LDTs

VALID and VITAL Are Back in Play—and This Time One of Them Might Actually Pass

The COVID-19 pandemic exposed the truth of something the lab industry has known and publicly stated repeatedly for over a decade: The FDA is ill-equipped to regulate Laboratory Developed Tests (LDTs) and allowing it to continue to do so, at least under its current model, stifles innovation and keeps needed tests off the market. Of course, many members of Congress on both sides of the aisles have shared in this knowledge. And now an increasing number of their colleagues do, as well. Accordingly, the renewal of efforts to impose legislative order might actually come to fruition this time. The spearhead of those efforts, at least for now, is the reintroduction of a pair of bills that failed to take hold the last time they were on the table: the VALID… . . . read more

Lab Safety

3 unwritten safety rules every lab should follow

By Dan Scungio Many years ago, a woman purchased a cup of coffee in a restaurant drive-through. Not having a cup holder available in her car, she placed the cup between her legs to hold the coffee while she reached for money to pay for it. She burned her legs, sued the restaurant, and actually won her court case. Now such restaurants are required to warn customers with signs stating the obvious; “coffee served hot.” Before this regulation came to be, however, many people were aware of the possible danger of placing a hot cup near their skin. Does having a posted sign make customers safer? What about in a medical environment? There isn’t an explicit safety regulation written for every action that could create an unsafe situation. So, what… . . . read more

TECHNOLOGY

5 Unintended Ways Companies Compromise Their Network Security

By Ron Slyker Solid organization security is a considerable necessity in today’s world, that is not going to come as a surprise to anyone. Nonetheless, making and keeping an impenetrable organization is something that stays a slippery objective for some enterprises. Organizations of all sizes are continuously struggling with the battle of guaranteeing that each potential security gap is sealed securely. Most organizations are coming up short with attempting to guard their organizations, making them defenseless against data theft and malicious network invasion. To feature exactly how genuine this issue is we will diagram five of the main manners by which endeavors are accidentally bargaining their organization security, and exactly how they can fix these oversights. 1 Sole Reliance on VPNs as a Security Band-Aid Virtual Private Networks (VPNs) assume… . . . read more

Inside the Diagnostics Industry

Infectious Disease Testing on Path to Steady Growth, Even Without COVID-19

From a pure business perspective, the pandemic has been a windfall for Abbott, Cepheid, PerkinElmer, Roche, Thermo Fisher Scientific and other COVID-19 testing companies. However, while the COVID-19 revenue windfalls of the past year are already starting to trail off, the long-term market for biomarker-based infectious disease testing is beyond sustainable. A new report from laboratory industry financial consulting firm Kalorama Institute says that the global market for such testing will reach nearly $15 billion in 2021. And that number does not even include COVID-19 testing. The Biomarker Infectious Disease Test Market Biomarkers are biological or biochemical molecules, genetic changes and other measurable characteristics that are used for diagnostic, treatment and medical research applications, including identifying diseases, prognosis, evaluating genetic risks for certain conditions, disease monitoring, determining appropriate treatment options,… . . . read more

Inside the Lab Industry

Even Without COVID-19, Infectious Disease Test Market on Track for Steady Growth

From a pure business perspective, the pandemic has been a windfall for Abbott, Cepheid, PerkinElmer, Roche, Thermo Fisher Scientific and other COVID-19 testing companies. However, while the COVID-19 revenue windfalls of the past year are already starting to trail off, the long-term market for biomarker-based infectious disease testing is beyond sustainable. A new report from laboratory industry financial consulting firm Kalorama Institute says that the global market for such testing will reach nearly $15 billion in 2021. And that number does not even include COVID-19 testing. The Biomarker Infectious Disease Test Market Biomarkers are biological or biochemical molecules, genetic changes and other measurable characteristics that are used for diagnostic, treatment and medical research applications, including identifying diseases, prognosis, evaluating genetic risks for certain conditions, disease monitoring, determining appropriate treatment options,… . . . read more

EMPLOYMENT LAW UPDATE

Disability discrimination and lookism in the workplace

By Mike O’Brien EEOC sues a work placement agency on behalf of disabled workers for disability discrimination The EEOC announced this week that it has filed suit under the Americans with Disabilities Act (ADA) against a Hawaii work placement agency for disabled workers. The suit alleges that the agency refused to provide sign language interpreters for deaf employees, despite repeated requests by several deaf individuals. The workers had asked for interpreters to be present at staff meetings where matters such as work safety, protocols, and assignments were discussed. Despite these requests for accommodation, the agency declined to provide interpreters and instead gave the deaf workers written notes and handouts, or asked a deaf employee to interpret for other deaf employees. The EEOC asserts that these accommodations were ineffective and that as a… . . . read more

Lab Safety

A Code Call for Your Lab Co-worker

By Dan Scungio The lab employee felt faint in the middle of her shift and she sat down quickly on the lab stool. She asked to be taken to the Emergency Department, so her co-worker rolled her down the hallway on the stool. In the hallway, the employee slipped off of the stool and fell to the floor hitting her head. A lab processor suddenly felt weak and slid to the floor. She told her co-workers she thought her blood sugar was low and she needed some orange juice. A technologist went to the cafeteria to buy a bottle of juice, and they made the processor stay on the floor in the laboratory while she drank it. A lab employee fell to the floor after standing up and stated he… . . . read more

Employment Law Update

New Guidance, Sort of, About COVID-19 in the Workplace

By Mike O’Brien EEOC provides new COVID-19 guidance The Equal Employment Opportunity Commission (EEOC) has released some new guidance on COVID-19 issues at work. Here are the four EEOC-noted highlights of the most recent update, in late May: First, an employer can require that all employees physically entering the workplace be vaccinated for COVID-19, so long as employers comply with the reasonable accommodation provisions of the laws prohibiting disability and religious discrimination. Additionally, from the EEOC’s perspective, “employers should keep in mind that because some individuals or demographic groups may face greater barriers to receiving a COVID-19 vaccination than others, some employees may be more likely to be negatively impacted by a vaccination requirement.” Second, the federal EEO laws do not prevent/limit employers from offering incentives to employees to get… . . . read more

