We are most accustomed to using (root) cause analysis in the
context of incident management investigations -- that, by tracing the sequence of
events backwards, and asking the what, how and why questions, we can determine
the true cause of these events. This
allows us to respond in the most effective manner not only to correct the damage
already done, but to put changes in place to prevent a re-occurrence.
However, we should not restrict our application of causal
analysis just to incident management situations, where application is
retrospective. Root cause analysis is a
useful preemptive tool when considering any changes considered for your
laboratory operation. As you well know, not all problems rise to the level of
an Incident, and not all issues are negative. Many issues simply occur out of evolving needs, but they all may require
changes in how the laboratory operates.
Here are some scenarios to illustrate evolving needs:
on staff are requesting new endocrinology tests and that these should be
performed in-house, but the present chemistry analyzer cannot perform
these. Buy a new instrument ?
2. More test
requests are coming to the laboratory earlier in the day with pressure to get
the results out sooner than previously; staffing may not be adequate to handle
3. You have
a new LIS and you are having performance issues with staff not doing all the
documentation required when reporting stat results, panic values and other
calls to nurses or physicians.
All of the above have obvious “common sense“ responses: meet physician needs with new
instrumentation, hire more staff, and perform more training -- if only it were
that easy! -- but there are other factors
to consider, such as cost, efficiency, shift responsibilities and
institutional resources available. This
is where preemptive root cause analyses are needed. By asking the right questions, delving into
the real origins of these issues and including discussions with all parties
involved, you can develop solutions that satisfy both the needs of the
physicians and the resource limitations
of the laboratory and institution.
For examples of some of the questions:
1. Why is it
necessary for all these new tests to be performed in house? What is the projected volume? Is it
sufficient to warrant investment in new
instruments? Or is this a turnaround
2. Why are
test orders coming in earlier? (Perhaps
a root cause is that test results presently are not available in time for
afternoon rounds; if so, why are test results delayed? Would it be a staffing issue? An
instrumentation issue? Test reporting
3. Why is your staff having problems with documentation? Is it a lack of training? Time? The clarity of the procedures involved?
Once these questions are answered, you may find that your
responses are not the obvious ones first considered. Delve into the causal factors of all issues;
once you get to the true cause, you can then arrive at your decisions with
greater confidence that the issues have been effectively addressed.
The development of personalized medicine holds the promise
of radically changing the practice of medicine from reactive to proactive. Historically,
medical treatment was initiated as a response to the symptomatic onset of
diseases -- and, because we haven’t fully understood the genetic and
environmental factors that cause diseases such as cancer, Alzheimer’s and
diabetes, our efforts to treat them have often been imprecise, unpredictable
Personalized medicine is changing this paradigm; it is
defined as the tailoring of medical treatment to the individual characteristics
of each patient during all stages of care, including prevention, diagnosis,
treatment and follow up. This approach relies on understanding how a person’s
unique molecular and genetic profile makes them susceptible to certain
diseases. Scientists advanced the cause of personalized medicine with the
decoding of the human genome.
New gene-based and other molecular diagnostic laboratory
tests can also be used to determine the benefits and harms for an individual of
taking certain medications. These tests are known as companion diagnostics.
Information on an individual’s drug metabolism, for example, can yield
information on who might benefit most from a drug and those at risk for
atypical adverse reactions. Tests can also inform the optimal dose or treatment
frequency needed to achieve a desired therapeutic effect in an individual
The advent and continuing evolution of personalized medicine
also offers significant challenges and opportunities for laboratories.
- Since personalized medicine can define the risk of
developing specific diseases, the challenge will be for laboratories to work
with physicians to integrate traditional diagnostic testing into specific risk
assessment profiles. These individualized test profiles will be key in
supporting personalized prevention and diagnosis efforts.
- Personalized medicine often begins with the primary care
physician. In addition to ordering traditional diagnostic tests, primary care
physicians will be ordering genomic-based tests that they are far less familiar
with. Laboratories can add value to the physician's practice through education
to physicians, nurse practitioners and physician assistants.
- By providing interpretations of genomic test results,
laboratories will strengthen their role of consultant, influencing the
management of patients and related clinical outcomes. Thus, lab managers will
need to join the healthcare delivery team and play a role in patient management.
