100 Years of Advocating for Laboratory Medicine, Pathology, and Quality Patient Care

Since 1922, the American Society for Clinical Pathology (ASCP) has advocated for quality on behalf of pathology and laboratory medicine. Over the course of its history, the Society has worked to advance knowledge, training, and skills for medical laboratory professionals and pathologists and, ultimately, to improve the quality of healthcare for patients.

“ASCP’s advocacy benefits the professionals, but it also benefits the patients,” says Barbara M. Castleberry, PhD, MT(ASCP), retired executive director of the ASCP Board of Registry, now the Board of Certification (BOC). “When we advocate for standards that improve the quality of laboratory results, we advance prevention, diagnosis, and treatment of disease.”

Advocacy has been an integral part of ASCP since its inception. From training for medical laboratory professionals to pushing for preferable legislation in Congress, ASCP has continually worked to elevate the quality of medical laboratory testing.

The early years

In the early years of ASCP, there were no mandatory standards for clinical laboratories or laboratory personnel. So began ASCP’s emphasis on the quality of training, which has continued over the decades. In 1928, ASCP established the American Registry of Medical Technicians, later renamed the Board of Registry (BOR). The BOR was established as part of an effort to advocate for minimum standards for laboratory services and to ensure the competency of laboratory technologists and technicians. These standards meant that laboratory personnel had to meet certain training requirements to demonstrate that they were prepared to work in the laboratory.

“The written exam began as 12 questions,” recalls Patricia Tanabe, MPA, MLS(ASCP)CM, who retired as the BOC Executive Director on June 30, 2022. By the 1930s, all ASCP Board of Registry applicants were required to pass both a written exam and a practical exam. When the United States entered World War II, so many of the nation’s men had enlisted that there were few healthcare professionals available to observe the BOC applicants working in the laboratory to see if they were qualified. Hence, the BOR stopped administering the practical exam.

After World War II, the practice of medicine changed substantially, with the expanded use of antibiotics, blood banking, and recent regulations put in place by the Food and Drug Administration (FDA). The federal agency oversaw the pharmaceutical industry and, over time, the medical device industry. The growth of the medical device industry created a need for more medical technologists to oversee clinical trials and an expanding array of hospital tests.

In the post-war years, the continuing advances in science and medicine brought with them more specializations. In 1948, the BOR advocated for the improved competency of these new specializations, and so it created new credentials, including the technologist in chemistry, the technologist in microbiology, and the histologic technician. Laboratories, too, became more specialized.

In the 1950s, to keep up with growth in the medical laboratory field, the BOR further expanded the number of certificate offerings to include several specialist categories. By the following decade, the BOC raised the standards to require that all medical technicians have at least three years of college training.

Clinical Laboratory Improvement Act

During the late 1960s, Congress enacted the Clinical Laboratory Improvement Act, ushering in the first regulations for medical laboratories, primarily covering independent and hospital laboratories. The passage of the Clinical Laboratory Improvement Amendment in 1967 brought hospital labs up to speed with independent laboratory quality standards. The amendment was updated in 1988, expanding the standards for cytologists and to other areas of laboratory personnel.

During the 1970s, ASCP reorganized its structure to spin off the BOR as an administratively separate entity.

The age of technology

Around that same time, automated equipment to test patient samples was coming online. While the equipment was tremendously expensive, it could process significantly more test samples much faster and more efficiently than the old, manual process.

“There was a fear that automation would eliminate jobs because if you could automate, you would need fewer people to work in the labs. But that did not happen,” says Gerry Piskorski, who retired in 2018 as administrative director to the BOC Board of Governors. “In fact, they needed more staff. We had shortages in the lab.”

Dr. Castleberry joined the BOR in 1977 as its first medical technologist executive director. Around that time, she recalls there was no “real data” on laboratory personnel statistics available. “The U.S. Bureau of Labor Statistics would call me, and a variety of other professional organizations and employers, and ask what I thought laboratory professionals earned or what the staffing need would be” in a given year, she says. To fill this void in data, ASCP created the Wage and Vacancy Surveys, which became a significant and highly regarded source of data, as well as a tool to advocate for the needs of the profession.

Another significant issue for which ASCP advocated revolved around licensure of laboratory staff. Laboratories were required to be accredited under the Clinical Laboratory Improvement Amendments, but the states were now becoming interested in licensing the staff who worked in the laboratories. Although the states of California and Florida had long had licensure requirements for technologists, in the early 1990s, a number of states introduced legislation to license laboratory personnel. Many of these efforts were unsuccessful. California was the first state to regulate laboratory personnel when it released an emergency rule to specify requirements for performing examinations of cytotechnology slides. ASCP worked to support licensure bills that created sound personnel standards and recognized legitimate private sector certification to achieve licensure.

“Licensure has everything to do with certification and who can practice in what states,” Ms. Tanabe says. “Everyone has experienced workforce shortages. And because we have ASCP International certification, we have internationally certified laboratory professionals. There are states that have been accepting ASCP International-trained professionals for their laboratories.”

The early 1980s were marked by the discovery of a new and unknown illness that came to be known as the human immunodeficiency virus-acquired immunodeficiency syndrome, or HIV-AIDS. Pathologists and laboratory professionals were involved in treatment testing and guideline issues that were advancing in the early years of the AIDS crisis. ASCP was very active during the early 1980s and through the 1990s to address this crisis and established a committee that actively advocated to bring awareness to tissue, blood, and safety issues for laboratory personnel.

