Clinical Chemistry / Automated Critical Value Notification
Evaluation of Effectiveness of a Computerized Notification
System for Reporting Critical Values
Elisa Piva, MD,1 Laura Sciacovelli,1 Martina Zaninotto,1 Michael Laposata, MD, PhD,2
and Mario Plebani, MD1
Key Words: Critical value reporting; Clinical pathology; Communication; Alerting system; Information technology; Errors; Short message
service; Patient safety
DOI: 10.1309/AJCPYS80BUCBXTUH
Abstract
Failure to adequately communicate a critical
laboratory value is a potential cause of adverse
events. Accreditation requirements specify that
clinical laboratories must undertake assessments
and appropriate measures to improve the timeliness
of critical value reporting and prompt receipt by
the responsible caregiver. Documentation and
communication processes must be regularly monitored
and implemented under ongoing systems for quality
monitoring. Critical value reporting is an important
phase of the clinical laboratory testing process, and
notifications of results outside the target time can
indicate ineffectiveness of the process. In the present
study, we report data obtained in a 12-month period of
critical values analysis and describe a computerized
communication system conducive to improving the
quality of critical value reporting at a university
hospital. Automated communication improves the
timeliness of notification and avoids the potential errors
for which accreditation programs require read-back
of the result. The communication also improves the
likelihood of reaching the physician on call and may
provide important decision support.
432 Am J Clin Pathol 2009;131:432-441
432 DOI: 10.1309/AJCPYS80BUCBXTUH
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After first advocated by Lundberg1 more than 30 years
ago, there has been wide agreement on how to define a
critical value when a result becomes life-threatening unless
some intervention is made by a physician and for which
interventions are possible. The development of a critical
values policy has become a quality practice in laboratory
medicine procedures, and, in the United States, the require-
ments for reporting critical values are specifically described
in the standards of accreditation agencies such as the Joint
Commission, formerly the Joint Commission on Accreditation
of Healthcare Organizations (JCAHO), and the College of
American Pathologists (CAP).2 Since 2005, the JCAHO has
released guidelines in which the reporting of laboratory criti-
cal values has become a National Patient Safety Goal.3 At an
international level, the most widely accepted standard in the
medical laboratory community, ISO EN 15189:2007, includes
(in clause 5.8.7) the immediate notification of a critical value
as a special requisite.4
In October 2004, the World Health Organization (WHO)
launched the World Alliance for Patient Safety to improve the
safety of care and facilitate the development of patient safety
policies and practices in all WHO member states. Every year,
the Alliance provides a number of programs covering system-
ic and technical aspects to improve patient safety worldwide.
Recently, the fourth of 23 potential patient safety solution top-
ics, entitled “communicating critical test results,” was selected
by the WHO International Steering Committee. It is currently
under development, and will be released in the near term.5
The reporting of critical values is an important phase of
the clinical laboratory testing process, and laboratories are
responsible for detecting life-threatening results, for report-
ing them to health care providers, and also for tracking and
© American Society for Clinical Pathology
 Clinical Chemistry / Original Article

improving the timeliness of reporting and the receipt of
results. To minimize communication errors, US accredita-
tion programs require that the critical value must be read
back by the health care worker, who must be contacted by
phone.6 An indicator of quality of the process may be the
critical value reporting rate; the failure to report these val-
ues, estimated at 0.1% to 10%, can indicate the operational
efficiency of laboratories.7
The sizable number of critical results, the failure to pro-
vide notification within the target time, and the time required
for phone calls may be considered tools to measure the
quality of critical value reporting. In the present study, we
Materials and Methods
Study Setting
The Padua Hospital, Padua, Italy, known as the Azienda
Ospedaliera, is a teaching hospital and research center of
national and international relevance, extending health care to
more than 400,000 people in the city and surrounding areas
and providing high specialty care to the entire nation. There
are a number of highly specialized surgical and medical
research areas, including transplantation, cardiology, hepatol-
ogy, gastroenterology, immunology, pediatrics, gynecology,
oncology, traumatology, and orthopedics. The hospital deals

