Cover Story

CONTINUING EDUCATION
To earn CEUs, see current test at
www.mlo-online.com
under the CE Tests tab. The CE test covers only “Weaving a web of
excellence through staff development and training.”
LEARNING OBJECTIVES
Upon completion of this article, the reader will be able to:
- Discuss traditional assumptions that have served as barriers in learning and teaching.
- List and discuss the three phases of educational experience.
- Describe the cognitive web and its implication for training.
- Differentiate among four domains in educational planning and implementation.
- Discuss setting and training formats to include implementing a learning strategy and ways of achieving a corporate web of excellence.
Weaving a web of excellence through staff development and training
By David Loughmiller, MBA, MT(ASCP) SC,
and Douglas Godwin, PhD
David Hornbeck, in sharing a challenge faced by his
laboratory at Suburban Hospital in Bethesda, MD, addresses a problem
confronting many labs today — internal attrition as baby boomers enter
retirement. The challenge led Suburban to acquire expensive equipment to
further automate the testing process. Yet, with the purchases, there
remains a substantial shortfall in professional expertise to meet the
demands placed on that laboratory. Hornbeck indicates, "While Suburban
Hospital’s laboratory has invested and will continue to invest in
technology to aid in meeting testing demand, administration sees
continuous staff development as the next horizon. As baby boomers
retire, an experience and knowledge void is being created. To help fill
the voids left by the boomers, Suburban has added two positions to
assist in keeping the staff trained on a continuous basis. The newest
administrative positions are the quality coordinator and educational
trainer/professional staff development coordinator …. Suburban’s hope is
that these new positions will deliver the education level needed to
continue to provide the tech-savvy technologists that the hospital and
lab require as well as retain those who have already reached that
level."1
A broader problem
Suburban Hospital’s challenges represent a microcosm
of those being confronted throughout laboratory medicine. Laura Landro
of The Wall Street Journal, in explaining the nature of the
deficit, quotes Michael Laposata, Vanderbilt’s head pathologist in
Nashville, TN. He indicates that labs of smaller hospitals around the
nation are insufficiently staffed to meet any serious epidemic, let
alone a threat of a potential pandemic like the influenza A/H1N1.
Vanderbilt itself has periodically required double shifts and shuffled
hospital staff to meet lab responsibilities. Landro expands on the
problem by pointing out, "While the United States is currently
experiencing a shortage of medical technologists, as well as virtually
all other healthcare professionals, student enrollment in MT programs is
steadily declining. Universities — University of Wisconsin-Madison being
the latest — have cut budgets for Clinical Lab Science programs or
closed them.2
The problem is two-dimensional — addressing attrition
while maintaining competency among the entire staff as new complex
technologies emerge in medical testing. Growing an atmosphere of
excellence remains an ongoing challenge for laboratories across the
country and training has served as a vital strategy for addressing this
in many quarters.3 This article focuses on training that
occurs to meet educational demands in the laboratory setting.
Understanding the training process
Everyone assumes that we all understand that
recurrent term — training. In the world of training, the product we
obtain depends on the delivery system we employ. Uninformed choices
often result in distorted, costly results, different from our intended
target. Part of the dilemma is that most laboratory trainers
understandably come from within the field, profiting from education and
experience of trainers steeped in the science of laboratory technology.
Assigning a trainer involves a fresh field of inquiry
— understanding learning and educational theory. It addresses two
questions:
- How do individuals learn?
- What teaching strategies best bring about
learning?
Research in brain development and the ensuing
principles of learning conducted over the past 40 years invalidated many
old assumptions about how individuals learn and develop. Discoveries in
neurology, new pedagogical strategies (teaching methodologies), and
revisions of traditional methodology have helped reveal the processes by
which ideas are linked together in the development of human
understanding. Without knowledge of these emerging insights, laboratory
trainers are left with antiquated training approaches with which to face
the growing complexity of technology in the field. Here is a brief
introduction to new training knowledge and a number of approaches for
implementing it.
