It appears that there is still some confusion among
laboratory personnel in differentiating QC from QA, and that this uncertainty
has been compounded by the introduction and implementation of the
Individualized Quality Control Plan (IQCP). These are different concepts, and
it is important to understand these differences—both from the practical
standpoint of what you are trying to accomplish, as well as how you get there.
Basically, laboratory quality control is designed to detect,
reduce and correct deficiencies in a laboratory's internal analytical process
prior to the release of patient results in order to ensure the quality of the
results reported by the laboratory. Quality control is a measure of precision,
or how well the measurement system reproduces the same result over time and
under varying operating conditions. Laboratory quality control material is
usually run at the beginning of each shift, after an instrument is serviced,
when reagent lots are changed, after calibration and whenever patient results
seem inappropriate. The effectiveness of quality control is assessed on a per-test
On the other hand, quality assessment is more broadly
focused; it is an on-going program for auditing an organization’s processes and
systems. It involves setting quality goals, deciding whether or not these goals
have been achieved and implementing corrective action if these goals have not
been reached. It includes auditing the effectiveness of your policies and
procedures, encompasses all phases of testing and general administration. There
are no limits for quality assessment audits—going well beyond the more test-specific
focus of quality control.
The CLIA regulations (Subpart K) address specific quality
assessment requirements. The Code of Federal Regulations (42 CFR 493) states
that laboratories “must establish and follow written policies and procedures
for a comprehensive quality assurance program that is designed to monitor and
evaluate the ongoing and overall quality of the total testing process.” The QA
the effectiveness of the lab’s policies and procedures.
2. Identify and correct
3. Assure the accurate,
reliable and prompt reporting of test results.
4. Assure the adequacy and
competency of the staff.
But now we have the Individualized Quality Control Plan (IQCP),
which is the new alternative QC option permitted by CMS and is based on risk
assessment. As such, the process of determining the appropriate IQCPs for your
laboratory involves many of the elements of the traditional quality assessment
process to determine the most effective QC based on examining all aspects of
the laboratory operation to determine risk.
In effect, this brings the QC/QA relationship full circle,
from where the traditional (analytic phase focused) QC is a key part of QA to
where QA processes are utilized to determine the best QC to use. However, the
one constant is that QA remains process and systems focused, while QC/IQCP is
still utilized for use on a per-test basis.
When we discuss all the changes that laboratories have to
deal with—from technical and regulatory to evolving views of healthcare
delivery and service expectations—we must include how these affect customer
service. Customer service is involved in every phase of the laboratory operation;
it is the face of the laboratory and, thus, reflects everything that is
Specifically, what are some of the new demands on customer
service brought about by these changes?
• Direct access by patients to their complete medical
records, including test results.
• Requests for interpretation of test results.
• Testing requests directly from the patient, without their physician orders.
• Increased interaction by patients with the laboratory through patient portals
available on their computer and mobile devices. These have almost an unlimited
capacity to replace in-person visits to access test information, receive
information about prescribed medication and complete required signature forms ranging
from insurance documents to consent agreements, as well as make future
appointments for office visits, submit questions and provide comments.
• Increased need for additional communication skills since customer service
personnel are now expected to provide a wider variety of information. This
includes cultural sensitivity as well as additional language options to match
the client population.
• Knowledge of HIPAA and other legal guidelines to be followed when imparting
• An awareness that social media provides a forum for both positive and negative
reviews of the services provided.
Things to Consider
It is important to understand the significance of the impact of the 2014
HHS rule change, which amended both CLIA’88 and HIPAA to allow direct patient
access to their test results. Laboratories must have the proper policies in
place permitting this. Anecdotally, I have heard that there are still some
laboratories that are still unaware of this rule change, have not adjusted
their policies and still require physician permission to release test results.
It is important to note that laboratories have flexibility
as to how to set up systems to receive, process and respond to access results. While
laboratories are required to provide access to completed test reports, they are
not required to interpret these reports.
The use of digital patient portals to access information, as
well as provide input ranging from questions and comments to insurance
information, has created the need for customer service staffing to include
someone who can assist patients with these portals.
Social media has become an important tool for popular
expression of satisfaction or dissatisfaction with specific physicians,
hospitals and all other healthcare services, including laboratories. Thus, the
benefits of quality customer service are multiplied in today’s environment, but
the price of poor customer service is multiplied as well.
