This is the first in a series looking at the motivations, methods and outcomes from our efforts at Charleston Area Medical Center (CAMC) to build a “best-in-class” patient centered quality management system (QMS) including accreditation via NIAHO/ISO 9001. These articles are designed to be quick reads, and capture the realities that we encountered in this quest.

1. Converting an Academic Medical Center to NIAHO/ISO 9001
Charleston Area Medical Center – A Case Study
Dr. Glen Crotty, Vicky Grate & Wes Chapman
September 29th, 2014
This is the first in a series looking at the motivations, methods and outcomes from our efforts at
Charleston Area Medical Center (CAMC) to build a “best-in-class” patient centered quality
management system (QMS) including accreditation via NIAHO/ISO 9001. These articles are
designed to be quick reads, and capture the realities that we encountered in this quest.
Buried in Documents
Identifying the Fundamental Problem
It began with two simple questions – how many policies and procedures do you have, and do you
actually train to them? These were both fair questions, were impossible to answer when we
started working together, and launched a major effort to streamline, simplify and make useful the
policies and procedures that defined all of the important aspects of care delivery and interaction
at Charleston Area Medical Center (CAMC).
CAMC - Background
Charleston Area Medical Center is a nonprofit, 908-bed, regional referral and academic medical
center with more than 6,000 employees. CAMC is made up of four hospitals and is home to one
of the largest heart programs in the United States; the only kidney transplant center in West
Virginia; the highest level trauma center; and the only freestanding children's hospital in the
state. All medical services are supported by primary care physicians throughout the region who
regularly treat their patients at CAMC hospitals or refer them to CAMC for specialty
consultation and treatment.

2. Like most large academic medical centers in the US, CAMC has been accredited through The
Joint Commission (TJC) and its predecessors since those organizations were given accreditation
power by CMS back in the 1960’s. Unlike many other centers, however, CAMC has had a long-term
commitment to the implementation and use of lean and six sigma (LSS) process
improvement tools and systems (for the last 8-10 years), and for the last 4-5 years has made a
major commitment to the Baldrige Criteria for Performance Excellence (Baldrige).
Tying together all of these quality efforts, we set the following high level goals for our entire
organization as part of our Baldrige efforts:
1) Best usage of our resources and elimination of waste,
2) A culture of employee involvement and engagement in solving problems and making
improvements,
3) Organized, efficient work areas that are maintained using visual management,
4) Standardized “best practice” processes to deliver consistent, top quality results, and
5) Increased satisfaction for staff, patients, and families.
Building an Efficient and Effective Quality System
From CAMC’s perspective, we built a three legged stool supporting our fundamental goal of
patient centered, clinical quality improvement: 1) TJC, controlling clinical operations,
documentation and training, 2) LSS, controlling process improvement, and 3) Baldrige, ensuring
integration of strategy and resources with continuous improvement.
Three Legged Stool Supporting Quality
The combination of LSS and Baldrige proved to be an effective platform for quality
development, and CAMC benefitted with continuous improvement in a broad spectrum of
quality improvement metrics, including Meaningful Use, the Value Based Purchasing initiative
through CMS and a broad spectrum of clinically specific accreditations and certifications.
Increasingly, however, the written process documentation – termed policies and procedures
(P&Ps) – required by TJC were proving to be material limitations on quality improvement.
We had documented a large number of clinical processes in a modern hierarchical system in our
EMR and through our LSS efforts. At CAMC, written process maps, and documented procedures
are critical components of medical care. Process maps and procedural documentation define
“best practices” and how care will be delivered in any clinical setting. This is critical to ensure
consistent patient care, and to facilitate efficient team work – minimizing waste. Policies are
guidance statements defining what we do and why we do it.

3. In most areas however, we were still dominated by a large, and clumsy set of P&Ps. As used
historically, P&Ps are an archaic construct, designed decades ago when medicine involved vastly
fewer procedures, offered fewer imaging and diagnostic tests, and the determination of best
practices was much less structured and timely. Additionally, computerized document control and
retrieval systems did not exist, and all documentation was maintained in departmental manuals to
facilitate ease of access. As care delivery systems became more complex, so did the documents
to define and support them – by 2013 we had a byzantine construct of over 150 manuals and
P&Ps numbering in the thousands.
Tied up in knots by archaic documents
Over the years, efforts to comply with the quality operating requirements of TJC resulted in first
more P&Ps, and then more manuals, and then both. The documents were inconsistent in design
and structure, impossibly long and complicated, redundant, contradictory and extremely difficult
to comply with, train to and maintain. The document system itself had become a major obstacle
to efficient operation, quality care delivery and continuous improvement. Something had to
change. We needed to simplify.

4. Simplicity is the Ultimate Sophistication
Leonardo da Vinci
Planning for Change
We set out with a simple project plan – filter the P&Ps in administration and nursing using 7-8
practical filters designed to determine need (looking at redundancy, contradictions etc.), rank
P&Ps according to risk according to 12 predetermined criteria, and then evaluate their
disposition. Using the pilot project as a “learning lab” then move forward based on what we had
learned, and what seemed to work.
In broad terms we set simple goals – reduce P&Ps by at least 25%, reduce total words by at least
50%, and use third party best practices where ever possible – such as the electronic version of
Lippincott’s Nursing Procedures. Finally, we set as an overall goal of having a set of P&Ps
capable of passing a “desktop audit within 12 months of starting the project.
Within the first six months we have “filtered and risk adjusted” all of our old P&Ps, and
earmarked well over 50% for retirement – through elimination, consolidation, and replacement
by third party standards. We are implementing a novel document maintenance, search and
retrieval system using a proprietary relational data base structure. This has allowed us to
maintain a good audit trail regarding document transitioning and retirement. We appear to be
well ahead of our initial goals of document reduction, and our simplification efforts should
dramatically improve document utility and value for training.

5. This has been much more intensive of senior management time then we had originally
anticipated, and this was the most noteworthy deviation from our original plan. This has proven
to be quite valuable, however, as the resulting simplicity should dramatically improve reporting
and shorten communication times. Anyway, that is what we are aiming for.
In the next article we will look more deeply at methods we are using, and surprises along the
way – and there have been quite a few.