Lab Safety

The Three Laws of Sharps Safety

By Dan Scungio In Isaac Asimov’s writings about science, he created “the three laws,” a set of rules designed by humans that robots must follow in that fictional society. Robots cannot harm human beings, they must obey humans (unless it conflicts with the first law), and they must protect themselves from harm (unless that conflicts with the first two laws).  With those in place, there should be no issues with the use of robots in society, but bending those laws provided interesting plots for many books and movies. There are three laws for sharps safety as well, but breaking those laws can be far more dangerous for healthcare workers. It is not an exaggeration to call the safety guidelines about medical sharps “laws.” In the United States the Occupational Health… . . . read more

Reimbursement

Getting Medicare Reimbursement for Telehealth Lab Services: The New CONNECT for Health Act

Like most cliches, the one about the COVID-19 pandemic’s transformation of medicine forever is laden with truth. Telemedicine is Exhibit A. Of course, telemedicine goes back decades. But the pandemic accelerated the breakdown of resistance on the parts of providers, regulators and above all, patients. It was supposed to be just temporary. But to use still one more cliché, now that the toothpaste is out of the tube, it becomes a matter of figuring out how to regulate it effectively. Ironically, but hardly unexpectedly, one of Congress’ first attempts to impose systematic regulation involves recycling a piece of legislation that failed to gain support in pre-pandemic times but may make it into law this time. Here’s a quick overview of the so-called CONNECT for Health Act and what lab managers… . . . read more

PAMA

Labs Lose a Battle But May Win the War Over Market-Based Pricing

In its crusade to get CMS to fix its warped Protecting Access to Medicare Act of 2014 (PAMA) market-based Medicare Part B pricing scheme, the lab industry lost a battle but may still end up winning the war. Here’s a rundown of the rollercoaster PAMA developments and what they may portend for your lab. The Pollution & Perversion of PAMA Market Pricing Back in 2014, the idea of substituting traditional Medicare Part B Clinical Laboratory Fee Schedule (CLFS) payment system in which rates were based on local, historical lab charges, updated for inflation, and capped at certain amounts with a system basing prices on real market rates seemed like an excellent idea whose time had come. Nor was there any real objection to putting CMS in charge of determining what… . . . read more

Reimbursement

CMS Mulls Automatic Medicare Coverage of MCIT Breakthrough Devices

Manufacturers of innovative medical devices are on pins and needles right now. That is because the Centers for Medicare and Medicaid Services (CMS) delayed implementation of a final rule that was supposed to take effect on March 15, 2021 that would have ensured at least four years of Medicare coverage for new medical products cleared by the Food and Drug Administration (FDA) as breakthrough devices under Section 510(k). Unlike many Trump administration regulations, the breakthrough device coverage rule may still come to fruition. But CMS is currently studying the rule and will not make a final decision sooner than May 15. Here is a look at the rule and its prospects of actually taking effect. The Final Rule Medicare covers only medical services and products that are “reasonable and necessary.”… . . . read more

Enforcement Trends

Silicon Valley Becomes Epicenter of Lab Investment Scams

On paper, the Silicon Valley venture capital and innovation that have lifted so many other industries seem like the perfect elixir for medical labs. Perhaps one day it will prove to be just that. But so far at least, things haven’t gone well. Instead of driving game-changing diagnostic innovation, the infusion of Silicon Valley can-do into the lab sector has yielded mostly massive Wall Street scandals. Stanford dropout Elizabeth Holmes has become the literal face of the beauty and perversion of the Silicon Valley-ization of lab diagnostics. The Steve Jobs-wannabe who appeared on the cover of Forbes magazine and became a media sensation transcending the white coat world of the testing lab with a breathtaking new modality capable of performing a full menu of rapid tests from a single drop… . . . read more

Employment Law Update

Court gives guidance about return to onsite work and ADA

By Mike O’Brien bio In ADA Case, Tenth Circuit says onsite work may be essential One of the most frequent questions that the writers of these updates receive is whether employers who moved to a remote workplace in response to the COVID pandemic may now recall employees to onsite work. Generally, we’ve advised employers that they are free to require onsite work, although they may need to make exceptions for employees with disabilities under the Americans with Disabilities Act (ADA) or provide leave to eligible employees under the Family & Medical Leave Act (FMLA). On April 8, 2021, the United States Tenth Circuit Court of Appeals (the federal appellate court for the mountain west region), issued an important ADA decision about onsite work requirements in the case of Unrein v. PHC-Fort… . . . read more

COMPLIANCE

Are you keeping your email compliant with HIPAA?

By Ron Slyker bio If you are a lab manager, you have more than likely heard the term “HIPAA compliance.” Most relate it to the protection of patient health information (PHI) within the office, but HIPAA compliance extends beyond internal communications. Ensuring email is HIPAA compliant is one of the most overlooked components of HIPAA compliance. A common misunderstanding is that an email is secure when you are sending it. Nevertheless, if the right protective layers are not configured, this is not the case. HIPAA compliant email communication is a necessity in today’s technical environment. Encryption Email encryption is almost always mandatory to be HIPAA compliant. Simply put, when an email is encrypted, the contents are masked to everyone but the recipient. There are two types of encryption: Transport level:… . . . read more

Lab Safety

From ant men to giant men

By Dan Scungio bio In January of 1962, Tales to Astonish #27, a comic book, featured a scientist who had created a special chemical. This chemical, when put in contact with an object, would shrink it! When the scientist tried the concoction on himself, he shrunk to the size of an ant! In time this scientist became the Astonishing Ant-Man, a super hero and a founding member of the team known as the Avengers. He worked on his chemicals and eventually gained the ability to grow very large. He then became known as Giant-Man. It’s quite a transition from ant to giant, and the scientist, Henry Pym, was able to do much in both roles. Something similar can happen in the workplace as well when considering safety. If the correct… . . . read more