We are rapidly approaching Medical Laboratory Professionals
the annual celebration of the medical laboratory profession, and those who play
such a vital role in the delivery of quality healthcare. It has been celebrated
annually since 1975, during the last full week of April, and once again, the
vital role of the laboratory is highlighted by recent advances in dealing with
the Zika virus—a public health threat, not only locally or nationally, but also
On February 23rd, USA Today reported that Texas Children’s
Hospital and Houston Methodist Hospital had developed a rapid test for the Zika
Virus based on genomic research. This new test detects the presence of genetic
material from the Zika virus, and this specificity allows the test to
distinguish Zika virus infections from other mosquito-borne infections like
dengue or the West Nile Virus. This is very significant, since Brazil, as well
as many other countries in the Americas, has mosquitos that can carry all these
infections, and distinguishing among these facilitates the correct response as
rapidly as possible. The tests, which can be performed on blood, amniotic
fluid, urine or spinal fluid, will provide results in just a few hours.
This information was provided in an interview with James Versalovic,
pathologist-in-chief at Texas Children’s Hospital. “We must be prepared for a
surge of Zika testing demand,” Versalovic said. “We must provide answers for
anxious moms-to-be and families."
As of February 23rd, 2016, at least 82 Americans had been
diagnosed with Zika after visiting areas with Zika outbreaks and returning to
the U.S., according to the CDC. Health officials expect hundreds more to
develop the virus because of travel, especially as Americans visit Brazil for
the Olympic games this summer. The mosquito that spreads the Zika virus, Aedes aegypti, is present in the South.
Many public health officials fear that the Gulf Coast could be vulnerable to
Zika, due to both its climate and pockets of poverty.
All of that could put pressure on public health
laboratories, which could struggle to keep up with the demand for Zika tests,
Doctors will initially offer the test to people who meet
specific criteria—such as recent travel to a place with an outbreak and
Zika-like symptoms, which include a rash, join pain or fever. Pregnant women
who have traveled to a place with a Zika outbreak also will be offered the
test, regardless of whether they have symptoms, according to Texas Children's
Hospital. Four out of five people with Zika infections have no symptoms.
Whenever possible, we should proudly celebrate the
contributions of our profession to public health and safety, and the leadership
role that laboratories and laboratory professionals continue to play.
The importance of properly managing inventory so that supplies
for all phases of testing in your laboratory are available, accessible and
in-date is critical, not only for providing quality patient care, but for the
fiscal solvency, operational efficiency, customer service and staff morale of
The goals of any inventory control system should include:
• Current inventory information
• The ability to track and account for all inventory changes
• Reorder points and adequate time-frames for timely replacement.
• Monitoring the environment to ensure proper storage conditions are maintained
An effective control system should include the following:
Each item in your inventory should have an item number, a quantity and a
basic description, which includes the vendor name and any other important
details (such as lot number and expiration date).
2. Inventory Updates
Pick an interval of time to regularly check inventory. The interval depends
on how fast your supplies move. Then compare what was purchased/acquired/received
within a certain time period (say, a week), as well as what was used during
that same time period. Your current inventory should be equal to whatever the
count had been the previous week, minus all usage for the current week, plus
the new inventory purchases.
Note: Store updated
documents in an organized manner. Make sure to store your periodic inventory
checks organized according to month. This way, if you need inventory data for a
particular week, you can readily find it. It is also helpful in the case your
accountant needs any information.
3. Maintain the Right
Level of Inventory
Analyze usage data. The goal of inventory management is to keep up with
demand, and this means having enough inventory to meet the projected usage. If
test systems or procedures have been in use for a period of time, use
historical data to predict (approximately) what the future use will be.
Decide how much stock to order and keep. How much you keep
and how much you order depends on your level of usage, the type and variety of
supplies and how much space is available. If you have minimal space, look at
previous usage and ensure you have slightly more than that to meet the projected
demand and be prepared for any unexpected situations. Always choose reliable
suppliers who can get you your inventory quickly and on-time. If you have a
larger space, consider taking advantage of bulk discounts.
Choose a re-order point. The goal is to always have enough
inventory to meet demand, while not carrying too much inventory as this ties up
your capital and space unnecessarily. To know when to re-order, one approach is
to specify a minimum level of stock, at which point you always re order. For supplies
that move quickly, or have the potential to move quickly, set a higher minimum
level. Arrange to have some "safety stock" to get you through
shortages from unexpected events.
