You are on page 1of 7

CAP Laboratory Improvement Programs

Laboratory Critical Values Policies and Procedures


A College of American Pathologists Q-Probes Study in 623 Institutions
Peter J. Howanitz, MD; Steven J. Steindel, PhD; Nan V. Heard, MD

● Context.—Critical values lists have been used for many pants’ data showed that most critical values reports (92.8%)
years to decide when to notify physicians and other care- were made by the person who performed the test, and that
givers of potentially life-threatening situations; however, 65% of reports for inpatients were received by nurses. For
these lists have not been studied widely. outpatients, physicians’ office staff received the largest per-
Objectives.—To investigate critical values lists in insti- centage (40%) of reports. The majority of participants
tutions participating in the College of American Patholo- (71.4%) had no policy on how repeat critical calls should
gists Q-Probes program and to provide suggestions for im- be handled. On average, completion of notification required
provement. about 6 minutes for inpatients and 14 minutes for outpa-
Setting.—A total of 623 institutions voluntarily partici- tients. Slightly greater than 5% of critical value telephone
pating in the Q-Probes program. calls were abandoned, with the largest percentage aban-
Design.—A multipart study in which participants re- doned for outpatients. More than 45% of critical values
sponded to information from preprinted lists, collected in- were unexpected, and 65% resulted in a change in therapy.
formation about current practices, completed a question- Although only 20.8% of 2301 nursing supervisors thought
naire, monitored critical values calls, reviewed patients’ critical values lists were helpful, 94.9% of 514 physicians
medical records, and surveyed nursing supervisors and found critical values lists valuable.
physicians about critical values. Conclusions.—Critical values systems were medically
Main Outcome Measures.—Defining critical values sys- important, highly variable, but also costly practices for par-
tems, including lists, personnel, costs, processes, useful- ticipants. We propose a number of recommendations for
ness, and related medical outcomes. improvement, including that the critical values list should
Results.—Critical values lists were determined for routine be approved by the medical staff, each laboratory should
chemistry and hematology analytes and were found to vary develop a written policy for handling initial and repeat crit-
widely among participants. In contrast, more than 95% of ical values reports, a foolproof policy should be established
participants reported positive blood cultures, cerebrospinal to report results from calls abandoned, and efforts at au-
fluid cultures, and toxic therapeutic drug levels as critical tomating the process should become widespread.
values. Based on more than 13 000 critical values, partici- (Arch Pathol Lab Med. 2002;126:663–669)

R ecently, laboratorians have begun to evaluate clinicians’


