The History of Six Sigma The roots of Six Sigma as a measurement standard can be traced back to Carl Frederick Gauss (1777-1885) who introduced the concept of the normal curve. Six Sigma as a measurement standard in product variation can be traced back to the 1920's when Walter Shewhart showed that three sigma from the mean is the point where a process requires correction. Many measurement standards (Cpk, Zero Defects, etc.) later came on the scene but credit for coining the term "Six Sigma" goes to a Motorola engineer named Bill Smith. (Incidentally, "Six Sigma" is a federally registered trademark of Motorola). In the early and mid-1980s with Chairman Bob Galvin at the helm, Motorola engineers decided that the traditional quality levels -- measuring defects in thousands of opportunities -- didn't provide enough granularity. Instead, they wanted to measure the defects per million opportunities. Motorola developed this new standard and created the methodology and needed cultural change associated with it. Six Sigma helped Motorola realize powerful bottom-line results in their organization - in fact, they documented more than $16 Billion in savings as a result of our Six Sigma efforts. Since then, hundreds of companies around the world have adopted Six Sigma as a way of doing business. This is a direct result of many of America's leaders openly praising the benefits of Six Sigma. Leaders such as Larry Bossidy of Allied Signal (now Honeywell), and Jack Welch of General Electric Company. Rumor has it that Larry and Jack were playing golf one day and Jack bet Larry that he could implement Six Sigma faster and with greater results at GE than Larry did at Allied Signal. The results speak for themselves. Six Sigma has evolved over time. It's more than just a quality system like TQM or ISO. It's a way of doing business. As Geoff Tennant describes in his book Six Sigma: SPC and TQM in Manufacturing and Services: "Six Sigma is many things, and it would perhaps be easier to list all the things that Six Sigma quality is not . Six Sigma can be seen as: a vision; a philosophy; a symbol; a metric; a goal; a methodology." We couldn't agree more. What does it mean to be "Six Sigma"? Six Sigma at many organizations simply means a measure of quality that strives for near perfection. But the statistical implications of a Six Sigma program go well beyond the qualitative eradication of customer perceptible defects. It's a methodology that is well rooted in mathematics and statistics. The objective of Six Sigma Quality is to reduce process output variation so that ±six standard deviations lie between the mean and the nearest specification limit. This will allow no more than 3.4 defect Parts Per Million (PPM) opportunities, also known as Defects Per Million Opportunities (DPMO), to be produced. As the process sigma value increases from zero to six, the variation of the process around the mean value decreases. With a high enough value of process sigma, the process approaches zero variation and is known as 'zero defects.' Statistical Take Away Decrease your process variation (remember variance is the square of your process standard deviation) in order to increase your process sigma. The end result is greater customer satisfaction and lower costs . Renaissance of Column 3 On a positive note, Column 3 remains alive and well in a number of incubator organizations. Those who continued to learn and lead Column 3 development are well positioned for a renaissance. Part of the renaissance of Column 3 management science will be an organizational post-mortem on why the 1987-1995 experience did not embed itself in health care. Typically, the reasons for failure surround: 1. The deeply embedded culture that is the legacy of Columns 1 and 2 was simply not ready for the invasion of so alien a culture as that surrounding modern quality science. The traditional Column 1 and 2 health care cultures responded to this invasion with a powerful "immune reaction," effectively "banishing" this new science back to exile in Column 3. 2. The business case for quality science was never effectively presented. Though it was clear that process improvement could reduce costs and improve quality, few health care organizations were able to leverage this as a significant strategic advantage. Two other problems were at work: a. Since health care quality measurement has been so rudimentary, higher quality was often opaque. Purchasers and patients couldn’t yet really distinguish high quality from mediocrity. b. Payment systems were not geared to reward value. Fee-for-service simply paid for doing more—sometimes a sign of poor quality with slow/incorrect diagnosis, excessive testing and complications that generated higher bills and more revenue. The bottom line is no one really achieved major competitive breakthrough by emphasizing quality. 3. Inadequate time to mature. Those involved with the introduction of Column 3 quality science to health care in the late 1980s still remember the admonitions of the "wizened veterans" of manufacturing’s world-class quality competition. "This transformation will take five to ten years to truly embed itself as your new way of doing business." In health care, other pressures intervened before even the most stalwart supporters of Column 3 could truly accomplish their organizations’ quality management goals. Health care’s crises with falling provider payment, balanced budget act implications, ambulatory fixed payment systems, rising costs and insurance premiums are relentlessly forcing health care provider organizations to move beyond Columns 1 and 2 . The renaissance of Column 3 is inevitable. The most progressive health care organizations will embrace it as rapidly as possible. Only Column 3 can bridge the gap from 4 to 6 Sigma quality. It also is the only body of knowledge that addresses the cost element of the cost/quality/value equation and the only column that leaders can use to address the economic issues. A call to action It is time for health care to mature as a true, value-adding industry. For this to happen, Column 3 management science must emerge as both a survival and strategic leadership commitment for health care provider organizations—as well as an ethical imperative in moving from 4 to 6 Sigma quality. 1. Maintaining the best values of medicine’s Column 2 learning science tradition, even as its practices are updated to embrace the information age. This means detoxifying medical peer review practices now extant in the vast majority of hospitals and restoring a learning-based peer case review, now supplemented by rigorous data analysis by physicians and others regarding practice patterns. 2. Understanding, creating and managing organizational culture. Nobody planned the "culture of blame" that IOM identified as a major impediment to current quality transformation. But culture fights to maintain itself and Columns 1 and 2 are deeply embedded in health care and very powerful. Successful health care organizations will develop effective strategies that honor the power of historic health care culture and consciously create new, positive and collaborative cultures to accomplish the clinical integration needed for 6 Sigma quality. 3. Developing new leadership concepts and practices. It’s not surprising that relatively few leaders whose heritage stems from Columns 1 and 2 have the depth of understanding and concomitant skills to master integration of modern quality science with health care practices. Even many who successfully embraced Column 3 during the "CQI glory years" have been battered by a combination of quality management decline, merger-mania, high level power struggles, increasing financial pressures, and health system downsizing. The good news? Research and the literature are overflowing with promising new leadership theory and practices. This literature suggests old-style, top-down hierarchical leadership has virtually no place in the present revolution. 4. Integrating Column 3 management science with clinical care and care system design. This involves a body of knowledge pervasive in the airline industry, but virtually unknown in health care: human factors science. This focuses on a deep understanding of how error occurs in complex human systems, and how communications protocols and other sophisticated techniques can virtually eliminate human imperfection as a source of error and injury in complex systems. The successful integration of Columns 2 and 3 holds promise in creating higher quality, more humane and far more healing environments than Columns 1 and 2 alone ever contemplated. 5. Establishing innovative external review processes that can genuinely help committed organizations achieve their 6 Sigma quality goals. External review As health care becomes increasingly market-driven, those purchasing and using its services will define health care quality and value. Patients will have a major voice in the future evolution of health care. But non-consumer-based quality assessment will remain vital to health care organizations. Optimal future quality will emanate from organizations that integrate the best of Columns 1, 2, and 3 into their external review systems. Quality practices related to the three columns will evolve along different tracks, though ultimately some convergence is likely. Column 1 The IOM report has placed the players of Column 1 in an extraordinarily difficult position. These public guardians of health care quality are presiding over an industry with 2-4 Sigma quality. They must find a way out of their dilemma. Society needs minimum standard certifiers. But historical players in this column must take a serious look at their practices and innovate them. Good regulation and competition may stimulate innovation and excellence in Column 1 external review. The greatest hope probably lies in enlightened innovation in such organizations as: • JCAHO • The National Committee for Quality Assurance ( NCQA)—focusing on managed care plans • The Peer Review Organizations (PRO—focusing on Medicare/Medicaid If JCAHO can reform its processes and innovate to offer greater value to its constituents, it might emerge as an important element in the future quality equation for health care organizations. For all the deficiencies of its current image and processes, it is deeply embedded in health care culture. JCAHO could become a beacon of transition for health care organizations still within its diminishing sphere of influence. A recent article suggests that JCAHO is indeed actively acknowledging and willing to work in a complementary fashion with newer external review frameworks. The NCQA and PROs also have positive potential. While maintaining their primary role of safeguarding Perhaps most of all, physician leaders face an urgent imperative to detoxify peer case review. minimum standards, many have moved on to establish more collaborative relationships with health care systems. With their vast data capability, the best PROs are already offering these systems both information support and technical consultation on how to improve systems Column 2 Because health care is offered from one human being to another human being one-at-a-time, review of individual patient care will never disappear. It will be important to conceive case review not simply as a narrowly defined, cost-generating process, but one that complements and supports the overall medical center quality/cost/value improvement strategy and practice. Perhaps most of all, physician leaders face an urgent imperative to detoxify peer case review. Negative peer review evokes fear, anger, resistance and professional conflict. It is antithetical to the original learning intent of case review and leaders are well advised to abolish this toxicity unequivocally. Column 3 The external review frameworks for Column 3 quality management presently are ISO 9000 and Baldrige. The Baldrige system of external review is based on criteria derived from the United States Baldrige National Quality Award, a highly prestigious achievement in the realm of world-class quality. Health care organizations are now using the Baldrige framework in two contexts: 1. Actually pursuing the award 2. As a template for quality systems development Few health care systems are striving for quality awards. Many more systems are seeking comprehensive frameworks to improve quality systems capability. It’s impossible to predict exactly what combination of Column 1-3 external review systems will prove optimal for both health care providers and the communities they serve. ISO 9000 and Baldrige took many industries to world-class quality: automotive, aerospace, information technology, telecommunications, machinery, electrical products, pressure equipmen, and transportation Perhaps these Column 3 review systems will help move health care down the path toward world-class, 6 Sigma quality, as well.
