As Boomers retire from labs, new safety leaders need to step up
By Dan Scungio The number of medical laboratory scientists (now clinical lab scientists) is dwindling. Baby Boomers have begun to retire, and even before that, there were more job openings than people to fill them. That means more opportunities in the lab field, and in some cases leadership roles are being obtained by less experienced people than in years past. Whether or not one has a long lab history, one aspect of any new leadership position that will be important to grasp is management of the lab safety program. The first step for a new lab leader is to ensure the existence of a functional laboratory safety program. To do this, look for specific components of the program: a laboratory safety manual, a safety committee, and lab safety indicators. If… . . . read more
Making hybrid work: Charting a new playbook for a future-ready workplace
By Lynne Curry Employers thought employees would want to come back to their offices, where they had easy access to equipment, coworkers, and managers. They were wrong. COVID-19 untethered us from our traditional workplaces and many employees don’t want to return. Employees enjoyed the flexibility and freedom, sometimes from micro-managing supervisors, they had when working from home. They discovered they could better balance home and work when they didn’t have to commute or leave home for eight hours daily. When the C-suite consulting firm McKinsey & Company surveyed more than 5,000 employees, it reported three-quarters of them want to work from home two or more days per weekly, with more than half of them wanting to work from home at least three days a week.1 Given this disconnect, if employers… . . . read more
Super villain origin stories in the lab
In the latest Marvel superhero movie, Shang Chi and the Legend of the Ten Rings, a new villain is introduced to fans not familiar with the comic books. Older readers know, however, that Shang-Chi’s father represents a well-known comic book villain, the Mandarin. The Mandarin found and explored the wreckage of a spaceship. Within the craft he found 10 rings which gave the bearer great powers. For years he used those rings to try to defeat the American hero Iron Man. That was the origin of the Mandarin in the comic books. As a laboratory safety consultant, I have billed myself as the “Superhero of Lab Safety”. I did that in part because I have been reading and collecting comic books for many years, and I wanted to insert my… . . . read more
“Long COVID” looms ahead as leading ADA claim?
By Mike O’Brien Legal commentators are already predicting that the condition now known as “long COVID” may displace back conditions as the leading impairment asserted in charges brought under the Americans With Disabilities Act (ADA). CNN recently reported, “A large study has revealed that one in three Covid-19 survivors have suffered symptoms three to six months after getting infected, with breathing problems, abdominal symptoms such as abdominal pain, change of bowel habit and diarrhea, fatigue, pain, anxiety, and depression among the most common issues reported.” To date, COVID-19 has infected some 43 million Americans. The United States Department of Health and Human Services (HHS) already has opined here that “long COVID can be a disability under” the ADA. The Equal Employment Opportunity Commission (EEOC) agrees, citing the HHS paper. Guidance issued for federal contractor vaccine… . . . read more
Watch for vaccine mandate and outcome of remote work lawsuit
By Mike O’Brien Watching for OSHA’s new vaccine mandate rule President Joe Biden has instructed the United States Department of Labor Occupational Safety and Health Administration (OSHA) to develop an emergency rule that will require private-sector employers with 100 or more employees to mandate that their employees be vaccinated or receive a weekly negative COVID-19 test. Employers who fail to do so will face fines. In addition, regardless of employee headcount, OSHA will require all federal contractors to mandate vaccinations for their employees with no option for employees to receive weekly testing instead. Similarly, OSHA will require all employers in healthcare settings that receive Medicare or Medicaid reimbursement to mandate employee vaccinations, with no weekly testing option. President Biden’s announcement was welcomed by many business leaders but criticized by Republican… . . . read more
White House requires all private-sector employers with 100 or more employees to mandate vaccination or a weekly negative COVID-19 test
By Mike O’Brien President Biden spoke from the White House Sept. 9 to announce his new Path Out of the Pandemic Plan. Among other things, President Biden has instructed the Occupational Safety and Health Administration (OSHA) to develop rules that will require private-sector employers with 100 or more employees to mandate that their employees be vaccinated or receive a weekly negative COVID test. Employers who fail to do so will face fines. Some media outlets report that such fines could be up to $14,000 per violation. Along with President Biden’s spoken remarks, the White House also issued this statement: The Department of Labor’s Occupational Safety and Health Administration (OSHA) is developing a rule that will require all employers with 100 or more employees to ensure their workforce is fully vaccinated… . . . read more
Is it worth the risk assessment?