Traditional assumptions as barriers
The first problem in training lies in the assumptions
about learning and teaching, most of which come from the way the
trainers were educated — many ways that did not work well. Such
suppositions affect the educational events that trainers plan and often
leave them wondering why their implementation fell short.
Barrier 1: One of the most common barriers to
effective training involves the way goals are set. The tendency has been
to focus on processes rather than outcomes. The purpose in all education
is to evoke change in students, not merely expose them to
experiences. Experiences are of value only to the degree that they
create a transformation. An appraisal of the outcomes should be the
criteria for measuring training effectiveness. The questions to be
addressed are:
- What is the end product we desire in our
trainees?
- What educational methods will best get them
there?
Focusing on processes is more than a casual barrier
and serves as one of the most deceptive practices in education, assuming
several forms. Exposing participants to educational material does not
serve as education. It is not uncommon for a trainee to be handed a
manual or article with the commission to study it and prepare for an
assessment. The assumption is that exposure equals growth. This spawns
rote memorization of facts, which knowledge dissipates soon after the
exam.
Barrier 2: The first barrier leads us to a
second assumption: If we, as trainers, covered the material, education
has occurred. We planned it and then taught it. We, therefore, have
trained our people. This pretext satisfies our curriculum planning and
our record keeping but often leaves the professional development we
desire lacking. Yet, professional growth — for which we have made a
substantial financial investment — is what we wish to accomplish. We
must think through our standards, phrasing them appropriately, and then
create the kinds of experiences that guide trainees to effectively meet
those standards.
Barrier 3: Current training procedures most
frequently overlook a variable that parallels an old axiom: How
you say it is more important than what you have to say.
Curriculum covers what needs to be said; it speaks to the content of
training. Pedagogy addresses how it will be both delivered and
learned. Learning is the paramount variable in the formula and is
dependent on how we say it. For transformation to occur,
motivation must be factored into the equation. Active interest directly
impacts the professional development we desire.
The three phases of education
Four decades of neurological research of educational
practice provided rich insights into how humans learn and develop. This
information stimulated a re-examination of teaching and instructional
theory, resulting in new and innovative ways of bringing about change in
human experience. Many of these have direct application to the medical
laboratory and serve as resources for leaders responsible for needed
change.
Another old idea is to inform people is to
educate them. To challenge this premise, Minzey points out that
there are three phases of education that unfold somewhat in sequence; 1)
conversion,
2) information, and 3) application.4
Conversion: Before an idea makes sense to us
and we weave what is being taught into our value system, we must first
understand it, buy into why it is important, and discover how it fits
our needs. As we begin to identify with the concept, we go through a
conversional process. Pure information does not ensure our conversion.
We all are somewhat informed about ideas to which we do not subscribe.
Knowledge alone has not persuaded us, and new information is ignored.
Being informed alone seldom does the job. We must first be persuaded not
by manipulation but by application of the principles of
positive influence.
Implications for training: Training
events in the conversional phase should spur interest and motivation by
including convincing elements and language. Helping staff see the "whys"
of practice and policy tends to ease the needed transitions. Activities
that allow participants to express themselves and share their attitudes
about and insights into the material are meaningful tools in generating
interest and motivation. The professional term is "establishing a
mindset" as educators help participants discover the value and
importance of the concepts. Conversion morphs schooling into education.
Information: Once converted, personal
motivation drives the experience, and participants are ready to be
informed and have a felt need for added comprehension. This phase
encompasses the conceptual and theoretical level of understanding and
performance. Now, information makes sense, and the learner merges it
into his present understanding.
Implications for training: Educational
experiences need to be equally motivational. How information is to be
gained requires careful consideration. Traditionally, lecture has been
the method of choice to relay information. Remember those late night
study sessions involving panicked memorization, creating mnemonic
devices, and intensive cramming? Students then came to an exam with
their heads full of facts and, once emptied, their minds were left void.
The only "education" they got was honing their survival skills.
Educational experiences that help participants link ideas together are
quite different from teaching designed to fill the mind.
