News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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History of the Clinical Laboratory Critical Values Reporting System

Development of the Critical Values system redefined what STAT means in clinical laboratory testing turnaround times

Where did the concept of critical values and having clinical laboratories report them to referring physicians originate? How did the concept blossom into a standard practice in laboratory medicine? Given the importance of critical values, a lookback into how this aspect of laboratory medicine was developed is helpful to understand how and why this has become an essential element in the practice of medicine and an opportunity for labs to add value in patient care.

According to Stanford Medicine, critical/panic values are defined as “values that are outside the normal range to a degree that may constitute an immediate health risk to the individual or require immediate action on the part of the ordering physician.”

In an article he penned for the National Medical Journal of India, George Lundberg, MD, Editor-at-Large at Medscape, states that the practice of reporting critical values originated with a case that occurred in 1969 at the Los Angeles County-University of Southern California Medical Center. Lundberg is also Editor-in-Chief at Cancer Commons, President and Chair of the Board of Directors of the Lundberg Institute, and a clinical professor of pathology at Northwestern University.

What you’ll read below is an insider’s account of the “birth of critical values reporting.”

According to Lundberg, an unaccompanied man was brought to the hospital in a coma and an examination revealed a laceration to his scalp. The patient was admitted to the neurosurgical unit where clinical laboratory tests were performed, including a complete blood count (CBC) analysis, urinalysis, and serum electrolytes. All the test results came back normal except the patient’s serum glucose (blood sugar level) which was 6 mg% in concentration.

“The hard-copy laboratory results were returned to the ward of origin within two hours of receipt of the specimens in the laboratory. However, the results were not noticed by the house officers who were busy with several other seriously ill patients. Ward personnel also failed to communicate the lab results to the responsible physicians,” Lundberg wrote.

When hospital staff did finally notice the test result the next morning glucose was immediately administered to the patient, but it was too late to prevent irreversible brain damage. The man soon passed away.

Following this incident, the hospital developed a “Critical Value Recognition and Reporting System.” The system generated new numbers that were termed “Panic Values.” 

However, “critics complained that good doctors should never panic, so the name was changed to Critical Values,” Lundberg explained.

When any of these critical test values were out of the norm, “we required the responsible laboratory person to quickly verify the result and use the telephone (long before laboratory computers) to personally notify a responsible individual (no messages left) who agreed to find a physician who could quickly act on the result. All was documented with times and names,” he wrote. 

“We understand that when a physician wants something, he/she wants it, no matter what. Well, in this patient-focused approach, the physician cannot have it, except as offered by the patient-focused approach, based on TAT [turnaround times of clinical laboratory tests],” wrote George Lundberg, MD (above), President and Chair of the Board of Directors of the Lundberg Institute, and Clinical Professor of Pathology at Northwestern University in an article he penned for the National Medical Journal of India (Photo copyright: Dark Intelligence Group. Shows Dr. Lundberg in 2011 addressing the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management.)

New Clinical Laboratory Standards

Recognition of the urgency to adopt new hospital standards related to certain clinical laboratory test results came swiftly. In 1972, Lundberg was invited to publish an article explaining the new Critical Value Recognition and Reporting System in Medical Laboratory Observer

“Within weeks, laboratories all over the USA adopted their own version of the system,” Lundberg wrote in his National Medical Journal of India (NMJI) article. “The test chosen, and critical values, were established by each medical staff. … A critical value system quickly became standard of practice as required by the College of American Pathologists (CAP) Laboratory Accreditation Program and the Joint Commission on Accreditation of Hospitals.”

According to Lundberg, “most laboratory tests that are done do not need to be done; the results are either negative, normal, or show no change from a prior result. But some are crucial.”

The original set of Critical Values included the following testing results:

The list of values were later expanded to include “vital values.” These values describe lab results for which “action” is important, but where timing is less urgent. Examples of vital values include:

STAT Lab Orders Redefined

Lundberg and his colleagues went on to redefine what constitutes a laboratory test and what renders a test successful. They discussed laboratory procedures with committees of clinicians, lab personnel and patients, and reorganized hematology, chemistry, and toxicology based on the turnaround time (TAT) of tests.