The benefits of improved inventory management include the
improved reliability of the laboratory to deliver test results on time, a more
efficient laboratory operation with improved staff morale, improved vendor
relationships, more accurate budgeting and better cost control (reduced
stock-outs and overstocks).
Last September, the FBI issued a warning that devices and
objects that connect to the internet to send and receive data are vulnerable to
cyber-attack. While this warning referenced many popular lifestyle devices such
as smart phones and wearable fitness monitors, it also included devices common
to laboratories and other businesses, such as printers, security systems and
The FBI recommended that the following steps be taken to
reduce the risk of being a victim of such cybercrime, including:
• Protect wireless networks with strong passwords
• Isolate devices on their own protected networks
• Use security patches when available
Since HIPAA compliance is about ensuring the security of
patient records, now is the time to evaluate the effectiveness of your
compliance program. The G2 Compliance Advisor listed six actions you can do now:
1. Conduct a self-appraisal of compliance with HIPAA’s
privacy and security rules. For instance, conduct a risk analysis of patient
information in electronic form to check for vulnerabilities, such as lack of
firewalls or weak passwords. Take steps to reduce or eliminate vulnerabilities
identified. Make sure all staff members are trained in HIPAA compliance.
2. Make sure you’ve entered into business associate agreements
with any entity or individual handling patient protected information on the
lab’s behalf, such as a billing company. HIPAA requires labs and other covered
entities to enter into these agreements to ensure that the business associate
will safeguard the patient information adequately.
3. Consider encrypting patient information. Encryption is
technically not required by HIPAA. However, a lab that opts not to encrypt has
to at least address why it isn’t encrypting and document what alternative it
will use instead to protect the data, according to Deven McGraw, deputy
director, health information privacy division for the HHS’ Office for Civil
Rights (OCR). “‘Addressable’ does not mean optional. It never has. We expect
you to address it," she explained. Note that patient data that is lost or
stolen but has been encrypted in accordance with NIST standards is
"secure" and does not need to be reported to patients or HHS.
4. Have an action plan to handle a breach of unsecured
patient information. There are steps a lab needs to take, such as conducting an
assessment of the likelihood that the information was compromised; timely
notifications to HHS, patients and, in some cases, the media; and corrective
action to forestall future breaches. You don’t want to be caught scrambling to
comply once a breach has occurred.
5. Remember state law. State laws are often broader than
HIPAA. For instance, labs suffering a breach of patient information may have to
report it more quickly to state authorities than to HHS.
6. Keep an eye out for future developments. There’s a lot of
activity concerning the privacy and security of patient data. In addition to
the revised audit protocol expected this year, OCR is planning on releasing new
guidance on patient access to their data. Other guidance or rules that are
still forthcoming include clarification on what disclosures of patient
information are the "minimum necessary," as well as a proposed rule
on how individuals that have been harmed by a data breach should receive a
portion of the penalty imposed on the violator. Both of those are part of the
HITECH Act of 2009 that amended HIPAA.
Today, we continue with our discussion of commonly misused
terms in healthcare information technology (IT). The recent and rapid
development of this technology, as well as the evolving applications of these
same terms, opens up the possibility of misinterpreted use. It’s important to
ensure that we are all on “the same page” when using these terms for the sake
of accurate communication and patient safety. These examples were recently
published in Health IT and CIO Review.1
Here are some additional examples:
Interoperability can refer to the capability of systems to talk to one
another and effectively move information back and forth in a usable format. Within
the Healthcare IT profession, the goal is to create an environment where EHRs
and software from different vendors are able to seamlessly interact with any
hardware or software that the client uses. It is not uncommon for healthcare
executives and administrators to use the term in place of, or in reference to,
information exchange—although the two are different.
Interoperability specifies how data is accessed, assimilated
and what can be done with it. It involves many “moving parts,” which include: enabling
legislation, new developments in hardware and software and cultural changes
toward increased openness in the sharing of healthcare data. Information
exchange is only one part of this picture.
The proper use of this term depends on context. It can be used to describe a
model of healthcare delivery, such as that delivered under Accountable Care
Organizations. It can also refer to analytics, big data or a certain group of
patients—either those that a particular organization is responsible for or those
within a specific geographic region. It is important to be aware of these
differences and to clarify the context when using this term in presentations or
discussions for effective communication.