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analyzed the size and type of the critical values in hospital
departments and for outpatients to understand the scope and
opportunities for improvement in critical value reporting. To
this end, we evaluated a computerized notification system,
implemented in collaboration with the information technol-
ogy (IT) department to improve timely notification and the
rate of successful notifications. In real time, with 2 devices,
the short message service (SMS) and an alert message on
the desktop computer, the automated notification of critical
values can be made to clinicians. The effectiveness of the
process before and after the start of the computerized alert-
ing system is also discussed.
with highly complex cases and large volumes of patients; in
2007, only 54% of admitted cases came from Padua and its
surrounding area, whereas 46% of inpatients came from other
parts of Italy, the south in particular. The clinical laboratory
includes clinical chemistry, hematology specialties, and vari-
ous others, such as molecular biology, immunology, proteom-
ics, and emergency testing.
Analysis of Critical Values
The list of critical values carried over from our laboratory
and used for the present study is shown in zTable 1z, zTable
2z, and zTable 3z. Critical values reported between January 1

zTable 1z
Critical Values by Test in Routine Testing

Test and Critical Value No. of Critical Values Percentage of All Critical Values Cumulative Frequency (%)

Neutrophil count, <500/µL (0.5 × 109/L) 549 12.49 12.49

Glucose, <45 mg/dL (2.5 mmol/L) 536 12.20 24.69
Prothrombin time, INR >4.5 435 9.90 34.59
Activated partial thromboplastin time, >85 s 427 9.72 44.31
Sodium, >160 mEq/L (160 mmol/L) 354 8.06 52.37
Platelet count, <10 × 103/µL (10 × 109/L) 348 7.92 60.29
Calcium, <6.5 mg/dL (1.63 mmol/L) 323 7.35 67.64
Digoxin, >3.6 ng/mL (2.8 nmol/L) 271 6.17 73.81
Magnesium, <1.0 mEq/L (0.5 mmol/L) 220 5.01 78.82
Phosphate, <0.12 mg/dL (0.36 mmol/L) 168 3.82 82.63
Sodium, <120 mEq/L (120 mmol/L) 163 3.71 86.35
Potassium, >7 mEq/L (7 mmol/L) 161 3.66 90.01
Gentamicin, >12 µg/mL (25 µmol/L) 90 2.05 92.06
Potassium, <2 mEq/L (2 mmol/L) 49 1.12 93.18
Calcium, >14.1 mg/dL (3.53 mmol/L) 43 0.98 94.14
Glucose, >991 mg/dL (55 mmol/L) 41 0.93 95.09
Amikacin, >35 µg/mL (60 µmol/L) 37 0.84 95.93
Phenytoin, >27 mg/L (108 µmol/L) 33 0.75 96.68
Hemoglobin, <5.0 g/dL (50 g/L) 31 0.71 97.39
Fibrinogen, <0.5 g/L 29 0.66 98.05
Magnesium, >4.9 mEq/L (2.45 mmol/L) 22 0.50 98.55
Leukocyte count, <500/µL (0.5 × 109/L) 20 0.46 99.01
Calcium, free, <3.2 mg/dL (0.8 mmol/L) 16 0.36 99.37
Calcium, free, >6.2 mg/dL (1.54 mmol/L) 14 0.32 99.69
Venous pH, <7.1 4 0.09 99.78
Osmolality, <250 mOsm/kg (250 mmol/kg) 4 0.09 99.87
Theophylline, >20 µg/mL (111 µmol/L) 3 0.07 99.94
Carbamazepine, >18 µg/mL (75 µmol/L) 2 0.05 99.99
Phenobarbital, >60 µg/mL (258 µmol/L) 1 0.02 100.01
Total 4,394

INR, international normalized ratio.

© American Society for Clinical Pathology Am J Clin Pathol 2009;131:432-441 433

433 DOI: 10.1309/AJCPYS80BUCBXTUH 433
Piva et al / Automated Critical Value Notification

zTable 2z
Critical Values by Test in Emergency Testing

Test and Critical Value No. of Critical Values Percentage of All Critical Values Cumulative Frequency (%)

