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CRI Lab Quality Advisor

Value-Based Mobile Technology
June 22, 2016 2:21 PM by Irwin Rothenberg

Two powerful forces have converged to change the practice of laboratory medicine in ways never imagined a generation ago. These twin forces are the movement to value-based healthcare from the fee-for-service model and the rapid development of mobile technology, allowing for continuous healthcare monitoring of patients beyond the clinical setting.

The central focus of value-based medicine is increasing the value of medical services provided for patients based on the health outcomes achieved per dollar spent. The goal is to achieve good outcomes efficiently. This is the most effective way to truly contain costs in healthcare. Achieving and maintaining good health is inherently less costly than dealing with poor health; reminiscent of the old adage, “An ounce of prevention…”

Laboratories can impact the value proposition by increasing the speed and accuracy of correct diagnoses, monitoring patient health to prevent disease, providing rapid turnaround times that allow reduction in length of hospital stays and promoting the most appropriate test selection options with applicable interpretations in order to help avoid adverse events and point to the most appropriate treatment protocol. Translating concept into practice, however, can be challenging. Generally, the biggest hurdle is obtaining the necessary data, which must be in the right format and of sufficient quality for decision makers to gain the medical information they need.

This is why point-of-care testing (POCT) has become the fastest growing area of laboratory medicine, bringing laboratory testing conveniently and immediately to the patient. The new technology is the merger of molecular biology, information technology and biomedical engineering. POCT increases the likelihood that the patient, physician and care team will receive the results sooner, allowing for more immediate clinical management decisions. With fast turnaround times and portability to a variety of settings, POCT offers many advantages for disease management. It enables migration of testing from core hospital labs to specialty-care units, doctors' offices and homes to provide access to healthcare services, thus improving patient compliance, reducing hospital stays and lowering overall healthcare costs.

It is this need for immediacy in data collection and dissemination that is further driving mobile technology beyond POCT to wearable technology, monitoring everything from glucose levels to cardiac function. This cuts costs, as well as increases connectivity and provides the platform for shared medical data in real time.

This new mobile technology is based on the same mobile platforms for telephones and tablets. It is expected that mobile technology will allow virtually universal quality, cost-effective preventable healthcare -- even in lesser developed countries -- in much the same way that mobile phone technology has allowed countries to leapfrog beyond landline phones to the cell phone era and all its possibilities.

It is now clear that the tech industry sees medicine as the next frontier for exponential growth. Companies such as Apple, Google, Microsoft and Samsung – as well as hundreds of start-ups -- also see the market potential and have big plans. This is happening because several technologies, such as computers, sensors, robotics and artificial intelligence, are advancing at exponential rates. Their power and performance are increasing dramatically as their prices fall and their dimensions shrink.

We will soon have sensors that monitor almost every aspect of our body’s functioning, inside and out. They will be packaged as wearables, watches, adhesive bandages, clothing and contact lenses. They will be in our toothbrushes, toilets and showers. They will be embedded in smart pills that we swallow. The data from these will be uploaded into cloud-based platforms

Artificial intelligence-based apps will constantly monitor our health data, predict disease and warn us when we are about to get sick. They will advise us on what medications we should take and how we should improve our lifestyle and habits.

All of this will translate to improved patient care through patient-centered preventive medicine at reduced cost, as well as more efficient treatment of both acute and chronic illnesses -- the very definition of quality care.


IQCP: Bridging QC and QA
May 11, 2016 2:50 PM by Irwin Rothenberg

It appears that there is still some confusion among laboratory personnel in differentiating QC from QA, and that this uncertainty has been compounded by the introduction and implementation of the Individualized Quality Control Plan (IQCP). These are different concepts, and it is important to understand these differences—both from the practical standpoint of what you are trying to accomplish, as well as how you get there.

Basically, laboratory quality control is designed to detect, reduce and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results in order to ensure the quality of the results reported by the laboratory. Quality control is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. Laboratory quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after calibration and whenever patient results seem inappropriate. The effectiveness of quality control is assessed on a per-test basis.

