ISO 9001:2015

SO NOW THAT YOU FINALLY UNDERSTAND THE

9001:2008 STANDARD,

"LET'S CHANGE EVERYTHING"

As you have probably heard, the ISO 9001:2008 standard is being revised to the ISO 9001:2015 version. Now don't get too nervous! Although the changes are significant, when you see the modifications and improvements to the standard, I think you will be genuinely excited! Currently the new ISO standard is in Draft mode. The Final Draft will be published in September of 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.

Over the coming months, ICH will be spotlighting one clause of the new standard each month, providing a sample of what we anticipate in the new standard. We will be highlighting not only the significant changes but also what your organization can do to be prepared and ensure a smooth transition. ICH will be on the front lines with you to offer support for you in the trenches.

Along with these monthly articles, ICH will be offering, tools, whitepapers, webinars, seminars, training material and courses. Many of these will be available at no cost. So make it a point to follow our newsletters and  Visit our website for more information!  

See you in 2015!

ISO 9001 Tips and Advice-Magnitude Level

ISO 9001 Tips and Advice 

Magnitude Level

Twenty years ago when I first started out in ISO the president of the company I worked for made a very insightful evaluation of the ISO 9001 standard. He said, "For years my people have been making stupid mistakes over and over, but with our Corrective Action process now they have to get creative to mess up!" He had captured the essence of corrective action. It's okay to "mess up" it's not okay to repeat it.

The question remains, how do you create a corrective action system that works and not a system that you have to constantly work? The answer is Magnitude Level.

Customer Complaints (required):  
Any customer complaint above “X” dollars to the customer or our organization, any customer complaint resulting in injury to the customer, any complaint that is reoccurs “X” number of time within “X” time frame, any customer complaint that at the discretion of the Management Representative or Management Review team requires formal corrective action.
Magnitude levels can be both Objective and Subjective.
Process Performance (required):
Any goal or objective that falls out of acceptance criteria by less than 5% for less than or equal to two months requires correction.
Any goal or objective that falls out of acceptance criteria by less than 5% for more than two months requires formal corrective action.
Any goal or objective that falls out of acceptance criteria by more than 5% for one month requires formal corrective action.
Now you have a system that my organization can actually live with and will provide return on investment.
Woody
ISO Consultants for Healthcare 

Congratulations for Making Beckers' Top 100 Community Hospitals

Congratulations to the Hospitals below that we have had the pleasure of working with that have made the Beckers Top 100 Community Hospitals list.

Advocate Good Samaritan Hospital (Dowers Grove, Ill.)
Asante Rogue Regional Medical Center (Medford, Ore.)
Holland (Mich.) Hospital
Sentara RMH Medical Center (Harrisonburg, Va.)
Scottsdale (Ariz.) Healthcare Shea Medical Center
Sentara Williamsburg (Va.) Regional Medical Center
Sky Lakes Medical Center (Klamath Falls, Ore.)
St. Joseph's Hospital and Health Center (Syracuse, N.Y.).

Please Click here for the full story.

Keeping You UP to DATE:

Keeping You UP to DATE:

Based on the Press release from CMS.Gov: 

CMS Issues Proposed Hospital Inpatient Payment Regulation

The Centers for Medicare & Medicaid Services recently issued a proposed rule for 2015 that reduces payment for readmissions and hospital-acquired conditions. This proposed rule is intended to strengthen the tie between payment and quality improvement.

CMS said in an announcement that the aim of the proposed rule is to improve hospital performance while "creating an environment for improved Medicare beneficiary care and satisfaction." The agency proposes to increase the payment rate for inpatient stays at general acute care hospitals by 1.3 percent in fiscal year 2015.The rule describes how hospitals can comply with the Affordable Care Act's requirements to disclose charges for their services online or in response to a request, supporting price transparency for patients and the public.

Readmission reductions: Increase the maximum reduction in payments under the Hospital Readmissions Reduction Program from 2% to 3% in fiscal year 2015. The agency is also considering assessing hospitals a penalty if they use the five readmissions measures endorsed by the National Quality forum.

Value-based purchasing: Increase incentive payments to 1.5% of base operating diagnosis-related group payment amounts to all participating hospitals. CMS estimated the total amount available for value-based incentives will be $1.4 billion.

Hospital-acquired conditions: A 1% reduction in payments for hospitals scoring in the top quartile of these preventable conditions. CMS projects the HAC program has saved close to $25 million by reducing Medicare payments for these conditions.

CMS will accept comments on the proposed rule until June 30, 2014

Go to www.ICH-Global.com and visit the News page for details and more information links.