Application: Putting ideas into action often
involves the development of a set of both skills and habits that are
embedded in the theoretical knowledge just learned. As the conceptual
level is laid down, participants become ready for skill acquisition and
application.
Implications for training: Skills
should not be taught in isolation but should be linked to the cognitive
framework that precedes them. It should be noted that training in skill
development requires focused, accurate repetition of techniques to guard
against using bad habits. Skills tend to be enhanced most efficiently
when outcomes are rewarded or recognized. Team training can be an
effective arena for skill development.
Conclusions: These three phases of experience
— conversion, information, and application — create a sound foundation
upon which other training strategies are fashioned. Effective training
procedures address all three levels of learning and development to serve
as an important base for the curriculum to follow.
Current brain theory and the nature of thought
The cognitive web:
Ideas do not exist in isolation but are linked together in mental
structures "cognitive webs" in psychology. Any idea externally or
internally generated gets woven together, as in a web, in the mind with
already existing related concepts. Chose a common laboratory test as the
central concept — troponin analysis (see Figure 1A). The concept of a
lab test is a function requiring specific actions. Usually when the
thought involves an activity, the mind begins to classify events that
follow. So, the first generation of sub-concepts becomes the three
stages of the analysis (see Figure 2B). Depending on the individual
learner, a mental image of the molecule, the setting in which the test
is conducted, the function of troponin in cardiovascular contractions, a
specific piece of equipment needed, or related chemicals would be among
the first level of supporting concepts. A second level of concepts
cluster around the main idea (i.e., for Preanalytical from left
to right: orders, collection, patient compliance, clinical history,
timing [see Figure 1C]). Each level adds more sub-concepts that help
form a learner’s understanding as it relates to the central idea of
troponin analysis, but all levels relate to the original concept. Each
second-, third-, and fourth-generation idea, in turn, can become a "web"
of related concepts of its own. Each item at any level in the map ties
to other ideas within the infrastructure and outside of this cognitive
web.
Implications for training: To develop
mental structures in training sessions, the trainer guides a discussion
in which members of the group make contributions to the formation of a
web. The process unfolds under the direction of a trainer, and learners
are exposed to the instructor’s cognitive web, which overlays their
experience (see Figure 1D).
Planning and implementing experiences for growth
What is the end product we desire in our trainees?
How does a laboratory trainer get a handle on the development desired in
the staff? How does a lab trainer transcend passing on the mere
documentation of the profession that so often leads to "minimums" in
meeting standards? There are four domains that should be considered in
planning and implementation:
- 1) knowledge — the conceptual framework of
understanding to be developed;
- 2) affect — the affective domain;
- 3) developmental requirements; and
- 4) the skill base to be mastered (see Figure 1D).
- Each domain should build upon the three phases of education.
Figure 1A-D: Demonstration of how the cognitive web stages work in laboratory science.
Click to enlarge image
The conceptual framework of understanding:
The curriculum content of the first domain involves an understanding of
theory, concepts, patterns, analyses, and contexts related to the
subject. These are woven together within cognitive webs created around
that content. While curricular essentials are most often laid out by the
standards of the profession and in the pre-service preparation of the
professional, usually every student has some understanding of the
material prior to a session. Each participant brings his own cognitive
web to the training setting, and the instructor will enrich that
knowledge base.
Implications for training: Learning
experiences should include both individual and team activities. The
instructor’s role is to both mentor and facilitate the learning process.
The methodology through which knowledge is gained is critical. The
instructor should carefully plan questions to ask his students.
Excellent phrases for formulating appropriate questions include:
- What is the implication of _____?
- How does _____ relate to _____?
- What is the connection between _____ and _____.
- How does it work?
- Relate what you have said to _____.
- Explain the dynamics of ____.
As with previous strategies, providing trainee’s
opportunities for expression, processing information, and analyzing
scenarios under supervision are important developmental activities.
