Critical values launch interpretive lab medicine and clinical

March 1, 2009

MLO: George D. Lundberg, MD, has
been credited with “inventing” — or, perhaps, more accurately “first
implementing” — the system of critical-value reporting in 1970. He
recently said that “… the critical value can serve as a nidus or a
launching part for the whole issue of interpretive laboratory medicine,
interpretive clinical pathology, because all of us in pathology know
that large numbers of clinicians haven't the foggiest notion how to
properly order laboratory tests or how to interpret them correctly.”
With the advent of lab automation, which is part of the solution to
losing scores of retiring “seasoned” MTs and MLTs who have the
experiential knowledge that newcomers do not, will the concept of
critical values and/or the process of establishing critical values
change in any substantial way(s) — how and why?

D. Robert Dufour, MD, FACP, FACB, is emeritus professor of
Pathology, George Washington University; and medical center consultant,
Hepatology and Laboratory Medicine at the VA Medical Center, Washington,
DC .

D. Robert Dufour, MD:
I believe that the idea of “critical
values” will persist, even with increasing automation. Even with
autoverification, there is a requirement to develop rules for results
that require review by a laboratory scientist before release to the
physician. Strong evidence suggests that the busy physician often
ignores unexpectedly abnormal results, so that notification of any
life-threatening values will remain important for patient safety. The
mechanism for determining critical values has been, for the most part, a
decision made at individual hospitals. I believe that a “consensus”
approach, such as has been developed in the state of Massachusetts, will
become more widely accepted as a way to determine critical values.

Gerald J. Kost, MD, PhD: The concept of
critical values, process of establishing them, and methods of closing
the loop clinically are evolving, and we hope for the better. When
reporting a critical value, as regulated by the The Joint Commission
(TJC) and its new national patient-safety goals, the laboratorian first
must verify the result and then notify the nurse or doctor of the
patient's critical value. The nurse or doctor receiving the information
is required to read back the critical value.1 Recently, TJC
requires documented confirmation that the patient's physician has
actually received the critical-value information, which will be entered
into the patient's electronic medical record.2 Furthermore,
when the nurse receives notification, she is given only about one hour
to contact the doctor and confirm closure in the patient's electronic
medical record.2
This process functions to ensure that the patient's critical value is
verified efficiently and that the essential information is disseminated
to the proper medical personnel. The endpoint, of course, is to treat
the patient promptly and as clinically indicated, thereby improving
outcomes. In fact, this was the subject of a cover story I wrote for
in March 1993 entitled “Using critical limits to improve patient

A medical technologist must verify the result,
even if the lab is automated. The effectiveness of coupling a
computerized notification system was evaluated in a recent study
conducted by Dr. Piva and colleagues at The Padua Hospital in Italy.3
Specifically, the communication process after the critical value was
verified by a lab technician was altered to a computer-based
dissemination model, which sought to eliminate errors associated with
the call back, that is, the read-back system reinforced by TJC and the
College of American Physicians (CAP).1,3,4 Results indicated
that the computerized process reduced notification time and eliminated
errors associated with phone notification and misinterpretation of
critical values.3 Thus, the coupling of laboratory process to
verify critical values with improved dissemination methods to notify
medical personnel of the critical values has the potential to positively
impact and refine the current model of critical-value-reporting
dissemination by reducing errors, improving notification time, and
enhancing reliability. It also allows the laboratory-quality department
to quantitatively monitor endpoint performance and prove high quality
during accreditation inspections.

MLO: In what ways do you perceive
handling critical-value reporting might change in the future? Will the
requirement for follow-up remain on the “shoulders” of the lab, or do
you think that clinicians will be more mindful of asking for specific
information regarding patients? Will electronic medical records change
the method by which critical values are reported? Are there any other
changes occurring within tthe lab that might usher in more regulation of
this area of performance, such as “globalization”?

Dufour: One way that reporting may change
is in developing different “priorities” of critical values. For example,
the state of Massachusetts established different levels of critical
values (red, orange, and yellow) that have different time thresholds for
reporting. The Massachusetts system also eliminated reporting for repeat
critical values for many tests. In our hospital, we adopted a similar
approach several years ago, based on the Massachusetts model. We have
seen a significant reduction in the number of calls made to clinicians
as a result.

