The ISO 9001:2015 Champion

“The credit belongs to the man who is actually in the arena…”

Theodore Roosevelt

My heart goes out to those in the Management Representative roles within healthcare organizations.  Many of you have literally spent years getting your organizations to the point where they are just now comfortable with the ISO 9001:2008 standard, and wouldn’t you know it, someone kicks sand in your eyes. When you open your eyes again, you are confronted with a brand new standard.  You’ve paid your dues, trained your leadership staff, educated your management staff, communicated to employees and trained auditors. Now you can look back and finally say, “I’ve come through it!”  You’ve committed no crime and yet now that September 2015 is upon us and the inevitable release of ISO 9001:2015 looms on the horizon, I know what you’re thinking.  “I’ve served my sentence.” 

 I truly do feel your pain and am living through it with you, only a few months ahead of schedule.  I can imagine some of the questions that must be going through your mind.  “How do I get trained on this new standard?” “How do I train leadership, managers, employees and my auditors on this new standard?”  “How do I make this fit into my budget for 2016?”  “Where do I find the time not only for myself, but all of the other staff?”  “Where can I even get my hands on the new standard?”  If you are hyperventilating, take a deep breath and allow me to put a little perspective on what’s to come. 

Although the new standard has raised the bar on organizations wanting to set themselves above and beyond the competition, not everything has changed.  So what has stayed the same?  Many of the day to day operations of patient care and support processes have remained relatively unchanged.  Many of the performance requirements, for monitoring, measurement, analysis and improvement (although increased slightly at the foundation) remain true to the previous standard.  Internal audits are still required.  So in a nutshell, you don’t have to start from ground zero and go through the whole process again, and you don’t have to spend a fortune.

ICH has developed the ISO 9001:2015 Standard Overview Champion Course for those organizations who have already gone through the process of developing a quality management system to the requirements of the ISO 9001:2008 standard.  This course is designed to train the participants to a complete knowledge of the new and existing requirements of the new standard.  It is an excellent course for those Internal Auditors who are now very familiar with auditing and need to know what the new requirements bring to the organization and how to audit to the new requirements.  Are you looking to train yourself as the management representative/”ISO Champion”?  Do you need to bring your department managers up to speed on their role in the organization?  At ICH, we have specifically designed this course to be a compliment to what your organization already has in place.  The Champion Class is a very concise course over two days to give you and your entire organization the knowledge base they need to move forward in the development of their management system. 

I know that ISO 9001:2008 has not been a bed of roses or a pleasure cruise, but the good news is that you are not starting from scratch when you implement the revised version.  Consider the new standard a challenge and get started today.  If you don’t know where to start, give us a call. It is our passion and privilege to support hospitals on this journey.

Woody Conway

Value Based Purchasing Newsletter Article Part II

                           Better Care.  Smarter Spending.  Healthier People.

Paying for Value – Not Volume!

Whether you are a patient, a provider, a health plan or a taxpayer it is in our common interest to build a healthcare delivery system that is better, smarter and healthier – a system that delivers better care; a system that spends healthcare dollars more wisely; and a system that makes our communities healthier!  We must develop and implement better ways as a country to deliver care, pay providers and distribute information.

Improving the quality and affordability of care for all Americans has always been a pillar of the Affordable Care Act, alongside expanding access to such care.  The ACA provides an opportunity to shape healthcare delivery, improve the quality of care provided and reduce overall growth of healthcare costs.  Value and care-coordination will now be rewarded, rather than volume and care duplication.  The Department of Health and Human Services has established and communicated the benchmarks and metrics that will be used for accountability and drive the attainment of goals for Value Based Purchasing.

There are actually four categories that currently outline this new structure for payments to providers:

1.     Category One – fee-for-service with NO link of payment to quality.

2.     Category Two – fee-for-service with a link of payment to quality.

3.     Category Three – alternative payment models built on fee-for-service architecture.

4.     Category Four – population-based payment.

Value-based purchasing includes payments made in categories 2 thru 4, with the goal of moving the majority of encounters to the population-based payment group.  The goal is to increase accountability for both quality and total cost of the care provided.  At the end of 2014, an estimated 20 percent of Medicare reimbursements had shifted to categories 3 and 4. 

