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CRI Lab Quality Advisor

Mobile Technology in Critical Value Reporting
October 17, 2016 11:14 AM by Irwin Rothenberg
One of the key areas of laboratory-to-physician communication is the reporting of critical values. Since regulators and accreditation organizations define critical values as abnormal test results that are potentially life-threatening and require a rapid response from caregivers, any steps taken to improve this process impacts the quality of patient care. This not only refers to the timeliness of reporting test results, but ensuring that these results reach the intended physicians no matter where they are, and that the information sent and received is secure.

Thanks to the rapid spread of mobile technology, including phones, pads and computers linked to electronic health records, new more secure messaging systems to report critical values are available.  These allow for more options and richer features far beyond that of current pager systems or traditional telephone communication. These systems offer security that normal cellphone text messaging lacks, and their two-way capabilities automate the kind of closed-loop system that patient safety experts have advocated. These mobile-friendly applications can keep critical results from falling through the cracks. They create an audit trail of message sending, delivery and receipt, and labs can configure software that escalates an alert when the initial caregiver does not respond in a timely manner. 

Another new application of mobile technology is real-time patient monitoring using wearable devices like watches and wristbands synced to mobile phones. In these cases, if critical values are detected, these values can be immediately transmitted to the laboratory’s electronic health records system (EHR) and the physician notified immediately.

However, along with these advances have come issues of information overload, which can act as a counter-force to the progress that these devices provide. In the same way that laboratories often feel frustrated when they are not able to reach physicians to release critical results, physicians increasingly feel overwhelmed with the high volume of alerts, calls and other messages that they are receiving   These alerts came from test results, referrals, notes, order statuses, patient change statuses and incomplete task reminders .

As a result, even with the increasing number of high-tech tools available, labs often struggle to optimize critical value reporting. Realistically, this cannot be solved unilaterally by the laboratory. There must be active ongoing collaboration with physicians to identify problem areas and seek solutions through mutually agreed-upon strategies. The problem with information overload is how to distinguish laboratory alerts from all the other alerts that are coming in as well. This collaboration should produce uniform policies applicable to all physicians on staff, not customized for individual physicians. 

Just one example of this approach is to consider utilization of computerized provider order entry (CPOE) systems and improved EHR software to help solve problems with tracking and feedback. According to Hardeep Singh, MD, MPH, a researcher at the Houston Veterans Affairs Health Sciences Research and Development Service, and a co-author of the recent study on EHR alerts, "Using CPOE to order lab tests is the way to go. You can have all sorts of fancy processes in place, but unless the results get back to the right person, you're not going to have any follow-up on it. CPOE is the beginning point of getting the results into a trackable, coded fashion that is recognized by the computer so that the communication loop can be closed." 

Of course, many laboratories still utilize the basic manual system of calling or paging the ordering physician directly whenever a critical value is reported, and documenting these contacts either electronically or on paper.   However, the same principle of collaboration and mutually agreed upon policies and procedures for critical values reporting applies.  The bottom line is that these results must get to the right person, as quickly as possible, so that the patient receives the highest quality of care regardless of new or traditional obstacles.
Building Effective Educational Outreach
September 21, 2016 2:57 PM by Irwin Rothenberg

In a medical office setting, the general office staff is often part of the de facto laboratory operation due to their responsibilities related to initially seeing and communicating with patients. This includes the intake and update of patient information, test ordering, specimen acquisition, labeling and initial handling, as well as post-analytic patient contact and data access. The importance of well-trained and competent office staff to perform these responsibilities cannot be overstated. The strategy for achieving this has been for the laboratory to initiate the outreach and provide the training. This approach has proven effective within the physician office setting.

However, we are now in an age of steadily increasing consolidation of healthcare delivery into comprehensive medical organizations, such as accountable care organizations (ACOs) and patient centered medical homes (PCMHs), as well as expanding hospital systems and specialty clinics. It is estimated that less than one-third of physicians remain in private practice. As a result, laboratories are increasingly operating as an integral part of the larger healthcare team. In order to ensure the highest level of patient care, laboratory-oriented ancillary training and competency assessment must now go beyond the immediate office staff to include additional individuals and departments. This can include outreach to the executive team, risk managers, physicians, nurses, patient care technicians and patient safety officers.