- The challenges that labs will face in offering panels of
new tests for early disease detection are many. New offerings will likely
affect every function of the lab, including staffing, processing, equipment
purchases, results reporting, billing, validation and continuous education and
One of the inevitable experiences of managing a workforce is
dealing with difficult employees. In the broadest sense, we mean those who have
demonstrated a lack of responsible behavior; but in a laboratory, where the
continuum of work goes well beyond specimen testing (analytical) to include
interaction and communication with the public (pre and post-analytical) as well
as with other professionals, the concept of difficult must include the lack of
professional behavior as well. This applies to all levels of laboratory staff
from phlebotomists to supervisors.
The term, “difficult,” can result from very tangible,
measureable occurrences, such as not meeting performance requirements and
goals, not adhering to official policies and procedures and acting out in ways
that have resulted in official complaints or have otherwise been observed and
documented. Often, this can be serious enough to be considered harmful to the
reputation of the laboratory. However, “difficult” can also be a very
subjective term – to include behavior that is considered unpleasant, exhibiting
attitudes that hurt morale (including the quaint term “trouble-makers”) and
include disrespect to fellow staff as well as management.
Of course, there are many reasons employees may be, or
become, “difficult,” and management should attempt to discern why this is
occurring. There may be personal and/or health reasons; stress factors, such as
the lack of proper communication to the staff of new expectations; lack of
organization; lack of adequate training; and lack of preparation before major
changes in operation are introduced.
Well-managed laboratories (and their parent organizations)
should have in place a clearly defined process for dealing with difficult
employees, escalating from verbal discussions and delineated expectations for
change thorough counseling, warnings and documentation of progress or failure
all the way to termination.
All this seems quite straight-forward, but as in all things
human, complications can arise. Subjective components of this determination
must be handled especially carefully. In these cases, one must ask, “Is there
another side to this? Are we dealing in perceptions rather than reality? Are
there other possible reasons for any change of behavior? If there are health or
emotional issues, can these be addressed differently, such as through Employee
Assistance Programs?” Discussions with the employee involved should at least
offer an opportunity for clarification.
Now for the kicker: suppose the employee in question is the
most productive (technologically) in the lab, and that termination would
definitely affect the productivity and, yes, even the quality of testing
performed. With all else being equal, how much should this enter into your
decision to terminate your employee? Should you pre-emptively ensure that you
have resources to back up this loss? Or should you attempt to isolate this
person and allow them to work with the least interaction with your other staff
(“Moving you into a position that ensures a better match between the needs of
the lab, and your skills and experience (not to mention your personality.”)?
What do you think?
One of the refrains I hear at every professional gathering
is how so many of our issues would be resolved if we could just get the word
out about our profession -- that is, if we could just educate other healthcare
professionals about our work. If we could just educate the public about how important
laboratory testing is; that our work is the basis for 70 percent of all
physician medical decisions; that, with 13 billion tests performed annually, we
directly affect healthcare decisions for millions of people.
All in all, we are eternally searching for the pathway, the
right strategy, that will deliver us from this obscurity; that, once this is
achieved, we will emerge into the sunshine to assume our rightful place of
public recognition and appreciation. From that place, we will gain traction for
better compensation, better working conditions and, as a result, larger numbers
of younger people will flock to our profession with the knowledge that they can
realize their desire to help people, become part of the healthcare continuum
and be properly recognized, compensated and appreciated.
Well, guess what?
Unless we personally take the initiative and pro-actively reach out,
Nirvana will always be a yearning away.
What can you do as an individual? What can you do as an experienced
member of our profession? You can get out and speak! So many of us belong to
other groups in our lives, whether related to hobbies, politics, religion,
exercise, social, whatever -- we all interact with “the public” apart from our
profession as friends and fellow group members. This opportunity to act is
staring us in the face. Think about it. We
can speak to various groups of people who really are the “general public,” but
we would not be speaking to them as strangers, rather as friends, neighbors, colleagues,
fellow religionists -- peers! We would
be speaking and possess the credibility of familiarity and friendship. This is where we could really talk about what
we do with passion, with knowledge, with care, to our audience. We would not only be informing them about our
profession in a way that helps us get the word out, but helping them to
understand better their own experience with, and benefits derived from, their
laboratory test interactions.
All we need is to…. just do it!
In the previous blog, we discussed the factors that make one
shift different from another, and how an awareness of these differences is
important for the proper management of the workload and staffing for these
shifts. Since each shift is part of the
continuum of the lab operation for that day, when chronic problems are
happening on a particular shift, it is important to determine if the problems
are centered within the shift, or are interrelated to the shifts that precede
or follow as well.