Coding names and systems not only vary between medical disciplines and
practices, but also from country to country. ICD-10, CPT, HCPCS and PCS all
have different structures and standards and are used in different places of
service. Mistaking one acronym for another is confusing for the recipient of
As communication within the healthcare profession continues
to evolve away from the direct, personal and local to the electronic,
programmatic and remote, the potential for misunderstanding and
misinterpretation increases. Thus, using this terminology appropriately assumes
1. Green, Max. Untangling The Lingo: 10 Most Misused Health
IT Terms. Health IT and CIO Review. Sept. 9, 2015. http://www.beckershospitalreview.com/healthcare-information-technology/untangling-the-lingo-10-most-misused-health-it-terms.html
I recently read an interesting article1 in Health IT and CIO Review that discussed
commonly misused IT terms in the healthcare profession. The fact that these
terms are misused so frequently is not solely due to misunderstanding or
unfamiliarity; it reflects how new the field of healthcare IT is and how the
meaning and interpretation of this terminology continues to evolve and reflect
new applications. So, consider this partial list a moving target, subject to
1. Interface vs. Integration
While used interchangeably, they mean different things. Interface refers to
communication and interaction, whereas Integration refers to combination.
Interface applies to hardware or software that communicates
information between users, devices or programs. It also applies to the
interaction that occurs among individuals, groups, and organizations.
Integration refers to the process of bringing related parts of a system together—combining
them, so to speak.
This refers to information science and the way data is processed, stored and
retrieved. Correct usage depends on understanding what it is you are
referencing. Are you talking about types of data involved (in healthcare, it
can include behavioral, medical or financial data) or are you discussing the
computational process (the calculations performed using algorithms specific to
the health data)? Be careful to avoid overusing this term as a trendy
substitute for “information” or “data” alone.
3. EHR vs. EMR
These are often used interchangeably. The electronic medical record (EMR) is
basically a paper chart in electronic format. Unlike an electronic health record
(EHR), it may not contain long-term health information or aggregated patient
data provided by other providers. The EHR includes these in order to provide a
comprehensive medical and prescription history.
There is a temptation to use this term immediately after the rollout of an IT
system in workflow, otherwise known as Implementation. Optimization is the
process of bringing the new system up to peak performance after it is
operational. The problem here is that the implementation phase may not have
been fully vetted before the emphasis shifts to optimizing or “polishing” the
system. The result is that organizations risk struggling to optimize a system
that still has workflow and service delivery problems.
Optimization is a seductive term, indicating a high level of
systemic strength and process reliability, when the reality may be otherwise. Be
careful not to overuse it (wishful thinking) when the focus should still be on
fixing implementation issues.
There are many more terms related to healthcare IT that are
often used inappropriately, and we will continue with this list in Part II.
1. Green, Max. Untangling The Lingo: 10 Most Misused Health
IT Terms. Health IT and CIO Review. Sept. 9, 2015. http://www.beckershospitalreview.com/healthcare-information-technology/untangling-the-lingo-10-most-misused-health-it-terms.html
We all understand how important good management is to the
overall success of a laboratory in providing quality patient care, but the
defining components of quality care are not static. Whether we are discussing
test accuracy, turnaround time, specimen acquisition or result reporting, the
technologies, regulations, compensation and treatment protocols are constantly
changing.These have been characterized in Dickensian terms as “the best of
times and the worst of times” in an article on leadership in a recent issue of
The “best of times” describes the flood of new diagnostic
technologies that make it possible for clinical laboratories to detect many
diseases earlier and more accurately than ever before. How increasing knowledge
of the human genome, proteome and microbiome is generating new ways that pathologists,
clinical chemists and laboratory scientists can help physicians and patients.
The “worst of times” relates to the steady erosion in the
prices for lab tests and the shrinking budgets seen at many labs today. Other
negative forces include the shrinking of the most experienced laboratory
workforce through retirement, labor shortages, the dislocations experienced
through changes in healthcare delivery settings, hospital closures and
These times call for more than good management; they call
for good leadership, but leadership that is more adaptive and agile than ever
before—resilient leadership! Leadership that understands change, and can adapt by
creating an organizational culture of resilience—enabling the laboratory to not
only survive, but prosper and grow.