requirements for rapid availability of test results and
have developed and implemented strategies to improve lab-
suitable treatment could occur quickly. As part of his pro-
cedure, Lundberg coined the term critical (panic) values for
these results, defining them as representing a pathophysi-
oratory test turnaround times.1 Although most clinical lab- ological state at such variance with normal as to be life-
oratory results have diagnostic and therapeutic implications threatening unless something is done promptly, and for
that do not require urgent physician attention, occasionally which some corrective action could be taken.2,3
laboratory results are so extreme that they may indicate a Soon after Lundberg’s classic observations in 1972,
potentially lethal situation requiring immediate notification many laboratories adopted his critical value concept and
and action by the physician. Lundberg2,3 was the first author its use became widespread throughout the world.4,5 Ulti-
to identify the value of rapid reporting. He developed a mately, accrediting agencies incorporated the critical val-
system in which clinical laboratory personnel reported ues list into their requirements, so that at least in the Unit-
these values immediately to appropriate individuals, so that ed States, almost every laboratory uses critical values pol-
icies and procedures daily for results indicating poten-
Accepted for publication January 10, 2002.
tially life-threatening situations.6,7
From the Department of Pathology, State University of New York, Despite widespread and long-standing use of critical
Downstate Medical Center, Brooklyn, NY (Dr Howanitz); the Public values, the scientific literature describing these policies
Health Practice Program Office, Division of Laboratory Systems, Cen- and procedures has been limited. A number of publica-
ters for Disease Control and Prevention, Atlanta, Ga (Dr Steindel); and tions have described critical values lists in a single insti-
the Department of Laboratory Medicine, West Los Angeles Veterans tution,4,5,8 but more recently, publications have described
Administration Medical Center, West Los Angeles, Calif (Dr Heard).
Reprints: Peter J. Howanitz, MD, Department of Pathology, Box 25, experiences from a number of institutions. In 1990, Kost9
State University of New York, Downstate Medical Center, 450 Clarkson published summary data from 92 medical centers in the
Ave, Brooklyn, NY 11203 (e-mail: phowanitz@netmail.hscbklyn.edu). United States, identifying 32 different critical value limits
Arch Pathol Lab Med—Vol 126, June 2002 Laboratory Critical Values—Howanitz et al 663
Table 1. Analytes From Supplied List Used on Participants’ Critical Values Lists*
Low Critical Value Percentile High Critical Value Percentile
50th 50th % Appearing
Analytes 10th (Median) 90th 10th (Median) 90th on Stat List (N)
Chemistry
Ammonia, mmol/L 0.0 4.4 22.2 19.4 43.3 110.8 46.4 (289)
Arterial pH 7.2 7.2 7.3 7.5 7.6 7.6 45.9 (286)
Arterial PCO2, kPa 2.5 2.7 4 6.7 9.3 9.3 45.3 (282)
Arterial PO2, kPa 5.3 5.3 8.0 7.3 14.8 33.3 44.4 (279)
Bilirubin (neonatal), mmol/L 0.0 0.0 17.1 206.2 256.5 307.8 66.1 (412)
Calcium (ionized), mmol/L 0.22 0.75 1.50 0.35 1.58 1.75 17.3 (108)
Calcium (total), mmol/L 1.50 1.50 1.75 3.0 3.25 3.50 82.5 (514)
Carbon dioxide, mmol/L 10 10 15 40 40 45 82.5 (514)
Chloride, mmol/L 70 80 90 115 120 130 73.4 (457)
Creatinine, mmol/L 0 18 44 265 442 884 60.5 (377)
Glucose (cerebrospinal fluid), mmol/L 1.10 2.15 2.31 4.13 11.00 27.50 63.7 (397)
Glucose (serum), mmol/L 2.20 2.20 2.75 16.50 24.75 38.50 57.6 (359)
Lactic acid, mmol/L 0.00 0.06 0.33 0.27 0.44 3.40 86.4 (538)
Lecithin/sphingomyelin (L/S) ratio 1.0 1.5 2.0 2.0 2.0 3.0 35.5 (221)
Magnesium, mmol/L 0.39 0.41 0.57 1.23 1.91 2.50 9.3 (58)
Phosphorus, mmol/L 0.32 0.32 0.65 1.78 2.58 3.23 57.9 (361)
Potassium, mmol/L 2.5 2.8 3.0 6.0 6.2 6.5 49.3 (307)
Osmolality, mOsmol/kg 219 250 270 300 323 350 86.2 (537)
Sodium, mmol/L 110 120 125 150 160 170 43.0 (268)
Urea nitrogen, mmol/L
Uric acid, mmol/L 0.0 1.1 2.1 17.9 28.6 35.7 85.9 (535)
0.0000 0.0590 0.1180 0.5990 0.7611 0.8850 65.2 (406)
Hematology
Activated partial thromboplastin time, s 0 19 23 40 78 118 81.7 (509)
Fibrinogen, mmol/L 0.50 1.00 1.50 3.75 8.00 8.00 65.8 (410)
Hemoglobin, g/L 50 70 80 180 200 210 83.0 (517)
Hematocrit, % 0.15 0.20 0.25 0.55 0.60 0.65 77.4 (482)
Platelet count, 3109/L 20 40 60 600 999 1000 83.0 (517)
Prothrombin time, s 0 9 15 17 30 40 83.0 (517)
White blood cell count, 3109/L† 1.0 2.0 3.0 20.0 30.0 60.0 78.8 (491)
* Values set in boldface type were reported by fewer than 100 participants; values set in italics were reported by 100 to 199 participants.
Conversion table for calculating conventional units follows references.
† Three hundred twenty-two (51.7%) of the participants included the differential on their stat lists.

