College of American Pathologists
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cap today



August 2006

bullet Critical values

Some of my colleagues and I were troubled by the reply from Nancy Yeransian, MT(ASCP)SC, manager of accreditation services, CAP Laboratory Accreditation Program, to an inquiry that appeared in the May 2006 issue. The reader’s question was as follows: "It has been our laboratory policy to call every critical value we get. Some of our physicians and special care areas do not want all these test results. How do we comply?"

The CAP’s response to this question did not really provide an answer; instead it focused on "special care areas" to suggest that whether or not a test result is critical depends on the clinical setting, and that the laboratory, in consultation with its physician clients, may establish different critical values for different settings (inpatient versus renal dialysis versus home health, versus initial or repeat value, etc.).

While the laboratory may indeed establish its own policy for critical test results, the question was related to calling every critical value. If the value obtained meets the definition of critical as indicated in laboratory policy, CLIA regulations and CAP requirements pursuant to LAP checklist question GEN.41320 require immediate notification of the physician or person responsible for using the results, and the client may not elect not to be notified immediately. Notwithstanding HIPAA privacy concerns, moreover, voicemail does not constitute immediate notification because the message is received at a later time or may never be received at all.

Second, we question the logic of calling a given value critical only in a particular setting, while not identifying that same value as critical in another setting. Similarly, we would oppose the establishment of different critical value ranges that were specific to the setting. It would be like saying your relative has a clinical laboratory test result that is life-threatening but only if he or she is in the hospital as an inpatient and not if your relative is elsewhere. Since your relative is not hospitalized at this time, we in the laboratory will not immediately notify anyone of his or her otherwise life-threatening value.

Critical values should not be reported only when it is convenient to do so, and the answer provided in CAP TODAY to the inquiry concerning this matter implies that laboratory policy be adjusted for the convenience of certain situations. We in this industry have a moral, ethical, and regulatory responsibility to communicate life-threatening laboratory results immediately whenever such results are encountered, 24 hours a day, seven days a week. To do less is unacceptable laboratory practice and demonstrates total disregard for the welfare of the patient.

Robert I. Footlik, MS, MT(ASCP), HCLD(ABB)
Laboratory Compliance Officer
Cedars-Sinai Health System
Los Angele

    arrow Stephen Sarewitz, MD, chair of the CAP Checklists Committee, replies: CLIA ’88 states: "The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values." Whether a particular laboratory result indicates an imminently life-threatening condition depends, under certain limited circumstances, on the clinical situation. For example, a low hematocrit value may not be imminently life-threatening in a hemodialysis patient, yet it could be imminently life-threatening in a patient from the general population. This distinction has nothing to do with anyone’s convenience; it is drawn cooperatively by the laboratory and clinicians, as a way to identify which laboratory values are truly critical.

The above practice is different from the situation in which a clinician just doesn’t want to be bothered by a telephone call for a critical value.

bullet Putting lab professionals in the spotlight

At a time when health care consumes 14 percent of the country’s GNP, clinical labs provide a significant level of value—contributing up to 80 percent of the objective information used to make diagnostic decisions, while making up only five percent of a typical hospital budget.

To highlight the importance of laboratory professionals and recognize those working in the field, Abbott has launched an initiative called "Labs are Vital." This multi-part, multi-phase effort involves launching an educational campaign to explain how laboratory professionals make compelling and life-saving contributions to health every day; donating $1 million worth of test equipment to educational institutions nationwide so students can be trained on state-of-the-art equipment; and providing lab professionals with tools to better explain the work they do to health care colleagues, policymakers, and patients.

A main goal of "Labs are Vital" is to bring new solutions to the table in addressing the critical and growing shortage of qualified laboratory personnel. Former HHS secretary Tommy Thompson declared the lab personnel shortage to be an even greater menace to the delivery of health care than the well-publicized nursing shortage.

There are many dimensions to the problem. First, vacancy rates for five of the 10 essential laboratory staff positions are at a 12-year high, according to the American Society for Clinical Pathology.

Second, the U.S. Department of Labor projected that approximately 13,800 medical laboratory professionals will be needed each year through 2012 to fill vacant laboratory positions. Unfortunately, fewer than 5,000 professionals are graduating from training programs each year.

During the past 10 years, one of every three medical technology schools has closed and more may close due to low enrollment. While the reduction in the number of training programs is particularly pronounced in rural areas, many urban areas have also been hit hard. For example, Los Angeles and Miami do not have any medical technologist or medical laboratory technician training programs.

Unless this trend reverses, the shortage will worsen over the coming decade—precisely the period when America’s aging Baby Boom population is expected to require triple the number of tests performed today.

The situation is so serious that the leading professional organizations for clinical laboratory practitioners, six government agencies, and six industry partners—including Abbott—have joined to form the Coordinating Council on the Clinical Laboratory Workforce, in a joint effort to identify and define the causes of the shortage and develop strategies to address the crisis.

But no one will pursue these promising career options unless they better understand the work of lab professionals. That’s why we believe the time is right for a high-profile communications effort to educate the public about the work of lab professionals. At the same time, this effort also will educate health care colleagues and policymakers on the contributions of laboratory scientists so their voice is heard on matters that affect their lives and the lives of the patients they serve.

It is expected that the communications campaign also will energize and rally the entire lab community, which deserves a much-needed boost for their work—almost taken for granted in health care today—because they have become so effective in quietly doing their jobs.

Don Patton, Vice President,
Global Commercial
Diagnostic Operations,
Abbott Diagnostics
Abbott Park, Ill.