As far as how much of a change electronic medical
records will make in the need to communicate critical values, I work in
a system with a very advanced computerized medical-record system.
Although the system can be set to make an “alert” for every critical (or
abnormal) value, many physicians have turned off these alerts. Also,
because the alerts go to the attending physician (who may not be the
doctor who has ordered the test, or who may be on vacation), alerts may
not be seen in a timely fashion even when the alerts are turned on. For
this reason, we have not found a reduction in need to use critical-value
notification, even when we have an electronic-alert system. I believe
that, in the interests of patient safety, there will continue to be a
need for communicating critical values in a timely fashion.

Gerald J. Kost, MD, PhD, directs the Point-of-Care Testing Center for
Teaching and Research at the University of California-Davis, among other

Kost: Fundamentally, the physician is
responsible and must inquire on behalf of the patient. Litigation proves
this point over and over. The laboratory, however, shares in the
responsibility. The concept of critical values will continue to be
important to the medical laboratory scientist, perhaps even more so in
the age of automation. As regulated by TJC, verification and reporting
of critical values relies on medical laboratory personnel1
even when testing is performed at the point of care. The method of
dissemination can be refined and modified as new technologies become
available, such as wireless telecommunication, which could even reach
out directly to the patient.

Laboratory personnel can integrate technological
advances into the dissemination process and decrease the critical-value
notification time. A study conducted by Dr. Kuperman and colleagues
found that an automatic alerting system for critical values facilitated
rapid transmission of information and could be used to improve patient
care.5 So, automation does not mean just mechanized testing.
Instead, we can automate information as we move forward into the realm
of cyberknowledge and cyberphysical computing, which represent current
research pursuits for seamless healthcare with the National Science
Foundation. Fast turnaround times for alerting medical personnel of
critical values are important for prompt clinical evaluation and patient
treatment. Remember, by definition, there should be the potential to
treat the patient if the analyte appears on the critical values list. We
are not talking about an academic exercise.

In the future, the handling of critical values
should combine the entire team of laboratorians, medical assistants,
nurses, doctors, informaticists, and cyberengineers cooperatively
working together to bidirectionally relay information from the lab to
the respective medical department, physician and patient for timely
clinical action. The use of electronic medical records to report
critical values is required by the TJC and now used during audits of
timeliness (closing the reporting loop) in medical institutions.1,2
In addition, having this information up to date and readily available
can aid doctors during urgent clinical evaluation and shorten the time
to diagnosis and treat.5 National patient-safety goals set
forth by the TJC (and CAP) provide guidelines that are followed for
critical-values reporting, and these guidelines and regulations will
continue to be improved upon and supplemented with the development and
integration of new cybertechnologies like automatic alerting systems and
electronic medical records.1,2,4,5

MLO: While critical-value notification
procedures are essential for clinical labs and are required by CAP's
lab-accreditation program and TJC standards, are there still any
variances among labs in certain areas of which you might be aware that
should be standardized across the board? Or over these past three
decades, have most of the “kinks” been “ironed out” of critical-values

Kost: Wow, kinks and maybe curves, too! We
wish the road were smooth and straight, but it is not.

Dufour: Critical-value notification
remains a significant issue for laboratories. Data from CAP Q-probe
studies continues to show that, particularly for outpatients, there are
often significant delays in communicating critical-value results. I
think, again, the approach taken in Massachusetts, of establishing
“back-up” physicians to take critical values is a significant part of
the solution to providing timely patient care. We have had such a
back-up system in our institution for over 20 years, with variable
success (generally, it works well for outpatients in getting the result
to a physician, but there are often problems in reaching the patient
with the critical result).

Kost: The guidelines and regulations set
forth by TJC and CAP provide the foundation for critical-value reporting
practices. Standards continue to evolve, however, and in some settings
are inadequate, such as for neonate and pediatric patients.4,6
A national survey I conducted sought to summarize the critical limits
utilized for newborns and children, which for these vulnerable
populations no published tables or lists by accreditation agencies were
available at the time.6 Results indicated the need to
standardize and distinguish critical tests for acute treatment, define
quantitative critical values relative to clinical diagnosis, and refine
critical tests based on various hospital units and age groups.6
Furthermore, the results encouraged making the concept of critical
limits and values straightforward to facilitate rapid turnaround
reporting times and prompt clinical evaluation.6 We must
close the information loop outside the hospital too. Information control
and monitoring in the outpatient setting are particularly challenging;
we only have partial solutions. Again, litigation proves the point. Each
year, there are instances where the ball is dropped — a critical result
missed — and sometimes, the patient suffers.