It is also no longer sufficient for this outreach to be uni-directional (i.e., focused on the needs of the laboratory only). There must be a mutual understanding and respect for the responsibilities and priorities of each profession to provide quality patient care. We must also understand the daily experiences and stresses of those who are nurses, OR and ER staff and other allied healthcare professionals such as respiratory and physical therapists.

This collaboration should explore the most effective strategies to ensure an integrated approach to patient care throughout the entire healthcare system. From the laboratory professionals’ point of view, we need to have others understand why pre- and post-analytical processes are so important; that more errors occur in the pre-analytic phase than in the other phases. These include delays in patient processing, errors in specimen collection and labeling, lack of patient pre-test preparation and incomplete test orders. These can lead to delayed testing, the need to immediately redraw, even the need to have patients return to be redrawn. These delays can affect diagnoses and treatment. Post-analytic issues may include erroneous digital data entry and retrieval, mishandling of follow-up calls from patients regarding their test results and contacts from reference laboratories.

Once this attitudinal framework is in place, the next step is to set up committees to discuss specific points of interaction between the laboratory and each department, identify areas of mutual concern, previous points of negative interaction and how these impact patient care. Once the issues are clarified, solutions can be offered in a setting of mutual understanding and strategies developed to implement these.

Besides these meetings and agreements, mechanisms for continuing education and competency assessments should be incorporated to ensure that quality standards are maintained. One approach is through the use of inter-professional online educational modules to strengthen the connection of quality and safety in laboratory medicine to clinical relevancy. This is how we can build institutional teams with enough respect, understanding and competency to ensure that mutual best practices can be established.

Millennials Redefine Quality
August 31, 2016 4:23 PM by Irwin Rothenberg

The impact of Millennials’ interpretations and expectations of quality service from the healthcare profession in general—and laboratories in particular—continues to grow with each passing year. Now the largest generation demographically, Millennials are coming of age and gradually assuming their rightful place as both mass consumers and providers of healthcare services. Quality service has always been defined in terms of technological processes, as well as customer service. The former is based on meeting or exceeding quality performance standards through all phases of testing to produce the most accurate results for the physician as soon as possible.

The level of customer service has historically been assessed by how well the laboratory communicated with the medical staff and “went the extra mile” to meet their needs and expectations. This included a test menu that matched the needs of the medical staff, test order guidance, result interpretation readily provided with clear and complete test reports.

However, under the ever accelerating rate of technological change and innovation, expectations of what the laboratory can do, should do and must do are changing. From a purely technical point-of-view, new test methodologies and instrumentation have enabled new test specialties to emerge. Customer service has now broadened beyond the laboratory/physician continuum to include direct patient access to laboratory services.

Why discuss the specific role of Millennials at this point? Because they are now transitioning to assume leadership and becoming the largest consumers in healthcare.

Unlike Boomers or Gen Xers, Millennials are coming of age when all these advances now exist, and their expectations are to fully utilize the newest technology already available. If laboratory test results can be digitally reported on hand-held devices, why shouldn’t patients have direct access to their results? Do they really need a physician as an intermediary when they can go online and self-diagnose? Why wait for an appointment?

These generational expectations become cultural norms, codified politically through new legislation enabling rightful use of this new technology (i.e., direct patient access for both requesting and receiving tests without the physician required as intermediary).

A few observations
Growing up with video games, Google and the various trappings of the digital age, Millennials’ perspectives are strongly shaped by having the internet and all its spoils literally at their fingertips. Millennials also aren’t as tied to the idea that they must have one specific doctor as their physician. For standard checkups and consultations, some don’t even feel the need to see a doctor at all. Instead, many Millennials are content with seeing a nurse practitioner or physician assistant.

 Millennials also topped a 2012 Deloitte survey as the generation that is most cost-conscious. It’s the group that’s most willing to switch doctors, use retail clinics and travel farther in order to save money on healthcare.

One way insurance providers are addressing Millennials’ penchant for pinching pennies is by offering new tools that allow customers to do price comparisons for services such as laboratory work. There is a company called ClearCost Health, which allows customers to do price checks between health services via computer, mobile or even a call center.

