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.

“A Deeper Dive: ISO 9001:2015”

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

As a certified diver, there is probably nothing more satisfying and thrilling than seeing all of your training and preparation pay off as you gently glide through the water with harbor seals and sea lion pups frolicking and dancing around you, begging you to play.  As a father of three certified divers and being obsessively compulsive about their safety, getting to the play portion can only come after the safety portion.  I have personally sat through the training program three times when each of my sons became old enough to enter this whole new world of adventure, and therefore I feel that I have earned the right to be in charge of all the rules.  As we in the ISO family begin this brand new adventure into an uncharted world, I can’t help but make some simple connections between ISO and SCUBA.

Before each and every dive there are some safety protocols that each and every “good” diver should go through.  As a diver, you Begin With Review and Friends (BWRF).  This acronym stands for each of the safety checks that you and your buddy check out on each other’s equipment before each dive to ensure a successful dive.  “B” stands for BCD, or your Buoyancy Control Device. Does your flotation device work?  “W” stands for weights. Can you and your buddy easily remove the weights in the event of an emergency and get to the surface?  “R” stands for regulator. Does your breathing device work? No explanation needed.  “F” stands for a final once over for all the gear that will be going down with you to make sure that nothing is tangled, loose, missing, or defective.  You don’t want to get to the bottom and find out something isn’t right.

For our adventure into the deeper and uncharted waters of the ISO 9001:2015 Standard, I want to encourage you to use the same acronym but with a little twist on Begin With Review and Friends, “BWRF”.    “B” stands for Base.  What you have already put in place with your ISO 9001:2008 standard will become the base of your 2015 program.  Do not think that you have to go and start all over again.  You do not have to recreate the wheel.  You would think that this is common knowledge; however, I have already been approached by organizations to help them redo what has already been determined to be effective, efficient and compliant with both the 2008 & 2015 Standard.  In each of the coming months as we discuss how to actually begin to implement the new standard, we will always start with what 2008 has given you as a base before we begin building what 2015 is asking for.

“W” stands for “Woody is right!” Just Kidding?

“W” stands for What.  What does the new ISO 9001:2015 standard actually require?  Already, we have received questions from clients that indicate that people and organizations are beginning to read into the standard requirements that simply are not stated in the standard, but are being drawn out by interpretations.  This can result in far more complex, restrictive and overbearing management systems that in time may prove to be so cumbersome that the organization fails to realize the return on investment for their efforts.  As we journey through the ISO standard, we will take just a few statements to clarify exactly what the standard is saying and what it is not saying.  Hopefully this will keep organizations from getting too deep without enough air to support themselves.

“R” stands for Reason.  Reason will have a twofold purpose in our coming articles.  The first purpose will be an explanation as to some of the reasons why the ISO 2015 standard is requiring what they are requiring. The second and most important purpose will be a clear, concise and logical approach to achieving the requirement.  Many times organization will put in place multiple control features to ensure compliance in every possible scenario at the expense of time, resources, money and much frustration and anxiety.  ICH hopes to bring to the table implementation ideas and concepts that will help your organization fulfill the new requirements without overtaxing the organization and its resources.

“F” stands for Final.  When we say final, we want to ensure that organizations do not put anything in place that is not a good business practice...that if implemented and not a final requirement of the ISO 9001:2015 Standard, would not in any way negatively impact the organization.   With that being said, the final sections of each of the following news articles will focus on where organizations can begin to implement the new standard and not be at risk of putting an unnecessary activity or process in place that is not beneficial to the organization.  We will offer suggestions for user friendly methodologies for compliance.  We will suggest multiple possibilities as to where the organization can use systems that are already in place for compliance.  We will recommend best practices that have been identified across the country in the healthcare industry.  We will do our very best to make this transition to the new standard as painless as possible. And as always, we will be there to lend a helping hand or be a sounding board for any of your questions.

Who’s ready to Dive Deeper?  Next month we cover Management Review and Risk Control.

In over my head and loving it,

“W”