While significant progress has been made in the
reporting of critical values, in part due to the standardization of
critical-value regulations by TJC and CAP, the development of new and
efficient technologies, particularly for outpatients, can only enhance
the system currently in place.1,4 In a study conducted by Dr.
Dighe and colleagues, the reporting of critical values was evaluated at
a large medical center to assess the effectiveness of the current
practice.7 Results suggested that using phone calls as the
main dissemination method for reporting critical values, in addition to
an increasing workload for laboratory technicians, is costly.7
A quick turnaround time for reporting critical values is necessary in
order to ensure a level of patient care and treatment consistent with
the standard of care nationwide. It was suggested that integrating new
technologies into the current system would alleviate time delays in
reporting critical values by the laboratory.7 Striving to
better current critical-value reporting is a continual process that
involves the entire continuum of care — hospital to home — and will
undergo revisions and developments as technological advances and
discoveries emerge.

Dr. Kost's comments were verified by
Kristin N. Hale, BS, BA, is a graduate student in Comparative Pathology at
UC-Davis. See the references she compiled below.


  1. Joint Commission on the Accreditation of Healthcare
    Organizations. National patient safety goals hospital program, goal
    2. Available at

    . Accessed February 24, 2009.
  2. Personal communication. Doug Wright. February 25, 2009.
  3. Piva E, Sciacovelli L, Zaninotto M, Plebani M. Evaluation of
    effectiveness of computerized notification system for reporting
    critical values. Am J Clin Pathol. 2009;131:432-441.
  4. College of American Pathologists. Accreditation and Laboratory
    Improvement. Available at
    Accessed February 24, 2009.
  5. Kuperman GJ, Teich JM, Tanasijevic MJ, et al. Improving response
    to critical laboratory results with automation: results of a
    randomized controlled trial. Journal of the Am Medical
    Informatics Association
    . 1999;6:512-522.
  6. Kost GJ. Critical limits for emergency clinical notification at
    United States children's hospitals. Pediatrics.1991:88;597-603.

Dighe AS, Rao A, Coakley AB, Lewandrowski KB. Analysis of laboratory
critical value reporting at a large academic medical center. Am J
Clin Pathol
. 2006;125:758-764.


Event reporting in laboratory medicine

Is there something we are missing?

By Giuseppe Lippi, MD; Camilla Mattiuzzi,
MD; and Mario Plebani, MD

Although no single recommendation or activity
offers a full solution to medical and diagnostic mistakes,
error-prevention experts agree that successful error-reduction
strategies depend heavily on responsible detection and open reporting of
errors. In the decade since the report of the Institute of Medicine
(IOM) “To Err is Human,1
event-reporting systems have become central elements in effective
patient-safety systems, so that the IOM released a further report in
November 2003 calling for development of a standardized report format to
support the full range of existing reporting systems in all settings.2
The Joint Commission (TJC) implemented a sentinel-event policy beginning
in 1996 to evaluate sentinel events in TJC-accredited hospitals.3
In July 2007, New York state also passed a law requiring office-based
surgery practices to become accredited on or before July 14, 2009, by a
nationally recognized accrediting agency, which was designated to be

According to TJC, a sentinel event is an
unexpected occurrence involving death or serious physical or
psychological injury, or the risk thereof, thus signaling the need for
immediate investigation and response. The terms “sentinel event” and
“medical error” are not synonymous; not all sentinel events occur
because of an error and not all errors result in sentinel events.
Although most sentinel events involve mishandled therapy or surgery, lab
professionals are patient fiduciaries and are responsible for every type
of problem involving a serious harm for the patient, considering that
laboratory data influence up to 70% of the most important decisions upon
admission, medication, and discharge.4 It is, hence,
surprising that event-reporting systems have not been so pervasive in
laboratory medicine as in other medical disciplines worldwide, most
experiences being developed on a voluntary basis rather than as a
formal, institutional duty.5,6
Such under-reporting is understandable but not idiomatic. It is rather
clear that if incidents are not systematically recognized and reported,
any reduction in risk of recurrence is also unlikely in lab medicine.