Below are some of the many factors that need to be
considered when performing a root cause analysis of problems that may occur on
- Total workload per person
- Total workload per person compared to other shifts
- Training and Competency of staff working each shift
- Permanent staff / shift ?
or does the staff rotate to/from other shifts
- Presence or availability of supervisory staff during the
- Awareness of personality differences and conflicts between
- Evaluations: are they designed for the specific tasks and
responsibilities for each shift and performed by supervisory personnel who are
familiar with the operations of that shift?
- Appropriateness of instrumentation for different workloads
and test menus
- Shift specific policies governing routine and STAT orders,
including which tests are included in each category, and expected turnaround
- Support when needed during each shift
- Policies for performance of quality control, calibrations,
and maintenance during each shift
- Policies for test management when expected testing cannot
be performed on each particular shift
- Inventory control
- Shared work between shifts: policies governing testing
already underway when next shift begins
- Availability of policy and procedure manuals, other
resources on every shift.
- Ability for all staff
to participate in laboratory meetings and continuing education
- If rotating staff: proper training for work on each shift.
- Communication with other departments that interact with
the laboratory: ER, ICU, Radiology, Respiratory Therapy, Outpatient.
- Expectations of Physicians, Nursing staff and other
professionals for turn around times for STAT and routine orders
- Have nurses and others external to the laboratory been
trained on proper specimen collection, labeling and handling?
- Listen to and act on all complaints and other feedback
from lab staff, physicians/nurses, and patients as soon as possible.
- Proficiency Testing needs to be performed by each shift
- QA each shift
- Review workload changes annually to adjust staffing levels
and instrumentation if appropriate.
These are not all the factors to be considered, of course,
but for effective corrective actions and the maintenance of quality standards,
these make a good start when getting to the root cause of chronic problems
occurring on different shifts.
Have you noticed that when you work a different shift, it
almost feels like you are working in a different lab? Whether we compare
day/evening, evening/night or night/day interfaces, we often have different
priorities, different responsibilities and different ways of communicating with
our clients. The outside world views the laboratory as a cohesive operation,
whether 24/7 or 9/5, and expects the same level of quality, turn-around time
and staff expertise, regardless of when testing occurs.
Of course, while many labs are busiest during the day,
especially those that serve physician offices, group practices, and hospitals,
there are many that are busiest in the evening or on the night shift, such as
reference labs, or Walk In / ER Clinic labs. Test volume is the single greatest
determinant of how the lab is organized for each shift: it determines test
menus, instrument needs, staffing size and specialty experience, extent of
automation for specimen handling, tests performed, results reporting, and
documentation. As a result, determinations are made as to when it is best to
perform instrument maintenance, calibration, quality control, performance
specifications, and staff training.
Of course, just because another shift may have fewer staff,
a limited test menu, and a different set of priorities, doesn’t mean that there
should be any less effort to ensure that the staff is properly trained on any
changes to the lab operation. The continued evolution of laboratory information
technology has made maintaining consistent record keeping among all shifts
easier to achieve, and monitor. But just because of these advances in
technology, we cannot overlook the need to constantly monitor staff competency,
especially for those who work alone, or nearly alone, on their shifts. On many
late shifts, there may be no supervisor on site, and there is the possibility
that the expected competency may not be maintained. Also, over time, each shift
develops its own culture, and in small ways, may individualize how some procedures
determinations of the type and variety of work to be done on any shift are made
based on how busy the staff is during their shift, and many labs choose to add
responsibilities rather than reduce staffing if the workload is unpredictable.
Many labs will have the night shift prepare and/or run the quality control
prior to the day staff coming in; or have the evening shift perform some of the
routine instrument maintenance. Any shift might check inventory. All these
determinations should be done through a realistic assessment of what can be
achieved in the way of routine work, in light of the priorities set for that
Through it all, regardless of what shift is involved,
efforts must be made to encourage a sense of community, trust, competency and
communication among all staff. If the lab staff is fragmented, or feels that
other shifts are treated in a better manner, this will definitely impact the
quality of work, as these issues can lead to distrust, miscommunication and
lack of teamwork.
