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.
As a laboratory procedure readily performed in physician
office settings, the simplicity of urine drug screening belies its importance
and impact as the test results can be used to monitor patients' medication
compliance, detect drug abuse, provide evidence in legal/forensic cases and
improve workplace safety.
Urine is the preferred specimen for drug testing primarily
because it is non-invasive. Urine specimens may contain detectable levels of a drug
over an extended period and at much higher concentrations than in blood. Urine
may also contain higher levels of drug metabolites than blood, providing
further evidence of drug use.
Immunoassay procedures, such as ELIZA or RIA, are performed
first as a screening method. If the immunoassay is negative, no further action
is required, and the results are reported as negative. If the sample is
positive, the more specific GC-MS is used as a confirmatory test to identify
individual drug substances or metabolites and quantify the amount of the
substance. Confirmatory tests, such as GC-MS, should be utilized prior to
reporting positive drug test results.
Below is a summary of the many reasons that urine drug
screens may be ordered:
- Suspicion of drug abuse
(e.g., unexplained negligence/impairment/behavior)
- Random testing outlined in
- Military service
- Sports participation
- Legal/criminal (e.g., post-accident,
- Drug-therapy compliance
- Drug abuse rehabilitation
- Postmortem investigation
Because of the personal, occupational and legal implications
that accompany drug testing, family physicians who perform urine drug
screenings must be confident in their ability to interpret screening results
and respond appropriately to that interpretation. Ordering and interpreting
urine drug screenings requires an understanding of the test procedure, the detection
times for specific drugs and the common reasons for false-positive and
false-negative test results. False negatives are uncommon but can occur as a
result of low drug concentrations in the urine, tampering and in other
situations. Possible reasons for false-negative results include:
urine (excess fluid intake, diuretic use, pediatric sample)
- Infrequent drug use
- Prolonged time since last
- Recent ingestion
- Insufficient quantity
- Metabolic factors
- Inappropriate test used
- Elevated urine lactate
Although immunoassays are very sensitive to the presence of
drugs and drug metabolites, specificity and accuracy varies depending on the
assay used and the substance for detection. This limitation may result in false-positives
from substances cross-reacting with the immunoassay. Many prescription and
nonprescription substances have been reported to cross-react with immunoassays
and cause false-positives. Most have only been documented in case reports. The
frequency of false-positives varies depending on the specificity of immunoassay
used and the substance under detection.
In short, the importance and impact of urine drug screen
results on the life of the individual tested requires a heightened awareness of
both the strengths and limitations of the methodologies used.
Concepts of what makes for effective quality control have continued to
evolve since the original requirements were defined by the Clinical Laboratory
Improvement Act of 1988, and became effective in 1992. At that time the minimum requirement was
established as testing two levels of external control materials each day of
patient testing. However, CLIA
Interpretive Guidelines have always allowed for an alternative to daily
external Quality Control requirements as long as “equivalent quality testing”
is assured. Since 2004, this alternative
has been Equivalent Quality Control (EQC).
Even though many laboratories implemented EQC without difficulty, there
were a number of potential errors that could lead to inaccurate results that
were not detected by the test system’s internal controls or by the EQC
qualifying studies. Out of these
concerns, the concept of quality
control based on Risk Management was developed.
CMS named this policy the “Individualized Quality Control Plan” (IQCP).
Presently, we are in the midst of a two year transition
period, during which laboratories have the time to study and learn about IQCP;
and to decide whether to move forward to develop and implement IQCP. To have an acceptable IQCP in place is not a
simple matter, and during this time, laboratories can continue to utilize EQC
as their QC option.
However, on January 1, 2016, EQC will no longer be an
acceptable option by CMS, and it will either be IQCP or returning to the
current CLIA quality control standards.
If you wish to move ahead with IQCP, now is the time to master the
concepts and applications of IQCP, and begin implementation.
If you are not familiar with the concept of Individualized
Quality Control Plans, here are a few key points:
- IQCP is
a QC program based on the individual risk factors involved in the performance
of each test in your laboratory. IQCP
consists of a Risk Assessment, a QC plan; and a Quality Assessment process to
monitor the effectiveness of the IQCP.
- IQCP is
voluntary; but it can be applied to all non-waived clinical laboratory testing
except within the specialties of Pathology including Histopathology; Oral pathology; and Cytology
- You must
follow manufacturer’s requirements for QC if they are equal to, or exceed CLIA
QC standards. If however, the
manufacturer’s QC requirements are less than CLIA QC requirements, you must
follow the more stringent CLIA requirements UNLESS you implement IQCP to
validate that the risk level is acceptable.