On the other hand, quality assessment is more broadly focused; it is an on-going program for auditing an organization’s processes and systems. It involves setting quality goals, deciding whether or not these goals have been achieved and implementing corrective action if these goals have not been reached. It includes auditing the effectiveness of your policies and procedures, encompasses all phases of testing and general administration. There are no limits for quality assessment audits—going well beyond the more test-specific focus of quality control.

The CLIA regulations (Subpart K) address specific quality assessment requirements. The Code of Federal Regulations (42 CFR 493) states that laboratories “must establish and follow written policies and procedures for a comprehensive quality assurance program that is designed to monitor and evaluate the ongoing and overall quality of the total testing process.” The QA program must:

1.            Assess the effectiveness of the lab’s policies and procedures.
2.            Identify and correct problems.
3.            Assure the accurate, reliable and prompt reporting of test results.
4.            Assure the adequacy and competency of the staff.

But now we have the Individualized Quality Control Plan (IQCP), which is the new alternative QC option permitted by CMS and is based on risk assessment. As such, the process of determining the appropriate IQCPs for your laboratory involves many of the elements of the traditional quality assessment process to determine the most effective QC based on examining all aspects of the laboratory operation to determine risk.

In effect, this brings the QC/QA relationship full circle, from where the traditional (analytic phase focused) QC is a key part of QA to where QA processes are utilized to determine the best QC to use. However, the one constant is that QA remains process and systems focused, while QC/IQCP is still utilized for use on a per-test basis.

Has Your Customer Service Kept Up?
April 11, 2016 1:06 PM by Irwin Rothenberg

When we discuss all the changes that laboratories have to deal with—from technical and regulatory to evolving views of healthcare delivery and service expectations—we must include how these affect customer service. Customer service is involved in every phase of the laboratory operation; it is the face of the laboratory and, thus, reflects everything that is happening.

Specifically, what are some of the new demands on customer service brought about by these changes?

• Direct access by patients to their complete medical records, including test results.
• Requests for interpretation of test results.
• Testing requests directly from the patient, without their physician orders.
• Increased interaction by patients with the laboratory through patient portals available on their computer and mobile devices. These have almost an unlimited capacity to replace in-person visits to access test information, receive information about prescribed medication and complete required signature forms ranging from insurance documents to consent agreements, as well as make future appointments for office visits, submit questions and provide comments.
• Increased need for additional communication skills since customer service personnel are now expected to provide a wider variety of information. This includes cultural sensitivity as well as additional language options to match the client population.
• Knowledge of HIPAA and other legal guidelines to be followed when imparting information.
• An awareness that social media provides a forum for both positive and negative reviews of the services provided.

Things to Consider
It is important to understand the significance of the impact of the 2014 HHS rule change, which amended both CLIA’88 and HIPAA to allow direct patient access to their test results. Laboratories must have the proper policies in place permitting this. Anecdotally, I have heard that there are still some laboratories that are still unaware of this rule change, have not adjusted their policies and still require physician permission to release test results.

It is important to note that laboratories have flexibility as to how to set up systems to receive, process and respond to access results. While laboratories are required to provide access to completed test reports, they are not required to interpret these reports.

The use of digital patient portals to access information, as well as provide input ranging from questions and comments to insurance information, has created the need for customer service staffing to include someone who can assist patients with these portals.

Social media has become an important tool for popular expression of satisfaction or dissatisfaction with specific physicians, hospitals and all other healthcare services, including laboratories. Thus, the benefits of quality customer service are multiplied in today’s environment, but the price of poor customer service is multiplied as well.

Laboratories Lead the Fight Against Zika
March 18, 2016 10:49 AM by Irwin Rothenberg

We are rapidly approaching Medical Laboratory Professionals Week, (MLPW), the annual celebration of the medical laboratory profession, and those who play such a vital role in the delivery of quality healthcare. It has been celebrated annually since 1975, during the last full week of April, and once again, the vital role of the laboratory is highlighted by recent advances in dealing with the Zika virus—a public health threat, not only locally or nationally, but also internationally.