- Definition of safety from IOM report Adverse event definition was provided by the Harvard Executive Session. Another definition is from the Harvard Medical Practice Study I (NEJM 324:370-376): "an injury that was caused by medical mismanagement (rather than underlying disease) and that prolonged the hospitalization , produced a disability at the time of discharge, or both.“ Safety Freedom from accidental injury Adverse Event (AE) “ an injury caused by treatment that results in a prolonged hospital stay or disability-may or may not be caused by error” Near Miss An event that almost happened The Distinction Between Errors And Accidents What is an error? From the external viewpoint, an error is a failure to perform an intended action which was correct given the circumstances. In my view an error can occur only if there was or should have been an appropriate intention to act on the basis of a perceived or a remembered state of events; and if the action finally taken was not that which was or should have been intended. An error is not defined by an adverse or serious outcome. An adverse outcome may occur with no error if the intention was the proper one, the action was properly executed, and the outcome was probabilistic in nature (as in playing a game, in deciding whether to carry an umbrella, or in administering a medication or performing an operation known to be risky.) What is an accident? An accident is an unplanned, unexpected, and undesired event, usually with an adverse outcome. An adverse outcome after an error, by this definition, must be construed to be an accident. No one plans an error; no one expects an error; no one desires an error. The Relation Between Errors and Accidents An error is a psychological event with psychological causes if errors are caused at all (there is always the possibility that causes of all or some errors can not be identified). An error may have any of a (possibly large) number of causes. A defined causal mechanism can give rise to a taxonomy of errors. There are many possibly causal taxonomies of error. DEFINING "MEDICAL ERROR" The IOM Committee on Quality of Healthcare in America defines error as "the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim" [3]. It is important to note that medical errors are not defined as intentional acts of wrongdoing, and that not all medical errors rise to the level of medical malpractice or negligence. Errors depend on two kinds of failures: either the correct action does not proceed as intended, which is described as an "error of execution," or the original intended action is not correct, which is described as an "error of planning" [3]. A medical error can occur at any stage in the process of providing patient care, from diagnosis to treatment, and even while providing preventative care. Not all errors will result in harm to the patient. Medical errors that do result in injury are sometimes called preventable adverse events or sentinel events. Sentinel, because they signal the need for immediate investigation and response. Preventable adverse events or sentinel events are defined as those events that cause an injury to a patient as a result of medical intervention or inaction on the part of the healthcare provider where the injury cannot reasonably be said to be related to the patient's underlying medical condition. Thus, for example, if a patient has a surgical procedure and dies post-operatively from pneumonia, the patient has suffered an adverse event. But was that adverse event preventable; in other words, was it caused by medical intervention or inaction? The specific facts of this case must be analyzed to determine whether the patient acquired the pneumonia as a result of poor hand-washing techniques of the medical staff, an error of execution, which would indicate a preventable adverse event, or whether the patient acquired the pneumonia because of age and co-morbidities, which would indicate a non-preventable adverse event. Healthcare professionals can learn much by closely scrutinizing and evaluating adverse events that lead to serious injury or death. The evaluation of such events would also enable healthcare professionals to improve the delivery of healthcare and reduce future mistakes. In addition, healthcare professionals must have a process in place to evaluate those instances where a medical error occurred and did not cause harm to the patient. By reviewing these processes, healthcare professionals are afforded the unique opportunity to identify system improvements that have the potential to prevent future adverse events. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), recognizing the importance of analyzing both preventable adverse events and "near-misses," has established guidelines for recognizing these events and requires healthcare facilities to conduct a "root cause analysis" to determine the underlying cause of the event [5].
- THE HISTORY OF THE health care quality process hit a critical turning point barely one month before the worldwide millennial celebration in November 1999. Americans who lauded the remarkable technical capability of modern medicine—"miracle" drugs, transplants, genome therapy —were astounded by the Institute of Medicine’s landmark report, "To Err Is Human."1 It turned out the same system accomplishing technical miracles was also responsible for 44,000 to 98,000 deaths annually in hospitals due to medical errors. As the IOM report made painfully clear, the health care system itself was between the fifth and ninth leading cause of death in the United States. And while the IOM report met with criticism and its numbers were recently disputed in a new study reported in the Journal of the American Medical Association , the issue of safe patient care and high quality still remains at the forefront of medical debate. In a consumer-driven world that demands and receives ever-higher levels of quality and value in virtually all other industries, how could health care mount such frightening statistics? As one senior manufacturing executive stated, "For the past decade every one of our suppliers—except health care—has offered us higher quality at lower costs. Health care alone continues to offer us lower quality at ever-increasing cost!" Why is health care so far removed from the economic mainstream when it comes to quality? The answer lies in the strange saga of how health care quality systems developed in total isolation from the rest of the American economy. The goal of this report is to break the cycle of inaction. The status quo is unacceptable and cannot be tolerated any longer.” Three historical traditions influencing the evolution of health care quality are depicted in Figure 1. They illustrate both the isolation of health care quality development and how it evolved.2 Until 1987, health care quality concepts remained isolated within a learning science tradition dating to Hippocrates (3rd century B.C.). Medicine was then, and still is, taught and learned as a craft. The modern physician is the product of a long textbook, classroom and apprenticeship process. Quality is based almost solely on the skills of the craftspeople. And craft traditions are virtually blind to systems issues central to Column 3’s management science. Medicine traditionally relies on the unique truism that "patients may die, despite consummate skills of the practitioner." No other field has this ready, plausible explanation for poor outcomes. "My patients are sicker!" has been a nearly impenetrable defense for fending off serious inquiry into the sickly statistics. With the exception of a few isolated and marginally influential researchers, only during the year since the release of the IOM report has the truth penetrated health care’s consciousness. It is not patient variation, but inconsistent quality of care that generates these widely variable patient outcomes from region to region, health system to health system. Leape reviews the data from the Harvard Medical Practice Study (5). This work was a landmark, in large part because it was the methodologically strongest study of its time to examine the epidemiology of iatrogenic injury. The study assessed a random sample of patients discharged from New York hospitals in 1984. Serious iatrogenic injury occurred in 3.7 percent of hospitalizations (6). On the basis of these results, it was estimated that iatrogenic injury contributed to as many as 180 000 deaths annually in the United States (7). This is four times the number of deaths caused by traffic accidents. Other industries have done much better; although airplane crashes get headlines, in 1998 no domestic airplane fatalities occurred in the United States. Nonfatal medical injuries resulting in disability or prolonged hospital stay occur in another 1.3 million U.S. patients per year (7). Even though medical professionals conscientiously strive to avoid the “wrong mistake,” two thirds of medical injuries are estimated to be preventable under the prevailing standard of care (7). In the human factors section of the book, Cook and Woods discuss the difficulties that arise between the “sharp end,” practitioners who actually care for patients, and those at the “dull end,” persons who control many of the resources (for example, administrators) (8). They argue that although superficial analyses are often focused at the sharp end, dull end factors are more important than generally appreciated and contribute critically to most accidents. Australian study Investigators reviewed the medical records of 14 179 admissions to 28 hospitals in New South Wales and South Australia in 1995. An adverse event occurred in 16.6% of admissions, resulting in permanent disability in 13.7% of patients and death in 4.9% 51% of adverse events were considered to have been preventable. The differences between the US and Australian results may reflect different methods or different rates Other, smaller studies (including one from Britain) show similar orders of errors There are few studies from outpatients or primary care An evaluation of complications associated with medications among patients at 11 primary care sites in Boston. Of 2258 patients who had had drugs prescribed, 18% reported having had a drug related complication, such as gastrointestinal symptoms, sleep disturbance, or fatigue in the previous year. In Australia medical error results in as many as 18 000 unnecessary deaths, and more than 50 000 patients become disabled each year. In the United States medical error results in at least 44 000 (and perhaps as many as 98 000) unnecessary deaths each year and 1 000 000 excess injuries. Recommendations for Avoiding Medical Error National Center for Patient Safety - $100 million/yr Nationwide Mandatory Error Reporting w legal safety Patient Safety as Focus of Accreditation and licensing Patient Safety in medical school and CME curricula FDA focus on drug naming and other errors Health Care organizations to implement med safety “ Culture of Safety” Pressure from Business and Consumers “ Health care has safety problems because it relies on outmoded systems.” – IOM study 2001 All practitioners adopt quality as goal Safe, effective, pt. centered, timely, equitable Continue development of Natnl Quality Report Redesign health care:EBM, shared knowledge AHRQ: to define 15 conditions as quality targets $ 1 billion for Health Care Quality Innovation Fund National workshops on quality Make scientific evidence more useful to MDs & public Build national information infrastructure: internet Structure payment incentives to promote quality More research, better medical school education