Activated partial thromboplastin time, >85 s 721 24.64 24.64

Prothrombin time, INR >4.5 302 10.32 34.96
Calcium, <6.5 mg/dL (1.63 mmol/L) 241 8.24 43.20
Platelet count, <10 × 103/µL (10 × 109/L) 210 7.18 50.38
Sodium, >160 mEq/L (160 mmol/L) 209 7.14 57.52
Leukocytes, <500/µL (0.5 × 109/L) 179 6.12 63.64
Magnesium, <1.0 mEq/L (0.5 mmol/L) 170 5.81 69.45
Potassium, >7 mEq/L (7 mmol/L) 150 5.13 74.58
Sodium, <120 mEq/L (120 mmol/L) 140 4.78 79.36
Hemoglobin, <5.0 g/dL (50 g/L) 125 4.27 83.63
Glucose, <45 mg/dL (2.5 mmol/L) 85 2.90 86.53
Digoxin, >3.6 ng/mL (2.8 nmol/L) 79 2.70 89.23

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Calcium, free, <3.2 mg/dL (0.8 mmol/L) 75 2.56 91.79
Venous pH, <7.1 55 1.88 93.67
Potassium, <2 mEq/L (2 mmol/L) 40 1.37 95.04
Calcium, free, >6.2 mg/dL (1.54 mmol/L) 39 1.33 96.37
Glucose, >991 mg/dL (55 mmol/L) 24 0.82 97.19
Calcium, >14.1 mg/dL (3.53 mmol/L) 23 0.79 97.98
Venous pH, >7.7 21 0.72 98.70
Phenobarbital, >60 µg/mL (258 µmol/L) 11 0.38 99.08
Arterial pH, <7.1 8 0.27 99.35
Magnesium, >4.9 mEq/L (2.45 mmol/L) 7 0.24 99.59
Phosphate, <0.12 mg/dL (0.36 mmol/L) 3 0.10 99.69
Arterial pH, >7.7 3 0.10 99.79
Neutrophil count, <500/µL (0.5 × 109/L) 3 0.10 99.89
Carbamazepine, >18 µg/mL (75 µmol/L) 2 0.07 99.96
Osmolality, <250 mOsm/kg (250 mmol/kg) 1 0.03 99.99
Theophylline, >20 µg/mL (111 µmol/L) 0 0.00 99.99
Phenytoin, >27 mg/L (108 µmol/L) 0 0.00 99.99
Gentamicin, >12 µg/mL (25 µmol/L) 0 0.00 99.99
Fibrinogen, <0.5 g/L 0 0.00 99.99
Amikacin, >35 µg/mL (60 µmol/L) 0 0.00 99.99
Total 2,926

INR, international normalized ratio.

zTable 3z
Critical Values by Test for Outpatients

Test and Critical Value No. of Critical Values Percentage of All Critical Values Cumulative Frequency (%)

Prothrombin time, INR >4.5 296 22.37 22.37

Activated partial thromboplastin time, >85 s 167 12.62 35.00
Calcium, <6.5 mg/dL (1.63 mmol/L) 104 7.86 42.86
Platelet count, <10 × 103/µL (10 × 109/L) 100 7.56 50.42
Digoxin, >3.6 ng/mL (2.8 nmol/L) 88 6.65 57.07
Magnesium, <1.0 mEq/L (0.5 mmol/L) 84 6.35 63.42
Glucose, <45 mg/dL (2.5 mmol/L) 83 6.27 69.69
Sodium, <120 mEq/L (120 mmol/L) 79 5.97 75.66
Sodium, >160 mEq/L (160 mmol/L) 74 5.59 81.25
Neutrophil count, <500/µL (0.5 × 109/L) 71 5.37 86.62
Potassium, >6 mEq/L (6 mmol/L) 51 3.85 90.48
Hemoglobin, <6.0 g/dL (60 g/L) 28 2.12 92.59
Potassium, <2 mEq/L (2 mmol/L) 24 1.81 94.41
Phosphate, <0.12 mg/dL (0.36 mmol/L) 16 1.21 95.62
Leukocyte count, <500/µL (0.5 × 109/L) 13 0.98 96.60
Phenytoin, >27 mg/L (108 µmol/L) 9 0.68 97.28
Calcium, >14.1 mg/dL (3.53 mmol/L) 6 0.45 97.73
Calcium, free, <3.2 mg/dL (0.8 mmol/L) 6 0.45 98.19
Amikacin, >35 µg/mL (60 µmol/L) 6 0.45 98.64
Gentamicin, >12 µg/mL (25 µmol/L) 5 0.38 99.02
Glucose >501 mg/dL (27.8 mmol/L) 4 0.30 99.32
Calcium, free, >6.2 mg/dL (1.54 mmol/L) 4 0.30 99.62
Theophylline, >20 µg/mL (111 µmol/L) 3 0.23 99.85
Osmolality, <250 mOsm/kg (250 mmol/kg) 1 0.08 99.92
Lithium, >1.5 mEq/L (1.5 mmol/L) 1 0.08 100.0
Total 1,323

INR, international normalized ratio.

