One ongoing challenge to effective management of a clinical laboratory safety program is maintaining full recognition of the multiple regulatory agencies governing clinical laboratory practice, and understanding and properly applying all relevant safety regulations and guidelines. Although it is common for certain rules from different agencies to overlap (or even contradict one another), many are unique to the individual regulatory or accreditation body and serve to lengthen the total list of standards that must be followed.
Further complicating this challenge is the matrix in which these various regulations work together; a network that demands the attention of lab leadership in order to ensure overall compliance. As the responsibility for laboratory safety is often shared or delegated among the lab manager, the quality director, the point-of-care testing coordinator, et al, the lack of a cohesive set of duties can force safety into the background—an action that jeopardizes staff, lab assets, and ultimately, the patient.
The Safety Puzzle
True laboratory safety does necessitate a focused attention, and while the need for a dedicated lab safety manager largely depends on facility size and the scope of operations, the staff member(s) in charge of ensuring safety regulations should be in place. The safety regulations should be made clear and it should be evident that the rules are followed.
To gain and maintain laboratory accreditation, assembling the multiple regulatory requirements into a cohesive program is essential. Program management personnel should begin by familiarizing themselves with the various regulatory agencies (via alerts, websites, literature, etc) with the intention of adopting any references or compliance checklists they may offer. The College of American Pathologists (CAP), for example, grants online access to CAP-accredited labs offering checklists that provide a path to full compliance with their regulations. Similarly, the Occupational Safety and Health Administration (OSHA) offers an open website with access to every lab-applicable standard, as well as educational material, fact sheets, and regulation interpretations. OSHA standards, in particular, provide the basis of a significant number of lab regulations, yet the resources offered by the agency often go underutilized by lab safety professionals. The Centers for Disease Control (CDC) is another helpful resource for safety best practices, and the Environmental Protection Agency (EPA) provides information and data regarding proper hazardous waste determination, handling, and recordkeeping requirements.
Reviewing regulatory agency references can provide a better understanding of lab safety program needs, but input from numerous sources may seem overwhelming. To help manage this, the Clinical and Laboratory Standards Institute (CLSI) provides an excellent resource to assist in tying the regulatory puzzle together. CLSI develops clinical laboratory standards based on input from, and consensus among, health care industry, government, and practicing professionals. The specific CLSI documents that cover laboratory safety were developed by teams citing information from the multiple accreditation and regulatory agencies (see FIGURE 1). These documents comprise detailed information and tools to help the lab bring together and successfully manage the abundant regulations.
Lack of Safety Compliance: Accreditation and Penalties
Becoming educated on lab safety regulations is essential, but studying all available material does not automatically produce a perfect lab safety culture. Management styles, time, staffing, and workflow also affect how the lab safety program functions. Unfortunately, failure to manage the program properly may lead to staff injuries and exposures, lab accreditation concerns, and possible regulatory fines.
Concern over laboratory accreditation can arise in various ways. An inspection performed by CAP, for example, may reveal safety violations that trigger the lab to be placed on probation or even have its accreditation revoked depending on the scale of the violation(s). (For accreditation to be revoked, the violations would have to be severe and have the potential to cause immediate employee or patient harm). The Centers for Medicare and Medicaid Services (CMS) also perform detailed lab inspections, and as a federal organization, has the authority to prevent a lab from receiving reimbursement from Medicare patients, a penalty that would halt the lab’s ability to function. Each year, CMS makes available a list of US labs that have faced limited, suspended, or revoked operational certificates.1 Incident investigations, complaint follow-up, and on-site audits performed by OSHA and the EPA also may negatively impact a laboratory’s accreditation status.
Only extreme safety problems will generate the revocation of a lab’s ability to perform testing, but lesser issues can lead to financial penalties. The EPA, CMS, and OSHA all have the authority to levy fines against a laboratory or its associated health care organization. The fines vary and tend to depend on the severity of the violation(s), the inspector, and the laboratory’s inspection history. Federal agency inspectors do not discuss fines during on-site investigations, but if they see repeat offenses or a lack of willingness to comply with regulations, financial penalties may be levied or increased. Cooperating fully with any federal investigations or inspections coupled with a sincere desire to comply with regulations often results in lower fines or even fine dismissals.