Compliance Perspectives

Medicare Medical Necessity Denials and How Your Lab Can Prevent Them

Ensuring that the lab services you bill for meet Medicare medical necessity requirements is one of the oldest challenges faced by lab compliance managers. And it doesn’t get any easier over time. The complication stems from the simple fact that, in most cases, labs perform but don’t order the services they bill for; those services are ordered by an unrelated physician. This creates an inherent tension between the sides to the extent that labs rely on ordering physicians to furnish the documentation needed to show that the services are medically necessary. The nature of medical necessity disputes has changed since the early years of Medicare because clinical labs must now submit a diagnosis code on Medicare payment claims, and ordering physicians must provide labs diagnosis or other medical information required… . . . read more

Reimbursement

CMS Closes the Free COVID-19 Tests Coverage Loophole

Getting Republicans and Democrats to agree on anything these days is a Herculean task, even during a global pandemic. One of the rare points of consensus is with regard to the notion that all Americans should be able to get free COVID-19 testing. Accordingly, the mandate that payors pick up the full costs of testing without charging copayments was baked into the bipartisan relief legislation that Congress adopted in response to the crisis last spring. Of course, things didn’t exactly go according to plan. Aided by CMS guidelines, payors were able to exploit an enormous loophole in the coverage policy to avoid paying for a crucial aspect of COVID-19 testing: screening of the asymptomatic. But now CMS has closed that loophole. Here’s a briefing of the new developments and their… . . . read more

HIPAA

Proposed HIPAA Privacy Rule: The 9 Changes That Will Have an Immediate Impact on Lab Operations

On Dec. 10, with just a few weeks remaining in its tenure, the HHS Office for Civil Rights (OCR) proposed a series of changes to the HIPAA Privacy Rule. Public comments on the proposed rule were scheduled to close on March 22. Unlike many of the other midnight healthcare regulations adopted by the Trump administration, the Privacy Rule changes remain on track. But the new administration wants a little more time to study them. So, on March 9, the OCR announced that it was extending the comment period on the proposed rule for 45 days until May 6. The 9 Key Changes The point of the proposed rule, which takes up nearly 100 pages worth of 3-columned Federal Register text, is to give individuals greater access to their protected health… . . . read more

LAB SAFETY

What Do We Say to Patients Who Ask about Our Team’s Vaccination Status?

By Paul Edwards bio As vaccinations continue to be distributed to more and more members of the American workforce, one of the recurring questions we are getting concerns how to respond to patients who ask about whether or not your team has been vaccinated. Patients might pose this question over the phone before their scheduled appointment, or might ask it to one of your employees during their visit. Your Employees’ Health Information Is Protected In response to such a question, it’s important to remember that your employees’ personal health information is protected in just the same way as your patients’ health information. Therefore, it is generally not a good idea to offer information to your patients that might expose any of your employees’ inability (or unwillingness) to get vaccinated. If a… . . . read more

The Business of Testing

Hospital Laboratories Take a Stand Against Controversial UnitedHealthcare Outpatient Reimbursement Policy

The cold war between hospital laboratories and the nation’s third largest health insurer, UnitedHealthcare (UHC), over reimbursement of diagnostic tests is getting hotter by the day. At the center of the conflict is a controversial new UHC policy that would require laboratories to meet the standards of its homegrown provider care quality and efficiency program to qualify for reimbursement. Hospitals are pushing back against the policy and have now asked the federal government to intervene in the dispute. The Reimbursement Challenge Payors of all stripe have a rich tradition of griping about the high costs of laboratory tests. A turning point came in 2014 when Congress enacted the Protecting Access to Medicare Act (PAMA) to mandate imposition of a market-based pricing regime for Part B Medicare laboratory test reimbursement. Although… . . . read more

Focus On

How the Transition from Trump to Biden Will Affect Federal Regulation and Reimbursement

“Meet the new boss. . . same as the old boss.” The Who’s “Won’t Get Fooled Again” is a rock classic; but as far as U.S. presidents and federal regulation are concerned, the “new boss” is almost never the same as the “old boss.” The typical pattern: The outgoing administration recognizes that its opportunity to impose its political agenda is running out and generates a final spasm of new regulation; the ingoing administration then reviews and in, many cases, revises or cancels those midnight regulations, not only because of its policy differences but also due to the fact that these regulations are typically rushed into effect without following the required notice and comment procedures. And that’s exactly how things are playing out on the healthcare front under the Biden administration…. . . . read more

Workplace Safety

The power of the pause for avoiding injury

By Dan Scungio bio The majority of laboratory injuries and exposures are preventable, and most of them occur because people are not paying close attention to the situation. They lose their situational awareness or were never paying attention to it from the start. Unfortunately, safety professionals spend a great deal of time investigating such incidents rather than focusing on preventing them. If the power of the pause was understood by more healthcare workers, there would be fewer dangerous incidents and exposures. One illustration of that power can be seen in a simple exercise. A group of people is asked to read aloud quickly a list of words that indicate different colors; green, red, etc. The words are read together at the pace of one second each, usually to someone clapping… . . . read more

FDA Watch

FDA Watch: Molecular Tests May Miss New SARS-CoV-2 Strains, Agency Warns

Like many viruses, the SARS-CoV-2 is a shape-shifter. And that may make it harder to detect. With this in mind, the U.S. Food and Drug Administration (FDA) is warning clinical laboratories and health care providers of the risk that genetic mutations to the virus may lead to false negative test results. The Diagnostic Challenge The first and vast majority of tests with FDA emergency use authorization (EUA) for SARS-CoV-2 are molecular assay designed to detect specific RNA sequences found in the viral genome. However, the SARS-CoV-2 virus mutates regularly, resulting in several genetically unique variants, each with different RNA sequences. The presence of SARS-CoV-2 genetic variants in a patient sample can potentially change the performance of the SARS-CoV-2 test. If a molecular test is not engineered to detect the particular… . . . read more