434 Am J Clin Pathol 2009;131:432-441 © American Society for Clinical Pathology

434 DOI: 10.1309/AJCPYS80BUCBXTUH

and December 31, 2007, were considered to determine type
and frequency of critical values among the hospital depart-
ments and outpatients. Multiple data sets of all critically high
or low laboratory values, used for the statistical analyses,
were sorted on the basis of analyte, department, patient, and
time. The frequency of critical values was measured as an
incidence rate (ie, the number of critical values occurring in
a department divided by number of hospital days in the same
unit), thus allowing comparisons to be made between different
hospital departments.
Phone Call System
Since 1994, our team has reported critical values for the
most important biochemical and hematologic analytes and
drugs and has amended the communication policy by identify-
ing a member of the staff responsible for this aspect, a physi-
cian on call. The notification given is reported in a register (a
quality document) together with the date, the time of the call,
the patient’s identification, bar code, location, test result, the
physician communicating the critical value, and the recipient
of the information. The percentage of unsuccessful notifica-
tions was calculated by taking into account a time lapse of 1
hour from the detection of the critical value in question.
Computerized Notification System: Alerting System
and SMS
The computerized notification system was begun on
January 1, 2008. The hospital clinical information system
(HCIS) (e-Health Solutions Medical Software, developed by
GMD, version 3.8, Noematica, Bologna, Italy) uses compo-
nents that allow the integration of medical and administrative
IT systems and workflow-oriented support for the clinical
workspace. For this purpose, HCIS manages all requests made
by clinicians and assembles the information coming from all
diagnostic services, including clinical laboratory and imag-
ing departments. In real time, the HCIS supplies clinicians
with laboratory results released by the laboratory information
system (LIS) (LM*X, version 22.01, TDLims, Grenoble,
France). Briefly, once a critical value has been identified and
validated by the clinical pathologist in charge, the transmis-
sion from the LIS to HCIS system creates an e-mail message
for automated notification.
On the HCIS patient record, this e-mail for critical value
notification generates 2 actions: an SMS to the cell phone of the
referring physician (the clinician on duty, supporting the order-
ing clinician for care of the patient) and at the department level,
an alert message by video to the ordering clinician. The alert
message flashes on the monitor until the physician or a nurse
in charge of notification confirms that the message has been
received; the flashing alert is stopped after 60 minutes. In con-
formity with the privacy law, both types of message (SMS and
alert) include the appropriate codes for patient identification, and
© American Society for Clinical Pathology
Clinical Chemistry / Original Article
they specify the analyte with the critical value and the mobile
telephone number of the physician on call in the laboratory. In
the laboratory, the HCIS documents the status of critical values
reporting, indicating the success or failure of the notification
process. If the message is successfully communicated within
60 minutes, the receipt is logged into the system. The HCIS
uses green color coding for the specific patient details, includ-
ing the test and the critical value. Failure to notify within the
target time is indicated with red color coding, and the term
expired appears. In this case, communication is made by tele-
phone. The process is shown in zFigure 1z.
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Data Collection and Statistical Analysis
The data reported in the present study were obtained from
reports generated from the LIS and exported to Microsoft
Excel (Microsoft, Redmond, WA). Statistical analyses were
made by using MedCalc software, version 9.6.4.0 (MedCalc
Software, Mariakerke, Belgium).
Results
Frequency of Critical Values
During the study period of 1 year (2007), more than 6
million routine tests and about 1.7 million emergency tests
were carried out in the laboratory. The total number of critical
values found was 7,320, approximately 60% of which resulted
from routine testing and 40% from emergency testing. The
prevalence of critical values was 7.3/100 for routine test-
ing and 16.7/100 for emergency testing. The frequency and
cumulative frequency were calculated for every critical value
(Tables 1 and 2). With the exception of hemoglobin, in routine
and emergency testing, 90% of critical values were generated
from the same analytes. The majority of tests expected to
generate critical values were performed in the clinical chem-
istry section, but the parameters with the highest frequency of
critical values (neutrophil count and activated partial throm-
boplastin time) were in the hematologic section.
Analysis of Inpatient Critical Values
Of all critical values, approximately 82% were found
in inpatients. Evaluation of the critical values was made by
measuring the incidence rate (ie, the number of critical values
occurring in a department divided by the number of hospital
days in the same unit) zFigure 2z. The frequency of critical
values was evaluated for each department; the greatest num-
ber, with the respective analyte type, is shown in zFigure 3z.
Analysis of Outpatient Critical Values
Critical values for outpatients account for approximately
18% of the total, and the ratio of attendances with critical val-
ues to the total number of outpatient encounters was 0.4/100.
Am J Clin Pathol 2009;131:432-441 435
435 DOI: 10.1309/AJCPYS80BUCBXTUH 435
Piva et al / Automated Critical Value Notification