used in many of his survey participants’ laboratories. Dur- voluntary quality improvement program, Q-Probes, has
ing the next few years, surveys of 39 pediatric hospital studied more than 100 indicators of quality for pathology
laboratories and 9 regional Veterans Administration hos- and laboratory medicine, describing benchmarks of perfor-
pital laboratories found that critical limits are similar be- mance and providing suggestions for improvement. In this
tween institutions, but also specific for the clinical needs article, we describe policies, procedures, practices, and out-
of each institution.10,11 A few years ago, Emancipator12 au- comes for laboratory critical values systems and provide
thored a practice parameter for the American Society of suggestions for their improvement. We believe this is the
Clinical Pathologists that provided guidelines for selection largest and most comprehensive report to date, studying
of critical value limits, as well as policies and procedures not only limits used as critical values, but also policies and
for their implementation. Others have studied critical val- procedures, costs, and perceived values of these laboratory
ues for a specific analyte, such as calcium,13 ionized cal- critical values lists.
cium,14,15 or potassium,16,17 but we are unaware of a com-
prehensive description and demonstrated value of critical MATERIALS AND METHODS
values systems. Participants registered and participated in the CAP’s volun-
Recently, measurement of clinical outcomes of patients tary quality improvement program, Q-Probes, according to a
has come into vogue in American medicine. For some ar- previously described study design.19 For this study, a critical
eas of medicine, such as clinical drug trials, patient out- value was described as a pathophysiological state at such vari-
come measures have become second nature and are sub- ance with normal as to be life-threatening unless something is
ject to routine regulatory review by the Food and Drug done promptly and for which some corrective action could be
Administration and other groups. However, for laboratory taken.2,3 The day shift, evening shift, and night shift were de-
medicine, only a handful of patient outcome studies have fined in terms of time of day, and the physician was defined as
been published, most of which were summarized recently the primary caregiver.
The study required participants to (1) select from a supplied
by Bissell.18 Because critical values occur frequently and list of 28 tests those laboratory tests that were included on their
represent life-threatening situations, the therapeutic man- critical values list and provide the limits they used for those tests;
agement physicians use in response to critical values could (2) provide information on up to 3 other chemistry or hematology
serve as a potentially important laboratory outcome mea- critical values used in their laboratory that were not on the pro-
sure that could be implemented widely. vided list; (3) select from supplied lists critical values for their
Since 1989, the College of American Pathologists’ (CAP’s) microbiology and drug assays; (4) answer general questions con-
664 Arch Pathol Lab Med—Vol 126, June 2002 Laboratory Critical Values—Howanitz et al
cerning the derivation and reporting of critical values; (5) review Table 2. Participants (%) Reporting Microbiology
the medical records of 10 patients with recent critical values to Results as Critical Values
determine the effect of critical values on medical care delivery;
(6) survey 3 to 10 nursing supervisors from different nursing Microbiology Result Participants, %
stations regarding the nursing staff’s awareness and use of crit- Positive blood cultures 95.0
ical values; and (7) survey up to 10 physicians regarding their Positive CSF cultures 91.2
awareness and use of critical values. Positive AFB smear or culture 71.9
Participants also collected data during a 30-day period on 24 Positive Gram stains of sterile body fluids 66.8
critical value calls; 6 critical values were selected from the middle Initial stool isolates of Salmonella, Shigella,
of each of the 3 shifts for inpatients, as well as 6 critical values Campylobacter, and Yersinia 59.7
for outpatients. These data included the length of time required Positive latex agglutination and/or antigen
to find a person to take each critical value call, the job title of the detection test 50.7
person making and taking the critical value call, the length of Positive CSF VDRL 25.7
time before each critical value call was abandoned, the inpatient Other microbiology critical values 44.8
or outpatient status of the patient, and the shift during which the * CSF indicates cerebrospinal fluid; AFB, acid-fast bacilli; and VDRL,
call was made. Venereal Disease Research Laboratory test.
The 13 general questions concerning the derivation and re-
porting of critical values were multiple-choice type with direc-
tions to choose the best answer or all answers that applied, de- Table 3. Participants’ Reporting Practices
pending on the question. For chart reviews, a preprinted single
sheet was provided so that each of 4 questions was answered by Drug Results Participants, %
making a mark in either the yes or no column. The nursing su- Drugs of abuse
pervisors were interviewed by telephone and were asked 3 ques-
Telephone all positive results 25.2
tions, each requiring either a yes or a no answer, and their re- Do not telephone all positive results 52.8
sponses were indicated on a preprinted interview form. The nurs- Not applicable 22.0