Federal Agencies Granted Greater Power
Although financial penalties do vary depending on who is performing the inspection, federal agency fine rates are not calculated randomly. The Federal Civil Penalties Inflation Adjustment Act of 1990 allowed many federal agencies to review and adjust their civil penalties once every 5 years. One exemption that was made at the time was that OSHA would be excluded from any penalty-adjusting authority. It took 25 years, but in 2016 OSHA was granted the ability to adjust its fines to match inflation rates. That meant that OSHA fines could potentially increase 80%—a $7000 fine would become $12,600 for a single violation and a “willful” violation charge would rise from $70,000 to $126,000.
A sharps container with no lid, for example, would now constitute a single violation with a fine of $12,600. An employee working with open specimens and no face protection likewise would incur a fine of $12,600. If a review of training records demonstrates the employee was trained on the proper use of personal protective equipment (PPE), that fine becomes categorized as willful, and it increases to $126,000. If safety violations can be tracked over several days, those fine amounts may be multiplied by the total number of days during which they are determined to have occurred. Clearly, compounded failures to comply with lab safety can become extremely (and unnecessarily) expensive. In some cases, the financial burden could lead to the closure of the facility or lab.
Based on the number of annual workplace injuries over time, hospitals were placed on OSHA’s list of high-risk workplaces in 2015.2 That means OSHA hospital and laboratory inspections are now likely to occur with greater frequency. Inspectors have been given specific instructions to focus on: musculoskeletal disorders related to patient or resident handling, workplace violence, tuberculosis, bloodborne pathogens, and slips, trips, and falls. The last two areas—bloodborne pathogens and falls—are of particular concern to laboratory safety.
Information about fines can be used to educate laboratory staff on the importance of following safety regulations. Personal health always should be a key motivator, but explaining the financial consequences of non-compliance can be impactful as well. Providing this education is key to improving overall laboratory safety culture.
Regulatory Updates and Changes
Laboratory safety rules are constantly evolving and at times, regulatory agencies will work together to make consensus changes to existing guidelines. In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law and immediately placed into effect. This law amended the Toxic Substances Control Act (TSCA) of 1976, a law that was originally designed to help the EPA protect the environment and the public from hazardous chemicals. Unfortunately, the original TSCA only granted the EPA the ability to evaluate new chemicals, not the over 60,000 already in use in the US at the time. Since 1976, the EPA has banned only five chemicals from use, none of which are common to the clinical lab.
Furthermore, 2016 turned out to be an important year for OSHA’s regulation governing chemicals in the workplace—the Hazard Communication Standard.3 Laboratories across the nation were affected by the final implementation step of the Globally Harmonized System (GHS), a major modification to the laws which govern hazard identification. Chemical labels, safety data sheets (SDS), and workplace procedures had to be altered in order to ensure updated compliance.
Traditionally, OSHA and the EPA have different sets of regulations that cover separate areas of responsibility; the EPA focuses on the environment, whereas OSHA has purview over employee protection. The 2016 amendment to the TSCA may ultimately create overlap in responsibility and an impetus for these agencies to work together. The EPA’s new Chemical Safety Act contains wording of a nascent sharing of responsibility with OSHA. In referring to the TSCA’s risk evaluation process, chemicals in use must have an accompanying scoping document that provides information about the chemical affecting, “potentially exposed or susceptible subpopulations.”4 According to Title I, Section 3(12) of the TSCA, “The term potentially exposed or susceptible subpopulation means a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.’’
The inclusion of workers in this list allows the EPA to employ risk to employees as a means of assessing chemical hazards and preventing their use, if warranted. This is an ability the agency has not had previously, and the protection of employees certainly aligns with OSHA’s overall goal. The EPA will now assess chemicals in use in the workplace and it will perform a pre-market review of new chemicals before they are available on the public market.