Next Blog: Part II: Issues
The laboratory profession is changing so quickly that
sometimes it is hard to keep up. Not only are we impacted technologically with
new tests, new modes of communication and new venues for storing and retrieving
data, but we are seeing innovative use of advanced technologies for our routine
testing (hello, LC/MS?). In addition, our whole regulatory environment is
changing just as fast. Add in wholesale changes to the very structure of
organized medicine (goodbye private practice, hello Integrated Healthcare
Networks). All these changes m -- whether on a macro institutional level, or micro,
departmental level -- impact our laboratories. More than ever, we must respond
by utilizing effective personnel training. It is the key to adapting
successfully to our changing times.
An important precept to begin with is “training is not just
telling.” Effective training must be well organized and strategies utilized to
ensure that the trainee understands the why and the when, not just the how, of
performing a procedure or following a policy. This is true whether the
laboratory trainee is a medical technologist or a medical assistant. It’s a
human thing. You get better performance and increased retention when a person
understands the rationale for the steps that have to be followed and the
consequences of not following directions (both for the trainee and the
An effective trainer should present the material in a
sequential manner, articulating clearly all the steps involved. Effective
training is interactive, ensuring that your trainee indeed understands the points
you are making, and allows for questions and clarifications. An effective
trainer utilizes supplementary visual materials, whether printed or electronic,
and employs scenarios -- especially when training about new policies and
protocols. Effective training may also mix the practical with the didactic
“hands on,” alternating with instructional modes -- not only for new
instrumentation and kits, but when training about quality control and quality
In some cases, such as with new, lesser experienced
employees in highly complex situations, it may help to assign an experienced
tech to act as a mentor or buddy for a period of time.
The world of laboratory medicine is a complex place, and grows
more complicated daily. All of us need ongoing effective training if we are to
maintain the highest level of quality care in this new environment.
I have never seen a well-run laboratory, providing quality
patient service, that did not have complete up-to-date and well-organized
procedure manuals. But the implication
of “procedure manual” as a descriptive term is really incomplete. It is more
than just the step-by-step directions for performing a test. If that was all we needed, then the
manufacturer’s insert would be far more than sufficient. A complete procedure
manual must also include all operational steps from the pre-analytical patient
preparation and sample integrity to post-analytical reporting protocol for
each test and each test system.
Before putting together or updating your procedure
manual(s), you should be aware of what CLIA requires and/or the requirements
of your accrediting organization. These
requirements include (but are not limited to):
for specimen collection, rejection, labelling, processing and storage
step of the procedure (including calculations and interpretation of results)
and Calibration Verifications
Range and Reference Ranges
- Steps to
be taken if your test system is down, and you cannot perform testing as
and Trouble Shooting procedures
lab referral protocol
- How the lab
reports and stores results.
It is acceptable to utilize manufacturers’ inserts as the
basis for describing test procedures, but additional required information must
also be present.
But there is so much more. It is also helpful to consider the development and use of procedure
manuals as a separate organizational piece of the laboratory operation. Why? Because, in addition to the requirements
listed above, you must add in the personnel component:
of all new personnel and training of all personnel to new/revised procedures
- It is
the source of information regarding the communication of test results, panic
values, problems with specimen acquisition and operational problems to
internal (clinic/office) staff as well as external customers, including physicians, nurses and patients.
There is also an organizational component:
procedures should follow the same format and organization.
procedures must be approved, signed and dated by the laboratory director. This process must be repeated anytime the lab
- Annual reviews by the
laboratory director or by technical supervisors.
procedures must be retained a minimum of two years; signed and dated when discontinued
procedure manual must be readily accessible to personnel, preferably in their
Thus, when we discuss procedure manuals, we are really
discussing a key component of laboratory quality matrix, involving not just the
test procedures themselves, but personnel, organizational and regulatory requirements.
We all want our employees to succeed; that is, do well in their job, and do their job well. This requires more that the didactic aspect of training, and goes beyond competency assessment. This requires the skill and intuitive ability of the manager to understand and apply what motivates their employees to do as well as possible, as well as moving beyond defining boundaries when staff do not meet standards.
Essentially, motivating your employees effectively means understanding the human component of work. While we are Professionals with a capital P, we are also human; both positive and negative reinforcement are essential to get the best out of our staff.
The plain fact is that everybody watches everybody else; how their fellow staff are treated; wary of any hint of favoritism or unfairness. So, we need to go beyond implementing and using the important dictums of clear communication, transparency, and competency, to an awareness of not just what you are communicating, but how you communicate: the language that is used: the tone, the volume, your body language; your concern and your sincere involvement.
