Hello, Welcome back to Progress Notes - PRN.
In this issue,
A BUSY YEAR AHEAD by Eric Schulze


A busy year ahead...

This year DNV-GL will begin to survey hospitals to the new ISO 9001:2015 standard AND likely an updated NIAHO standard. NIAHO is in the process of being updated to meet the new CMS requirements as well as to stay in alignment with the ISO 9001:2015 revision.

Your survey schedule will likely play a role in how you are surveyed this year.

Most hospitals will probably be surveyed to include the new ISO 9001:2015 standard as part of their annual survey. The inclusion of the 2015 requirements are meant to provide you with a report documenting the non-conformances in your current state to the new standard. This is commonly referred to as a Stage 1 audit.

I will briefly explain a Stage 1 audit. The objective of the audit is to:

  • review your management system documentation,
  • confirm that a scope has been properly defined (expanded in the 2015 revision to include context and interested parties),
  • review your management system documentation to meet the new requirements,
  • determine the current state of implementation to the new requirements.

Naturally, some nonconformances are going to exist. In addition to the new leadership requirements, and risk-based thinking, exclusions are different in the 2015 standard. Most hospitals took an exclusion to 7.3 Design & Development in the 2008 revision, this blanket exclusion is not allowed in the 2015 revision. The new control is found in chapter 8 process control number 8.3.

We are going to write a blog providing some thoughts on how to begin using the 8.3 design and development controls in the 2015 standard. We will include it in the next Progress Notes - PRN and post the article in our blog page on the BlueSynergy website.

While the 9001:2015 standard is less prescriptive about required documents, the current NIAHO standard requires them, therefore we have to keep them all and hope that the next revision of NIAHO aligns with the 9001:2015 standard. As a general note, if there are other differences between ISO 9001:2015 and the current version of NIAHO, the most strict requirement is followed (i.e.- a Management Representative is still required unless NIAHO changes that in a future revision).

Hacking Medical Devices

In 2011, at a hacking convention known as Black Hat, a security researcher and insulin pump user demonstrated how he could remotely disable and modify his insulin pump over a wireless connection using inexpensive and readily available equipment(1). In 2012, another security researcher demonstrated how he could capture and reverse engineer wireless communication from an Implantable Cardioverter Defibrillator (ICD) and cause the device to deliver a lethal shock to the heart(2). Then this year another security researcher was able to connect to a commonly used infusion pump and alter the firmware (the software on the device that provides the rules for how it communicates with other hardware) which could give the hacker complete control of the device allowing an overdose to be given while disabling the alarm(3).


Public Training Course in Atlanta, GA.






ISO 9001 Internal Auditor (Exemplar Global) w/ Value-Added Auditing emphasis

ISO 9001 Internal Auditor (Exemplar Global) w/ Value-Added Auditing emphasis

ISO 9001 Internal Auditor (Exemplar Global) w/ Value-Added Auditing emphasis

Risk-based thinking in Healthcare

NIAHO integration and optimization

How do you move your hospital activities to a sustainable improvement platform?

Optimizing your accreditation - PRN

An accredited training course on:

  1. the ISO 9001:2015 standard
  2. NIAHO
  3. Cost of quality
  4. Performance improvement

Performance based auditing, Risk based thinking, and NIAHO optimization create a solid platform for your accreditation to show sustainable performance. As resources get tighter, this is quickly becoming a common perspective... accreditation should not be overhead. Figuring out how to make this rational move is the challenge. By maximizing your current accreditation requirements you can do just that!

To keep the momentum going after your class, you will receive (2) hours of FREE advising when you get back to your hospital so you don't experience the post training "blues". This is a limited time offer.

Question: How much value does your leadership see in all the reported data through management review?

We are conducting this 5 day class in Atlanta, GA.

Here is what you get for signing up this week:

Two (2) hours of free advising on how to best transition your system to ISO 9001:2015 (A $500 Value)

Register before Saturday, February 20th and receive your choice of one of these top ISO 9001:2015 best sellers (A $100 Value)

- "Value-Added Auditing, The standard Manual of Risk-Based, Process-Auditing” by Greg Hutchins OR

- “Risk-Based Thinking, CERM Academy Series on Enterprise Risk Management” by Greg Hutchins

HAC (Hospital-Acquired Conditions) Hospitals, call us to learn more about specials just for you

That’s a $600 package of assistance to help you fill the void of knowing “what" to do after you leave this course!

Coming to BlueSynergy in 2016

Here is a brief listing of what we will be sharing with you in 2016. We know that you'll enjoy these enhancements!

- BlueSynergy University: We will launch in the second quarter of 2016 our BlueSynergy University, or BSU! BSU will roll out in stages, beginning with on-demand videos, addressing topics you have been asking about for years! Stage 2 will roll out in late 2016 or 2017 and will include among others, employee certifications, orientation training and videos for your hospitals' use for new employees, etc. BSU will be a subscription service with some freebies early in it's release. BSU will be hosted on our BlueSynergy website.


- DNV-GL Corner: We'll take current hot issues related to your accreditation and discuss them further. We intend to provide clarity on these issues so that you can focus on doing your work. We will do the legwork for you and ensure that our discussions align to those at DNV-GL.

- Monthly Quality Tools: We will offer a monthly toolbox on how to effectively use certain quality tools to enhance your accreditation. This "how-to" section will contain tools ranging from problem-solving to risk-assessment to Cost of Quality.

- Healthcare Subject Matter Experts: We've enlisted healthcare professionals (clinicians and non-clinicians) who excel in many functions in your accreditation to offer their expert opinions. Who wouldn't want to know how to most effectively engage your medical staff or how to manage your Contracted Services more efficiently?

- Blog and Social Media Themes: We will offer even more information to you on a push/pull basis on topics that are relevant to you now! Our themes will be mostly quarterly, but may change as priorities change....for instance, we'll interrupt our regularly scheduled programming of Management reviews for updates on "Zika" Virus. LIke this, here's a link to the CDC website for information for healthcare workers.

We hope that you will enjoy these updates. Look for even more to come as we develop and prove some additional new innovative concepts! We want to be the valued resource for all of your accreditation questions...and beyond!

Webinar Training

FREE personal advising webinar promotion

We have 3 different webinar topics to help you transition to the new standard. Each are (1) hour in length and are limited to (5) attendees per session. FREE advising with these webinars.

  1. 2015 Transition planning
  2. Changes to the standard
  3. Risk - based thinking

FREE webinar on ISO 9001:2015

We are continuing to offer our complimentary webinar about the changes to the 2015 standard. Please click on the link to see the updated dates.

Do you have a group of people who can listen in a meeting room, just let us know, we have been able to schedule this webinar to accommodate group training.

Follow us on Social Media.

We engage in current conversation on topics that affect your hospital, patient safety, and risk-based thinking, all relevant and on point.

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BlueSynergy Associates LLC

8137 Autumn Ln Suite 100

West Chester, Ohio 45069