ing supervisors selected were to represent the emergency de-
partment, an intensive care or critical care unit, and at least 1 Therapeutic drugs
medical/surgical unit. Immediately after receiving a critical val- Telephone all toxic values 96.3
ue, the physicians were mailed a form with 6 questions about the Do not telephone all toxic values 2.9
critical value and were asked to circle either yes or no for each Not applicable 0.8
question. An accompanying letter signed by the laboratory di-
rector requested the physicians to immediately complete and re-
turn the short questionnaire. matology analytes, such as hemoglobin, hematocrit, plate-
Demographic information was obtained from a yearly partici- let count, and white blood cell count, almost all of labo-
pant enrollment form. Based on the data submitted, participants’ ratories had both high and low critical values. In contrast,
results were ranked according to the usual Q-Probes percentile
fewer than 100 participants had both high and low critical
rankings, with the 10th percentile corresponding to the lowest
critical values and the 90th percentile corresponding to the high- values for ammonia, ionized calcium, lactic acid, and the
est critical values. When participants did not complete all re- lecithin/sphingomyelin (L/S) ratio. For some analytes,
quired information, they were excluded from the database only such as arterial PO2, the majority of laboratories had only
for the missing information. Some laboratories did not complete low critical values, whereas for other analytes, such as cre-
the yearly demographic form, and for these, their bed size was atinine and prothrombin time, the majority of participants
listed as unknown. Laboratories reported data using the units of had only high critical values. Sixty-five other chemistry or
the test results they commonly used, and these units were con- hematology analytes appeared on at least 1 laboratory’s
verted to SI units at the CAP computer center by applying widely critical values list, and of these, amylase was the most
used conversion factors. common. Amylase was found on 66 (10.7%) participants’
lists. Also listed in this table is the percentage of analytes
RESULTS
with critical limits that were on participants’ stat test lists.
Data were submitted by 623 institutions, of which 31% Table 2 shows the percentage of participants with re-
were teaching and 69% were nonteaching. Most institu- sults of common microbiology procedures on their critical
tions were nongovernmental (76.1%); the remainder were values lists. Almost all laboratories provided notification
governmental (5.5% federal and 18.4 nonfederal). In rela- for a positive blood or cerebrospinal fluid culture. Table 3
tionship to size, 23.2% had fewer than 150 beds, 34.6% shows participants’ reporting practices for positive find-
had 151 to 300 beds, 21.7% had 301 to 450 beds, 11.0% ings for drugs of abuse and toxic levels for therapeutic
had 451 to 600 beds, and 9.5% had more than 600 beds. drugs. The majority (52.8%) of participants did not im-
The majority of participants (62.8%) were located in cities, mediately report all positive drugs of abuse results,
19.3% were suburban, 16.0% were rural, and 1.9% were whereas most (96.3%) immediately reported all toxic val-
classified as ‘‘other.’’ Occurrences of critical values ranged ues for therapeutic drugs.
from 1 in 120 to 1 in 957 tests, with more frequent values Of the methods used to report critical values, 99.2% re-
occurring in larger hospitals. ported they used telephone contact, 29.5% used a fax ma-
Table 1 shows participants’ low and high critical limits chine or similar transmission device, 10.0% used a com-
in terms of the number of institutions using various limits. puter report as the primary means, 42.2% used a computer
Also in this table is the distribution of values for each of report as a secondary means, and 6.9% used an answering
the low or high critical limits expressed as the 10th, 50th machine or voice mail system.
(median), and 90th percentile. The choice of the limit for Participants made a total of 275 872 critical value calls
either the 28 low or 28 high critical values was highly during the 30-day study period and recorded specific in-
variable, with no value being the same in 80% or more of formation on 12 930 (4.7%) calls. Table 4 shows that the
the laboratories. For some chemistry analytes, such as glu- mean time participants spent to complete a critical value
cose, potassium, sodium, and calcium, and for some he- call for inpatients was 6.1 minutes, whereas for outpatients
Arch Pathol Lab Med—Vol 126, June 2002 Laboratory Critical Values—Howanitz et al 665
Table 4. Time Spent to Complete or Abandon a Critical Value Call
Mean Time to Complete Call, min (No. of Participants) Mean Time to Abandon Call, min (No. of Participants)
Inpatient Inpatient
Outpatient, Outpatient,
No. of Beds Night Evening Day All Shifts Night Evening Day All Shifts
Unknown 6.8 (8) 12.6 (9) 6.9 (9) 16.5 (8) ... 5.0 (1) ... ...
0 ... ... ... 11.2 (2) ... ... ... ...
1–150 7.0 (110) 10.1 (127) 8.3 (136) 13.2 (123) 9.8 (4) 46.6 (8) 54.8 (9) 23.4 (14)
151–300 5.7 (190) 5.8 (196) 5.9 (203) 11.4 (185) 3.5 (8) 7.3 (8) 7.5 (8) 27.2 (26)
301–450 5.4 (124) 6.0 (128) 7.5 (131) 21.2 (123) 15.7 (4) 36.4 (5) 6.4 (4) 108.6 (15)
451–600 2.9 (63) 3.4 (65) 4.0 (66) 9.5 (60) 0.8 (1) 0.5 (1) 6.1 (3) 28.3 (3)
.600 3.1 (51) 4.7 (53) 3.3 (54) 9.3 (49) 15.0 (2) 13.3 (3) 0.0 (1) 34.2 (5)
All 5.3 (546) 6.5 (578) 6.4 (599) 13.7 (550) 8.5 (19) 25.3 (26) 23.9 (25) 46.3 (63)

