All health care providers are experiencing tremendous change as well. Specialty physicians such as anesthesiologists are being replaced by generalist practitioners such as family practice physicians. Nurse practitioners are taking a primary role in screening and referring patients, as well as in prescribing medications. Some professions such as those in physical therapy have by state law an independent practice that does not require physician referral and is reimbursed directly for services provided.
Health care institutions themselves are undergoing change. Managed care, emphasizing wellness and disease prevention is replacing the traditional hospital as the main site for providing health services. Surgeries are being performed in ambulatory care settings. More and more laboratories are located outside of traditional hospitals and clinics. And, the reimbursement for all services is changing as well.
Thus, clinical laboratory science is going through changes today in relation to medicine and, to a lesser extent, to nursing and to other allied health professions. Such changes are taking the forms of issues that must be resolved, first within each profession through the process of building consensus, and then among the professions involved.
Political issues are just as important for the professional to master and affect as are the scientific, technical, and valuing principles underlying his or her field. Politics have an enormous influence on what professionals do every day; whether they will be able to expand their roles and duties as new technologies and new roles broaden their competence; and how much satisfaction and money they will derive from their profession.
This chapter focuses on a few of the main issues with which today’s clinical laboratory professionals are grappling. They include: professional independence, health care cost containment and laboratory reimbursement, and potential changes in practice patterns.
The Struggle for Professional Independence
One of the more intriguing aspects concerning contemporary health care is the struggle being waged by the allied health professions, including clinical laboratory science, for independence from medicine. Like nursing, many of the allied health professions began as helping occupations, and early on they were subordinate to medicine. Practitioners performed routine tasks as requested by doctors.
However, changes in science, technology, and professional expertise, coupled with insights into health care needs and capabilities and, lately, unprecedented pressures on the health care delivery system, have combined to advance these former "helping occupations" to their status today as professions, or near-professions. With that step has come laboratory science practitioners' understandable desire to practice to the full extent of their professional abilities. As their competence in laboratory science has expanded, however, it has inevitably brought practitioners from an earlier subordinate position to collegial status. Results have included tensions over professional territory and compensation.
The issues at stake are basically how the two fields, pathology and clinical laboratory science, will interact in the future, and whether clinical laboratory science will gain autonomy from pathology. The struggle began over sixty years ago; just how far clinical laboratory science has come can be seen in a brief history of the field and in how its statements, or codes, of professional ethics have evolved.
A Brief History of Clinical Laboratory Science
M. Ruth Williams, an early historian of the profession, has provided several possibilities for how clinical laboratory science began. One possibility, which she attributes to Vivian Herrick, a medical technologist writing in 1937 in the American Journal of Medical Technology, is that the profession can trace its beginnings to 1550 B.C., when certain intestinal parasites were mentioned in writing, Another is that in the fourteenth century, in Bologna, Italy, a young woman named Alessandra Giliani served as the first laboratorian. She was employed, we are told, by a physician at the University of Bologna in "performing certain tasks which would now be considered those of the technologist." She eventually died from a laboratory-acquired infection.
Others, however, prefer to date the profession much later, in the 1600s. According to Herrick, "Malpighi (1628-1694) is described as the greatest of the early microscopists and his work in embryology and anatomy definitely marks him as the founder of pathology." Others date the founding of laboratory science "with Anton van Leeuwenhoeck's description of red blood cells (1674), protozoa and bacteria (1677)."
Some prefer an even later date, linking the professions origins to Pasteur and Koch and their advances in bacteriology (1857 and 1876, respectively), or to Virchow who specialized in cellular physiology and who is credited with having founded the Archives of Pathology in Berlin, in 1847.
Williams writes that the first "chemical laboratory" associated with medicine in the United States was founded at the University of Michigan around 1844. A laboratory assistant at that time (later to become a physician and dean of the Michigan College of Medicine) described some of his work:
I remember with what pride I demonstrated leukemic blood and urine to the class; how I exhibited crystals of tyrosin and leucin in the urine in a case of cancer of the liver, a rare opportunity indeed; how I showed the presence of urea in the perspiration of a man dying of kidney disease. (Vaughan)
Although some of the procedures Vaughan describes are routine today, he captured an excitement that still is felt when a clinical laboratory professional discovers an important diagnostic clue.
