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Personnel licensure: making slow inroads - includes related article - Cover Story

Medical Laboratory Observer - February 1, 1995

Ten states now offer licensure for laboratorians, but powerful opponents and the new Republican Congress could change everything.

A 6-year-old girl was admitted to the emergency room of a Northeastern hospital late one night complaining of fever and listlessness. The ER staff performed a spinal tap and sent the fluid and other specimens to the laboratory. An improperly trained night-shift employee failed to recognize bacteria in the Gram stain of spinal fluid. Because no organisms were reported to the attending physician, no action was taken. The next day the girl died of bacterial meningitis that could likely have been successfully treated.

Anecdotes such as this make a compelling case for laboratory personnel licensure - an attempt to guarantee to the public that those who handle and analyze body specimens are adequately educated, trained, and experienced. Nearly all laboratory professional groups support licensure for lab personnel. Other organizations, however, oppose provisions giving professional exclusivity to laboratorians.

* Weakened standards. Five years ago, MLO examined the status of laboratory personnel licensure laws.[1] At that time, only seven states, Puerto Rico, and New York City had enacted licensure for clinical laboratory professionals. Since then three more states adopted licensure, while New York City dropped its unique licensing effort in favor of a statewide program that's currently stalled in the legislature.

Recent developments in Government and industry could relax or override personnel standards for some kinds of clinical testing. CLIA sought to relax staffing rules in some cases, a development that coincided with the arrival of advanced bedside testing instrumentation that could be operated by lesser trained persons. If this coincidence wasn't enough to complicate laboratorians' fight for licensure, the 1994 elections brought to Congress the first Republican majority in four decades. That party's historic antiregulation stance could well affect licensure.

The new game in Washington. If the newly sworn in, Republican dominated 104th Congress decides to tackle health care reform at all, such reform will be incremental rather than comprehensive. (Odds are that health care reforms affecting clinical laboratory practice will not be high on the new conservative agenda.) But there still could be new legislation that circumvents state scope-of-practice and licensure laws. In the 1994 session of Congress, at least one bill contained a provision that would have preempted state professional licensure laws.

The rise (and fall?) of CLIA. According to some laboratory groups, CLIA rules have weakened rather than strengthened personnel standards. At least two influential Republican members of Congress - who at press time were due to win the chairmanships of health committees - have sought to dilute or dismantle CLIA regulations in the past. One industry observer noted that 1995 might be an even better year for the states to pass personnel licensure because CLIA could be threatened once again.

Point-of-care testing. Certain manufacturers and professional organizations oppose specific personnel provisions in licensure bills, particularly those pertaining to point-of-care testing (POCT). These powerful forces seek to protect the rights of nonlaboratory personnel to conduct POCT with new, easy-to-use equipment.

* Licensure spreading. Figure 1 shows the states or territories that now have licensure laws and the status of licensure activity in the other states.

This is not to say that passage of pending licensure bills will be easy. Louisiana finally passed its licensure bill after a 5-year struggle. After altering the bill - in part to allow other health care professionals to perform tests - the state granted licensure to lab personnel.

The American Society for Clinical Laboratory Science (ASCLS) and the American Society of Clinical Pathologists (ASCP) support groups seeking state licensure for clinical laboratory technicians (medical laboratory technicians). In fact, in 1993 the ASCLS published a members-only, how-to guide for those seeking licensure. The ASCP has long believed that accurate testing by medical laboratories is dependent on the competence of personnel. Hence, the organization supports personnel standards on a Federal and state level, either through regulation or licensure. Preventing harm to the public is one of the ASCLS's and other groups' main arguments for personnel licensure.

* Implementation moratorium. With a facility licensure bill currently being held in an implementation moratorium, Nebraska mandates a process whereby any professional group requesting licensure must meet four conditions:

* There must be sufficient potential harm to the public to justify the state's restricting entry into the practice of a previously unregulated field.

* Practitioners must be highly independent (i.e., they cannot be closely supervised).

* The scope of practice must be clearly and succinctly defined to the extent that its actions are easily distinguishable from those of other regulated professions.

* The acts constituting the scope of practice must not predominantly be actions that are generally considered part of the public domain, according to Diana Headley, M.A., MT (ASCP)SC, who chairs the ASCP's Associate Member Section government relations committee and who led the personnel licensure effort in Nebraska in 1988.

* Why licensure? An industry consultant who prefers anonymity takes pains to explain that she and others do not oppose laboratory personnel licensure per se. "They can't go for exclusivity, however," she says. "That's just not the way that medicine is being practiced anymore and not way that technology is going. Other health care professionals should be able to do testing, too."

Some professional organizations have considered the alternatives to licensure, among them a code of ethics and the registration of laboratorians. To the former, the ASCLS responds that "a code of ethics, well intentioned as it may be, is not enough to insure that testing in every site is delivered faithfully and accurately." Likewise, the registration of medical personnel does not insure standards of practice or define necessary training.

American Medical Technologists (AMT) is a certifying board and professional organization for medical laboratory technologists and technicians. According to executive director Gerard Boe, Ph.D., licensure may not really be necessary. In his opinion, the nation has in place valid national certification examinations that can accomplish the same thing as licensure. Moreover, exams are less costly for the public as well as for laboratorians who would have to pay for both certification and licensure.

The ASCLS, on the other hand, feels that licensure would insure all of the desired aspects of clinical laboratory science - education, training, and scope of practice - and that certification or registration alone cannot. And while the ASCP supports personnel standards that define bench level medical technologists as individuals with baccalaureate degrees who have achieved satisfactory performance on a nationally recognized certification examination, they feel that enforcement of these standards may take place at either the Federal or state level, and through personnel regulations, licensure, and/or registration.

The industry consultant who spoke with MLO supports the right of technologists to license themselves but disagrees with blocking the right of other trained and competent health care professionals to perform critical testing at the point of care. She believes that the central laboratory, with such critical functions as microbiology, can coexist with decentralized testing sites.

* CLIA and licensure. Controversy has also arisen surrounding CLIA's personnel rules. Some feel they are fair; others believe they are too weak.

Personnel rules are inadequate for labs that wish to get a certificate, according to Carey O'Connor, state affairs manager of ASCLS. CLIA still does not require personnel standards for waived testing at the supervisory or bench level, she notes. CLIA also relaxed some personnel rules for moderate and high complexity testing.

For example, CLIA '88 allows the general supervisor of a high complexity lab to have an associate degree plus 2 years of experience (or to be qualified under CLIA '67). Another personnel concern of laboratory groups is that the final CLIA rules allow high school graduates with no formal training or experience to perform high complexity tests under the direct supervision of a general supervisor until 1997.

"I think the tremendous increase in licensure activity at the state level has to do with the regulations we see in CLIA '88," says Headley. "States are fearful the Federal regulations are not stringent enough to protect their citizens."

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