Who notifies? Notification method Person notified?

Alert SMS Y Responsible

(mobile phone) (referring) MD
Y
At lab, MD Validation
on call Ordering MD,
of CV Alert message Y
(computer) appointed nurse, or Confirmation
resident
N

If alert not N
Y acknowledged
within 60
minutes

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At lab, MD Communication Y
Responsible MD
on call (phone call)

zFigure 1z Flow chart showing the notification process. See text for detailed explanation. CV, critical value; SMS, short
message service.

50
47.55

45
Incidence Rate of Critical Values/1,000 Hospital Days/Year

40

35

30

25 23.88

22.18

19.97
20
16.23 16.04
15.28
15
11.31

10 8.78

4.57
5 3.84
2.73 2.52
1.44
0.59

0
ICU Nephrology Hematology Pediatrics Internal Cardiovascular Oncology Geriatrics Medical Neurology General Obstetrics Surgical Psychiatry Orthopedics
Medicine Thoracic Specialties Transplant and Specialties
Department Surgery Gynecology

Departments

zFigure 2z Incidence rate of critical values, calculated as the number of critical values per 1,000 hospital days per year. ICU,
intensive care unit.

436 Am J Clin Pathol 2009;131:432-441 © American Society for Clinical Pathology

436 DOI: 10.1309/AJCPYS80BUCBXTUH
 Clinical Chemistry / Original Article

200 PMN

180

160

140 Glucose
<2.5 mmol/L
No. of Critical Values

120 Na
Plts >160 mmol/L

100

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Glucose
<2.5 mmol/L
80

Na
60 >160 mmol/L Mg
<0.5 mmol/L aPTT
Ca
aPTT aPTT <1.63 mmol/L
40 Glucose
<2.5 mmol/L

aPTT
20 Ca
<1.63 mmol/L

Hb
0
Internal Pediatrics Hematology Geriatrics Obstetrics ICU Oncology Medical Cardiovascular Emergency Nephrology General Neurology Surgical Orthopedics
Medicine and Specialties Thoracic Transplant Specialties
Gynecology Department Surgery

Departments

zFigure 3z The test with highest number of critical values for each hospital department. aPTT, activated partial thromboplastin
time; Hb, hemoglobin ICU, intensive care unit; Plts, platelets; PMN, polymorphonuclear neutrophil. Critical values are given
in Système International units; conversions to conventional units are as follows: glucose (mg/dL), divide by 0.0555; sodium
(mEq/L), divide by 1.0; magnesium (mEq/L), divide by 0.50; and calcium (mg/dL), divide by 0.25.