The Department of Health and Human Services has set a goal that by the end of 2016, 30 percent of all Medicare payments will be in categories 3 and 4, and that goal increases to 50 percent by the end of 2018.  Part of this will be accomplished by utilization of alternative payments models such as the medical home, bundling payments and utilization of Accountable Care Organizations. Ultimately the goal is that by the end of 2018, 90 percent of Medicare fee-for-service payments will be in categories 2 thru 4.  In these alternative payment models, providers are accountable for the quality and cost of care for the people and populations they serve moving away from the old way of doing things which amounted to “the more you do, the more you get paid”.

Let’s expand a bit on one of the alternative models.  In the Patient Centered Medical Home model, instead of physicians working in silos, separately, care coordinators oversee all the care a patient is getting.  This means patients are more likely to get the right tests and medications rather than getting duplicated tests, procedures, etc.  These medical homes typically offer patients access to a physician or other clinicians 24/7, and some may offer extended office hours.

According to the Secretary of the Department of Health and Human Services in a statement earlier this year, she stated the progress made thus far has saved taxpayers more than $116 billion. This savings translates in the ability of organizations to reduce expenditures and reinvest those dollars in higher quality care for their employees – wellness programs, for example.

America’s healthcare system is poised to move into its next phase – a coordinated, cost-efficient and quality driven system that promotes and supports individuals and community health.

New drivers have been implemented to foster these changes and next month we will share information on The Center for Medicare and Medicaid Innovation, Transforming Clinical Practices Initiative and the National Quality Strategy. 

Putting all the Pieces Together

It is our strong recommendation that organizations do not make changes to their quality management systems until the formal standard is released in 2015.

I love jigsaw puzzles.  Almost every vacation my family takes includes a brand new puzzle, which my family and I will spend the quiet moments assembling.  I have a confession to make; I steal the last piece long before the puzzle is ever done.  There is just something about bringing all the pieces together, that in and of themselves’ has no true image or meaning, but when combined make a beautiful picture.  The reality is that each of my children and my wife contribute to the masterpiece just as much as I, but as the family’s “TOP MANAGEMENT” person I get to put in the last piece. It probably wouldn’t surprise anyone that my children have begun to replicate the process of stealing a piece, so at the end there are six pieces missing and a battle ensues for the placement of that final piece.

In section 7 “Support” of the ISO 9001:2015 standard we see the same puzzle coming together to help present the organization in its best light.  The good news is that, as far as significant changes in implementation, there are few.  Infrastructure and Work Environment remain virtually unchanged.  If you are an ISO geek like me, you may have noticed the note in 7.1.4 that Environment can include physical, social, psychological, environmental and other factor.  Don’t get too excited about trying to maintain and control social and psychological factors at this point.  They tried to put this same language into the 2000 revision of the ISO standard, but it never made the cut.  I suspect that it will quickly disappear in this version as well.  

Calibration remains primarily the same with the exception of the defining characteristics of when an organization implements full and traceable calibration.  In the 2008 standard the deciding factor is, “Where necessary to ensure valid results…..” in the 2015 standard the factor is, “Where measurement traceability is: a statutory, regulatory, customer, interested party, or organizational requirement.”

Training and competency remains the same, although the 2015 standard has extended the language.  The new standard incorporates items such as the quality policy, relevant objects, etc., into this section called Organizational knowledge, Competence and Awareness.  

The very end of section 7 is where one would find the most significant change to the standard.  Document Control and Record Control no longer exist as two separate requirements, but have been combined into what the standard is calling “Documented Information”.  Don’t let this throw you off.  Here are a few clarifying notes, “a peak at the puzzle box” to help you put it all together.

1.      There are only two statements directing the organization as to what documented information needs to be controlled.  (ISO required & Organization Required)

2.      There is no formal requirement for a Quality Manual or the ISO 9001:2008 six required procedures.

3.      The only definitive (called out by name) requirement is for a Quality Policy and Quality Objectives.

4.      The term “documented information” has replaced “documented procedure” as the identifier as to when the requirements for the control of documents and records is to be implemented.