The affective domain: This dimension explores
values, attitudes, perceptions, habits, norms, and related social
relationships, which form the essence of who we are, thus making this
second domain of critical value in training. Trainers explore these
attributes as they relate to professional roles their trainees play out
in the lab. These attributes combine to drive motivation in
participants, again a key ingredient in professionalism. Once motivation
becomes intrinsic, the laboratorian will work from personal and
professional ambition rather than from the standpoint of simply "having
a job."
Implications for training: Since the
affective domain addresses dimensions of personality, interpersonal
instructional strategies are important. Because the dynamics of the
affective domain function in the workplace by design or default, the
effectiveness of the lab is enhanced when these forces are accounted for
in planning and training. Training-event planning begins by considering
those dimensions: attitudes, values, perceptions, and other elements
found in a productive, successful laboratory environment.
"Teaming" methodology is critical to the affective
domain. The give-and-take of group activity enhances "people skills" —
when properly facilitated by the leadership — interweaving with the
learners’ technical competency to enrich professional performance. Group
experiences should provide opportunities for sharing views and opinions,
which leads to professional bonding that builds corporate culture. Such
exchanges also allow participants to realign their values and
perceptions.
Additionally, each individual’s need for status
should be facilitated in these sessions; therefore, the leadership
methods needed for this sphere are mentoring, coaching, facilitating,
analyzing, demonstrating, and modeling.
The developmental (psychomotor) domain: By
definition, this domain involves those characteristics that are produced
by natural physiological development: nature more than nurture. In the
lab, the developmental domain means addressing activities involving
hand-eye coordination. Pipetting, pouring, and other close manipulative
work are among the skills that are required. Refining these traits often
requires practice.
The skill domain: Skills emerge from the
other three domains. Cognitive skills such as analysis, synthesis,
observation, problem solving, and both inductive and deductive reasoning
are interwoven with inter- and intra-personal skills of the affective
domain, along with those of the developmental domain, collectively
meeting the demands of professional standards.
Implications for training: Skill
development requires special attention in planning. Since skill
acquisition is a personal achievement for each laboratorian, the
one-on-one instructional strategies of mentoring, coaching, observing,
demonstrating, modeling, and peer teaching tend to be most effective.
Normal interaction in the lab usually provides many mentoring
opportunities for leaders.
Conclusions: Utilizing these four domains for
both curriculum and teaching planning provides a laboratory trainer with
a framework for 1) clarifying and formulating the specific standards
being addressed; 2) establishing the conceptual, affective,
developmental, and skill acquisition desired; and 3) creating
educational strategies by which students will gain these four dimensions
of learning and change.
Settings and training formats
For different elements of the training experience,
trainers need an overlap in talent. While certain learning strategies
are facilitated better in some formats more than others, there remains
that "web" of mental activity among all formats of learning.
The training arena: Whether at the university
or in the workplace, training environments may bring to mind the
classroom, the conference room, and/or the lab, although the first two,
unfortunately, have been used more for lecture than any other strategy.
The rule of thumb in teaching/learning is to plan the routines that
achieves the type of transformation we seek in participants, then modify
the environment accordingly. For example, when employing teaming tasks,
a classroom may be divided into sections by round tables or clustering
chairs in circles. These simple approaches enable individual
participation, allow leadership to emerge within groups, and provide
cross-fertilization of thought and insight.
Implementing a learning strategy: Brief
lectures have contributions to make but should not play center stage in
the training process. When used, lecture should be followed with a
number of interactive strategies addressing concepts, vocabulary, and/or
skills. For example, when employing a "cycle of learning" strategy,
lecture and teaming methods are rotated. It begins when new concepts,
attitudes and/or skills are shared with the entire group. Learners are
then divided into clusters with specific assignments to complete.
The first task in each group is to choose a leader.
The instructor might encourage discussion, demonstration, analyses and
problem solving within each cluster. The instructor and assistants
rotate among groups to facilitate the process. The full group is then
reconvened, each team reporting on its discussion. This session is
opened for comments from all participants. The teams are then
reassembled for the next level of assigned tasks and ideas. At a
designated time, the full group is gathered for a final analysis. This
is known as spiral curriculum, as each phase of the cycle raises the
sophistication of both performance and comprehension. As with each
format, planning for this strategy is guided by an awareness of the
educational principles appropriate to the venue.