What is a Culture of
The properties necessary for resilient organizations include:
Top management must recognize performance concerns and address them with
continuous and extensive follow-through.
Just Culture: The
reporting of issues, problems, events and errors throughout the organization is
supported, and culpable behaviors are not tolerated.
Issues, problems, events and errors are handled with an eye toward repair and
true reform, not denial.
Management is aware of the laboratory’s proximity to serious problems and
events due to weaknesses inherent in their operation.
Management collects ongoing data to gather insight into quality of performance,
problems and the state of safety defenses.
Management must actively anticipate problems and prepare for them.
or complex problems are handled in a way that maximizes the ability to solve
the problem without disrupting overall work.
Out of this develops a resilient testing process, a process
capable of adaptively learning to correct errors and to take advantage of new
opportunities (e.g., information technology) to improve quality. The end result
is the leveling of silos; enhancing communication; and creating a workforce
that is not hesitant to innovate and adapt to change, feels appreciated and
experiences less stress when change is needed.
1. Does Your Clinical Laboratory or Pathology Group Have the
Effective Leaders It Needs During These Challenging Times? http://www.darkdaily.com/does-your-clinical-laboratory-or-pathology-group-have-the-effective-leaders-it-needs-during-these-challenging-times-31615#ixzz3tISKg0VS
2. Elder N, McEwen T, Flach J, Gallimore J. Creating Safety in the Testing Process in
Primary Care Offices. http://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/patient-safety-resources/resources/advances-in-patient-safety-2/vol2/Advances-Elder_18.pdf
The practice of laboratory medicine is undergoing rapid
change, both leading as well as reflecting changes in our healthcare system. These
changes are driven by new technologies that now enable molecular and genomic
testing, electronic data collection and integration, personalized and
evidence-based medicine and the vertical and horizontal integration in all
areas of healthcare. The laboratory is in the center of these massive changes,
with clinical laboratory test results a key factor in 70 percent or more of all
The transformation of the clinical laboratory from a passive
service role to an active role in patient diagnosis and management has
encouraged non-physician laboratory professionals to become involved beyond the
bench. Their expanding role in what has historically been recognized as the
practice of medicine has created a conundrum: are non-physician professionals
truly qualified to advise clinicians, interpret tests in clinical contexts
and/or recommend testing for specific patients?
The question has been raised as to whether laboratory
medicine, as practiced today, requires direct pathologist involvement in the
selection and interpretation of test results integrated into specific clinical
contexts on a routine basis.
Studies have shown the clinical and economic value of
properly trained laboratory professionals who are truly expert in assisting
attending physicians with test selection and interpretation. The lack of
clinical involvement is associated with significant consequences. 15 – 54 percent
of primary care medical errors are related to the testing process; 17 percent
of healthcare spending in the U.S. is due to test overutilization; and nearly a
third of total healthcare spending may be due to potentially avoidable clinical
Is consultation provided by medically-trained laboratory
professionals, including pathologists and other physicians with laboratory
training, more closely associated with improved clinical outcomes than
consultation provided by non-medical laboratory professionals? In a recent
study, researchers concluded that non-medical scientists “have also
successfully undertaken leadership roles within laboratory medicine, including
the directorships, thus precluding the absolute need for a medical degree in
fulfilling most of the laboratory professional’s responsibilities.”
However, it is acknowledged that quality laboratory service
is not just about providing accurate, useful and timely information to the
attending physicians; it must be provided within the context of the particular
patient’s circumstances. As a result, in many instances, without medical
training and experience in the care of patients, non-physician clinical
laboratory professionals generally do not have the contextual background to
fully and optimally assist the clinician.
It is in this environment of interacting interests and
forces that the laboratory and its professional personnel must redefine their
roles, including who provides what types of consultation to attending
It is a well-known fact by now that most laboratory errors
occur in the pre- and post-analytic phases of testing and that these errors can
have a significant impact on patient care. Often, these activities do not occur
within the physical confines of the laboratory, but in other locations—often by
personnel not directly managed by the laboratory. There have been studies performed to assess how
to best address these issues (i.e., what are the most effective interventions
for identifying and controlling these errors?).
One such study, focusing on controlling specimen
identification errors was conducted by Elizabeth Wagar, MD, at UCLA. Not only were there statistical analyses of
how, when, where and why these errors were occurring and the resultant reports
of patient harm, but she also included quizzes of laboratory personnel to
assess “in-house” viewpoints as to the best way to address these.