FDA

FDA Sounds Alarm on Potential Impact of Genetic Mutation on SARS-CoV-2 Molecular Test Accuracy

As if COVID-19 testing wasn’t challenging enough, the emergence of new variants has made the SARS-CoV-2 virus a moving target. With this in mind, the FDA is warning clinical labs and health care providers of the risk that genetic mutations to the virus may lead to false negative test results. In its Jan. 8 letter, FDA identifies specific molecular tests that have received Emergency Use Authorization (EUAs) whose performance could be impacted by SARS-CoV-2 genetic variants. The Diagnostic Challenge The first and vast majority of tests with EUA for SARS-CoV-2 are molecular assay designed to detect specific RNA sequences found in the viral genome. However, the SARS-CoV-2 virus mutates regularly, resulting in several genetically unique variants, each with different RNA sequences. The presence of SARS-CoV-2 genetic variants in a patient sample… . . . read more

Lab Safety

What will 2021 bring for lab safety programs?

By Dan Scungio bio As we say goodbye and good riddance to the year 2020, we hesitatingly welcome 2021. What will the new year bring? Can it be worse than the last year? Are we prepared to deal with what else may be coming? Did we learn lessons in 2020 that will help us? These are valid questions for everyone, and they apply equally to lab safety professionals. We dealt with PPE shortages, new and additional testing, staffing shortages, and even the fears felt by our co-workers. Some of these issues persist, but there are ways to deal with them. Maybe the past year made you feel like you and your staff didn’t have a strong enough grasp of biosafety practices in the workplace. After all, questions came up about… . . . read more

Lab Safety

“COVID captains” promote safety precautions

By Dan Scungio bio The year 2020 is roaring to a close, and COVID-19 is unfortunately still around. We have made changes to our lives at home, in public, and at work. Lab workers and other healthcare workers, in particular, made several changes early on with PPE use and work practices that are still in effect today. A great deal of work had to be done early on this year to provide information to staff in healthcare facilities regarding this updated safety information. At this point, the initial work that needed to be done by safety professionals has been completed. Education was given regarding safe collection, transport, and testing of specimens. Risk assessments have been performed for new testing platforms. Employees have been educated regarding the continued use of Standard… . . . read more

DOJ

EKRA Prosecution: What Does this Mean for the Laboratory Industry? 

By Charles Dunham, IV, Shareholder at Greenberg Traurig, LLP & Benjamin Nipper, Associate at Greenberg Traurig, LLP  In January 2020, the U.S. Department of Justice (DOJ) made its first public announcement of a prosecution under the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) of a former manager of a substance abuse treatment clinic, who pled guilty to violating multiple federal health care fraud laws. News of the charge and guilty plea may cause concern to the laboratory industry because no regulations or guidance have been released since its enactment in October 2018, despite concerns raised by industry stakeholders to both Congress and DOJ that the statutory provisions are unclear and conflict with long-standing safe harbors under the federal Anti-Kickback Statute (AKS). While the DOJ has not secured a conviction… . . . read more

EMPLOYMENT LAW UPDATE

The Workplace in 2020: Political Talk, COVID-19 Violence, Executive Order

By Mike O’Brien bio Don’t forget labor relations rules when employees talk politics at work During this month’s contentious election season—with a highly polarized American electorate—many employers may be grappling with problems arising from workplace political discussions. Research by the Society for Human Resource Management (SHRM) has indicated that more than a quarter of workers report regularly talking about politics at work. Disputes and tension often result. Employers wishing to regulate political speech at work should remember that the National Labor Relations Act (NLRA) may affect their options. Although employees often assert that they have a First Amendment right to free speech, this is a misconception. The First Amendment restricts government action, not that of private employers. However, Section 7 of the NLRA gives employees the right to talk to… . . . read more

Employment Law Update

New COVID-19 Guidance for Your Lab from EEOC

By Mike O’Brien bio The Equal Employment Opportunity Commission (EEOC) recently updated its COVID-19 guidance page, addressing a number of issues. Here are some of them: On coronavirus testing, the EEOC said general testing administered by employers consistent with current CDC guidance will meet the ADA’s “business necessity” standard, and noted that employers should ensure that the required COVID-19 tests are accurate and reliable according to the FDA, CDC, and other public health authorities. If an employer wants to test only one employee, however, the employer should have a reasonable objective belief that he/she might have the disease. The EEOC says an employer can ask employees whether they have had contact with anyone diagnosed with COVID-19 or who may have symptoms associated with the disease, but should not phrase that… . . . read more

COVID-19

Back to the Foundational Facts of Lab Safety

By Dan Scungio bio Things have changed drastically over the past several months as the COVID-19 pandemic continues. Many adjustments to how we work and live have been made and it has become difficult to separate fact from fiction. Should masks and goggles be worn at work? What type? Can we eat together on breaks? Information about the pandemic is abundant on news outlets and social media. Not all this information is correct, there are many coronavirus myths and misconceptions that are promoted online. However, many people treat all this information as gospel—a dangerous practice for those working in the laboratory. How can laboratorians discern fact from fiction or opinion? There are at least two basic truths of safety we should never forget. These foundational facts can help us to… . . . read more

EMPLOYMENT LAW UPDATE

Here’s new guidance on COVID-19 and FLSA

By Mike O’Brien bio For managers in charge of HR, the so-called lazy days of summer have been anything but lazy, as they strive to adapt to the COVID era and stay up to date on seemingly constant new government guidances. The Department of Labor has provided more information for employers regarding pandemic-related wage and hour issues. Specifically, the agency answered questions about hazard pay, FLSA’s overtime and minimum wage exemptions, and what time is compensable with respect to pandemic-related telework arrangements: DOL notes that hazard pay is not required under FLSA, but may be required under state or local laws, collective bargaining agreements, or company policies. DOL makes clear that taking leave under the Families First Coronavirus Response Act (FFCRA) will not jeopardize an employee’s exempt status under FLSA’s… . . . read more