- There is
no grandfathering in of test procedures presently using EQC; all IQCP must be
newly developed for each test involved.
Laboratory Director is responsible for deciding whether the laboratory will
utilize IQCP; the development of the IQCPs; and approval of the IQCP before
putting it into use.
There are many sources of information available that provide
both basic information about IQCP, as well as implementation tools.
The next thirty years comprise a perfect storm scenario for
laboratory medicine in terms of meeting professional staffing needs:
more people will be insured and able to access the healthcare system far more
comprehensively than ever before, including laboratory services.
of baby boomers adding to the post-65 year old demographic, requiring more
frequent and intensive healthcare, including laboratory services.
numbers of boomer clinical laboratory professionals are part of this retirement
tidal wave, contributing to the shortage of available staff.
continued rapid development of advanced technology such as molecular genetics,
requiring ever more sophisticated instruments and advanced training by staff.
competition from other healthcare professions that are able to promise and
deliver on better working conditions, higher compensation and greater
- Lack of
adequate funding for enough schools and graduation capacity to provide the
needed numbers of laboratory professionals.
Through all these challenges and stresses, the backbone of
the laboratory operation continues to be, and will always be, the dedicated,
competent, hard-working laboratory professionals who staff all shifts,
multi-task and respond to callers impatient for test results. Those who handle
all of this should not be taken for granted. If you lose a good employee,
replacement might not be possible for an extended period of time.
A good laboratory manager knows that to retain good staff,
you must offer them more than just wages and benefits:
with your employees, always greet them by name. Be friendly. Be willing to
listen. Create a sense of family among your staff. You cannot reduce the daily
stress of testing, emergency situations, time pressures, dealing with difficult
people, etc. -- but you can humanize the environment.
achievements, even if they are routine. If they day has gone well, say so. If
the lab received a compliment, note it. If the lab achieves a mile-stone (say,
a great inspection by your accreditation agency), celebrate it.
and celebrate personal mile-stones, such as birthdays and employment
your staff by providing educational opportunities. Hold regular meetings and
encourage all staff to talk about issues in their work areas and how
improvements can be made. Be current on performance evaluations.
transparent. Keep your staff informed of all happenings, both good and bad. This
can open up new avenues of discussion, problem-solving and team-building.
These are a few basic, yet effective strategies to humanize
the workplace and to enhance the sense of being a valued part of the healthcare
team. Improved wages and benefits may not be within your control, but these
actions are, and they reflect your leadership skills.
We live in an age of increasing individualism facilitated by
technology that allows immediate access to information in the format, the
setting, and the time of our own choosing. This change is occurring as rapidly
as we can adapt to it, accompanied by social media-facilitated feedback,
commentary and communication. These are new manifestations of individual
empowerment. All phases of our society have been impacted and are adapting,
willingly or otherwise, to this new world. The healthcare profession, including
laboratory medicine, is no exception.
We, as laboratory professionals, are at the nexus of these
changes -- not only in terms of information technology as discussed above, but
also in terms of advances in molecular diagnostics that are facilitating the development
of personalized (i.e. individualized) medicine. The latter, through the
decoding of the human genome and genetic mapping, allows the tailoring of
medical treatment to the individual characteristics of each patient, through
all stages of care, from prevention, diagnosis, treatment and follow up. The
result is a leveraging of both information and biomedical technology to empower
individual participation through all stages of medical care.
How does this affect us?
As the healthcare industry starts to reengineer healthcare
delivery to accommodate these new advances and demands, providers on the front
lines of change recognize the need for increasing patients’ engagement in their
own health care. This means that patients must be more involved in the
self-management and the modification of their own risk factors. Educating
patients about the meaning of their laboratory tests promotes this goal. When
the patient understands the reasons specific tests are ordered; what the
results mean; and how they are utilized in the diagnosis, treatment, and
monitoring of their conditions, the more likely it is that the patient will do
what is needed to attain and maintain a healthier state.
Patient education can be provided in many ways:
• Laboratory staff and other
office staff who have the education to provide this information, such as nurses
• The Reference laboratory --
either directly, if the patient visits, or by hard copy / on-line
• Laboratory Information
sites, such as Lab Tests Online or Health Network Laboratories
• Laboratory testing
Information online provided by major clinics and hospitals.
The importance of patient education about laboratory testing
is heightened even more by the increasing acceptance of laboratory test orders
originated directly by patients without a doctor’s order. This is now permitted
by several states with more added every year. This is another manifestation of
patient empowerment. When patients order their own tests, they must have the
correct and complete information to understand what the results mean; when it
is necessary to follow up with physician visits; and even when to seek