Table 5. Personnel Involved in Critical Value Calls


Inpatients, No. (% of Total) Outpatients, No. (% of Total)
Reporting personnel
Person performing test 11 587 (91.0) 2308 (77.3)
Section supervisor 330 (2.6) 117 (3.9)
Laboratory clerk 718 (5.6) 515 (17.2)
Other management personnel 96 (0.8) 47 (1.6)
Receiving personnel
Registered nurse 4775 (37.8) 622 (21.2)
Any staff nurse 2307 (18.3) 393 (13.3)
Unit clerk/office staff 3985 (32.5) 1237 (42.1)
Medical student 21 (0.2) 3 (0.1)
Any physician on call 455 (3.6) 196 (6.7)
Physician ordering test 1090 (8.6) 490 (16.7)

Table 6. Repeat Critical Value Calls Table 7. Use of Critical Values as Indicated by Chart
Review and Physician Surveys
Policy Participants, %
5426 4237
No policy on how handled 71.4 Charts Physicians
Repeat values not called 11.6 Finding Reviewed Surveyed
Values not called on physician request 6.8
Seed physicians’ permission to not call 1.9 Critical value anticipated, % 54.3 59.3
Have preset policy on no. of calls 1.8 Critical value influenced
Seek physicians’ permission not to call therapy, % 64.9 62.9
after preset no. of values 0.3 Test reordered, % 66.3 43.3
Use another policy 6.1 Found in nursing or progress
notes, % 75.5 ...