Lab Safety

3 signs nobody is paying attention to safety

By Dan Scungio bio The safety officer walked into the satellite laboratory and saw an employee scrolling through social media on her cell phone. Another employee was wearing mesh sneakers and chewing gum in the department. In the storeroom chemicals were stacked on high shelves and the aisles were blocked with empty boxes. The safety officer had come to perform an audit, but it was clear in a minute that the safety culture here was not great. Visual cues are a fast way to see that no one is paying attention to safety, but there are other methods as well, and it’s important to use them. Not paying attention to safety has consequences. 1 Visual Cues Picking up on visual cues is not a talent you should expect to perfect… . . . read more

Employment Law Update

COVID-19, immigrant worker, discrimination and DACA developments

By Mike O’Brien bio EEOC says no to COVID-19 antibody testing: The Equal Employment Opportunity Commission (EEOC) recently (6/17/20) updated its COVID-19 guidance to indicate that employers should not be requiring employees to submit to antibody testing. Here is the verbatim Q&A (found at EEOC Guidance): Question: (A.7.): CDC said in its Interim Guidelines that antibody test results “should not be used to make decisions about returning persons to the workplace.” In light of this CDC guidance, under the ADA may an employer require antibody testing before permitting employees to re-enter the workplace? Answer: No. An antibody test constitutes a medical examination under the ADA. In light of CDC’s Interim Guidelines that antibody test results “should not be used to make decisions about returning persons to the workplace,” an antibody… . . . read more

Employment Law Update

Supreme Court ruling extends workplace protections to LGBTQ workers

By Mike O’Brien bio SEXUAL ORIENTATION AND TRANSGENDER STATUS NOW ARE PROTECTED CLASSES NATIONALLY: Federal civil rights law protects gay, lesbian, and transgender employees, the United States Supreme Court announced June 15 in a landmark ruling. The historic decision will extend workplace anti-discrimination and anti-harassment protections to about 8 million LGBTQ workers nationwide. The ruling also vindicates a position long taken by the federal Equal Employment Opportunity Commission (EEOC). It is a defeat, however, for the Trump administration, which opposed the EEOC. President Trump instructed the Department of Justice to argue that the provision of Title VII of the Civil Rights Act that bars discrimination based on sex did not extend to claims of gender identity and sexual orientation bias. This led to the odd circumstance where two parts of the same government argued for opposite… . . . read more

Lab Safety

How we return to lab and clinic “normal”

By Dan Scungio bio The evolving COVID-19 pandemic has changed the world – the way we educate, the way we conduct business, and the way we socialize (or don’t). In the lab and clinic settings, there are many practices and procedures that have changed or are now being questioned. Sometimes the answer evolves quickly, sometimes there is national guidance to assist with a particular issue, and sometimes your own facility or organization makes the decisions for you. As we begin a return to “normal” practices, as the pandemic starts to wind down, it’s time to address some issues that arose often in recent months but that should always be considered for employee safety. Q: Should nurses or other staff come into the lab department wearing gloves? A: No, it is… . . . read more

Technology

Choosing A Partner to Automate Your Compliance Department

By Kristi Williams bio Sometimes the obvious isn’t so obvious.  And sometimes it takes fresh eyes to see what has been right in front of you all along.  Such is the case with automation in healthcare. Today, healthcare organizations find themselves continuously challenged to keep up with changing regulatory requirements and to ensure that their business practices adhere to external rules and internal controls. That responsibility falls directly on the shoulders of the compliance department who is tasked with identifying risks that an organization faces and implementing controls to protect the company from those risks. The need for an effective compliance program is not new.  It has been understood by health plans for years.  What is new however is that an increasing number of health plans are turning to automation… . . . read more

COVID Restrictions Ease

Top 10 questions an employer should ask before returning employees to work

By Mike O’Brien bio As various states and municipalities across the country lift shutdowns and begin easing COVID restrictions, employers are faced with complex questions about safely bringing their employees back to the workplace. We’ve compiled the top 10 questions every employer should consider before returning employees to work.   How do we implement proper infection prevention measures? First, and perhaps foremost, employers should design, implement, communicate, and begin to monitor basic infection prevention measures as they return employees to onsite work. Although a complex task, OSHA and CDC have both published step-by-step instructions for employers on how to implement appropriate infection prevention measures. OSHA has published an employer Guidance on Preparing Workplaces for COVID-19, which outlines the specific steps it believes all employers should take to reduce workers’ risk of… . . . read more

Employment Law Update

Employment law changing on the fly in response to COVID-19

By Mike O’Brien bio COVID-19 has ushered in a variety of new, and fast-evolving employment law changes, from the Families First Coronavirus Response Act (FFCRA) to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). EMPLOYEE RETENTION TAX CREDIT:  The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes a tax credit for employers that retain employees during the COVID-19 crisis.  The credit generally provides relief to employers of all sizes in the form of a refundable payroll tax credit of 50% of all “qualified wages” paid (up to $10,000 per employee) during the COVID-19 crisis if (i) operations were fully or partially suspended or subject to a shut-down order; or (ii) gross receipts declined more than 50% compared to the same quarter in the prior year.  Note that for… . . . read more

Employment Law

Coronavirus pushing rapid changes in employer law

By Mike O’Brien bio Employer law is rapidly changing amid the coronavirus pandemic. For one thing, Congress has passed another coronavirus related law. The United States Department of Labor (DOL) has provided some helpful guidance and answered a number of questions about the recent expansion of the Family and Medical Leave Act (FMLA) and about the new paid sick leave law, see: DOL FFCRA Q&A. Here are updates: PAID LEAVE UNDER THE EMERGENCY PAID SICK LEAVE ACT (EPSLA): Employees of covered employers (private employers below 500 employees and certain public employers) are eligible for up to two weeks (80 hours) of paid sick leave for certain COVID-19 related reasons. If leave is because he/she is quarantined (by government order or a health care provider), and/or experiencing COVID-19 symptoms and seeking medical… . . . read more

COVID-19 Alternative Safe Practices

My PPE is Back-Ordered: Now What?