5.      All the requirements in section 7.5 “Documented Information” can be applied to either a Document or a Record, however, as you are reading this section you will see that section 7.5.1,2,&3 most closely resembles the old document control and section 7.5.3.2 most closely resembles the old record control.

As you read through the new standard and begin to turn the pieces over from the blank side to the picture side, I am confident that you will breathe a sigh of relief. Before your eyes the puzzle will begin to show a picture that the intent of the standard has not really changed much.  The box of pieces has been shuffled, but the picture on the box remains the same. 

What we must keep in mind is that there is just something about bringing all the pieces together, that in and of themselves’ has no true image or meaning, but when combined in the right place, makes a beautiful picture. Each member of your team will contribute and hopefully you will not have any “piece thieves” along the way. This puzzle will require all members of the “family” to work together in contributing to the final piece of the puzzle placement! 

Last Piece Thief

Woody

I Don’t Have a Clue Why Anyone Would Do ISO!

Over the last five years ISO 9001 has been whispered across the Healthcare Industry, as the latest

flavor in quality management and improvement.  Many healthcare professionals are asking the same question, “Why ISO?”  CEO’s, Nurse Executives, Quality Managers, Accreditation Directors and the like have had one common theme that recurs,  “With all these programs, regulations, standards, audits and quality tools, why are we still seeing the same problems again and again over the course of time?”  Audit after audit, tool after tool, program upon program end with the same results in the same fundamental problems or fires that the management team continues to try and put out.”  

The second question Healthcare Professionals ask is, “How is ISO going to change what the others haven’t accomplished?”  The answer is management has to stop putting out the fires of the past and install a sustainable system to identify and control fires before the smoke can be seen on the horizon. 

When an organization does not have a strong quality business management system supporting the activities and processes of their organization, top management has relegated themselves to putting out fires from the past.  One CEO stated, “The best thing about ISO is we have to get creative in current mistakes, because the issues/fires of the past are gone.”  Organizational committees, management oversight committees, executive councils and board of directors have found themselves comfortable in their role as fire fighters. What if we could install an early warning system when and where the fires were igniting?  What if we began to put the fire hose into the hands of our process owners to extinguish the fire before it requires involvement and resources from top management?

Initial implementation of ISO 9001 installs an early warning and control mechanism to ensure issues

within the organization no longer get out of control. They begin to place these early fire warning devices across their organization based on the risk and impact to the patient, to highly susceptible processes, potential financial loss or gain centers, and even areas where the organization may be in jeopardy of legal, statutory or regulatory findings.  One of the most exciting evolutions in this system is top management is no longer the only ones identifying fires.  The entire organization is tasked with sounding the alarm and the front line process owner is able to extinguish the flare up before top management ever arrives on the scene.  

In ISO language we call this top management responsibility for establishment of the quality management system, effective goals and objectives, corrective action and management review.  ISO drives an organization even further in the development of processes that can actually detect and extinguish fires (issues) before they even flare up.   

As an organization’s quality management system begins to mature, the natural growth is reflected in the organizations ability to install applications of control for all the past fires across the entire organization.  

Top management reports not only identify the issues and problems within the department, but also the

solution and application of control applied. This reporting would provide confidence that the issue will not reappear.  Instead of a fire brigade of a dozen (management team) now we have a virtual army of fire fighters.  In ISO language top management has established the goals and objectives of the organization.  Process or department managers now measure and monitor their process to do their part to see the organizational objectives are achieved.  This information is used on the department or process level to implement corrective action, analyze for future potential issues, and plan to eliminate fires of tomorrow. With the loss of top management’s firefighting duties, more time is available to lead the organization into the future. 

Finally a fully mature quality management system has reached the point where systems are set in place to identify current potential failures and the risks associated with them.  Top management now relies on their staff to firefight and they now look to the future for the success of the organization, not the maintenance of the organization.  The ISO standard in its fullest implementation is a system of risk (fire) identification, risk control, risk mitigation, risk prevention and risk preparation. 

Why do ISO?  Healthcare needs a sustainable system of risk management because healthcare inherently has great risk.