- Method: sample of 30,195 randomly selected records, identified 1133 patients (3.7%) with disabling injury caused by medical treatment. One of the authors classified each event according to injury. Definition of operative : wound infection, technical complication, late complication, nontechnical complication, surgical failure. Definitive of non-operative : Drug related (19.4%) , diagnostic mishap (8.1%), therapeutic mishap (7.5%), procedure-related (7.0%), fall (2.7%), fracture (1.2%), postpartum (1.1%), anesthesia related (1.1%), neonatal (.9%), system and others (3.3%) Most frequent drug related complications according to class of drug: antibiotic 16.2% Most frequent types of Drug-Related complications marrow suppression 16.3%
- Simply speaking: we see what we want to see - it is a normal pathology Performance degraded by: habit interruptions fatigue Anger illness alcohol sleep deprivation boredom fear anxiety Once again: the name of the game is, “how do we get around it?” An individual failing Only the minority of cases amount from negligence or misconduct; so it’s the “wrong” diagnosis It will not solve the problem--it will probably in fact make it worse because it fails to address the problem Doctors will hide errors May destroy many doctors inadvertently (the second victim) All humans make errors: indeed, “the ability to make mistakes” allows human beings to function Most of medicine is complex and uncertain Most errors result from “the system”--inadequate training, long hours, ampoules that look the same, lack of checks, etc Healthcare has not tried to make itself safe
- By January of 2002, just seven years after JCAHO enacted its Sentinel Event Policy, the Accreditation Committee had reviewed more than 1,541 reported sentinel events. It found that the most common categories of sentinel events were patient suicide (16.7%), operative and post-operative complications (12.1%), medication errors (11.6%), wrong-site surgeries (11%), and patient falls (5.1%) The American Hospital Association cites a number of common medication errors, which are frequently cited as problems within hospitals: incomplete patient information (e.g., not knowing about patients' allergies, other medicines they are taking, previous diagnoses, and lab results); unavailable drug information such as lack of up-to-date warnings; miscommunication of drug orders as a result of poor handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metrics and other dosing units, inappropriate abbreviations; lack of appropriate labeling as a drug is prepared and repackaged into smaller units; environmental factors, such as lighting, heat, noise, and interruptions that distract health professionals from their medical tasks. Understanding the nature of these errors is the first step in eradicating them. Employing an effective method to gather and analyze all necessary information is critical to this effort. There is a recent example of confusion between the metric and English systems in a non-health care system. Engineers at Lockheed Martin Corporation provided NASA scientists with figures on the orbiter’s thrust in pound-seconds, in English units, but NASA believed that the figures were in metric measures. The outcome sent the spacecraft off course and it’s status unknown. Handwriting: there was a recent lawsuit against a cardiologist
- Although you may have seen a slide like this before, it is an illustration of the challenges to health care professionals. The USP Practitioner Reporting Network has received many reports about confusion with celebrex. Originally, celebrex was to be celebra. There was confusion between the name celebra and the antidepressant celexa. To complicate matter further, celebrex can be misinterpreted as cerebyx, an anticonvulsant drug.
- Three historical traditions influencing the evolution of health care quality are depicted in Figure 1. They illustrate both the isolation of health care quality development and how it evolved.2 Until 1987, health care quality concepts remained isolated within a learning science tradition dating to Hippocrates (3rd century B.C.). Medicine was then, and still is, taught and learned as a craft. The modern physician is the product of a long textbook, classroom and apprenticeship process. Quality is based almost solely on the skills of the craftspeople. And craft traditions are virtually blind to systems issues central to Column 3’s management science. Medicine traditionally relies on the unique truism that "patients may die, despite consummate skills of the practitioner." No other field has this ready, plausible explanation for poor outcomes. "My patients are sicker!" has been a nearly impenetrable defense for fending off serious inquiry into the sickly statistics. With the exception of a few isolated and marginally influential researchers, only during the year since the release of the IOM report has the truth penetrated health care’s consciousness. It is not patient variation, but inconsistent quality of care that generates these widely variable patient outcomes from region to region, health system to health system. Learning science Quality assessment began during a remarkable period of reform within the medical profession. The American College of Surgeons (ACS) was founded in 1913 to address great variations in the quality of medical education and the competence of physicians. By 1917, the ACS developed the Hospital Standardization Program.3 HSP was a set of uniform, high standards to apply to physicians practicing at hospitals seeking the distinction of achieving the standards. By the mid-1930s, only about half of hospitals seeking HSP distinction achieved it, and failure was not dishonorable. The unit of quality assessment under HSP was peer case review. Properly conceived and executed, this process can be a valuable learning experience. Following a death or other adverse outcome, physicians gather to review the record and discuss the case. They assess whether the outcome might have been preventable. Literature of the period suggests this learning-based model of quality assurance successfully improved hospital standards throughout the early decades of HSP. But in the 1950s and ‘60s, something went seriously awry with peer review. What went wrong? As modern elements of Column 1evolved, Column 2 effectively split into two channels. One channel of the learning column tracked true. It maintained the learning science origins and continues today with great vigor in academic medical centers. It persists primarily in the form of morbidity, mortality and other educational information: • Avedis Donabedian’s structure process-outcome quality model • Paul Ellwood’s outcomes measurement concepts • Modern case management systems The second channel of this split came under the influence of Column 1’s regulatory mindset and practices, and increasingly distant from Column 2’s learning tradition. The origins of Column 1 are even more ancient, dating to the 2100 B.C. Code of Hammurabi—when the penalty for surgical malpractice was to amputate the hands of the surgeon! This code focused historically on "bad care," and more recently the establishment and maintenance of minimum standards. Three fundamental characteristics distinguish modern Column 1players: 1. They establish comprehensive, general standards external to the institutions/practitioners actually providing care. Examples include licensure criteria, accreditation standards and laws. 2. They measure or survey the provider entity against these standards, typically through onsite inspections, often supplemented by data analysis. 3. If they judge a provider in noncompliance with standards, they can hold the provider accountable through mandatory recommendations, sanctions, financial penalties, and even imprisonment. This is a far cry from learning. It is fear. Not surprisingly, this motivational base has a spotty effect on actual quality at the bedside. The IOM explicitly labeled the "culture of blame" as a major impediment to improving health care quality systems. The point here is not to condemn Column 1 practices; few question their importance in preventing practitioners and institutions from falling below minimum expected standards of practice. But can a process heavily associated with a "culture of blame" genuinely inspire excellence? Column 1 players are inevitably in the "minimum standard" business, holding provider entities accountable when they slip below recognized standards. Excellent performance in Column 1 responsibilities assures a basic level of quality standards and complements the more excellence-oriented aspirations of Columns 2 and 3. As the ACS transferred ownership of the original HSP to the Joint Commission on Accreditation of Hospitals (now Healthcare Organizations, JCAHO) in 1951, Column 1’s legal and regulatory processes became more influential. How do current health systems leaders view Column 1 approaches? Some leaders are abandoning non-compulsory JCAHO review, and others are seeking innovative external review, such as the Baldrige and ISO 9000. A new era is at hand. What went wrong? As modern elements of Column 1evolved, Column 2 effectively split into two channels. One channel of the learning column tracked true. It maintained the learning science origins and continues today with great vigor in academic medical centers. It persists primarily in the form of morbidity, mortality and other educational information: • Avedis Donabedian’s structure process-outcome quality model • Paul Ellwood’s outcomes measurement concepts • Modern case management systems The second channel of this split came under the influence of Column 1’s regulatory mindset and practices, and increasingly distant from Column 2’s learning tradition. The origins of Column 1 are even more ancient, dating to the 2100 B.C. Code of Hammurabi—when the penalty for surgical malpractice was to amputate the hands of the surgeon! This code focused historically on "bad care," and more recently the establishment and maintenance of minimum standards. Three fundamental characteristics distinguish modern Column 1players: 1. They establish comprehensive, general standards external to the institutions/practitioners actually providing care. Examples include licensure criteria, accreditation standards and laws. 2. They measure or survey the provider entity against these standards, typically through onsite inspections, often supplemented by data analysis. 