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CRI Lab Quality Advisor

Cyber Insecurity
January 29, 2016 11:42 AM by Irwin Rothenberg

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 even thermostats.

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.

Do You Speak IT? (Part 2)
January 11, 2016 11:35 AM by Irwin Rothenberg

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 vs. Information Exchange
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.

Population Health
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 Nomenclatures
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 the information.

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 preemptive importance.



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

Do You Speak IT? (Part 1)
December 21, 2015 10:44 AM by Irwin Rothenberg

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 continued modification:

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.

2. Informatics
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.

4. Optimization
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

How Resilient is Your Laboratory?
December 7, 2015 8:23 AM by Irwin Rothenberg

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 Dark Daily.1

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 organizational mergers.

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 Resilience?2
The properties necessary for resilient organizations include:

Top-level Commitment: 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.

Learning Culture: Issues, problems, events and errors are handled with an eye toward repair and true reform, not denial.

Opacity: Management is aware of the laboratory’s proximity to serious problems and events due to weaknesses inherent in their operation.

Awareness: Management collects ongoing data to gather insight into quality of performance, problems and the state of safety defenses.

Preparedness: Management must actively anticipate problems and prepare for them.

Flexibility: New 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 Evolving Role of Clinical Laboratory Consulting
November 18, 2015 2:44 PM by Irwin Rothenberg

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 medical decisions.

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 care.

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 physicians.

Controlling Specimen Identification Errors: A Quiz
October 26, 2015 10:55 AM by Irwin Rothenberg

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.

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 labels.
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?
A. Mislabeling
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 approach.

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. https://www.pathology.med.umich.edu/intra/LabSafetyRept/March.April2007.pdf

Adding New Staff to an Old Team
October 6, 2015 8:00 AM by Irwin Rothenberg

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. 

Laboratory Testing: Reflecting Our Changing Society
September 18, 2015 5:54 PM by Irwin Rothenberg

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 and opiates.

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 reliable.

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

Assess the Quality of Your Waived Testing
September 2, 2015 9:30 AM by Irwin Rothenberg

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:

-              More 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:

1. Self-assessment 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.

Don’t Be Careless About Lab Safety
July 13, 2015 1:50 PM by Irwin Rothenberg

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:

- Always 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 gets hurt.

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 work.

Finally, emphasize that safety awareness doesn’t end at the laboratory exit, but encourage the same safety-consciousness throughout your facility. 

Cultural Competence
June 25, 2015 3:55 PM by Irwin Rothenberg

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.

Urine Drug Screen Reports Can Change a Life
May 27, 2015 4:40 PM by Irwin Rothenberg

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:

-              Pre-employment
-              Suspicion of drug abuse (e.g., unexplained negligence/impairment/behavior)
-              Random testing outlined in employment contract
-              Military service
-              Sports participation
-              Legal/criminal (e.g., post-accident, parole, date-rape)
-              Drug-therapy compliance monitoring
-              Drug abuse rehabilitation monitoring
-              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:

-              Dilute urine (excess fluid intake, diuretic use, pediatric sample)
-              Infrequent drug use
-              Prolonged time since last use
-              Recent ingestion
-              Insufficient quantity ingested
-              Metabolic factors
-              Inappropriate test used
-              Elevated urine lactate
-              Tampering:

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.

Trending… EQC to IQCP: All Aboard!
April 16, 2015 1:29 PM by Irwin Rothenberg

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.

-              The 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. 

These include:

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.



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