Error reporting is usually sorrowful and
frustrating because disclosure typically exposes clinical labs and
individual practitioners to financial penalties, punitive actions
concerning professional and organizational licenses, and legal and
public scrutiny. Since the assessment of clinical outcomes in relation
to laboratory diagnostics is notoriously challenging, a further problem
is the identification of those lab events arising transversally across
the entire testing process that are more closely associated to an actual
harm for the patient. This calls for the compelling need to develop and
implement reliable and universally agreed-upon performance indicators
that would reflect the “best practice” throughout the total testing
process, as well as recognize “laboratory sentinel events.” This would
allow both laboratory professionals and healthcare administrators gain
new knowledge about incidents and hold both providers and stakeholders
accountable for patient safety. The translation of some powerful
instruments for risk management to healthcare and laboratory medicine
(Six Sigma, LEAN, hazard analysis and critical control, failure mode and
effect analysis), along with the outcome of some controlled trials on
this topic, can help identify the most critical aspects to be targeted.
According to the available data, potential “sentinel events” might
include several aspects of the analytical, preanalytical, and
post-analytical phases listed in Figure 1.

Some fundamental pre-requisites for improving
patient safety in laboratory medicine have been achieved recently,
including broad consensus on the taxonomy and the need to consider the
total testing process (TTP) in its integrity, as the unique framework
for error detection and reduction.7 There are some other
ongoing initiatives aimed at recognizing reliable quality indicators,
and their success will be crucial to help clinical laboratories
identify, measure, and reduce the rate of error and non-conformities in
each and all steps of the TTP and, ultimately, introduce benchmarks in
this area. Among others, the Institute for Quality in Laboratory
the European Preanalytical Scientific Committee,9 and the
International Federation of Clinical Chemistry (IFCC) and Laboratory
Medicine Working Group on Laboratory Errors and Patient Safety10
have identified several goals to pursue the objective of patient safety,
including developing and promoting the best indicators for measuring the
quality of laboratory services; developing sentinel networks of
laboratories that provide regular, factual information on the state of
laboratory practice; and producing reliable quality indicators and
quality specifications, which would allow each clinical laboratory to
compare its data with other institutions, the final goal being the
continuous improvement based on achievable targets.

Laboratory medicine is evolving as a whole,
facing new challenges represented by translation of techniques developed
for basic research (e.g., genomics, proteomics, theragnostics) in the
routine of most clinical laboratories.11 Considering ethics
as a mandatory behavioral code in our profession,12 however,
total quality and patient safety in laboratory diagnostics will remain a
strenuous but indispensable endeavor.11 Therefore, we believe
that the introduction of event-reporting policies meeting reliable
criteria for reviewable sentinel events should be firmly encouraged by
the IFCC as well as by other national and international scientific
societies, to facilitate learning, develop solutions, and establish a
more positive safety culture.

Giuseppe Lippi, MD, is affiliated with the
Sezione di Chimica Clinica, Universit`a di Verona, Italy, and a member of
both the IFCC LEPS and the ESAP.
Camilla Mattiuzzi, MD, works with the Direzione Medica, Azienda
Ospedaliero-Universitaria di Verona, Italy.
Mario Plebani, MD, is part of the Dipartimento di Medicina
Laboratorio, Universit`a di Padova, Italy; and he, too, is a member of
the IFCC LEPS and the ESAP.


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    a safer health system. Washington, DC: National Academy Press; 2000
  2. Institute of Medicine. Patient safety: achieving a new standard
    of care. Washington, DC: National Academy Press; 2003.
  3. Joint Commission. Event Reporting and Analysis – From Evaluation
    to Solution. Available at:
    Accessed February 14, 2009.
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    MLO Med Lab Obs
    . 2001;33:13.
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    risk management and continual improvement: complementary element.
  8. Stankovic AK. The laboratory approach to patient safety.
    MLO Med Lab Obs
    . 2004;36:56.
  9. European Preanalytical Scientific Committee. Available at
    . Accessed February 14, 2009.
  10. International Federation of Clinical Chemistry and Laboratory
    Medicine (IFCC) Working Group on Laboratory Errors and Patient
    Safety. Available at
    . Last accessed February 14, 2009.
  11. Lippi G. Wisdom of theragnostics, other changes.
    MLO Med Lab Obs. 2008;40:6.
  12. Statland BE. Ethics: a code for the laboratory. MLO Med Lab Obs.