3. If they judge a provider in noncompliance with standards, they can hold the provider accountable through mandatory recommendations, sanctions, financial penalties, and even imprisonment. This is a far cry from learning. It is fear. Not surprisingly, this motivational base has a spotty effect on actual quality at the bedside. The IOM explicitly labeled the "culture of blame" as a major impediment to improving health care quality systems. The point here is not to condemn Column 1 practices; few question their importance in preventing practitioners and institutions from falling below minimum expected standards of practice. But can a process heavily associated with a "culture of blame" genuinely inspire excellence? Column 1 players are inevitably in the "minimum standard" business, holding provider entities accountable when they slip below recognized standards. Excellent performance in Column 1 responsibilities assures a basic level of quality standards and complements the more excellence-oriented aspirations of Columns 2 and 3. As the ACS transferred ownership of the original HSP to the Joint Commission on Accreditation of Hospitals (now Healthcare Organizations, JCAHO) in 1951, Column 1’s legal and regulatory processes became more influential. How do current health systems leaders view Column 1 approaches? Some leaders are abandoning non-compulsory JCAHO review, and others are seeking innovative external review, such as the Baldrige and ISO 9000. A new era is at hand. Health care and other industries To fully comprehend the IOM’s findings, compare health care’s quality statistics with those of other industries. To compete in world-class markets, manufacturing and service industries must operate with quality systems capability in the range of 5-6 Sigma—that is, between 230 and 3.4 defects per million opportunities. According to recent studies, the quality capability of the systems derived from Figure 1’s Columns 1 and 2 in health care today range from 2 Sigma to 4 Sigma. That translates to somewhere between 308,000 defects per million —the number of cardiac patients who would benefit from aspirin administration daily, but who don’t receive it—and 6,210 defects per million—the current rate for hospital medication ordering and administration practices. The only known health care exception to these startling numbers is anesthesia mortality. Through a unique effort combining the knowledge of committed anesthesiologists and pervasive use of virtually foolproof equipment, anesthesia mortality presently approaches 6 Sigma. Column 3 and the future This huge health care "Sigma gap" sets the stage for a genuine quality revolution in health care. And the earliest skirmishes of the revolution are already under way. Columns 1 and 2 remained impenetrable to the quality methods of Column 3’s management science until 1987. Then, some pioneering It is time for health care to mature as a true,value-adding industry. physicians, hospitals and other health care organizations combined with quality experts from manufacturing and service industries to launch an ambitious experimental introduction of Column 3 management practices. This experiment was a definitive success, proving that management science-based techniques could duplicate in health care exactly what it had done in all other industries.4 With proof that process improvement can simultaneously improve quality and lower cost, the continuous quality improvement wave in health care was under way. Organizations spent millions on continuous improvement processes, realizing impressive results and some failures. But the wave passed by. Modern quality management science failed to take hold in a critical mass of health care organizations. Most that experimented with Column 3 reverted to the more familiar practices of Columns 1 and 2. And they unwittingly locked their institutions into the 2-4 Sigma quality capability of today’s health care system. Renaissance of Column 3 On a positive note, Column 3 remains alive and well in a number of incubator organizations. Those who continued to learn and lead Column 3 development are well positioned for a renaissance. Part of the renaissance of Column 3 management science will be an organizational post-mortem on why the 1987-1995 experience did not embed itself in health care. Typically, the reasons for failure surround: 1. The deeply embedded culture that is the legacy of Columns 1 and 2 was simply not ready for the invasion of so alien a culture as that surrounding modern quality science. The traditional Column 1 and 2 health care cultures responded to this invasion with a powerful "immune reaction," effectively "banishing" this new science back to exile in Column 3. 2. The business case for quality science was never effectively presented. Though it was clear that process improvement could reduce costs and improve quality, few health care organizations were able to leverage this as a significant strategic advantage. Two other problems were at work: a. Since health care quality measurement has been so rudimentary, higher quality was often opaque. Purchasers and patients couldn’t yet really distinguish high quality from mediocrity. b. Payment systems were not geared to reward value. Fee-for-service simply paid for doing more—sometimes a sign of poor quality with slow/incorrect diagnosis, excessive testing and complications that generated higher bills and more revenue. The bottom line is no one really achieved major competitive breakthrough by emphasizing quality. 3. Inadequate time to mature. Those involved with the introduction of Column 3 quality science to health care in the late 1980s still remember the admonitions of the "wizened veterans" of manufacturing’s world-class quality competition. "This transformation will take five to ten years to truly embed itself as your new way of doing business." In health care, other pressures intervened before even the most stalwart supporters of Column 3 could truly accomplish their organizations’ quality management goals. Health care’s crises with falling provider payment, balanced budget act implications, ambulatory fixed payment systems, rising costs and insurance premiums are relentlessly forcing health care provider organizations to move beyond Columns 1 and 2 . The renaissance of Column 3 is inevitable. The most progressive health care organizations will embrace it as rapidly as possible. Only Column 3 can bridge the gap from 4 to 6 Sigma quality. It also is the only body of knowledge that addresses the cost element of the cost/quality/value equation and the only column that leaders can use to address the economic issues. Sigma Defect Per Million1690000230800036680099%1000046210523063.4Five elements of a successful transition to Column 3 include: A call to action It is time for health care to mature as a true, value-adding industry. For this to happen, Column 3 management science must emerge as both a survival and strategic leadership commitment for health care provider organizations—as well as an ethical imperative in moving from 4 to 6 Sigma quality. 1. Maintaining the best values of medicine’s Column 2 learning science tradition, even as its practices are updated to embrace the information age. This means detoxifying medical peer review practices now extant in the vast majority of hospitals and restoring a learning-based peer case review, now supplemented by rigorous data analysis by physicians and others regarding practice patterns. 2. Understanding, creating and managing organizational culture. Nobody planned the "culture of blame" that IOM identified as a major impediment to current quality transformation. But culture fights to maintain itself and Columns 1 and 2 are deeply embedded in health care and very powerful. Successful health care organizations will develop effective strategies that honor the power of historic health care culture and consciously create new, positive and collaborative cultures to accomplish the clinical integration needed for 6 Sigma quality. 3. Developing new leadership concepts and practices. It’s not surprising that relatively few leaders whose heritage stems from Columns 1 and 2 have the depth of understanding and concomitant skills to master integration of modern quality science with health care practices. Even many who successfully embraced Column 3 during the "CQI glory years" have been battered by a combination of quality management decline, merger-mania, high level power struggles, increasing financial pressures, and health system downsizing. The good news? Research and the literature are overflowing with promising new leadership theory and practices. This literature suggests old-style, top-down hierarchical leadership has virtually no place in the present revolution. 4. Integrating Column 3 management science with clinical care and care system design. This involves a body of knowledge pervasive in the airline industry, but virtually unknown in health care: human factors science. This focuses on a deep understanding of how error occurs in complex human systems, and how communications protocols and other sophisticated techniques can virtually eliminate human imperfection as a source of error and injury in complex systems. The successful integration of Columns 2 and 3 holds promise in creating higher quality, more humane and far more healing environments than Columns 1 and 2 alone ever contemplated. 5. Establishing innovative external review processes that can genuinely help committed organizations achieve their 6 Sigma quality goals. External review As health care becomes increasingly market-driven, those purchasing and using its services will define health care quality and value. Patients will have a major voice in the future evolution of health care. But non-consumer-based quality assessment will remain vital to health care organizations. Optimal future quality will emanate from organizations that integrate the best of Columns 1, 2, and 3 into their external review systems. Quality practices related to the three columns will evolve along different tracks, though ultimately some convergence is likely. Column 1 The IOM report has placed the players of Column 1 in an extraordinarily difficult position. These public guardians of health care quality are presiding over an industry with 2-4 Sigma quality. They must find a way out of their dilemma. Society needs minimum standard certifiers. But historical players in this column must take a serious look at their practices and innovate them. Good regulation and competition may stimulate innovation and excellence in Column 1 external review. The greatest hope probably lies in enlightened innovation in such organizations as: • JCAHO • The National Committee for Quality Assurance ( NCQA)—focusing on managed care plans • The Peer Review Organizations (PRO—focusing on Medicare/Medicaid If JCAHO can reform its processes and innovate to offer greater value to its constituents, it might emerge as an important element in the future quality equation for health care organizations. For all the deficiencies of its current image and processes, it is deeply embedded in health care culture. JCAHO could become a beacon of transition for health care organizations still within its diminishing sphere of influence. A recent article suggests that JCAHO is indeed actively acknowledging and willing to work in a complementary fashion with newer external review frameworks. The NCQA and PROs also have positive potential. While maintaining their primary role of safeguarding Perhaps most of all, physician leaders face an urgent imperative to detoxify peer case review. minimum standards, many have moved on to establish more collaborative relationships with health care systems. With their vast data capability, the best PROs are already offering these systems both information support and technical consultation on how to improve systems Column 2 Because health care is offered from one human being to another human being one-at-a-time, review of individual patient care will never disappear. It will be important to conceive case review not simply as a narrowly defined, cost-generating process, but one that complements and supports the overall medical center quality/cost/value improvement strategy and practice. Perhaps most of all, physician leaders face an urgent imperative to detoxify peer case review. Negative peer review evokes fear, anger, resistance and professional conflict. It is antithetical to the original learning intent of case review and leaders are well advised to abolish this toxicity unequivocally. Column 3 The external review frameworks for Column 3 quality management presently are ISO 9000 and Baldrige. The Baldrige system of external review is based on criteria derived from the United States Baldrige National Quality Award, a highly prestigious achievement in the realm of world-class quality. Health care organizations are now using the Baldrige framework in two contexts: 1. Actually pursuing the award 2. As a template for quality systems development Few health care systems are striving for quality awards. Many more systems are seeking comprehensive frameworks to improve quality systems capability. It’s impossible to predict exactly what combination of Column 1-3 external review systems will prove optimal for both health care providers and the communities they serve. ISO 9000 and Baldrige took many industries to world-class quality: automotive, aerospace, information technology, telecommunications, machinery, electrical products, pressure equipmen, and transportation Perhaps these Column 3 review systems will help move health care down the path toward world-class, 6 Sigma quality, as well.