it took 13.7 minutes to report a value. In contrast, on av-


erage, critical value calls were abandoned in 20.2 minutes institution) about recently reported values. A survey of
for inpatients and in 46.3 minutes for outpatients. The time physicians and review of the medical records found that
spent in reporting a critical value call was related to the the majority of critical values were expected. For those
shift, the bed size of the institution, and the patient’s status unanticipated critical values, both the majority of inter-
as an outpatient. views and review of the medical records indicated therapy
Table 5 describes the personnel involved in critical value was influenced by the result. Although a minority of phy-
calls. For inpatients, the call usually was made by the per- sicians contacted stated they reordered the test result
son performing the test (91.0%) to either a registered (43.3%), the majority (66.3%) of medical records contained
nurse (37.8%), a clerk (31.5%), or staff nurse (18.3%). In documentation that the test was reordered.
contrast, for outpatients the call was made by the person Table 8 shows hospital personnel’s perceptions of criti-
performing the test (77.3%) or a laboratory clerk (17.2%) cal values as surveyed by clinical laboratory personnel. An
to either a clerk (42.1%), a registered nurse (21.2%), or the average of 7.4 nursing stations and 6.8 physicians recently
physician ordering the test (16.7%). receiving a critical value report were queried. The majority
Participants’ policies on repeat critical values are shown of nursing personnel surveyed were not aware of the crit-
in Table 6. Most (71.4%) did not have a policy on repeat ical values list, did not think the list is a valid indicator of
critical values for the same analyte on the same patient, the patient’s condition, nor did they feel calls were helpful.
although in some institutions (11.6%), the policy was that In contrast, most physicians surveyed were aware of the
repeat values were not reported. critical values list, thought it was a valid indicator, and felt
Table 7 demonstrates results of 5426 chart reviews (8.7 calls were helpful.
per institution) and 4237 surveys of physicians (6.8 per Table 9 contains descriptions of the derivation of lab-
666 Arch Pathol Lab Med—Vol 126, June 2002 Laboratory Critical Values—Howanitz et al
Table 8. Perception of Critical Values
% Think List Is a % Feel Calls Are
Location* Respondents % Aware of List Valid Indicator Helpful
Emergency department 575 nursing supervisors 17.3 16.7 19.1
ICU/CCU 576 nursing supervisors 23.6 23.3 27.6
Medicine/surgery 576 nursing supervisors 33.5 33.4 40.8
Other station 574 nursing supervisors 16.0 16.2 20.6
Hospital 514 physicians 76.9 78.6 94.9
* ICU indicates intensive care unit; CCU, critical care unit.