Table 3 shows the frequency and cumulative frequency of those observed in 2 months during which time notification was
critical values for the outpatients. A cumulative frequency made by telephone. The time required for the communication
of 90.48% was reached with 11 analytes (4 in hematology, 6 was also calculated. The average time for notification using the
in biochemistry, and 1 drug). The parameter with the highest telephone call system was 30 minutes, considering the overall
frequency was the international normalized ratio (INR), and time (looking up the phone number and dialing it, finding the
digoxin was the most frequent analyte in proportion to the test responsible clinician, relaying information, and reading back).
volume. Critical INR values were for 242 patients; 22 (9.1%) More than 50% of notifications were unsuccessful (ie, notifica-
patients had 2 critical INR values in different attendances; 12 tion made after an interval of >1 hour). The average time for
(5.0%) patients had a critical INR value more than twice. computerized notifications was 11 minutes, considering the
overall time for receipt of the alert and confirmation. The rate
Notification of Turnaround Time and Rate of of unsuccessful notifications (computerized notification with-
Unsuccessful Notifications out confirmation within an interval of 1 hour) was 10.9%.
Trends for the critical values were analyzed over time. The rate of successful notifications, that is, communi-
The greatest number was recorded in March (n = 873) and cation within 1 hour, for the traditional phone process was
the smallest in September (n = 448); their frequency during compared with that for the computerized system for hospital
24 hours considered is shown in zFigure 4z. The communica- departments zFigure 5z.
tion process was analyzed before and after the computerized
notification system was initiated, and an evaluation was made
to assess the improvement achieved in the process using this Discussion
technology. Critical values observed during the 2-month initial Critical values, formerly known as panic values, are
period using the new notification system were compared with abnormal laboratory results that constitute a life-threatening

© American Society for Clinical Pathology Am J Clin Pathol 2009;131:432-441 437

437 DOI: 10.1309/AJCPYS80BUCBXTUH 437
Piva et al / Automated Critical Value Notification

1,200

1,000

800
No. of Critical Values

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600

400

200

0
1.00- 5.00- 7.00- 8.00- 9.00- 10.00- 11.00- 12.00- 13.00- 14.00- 15.00- 16.00- 17.00- 18.00- 19.00- 20.00- 21.00- 22.00- 23.00-
2.00 6.00 8.00 9.00 10.00 11.00 12.00 13.00 14.00 15.00 16.00 17.00 18.00 19.00 20.00 21.00 22.00 23.00 24.00

Time Over 24 h

zFigure 4z Distribution of critical values as a function of time.

condition for the patient, but any values for which delays in
reporting can result in adverse outcomes for patients represent
a potential critical value. Although it is widely agreed that
clinicians must be immediately informed of these values, the
criteria for considering test results critical are controversial.
It has also been emphasized that critical values and criti-
cal tests are not necessarily the same thing. Critical tests are
especially relevant to the emergency department (ED). In
this setting, communication of critical values should be made
without excessive communication with the medical team,
highlighting only the critical values. In the Padua Hospital for
ED patients, the times to test ordering and to test results are
strictly monitored, and, when critical values are detected, an
alert message requiring attention appears in the report. The
SMS device was not applied because clinicians are usually
very busy. According to all ED physicians, we consistently
provide results promptly and highlight the critical values.
There are not clear recommendations about this issue,
nor is there consensus in the medical community about the
formulation of a standard list or target time frames for criti-
cal values. Laboratories have therefore developed their own
lists, which has led to great variability in the number of tests
considered critical. No standards are available for pediatric or
neonatal critical values. Any attempt to establish interpretive
critical values reporting for inpatients hospitalized in differ-
ent diagnostic departments is beset with difficulties, as is the
management of outpatient critical values.
Institutions and agencies for health care have stated that
critical results are not only those from laboratory tests, but
also those from diagnostic tests conducted in the departments
of anatomic pathology, radiology, and cardiology.8 The term
action alert has been proposed for critical pathology find-
ings requiring special communication. This alternative term
has been considered necessary because the nomenclature has
regulatory and accreditation consequences.9 Significant find-
ings in diagnostic departments (including laboratories and
cardiology, radiology, and pathology departments) should be
communicated by using health information systems.
The analysis of critical values made in the present study
allowed us to compare values obtained in one hospital setting
with those reported in the literature. The critical values list
adopted in our laboratory takes into account only the analytes

438 Am J Clin Pathol 2009;131:432-441 © American Society for Clinical Pathology

438 DOI: 10.1309/AJCPYS80BUCBXTUH
 Clinical Chemistry / Original Article

Before computerized alert

After computerized alert

100

90

80
Successful Notifications (%)

70

60

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50

40

30

20

10

0
Cardiovascular Emergency General Geriatrics Hematology ICU Internal Medical Nephrology Neurology Obstetrics Oncology Pediatrics Surgical
and and Medicine Specialties and Specialties
Thoracic Transplant Gynecology
Department Surgery