One of the first official references to laboratory workers is found in the 1900 census which listed 100 technicians, all male, employed in the United States. These were not all medical technicians, but included some dental and industrial workers. The number of technicians had increased to 3,500 by 1920, with 2,000 of these female. . . . [By] 1922, 3,035 hospitals reported they had clinical laboratories. (Williams)
Following World War I, the demand grew for appropriately trained laboratory technicians. In 1922 the first baccalaureate program in medical technology was founded at the University of Minnesota, to be followed shortly thereafter by another baccalaureate-level program at the University of Tennessee.
In 1928 the American Society of Clinical Pathologists (ASCP), an organization of pathologists who employed technicians, established certain qualifications for technicians and then created a Board of Registry to certify individuals who met its qualifications to practice. By 1933, however, some technicians recognized the need for their own professional association. With the founding that year of the forerunner of the American Society for Clinical Laboratory Science-then called the American Society of Clinical Laboratory Technicians-the struggle for professional independence had begun. For example, by 1943, Frieda Claussen, the fourth national president of the Society, wrote of the confusion regarding ASCP s Board of Registry being a certifying agency while ASCLT was a professional association of laboratory technologists. In her minutes of the Board of Registry meeting with its Advisory Committee, she noted:
The fact that we have a national organization, the American Society of Medical Technologists, whose membership is composed entirely of technologists registered with the A.S.C.P., seems to have escaped the notice of many registrants, who are not aware that the national organization and the Registry are not one and the same, and who through this lack of understanding have failed to give their support to the A.S.M.T. Without a strong national organization the technologists of America can never hope to hold their own in the solution of any problem. Registration with the "Registry" is not the same as belonging to the American Society of Medical Technologists as the Registry is not a society.
Although clinical laboratory practitioners may work closely with pathologists in the laboratory clinical laboratory science is not part of the practice of medicine. However, because some pathologists provide clinical laboratory services and because laboratory science has a history closely associated with pathology, some disagree.
Nevertheless, several state attorneys general and the United States Department of Health and Human Services (HHS), in a regulation upheld by the United States Court of Appeals, found that medicine and clinical laboratory science were different professions. In a 1976 opinion, for instance, the Attorney General for Minnesota, Warren Spannaus, wrote to Arthur W. Poore, Executive Secretary, Minnesota Board of Medical Examiners (Correspondence. January 5, 1976 [303c]):
You ask . . . substantially the following. . . . Does the scientific testing and reporting of results of medical laboratories of samples obtained from human beings performed only for and at the request of licensed physicians, constitute the practice of medicine?
We answer your question in the negative. In our opinion, the function performed by the medical laboratories does not constitute diagnosis. . . . Rather, the labs are engaged in ascertaining observable or quantifiable facts. . . . This result is consistent with the opinions of Attorneys General of other states dealing with the line between the unauthorized practice of medicine and licensed laboratory testing. . . .
The advent of automated test technologies in the 1950s and the creation of the Medicare and Medicaid programs in the late 1960s, together with the assertions of laboratory professionals in the 1960s, intensified the struggle between pathology and clinical laboratory science.
Automated multichannel test instruments meant that large volumes of samples could be tested quickly, cheaply, and usually reliably. Medicare and Medicaid programs, which were created in 1965, transformed the federal government into a major purchaser of laboratory services for the elderly and the needy, stimulating a huge demand for health care services that has still not been contained. The question of laboratory ownership, direction, and control became a struggle between elements of organized pathology and nonphysician clinical laboratory practitioners; the real issues-professional autonomy and access to compensation for services within ones scope of practice-were often buried beneath unjustified challenges regarding the nonphysician's competence and qualifications to serve in directoral roles.
Three major events contributed to the pathologist versus technologist rift that occurred in the 1960s. First, Janice Higgins, a registered technologist from New Jersey, was denied recertification by the Board of Registry of ASCP. Higgins worked in a bioanalyst lab oratory, and she had no pathologist to cosign her recertification form, a requirement at that time. In 1964 Higgins sued the Board of Registry of ASCP because her livelihood was threatened, and in 1968 the Supreme Court of New Jersey ruled in her favor. More than the ruling, the case brought to light that medical technologists' very employment was dependent on pathologists' approval.
Second, in 1966 the Justice Department investigated the College of American Pathologists (CAP) for antitrust action, primarily regarding fee-setting and exclusionary practices. The Justice Department settled with CAP in a cease-and-desist order. However, because ASMT had collaborated with the other pathologist group, ASCP, in accreditation and in certification (the Board of Registry), the Justice Department also cited ASMT for taking a "supine" position in the matters of antitrust as well as credentialing. Members of the Board of Directors of ASMT were astounded that they should be so cited, but their eyes were also opened as to how this affiliation with ASCP was perceived by others.