Once an employee has achieved competency, and is doing their job well, how often do they get recognized, praised, and rewarded? How often are they told that their efforts are not only saving lives, maintaining the quality and integrity of the laboratory and their organization, but serving as an example and inspiration for their fellow staff. How often do you instill pride in your staff?
If an employee is not performing to standards consistently, do you go beyond discipline? Beyond retraining? Do you try to find out if anything else is going on that is affecting their performance? This is not to say, you should go where you are not welcomed, but that you communicate your readiness to listen to your staff if they wish to talk to you about other issues?
How cognizant are you about the dynamics of your laboratory culture? Are you aware of the politics and power plays that go on, that may also affect performance? Do your supervisors share your philosophies of management? Do your employees feel comfortable having a private conversation with you about factors that may affect their work?
Good, solid, competent and experienced staff are to be valued and supported; when things go awry, you may have to look beyond training and competency assessment to the human factors that govern behavior, and by extension, performance.
The result is truly effective management; and this aligns with driving quality laboratory medicine.
By the way, who do you talk to?
We have all been in situations where we start our workday, and find the unexpected has happened, and that we cannot proceed as planned. Frustrating! From the viewpoint of a laboratory professional, this can include all those situations that prevent us from fulfilling our responsibilities to perform the testing ordered, and to report the test results in a timely manner.
These situations can include problems with:
- Instruments and Kits
- Quality Control / Reagents
- Inventory control ("what do you mean that we are out of test packs?")
- Personnel issues: sudden short staffing; performance errors; injuries on site.
- Ancillary system malfunctions such as refrigeration and incubation failures
- Computer / Laboratory Information Systems down
- Utilities out; leaky plumbing in the work area......anything!
The bottom line is that when these occur, the laboratory cannot deliver what is expected.
How do you handle this? After all, patient care is on the line; physicians are expecting test results in a timely manner; and there may be Stats among these orders. Without a plan, the credibility of the laboratory is at stake.
Whether the service interruption is a temporary delay measured in hours, or one that lasts for several days (or longer), the laboratory must have plans in place for dealing with service interruptions. These should include:
- Protocol for contacting the ordering physicians as soon as you know there will be a significant delay;
- Procedure for accurately informing the rest of the laboratory staff what has happened; so if they receive calls about the delayed work, they will have an informed response.
- Procedure to inform other departments in the facility if their work will be affected by these delays.
- Procedures for when and which specimens are to be retained or sent out for testing, depending on the length of the delay; and which laboratories to use for referred testing.
- Procedures for reporting test results if it is the information system that is not operating.
- Protocol for delays longer than one day.
Effectively planning for these situations, (as much as one can) will go a long way toward reducing stress for the staff, allowing them to focus on the tasks at hand; ensure proper communication to your clients, and preserve the credibility of the laboratory for its professionalism and quality.
By Irwin Rothenberg and Nancy Alers
In recent years, the concept of quality monitoring for laboratory testing has broadened beyond quality control focused on the analytic phase, to encompass the entire spectrum of the testing process from the physician's order through the final report. The impetus for this has been the realization that "up to 70% of all errors made in laboratory testing occurs during the pre-analytic phase, most of which arise from problems in patient preparation, sample collection, transportation, and preparation for analysis and storage."1
It is somewhat surprising to think that we are just now recognizing the importance of quality monitoring in the pre-analytic phase. However, unlike the analytic and post analytic phases, the processes of the pre-analytic phase often involve personnel that are not under the direct supervision of the laboratory, making it more challenging to control.
In house, laboratories must check the orders received for accuracy and completeness. One thing that is often overlooked is the importance of providing correct instructions to the patient for the self-collection of specimens. Patients may need to fast, observe specific guidelines such as the clean catch urine procedure, or collect samples over a 24 hour period prior to testing. Not following the correct instructions for sample collection has a direct impact on the quality of the samples received.
Next, the specimen labeling system and patient identification procedures must be in place and followed. It is imperative that labs utilize at least two unique identifiers for the correct identification of patients and their specimens.
For phlebotomy related tasks, it is recommended that labs assess the competency of all drawing staff, whether they are part of the laboratory or not. This includes nurses, respiratory therapists, medical assistants, anyone who draws blood or collects other specimens for laboratory testing. It is a good idea to track all rejected specimens, making sure to specify the reason for the rejection. For example, an increase in the number of samples rejected for insufficient quantity; for hemolysis; wrong vacutainer utilized, and so on, may point to a phlebotomy training issue that needs to be addressed.