ISO 9001 Tips and Advice

ISO 9001 Tips and Advice 

 

After 20 years of auditing, consulting, teaching and explaining the simplicity of the ISO standard it still amazes me how complicated we make it. With that in mind, in each newsletter ICH will hopefully make the ISO standard just a little easier to understand and hopefully your Quality Management System a little easier to live with.

 

4.2.1 General

The quality management system documentation shall include.....

d) Documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

 

What does "determined by the organization to be necessary" mean? The organization needs a procedure on how to change a light bulb or get a bucket of water? Yes, it is a true story I have seen both of these. The question that begs to be asked is why did the organization determine these documents to be necessary? Did we hire individuals that are not competent for the above mentioned tasks?

 

Organizations have nursing standards rewritten in their entirety within the documents of the Quality Management System, when all they need to do is simply state within their quality management system that all nursing service follow Lippincott standards.  Nurses are trained to Lippincott standards during orientation periods. Nursing competency reviews are also based on these standards. The competencies themselves serve as the procedures and if a Nurse does not remember a procedure, simply utilize the charge nurse's standard copy for review.

 

Some facilities management services say, "We follow the NFPA codes". What really gets me is when they proceed to rewrite the standards word for word into their own hospital policies. Instead, state in their quality management system that all facility management services will follow the relevant version of the NFPA code. Then as both instructional for employees and evidence of compliance, develop facility checklists to reflect everything necessary from the NFPA codes.

 

Some organizations are certified to the ISO standard and meeting the requirements of the ISO standard for management review. Why-oh-why did they not just stop there? They wrote their quality manual to reflect the ISO standard word for word, specifically management review, and then wrote a management review procedure which again did nothing more than restate the ISO requirements for management review. Then they put together an agenda which mirrored the ISO standard. Lastly they developed a management review meeting minute's template that once again outlined the ISO standards requirements for management review. Stop killing the trees!! Simply follow the ISO standard and maintain the meeting minutes that show objective evidence of compliance.

 

It drives me insane when people will say that ISO is a "DOCUMENT MONSTER" and yet they do not realize that in many cases they themselves are "DR. FRANKENSTEIN"

 

Woody Conway

ICH Lead Trainer

RAB Certified Lead Auditor

Visit our website for more information!  

Keeping You Up to Date

Keeping You UP to DATE:

In the news: Healthcare Reform and the new Medicare reimbursements conditions have affected everyone in healthcare. Often people have asked why the changes? The article written by Bob Herman  April 14, 2014 for Becker's is based on the findings from a recent statistical brief showing the staggering effects of the costs of the ten top Medicare readmission conditions. Readmissions added $41.3 billion in hospital costs in 2011, and 58 percent of those costs stemmed from Medicare patients. Those findings come from an Association for Healthcare Research and Quality statistical brief, released this month. All told, Medicare patients represented 56 percent of all readmissions in 2011. Here are the costs of the 10 most common Medicare readmissions, according to the AHRQ brief. 1. Congestive heart failure - $1.75 billion (134,500 total readmissions) 2. Septicemia (except in labor) - $1.41 billion (92,900 total readmissions) 3. Pneumonia (except caused by tuberculosis or STDs) - $1.15 billion (88,800 total readmissions) 4. Chronic obstructive pulmonary disease and bronchiectasis - $924 million (77,900 total readmissions) 5. Cardiac dysrhythmias - $835 million (69,400 total readmissions) 6. Complication of device, implant or graft - $742 million (47,200 total readmissions) 7. Heart attack - $693 million (51,300 total readmissions) 8. Acute and unspecified renal failure - $683 million (53,500 total readmissions) 9. Urinary tract infections - $621 million (56,900 total readmissions) 10. Acute cerebrovascular disease - $568 million (45,800 total readmissions)

Announcing Client Support Specialists

ICH is moving forward. After working with hundreds of hospitals and thousands of staff, we are making some changes. Hospitals have asked for a simpler process for beginning and follow through of their implementation of ISO 9001 in healthcare. This can be achieved in less then six months when managed using the ICH proven implementation method, where 100% of all clients using ICH have been certified or deemed compliant. More information is available at www.ICH-Global.com . 

A Client Support Specialist program has been put in place. Every ICH client has a specialist assigned to ensure their needs are met. This specialist will be the hospital's "go to" person for all of their ISO 9001 training, consulting and auditing needs. The Specialist will follow the hospital from the beginning of the journey, through the surveys and certification (if they choose) and ultimately for continued support to ensure continual improvement!

ICH is very excited about the future of healthcare and hospitals and confident that ISO 9001 provides the framework for the solutions many seek to improve quality, while managing costs efficiently. Call ICH today to meet your personal Client Support Specialist!