Figure 2: The four dimensions of educational planning and implementation.
Informal settings: By mating emphasis with
redundancy, informal events are equally critical in effective training —
many times, more so. Interpersonal coaching emerges in the teachable
moments of the office, at lunch, during breaks, in lab activities, and
during team experiences, building competency among lab associates one
event at a time.
The training of trainers: The acquisition of
training skills for laboratory leadership can be obtained through
educational and consulting experiences, which serve leaders in both line
authority and directors of laboratory training. Each position plays a
key role in the educational process in the laboratory, and receiving
training as a pair is the optimum format. Once acquired, educational
skills tend to be disseminated throughout the laboratory over time.
Building and maintaining a corporate web of excellence
Corporate culture as a training venue:
A number of settings and training formats can be part of the educational
process in a laboratory. The ultimate training component for a highly
proficient, successful laboratory, however, is more than a bevy of
training experiences. It is the social structure of the laboratory
environment itself. It is the standard of excellence the lab has set for
itself and the means by which all staff become committed and trained
toward that end.
Leadership from which high standards are suggested to
the staff is where training for the corporate venue begins. These are
not top-down mandates but rather points of introduction to a set of
stakeholders who will, in turn, provide input, discussion, and
recommendations. Standards set by a group are owned by the group. The
use of conversional methodology assumes the form of team-building and
the establishment or enhancement of corporate culture producing
meaningful input from both the bottom up and top down and unifying its
people into a cohesive, integrated workforce.5
This is conversion in action,
which invites an investment into the idea.
The maintenance of success: Effectively
integrate all new employees into the network in order to avoid dips in
competency and commitment due to attrition. Assuming an attitude of
"stakeholder" does not come automatically for new staff, and both
mentoring and coaching are important strategies in helping each person
become an effective part of the team. It is vital that recent hires gain
ownership of corporate values with the expectation that they will have
ongoing input.
The shared focus of training: The ultimate
objective of the laboratory is to provide a synergistic collaboration
that produces a gestalt — the whole is greater than the sum of its
parts. Such teamwork forms a web of excellence that guides the
professionalism of the lab and improves the service it provides its
clientele.
David Loughmiller, MBA, MT(ASCP) SC,
is CEO of Scepter Media and Training, LLC, in St. George, UT, and
currently provides consulting services for the Fifth District Court of
Utah, interpreting drug testing and providing expert testimony.
Douglas
Godwin, PhD, is
Scepter’s vice president of R&D, and has published numerous curriculum
documents, as well as technical and training manuals. The authors can be
reached via
dloughmiller485@gmail.com .
References
- Hornbeck D. Boomers change the medical landscape.
MLO. 2009;41(7):51-52.
- Landro L. Lab retirees now make up a portion of
"boomer consumer" statistics. MLO. 2009;41(7):51-52.
- O’Neal S. On the job training: should it stay or
go? ADVANCE for Medical Laboratory Professionals,
2008;20(11):8.
- Minzey J. The three phases of education. Keynote
address presented at The National Community Education Program,
October 1970, Phoenix, AZ.
- Stewart TA, Raman AP. Lessons from Toyota’s long
drive: a conversation with Katsuaki Watanabe. Harvard Business
Review. 2007;85(7,8):74-83. Retrieved from ABI/INFORM Global.
(Document ID: 1296061291). Accessed March 20, 2010.

The work of laboratory professionals is described best by an anonymous quote I have admired for many years: “Every job is a self-portrait of the person who does it.” As professionals, we autograph our work with excellence. We are unequivocally top-notch in the contributions we are routinely able to make to patient care. Thanks to one and all!
—Sharon M. Miller, PhC, MT(ASCP), CLS(NCA),
Professor Emerita, Clinical Laboratory Sciences,
College of Health and Human Sciences,
Northern Illinois University, DeKalb, IL
Update on lab regulatory preparedness for inspections
Kirsten Cowan
By Kirsten Cowan
The landscape of laboratory regulations is continually
changing. For example, major accreditation agencies are making changes
in how they do inspections or in the stringency of their requirements.