By Dan Scungio bio The COVID-19 pandemic is peaking in the United States, and many things are being affected in unprecedented ways. Schools are closing, business travel is banned, gatherings are canceled, and stores are out of…toilet paper. There are supply shortages that are peaking as well, and some of the items that have become hard to get include personal protective equipment (PPE). Does that mean we can work without it in the laboratory setting? Absolutely not, neither OSHA nor any other regulatory agency will put a halt to safety practices that protect workers in any setting. But what if you really can’t get the PPE supplies you need? There are some alternatives. One thing to remember is that PPE should be used wisely and efficiently, even when there is… . . . read more

Lab Safety

Coronavirus in the Histology Laboratory

By Clifford M. Chapman bio The current world health care concern over coronavirus (i.e., COVID-19) has generated many questions regarding many aspects of this fast spreading disease. It is important to address the subject of the affect, if any, of this disease on how we work in and operate histopathology laboratories. An important and timely article was published online in the Journal of Histotechnology 01 March 2020. The article “Coronavirus disinfection in histopathology” by Anthony F. Henwood (1) was referenced by Gayle Callis on the NSH Open Forum and has been granted open access. Everyone is urged to read the entire article. Herein is a review to provide the essential findings of the article. The author provides a brief history of the coronavirus outbreak and its relationship to previous outbreaks… . . . read more

Increasing Profits  

Strategic planning needs to evolve over time

By Nick Hernandez bio Some of my counterparts have a firm belief that strategic planning is a rigid process which should occur once every three to five years. The process they undertake is often done during an off-site planning session with the outcome being printed up in a large three-ring binder. In less than six months, those binders are sitting on a shelf somewhere collecting dust, never to again see the light of day. I, on the other hand, believe that strategic planning should be a continuous process involving the ongoing adjustment of means and ends. We should also view planning as an evolutionary process involving continuous adjustment and improvement. We can think of strategic planning as a solution-by-evolution rather than solution-by-engineering. We should generally not view strategic planning as… . . . read more

Lab Safety

Doing What We’ve Always Done

By Dan Scungio bio Scenario: The reference cytology lab has always had limited storage space for supplies and specimens. They use tall wire racks to store the many liquid-based cytology specimen vials. The vials contain small amounts of flammable chemicals, and the shelves are seven feet high. They have followed this storage procedure for 10 years. It took Jan four years to get her clinical lab staff to a decent point of compliance with regard to PPE use. They were pretty good now about donning lab coats and gloves, and even the use of face protection while handling open specimens has improved greatly. There were, however, many staff members who refused to give up wearing mesh sneakers while at work. Given the amount of work she put in already to… . . . read more

Billing & Collections

Finding the “Backdoor” into Payer Networks

By Steve Selbst bio  I am delighted to be able to share with you a key “secret to success” about payer contracting. Today’s article is about getting in the “backdoor” with payers and complementing your payer network by building your patient/customer base. In my journey navigating tens of thousands of payer contracts’ negotiations, it has become clear to me that there are times when a payer will close its network to certain provider types, based on its network need. Don’t despair; there are other “paths to Oz.”  Certainly, there are ways to build value propositions and ways to escalate up the payer management chain. These are topics for another day. Today, we’ll talk about an even easier to implement alternative: complementary payers! Complementary payers What is a complementary payer? Looking… . . . read more

Employment Law Update

New overtime rule now in effect

By Mike O’Brien bio Jan. 1, 2020 was the deadline to comply with new FLSA overtime rule. At the end of September the Department of Labor issued its long-awaited final rule updating the salary level test for white-collar overtime exemptions under the Fair Labor Standards Act. Under the new rule, the minimum salary level for exemption is raised from $455 a week to $684 a week, or $35,568 annually. The change marks the first increase in the minimum salary level to take effect in more than 15 years. It is expected to bring overtime eligibility to over a million employees who are ineligible under the current threshold. Although the DOL released a final rule raising the salary level in 2016, the rule was blocked by a federal district court and… . . . read more

BILLING & COLLECTIONS

Accessions Disappearing or Not Getting Billed?

By Sean McSweeney bio Ever get that feeling that there should be more charges in the billing system? How many times have you or someone else said something like “we did 3000 samples last month, but we only see 2500 that got billed”? Are salespeople complaining that all their samples aren’t in there? How can you tell if they are just complaining, whether the referral source didn’t send as many as they think or claim (which we all know happens), or if there were more samples sent or received and instead of getting billed they are just going “poof”? Where can revenue be lost? Tons of places. Most people in the laboratory world are familiar with the concept that not all claims get paid. Everyone is used to this concept… . . . read more

BILLING & COLLECTIONS

5 ways to break down bureaucracies to get payer contracts

By Steve Selbst bio It is important to remember that payers are large companies, with protocols, policies and business practices. As with any large company, there are bureaucracies, and they are necessary to maintain the order and success of these organizations. Therefore, the first tip is to understand that to get contracted you need to identify the right department and right person to send your request to get contracted. This is usually the payer contracting department and payer contracts’ manager. Generally, you will be sending your requests to the payer contracts’ manager in your state. A common mistake is to—instead—send these requests to provider relations or to another department. This brings us to our second tip. That is, figure out the approach the payer is using to establish its fee… . . . read more

Why Cleaning Up Your Dirty Data is Critical to Clinical Interoperability and Financial Survival