Third, many members of ASMT were disconcerted with the management of the Board of Registry. Again, Ruth Williams has chronicled the events. She writes:
Throughout the 1960s, ASMT representatives to the Board of Registry believed they were being ignored in matters of policy. A proposed amendment to the ASCP bylaws was interpreted to indicate that the ASCP expected to elect the ASMT representatives to the Board. An attempt was made to settle the dispute before a neutral mediator, and promises were exchanged, but neither side yielded.
The ASCP continued to maintain that the Board of Registry was constituted as, and remained a standing committee of the ASCP. The ASMT continued to express the desire to assume a larger role in decision making in areas affecting medical technology. The breach between the societies widened when ASCP voted a third category of laboratory workers (the medical laboratory technician) without consultation with the members of the Board.
When it became apparent to the officers of the ASMT that no further progress in achieving harmony was possible, the ASMT decided it had no recourse except to refer the disagreements to the court. Hence, in May 1969, suit was filed in the U.S. District Court of the Northern District of Illinois. The complaints, in brief, were:
- ASCP had attempted to monopolize interstate trade and commerce in commercial medical laboratories in violation of the Sherman Act.
- The monies collected by the Board of Registry for examinations, renewals of certificates, etc., came from medical technologists. Such monies should not be diverted to uses other than operation of the Registry.
- ASCP had not granted equal representation to ASMT on the Board of Registry.
- The ASCP took action to change the composition of the Board of Registry with the exclusion of ASMT alleged this constituted a violation of federal antitrust laws, since it was an attempt to achieve complete monopoly in the laboratories.
- The "affiliate" (but non-voting) membership offered to medical technologists by ASCP threatened to monopolize and control the profession.
- Because pathologists had the power to fix salaries of medical technologists, this power could be used to coerce them to join ASCP as affiliate members.
The Board of Directors of ASMT decided against pursuing additional appeals, since negotiations with ASCP resulted in the formation of the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS), a freestanding accreditation agency, in 1973. When the ASMT proposed further discussion with ASCP about control of the Board of Registry in 1974, ASCP refused to consider the matter.
The rift between ASCP and ASMT continued into the 1970s, when ASMT withdrew its representatives to the Board of Registry in 1976 and established the National Certification Agency for Medical Laboratory Personnel (NCA)-now known as the National Credentialing Agency for Laboratory Personnel-independent of a "sponsoring" group.
Why do many laboratorians believe that NCA is so important to the profession, and why might it be important in the future? First, in the very definition of a profession, it is crucial that the profession-not another group-determine how entrance to the practice is achieved. Whether credentialing by certification or licensure, each profession must define its own standards for practice as well as entry to that practice.
Second, to ensure credibility with the public, each profession must establish its standards for demonstrating continued competence. The NCA, through its recertification process (usually via continuing education), verifies to the public that its registrants maintain high standards of practice, even years after initial certification.
Third, unless clinical laboratorians are in control of their own certification or licensure processes, they will be viewed by colleagues in nursing, physical therapy, pharmacy, medicine, and others, as less than equal. Many allied health professionals cannot understand why, with the education and training laboratory scientists hold, they do not take full control of their own destiny Fourth, with federal and state governments enacting legislation and ensuing regulations, it is important that these legislators and agency officials respect the profession. To earn that respect, and these persons' attention, laboratory professionals need to demonstrate that they-not a pathologist group-best represent the profession.
The struggle continued throughout the 1980s, especially-through laboratorians' support of the Clinical Laboratory Improvements Act (CLIA) of 1988, which was enacted to give ail laboratories the same set of standards for testing. Establishing the regulations to accompany this Act were further complicated, and for more than twelve years, often divisive. In the 1980s and 1990s ASCP took few positions on CLIA even though ninety thousand physician office laboratories were unregulated. The main concern of the ASCP involved who was directing the laboratories, e.g., physicians. In contrast, ASMT and its successor, ASCLS, fought for personnel standards, the credentialing of personnel performing tests, and evidence of continued competency. In the 1990s ASCLS and ASCP continued to have different positions regarding government regulations and personnel.