The move to unannounced inspections, in particular, has had long-ranging
effects on how labs conduct their quality-management programs and their
operations in general. Other labs find that as they build their volume
of outreach work in other states, they now undergo inspections from
those states’ regulatory agencies. Another big change is the adoption of
ISO 15189 accreditation: more clinical labs in the U.S. are following
the lead of their international counterparts and are exploring what it
takes to prepare for ISO 15189 inspections.
All of these changes point to the need for more
thoughtful, adaptive preparations for regulatory inspections. In the
words of Lab Director Roberta Provencal, "unannounced CAP and AABB
inspections keep us in a state of readiness 365 days a year." We asked
Ms. Provencal of Catholic Medical Center (CMC) in Manchester, NH, how
labs like hers have changed the way they do things to answer to the need
for constant preparedness. For another perspective, especially on making
the change to ISO 15189 inspection preparedness, we also talked to
Bonnie Van Schoik (director of Laboratory Services) and Doug Hughes (LIS
coordinator), both of Blanchard Valley Hospital in Findlay, OH.
Kirsten Cowan: Tell us some quick facts about your
lab.
Roberta Provencal
Roberta Provencal: CMC is a
community hospital with 330 licensed beds; our lab-test volume is about
45% inpatient; and 55% outpatient including outreach. We are a
full-service laboratory with lines of automation to include
preanalytical, hematology, and chemistry. CMC lab services used to be
contracted out to LabCorp but came back under the hospital in 2007. We
moved into a new clinical lab facility on the main level of the hospital
last year, and we just opened pathology services in a new LEAN facility
in January 2010, after being contracted off-site for 11 years.
Bonnie Van Schoik: The
laboratory at Blanchard Valley Hospital is a full-service laboratory
performing more than 500,000 billable procedures annually. Our facility
supports a Level III trauma emergency department as well as an
open-heart surgery service. We were the third laboratory in the nation
to become accredited to the College of American Pathologists (CAP) ISO
15189 standard.
Cowan: What regulatory inspections does your lab
undergo?
Bonnie Van Schoik
Van Schoik:[In addition to
ISO 15189], we are accredited by AABB, CAP, and our hospital is a Joint
Commission-accredited facility.
Provencal: [We are
inspected by] AABB, CAP, and the state of New Hampshire.
Cowan: Describe some of the lab’s operations that are
most directly involved in regulatory compliance.
Provencal: [Some of the
areas involved are] document control; our quality-management (QM)
program, which includes quarterly QM meetings; an annual quality plan;
and quality-plan annual appraisals. We also have 15 quality-improvement
indicators in process currently, and we monitor 35+ quality-assurance
indicators.
Doug Hughes
Doug Hughes: Our laboratory
has made an investment in our document-control and quality-management
systems (QMS) as required by our ISO 15189 accreditation.
Cowan: Have there been any
changes or updates in the regulatory inspections to which your lab has
had to adapt?
Hughes: The largest, latest
change in our regulatory inspections has been achievement of CAP ISO
15189 accreditation. We have had to examine all of our processes
in great detail over the past couple of years for improvement and
quality. Without a solid QMS in place, our job of achieving and
maintaining this required quality/process improvement would be so much
harder. Our staff worked very hard to reach this lofty goal, and our
document-control software was a key vehicle to complete our journey.
Provencal: Document-control
software has been integrated into our quality-management program since
2009, and aids in efficient and effective documentation of procedural
updates and ease of access to procedures 24/7.
Cowan: What were the most difficult challenges for
your lab in terms of regulatory compliance?
Provencal: When we were
still using a manual system for QM/document control, ease of access to
updated procedures was a challenge, and so was managing the flow of
updates to procedures and annual procedural reviews. The time for all
involved parties to review a procedure was lengthy and cumbersome.
Hughes: Where do I start?
