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CRI Lab Quality Advisor

Strong Staff Morale: Your Umbrella for the Perfect Storm
March 24, 2015 12:21 PM by Irwin Rothenberg

The next thirty years comprise a perfect storm scenario for laboratory medicine in terms of meeting professional staffing needs:

-              Millions more people will be insured and able to access the healthcare system far more comprehensively than ever before, including laboratory services.

-              Millions of baby boomers adding to the post-65 year old demographic, requiring more frequent and intensive healthcare, including laboratory services.

-              Significant numbers of boomer clinical laboratory professionals are part of this retirement tidal wave, contributing to the shortage of available staff.

-              The continued rapid development of advanced technology such as molecular genetics, requiring ever more sophisticated instruments and advanced training by staff.

-              Increased competition from other healthcare professions that are able to promise and deliver on better working conditions, higher compensation and greater recognition.

-              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:

-              Chat 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.

-              Recognize 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.

-              Recognize and celebrate personal mile-stones, such as birthdays and employment anniversaries.

-              Support 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.

-              Be 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.

Effective Laboratory Medicine in the Era of Individualized Healthcare
March 2, 2015 10:30 AM by Irwin Rothenberg

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:

•             The physician directly
•             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 immediate help.

Pre-emptive Causal Analysis Applied to Change-Decisions
February 16, 2015 12:23 PM by Irwin Rothenberg

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:

1.            Physicians 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 this need.

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 time issue?  

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 problem? )

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.

Personalized Medicine: Opportunities and Challenges For The Laboratory
January 12, 2015 5:16 PM by Irwin Rothenberg

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 and ineffective.

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 patient.

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 training.

Difficult Employees
December 17, 2014 9:52 AM by Irwin Rothenberg

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?

Just Do It!
December 1, 2014 11:51 AM by Irwin Rothenberg

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!

Different Shifts, Different Worlds -- Part 2: Factors To Consider
November 13, 2014 11:51 AM by Irwin Rothenberg

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 any shift:


- 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 shift

- Awareness of personality differences and conflicts between shift staff

- 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?

Policies and Procedures

- 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 times.

- 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

Internal Communication

- 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.

External Communication

- 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.

Different Shifts, Different Worlds -- Part I: Consistency Between Shifts
October 20, 2014 11:38 AM by Irwin Rothenberg

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 are performed.

 Of course, 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 shift.

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 Between Shifts

Training Isn’t Just Telling
October 2, 2014 5:16 PM by Irwin Rothenberg

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 patient).

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 assessment procedures.

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.

Procedure Manuals: Integral Part of the Laboratory Quality Matrix
September 17, 2014 10:25 AM by Irwin Rothenberg

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):  

-              Instructions for specimen collection, rejection, labelling, processing and storage

-              Every step of the procedure (including calculations and interpretation of results)

-              Calibration and Calibration Verifications

-              Quality Control

-              Reportable Range and Reference Ranges

-              Panic Values

-              Steps to be taken if your test system is down, and you cannot perform testing as expected

-              Maintenance and Trouble Shooting procedures

-              Reference 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: 

-              Training 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:

-              All procedures should follow the same format and organization.

-              All procedures must be approved, signed and dated by the laboratory director. This process must be repeated anytime the lab director changes. 

-        Annual reviews by the laboratory director or by technical supervisors.

-              Discontinued procedures must be retained a minimum of two years; signed and dated when discontinued or replaced.

-              The procedure manual must be readily accessible to personnel, preferably in their work area.

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.

Beyond Competency
August 27, 2014 12:55 PM by Irwin Rothenberg
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?

Operational Failures
August 12, 2014 3:07 PM by Irwin Rothenberg

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.

The Error-Prone Zone
July 28, 2014 11:55 AM by Irwin Rothenberg

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.


  1. 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.
Correcting Laboratory Report Errors
July 1, 2014 11:29 AM by Irwin Rothenberg

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:

  1. Identify who to notify when the error is detected?
  2. Document all steps taken to correct the error;
  3. Provide the ordering physician with the corrected report;
  4. Retain the original report and the corrected report for future reference
  5. Perform a Root Cause Analysis if systemic issues are involved; if serious enough, perform an Incident Management study.
  6. Alternative contact plans if the laboratory is unable to reach the ordering physician or provider in a timely manner.
  7. 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.

Right-Sizing Your Lab
June 19, 2014 11:35 AM by Irwin Rothenberg
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!



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