However, due to the support of multiple laboratory organizations, in April of 1995, the National Labor Relations Board (NLRB) officially included medical technologists among its "professional employees" as defined by Section 2(12) of the National Labor Relations Act. This decision was based on the education and training required of technologists, the need for judgment in evaluating test data, and CLIA regulations requiring laboratorians' participation in proficiency testing to ensure the accuracy of their work. The NLRB decision noted that "this congressional concern (CLIA) regarding the skills required of medical technologists underscores the professional nature of their work." The NLRB also compared the educational requirement for laboratorians and registered nurses and stated that the education and certification procedures for technologists were often equal to or greater than those for RNs, Following are the categories of personnel within the National Labor Relations Boards jurisdiction.
Hospital Employee Categories as Established by the National Labor Relations Board
- Physicians
- Registered nurses
- Other non-MD professionals, e.g., medical technologists (clinical laboratory scientists)
- Technical employees, e.g., medical (clinical) laboratory technicians
- Clerical employees
- Skilled maintenance workers
- Other nonprofessionals
- Security guards
Professional Ethics
A great deal can be learned about the evolution of a profession from comparing its various codes of ethics in a historical context. Codes of ethics address what members of a profession believe are its defining characteristics, the functions and roles that distinguish them from others, and their duties and responsibilities to society.
In 1928, when the Board of Registry of Laboratory Technicians was formed via a physician group, a code of ethics was submitted that those who were registered would agree to follow. It reads:
All registered technicians and technologists shall be required to strictly observe the Code of Ethics as defined by the American Society of Clinical Pathologists, namely, that they shall agree to work at all times under the supervision of a qualified physician and shall under no circumstances, on their own initiative, render written or oral diagnoses except insofar as it is self-evident in the report, or advise physicians or others in the treatment of disease, or operate a laboratory independently without the supervision of a qualified physician or clinical pathologist. (Registry of Technicians, ASCP [1928])
For many years, medical technologists followed the Code, established by the ASCP.
In 1955, the American Society of Medical Technology published its first Code of Ethics, based on premises established by the ASCP:
Section 1: A member of the Society shall at all times work only under the direction and supervision of a pathologist or duly qualified doctor of medicine or specialist in one of the divisions of clinical pathology, such qualifications being determined on the basis of accepted medical ethics.
Section 2: A member of this Society shall make no diagnosis or interpretations other than those in the reports prepared by him.
Section 3: A member of this Society shall not advise physicians or others how to treat disease.
Section 4: A member of this Society shall not train students without supervision of a clinical pathologist.
Section 5: A member of this Society shall not engage in laboratory work independent of qualified supervision (as provided in Section 1) nor shall he operate an independent laboratory.
Section 6: It is ethical to perform laboratory work on a commission basis under contract with a public health, research, or clinical laboratory when such work is done as provided in Section 1 above and when all contractual agreements are approved and signed by the director of the organization contracting for such services.
However, only two years later, in 1957, the ASMT adopted a different Code of Ethics:
Being fully cognizant of my responsibilities in the practice of Medical Technology, I affirm my willingness to discharge my duties with accuracy, thoughtfulness, and care.
Realizing that the knowledge obtained concerning patients in the course of my work must be treated as confidential I hold inviolate the confidence (trust) placed in me by patient and physician.
Recognizing that my integrity and my profession must be pledged to the absolute reliability of my work, I will conduct myself at all times in a manner appropriate to the dignity of my profession.
Forty-five years ago the practice of laboratory science, as perceived by members of its first professional association, was simply a matter of accuracy, confidentiality, reliability, and dignity-all essential behaviors, but behaviors that should characterize any professional, That early code really pertained to a supporting practioner; it did not address the duties a true profession would expect from and require of its members.
The ASMT Code of Ethics was revised considerably in 1988 and then updated by the ASCLS in 1995. Today it describes a much different professional, this one with clear responsibilities in the laboratory, to the patient, to the profession, and in the community at large.
Code of Ethics of the American Society for Clinical Laboratory Science (1995)
Preamble
The Code of Ethics of the American Society for Clinical Laboratory Science (ASCLS) sets forth the principles and standards by which clinical laboratory professionals practice their profession.
I. Duty to the Patient
Clinical laboratory professionals are accountable for the quality and integrity of the laboratory services they provide. This obligation includes maintaining individual competence in judgment and performance and striving to safeguard the patient from incompetent or illegal practice by others.
Clinical laboratory professionals maintain high standards of practice. They exercise sound judgment in establishing, performing and evaluating laboratory testing.
Clinical laboratory professionals maintain strict confidentiality of patient information and test results. They safeguard the dignity and privacy of patients and provide accurate information to other health care professionals about the services they provide.
