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.

“On the Eighth Day of ISO….”

“On the Eighth Day of ISO….”

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

My Management Rep. gave to me . . . . No significant changes!  This fact alone will make many people, primarily those in that actual patient care processes, very excited!  Currently, remember the Standard is not final, in the ISO 9001:2015 Standard in Section eight; Operations, there are limited changes to what is asked of an organization.  So rest at ease and enjoy the holiday season knowing that the Eight Maids a Milking will continue to Milk just as they always have.

However, there are the “Five Golden Rings” for operations that you may want to take a peek at before the holiday rush.

The planning of service provision will have precise requirements for implementation. The intent is to resolve the risks to an organization defined in section six of the Standard.  What we do as we implement our processes must now be inclusive of planning, and carrying out our processes to deter issues within the organization. (8.1) 

One unique change in determining the requirements related to patient service provision is a distinct call out for the organization to ensure they meet the defined requirement, and substantiate any claims they make for service provision.  I am not sure how this will shake out in the healthcare world, but organizations should begin to think about what they promise patients, in regards to the services they provide. (8.2.2)

The materials or purchasing process in the new standard is now inclusive of outsourced processes, just as if they were a supplier of any other stock item.  This means that the criteria for evaluation, selection, performance monitoring and re-evaluation apply to all product or service providers.  This goes even one step further in including suppliers that provide product or service directly to your patients on your behalf.  This is where those six geese might lay an egg that we are not fully prepared for.  So how do we deal with these six geese?  Here are the six eggs the ISO standard is asking you to communicate to “ANY” supplier: (8.4)

·         Product or Service we are purchasing

·         How said product or service is approved

·         Any qualification service providers need

·         Any interaction with the QMS that the vendor may need to control

·         How their performance is going to be monitored

·         Any onsite inspections/surveys the organization intends to perform at the vendors premise

Customer Property has now been expanded to include property of external providers.  Simply put, if we damage customer or vendor product we are responsible to let them know.  I would hold off on setting up any kind of processes to notify vendors of damaged product due to the fact that this may be one of those areas that may fall off in the final draft of the standard. (8.5.3)

I told you that there were no significant changes to operations, however, if you will recall in the 2008 Standard, Nonconforming Product was not a part of operations. It was included in the measuring, monitoring and improvement section of the Standard.  It has moved into the operations section and with one significant change.  Let me caution you as you read this next section not to get too scared, overwhelmed, excited or exacerbated.  This is a section that is going to cause a lot of discussion as to the intent and the expectations and implementation for the Standard is in a certified organization.  Let the dust settle and wait, wait, wait, for the final version to be released. Remember a bird in the hand is better than two in a pear tree.

Let me outline this for you so as to present clear understanding:

·         ISO 9001:2008            NCP required identification and segregation of bad product and                                        product means product.

·         ISO 9001:2008            NCP requires a record of the actions taken for nonconforming                                           product to be maintained but that was for product only.

                                   (1 Record)

·         ISO 9001:2008            Process failure was governed by 8.2.3 Measuring and Monitoring                                     of Processes and subsequently 8.5.2 Corrective Action.

                                   System failure was governed by 8.2.2 Internal Audits and                                                   subsequently 8.5.2 Corrective Action.

                                   Service failure was governed by customer complaints and                                                 subsequently 8.5.2 Corrective Action.

                                   These last three only required a record if the magnitude level                                      was such that formal and complete corrective action was                                                         determined to be necessary by the organization.

·         ISO 9001:2015            Is not only inclusive of all the requirements for nonconforming                                          “product” but is also inclusive of Nonconforming process                                                   outputs and Nonconforming services.

Here is where the new Standard is going to get all the ISO lords a leaping.  Question? “So does that mean that I have to have both a NCP records and a corrective action record for every nonconforming product?  Process Failure?  Process Performance Failure? Customer Complaint?  System Failure?   

The Answer is simple, but requires patience.  The answer; wait until the dust settles. Most likely there will be some significant changes and/or clarification to this portion.  If it were my QMS, I would not touch NCP or Corrective Action until I had the final “Gospel” version-gave to me. (8.7)