Choosing Wisely

From the 1980s to the present, the costs of healthcare have escalated dramatically. Many factors have contributed to this increase, including government policy, technological advances, and the inception of national programs such as Medicare and Medicaid. To rein in these expenditures, many of which were duplicative or unnecessary, the ABIM Foundation in 2012 launched the Choosing Wisely campaign, which seeks to engage physicians in being better stewards of finite healthcare resources and to advance a national dialogue on avoiding unnecessary medical tests, treatments, and procedures.

ASCP was among the medical organizations that joined the Choosing Wisely campaign at the very beginning. Today, ASCP is one of 70 medical societies in the Choosing Wisely campaign and is the only society representing pathologists and laboratory professionals. ASCP has recommended a total of 35 targeted, evidence-based tests that patients should discuss with their physicians about whether they are truly necessary.

The evolution of science and advances made in gene sequencing had a profound impact on biomedical research and preventive health. It also raised questions as to whether genes could be patented. That issue was brought to the forefront when a group named Myriad Genetics secured a patent in 1996 on the BRCA1 and BRCA2 genes that it had identified and isolated. The two genes are responsible for diagnosing an elevated risk of breast and ovarian cancer. Myriad claimed exclusive rights on BRCA1 and BRCA2 DNA, mutations, and diagnosis. Two years later, it also filed for a patent on the method of detecting BRCA2 mutations and antibodies. In 2013, the U.S. Supreme Court ruled in favor of a lawsuit filed by the Association for Molecular Pathology, ASCP, and other medical groups against Myriad Genetics.

ASCP and the other plaintiffs argued that the patent violated §101 of the Patent Act as they pertained to laws of nature and this patent limited scientific progress. Under the Patent Act, three categories of “inventions” are not patentable: laws of nature, natural phenomena, and abstract ideas. In deciding the case, the U.S. Supreme Court held in AMP v. Myriad Genetics that naturally occurring gene sequence and their natural derivatives products are NOT patent eligible. “Patents prevent competition, so prices tend to be higher,” says Matt Schulze, ASCP’s Director of the Center for Public Policy. “Also, patents can block innovation and second opinions.” In short, the patents could have affected patients’ access to genetic testing. Meanwhile, ASCP’s advocacy efforts had a major effect on the question of whether individuals with a bachelor’s degree in nursing were adequately trained to perform high complexity laboratory testing. The issue was raised in April 2016, when the Centers for Medicare and Medicaid (CMS) sent a memo to its CLIA inspectors, opining that a bachelor’s degree in nursing was equivalent to a bachelor’s degree in biological sciences and, therefore, nurses would be allowed to conduct high complexity testing. It touched a nerve with many ASCP members. ASCP wrote a letter to CMS, arguing that the two degrees were not equivalent and that nurses did not possess the proper training to perform high complexity laboratory testing.CMS then released a notice announcing its intention to develop a regulation to implement its 2016 opinion.

“CMS received 10,000 comments on this proposal and only 20 of those comments supported CMS’ position,” Mr. Schulze says. “Consequently, there has never been a rule. That was a big win for ASCP.”

ASCP is also working to reform the Protecting Access to Medicare Act (PAMA). When PAMA was enacted in 2014, it required CMS to revalue the Medicare Clinical Laboratory Fee Schedule (CLFS). As a result of CMS’ flawed implementation of PAMA, CMS has drastically cut reimbursement for laboratory tests. The flawed pricing scheme has been adopted by private insurers to cut fees as well. The result has been a significant decrease in revenues of scores of laboratories and has undermined the ability of laboratories to properly staff their facilities.

ASCP has also lobbied Congress to reform federal self-referral laws to cover anatomic pathology services. ASCP and others worked to support the Promoting Integrity in Medicare Act, which bars physicians from profiting on the anatomic pathology and other services they order. The measure would close a loophole in Medicare that is harmful to some patients and wastes billions of dollars in taxpayer funds.

Workforce shortage

From the very beginning of the COVID-19 pandemic to the present, ASCP has been on the front line advocating for the needs of the pathology and medical laboratory community. This includes advocating for testing to be done in hospital laboratories to have timely results that could benefit patient care.

Very early on, ASCP called for the creation of a national strategy for the COVID-19 response to the pandemic, something that President Joe Biden later established. The President’s plan included signature policies and proposals that ASCP had championed over the past year. The President also called for the creation of a National Pandemic Testing Board, for which ASCP had strongly advocated.

Pathology and the medical laboratory profession served as the bedrock of health care throughout the coronavirus pandemic. Yet the coronavirus pandemic has put extreme pressure on healthcare services worldwide and pushed many healthcare workers past their breaking point. Many have left the profession, exhausted, leaving laboratories scrambling to fill vacancies at a time when testing has skyrocketed.

“Throughout this pandemic, ASCP members’ unfailing dedication and perseverance to battle on has shown to the world that pathology and laboratory medicine play a crucial role in patient care,” says ASCP President Henry M. Rinder, MD, FASCP.

Raising the visibility of the medical laboratory profession and expanding the pipeline of future pathology and laboratory professionals has always been a high priority for ASCP. This year, the Society is putting an even greater effort on revitalizing the field.

“ASCP will continue to support our members with all of the tools necessary to maintain and improve upon the important work of pathology and the laboratory,” Dr. Rinder says. “Underlying all of ASCP’s efforts is our focus on improving the delivery of patient care, through improved patient safety, diagnostics, and pathology and laboratory staffing.”

Right test for the right person

Since its founding a century ago, ASCP has been dedicated to fulfilling its mission to improve patient care. That has meant pushing for higher standards for personnel, for testing and for diagnostics. ASCP’s advocacy work has ranged from efforts to prevent inappropriate billing practices and mark ups, to reducing unnecessary testing, and much more. These efforts are aimed at ensuring that patients receive high-quality care with the right test at the right time.