It is difficult to imagine trying to meet our new quality standards
using our old manual practices. Before implementation of our QM
software, we struggled mightily with document control. Our staff could
not be sure documents were always being reviewed properly — we used
paper sign-off sheets — lost large amounts of time with the review
process we used for the new or edited paper documents, and often
duplicated procedures because we did not know one already existed.
Automating the document life cycle has solved these problems for us.
Using a manual system to try to track and trend
problems for quality improvement was difficult at best. Most of the
time, the data collected was only a small representation of what was
actually occurring, so any conclusions drawn from it would be flawed. By
automating the entry of these problems, we made it easier for users to
document when/what has occurred and easier for our management staff to
compile the data into a useful tool for quality improvement.
Last, our manual system of preparing for audits, such
as CAP, AABB, ISO, and others, was very paper oriented. It is quite a
contrast to see an inspection team sit down with several tables loaded
with manuals and binders containing policies, procedures, and evidence
from our old system compared to now, with our software, where
inspector(s) can sit at a PC and see everything they need. No more
books!
Cowan: How has the change to using software for
document control improved your readiness for regulatory compliance?
Provencal: Now only
up-to-date policies and procedures are available online and accessible
24/7 which always meets regulatory requirements and reduces risk. The
keyword searches have been valuable for quick retrieval of information.
The approval process for updates and new procedures has been streamlined
and is much more efficient. Also, security in the document-control
system only allows for authorized users to view documents and edit
documents.
Hughes: The manual paper
system we used to use was difficult to maintain. Often, documents would
slip through without being regularly reviewed. Paper had to be shuffled
from one desk to another. Hard copies of procedures had to be maintained
in books when obsolete or retired. In short, the paper system was
inconsistent and costly — in time and money. With electronic
regulatory-compliance software, each stage in the document-control
process has been automated and can be tracked. Also, documents can be
easily archived and old versions can be stored. All of this can be
tracked and viewed to show historical information for any instance.
Cowan: Apart from better
preparation for regulatory inspections, have the changes that you have
made to your QM and document-control processes had any side effects?
Provencal: Shortly after
our document-control software was installed and implemented, I received
a call at 4:55 on a Friday afternoon; everyone had just left for the
weekend. Nursing was looking for a policy pertaining to whether or not a
patient could have an item which had been surgically removed. With the
thousands of procedures in the lab, this would have been a cumbersome
search. By using keywords to search procedures within the
document-control system, the related policies and procedures were able
to be referenced within minutes.
Van Schoik: Before the
implementation of our QM software, a very experienced tech
informed me that it took her 20 minutes to find one procedure in a
manual with which she was not familiar. Now, with the electronic QMS
system, in just a few seconds a search is complete.
A never-ending process
Lab directors, quality managers, and others who are
familiar with clinical laboratory regulatory compliance see several
trends that bear out the experiences shared here. First, a growing
number of labs are turning to automated systems to enable 24/7
preparedness for inspections. Second, labs are undergoing more
inspections (sometimes by choice, as with Blanchard Valley Hospital
seeking ISO 15189 accreditation), and often those inspections are
increasingly focused on document control as a part of QM compliance.
Last, and most important, better regulatory preparedness means that the
lab is operating more efficiently — so assessing and improving the lab’s
QM system is not only better for regulatory inspections but turns out to
be better for the laboratory overall.
Over the years, hundreds of laboratorians across the
country have pointed to a growing awareness of quality management in
general. Whereas at one time the quality manager or regulatory
compliance specialist was the perceived owner of quality-management and
document-control processes in the lab, this awareness is now more likely
to be shared, especially with section supervisors and other management
personnel. Whether due to the need for better inspection readiness or to
a shift toward 24/7 QM awareness, the end result has been that the
day-to-day thinking of laboratorians now includes thinking about quality
management as an ongoing process — not just something that must be done
when an inspection team is due.
Kirsten Cowan is chief healthcare liaison for
SoftTech Health, a software-development firm in New York, specializing
in document-control and quality-management applications.