- An acknowledged measure of comparison for quantitative or qualitative value; a criterion. An object that under specified conditions defines, represents, or records the magnitude of a unit. The set proportion by weight of gold or silver to alloy metal prescribed for use in coinage. The commodity or commodities used to back a monetary system. Something, such as a practice or a product, that is widely recognized or employed, especially because of its excellence. Definition: [n] any distinctive flag [n] an upright pole or beam ( especially one used as a support ); " distance was marked by standards every mile "; " lamps supported on standards provided illumination " [n] the ideal in terms of which something can be judged ; " they live by the standards of their community " [n] a basis for comparison ; a reference point against which other things can be evaluated ; " they set the measure for all subsequent work " [n] the value behind the money in a monetary system [n] a board measure = 1980 board feet [adj] commonly used or supplied ; " standard procedure "; " standard car equipment " [adj] regularly and widely used or sold ; " a standard size "; " a stock item " [adj] established or widely recognized as a model of authority or excellence ; " a standard reference work " [adj] conforming to or constituting a standard of measurement or value ; or of the usual or regularized or accepted kind ; " windows of standard width "; " standard sizes "; " the standard fixtures "; " standard brands "; " standard operating procedure " [adj] ( linguistics ) conforming to the established language usage of educated native speakers ; " standard English " ( American ); " received standard English is sometimes called the King ' s English " ( British )
- Introduction to ISO 9000, a management tool for overall business excellence in your organization. ISO 9000, a brief introduction to the basic concepts. The term “ISO” is derived from the Greek word "isos", meaning equal. ISO standards are developed and administered by the International Standards Organization, an international organization to which approximately one hundred countries belong. The US representative is the American National Standards Institute. The general purpose of ISO is to provide standards for the development, implementation and management of a quality management system. ISO 9000 registration is best viewed as a management tool that reaches far beyond the province of "quality control" in a manufacturing environment, the application that first comes to mind to many business people. For ISO 9000 purposes, the term "quality" should be viewed as being synonymous with "excellence" and as applying to all segments of a company's operations, even those administrative functions that are sometimes not viewed as being part of the overall goals of the company in meeting its customers needs. When used properly, ISO 9000 is a great management tool to promote excellence throughout all functions or all enterprises in all sectors of the economy, from manufacturing companies to service businesses to health care providers. The innovation friendly ISO standards for systems and procedures documentation have received nearly universal acceptance in business and industry and is a virtual necessity for companies of all kinds doing business in or with European countries. In recent years, adoption of ISO 9000 or the related automotive industry focused QS 9000 standards for documenting quality systems has become very wide spread in the US. International Organization for Standardization (www.iso.ch/) Origin and focus —European manufacturing industry 1946; quality systems (often within individual department or function) Standards —ISO 9000 series (quality systems); also specific for radiology and laboratory systems Products —Certification International Organization for Standardization— The ISO 9000 series of standards were designed for manu facturing industries and have been criticised for using language that is difficult to interpret in terms of health services. The 2000 version will be more readily applied, and US and European initiatives are under way to develop ISO guidelines specific to health care. What is ISO? The International Organization for Standardization (ISO) is a non-governmental entity that was founded in 1947 by 25 countries as a way to develop voluntary technical standards for businesses. Its intent was to provide consensus for an approved methodology that could ensure consistency in the manufacturing of materials and products, by ensuring standardization of processes and services in accordance with customer requirements. Now, the ISO membership is comprised of over 140 National Standards Bodies, one from each affiliated country, of which the U.S. representative is the American National Standards Institute (ANSI).1 The ISO 9000 Quality Management System was originally created in 1987 to non-prescriptively provide a management system quality standard for non-technical business functions. It was later perfected in 1994 and released as three distinct standards (ISO 9001, 9002, and 9003) in an effort to better generically differentiate design, development, production, installation, and servicing processes. The latest solution, ISO 9001:2000, was fielded as a consolidated framework on December 15, 2000.2 The ISO 9001:2000 principles inculcate a customer focus, leadership, involvement of personnel, a process approach, a system approach to management, continual improvement, a factual approach to decision making, and mutually beneficial supplier relations. Its structural methodology non-prescriptively requires you to describe your quality management system, management responsibility, resource management, service realization, and measurement, analysis, and improvement methods. [ top ]
- There are six required documented procedures: control of documents, control of records, internal audits, control of non-conformances, corrective actions, and preventive actions.3 The ISO 9000 Quality Management System allows the healthcare organization to design and implement a management system with integrated and synchronized patient care and business processes. Establishing and achieving management system quality with ISO 9001:2000 is the essential core change strategy for achieving a seamless and transparent organizational system for quality.4 What Are the Business Results of ISO Certification? Any time you are able to improve delivery of care and delight your patient beneficiaries, you enhance your clinic’s reputation and improve your market position. As we all know, the quality of the patient/employer experience critically factors into an employer’s willingness to continue a relationship with a clinic facility. Companies registered to ISO 9000 have reported significant reductions in customer complaints, improved client relations, and reductions in operating costs. Other well recognized returns on the investment have been an increased demand for services, increased market share, and increased profits. Additionally, achieving management system quality will positively engage your clinic staff with better working conditions by integrating and synchronizing workflow process control. Improving this aspect of your practice, alone, can help to reduce stress among your staff, thereby favorably enhancing the caregiver/patient interface and reducing staff turnover. How to Implement ISO 9000? Once an organization has made the commitment to implement the ISO 9000 Quality Management System, a logical series of steps is taken to move forward towards validation and certification of the healthcare organization’s management system quality. The following simple steps offer an overview for how to earn ISO 9000 registration:5 • Get top management’s commitment • Select an ISO registrar early in the process • Train personnel • Prepare quality policy manual • Prepare operating procedures • Hold internal audit • Conduct management review • Complete certification process • Obtain ISO 9000 registration "Document what you do and do what you document," the essence of ISO 9000. The essence of ISO 9000 is for a company to "document what it does and do what it documents." The documentation is developed through the facilitation process and consists essentially of work instructions and quality and operational procedures designed to assure that goods and services are developed, created and delivered in a consistent manner that reflects the quality goals of the organization. This built-in consistency not only promotes the interest of the customers of the organization (they get what they have been promised or expect), it promotes the efficiency and thus the profitability of the organization! When properly facilitated and used, the documentation developed in the facilitation process and the ISO 9000 registration and audit process itself becomes a management tool to promote excellence throughout the business. Some business executives have looked at ISO merely as a registration needed to do business. Consequently, they take short cuts to achieve registration with "canned" documentation and using a registrar who focuses on whether the forms are filled out and not auditing the business' documentation to see if they really "document what they do and do what they document." This is a very short sighted and ill-informed approach and can result in registrations that are essentially fraudulent; i.e., they misrepresent to their customers or others what is actually going on in the company. Just as financial audits of a company by its CPA serve to provide an independent third-party assurance as to the financial status of a company, audits of a company's quality systems and procedures serve to assure the customers that the company continues to implement the procedures and quality systems necessary to maintain the consistency of the company's products or services and that these procedures and systems are properly and timely documented." An essential feature of ISO 9000 is that it does not prescribe quality standards. The registered companies are free to define the quality standards or "best practices" that are sufficient to meet the needs of their customers and market within which they operate. All that ISO 9000 requires is that the applicable standards are documented in a certain way. This innovation friendly aspect of ISO 9000 assures that companies are not locked in to stagnant, expensive and bureaucratic systems and procedures that may or may not meet the needs of their customers.