Here are a couple of the quiz questions, along with some commentary
afterward. Take this quiz and see whether
your responses would have been in agreement with Wagar’s commentary.
1. Which of the following interventions is most likely to lead to a
sustained, significant decrease in mislabeling errors?
A. Quietly tell nurses and
phlebotomy staff to be more careful.
B. Loudly tell nurses and phlebotomy
staff to be more careful.
C. Place warning labels near blood
collection tubes reminding nurses to correctly match the patient with their
D. Barcode-based patient identification
and specimen collection.
2. In clinic Z, a
mislabeled specimen occurs an average of once per week, and one patient had
minor harm because of this in the last year. In the same clinic, failure to
retrieve a lab result also occurs once per week, and ten patients have been
harmed in the last year, including one seriously. What quality improvement project should the
clinic focus on first?
B. Failure to retrieve results
C. Line contamination
Question 1: The correct answer is
“D,” barcode-based patient identification and specimen collection. 91 percent of the laboratory participants chose
this answer. Warning labels (answer C) was chosen by 8 percent, and 1 percent
chose the call for enhanced vigilance, whether it be quiet (answer A) or loud (answer
B). Enhanced vigilance (whether quiet or
loud) and warning labels are weaker interventions that lead to only transitory
reduction in errors. However, this large sample of laboratory workers understands
the difference between a weak and a strong intervention. Hopefully, this
knowledge drives enhanced interventions in their workplaces.
The patient safety movement is based on implementing systems
that have error-proofing and do not rely on human vigilance. Thus, semi-automation,
in the form of barcode-based patient identification with barcoded tube labels
at the point-of-care, is the strongest intervention of those listed.
Question 2: The
correct answer is “B,” failure to retrieve lab results because, in clinic Z,
this error causes more patient harm than mislabeling—and this was chosen by 80
percent of the participants. Mislabeling
was chosen by 19 percent, and line contamination was chosen by 1 percent. The
most important errors to work on are those that harm patients. Thus, an error
that has a rate of ten cases of patient harm per year (one very serious) is a
more important focus for quality improvement than an error that causes one case
of minor patient harm per year.
Why did so many people choose mislabeling in this case even
though it was less clinically significant in Clinic Z than failure to retrieve
results? This judgment may have been based on personal experiences from their
workplaces or from all the press given to identification errors. After all,
decreasing mislabeling is a national patient safety goal and a huge focus of
quality improvement at many facilities.
Healthcare facilities differ regarding the errors most
likely to harm patients. In one facility, mislabeling may be the most
harm-causing error; in another facility, it might be phone communication
errors; and in a third, it might be failure to retrieve results. This is why it
is good for laboratory leadership to collect patient outcomes related to
laboratory errors. Knowledge of which errors are most likely to harm patients
helps the leadership focus their quality improvement efforts on the right
How did you do?
1. Decreasing Patient and Specimen Identification Errors. An
interview with Elizabeth Wagar, MD. Laboratory Errors & Patient Safety. Volume 3, Issue 5.
Sometimes, you have the good fortune to find qualified staff
within a short time to replace those who have left, minimizing the disruption
to your daily routine. More often than not, it takes a while to find the
“right” person for your lab. In the meantime, the remaining techs have to take
on extra shifts, work in other specialties or take on additional
responsibilities. So, everyone’s glad when a qualified “newbie” has been hired.
This is the time to have a comprehensive orientation and
training protocol in place not only for the purely technical responsibilities
of the position, but to facilitate their integration into the working culture
and value system of the laboratory. This is important for the smooth transition
from being an “outsider” to an accepted member of the team. Institutional
culture is a combination of commonly agreed upon values, behavior, performance
and expectations for the work environment.
The institutional culture of the laboratory is characterized
by expectations that peer behavioral and performance standards for work will be
met. This not only refers to technical competencies, but also to
social-interactive competencies such as whether it is okay to be connected to
your iPod while working; the frequency of personal calls or texting; or
rotational preferences. It also defines the consequences of not meeting these
standards and how tolerant the rest of the staff is when these occur.
None of the examples above are meant to diminish the
importance and right of individuals to be who they are, but to promote how vital
it is to have an awareness of your “mini-society.”
