Compliance is About More than Kickbacks, Referrals, & False Claims Liability: Check Our Top 3 Compliance Areas You May be Overlooking

Violations of Medicare-related laws such as the Anti-Kickback Statute, self-referral law and the False Claims Act can cost laboratories and pathology groups potentially millions of dollars and thus, compliance regarding these laws gets a lot of attention. However, there are other compliance risks laboratory compliance officers shouldn't lose sight of as well.

While the OIG, DOJ, CMS, and FDA may be acronyms that you think of most often when you think of compliance, there are some other enforcement agencies that should also figure prominently in compliance programs. In this article we'll focus on three government agencies that should be getting your attention:

#1. OSHA
As employers, laboratories have a duty to provide a safe workplace for their employees. The Occupational Safety and Health Administration (OSHA) enforces workplace safety law which includes a general duty clause that covers a lot of ground. But there are some specific safety issues that labs should be paying particular attention to:

Bloodborne pathogens
Bloodborne pathogens are an obvious issue for clinical laboratories but it's often easy to overlook the obvious. Just about two years ago LabCorp found itself in trouble with OSHA and paid more than $50,000 in fines relating to bloodborne pathogen hazards. OSHA claimed that phlebotomy technicians didn't receive required training before working with blood and workers didn't receive training about handling exposure incidents.

More recently, this month, OSHA announced that an emergency medical transport company could be subject to more than $235,000 in fines after OSHA inspectors found during a February 2015 inspection that the company failed to protect workers from bloodborne pathogens. Allegations included claims that the company failed to train workers regarding hazards and precautions to prevent exposure and didn't require workers to use gloves and face masks when in contact with infectious materials.

OSHA's bloodborne pathogen standards require regular training for workers before they work with blood and the training must address what to do in response to an exposure incident. So do a compliance review of your training programs, and your policies and procedures with regard to bloodborne pathogens and make sure they are up-to-date and being consistently followed.

Workplace violence
Earlier this year, in an April 2015 press release, OSHA announced updated guidance for protecting healthcare workers from workplace violence titled Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers. In the press release, OSHA cited 2013 Bureau of Labor Statistics information that indicate more than 23,000 injuries occurred at work due to assault and "[m]ore than 70 percent of these assaults were in health care and social service settings." OSHA declared "health care and social service workers are almost four times as likely to be injured as a result of violence than the average private sector worker."

The updated guidance addresses research regarding the workplace violence causes and risk factors unique to health care work environments. The guidance also calls for written workplace violence prevention programs that include worker and management collaboration, analyzing the worksite, training, recordkeeping, and hazard prevention and control.

Hazard communication
In an effort to harmonize standards internationally, OSHA's Hazard Communication Standard was revised to now require chemical manufacturers and importers provide required hazard information on labels and material safety data sheets according to a specific set of harmonized criteria for classifying chemicals according to health and physical hazards.

Why is this important for laboratories if the manufacturers and importers must create compliant labeling? Because laboratories, like all other affected employers, are required to provide training to workers regarding this new communication standard. The safety data sheets include 16 specific sections and the new labeling requirements call for use of signal words, pictograms, a hazard statement, and precautionary statement. Initial training on these new labels and data sheets, to ensure workers understand the new formats and information provided, should already have been provided by the end of 2013. But the lab's obligations don't end there.

OSHA also requires that by June 2016 employers "update alternative workplace labeling and hazard communication program as necessary" and "provide additional employee training for newly identified physical or health hazards." Additionally, while the manufacturers have to supply the safety data sheets, your lab should conduct an inventory and make sure you've received all the updated safety data sheets that you need for your laboratory. Also, include this OSHA training as an item in your compliance audits to ensure all requirements are met and training is up-to-date. Just last month, July 20, 2015, OSHA announced instructions to compliance officers for how to ensure enforcement of the new Hazard Communication Standard.

On a related note, OSHA also currently is awaiting responses to a Request for Information on Chemical Management and Permissible Exposure limits. It extended the comment period until October 8, 2015. The initial request and specific questions on this topic was published October 10, 2014.