- ISO 9000 CERTIFICATION FOR HEALTH CARE ORGANIZATIONS INTRODUCTION ISO 9001:2000 is an international quality standard that defines a quality management system framework/foundation. The Standard is approximately 23 pages long and covers, in a process-oriented fashion, all aspects of business from the initial contracting stages (e.g. patient informed consent process) through to the delivery of service (e.g. patient care/treatment). It is a standard that has been applied in a variety of industry sectors and specifically has been adopted in a wide range of health care organizations including, but not limited to, full-service hospitals, home health agencies, physician practices, ambulatory care centers, occupational health facilities, laboratories, blood banks, medical equipment suppliers as well as third party administrators and health insurance companies. Holding the largest number of certificates in the United States, SGS International Certification Services, Inc. (SGS ICS) is the leading registrar offering ISO 9001:2000 registration to the health sector. SGS ICS has a unique international presence in the health sector as well, having certified over 900 health care organizations worldwide to ISO 9000 Standards. As a result, the SGS ICS auditor knowledge and expertise in the health care arena is second to none. WHAT ARE THE BENEFITS OF ISO 9001:2000 FOR HEALTH CARE ORGANIZATIONS? ISO 9001 serves as a basis to: Achieve better understanding of all quality practices throughout the organization Ensure continued use of the required quality system year after year Improve documentation and records Improve quality awareness Strengthen both supplier and customer confidence and relationships Yield cost savings and improve profitability Form a foundation for improvement activities within Total Quality Management Complying with ISO 9000 Standards does not indicate that every product or service meets the customer's requirements, only that the quality system in use is capable of meeting them. ISO 9001 requirements describe what must be done to make up a quality system, not how to set it up. Once ISO 9001 is implemented, the very nature of the process ensures continuous quality improvement, whereby problems and process variations are dealt with quickly and permanently. With periodic audits to monitor continued compliance, there is relatively little interruption in the delivery of care. If a health care provider is ISO 9001 registered, any other survey process will be much simpler and less costly regarding both preparation and compliance demonstration. While ISO is not intended to replace JCAHO, URAC, NCQA, or CAP, it does make the compliance demonstration process must easier to manage, less time consuming, and less costly. Additional benefits for blood banking organizations exist because the AABB standards are based on the same principles and concepts as the ISO 9001 Standards. Amongst others, insurers/payors can realize the benefits simply by applying the general business concepts and principles inherent in the ISO 9001 Standards to their daily operations to improve overall efficiency and effectiveness. Other benefits reported by companies that have successfully implemented ISO 9001 are: Improves Competitive Advantage Proceduralize Operations/Processes Makes Operations/Processes Consistent Helps Establish a "Quality Company" Encourages Self-Assessment Empowers Employees Establishes Internal Trust Improves Communication Preliminary results of a worldwide survey of SGS ICS registered health care clients reveals the following aspects of business to be favorably impacted via ISO 9001 registration: Consistency of services during times of change Patient/customer satisfaction Competitiveness in the health care market Accountability and Empowerment of employees Ability to evaluate effectiveness of processes through internal audits Communications within the facility Compliance with regulations, contract requirements, codes THE SGS ICS APPROACH TO ISO 9001:2000 CERTIFICATION IN HEALTH CARE ISO 9001 registration involves many stages. First and foremost, an organization is required to define and document its processes and daily activities while addressing each of the requirements of the international quality standard. Once defined, the organization is then charged with implementing their documented system. Typically, a registrar is selected during the implementation phase. In your case, SGS International Certification Services, Inc is a prospective registrar. The registrar is an independent third-party organization that carries out the assessment of your quality system, determines that it meets the Standard, and issues a certificate that is internationally recognized for your ISO 9001 registration achievement. The registration process is made up of three primary activities: a document review that assesses whether all of the requirements of the Standard have been addressed followed by the onsite audit that determines whether all of the processes have been implemented. Following the initial audit, annual surveillance (or maintenance) visits take place to ensure your quality system continues to be effective and is adequately maintained. The registrar selects the Audit Team based on their knowledge and experience in the industry. These auditors have extensive quality system auditing experience as well as specific expertise in the health care sector. The Audit Team will submit an audit itinerary in advance of the audit that will cover the entire quality system dividing departments into blocks of time. This agenda can be flexible to accommodate the staff's availability and/or the physical layout of the organization. Once onsite, the objective of the Audit Team is to facilitate the ISO 9001 registration process. The approach of SGS ICS is to seek compliance to the Standard. To do this, the Audit Team will gather objective evidence through interviews with personnel at all levels, review documentation of procedures, review records of activity actually occurring, and direct observation.Little time will be spent in conference rooms looking through manuals. Most of the assessment will be carried out directly where the activity occurs on a daily basis. The SGS ICS auditors will use a customized checklist derived directly from your procedures reviewed at the time of the document review. As a result, the auditors will use language familiar to your organization and minimize any anxiety during the interviewing process. Any issues that arise during the audit will be openly discussed as they occur. In this way, there will be no surprises and the organization will know exactly where they stand during the entire process. A short debrief will take place at the end of each day as an overall review. After the assessment is completed, the Audit Team will have a Closing Meeting to officially discuss the audit findings and determine whether or not the organization is being recommended for registration. The relationship between your organization and SGS ICS is that of a partnership. Not only is our goal to facilitate certification, but also to provide added value to your organization through the ISO 9001 process. Although SGS ICS cannot provide consultative services, we hope to share our experience and knowledge with you to help you improve your organization, become a more efficient and effective organization, and improve the overall service you provide to your customers. HOW TO FIND OUT MORE ABOUT OUR ISO 9001 PROGRAM FOR HEALTH CARE ORGANIZATIONS If you are interested in receiving a copy of the ISO 9001:2000 Standard, copies can be purchased through the American Society for Quality at 1-800-248-1946. If you want to learn more about ISO Standards available, please visit the website www.iso.ch . For those organizations interested in receiving a package of additional information about our ISO 9001 program including a listing of our registered health care organizations, please feel free to contact any of our SGS ICS offices in Rutherford, NJ, Lombard, IL, Los Angeles, CA, Houston, TX, or Mississauga, Ontario. For technical questions, feel free to contact Laura Prioli, Health Care Services Manager, at 1-800-313-2437 or 281-873-5800 or [email_address] . If you are interested in receiving a proposal for registration services, please complete the health care questionnaire on-line and we will be happy to generate a quotation for you. We look forward to partnering and doing business with you in the near future. EN Training Events Request More Information Useful Links Health Care Applications The adoption and use of ISO 9001:2000 series standards and guidelines by institutional, managed care and physician practice health care providers can result in many benefits. This material contains several unique approaches useful in the implementation of ISO 9001:2000 in the health care setting. Institutional health care providers , i.e., are those hospitals, medical centers, clinics, et al, that currently submit to and comply with Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for the primary purpose of obtaining Medicare reimbursement for providing health care services to Medicare patients. The Medicare system is administered by the Federal Health Care Finance Administration (HCFA). Because HCFA does not have sufficient staffing to perform site surveys of all Medicare provider facilities, HCFA has given the JCAHO what is known as “deemed status”, meaning that if a hospital or dissimilar institutional facility/program has received JCAHO accreditation, HCFA will accept that accreditation in lieu of it’s own survey. HCFA does bear primary survey responsibility under the Law, however can and has delegated survey and compliance monitoring to State or other authorized health care jurisdictional authority. The benefit to the use of ISO 9001:2000 compliance and registration is that once ISO 9001:2000 is implemented, the very nature of the process assures Continuous Quality Improvement (CQI), whereby problems and process variations are dealt with quickly and permanently. With ISO 9000 Registration, only periodic audits are needed to monitor continuing compliance. There is relatively little interruption in the delivery of health care as is experienced with the three year JCAHO accreditation cycle. Anyone that works in the hospital, long term care facility or clinic environment is very well aware of the typical six to nine month preparation process that takes place before a JCAHO survey. Health care, allied health care professionals and management leaders are diverted from providing health care and spend considerably time “gearing up” for surveys. The number of hours converted into dollars is considerable, not to mention the cost to the institution for the actual JCAHO survey. Managed Care and Health Maintenance Organizations (HMO) experience similar kinds of problems in preparation for National Committee for Quality Assurance (NCQA) HEDIS Report Card System. NCQA does both Accreditation and Performance Measurement (i.e., HEDIS). While the standards are different, the “process” is essentially the same as far as the long lead-time and costly preparation time and survey costs. Physician Group Practices , i.e., IPOs, PPOs, et al, can benefit because of two major and significant reasons. First, implementation of the ISO 9001:2000 process can create a more efficient practice that can identify problems early and initiate corrective action to solve problems more quickly and better monitor, control and reduce costs in the process. The second major reason is that an ISO 9001:2000 registered practice can point to registration as a benchmark of an efficient and controlled operation. This is, more and more, what insurance companies, payers and larger institutional provider organizations are looking for in terms of stable physician group practice providers. Medical Equipment Service Providers include the original equipment manufacturers (OEM), in- house Biomedical Engineering programs, Independent Service Organizations, and equipment remanufacturers. The US Food and Drug Administration requires medical equipment manufacturers to comply with federal requirements known as Good Manufacturing Practices (GMP). The FDA is currently attempting to pass legislation to require all such service providers to comply laws that will impose requirements upon providers in the area of tracking of devices after sale and during the entire life of the equipment until it is replaced. Given the large volume of medical equipment in use today, as well as the portable nature of the equipment, the ability to comply with such requirements is virtually impossible. New legislation would prove to be a cross between the Safe Medical Device Amendments of 1990 and the GMPs. After significant service provider protests, the FDA has backed of for the time being while at the same time told the service providers to implement a quality systems standard of it’s development or be faced with GMPs or equivalent legislation. ISO 9001:2000 is a quality management system that can solve the problem with less impact on service costs than any other system currently available. Overall, it has been well demonstrated that if a health care provider is ISO 9001:2000 