“We ‘started the clock’—any and all days/times 24×7—when a specimen arrived at some place within the laboratory, and stopped the clock when a final result was available somewhere in the laboratory,” Lundberg wrote in NMJI. “We categorized all tests as: less than one hour, less than four hours, less than 24 hours, and more than 24 hours, guaranteed, 24×7. As a trade-off, we abolished the concept of ‘STAT’ orders … NO EXCEPTIONS. The rationale of each TAT was the speed with which a result was needed to render proper medical care that mattered to the welfare of the patient, and, of course, that was technically possible.”

Since then, very little has changed for the Critical Values System over the past 50 years. The majority of values added have fallen under the “Vital” category and not the “Critical” category. Today, most health systems and clinical laboratories create their own internal processes and procedures regarding which values need to be reported immediately (critical), which values are not urgent (vital), and how those results should be handled.

—JP Schlingman

Related Information:

The Origin and Evolution of Critical Laboratory Values

Critical Values

Critical Laboratory Values Communication: Summary Recommendations from Available Guidelines

Clinical Laboratories Considering Total Laboratory Automation Are Increasingly Using Lean Methods to Develop Proposals, Select a Vendor, and Implement the Solution

Top-performing medical laboratories are using Lean to help craft RFPs, evaluate TLA options, then implement the automated systems to achieve optimal quality and productivity

In recent years, there’s been a big change in how clinical laboratories purchase total laboratory automation (TLA) solutions, and then integrate this automation into their lab operations. Using a strategy that is somewhat off the radar, top-performing medical laboratories will purchase and install TLA only after applying the principles of Lean to the physical layout and overall workflow within their labs.

This development demonstrates the growing acceptance of Lean, Six Sigma, and continuous process improvement methods at hospital-based laboratories and independent clinical laboratories.

As lab budgets get squeezed down each year and specimen volume increases, pathologists and clinical lab managers face the twin challenges of reducing costs while increasing the quality of their lab testing services. (more…)

Hospitals Take Steps to Drive Down Medical Errors in Their Emergency Departments

Clinical laboratory managers are often part of the ER’s process improvement team

Hospital emergency rooms (ER) across the country are intensifying their focus on improving patient safety  and reducing errors. The cost of malpractice lawsuits filed after errors in emergency rooms is a major reason why growing numbers of hospitals are initiating formal programs to identify and eliminate the source of errors and wrong care provided to patients.

It probably won’t surprise most pathologists and clinical laboratory managers to learn that diagnostic errors are one significant source of malpractice claims that result from care provided by hospital emergency rooms, which can often be chaotic and overcrowded. Recently, The Wall Street Journal reported that a large percentage of medical errors in hospitals—and the resulting malpractice suits—occur because of mistakes in the emergency room. Studies of closed claims show that 37% to 55% of the malpractice suits are attributable to diagnostic errors. (more…)

Laboratory Automation One Solution to Workforce Shortages in Clinical Pathology Laboratories

Gap between supply and demand for Medical Laboratory Technologists (MT) encourages greater use of laboratory automation

If there is a Sword of Damocles hanging over the heads of pathologists and clinical laboratory managers, it is the largest workforce shortage in the history of the medical laboratory industry. For 2011 and beyond, demand for skilled medical technologists (MT) and clinical laboratory scientists (CLS) will far outstrip supply.

Today, many hospital and health system laboratories operate short-staffed. They are unable to recruit and retain even the number of staff positions that are authorized and budgeted. In cases where a thriving hospital laboratory outreach program is generating substantial annual increases in the volume of specimens to be tested, the medical laboratory’s inability to recruit the additional MTs and CLSs required to handle this work creates a high-stress environment for everyone in the laboratory organization.

(more…)

Immunoassay and Infectious Disease Analyzers Evaluated during Use by Clinical Pathology Laboratories

Industrial engineering firm issues “Consumer Report”-type assessment of mid-volume, automated IA and ID analyzer systems


It’s not often that pathologists and clinical laboratory managers can access a Consumer Reports-type of comparison of laboratory analyzers as they prepare to purchase new diagnostic systems. In the case of mid-volume analyzers for immunoassy (IA) and infectious disease (ID) testing, such a report is now available—and it is immediately available on the Web.

The report is titled “Using Quality Management Methods to Compare Competing Mid-Volume Segment Immunoassay Systems that Perform Infectious Disease Testing.”  This report can be immediately downloaded and viewed by visiting the darkdaily.com web site.

(more…)

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