Culture is also defined by the type and direction of
communication. Is yours a top-down or a bottom-up lab? The former is where
decision making primarily flows from supervisors and managers to staff; the latter
is where staff participation in decision making is encouraged and appreciated. If
a new employee is unaware of this dynamic, there can be problems.
Of course, these dynamics are not usually incorporated into
job descriptions or the Human Resources handbook, but a lack of awareness of
group dynamics can contribute to an uncomfortable work environment. An assigned
mentor who can provide both cultural and technical orientation and training
will increase the probability of successfully retaining the newly hired member
of the laboratory team.
As laboratory professionals, our focus on quality begins by
looking inward at our operational processes -- from specimen collection to
result reporting. But the application of this work is then externalized, sent
to the ordering physicians and applied to their patients. The way we perform and report our work and
its effect on patient care ultimately affects the greater community. This we already know, and it is one of our
strongest motivators to maintain the best quality possible. What we may not see as clearly is how changes
in the world around us are constantly impacting our own work environment,
challenging established routines and time tested views of our profession.
While change brings up thoughts of new tests, new
instruments, new procedures and more training, it can also require conceptual
re-orientation of what we are achieving.
An example of this is the emergence of genomics and genetic testing,
enabling the rise of personalized medicine. Our test results contribute to the
development of individualized treatment protocols
But we also live in an era where laboratory testing has
become intertwined with political, social and technological change to a degree
unheard of in years past. Laboratory testing has always been in the epicenter
of efforts to control and monitor disease outbreaks, such as HIV (with all the
attendant societal issues surrounding it). Now, we are in the midst of an
epidemic of illicit drug usage, particularly prescription pain killers like opioids
This category of laboratory testing is the fastest growing
not only in the United States, but in the UK, Japan, Germany and other European
countries. Illicit drug users now exceed 315 million globally, approximately
6.9% of the global adult population. Imagine the unmet need for additional
laboratory testing: drug screening, confirmation and monitoring. Progress in
dealing with this epidemic cannot be made unless our work is accurate and
Additionally, we cannot help but be part of preparation and
planning regarding the possibility of bioterrorism. Whether we are in public
health, the hospital, the physician office or reference laboratories, we will
be involved. Our concerns range from
disseminated Anthrax to Yersinia pestis (plague) to everything in-between. The
importance of the quality of our work extends far beyond immediate patient
treatment to a new and higher societal level.
1. Drugs of Abuse Testing Market-Global Industry Analysis, Size, Share,
Growth,Trends and Forecast to 2018. http://www.prnewswire.com/news-releases/drugs-of-abuse-testing-market---global-industry-analysis-size-share-growth-trends-and-forecast-to-2018-246543051.html
According to CMS, there were 229,815 laboratories in the
U.S. , in 2012, of which 150,256 were Certificate of Waiver sites. Stated
another way, this means that some 65 percent of laboratories in the U.S. do not
have any routine oversight. The number of waived tests has grown from just 9
tests in 1993 to 119 analytes using more than 5,400 test systems. From diabetes
management and monitoring anti-coagulant therapies to screening for infectious disease,
waived tests are now an integral part of patient care. Laboratory professional
groups have long recognized the need for increased oversight of these waived
tests, and unfortunately, evidence is mounting that significant quality
problems exist in the largely unregulated labs relying on these.
According to a report from the Centers for Disease Control and
Prevention, for example, 31-43 percent of waived labs do not follow
manufacturer’s instructions. Some other examples of notable problems among the
more than 150,000 waived testing sites in the U.S. include:
than 20 percent do not routinely check the product insert or instructions for
changes to the information
- More than 20 percent do not
perform Quality Control testing as specified by manufacturer’s Instructions
- Nearly half do not document
the name, lot number and expiration dates for tests performed
How can we deal with these issues using direct action that
produces relevant measurable results within discrete time frames? I suggest the
following five activities as effective strategies to assess the state of your
waived testing, which engage your staff in this campaign for excellence:
of the waived testing performed
2. Competency assessment of staff
performing waived testing
3. Proficiency testing for your
waived test menu
4. Quality assessment of how your
laboratory handles waived testing issues
5. Continuing education for your staff
engaged in waived testing
Any or all of these can be carried out independently of the
rest; you can choose which to use for your determination of quality
performance; and all can be compartmentalized and measured within discrete time
frames or events, including continuing education.=
The idea is that, to improve the quality of your waived
testing, you choose the activities most suitable to your laboratory that
achieve relevant measurable results and provide information you can act upon
and measure improvement over time. Choose assessments that motivate and educate
your staff. This promotes buy-in and commitment to continuous improvement.