qualified and/or registered, any other survey process will be much simpler and less costly regarding both preparation and compliance demonstration. While ISO 9001:2000 registration is not intended to replace JCAHO or NCQA accreditation, it does make the compliance demonstration process appreciably less difficult, time consuming and costly. What is ISO 9001:2000? From 1994 to 2000, the core of the ISO 9000 Quality Systems Standard was a series of five international standards that provide guidance in the development and implementation of an effective quality management system. Not specific to any particular product or service, these standards are applicable to manufacturing and service industries alike. In 2000, the International Standards Association in Geneva, Switzerland revised the international ISO Core Standards. Effective in 2000, there are four documents: ISO 900:2000, ISO 9001:2000, ISO 9004:2000 and ISO 19011 . ISO 9002:2000 is a requirement standard. ISO 9000:2000, ISO 9004:2000 and ISO 19011 are guideline documents. They are defined in the following section. A quality management system refers to the activities you carry out within your organization to satisfy the quality-related expectations of your customers. To ensure that you have a quality management system in place, customers or regulatory agencies may insist that your organization demonstrate that your quality management system conforms to the ISO 9001:2000 quality system model. Then, the customer "second party." or an independent "third party" registrar comes into your organization to "audit", or verify, that you have such a system in place. When a registrar finds your organization fulfills the requirements of the ISO 9001:2000 standard, your organization becomes "registered" and receives a certificate that is accepted by many of your customers. Organizations not concerned with becoming, registered may, nevertheless, want to comply with ISO 9001:2000. ISO 9001:2000 Process Improvement Techniques Implementation of ISO 9001:2000 in all aspects of health care delivery requires unique approaches. Because ISO 9001:2000 is a process based system rather than a compliance/standards requirement based system, the overall process is less complicated than either of the so-called “deemed status” JCAHO or NCQA/HEDIS accreditation systems. The following material identifies and describes some of the unique approaches that can be used in part to implement ISO 9001:2000 in Health Care. The ISO 9001:2000 quality management system works on the principle that an organization; i.e., health care provider, defines it’s own quality system based on the processes that work best for that health care provider. When we identify and document those processes, the first step is to identify the Health Care Measures in a given program. Those measures include the Measures to be examined, the Setting in which health care is delivered and the Services provided. The material on Quality Performance Wheels provides a system for establishing goals for Performance and Improvement , Program Costs and Customer Satisfaction . Any successful program must address all three topics. While the use of quality management systems is well established in the industrial environment, these concepts are, with a few exceptions, generally less than a decade old in the health care community. One of the problems that this relative newness is that many health care providers have precious little training and/or experience in statistical and analytical tools, techniques and applications. There are many statistical and non-statistical tools available, however health care professionals can find themselves at a loss as to when to use which tools in problem solving or identifying process problems. The material on Statistical and Analytical Tools addresses this situation by demonstrating a Tools “flow chart; coupled with problem solving tools. In health care delivery, two words: Process and Outcomes are often the focus of health care professionals and management. Clinicians often stress outcomes with less concern for how they arrived at that Outcome/Management yet, stress Process in the act of running the delivery system. We have developed a way to allow both Process and Outcome to work together. This material is shown in the Integrated Health Care Quality Management Model. Why Adopt ISO 9001:2000 in Health Care? Health Care organizations adopt ISO 9001:2000 standards for a variety of different reasons. Your organization's decision to do so may include: Form a foundation for improvement activities within Total Quality Management Of course, these benefits are achieved only with good planning, hard work, and continuous improvement. Complying with ISO 9001:2000 requirements does not indicate that every product or service meets the customers' requirements, only that the quality system in use is capable of meeting them. That is why continual assessments of customer satisfaction constantly shape and ultimately improve the processes that produce the product/service offerings.
- Clauses in the ISO 9001 Quality Systems Standard ISO 9001:2000 consists of five primary clauses that contain 23 sub-clauses. These requirements spell out what your organization and possibly you must do to conform to the standard. All the requirements must be documented and controlled. The Clauses are as follows: 4 Quality Management System 4.1 General Requirements 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Records 5 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Planning 5.4 Planning 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communication 5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output 6 Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.2.1 General 6.2.2 Competence, Awareness and Training 6.3 Infrastructure 6.4 Work Environment 7 Product Realization 7.1 Planning of Product Realization 7.2 Customer-related Processes 7.2.1 Determination of Requirements related to the Product (or Service) 7.2.2 Review of Requirements Related to the Product (or Service) 7.2.3 Customer Communication 7.3 Design and Development 7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation 7.3.7 Control of Design and Development Changes 7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Processes for Production and Service Provision 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Monitoring and Measurement Devices 8 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Auditing 8.2.3 Monitoring and Measurement of Process 8.2.4 Monitoring and Measurement of Product 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action
- the act of granting credit or recognition ( especially with respect to educational institution that maintains suitable standards ); " a commission is responsible for the accreditation of medical schools " Accreditation Origin and focus —US health care 1919; service organisation, performance Standards —Published with criteria such as acute care, long term care, primary care, networks Products —Accreditation (of organisation or service) Accreditation —The international arm of the US Joint Commission on Accreditation of Healthcare Organisa tions has developed a set of multinational accreditation standards.20 In addition the International Society for Quality in Health Care has developed (“ALPHA”) standards and criteria (available from the society's website www.isqua.org.au) against which an accreditation programme may apply to have its standards and process assessed and internationally accredited.21 These also offer a template for standardisation and self assessment to any external assessment programme.
- The mission of Joint Commission Resources is to continuously improve the safety and quality of care in the United States and the in the international community through the provision of education and consultation services and international accreditation Quality assessment began during a remarkable period of reform within the medical profession. The American College of Surgeons (ACS) was founded in 1913 to address great variations in the quality of medical education and the competence of physicians. By 1917, the ACS developed the Hospital Standardization Program.3 HSP was a set of uniform, high standards to apply to physicians practicing at hospitals seeking the distinction of achieving the standards. By the mid-1930s, only about half of hospitals seeking HSP distinction achieved it, and failure was not dishonorable. The unit of quality assessment under HSP was peer case review. Properly conceived and executed, this process can be a valuable learning experience. Following a death or other adverse outcome, physicians gather to review the record and discuss the case. They assess whether the outcome might have been preventable. Literature of the period suggests this learning-based model of quality assurance successfully improved hospital standards throughout the early decades of HSP. But in the 1950s and ‘60s, something went seriously awry with peer review. As the ACS transferred ownership of the original HSP to the Joint Commission on Accreditation of Hospitals (now Healthcare Organizations, JCAHO) in 1951, Column 1’s legal and regulatory processes became more influential. Joint Commission Resources (JCR) is a subsidiary of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Joint Commission International (JCI) is a Division of JCR International Accreditation is a separate division of JCI
- Accreditation of hospitals outside the U.S. was prohibited by JCAHO bylaws, except for U.S. military and U.S. Congress chartered (only one) Filled with U.S. and state laws and regulations such as “waived testing” Contained many “political” considerations such as requirements for an organized medical staff Used U.S. jargon such as “advanced directives” Relied on NFPA requirements for facility review with no international version of those requirements Had a U.S. cultural overlay for patient rights International Accreditation director appointed in January 1998-former JCAHO Department of Standards Director International Principles and Standards Development Task Force formed February 1998 First meeting of the Task Force in June 1998 Meetings held in Chicago, Budapest, Barcelona
- Accreditation, by its very nature, is only intended to "prescribe minimum requirements. ISO Quality Management System culturally moves the organization far beyond minimums by establishing the foundation and structural framework for "non-prescriptive management system quality. ISO 9000 is not intended to prescriptively validate efficacy of patient care nor the effectiveness of the clinician. International standards include all topics from JCAHO standards including newer ones related to pain management, and care at the end of life International standards contain many of the quality control and quality leadership ISO 9000 criteria International standards include the criteria of the European (EFQM) and U.S. (Baldrige) quality awards Is There a Relationship Between Accreditation and ISO Certification? One must first differentiate accreditation from certification. Accreditation, by its very nature, is only intended to "prescribe minimum requirements," whereas the ISO Quality Management System culturally moves the organization far beyond minimums by establishing the foundation and structural framework for "non-prescriptive management system quality." For this very reason, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Senior Vice President, Dr. Paul M. Schyve, stipulated that the solution to preventing medical mistakes is "to change the systems and processes within which people work." He concluded that accreditation and ISO 9000 can fit well together and complement one another.6 It should be noted that the ISO 9000 is not intended to prescriptively validate efficacy of patient care nor the effectiveness of the clinician, other than in terms of management system quality and the inter-connectivity of the organization’s stated management processes and procedures.7 ISO 9000 and Health Care, an efficient accreditation alternative that meets other essential needs. While ISO is generally thought of in terms of the manufacturing segment of the economy, it is equally applicable to service firms, as we will illustrate with respect to health care. Many hospitals, especially those in the UK, Australia, New Zealand and other Pacific Rim countries rely on ISO registration to document their quality systems and procedures. ISO registration will provide a standard easily recognized and respected by business and industry leaders in the communities served by health care institutions adopting it. This will provide added credibility to the institution to those persons and companies that are the ultimate source of health care funding for nearly all non-governmental insurance and self-funded benefit plans. Institutions adopting ISO in lieu of Joint Commission on Accreditation of Healthcare Organizations ("JCAHO") need not fear loss of Medicare approved status as governmental regulations require either JCAHO accreditation or surveys by the Health Care Finance Administration ("HCFA") designated state agency, the avenue to approval relied upon by the 20% of hospitals not JCAHO