By Gregg Church bio
Hospital-based and commercial labs are flooded with all types of mismatched patient data. However, disparate systems coupled with a lack of universally mandated data standards and protocols means that big data just gets bigger—and clinical interoperability challenges just get larger…


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EMPLOYMENT LAW UPDATE

Immigration alert, social media, salary threshold, minimum wage, trafficking and more

By Mike O’Brien bio
Immigration alert—more Social Security “no-match” letters to issue this fall: The Social Security Administration (SSA) has announced its plan to mail a second set of “no-match letters” to employers this fall…


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HIPPA

Compliance Perspectives: Using Document Management Systems to Avoid HIPAA Pitfalls

By Andreas Rivera bio
Record-keeping can be one of the most stressful aspects of running a healthcare business since privacy compliance is scrutinized in healthcare more than any other industry.
Anyone with experience in the healthcare industry knows that violating HIPAA comes with steep penalties…


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CO-ORDINATING DATA

Laboratory Information Systems (LIS): What You Need To Know To Get Paid

By Sean McSweeney  bio
Today, laboratory billing claims require more and more data to successfully get paid.
One of the biggest reasons your claims may be getting denied is because…


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COMPLIANCE

Genetic Testing Fraud Prosecutions are on the Rise around the Country. Are Your Genetic Testing Practices Compliant?

By Robert Liles  bio
Over the last year, a number of genetic testing fraud investigations and prosecutions have been initiated by…


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LAB OPERATIONS

Earning our Spot on the Patient-Centered Care Team

By Jennifer Dawson, MHA, FACHE, CPHQ, LSSBB, DLM(ASCP)SLS, QIHC, QLC  bio
There is a lot of talk these days about integrating the laboratory into patient-centered care teams1 and about forming…


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OIG OPINION

Is Your Billing Company Putting You At Compliance Risk?

By Sean McSweeney  bio
Does your orthopedic billing company charge a percentage of collections for their coding and billing…


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SAFETY

Ergonomics in the Laboratory Setting

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
Sometimes when I am talking about lab safety and the topic turns to ergonomics, I get an unusual reaction from the audience…


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TECHNOLOGY

Top 4 trends shaping the healthcare industry

By Leora Borgenicht  bio
Before the healthcare industry can ambitiously transform to offer more accurate and personalized patient care, certain stepping stones must…


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LAB SAFETY

Changes in hazardous waste management: the Generator Improvement Rule

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
If you haven’t heard by now, you should know that the EPA published its Generator Improvement Rule (GIR) in 2016. It is an update to the…


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COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio
Despite it being a continual topic of discussion, the Food and Drug Administration (“FDA”) enforcement in the realm of laboratory developed tests…


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PAYER CONTRACTS

Three key items to negotiate for successful payer contracts

By Steve Selbst  bio
The purpose of this article is to help you, as a provider, to focus on three key items to look for in payer contracts that will help you to get profitable contracts in place…


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LAB SAFETY

When Your Lab Has to Work through a Weather Emergency

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
I read a written Laboratory Emergency Management Plan, and at the end of the document there was a short section called…


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LEGISLATION

New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more

By Danielle Sloane  bio and Chris Climo  bio
In a recent piece of federal legislation intended to address the opioid crisis across the United States, Congress enacted a new all-payor kickback law that applies to…


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COMPLIANCE

Q&A on Lab Waste Management

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
Understanding the proper separation and disposal of the various waste types generated in the lab setting is an important piece of managing the…


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DATA

6 Steps to Data-Driven Transformation

By Nir Kaldero  bio
We’re now well into the Fourth Industrial Revolution. The First Industrial Revolution was about steam and railroads, the Second about electricity, and the…


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LAB SAFETY

The Safety Interpretation

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
When hospitals were placed on OSHA’s list of “high-risk” workplaces, no one had to ask why. OSHA adjusts that list based on the number of injuries that occur on the job…


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SPECIAL FOCUS

Cost Avoidance vs Cost Savings: What’s the Difference?

By Jennifer Dawson, MHA, DLM (ASCP)  bio
As I work to spread awareness within the clinical laboratory community about the Cost of Poor Quality (COPQ) concept and its benefits as a method to demonstrate…


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LAB SAFETY

Changes in laboratory waste management

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
In the past, if a laboratory or a facility generated less than 220 pounds (or 100 kilograms) of hazardous (chemical) waste each month…


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EARNINGS

How to Avoid a Laboratory Audit

By Sean McSweeney  bio
Laboratory audits have a much harder impact on your lab than intended. As detailed by the NCBI, the audit’s intent is to review and…


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COMPLIANCE

Where’s your lab safety manual?

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
Laboratory leadership should be committed to providing a safe working environment, and they should believe their employees have a right to know…


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PAMA

PAMA Unlocks Golden Age for Innovative Diagnostics

By Chance Scott  bio
The publication of the 2018 Clinical Laboratory Fee Schedule (CLFS) in January saw a long and heated debate within the lab community come to fruition…


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MACRA REQUIREMENT

How to Adjust to the April 2018 Medicare Beneficiary Cards

By Sean McSweeney  bio
In a press release on May 30, 2017, the Centers for Medicare & Medicaid Services (CMS) commented regarding their fraud prevention initiative program and their planned changes regarding…


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FEE SCHEDULES

How PAMA’s Effect in 2018 Molecular Diagnostic Reimbursement Will Make Labs More Money

By Sean McSweeney  bio
The year 2018 is slated to be much brighter for molecular diagnostic labs as PAMA fee schedules show a higher payment rate and amount for many cancer genomics and…


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BILLING AND COLLECTIONS

Should You Contract with The Blues?