Departments

zFigure 5z Comparison of successful notifications, that is, communication within 1 hour, for the traditional phone process with
those of the computerized system. Information technology improved the rate of notification in all hospital services except
medical specialties. ICU, intensive care unit.

with a “red” level of criticality, which we indicate as truly life- for outpatients were evaluated using data obtained on cases
threatening. This list and the cutoffs used by us are similar to during a 1-year period. We believe our results can be repre-
those used at Massachusetts General Hospital, Boston.10 Also, sentative of a large hospital setting in developed countries. To
the percentages of inpatients and outpatients are comparable our knowledge, there are no data from large hospitals about
(in the present study, the ED was included in the inpatient the incidence of critical values between clinical services and
category). By comparing our critical values for chemistry and few data about the distribution of critical values for patients,
hematology with those outlined by Howanitz et al11 in a 2002 analytes, and time. Data may be evaluated to detect adverse
Q-Probes program, our values seem stringent. events by service, facilitating timely investigation when war-
Despite this policy, however, we have a large number of ranted.12
critical values to communicate each day. The system involv- As an example, in the nephrology department, we found
ing the use of the telephone is known to be distracting if the the most frequent critical value was a low calcium level.
call back is made by the people performing the tests, and it Abnormal calcium levels are common in chronic kidney
is time-consuming. Technological solutions with wireless diseases and not only cause significant bone disease but
devices present a strategy to improve communication of criti- also contribute to cardiovascular disease. In patients with
cal values. In the last 3 years, the workload in our laboratory hypocalcemia, the most common diagnoses were trauma,
has increased significantly, calling for a better solution. gastrointestinal disorders, and renal failure.13 Often, in the
Before changing the communication process and to latter condition, hypocalcemia can be controlled with supple-
achieve a better solution, the frequency of critical values and mental vitamin D. In the outpatient setting, the INR showed
the incidence rates for different hospital departments and the highest test volume. This may be because outpatients