II. Duty to Colleagues and the Profession
Clinical laboratory professionals uphold and maintain the dignity and respect of our profession and maintain a reputation of honesty, integrity and reliability. They contribute to the advancement of the profession by improving the body of knowledge, adopting scientific advances that benefit the patient, maintaining high standards of practice and education, and seeking fair socioeconomic working conditions for members of the profession.
Clinical laboratory professionals actively strive to establish cooperative and respectful working relationships with other health professionals with the primary objective of ensuring a high standard of care for the patients they serve.
III. Duty to Society
As practitioners of an autonomous profession, clinical laboratory professionals have the responsibility to contribute from their sphere of professional competence to the general well being of the community.
Clinical laboratory professionals comply with relevant laws and regulations pertaining to the practice of clinical laboratory science and actively seek within the dictates of their consciences, to change those which do not meet the high standards of care and practice to which the profession is committed.
Pledge to the Profession
As a clinical laboratory professional, I strive to:
- Maintain and promote standards of excellence in performing and advancing the art and science of my profession;
- Preserve the dignity and privacy of patients;
- Uphold and maintain the dignity and respect of our profession;
- Seek to establish cooperative and respectful working relationships with other health professionals; and
- Contribute to the general well being of the community.
(Reprinted with permission of the American Society for Clinical Laboratory Science, © 1997-2001)
How Law and Regulation Affect the Profession
Today federal, state, and local laws and regulations influence every facet of any health care profession. Some laws and regulations influence who may perform clinical laboratory services; some determine how they shall be paid; others mandate safety precautions to protect the patient and practitioner; and others establish general quality assurance safeguards, to name just a few of the issues.
In fact, a great deal of what takes place every day in the laboratory occurs at least partly because of federal, state, or local governmental requirements. Laboratory practitioners themselves carry out the quality control, record-keeping, hiring, safety, and other requirements of law or regulations not only because these functions represent safe and competent practice, but also because they are responsible for ensuring compliance with such requirements.
Drug testing gives an example of how the federal government affects daily practice in the laboratory. Who performs drug testing; what drugs are involved; what quantities of each (or thresh old concentrations) will be detected; and what technical procedures, quality control, security, and confidentiality safeguards are imposed on the specimen collection, handling, and testing process are among the issues addressed in regulations concerning drug testing for military personnel and certain civilian employees, such as airline pilots.
Taken as a whole, federal, state, and local laws and regulations govern the laboratory facility, its personnel, many of its analytic procedures, and its quality assurance practices. Federal laws and regulations also provide civil rights protections and antidiscrimination safeguards for employees; set up procedures for labor disputes; regulate medical devices, blood, and blood products; and influence a great many other aspects of laboratory practice.
More important in some ways, however, federal regulations especially influence the profession, the practitioner, and the public in other ways that are perhaps more profound but not necessarily as evident.
Thus, practicing professionals must have a thorough understanding of the government’s role, and prospective students should be aware of the powerful influence exerted by laws and regulations on the profession and the practitioner. In fact, it might be said that one of the distinguishing marks of the many committed clinical laboratory professionals is their active involvement in the governance process, at the local, state, or federal level.
Knowing government's considerable influence on the profession, laboratory practitioners in leadership positions take responsibility for the appropriateness of the laws and regulations that affect their profession. They participate and encourage their colleagues to participate as private citizens in the process of electing and communicating with lawmakers and other public officials.
They also exercise this responsibility by participating and encouraging their colleagues to participate in national associations representing the profession, such as the American Society for Clinical Laboratory Science.
Professional organizations provide mechanisms by which current and pending federal and state legislative and regulatory developments are monitored and assessed. They also are the source of new legislative and regulatory proposals. And they provide a means through which the views of their members can be expressed effectively to lawmakers and other government officials.
In addition to government influences on professional practice, laboratorians have an inherent duty to the patient. The ASCLS Code of Ethics addresses this duty.
History, new scientific and technical developments, competition, laws and regulations, health care cost containment, and ethics are issues vital to the clinical laboratory practitioner. In fact, in the early years of this century we are witnessing clinical laboratory scientists taking a more interactive role with patients and other providers to teach, explain, and advice about laboratory testing.
Technology remains very important, but today's laboratory professionals no longer just operate instruments. The field has become more and more collegial with other health care practitioners. Those considering this field should be aware that these are exciting and still evolving times in which to be a clinical laboratory professional.