By Sean McSweeney  bio
Should you contract with the Blues? Many BCBS insurers around the country are opening up to paneling laboratories where previously that had not often been possible. They are offering…


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SAFETY

Diagnostic danger in the lab: Time to reform how we process orders

By Oleg Bess, M.D.  bio
I don’t know about you, but I was stunned by the findings from a recent report published by Coverys, a national liability insurer, which I feel should…


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REIMBURSEMENT

Out of Network: 6 Frequently Asked Questions

By Richa Singh  bio
As labs face an increasingly challenging reimbursement environment, more providers are doubling down on out-of-network strategies to maximize on collections opportunities…


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ANNUAL SURVEY

Outreach Survey Focuses on Clinical Laboratory Industry Trends Amidst Greatest Disruption in Three Decades

By Jeff Myers  bio
Accumen Inc. is pleased to announce the launch of the 17th Annual National Hospital and Health System Laboratory and Outreach Survey. The survey is designed to capture intelligence on…


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LAB SAFETY

Emergency Staffing ABCs

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
When I was growing up near Buffalo, New York, experiencing two snow storms in three weeks was no big deal; in fact, it was rather commonplace. When I…


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LAB SAFETY

Safety lapses continue with select agents

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
The approach of the holiday season signals the end of another year. Was this just another year in a long line of them for you in lab safety, or was it…


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EMPLOYMENT LAW

Employment Law Update: The Weinstein Edition

By Mike O’Brien  bio
Your news feed, like mine, has exploded with references to someone named Harvey Weinstein for the past few weeks. What’s up? Weinstein is…


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EMPLOYMENT LAW

Employment Law Update for HR Managers October 2017

By Mike O’Brien  bio
Here is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…


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LAB OPERATIONS

Don’t Crash & Burn: Why Cutting Your Quality Department’s Budget is not a Good Idea

By Jennifer Dawson, MHA, DLM (ASCP)  bio
Do you think that you can improve your organization’s bottom line by reducing the budget to your quality program and cutting its staff…


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LAB SAFETY

Fanning the Flames

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
Memorizing what actions to take in a fire situation is important, and reviewing this topic in October, National Fire Prevention Month, is both timely and…


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PAMA

Draft 2018 CLFS Reveals Fundamental Flaws in PAMA Reporting Exercise; Time to Take Action

By Lâle White  bio
As XIFIN predicted, the PAMA reporting exercise has resulted in significant proposed laboratory fee cuts. In fact…


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COMPLIANCE

Here’s my latest Employment Law update prepared for many HR professionals

By Mike O’Brien  bio
Lots of ADA Facility Lawsuits in Utah: Here is an interesting legal news update from my partner Mike Judd: Title III of the Americans with Disabilities Act (ADA) requires places of…


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MANAGING THE LAB

Should you be paying your staff overtime?

From – G2 Blog
It is a recurrent challenge for human resource professionals: Determining whether an employee is exempt from the overtime requirements of the…


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FOCUS ON

Decoding Quality Terminology

By Jennifer Dawson, MHA, LSSBB, DLM(ASCP)  bio
Quality has been defined as fitness for use, conformance to requirements, the pursuit of excellence and a product or service free of deficiencies …


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OPERATIONS

Lean Six Sigma is Not Quality

By Jennifer Dawson, MHA, LSSBB, DLM(ASCP)  bio
Now before the entire industry lynches me for the sacrilege of the title of this article, let me explain what I mean. I have known Lean Six Sigma skeptics and outright haters and trust me…


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LAB SAFETY

By the Numbers: Lab Injury and Exposure Data

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
Finding information about the number of Laboratory Acquired Infections (LAIs) and other laboratory injuries in the United States is difficult…


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EMPLOYMENT LAW

Employment Law Update for August 2017

By Mike O’Brien  bio
Here is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…


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MANAGING THE LAB

Why Your Best Talent is Leaving and Four Ways to Win Them Back

By William A. Schiemann, Ph.D  bio
Most leaders of companies today recognize the importance of having engaged people at work. Yet research from the Metrus Institute, Gallup, and others say that…


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EMPLOYMENT LAW

Employment Law Update for HR Managers

By Mike O’Brien  bio
This is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…


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DOJ

Medical Necessity Requirement Bites Anatomic Pathologists

By Robert Mazer  bio
The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains…


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LAB SAFETY

Getting a new lab space? Design it for safety now and save thousands later

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
Let me tell you a story. Once upon a time, there was a laboratory manager who worked in a hospital that was designing a new stand-alone emergency department building which would include a…


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MANAGING THE LAB

5 ways to end generational stereotyping in your lab

By Dr. William A. Schiemann  bio
These days, the Millennial Generation is hyped, perhaps even more than Baby Boomers were hyped in the 1950s and 1960s. As I meet with executives around the globe, there is widespread confusion and…


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PATIENT SAFETY

Do No Harm: Diagnostic Errors and the Lab

By Jennifer (McMahon) Dawson, MHA, DLM (ASCP)  bio
“Do no harm” is the mantra that health care providers live by. Doctors, nurses and laboratory professionals alike enter into the business of health care because they are motivated to…


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MANAGING STAFF

Watch Out for Resume Fraud

By Lynne Curry, Ph.D  bio
You know that new laboratory assistant you just hired—the one with the terrific resume and reference? It turns out she never worked for the employers named on the resume or…


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LABORATORY SAFETY

Making Laboratory Safety as Simple as ABC

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio
When it comes to safety in the laboratory, there are several rules, regulations, and guidelines to keep track of from multiple organizations. If your responsibilities for lab safety are…


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INFORMATION TECHNOLOGY

Role of Healthcare AI in the Lab: Today & Tomorrow

By Jason Bhan, MD, Co-Founder, Chief Medical Officer at Prognos  bio
Laboratories have traditionally directed their information technology (IT) focus to support their main business of testing. The IT infrastructure they have invested in allows them to…


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EMPLOYER COMPLIANCE

The New Overtime Rules are Put on Hold. What Does That Mean for You?

By Mike O’Brien  bio
As most of you know by now, I’m sure, the United States Department of Labor (DOL) has finalized a new Fair Labor Standards Act (FLSA) rule that, among other things, raises the minimum salary threshold required to qualify for…


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