One of the top priorities for every laboratory should be the
safety of its employees facilitated by creating a culture of safety
consciousness, education, organization and accountability. Managing safety is
more than having a top-down list of dos and don’ts, viewing educational videos,
providing protective wear and having policies for incident management. A safe
lab environment requires an ongoing active involvement by everyone. It’s about
having strategies for prevention, an awareness of your individual laboratory
environment and the potential for accidents and taking responsibility when
action is needed.
So, while there are universal guidelines for safe laboratory
practices, each laboratory’s policies and procedures should reflect particular
considerations of hazards arising out of the use of its own instrumentation,
testing requirements, physical structure, workflow and traffic patterns.
We are all familiar with the general safety guidelines:
wear appropriate personal protective equipment.
- Wash your hands after
working with potentially hazardous materials and before leaving the laboratory.
- Do not eat, drink, smoke,
handle contact lenses, apply cosmetics or store food for human consumption in the laboratory.
- Follow the institutional
policies regarding safe handling of sharp objects.
- Take care to minimize the
creation of aerosols and/or splashes.
- Decontaminate all work
surfaces before and after work and immediately after any spill or splash of potentially infectious
material with an appropriate disinfectant.
- Decontaminate all
potentially infectious materials before disposal.
- Report any incidents that
may result in exposure to infectious materials to appropriate personnel (e.g., laboratory
supervisor, safety officer).
However, an effective safety program must also incorporate
the (now) standard phrase, “If you see something, say something.” Too often I
have heard people say that they were aware that there were “problems” (such as
a slippery spot in the break room, a loose leg on the phlebotomy chair, an
unstable shelf above their work area, etc.), yet said nothing, assuming someone
else would notice it and fix it. Take personal responsibility before someone
We must also remember that following safe practices is a
choice. Management can provide all the education and protective equipment in
the world – but an employee deciding to ignore safety rules will do so. Every
individual makes the decision to follow the guidelines or not. Ensure anyone
seen acting in an unsafe manner is taken aside, coached and not allowed to
continue that way. Anyone repeatedly ignoring safety guidelines and putting
fellow staff in jeopardy should be encouraged to choose a different place to
Finally, emphasize that safety awareness doesn’t end at the
laboratory exit, but encourage the same safety-consciousness throughout your
The term, “creating a culture of…” has become the cliché of
the 2000s’ ethos of competent management. It is no longer enough to lay down
the rules, train your personnel and maintain documentation. Now, we must create
an all-enveloping world of understanding, communication, compassion and comfort
with the organization’s operating standards. This new modus operandi applies to all organizational settings -- whether
offices, factories, retail, education, healthcare, etc. We are all enveloped by
our new cultures.
In the laboratory, we talk about the “culture of quality,”
but we can also be more specific and feel good about our “culture of customer
service,” our “culture of safety,” our “culture of personal responsibility” and
our “culture of teamwork.”
Contrary to what you might be thinking at this point, I
heartily support this evolution of organizational behavior and standard
setting. Just as we are undergoing a revolution in the technology of how, where
and when we communicate and relate to each other, we are finding that this is
changing everything related to human interaction. It isn’t just the smart phone
or the use of social media or the ability to message each other 24/7; it’s the
idea that we all now have the ability to create instant communities wherever we
are. When we are in the laboratory, we
are immersed in our laboratory community; in the office, we are immersed in our
office community; in the gym or spa, we are immersed in our exercise community;
and, with family, we are immersed in personal community.
So, when you read about your laboratory creating a “culture
of [whatever],” buy into it because this is the future of all organizational
and societal aspiration.
For laboratories in particular, it is no longer enough to
just set down the standard operating procedures and do the technical
orientation and training. Today’s generation of laboratory professionals are
already accustomed to operating in different organizational cultures.
Effective managers will already have embraced this and
understand that successful laboratories will have to create cultures of their
own. This means that the old models of hierarchical management will no longer
work. The new cultural models are driven by two-way communication and the
acknowledgment that all input, including new employees,’ should be listened to
and valued. If this is not the case, you will have a difficult time retaining
new, younger, energetic staff.