What this means for the future relationship between OSHA and the EPA remains to be seen, but each agency’s focus is more aligned than ever regarding chemical safety, and the EPA has already outlined its activities for the first year. The law required the EPA to begin safety reviews on 10 chemicals within 180 days of enactment and on another 20 chemicals considered high priority within the first 3.5 years. [See FIGURE 2 for the first set of chemicals to be evaluated.] While none listed is commonly used in clinical laboratories, that could easily change as the EPA’s evaluation list continues to grow.
At times, regulatory agencies work together deliberately for a common safety cause, but other times, a single regulatory agency’s change can force accrediting bodies to update their requirements. One complicated example from 2016 involves CMS’ adoption of fire safety standards formulated by the National Fire Protection Association (NFPA). This regulatory change will affect many laboratories, but the accrediting bodies that will enforce the new standards may vary.
CMS adopted two updated NFPA standards in 2016—the Healthcare Facilities Code (NFPA 99) and the Life Safety Code (NFPA 101). Although these are not the most recent versions of these codes, CMS believes these 2012 versions to be appropriately relevant to hospitals, as they contain the most significant advances in fire safety and technology since the previously published editions. The adoption of these codes means that laboratories in health care facilities that are inspected by CMS must meet these updated standards for fire safety.
NFPA Codes 99 and 101 include a requirement to install automatic sprinkler systems in hospitals taller than 75 feet. There also is a requirement to have a fire watch or building evacuation if the sprinkler systems are out of service for more than 10 hours. A third new NFPA requirement affecting labs states that all doors to hazardous areas must be self-closing or must close automatically.5
CMS grants certain accrediting organizations “deemed status,” with the expectation that these organizations will accredit labs and health care facilities as meeting the Medicare and Medicaid certification requirements. The major US hospital accrediting agencies—The Joint Commission, Det Norske Veritas (DNV), and Healthcare Facilities Accreditation Program (HFAP)—all must adopt the same standards versions that CMS uses. Therefore, all these accrediting agencies are now inspecting laboratories and hospitals for compliance with the same updated NFPA codes across the country. If the fire codes are unclear, contact a facilities expert or your local fire authority to gain a better understanding for compliance in the laboratory.
Looking Ahead and Remaining Current
Additional regulatory updates and changes related to laboratory safety are on the horizon. OSHA is considering another revision of the Hazard Communication plan in response to complaints from certain US stakeholders regarding labeling issues (US distributors have to relabel containers from foreign countries if their labeling convention does not match that of distributors in this country) and a lack of standardization among foreign chemical manufacturers. Errors at the CDC—including the mishandling of anthrax, a contagious bird flu virus, and samples containing the deadly Ebola virus—and other national laboratories may lead to the development of new safety guidelines as well. CMS has published a new final rule6 for health care facility emergency preparedness defining new requirements, and the US Bureau of Labor Statistics has released its most recent update7 on clinical laboratory workplace injuries.
There are a number of additional approaches to remaining up-to-date on the latest safety issues affecting clinical labs:
The role of a laboratory safety professional is vital, even when the position has shared responsibilities. The focus should always include increased staff safety awareness, regulatory compliance, and reduced employee injuries and exposures. To accomplish those goals, the lab manager or safety lead must be able to successfully navigate the various regulations, organizations, and accrediting bodies. While working to piece the safety puzzle together requires many steps, remaining abreast of the latest changes in the field of safety will pave the way for an improved lab safety culture.
Daniel J. Scungio, MT(ASCP)SLS, CQA(ASQ), has over 25 years of experience as a certified medical technologist. He worked as a laboratory generalist in hospitals ranging from 75 to 800 beds before becoming a laboratory manager, a position in which he served for 10 years. Dan is now the laboratory safety officer for Sentara Healthcare, a system of more than seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. As “Dan the Lab Safety Man” he also serves as a professional speaker, trainer, and lab safety consultant. Dan received his BS in medical technology from the State University of New York at Buffalo.
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