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439 DOI: 10.1309/AJCPYS80BUCBXTUH 439
Piva et al / Automated Critical Value Notification
receiving oral anticoagulant therapy need to be monitored
for pharmacological effects. A meta-analysis of prospective
research studies by Levine and colleagues14 showed that war-
farin caused major bleeding in 0.8% to 4.1% of patients per
year (average, 1.7%) and fatal bleeding in 0.2% to 2.3% of
patients per year (average, 0.8%). In another meta-analysis,
by Landefeld and Beyth,15 the average annual frequencies of
major and fatal bleeding per year with warfarin therapy were
3% and 6%, respectively. In the outpatient setting, the risk of
fatal bleeding with vitamin K antagonists has been calculated
at 1%16 to 2%17 per year. Among outpatients taking warfarin
for whom INR values have been proven critical, 5% of cases
had more than 2 critical INR values, showing poor therapeutic
control. Although other studies are needed using this database,
we use it as a monitoring tool for patient safety.
Failure in communication, particularly in this type of
situation, continues to be one of the most common fac-
tors contributing to the occurrence of adverse events.18
Opportunities in IT are and will continue to be available. The
ability to interface the LIS and, for example, the radiology
information system from the hospital information system with
the electronic medical record is still a major challenge. For
example, a voice-driven automated system, Veriphy (Vocada,
Dallas, TX), developed for radiologic reporting, has recently
been made available in the United States for the management
of critical results in radiology, laboratory, pathology, and
cardiology testing, promoting the communication required by
the Joint Commission.19
Other professional organizations also promote improve-
ments in communication: the CAP, in the 2008 survey
of critical value reporting, showed that only 8.6% of 623
institutions communicate critical values using wireless tech-
nologies.20 A national survey on critical values reporting in
a cohort of Italian laboratories concluded that the importance
of critical values reporting was poorly recognized and that
internationally accredited practices for communication were
not implemented.21
By working together in an interdepartmental team using
IT, our laboratory found it possible to revise its report-
ing system. For the automated process, according to one’s
own institution, the clinical laboratory must define a policy
identifying the clinician responsible for receiving commu-
nication of critical values. At our hospital, the responsible
clinicians are those receiving the SMS, ie, the physicians
on call in the department who are available at all times for
urgent situations. On the clinical wards, there is only 1 cellu-
lar phone, and it is used by the responsible clinician. Mobile
phones linked to the information system provide real-time
event notification for the physician on call, thus meeting the
Joint Commission requirement that the laboratory is respon-
sible for ensuring that the “responsible, licensed caregiver”
is contacted. To confirm an alerting message on the desktop
440 Am J Clin Pathol 2009;131:432-441
440 DOI: 10.1309/AJCPYS80BUCBXTUH
computer, the ward identifies the authorized provider for
patient care, usually the ordering clinician. In case this per-
son is not available, a resident or the nurse in charge may be
appointed to receive the message. This reporting system was
started for the inpatient setting but, by working with a group
of general practitioners, will be extended to the outpatient
setting.
In the LIS, outpatients are recorded in association with
their own family doctor. To maximize efficiency of calls,
there is a large list of general practitioners and their mobile
phone numbers. The family physicians for outpatients are the
responsible physicians available at all times. Unfortunately,
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delays in communication may still occur if a general prac-
titioner is unavailable or his or her mobile phone number is
missing from the list.
There is broad consensus that errors in communicat-
ing test results are frequent and potentially dangerous, and
several groups have defined guidelines and useful strategies
to improve communication processes.22,23 Alerts are known
to be a crucial part of a clinical decision-support system,
and their value has been demonstrated in controlled trials.
Kuperman et al24 observed that, when clinicians were paged
about “panic” laboratory values, the time to therapy decreased
by 11% and the mean time to the resolution of an abnormality
was 29% shorter. In another study, Kuperman et al25 showed
that an automatic alerting system reduced the time until the
provision of appropriate treatment in patients with critical
laboratory results. In our setting, computerized communica-
tion demonstrated a reduction in time notification and yielded
further benefits: it eliminated the risk of errors occurring in
phone notification and erroneous patient identification and
test and value reporting, which occurs if the read-back step
is not used.
In the present study, it was not possible to calculate errors
in communication occurring before the introduction of the
computerized notification system. However, data available
in literature indicate an error rate of 3.5% for all telephone
calls made from laboratories.26 The use of IT is, therefore, of
crucial importance in reducing the communication error rate.
Computerized reporting does not call for read-back from the
recipient, as it ensures reliable communication and interpreta-
tion of results. In addition, the use of SMS messages ensures
that physicians on call are always reached; in the near future,
it should be possible to immediately communicate options
available for action to clinicians.27
In using improved communication strategies, however,
it is important to avoid overdefinition of critical values.
The list should include tests that truly meet the criteria for
life-threatening, and the choice of certain analytes should be
tailored to each diagnostic discipline involved and endorsed
by physicians. For example, the critical value for activated
partial thromboplastin time differs depending on whether a
© American Society for Clinical Pathology

patient is receiving heparin therapy. A low platelet count can
be a critical value if it is an unexpected finding, but even in
a hematologic or oncologic setting, it can become a critical
value because it can contribute to decision making about the
type of therapy to provide and may indicate that additional
support, such as platelet transfusion, is required. The clinical
usefulness of a critical value hinges on a careful evaluation
of the cutoff limit, in consultation with clinicians. With these
issues open, IT improves the timeliness of reporting. In the
modern world of computerized laboratories and hospitals,
the critical value reporting process should be revisited, and
methods to improve reporting and communication strategies
should be realized in a hospital setting as a multidisciplinary
effort. Currently, computerized reporting of critical values
meets accreditation and clinician requirements, has the poten-
tial to improve patient safety, and provides context-sensitive
reporting. Better communication, guaranteeing the correct
notification of important results such as critical values, must
be achieved because it is key to improving patient outcomes.
From the 1Department of Laboratory Medicine, Padua University
School of Medicine, Padua, Italy; and 2Vanderbilt University
Hospital, Nashville, TN.
Address correspondence to Prof Plebani: Dipartimento
Medicina di Laboratorio, Azienda Ospedaliera-Università di
Padova, Via Nicolò Giustiniani 2, 35128 Padova, Italy.
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441 DOI: 10.1309/AJCPYS80BUCBXTUH 441