In summary, quality laboratory service now includes:
- 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 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, 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 by laboratory staff, since customer service personnel are now expected to provide a wider variety of information.

- An awareness that social media provides a forum for both positive and negative reviews of the services provided.

One last note: It is important to hire these younger people who are comfortable with new technologies and open to trying new concepts in the field. Just as Millennials can make a difference as patients, they also can also contribute as laboratory staff


1.       2012 Survey of U.S. Health Care Consumers: Five-Year Look Back-Key findings, strategic implications. December 14, 2012. 

RFID: No More Hide and Seek
July 14, 2016 6:56 PM by Irwin Rothenberg

Radio Frequency Identification (RFID) is a wireless, non-contact use of radio-frequency electromagnetic fields that transfer data for the purposes of automatically identifying and tracking tags containing electronically stored information attached to objects. An RFID system has two basic components: a reader and one or more uniquely identifiable tags. The reader can wirelessly interact with the tags in different ways.

Typically, the reader transmits a signal and listens for a tag-modified echo. The differences between the transmitted and received signal encode information from the tag. This technology offers real time visibility that barcode identification systems currently lack. Presently, RFID uses in the healthcare and hospital setting are seen in patient monitoring, asset management, equipment tracking, EMR data collection, waste management and sample tracking.1

How does this technology impact our profession?

In the laboratory, inventory management software with RFID technology is just starting to be adopted. Several well-known vendors are now marketing this technology to automate inventory monitoring, tracking, stocking and ordering processes. The system can track key laboratory supplies such as reagents, calibrators and controls. Another equally important application is the emerging use of RFID to tag and monitor patient specimens.

Why do we need to consider utilizing this new technology? There are several advantages of RFID over more traditional barcode labeling:

Comparison of RFID and Bar codes2



RFID Tags and Labels

Holding data

Barcodes can be reprinted / photocopied.

RFID tags and labels carry unique identifiers that positively identify the item they are attached to.


Barcode scanners require direct line of sight to the printed barcode.

RFID readers do not require a direct line of sight to the RFID tag or label nor does the sample need to be touched by the operator or RFID scanner.


The range to read a barcode is typically no more than 5 meters.

RFID tags can be read at much greater distances (depending on tag type up to 100 meters) making them very useful for tracking samples in a busy laboratory, freezer or other storage location.

Multiple Reading

Barcodes must be read one at a time.

Multiple RFID tags can be read simultaneously by a variety of reader types to suit reading of different containers including boxes and racks of samples.


Reading barcodes is time-consuming as direct line of sight is required.

RFID readers can read RFID tags much faster (e,g. >40 UHF tags/second).


Barcode labels must be placed on the outside of the sample container or asset.

RFID tags can also be used within the sample or container of samples, so they could be used throughout an analytical workflow providing a more complete custody trail.


Barcode label stock material can be plastic coated and used with different glues for durability.

RFID tags are typically more rugged to different environments and can be protected in a plastic cover creating the opportunity to create novel applications.


Barcode labels are read-only.

Read/write RFID tags can be used which allow new data to be written back on the tag which allows for new applications.


Barcode labels are generally cheaper but are not reusable.

RFID tags can be reused and the flexibility of uses and associated savings described above can offset the additional cost.


In fact, when working with samples stored in a freezer, an important longer-term advantage of RFID-tagged samples is that the scanner technology described above can, with careful design, be implemented in the freezer itself. This would allow the freezer to inventory itself and report its contents to the user without removing samples from the freezer. If this can be implemented, the security of a the laboratory specimens will increase because any changes to the contents would be traceable to whoever accessed the freezer.3



1. M. Hernandez. Managing Laboratory Inventory: RFID. MD Buyline. Blogs Sept. 9, 2014.

2. RFID Labeling for Laboratories. CSols-AdminLeave a Comment. Dec 19, 2011.

3. H. Davidowitz. Use of RadioFrequency Identification (RFID) for Sample Tracking. July 31, 2012.

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.

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.

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?

2. Elder N, McEwen T, Flach J, Gallimore J.  Creating Safety in the Testing Process in Primary Care Offices.


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.



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