Equally important is specimen handling and transport. A specimen collected properly is not going to be of use if it is not handled and transported correctly. Are specimens centrifuged and aliquoted within the specified time? How about refrigeration or freezer requirements if testing cannot be performed immediately?
Specimens received from outside collection sites pose a different risk for laboratories. Upon receipt of specimens, utilize a checklist to ensure that all the above requirements have been met prior to accepting the specimen. A specimen rejection policy is a must.
Your Quality Assessment plan should include evaluations of all phases of the testing process to ensure that errors detected have been addressed effectively.
- Quality Indicators To Detect Pre-Analytical Errors In Laboratory Testing. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC3428256. Last accessed July 28, 2014.
By Irwin Rothenberg and Nancy Alers
When a laboratory report must be corrected, and the amended results are sent to the ordering physician, questions may be raised regarding the quality of the laboratory work; the proper operation of the instrumentation involved; the competency of the testing staff, and whether the laboratory director or technical consultant/supervisor were fulfilling their oversight responsibilities.
While the report is the end result of the testing process, the reasons for the release of an erroneous report must be investigated, and the investigation may need to go all the way back to the pre-analytical phase, from test ordering to specimen collection and handling, through the analytical phase (instruments/reagents/staff competency), to the post-analytic phase that includes verification of the LIS (lab information system) for automated and manual results transfer.
Of course, erroneous reports may be due simply to a manual transcription error, initial verbal reports that were misunderstood; or a manual patient mix up. But as simple (though serious) as these are, the reasons these occurred at all still indicates a problem that may involve the core issues of oversight, training, communication and documentation.
There needs to be a formal laboratory policy and procedure for the correction of erroneous laboratory reports (after the correct results are obtained), and for sending amended reports as soon as possible.
These should include the following policies:
- Identify who to notify when the error is detected?
- Document all steps taken to correct the error;
- Provide the ordering physician with the corrected report;
- Retain the original report and the corrected report for future reference
- Perform a Root Cause Analysis if systemic issues are involved; if serious enough, perform an Incident Management study.
- Alternative contact plans if the laboratory is unable to reach the ordering physician or provider in a timely manner.
- Inclusion of this event as part of Quality Assessment; include follow up to ensure that the corrective actions taken were effective.
Following these policies and procedures will ensure a consistent quality laboratory response when erroneous reports are issued.
When we discuss the characteristics of a quality laboratory, we naturally look at those areas of the laboratory operation encompassed by CLIA/AO requirements, including Personnel training and Competency Assessment, Organization, Instrument Verification, Quality Assessment, Record Keeping and Documentation, Proficiency Testing, Facility safety, and so on.
However, one area that is often overlooked when assessing factors that contribute to quality laboratory work is the appropriateness and "do-ability" of the test menu. In fact, this is really such a fundamental aspect of the lab operation, that problems in this area affect everything else.
Whether you are planning a new, start-up lab operation, or performing a cost/benefit analysis of current testing, or thinking of purchasing a new or replacement instrument, you must do a realistic assessment of not only what you want to offer your patients, but what you can realistically offer your patients.
When your instrumentation/test menu creates problems with staffing, time management; work overload, and expiration of unused reagents; when quality control, calibration and maintenance requirements exceed test time for infrequently utilized instruments ... you've got problems!
Your decision making should first include a cost/benefit analysis:
- Instrument cost (purchase or lease?)
- Reagent cost (are you obligated to purchase reagents from a particular manufacturer?)
- Reagent life (expiration dates: days, weeks, months before/after opening packages)
- Storage requirements (buying a new refrigerator or freezer?)
- Calibration, maintenance frequency.
- Tests run singly or in batch mode?
- Comparison to reference laboratory charges and turn-around time
- Staffing requirements: number, training expenses; qualifications and experience beyond present staffing; continuing education.
- Proficiency testing
- Facility space, ventilation, electrical needs; hazardous disposal requirements
- Time and involvement of the lab director, and the technical consultant
- Document storage requirements/LIS capacity
- Adjusting the front office staffing to handle additional pre and post analytical paperwork and communications.
Of course, providing the highest level of service for your patients may justify costs associated with the above considerations, but you must right-size the instrumentation to meet the demand in terms of test volume capacity, variety of tests offered, operating times and staffing. Having a laboratory with excess capacity and operating requirements can ultimately bankrupt a practice. Investigate what instruments can meet your present needs, and for the near future, and be cost effective.