On February 23rd, USA Today reported that Texas Children’s Hospital and Houston Methodist Hospital had developed a rapid test for the Zika Virus based on genomic research. This new test detects the presence of genetic material from the Zika virus, and this specificity allows the test to distinguish Zika virus infections from other mosquito-borne infections like dengue or the West Nile Virus. This is very significant, since Brazil, as well as many other countries in the Americas, has mosquitos that can carry all these infections, and distinguishing among these facilitates the correct response as rapidly as possible. The tests, which can be performed on blood, amniotic fluid, urine or spinal fluid, will provide results in just a few hours.

This information was provided in an interview with James Versalovic, pathologist-in-chief at Texas Children’s Hospital. “We must be prepared for a surge of Zika testing demand,” Versalovic said. “We must provide answers for anxious moms-to-be and families."

As of February 23rd, 2016, at least 82 Americans had been diagnosed with Zika after visiting areas with Zika outbreaks and returning to the U.S., according to the CDC. Health officials expect hundreds more to develop the virus because of travel, especially as Americans visit Brazil for the Olympic games this summer. The mosquito that spreads the Zika virus, Aedes aegypti, is present in the South. Many public health officials fear that the Gulf Coast could be vulnerable to Zika, due to both its climate and pockets of poverty.

All of that could put pressure on public health laboratories, which could struggle to keep up with the demand for Zika tests, Versalovic said.

Doctors will initially offer the test to people who meet specific criteria—such as recent travel to a place with an outbreak and Zika-like symptoms, which include a rash, join pain or fever. Pregnant women who have traveled to a place with a Zika outbreak also will be offered the test, regardless of whether they have symptoms, according to Texas Children's Hospital. Four out of five people with Zika infections have no symptoms.

Whenever possible, we should proudly celebrate the contributions of our profession to public health and safety, and the leadership role that laboratories and laboratory professionals continue to play.

Managing Your Inventory
February 22, 2016 11:52 AM by Irwin Rothenberg

The importance of properly managing inventory so that supplies for all phases of testing in your laboratory are available, accessible and in-date is critical, not only for providing quality patient care, but for the fiscal solvency, operational efficiency, customer service and staff morale of the laboratory.

The goals of any inventory control system should include:

• Current inventory information
• The ability to track and account for all inventory changes
• Reorder points and adequate time-frames for timely replacement.
• Monitoring the environment to ensure proper storage conditions are maintained

An effective control system should include the following:

1. Inventory Identification
Each item in your inventory should have an item number, a quantity and a basic description, which includes the vendor name and any other important details (such as lot number and expiration date).

2. Inventory Updates
Pick an interval of time to regularly check inventory. The interval depends on how fast your supplies move. Then compare what was purchased/acquired/received within a certain time period (say, a week), as well as what was used during that same time period. Your current inventory should be equal to whatever the count had been the previous week, minus all usage for the current week, plus the new inventory purchases.

Note: Store updated documents in an organized manner. Make sure to store your periodic inventory checks organized according to month. This way, if you need inventory data for a particular week, you can readily find it. It is also helpful in the case your accountant needs any information.

3. Maintain the Right Level of Inventory
Analyze usage data. The goal of inventory management is to keep up with demand, and this means having enough inventory to meet the projected usage. If test systems or procedures have been in use for a period of time, use historical data to predict (approximately) what the future use will be.

Decide how much stock to order and keep. How much you keep and how much you order depends on your level of usage, the type and variety of supplies and how much space is available. If you have minimal space, look at previous usage and ensure you have slightly more than that to meet the projected demand and be prepared for any unexpected situations. Always choose reliable suppliers who can get you your inventory quickly and on-time. If you have a larger space, consider taking advantage of bulk discounts.

Choose a re-order point. The goal is to always have enough inventory to meet demand, while not carrying too much inventory as this ties up your capital and space unnecessarily. To know when to re-order, one approach is to specify a minimum level of stock, at which point you always re order. For supplies that move quickly, or have the potential to move quickly, set a higher minimum level. Arrange to have some "safety stock" to get you through shortages from unexpected events.

The benefits of improved inventory management include the improved reliability of the laboratory to deliver test results on time, a more efficient laboratory operation with improved staff morale, improved vendor relationships, more accurate budgeting and better cost control (reduced stock-outs and overstocks).

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. 



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