TB in health care settings
In July, OSHA issued updated instructions regarding inspections and enforcement concerning tuberculosis exposure in health care settings. While this doesn't change any employer obligations, it is a sign that OSHA is paying attention to this issue. The press release announcing the updated instructions highlights the fact that the new instructions cover "additional workplaces regarded as healthcare settings such as sites where emergency medical services are provided and laboratories handling clinical specimens that may contain M. tuberculosis."

Emphasizing the importance, OSHA notes that "[m]ulti-drug-resistant and extremely drug-resistant TB continue to pose serious threats to workers in healthcare settings." It also cites CDC statistics indicating that TB is "the second most common cause of death from infectious disease in the world" behind HIV/AIDS.

So your laboratory should review its policies and procedures and its TB infection control plan and make sure they are up to date and consistently implemented to reduce the risk of tuberculosis infection for your workers. The instructions state that TB infection control plans should be updated annually and supervised by appropriate personnel.

Injury reporting
Earlier this year the reporting rules changed. While laboratories have a partial exemption, some aspects have changed that affect all employers subject to OSHA—laboratories should be notifying within eight hours of fatalities or an employee being hospitalized, suffering amputation or eye loss. The amputation and eye loss reporting requirement is new and reports were only required when at least three employees were hospitalized rather than just one employee. Check to make sure your reporting procedures have been updated and that all employees are trained on these requirements.

The bottom line for laboratories is that with all these fairly recent developments in workplace safety, it's clear that OSHA hasn't gotten complacent and is updating its standards to respond to changing workplace environments and developing hazards. Thus laboratories must be vigilant and review safety policies and procedures to ensure laboratory workers are protected—or risk significant financial liabilities.

#2. IRS and DOL
For flexible staffing and filling in holes in your schedule, it may be appealing to hire independent contractors. But make sure your arrangement is truly an independent contractor arrangement and not employment. Just the label you give it isn't the determining factor.

The IRS looks at the degree of control and independence in three areas: behavioral control (regarding what the worker does and how he does it), financial control (the business aspects such as how the worker is paid and how expenses are handled) and type of relationship (is the arrangement written, does the worker get certain benefits such as pension, is the work performed a key aspect of the business?).

Whether a worker is an employee or independent contractor is important not just for tax considerations but also because employees are entitled to protection under the Fair Labor Standards Act (regarding minimum wage, overtime, workers' compensation). So, in addition to the IRS, the Department of Labor (DOL) is also concerned about how workplaces classify their workers.

Finally, improperly classifying individuals as independent contractors could impact compliance with the Affordable Care Act (ACA) and obligations to provide health insurance benefits because an organization's number of employees affects its obligations under the ACA.

In July, the DOL issued an Administrator's Interpretation regarding the Fair Labor Standards Act's terms for classifying workers as employees and notes that its Wage and Hour Division has received "numerous complaints" from workers alleging misclassification as independent contractors and that in response to this "problematic trend" many states have established task forces focused on misclassification of workers. The DOL's July interpretation document also notes the agency has entered into a memorandum of understanding with the IRS and individual states to coordinate their efforts on this issue. In fact, memoranda were announced just this month between the DOL and the states of Alaska and Idaho.

The DOL indicates that in 2014, its Wage and Hour Division recovered a total of $79 million in back wages for more than 109,000 workers. While this has been getting a lot of attention in the home health industry, it's unwise for any employer, in any industry, to ignore the classification issue. If you are wrong in classifying workers as employees or independent contractors, you risk liability for unpaid income and unemployment tax withholdings, unpaid wages, unpaid workers' compensation premiums and other benefits and potential liability for failure to provide health insurance benefits under the ACA.

#3. EEOC
The Equal Employment Opportunity Commission (EEOC) may not be on your radar but as you struggle to adapt to a changing and competitive laboratory market and manage tight budgets, make sure your employment decisions don't give rise to claims of discrimination. Recently, in June, the EEOC called attention to pregnancy discrimination, issuing a Notice of Enforcement Guidance on the topic and recent enforcement cases have involved pregnancy discrimination.

Also, in July, a health care system agreed to pay $80,000 to settle disability discrimination claims. While that number is small potatoes compared to the numbers we see in False Claims Act enforcement, that settlement addressed claims involving just one individual.