By Dan Scungio As a safety professional, we know performing risk assessments is worth it—it is an integral piece of managing a safety program. Assessing risks and identifying hazards are considered the beginning steps that must be completed when approaching the management of any safety-related area. Risk assessments are the starting point for handling a bloodborne pathogens program, chemical hygiene, personal protective equipment, and many other lab matters. But how can you be sure they have been performed correctly, and how often should they be performed? OSHA says performing the risk assessment is worth it. They state, “The employer shall assess the workplace to determine if hazards are present, or are likely to be present, which necessitate the use of personal protective equipment (PPE).” They go on to say, “the… . . . read more
Paid leave for vaccine tax credit updated & employer ups premiums for unvaccinated
By Mike O’Brien Update to the paid-leave tax credit expansion—paid leave for employees to receive a COVID-19 vaccine As previously described in these updates, the Treasury Department and the IRS announced that eligible employers could receive paid-leave tax credits under the American Rescue Plan Act (ARPA) for providing leave for each employee receiving a COVID-19 vaccine and for any time needed to recover from the vaccine. Generally, the tax credits are available for qualified leave wages an eligible employer provides with respect to leave taken by employees beginning on April 1, 2021, through Sept. 30, 2021, if the leave would have satisfied the requirements of the Emergency Paid Sick Leave Act and the Emergency Family and Medical Leave Expansion Act, as amended for ARPA. An eligible employer is generally an… . . . read more
Illumina Rolls the Dice by Acquiring Grail Without Regulatory Approval
Deliberate defiance of government regulators takes gumption, even when those regulators are located an ocean away. However, that’s the strategy that Illumina’s corporate leadership has chosen in announcing that the company has completed its acquisition of Grail even though the European Union (EU) has not and may not approve the deal due to its anti-competitive effects. The Illumina Acquisition of Grail On Sept. 21, 2020, Illumina announced that it had signed a definitive agreement to acquire Grail, the liquid biopsy firm it spun off in 2016 and which had announced its own plans to go public just a week earlier. The price: $3.5 billion in cash and $4.5 billion in shares of Illumina common stock. Under the acquisition agreement, which was approved by each company’s board of directors, Grail shareholders,… . . . read more
OSHA Updates Guidance to Track the Latest CDC Mask Recommendations
By Mike O’Brien The U.S. Occupational Safety and Health Administration (OSHA) has updated its COVID-19 workplace safety guidance entitled, Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace. OSHA’s latest update on Aug. 13 “reflect[s] the July 27, 2021 Centers for Disease Control and Prevention (CDC) mask and testing recommendations for fully vaccinated people.” Prior to this update, OSHA had stated that fully vaccinated employees did not need to wear masks and that COVID safety precautions really were focused on protecting only unvaccinated workers. However, that guidance has now changed in response to the highly contagious Delta variant. OSHA’s guidance includes “recommendations,” that do not carry the force of law and “creates no new legal obligations.” Still, OSHA’s counsel likely becomes a standard of reasonableness… . . . read more
Four Motivators Every Lab Safety Professional Should Know
By Dan Scungio If you search for top motivational movie speeches, you will see things that might work in real life. The President’s speech from Independence Day (1996), for example, might influence you to never be oppressed by alien tyranny. Freedom will be your rallying cry after listening to William Wallace in Braveheart (1995), or Maximus from Gladiator (2000) can speak to your heart about teamwork. Unfortunately, such speeches do not tend to maintain motivation for great lengths of time. Also, none of them will translate to a motivational discussion about safety with your staff. Over the years I have watched what motivates people to do the right thing or take the safe actions in the laboratory, and that motivation varies. Different groups of people are persuaded by different forces, and understanding that can… . . . read more
Three Common PGx Compliance Traps for Laboratories to Avoid
By Adam M. Walters Walters Law, P.C. In recent years, many clinical laboratories have started offering Pharmacogenetics Testing (PGx) to assist physicians in avoiding prescribing medication doses that may cause adverse reactions in patients with certain genotypes and/or alleles. For example, people with the HLA-B*1502 allele are at a higher risk of developing toxic epidermal necrolysis (TEN) when using the anti-convulsant Carbamazepine. By using a PGx test for the HLA-B*1502 allele prior to prescribing Carbamazepine, a physician may prevent Carbamazepine induced TEN. While the PGx test is a highly valuable form of medical test, it is also presently one of the most highly scrutinized tests test by CMS. While not an exhaustive list, following the below referenced guidelines should enable laboratories to minimize compliance risks associated with PGx testing. Documenting… . . . read more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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: 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 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
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
“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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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 …
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…