In today's world, when compensation for laboratory testing is constantly under pressure, right-sizing your lab means better financial health; better resource utilization, and ultimately, better service for your patients. This spells Quality!
Were you ever one of those techs that questioned the utility
of parallel testing? Ok, I admit it, me
too! I used to think that lot-to-lot verification, also referred to as
crossover studies or parallel testing, was a nuisance, but that is because I
didn’t fully understand it. Therefore, I get it when customers call me with
questions about this process. In fact, lot-to-lot verification is one of the
hot topics of the CQA line.
Simply put, parallel testing helps ensure the integrity of
the new lot before it is used. Parallel testing helps us assess: 1) the integrity
of the lot (kit, controls and reagents) and 2) lot performance or, in other
words, ensures that the recovered expected results are accurate. It is
essential to assess the integrity of the new lot before being used and to
ensure that there were no changes during shipment. This is particularly
important if there is any chance supplies were subjected to drastic climate
changes in transit.
While qualitative tests just need to have positive and negative
reactivity verified, quantitative assays need to be verified over a range of
values. Generally, five values are considered adequate when verifying a new lot
number.* Be sure to check the package insert and your accrediting agency’s
recommendations for specific requirements. Essentially, parallel testing, in
addition to being a regulatory or compliance requirement, is an exercise in
good laboratory practices. Here are a few tips when doing lot to lot
1. Check the lot
inventory to ensure expiration date of reagents, storage conditions and that
inventory levels are adequate to perform the crossover studies.
2. Assign the
lot to lot verification to a specific staff member or communicate to all
testing staff assigned to the bench, so as not to miss any runs. It is
recommended the verification is done over the span of a few days vs. all in one
3. Check your
accreditation agency standards and manufacturer’s instructions to determine the
number of data points or values needed.
procedure manual/package insert instructions to perform the verification.
qualitative tests, the laboratory must ensure positive and negative reactivity.
quantitative test, if the new lot results are within the manufacturer’s
specifications or the criteria established by the lab director, then the
verification was successful.
7. Make sure to
analyze the data and note any calculations needed. Remember, documentation is
laboratory director or designated person must review and evaluate the
verification and determine if it was acceptable or not.
9. If the
verification is not acceptable, be sure to perform a root cause analysis and
implement a corrective action plan.
Have you ever had a situation where the current lot runs out
before the new lot gets verified? How did you handle that?
*COLA Laboratory Accreditation Manual, April 2014
An ongoing concern among our laboratories is how to ensure
that bedside or remote laboratory testing is of the same quality as that performed in-house.
Technological advances have resulted in an explosion in the number of tests that can be
performed outside the laboratory setting; locations include the operating
room, the nursing station, bedside, and nursing homes to name a few. More than ever, the laboratory must be proactive in monitoring this if
quality care is to be maintained. This
means that all point-of-care testing (POCT) personnel must be properly trained
(with the training documented) and have
their competency periodically assessed, even if all of their testing is waived. All instruments involved should be used in
accordance with manufacturer’s requirements with quality control, calibration and maintenance records monitored; and
test results verified to accuracy and (if the patient has been previously
tested) consistent with a patient’s history. Don’t forget to monitor reagent storage and handling as well. Utilization of split sampling and proficiency
testing is also recommended for monitoring quality.
Many laboratories, mindful that POCT may be performed
by non-laboratory staff, often have a staff tech responsible for monitoring
this testing, acting as both a liaison to
the laboratory as well as a technical resource for the POCT staff. This is an important responsibility, as
feedback from the field to the laboratory is needed to identify potential
communication problems, complaints and the needs of both patients and staff.
In this new era of the Affordable Care Act and PCMH, the
same standards now apply to POCT as to in-house laboratories: the need
for efficient test utilization, the
importance of interfacing remote test
results with all laboratory testing on that patient and ensuring that all healthcare providers have the same access to these
results as they would for in-house testing. New generations of POCT instruments have interfacing capabilities.
There is even talk of using smart phone technology for
performing certain tests (such as reading indicator strips) and interfacing
these results with the patient database. I can almost see the vision of the
original Startrek infirmary where Dr.
McCoy diagnosed his patients with the use of a Medical Tricorder.
The bottom line is that there should be no difference in the
quality of patient care provided by the laboratory, whether performed within
the confines of the laboratory itself or anywhere else. Ultimate
responsibility lies with the laboratory administration and staff.