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. 

The Masters

“You don’t want to overanalyze or make it harder than it is.”

Michael Greller, caddie for 2015 Master’s Golf Champion Jordan Spieth

I came across this quote as I was reading all the great stories of the 2015 Master’s Golf tournament, and it struck me that this is my message in a nutshell to all those wonderful organizations that work so hard at making their facilities better.  You don’t want to overanalyze or make it harder than it is.  As with ISO 9001:2008, the 2015 version of the standard has already begun to cause anxiety among many of our clients.  Not to mention the many frustrations that come with the day to day implementation of an ISO program, such as the bogey of document control, the double bogey of good cause analysis for corrective action or the triple bogey of trying to maintain the internal audit process.  From our beginnings, ICH has strived to be the caddie not only for organizations wanting to shoot “par” as they prepare for accreditation and certification, but also for those organizations wanting to find themselves at the top of the leader board for performance and excellence.

Sometimes it amazes me when organizations find themselves with as many different audit programs as the back nine of any golf course.  And very often, they find themselves struggling just to complete the course of audits they have set in place.  We commonly see Environment of Care Audits, Infection Control Audits, Tracer Audits, Mock Audits, ISO Audits and the list goes on and on.  Is it any wonder that the organization quickly finds itself overwhelmed and 6 over par when the accreditation and certification surveyors arrive on site with their score cards?  As your caddie, ICH is offering you the best “driver” in our bag. 

The Master Surveyor Program

“The Birdie”:  Through the Master Surveyor Program, ICH will endeavor to raise the level of your auditing teams closer to that of a surveyor employed by a registrar or accreditation body, or that would be contracted for a Mock Survey.  ICH will train three clinicians, three generalists and three life safety specialists within your organization.  This provides the organization with three fully trained Mock Survey teams within your own organization to be mobilized at any given time.

“The Eagle”:  In raising the level of your auditing cadre, we anticipate that organizations that complete this course will find themselves to be very comfortable and accreditation ready when the surveyors arrive.            

“Double Eagle”:  Wow, wouldn’t it be great if we could combine all the audit programs within the organization down to one program?  No longer would a hospital have to navigate nine holes in the eleventh hour, just one.  ICH will customize a specific single audit program with your approval that will completely meet all regulatory requirements.  This one system will greatly reduce not only the number of man hours that are spent each and every year to maintain the system and report the results, but also the number of man days required for implementation of organizational audits.           

“Hole in One”:  Here is the best part, return on investment.  It is estimated that the average expenditure of all the audit programs within a healthcare organization is $150,000 dollars per year.  This is not difficult to imagine when you include internal training programs, external training programs, retraining due to attrition, salaries to do something besides primary responsibilities, maintenance of multiple programs, reporting, third party mock surveys and on and on and on.  Just imagine what the cost savings could reach.

If your audit programs have become more of a sand bunker than a putting green, ICH is offering you a sand wedge to help dig you out.

Woody “The Caddie” Conway

P.S. Thanks to my caddie, ICH Team Member Tracey Martin, for his expert assistance with golf references.

For more information, please visit ich-global.com or call 937-569-4134.

Avoid Titanic Failures with ISO 9001

Titanic Failures

             ISO 9001:2015 standard:ISO 2015 Life Preservers-On Sale Now!

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

White Star Line: Titanic

The story of the Titanic is amazing and great movie. So many things could and do go wrong and have such cataclysmic effects. When you look deeply into the story and history of the Titanic, the question surfaces, "What were they thinking?" Here are just a few of the things that went wrong some you may know, some you may find quite prophetic as you and your organization plan for the ISO 9001:2015 transition.

-Only 20 lifeboats.

-Compliant with code for a 10,000 ton ship, there was no documented code for a ship of 46,000 tons like the Titanic.

-There was only 6 - 7 hours of testing and never at any testing at top speed for maneuvering.

-Life safety training only involved lowering two life boats, giving an inaccurate time of evacuation.

-Binoculars and Searchlights were in short supply.

-State of the art Marconi wireless telegraph system had just a few people trained to operate and/or receive messages.

-There was a fire in the coal bunker that started just prior to the voyage and took several days to extinguish. It is believed the fire may have weakened part of the ship's hull, which aided in the sinking.

-Four cautionary warnings of ice were received between one to six hours prior to the collision.

So why all the statistics and the history lesson? It's in the history that we learn what mistakes not to make.

The ISO 9001:2015 standard has gone to great lengths to encourage an organization to take a long hard look at what the risks and opportunities are and then to proactively respond to them. Section 6 of the ISO standard ties all risk and opportunity assessments together into the planning process for mitigation or continual improvement. We can no longer only look within our organization for threats and opportunities for advancement; we must also look at the empirical data that surrounds our context for avenues of success.

The very first requirement of section 6, requires organizations to include issues (Risks and Opportunities) identified in 4.1, understanding the organization and its context and 4.2 needs and expectations, or interested parties in their quality management system planning. If you had been on the board of directors for the White Star Line, the creators of the Titanic, what would have gone into your planning process?

6.1.1 a) Would 6-7 hours of testing at partial speed given you the assurance that your organization could achieve its intended results? The assurance the ship would safely arrive?

6.1.1 b) Would 20 lifeboats although very much compliant with the "Codes and Standards" of the day, met your criteria to prevent, or reduce, undesired effects?

6.1.1 c) Would the revolutionary Marconi wireless telegraph system have shown evidence of achieving continual improvement?

What would you and your organization have done differently, given the opportunity? What would your strategic plan for success have addressed?

6.1.2 a) Would you have taken actions to address these risks and opportunities, maybe purchased a few more binoculars and search lights?

6.1.2 b) Would you have delayed the launch to integrate, implement and evaluate the effectiveness of the lifesaving protocols?

Any one singular action take to address the known risks would have either decreased the number of lives lost or could have potentially prevented the collision with the iceberg altogether. Section 6.1 closes out the section on Quality Management System Planning with a wonderfully freeing statement. "Actions taken to address risk and opportunities shall be proportionate to the potential impact on the conformity of products and service".

You may feel your organization is just waiting for an iceberg to come floating along and all is lost. However, all is not lost, yet; can you take just one small step today? Start by identifying the biggest risk and begin to address it. Find the easiest risk to correct and address it.

Prior to the voyage, if the Titanic had adequate equipment and supplies, proper testing and training, cautionary warnings heeded and safety plans practiced, many lives could have been saved. If the voyage had been delayed to extinguish the fire in the coal bunker of the Titanic, the great movie may have had a much different ending!

The ISO 9001:2015 standard is only asking you to assess and address those things that could sink you and your organization, to ensure a desired ending.

ISO 2015 Life Preservers-On Sale Now
Woody Conway, ICH Lead Trainer
RABQSA Certified Lead Auditor

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.