accredited. Additional Challenges for Health Care Providers Approved payee status for federal health care programs is not the only challenge facing health care providers, however. Additional issues confronting health care providers are as follows. Providers should keep in mind that all of these issues are inter-related. Problems in all of these areas have the same root causes. Maintaining compliance with federal regulations regarding the coding and billing of health care services to both public and private payors is a substantial challenge for many providers. The sanctions for violations can be substantial and criminal penalties may be invoked. Often well founded concerns over the quality of health care and the frequency of medical mistakes are becoming more prevalent in the media and are causing concern among providers, payors and the public. Recent articles in the media have drawn very unfavorable analogies comparing health care with high risk industries such as aviation and nuclear power. A recent report from the Institute of Medicine indicates an estimated 44,000 to 88,000 people die in hospitals each year as a result of preventable mistakes. This is the equivalent of an airliner crashing every day. The current managed care operating environment has put a severe squeeze on the revenue of health care providers. Many providers have seen their profitability evaporate and some are faced with either selling out to larger concerns that are more financially viable for the moment or ceasing operation entirely. Cuts in revenue are often tied to a decline in the quality of health care, further exacerbating the overall problems faced by health care. An additional quality and cost related issue is the focus of many large employers (the ultimate payors under private payment plans) on current health care financing and delivery systems. Employers are concerned about both the quality and cost of health care. The Big 3 automakers are reviewing whether all of the health care providers furnishing care to their employees and those of their suppliers (a significant segment of the consumers of health care services in many eastern and mid-western communities) need to be ISO 9000 registered as is required of the suppliers themselves. Liability insurance premiums are expected to increase dramatically over the next several months as property and casualty insurers raise rates in an effort to improve their profitability and make up for past losses. Given the underwriting process used by insurers, the providers with the worst track record in terms of quality (the highest loss costs for settlements, judgments, litigation and other expenses) will have their premiums increase the most, but all providers will be looking at an increase. Property and casualty premiums for all commercial concerns are expected to increase by a minimum of 25%. This additional cost increase will put even more pressure on providers' bottom line. Several Issues, One Solution When facilitated with the proper systems and procedures and with the review of a dedicated registrar, ISO 9000 can become the tool for managing all of these issues. Why? The root cause of problems in all of these areas is the lack of systems and procedures that drive the organization to quality and continuous improvement. Health care has historically relied upon intensive training of professionals and administrative staff and then punishing them when mistakes are made. Problems with this approach are as follows. There is an over reliance on personal behavior and not on systems. Aviation, nuclear energy and other high risk endeavors are all driven by systems and procedures that provide a check and balance on individual efforts. It is much easier to change a system than it is to change individual behaviors. Since reprimands are the end results with this system, the natural tendency is to fail to report problems and mistakes so that corrective action can be implemented to avoid their repetition in the future. It is impossible to construct systems and procedures to avoid mistakes in the future when no one will admit they occurred in the first place. Providers often tend to fear documenting problems or failures in that it will create legal liabilities for them. However, peer review statutes in all states provide a vehicle for creating an environment of continuous improvement in a privileged context so the process will not be admissible in evidence. It fails to recognize that many mistakes are not the failure of one person making a large mistake, but a convergence of small mistakes not readily foreseeable by any one person. Only systems and procedures which facilitate continuous improvement can avoid these types of problems. The majority of airliner crashes are the result of several small failures or one major failure in highly unusual circumstances. To avoid these problems, modern aircraft have redundancies in their design and construction and the pilots and maintenance crews rely on documented systems and procedures, checklists and manuals to assure a safe flight. As will be noted from the general discussion of ISO 9000, above, the whole thrust of the facilitation, registration and surveillance processes are to promote quality and excellence through defined, documented and communicated systems and procedures to reach the quality goals of the organization. In the context of a health care provider, ISO standards would require a provider to have documented systems and procedures to address its needs with respect to: Admission and registration of patients; Diagnosis, treatment and care, including the documentation thereof; Acquisition, storage and administration of pharmaceuticals and medical devices; Maintenance, storage, control and access to medical records, including maintenance of medical confidentiality; Handling, storage and disposal of medical or hazardous wastes; Patient emergency procedures; and, General health and safety for staff and patients, including infection control and immunizations. The process shouldn't stop there, however. Systems and procedures should be documented for all of the organization's activities, even those considered "administrative." All of these activities will have either a direct or indirect impact on a provider's quality and profitability. Examples are: Hiring, discipline, termination and related human resources functions; Licensing of professionals, including continuing education; Regulatory reporting; Public and private payor coding and billing; Building, systems and equipment acquisition and maintenance; External or natural emergency or disaster procedures, including disaster recovery; Acquisition, storage and use of non-medical supplies; and, Executive and financial management, including risk management and legal compliance. These are but a few examples of the systems and procedures that need to be defined, documented, communicated, enforced and continuously improved. An additional review of how these issues inter-relate can be found in the Risk Management Techniques for Health Care page and the Risk Management Chart following it. The documentation process for ISO 9000 registration is essentially the same as that used for Medicare-Medicaid compliance plan development and implementation. Additional Benefits of ISO 9000 Registration for Health Care Providers. In addition to the ability to improve quality and profitability as noted above, additional benefits of ISO 9000 as an alternative to JCAHO for health care providers are as follows: The ISO 9000 continuing internal and registrar surveillance audits are far less time consuming and intrusive than the traditional months of preparation for a JCAHO review. It is non-prescriptive, allowing providers to innovate and develop new best practices for the industry. Overall risk management is improved as noted in the Risk Management Techniques for Health Care page and the Risk Management Chart following it.
- Capability Maturity Model® (SW-CMM®) for Software The Capability Maturity Model for Software describes the principles and practices underlying software process maturity and is intended to help software organizations improve the maturity of their software processes in terms of an evolutionary path from ad hoc, chaotic processes to mature, disciplined software processes. The CMM is organized into five maturity levels: 1) Initial. The software process is characterized as ad hoc, and occasionally even chaotic. Few processes are defined, and success depends on individual effort and heroics. 2) Repeatable. Basic project management processes are established to track cost, schedule, and functionality. The necessary process discipline is in place to repeat earlier successes on projects with similar applications. 3) Defined. The software process for both management and engineering activities is documented, standardized, and integrated into a standard software process for the organization. All projects use an approved, tailored version of the organization's standard software process for developing and maintaining software. 4) Managed. Detailed measures of the software process and product quality are collected. Both the software process and products are quantitatively understood and controlled. 5) Optimizing. Continuous process improvement is enabled by quantitative feedback from the process and from piloting innovative ideas and technologies. Predictability, effectiveness, and control of an organization's software processes are believed to improve as the organization moves up these five levels. While not rigorous, the empirical evidence to date supports this belief. Except for Level 1, each maturity level is decomposed into several key process areas that indicate the areas an organization should focus on to improve its software process. The key process areas at Level 2 focus on the software project's concerns related to establishing basic project management controls. They are Requirements Management, Software Project Planning, Software Project Tracking and Oversight, Software Subcontract Management, Software Quality Assurance, and Software Configuration Management. The key process areas at Level 3 address both project and organizational issues, as the organization establishes an infrastructure that institutionalizes effective software engineering and management processes across all projects. They are Organization Process Focus, Organization Process Definition, Training Program, Integrated Software Management, Software Product Engineering, Intergroup Coordination, and Peer Reviews. The key process areas at Level 4 focus on establishing a quantitative understanding of both the software process and the software work products being built. They are Quantitative Process Management and Software Quality Management. The key process areas at Level 5 cover the issues that both the organization and the projects must address to implement continual, measurable software process improvement. They are Defect Prevention, Technology Change Management, and Process Change Management. Each key process area is described in terms of the key practices that contribute to satisfying its goals. The key practices describe the infrastructure and activities that contribute most to the effective implementation and institutionalization of the key process area. For a more detailed overview of the CMM, see: Mark C. Paulk, Bill Curtis, Mary Beth Chrissis, and Charles V. Weber, "Capability Maturity Model, Version 1.1," IEEE Software, Vol. 10, No. 4, July 1993, pp. 18-27. or the CMM itself. Version 1.1 of the CMM, which was released in 1993, is now available as a book: Carnegie Mellon University, Software Engineering Institute (Principal Contributors and Editors: Mark C. Paulk, Charles V. Weber, Bill Curtis, and Mary Beth Chrissis), The Capability Maturity Model: Guidelines for Improving the Software Process , ISBN 0-201-54664-7, Addison-Wesley Publishing Company, Reading, MA, 1995. For information on the benefits of CMM-based software process improvement, see: James Herbsleb, Anita Carleton, et al., "Benefits of CMM-Based Software Process Improvement: Initial Results," Software Engineering Institute, CMU/SEI-94-TR-13, August 1994. Patricia K. Lawlis, Robert M. Flowe, and James B. Thordahl, "A Correlational Study of the CMM and Software Development Performance," Crosstalk: The Journal of Defense Software Engineering, Vol. 8, No. 9, September 1995, pp. 21-25.
- Hippocratic Oath -- Modern Version I swear to fulfill, to the best of my ability and judgment, this covenant: I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow. I will apply, for the benefit of the sick, all measures which are required, avoiding those twin traps of overtreatment and therapeutic nihilism. I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug. I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery. I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God. I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick. I will prevent disease whenever I can, for prevention is preferable to cure. I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm. If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help. Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, and used in many medical schools today.