Originally aimed at enhancing and promoting quality standards among all laboratory testing sites in the United States, Congress enacted the Clinical Laboratory Improvement Amendments (CLIA) in 1988. This law was later revised by the Centers for Medicare and Medicaid Services (CMS) in 1992. This regulation originally perceived that in Anatomic Pathology (AP) laboratories, the testing was performed by the pathologist and excluded all other professions in the AP lab.

This was not the case in the clinical lab, where other professions such as clinical laboratory scientist (CLS), medical laboratory technologist (MLT), cytotechnologist (CT) and other limited specialties were included in its language, thus creating a natural experiment setting which implied certain laboratory professions are important enough to garner certification while others are not.

Unintended Consequences of CLIA Regulation: A Threat to Patient Safety and Laboratory Quality

In contrast, when a patient has surgery, a dedicated team of medical staff work together each step of the way. While surgical teams often vary based on the type of procedure, the team usually consists of a surgeon, anesthesiologist, certified register nurse, surgical techs and physician assistant (PA) to name a few.  Surgical team performance is critical, as poor team performance can negatively impact patient outcomes.

Imagine a world where, by law, the only trained and board-certified person in a surgical team is the surgeon, while there are no education, certification or experience standards for others in the operating room performing critical, lifesaving tasks. As a result, patients may not be receiving the care they deserve. Recent changes in health care have shifted from a “fee for service” model to an integrated team approach focused on patient outcomes. This approach uses the total testing process (TTP), which considers both laboratory work and patient care.

Prior studies have linked the quality of the cancer diagnostic service performed as being influenced by the status and experience of the clinical, surgical and diagnostic medical staff such as pathologist and radiologist. However, after the surgical tissue or biopsy sample leaves the surgical room for testing and diagnosis (i.e., brain cancer, breast cancer, colon cancer, prostate cancer, lung cancer etc.) it is those other anatomic lab professionals that were excluded such as pathologists’ assistants (PA), histologist, i.e., histology technicians (HT), histotechnologists (HTL) and qualification in immunohistochemistry (QIHC), that play an essential role by continuously assessing each sample and multiple time points during the testing process, for each specimen, to produce a valid result for interpretation.

The Great Divide: Certified vs. Non-Certified

This regulatory framework resulted in creating an artificial environment of exclusion among laboratory professionals, with some being recognized and accredited while others were not. This exclusion has led to negative consequences, including decreased job satisfaction, motivation and performance among the excluded professionals.

The first article highlights the importance of accurate diagnoses in anatomic pathology (AP) laboratories and the potential consequences of these errors. It also discusses how CLIA regulation has created a sense of injustice and unfairness among those professions that were excluded, which can decrease employee retention, performance, motivation, morale and engagement.

As screening programs continue to evolve, and the need for pathology services continues to increase, instituting a regulatory framework that standardizes the level of education and experience necessary for those individuals that are handling those patient’s samples could reduce health care costs through improvements in diagnostic material quality and improving patient outcomes.

The second article explores the long-term lasting impact of government regulatory policies on the lives of professionals affected by them. Outlining the inadvertent consequences seen on these professions, creating a divide amongst healthcare professionals, influencing their sense of Identity and Justice.

It finds that the regulated professionals (those included in CLIA) have a stronger sense of positive professional identity, increased procedural and distributive justice, and reduced turnover intentions. In contrast, the unregulated professionals (those excluded from CLIA) have a higher sense of negative professional identity, which is correlated with increased turnover intentions.

Our findings reveal that the legacy of CLIA regulations goes beyond compliance; it fundamentally shapes the professional identities and experiences of laboratory professionals. By addressing the disparities created by these regulations, we can foster a more inclusive and equitable environment for all.

But what’s behind this continued exclusion?

Private interest groups, such as The College of American Pathologists (CAP), have successfully lobbied in the past to maintain the current practice of keeping some professions outside the scope of CLIA. They have also opposed state licensure for those excluded professions, arguing that it is unnecessary.

CAP and other private interest groups have argued that any additional regulations would hamper staffing levels within the anatomic laboratory. However, this research demonstrates the opposite. The study found that turnover intention and performance are linked, and that turnover is primarily affected by negative professional identity and reduced perception of fairness.

In other words, the environment created by these regulatory frameworks is contributing to the very problems that private interest groups claim would be exacerbated by additional regulations. By excluding certain professions from CLIA, these groups are perpetuating a system that undermines the morale and motivation of laboratory professionals, ultimately putting patient safety and laboratory quality at risk.

The Power of Inclusion

The authors emphasize the human impact on professions such as, teachers, nurses, surgical techs, barbers and cosmetologist’s standard of practice are recognized through professional licensure, while those professions conducting crucial cancer diagnostic tests in pathology labs were excluded from CLIA and from federal and state regulatory frameworks.

These findings have significant implications for healthcare organizations and policymakers, which can ultimately lead to promoting a more positive work environment.

We can promote a more positive and inclusive work environment. This can ultimately lead to better patient outcomes and improved health care quality.

• Recognizing the value and contributions of all laboratory professionals, regardless of their role or specialization.
• Revising the CLIA regulation to include all laboratory professionals, regardless of their role or specialization.
• Developing policies and procedures that promote fairness, equity, and recognition among all laboratory professionals.

The Future of Laboratory Professionals

Pathology Lab testing of surgical biopsies for cancer care has become highly complex, and with personalized medicine becoming the standard of care, the technical quality of the tissue specimen can directly impact quality patient outcomes. Not only are the procedures highly invasive, requiring vast amounts of resources from the healthcare system, but and unlike with phlebotomy blood samples, where the patient can be easily redrawn, errors in pathology processing are often irreversible, requiring surgical interventions. Although industry structures are beyond management’s control, leaders can devise internal structures that aim to drive innovation, creativity, and educate the workforce. Sustaining an increased level of staff engagement through interacted learning action loops may also moderate the negative effects of staff withdrawal and perceptions of disenfranchisement, decreasing complacency and inertia, and enabling organizations to actively pursue increased levels of alignment.

Converging on greater alignment among various organizational components, management should focus on performance related to technological innovation and knowledge management through structural changes to the career latter.  Encouraging engagement through a combination OJT and formal education programs that focus on advancing scientific education, KSA training, and expertise, as well as the critical thinking and decision-making skills necessary for national certification.

In health care, finance and quality should not be at odds with each other, they should be complementary to support a healthy environment. As such, policies can bring people together or drive a wedge between groups, regardless of ethnicity, race or gender. In a system that is plagued by burnout and turnover, operational inefficiencies that increase resource utilization and cost, future polices should be informed to enable them the opportunity to ameliorate these elements and promote a healthier healthcare system and improve population health outcomes.