Table 9. Source of Laboratory Critical Value Policy for microbiology. Almost all laboratories reported results
of a positive blood culture and had critical values lists for
Literature review only (includes manufacturer’s
therapeutic drugs, and most reported all toxic values;
help), % 18.60
Literature review and laboratory meetings however, the majority did not include drugs of abuse on
(includes manufacturer’s help), % 36.00 their lists. Perhaps one reason that so many laboratories
Literature review modified by hospital committees had similar practices for critical values for blood and ce-
(includes in-house studies), % 16.80 rebrospinal fluid cultures was that these results are qual-
Literature review modified by in-house studies itative values. In contrast, critical value limits differed
and medical staff consultations, % 72.70
among participants for hematology and chemistry because
these limits are quantitative. Although we did not ask par-
ticipants to list critical values used in their transfusion
oratory critical values policies. Most institutions based medicine laboratories, others have indicated that there are
their choices on data from several sources, including some tests that should be considered.4
manufacturers, hospital committees, and medical staff One of the ways of defining expert opinion is to ascer-
members. tain the practice patterns of the majority and use these
COMMENT patterns as the standard of practice. A number of critical
values lists have been published for a group of laborato-
We used the definition of critical (panic) values origi- ries, and there are major similarities among these lists.
nally described by Lundberg as ‘‘life-threatening unless Comparisons between the list we developed and the lists
something is done promptly and for which some correc- used for both adults and children as reported by Kost in-
tive action could be undertaken.’’2,3 We chose this defi- dicate our median values approximate those of Kost.9,10
nition because we thought that all participants would be Our list is the most complete to date, but will need to be
able to identify their institutional lists in these terms. updated as new tests are developed and added to critical
Even though all participants were able to provide the values lists. An example of the changing list of critical
required information about their critical values lists, it
values is that now almost all laboratories have toxic levels
was clear that most included critical limits for analytes
of therapeutic drugs on their critical values list. However,
that were not life-threatening or for which some correc-
when the critical values concept first was developed, ther-
tive action could not be undertaken. Many would argue
apeutic drug monitoring was not widespread, consequent-
that all 28 analytes listed in Table 1 would fulfill Lund-
ly very few laboratories had critical values for these drug
berg’s definition; however, among the list of the 65 other
analytes submitted were some that might be considered levels. Since the time this study was conducted, troponin
as not fulfilling this definition, such as mean corpuscular measurements have become widespread, and we predict
volume, urine crystals, haptoglobin, prealbumin, and li- that a number of laboratories already have added troponin
docaine. The use of critical limits for non–life-threatening to their critical values lists.
situations has led others to conclude that these lists Tate and Gardner21 found that fewer than 10% of critical
should be now be entitled ‘‘Vital Laboratory Values’’ or values were reported in their institution. They identified
‘‘Alert Values,’’ rather than critical values.5,8,20 Hortin and weaknesses in the reporting process as (1) critical values
Csako20 found that alert values frequently serve not to were not always reported by the clinical laboratory; (2)
alert clinicians of a medical emergency, but rather iden- when critical values were reported, it was often to someone
tify for laboratorians a valuable quality improvement op- not directly involved in the patient’s care; (3) documenta-
portunity. This distinction arises because a substantial tion of critical value reporting by the laboratory was incom-
proportion of critical values occur from preanalytic prob- plete; (4) clinicians’ awareness of critical values was not al-
lems or analytical interferences and offer opportunities ways documented; (5) clinicians’ decisions on corrective ac-
for improvement of processes or methodologies that re- tions were not documented adequately; and (6) the time
side within the clinical laboratory. interval between the availability of critical test results and
Our survey led to presentation of critical values in the the institution of corrective measures was sometimes un-
usual percentile ranking used in Q-Probes studies; such a acceptably long. Improvement in the reporting of critical
presentation can be used to provide guidance to labora- values requires that the process is well defined and widely
torians. By listing values in terms of the number of par- supported by users of laboratory services.
ticipants and critical limits medians, 10th, and 90th per- In our study, technologists performing the procedure
centile critical limits, interested laboratorians can compare made the critical value calls for inpatients in more than 90%
their own values with this list and adjust their values to of cases; for outpatients, the persons performing the proce-
be similar to the median, the most lenient, or the most dure still made most of the calls, although more than 17%
stringent policy. Laboratories also had critical values lists of calls were made by laboratory clerks. In most laboratories,
Arch Pathol Lab Med—Vol 126, June 2002 Laboratory Critical Values—Howanitz et al 667
personnel performing chemistry and hematology procedures a second critical value for the same analyte on the same
work in teams. We recommend that all critical values be re- patient should be handled have not been defined clearly in
ported by one of the team members performing the proce- most institutions. It is our belief that with the limited in-
dure, thereby providing the most direct system for the action. formation available to the technologist and the short period
Critical value policies require notification of the abnormal of time a technologist has to make a critical decision on a
result to someone who can take appropriate action, and in patient’s results, it is difficult to develop a policy that is
our study, a variety of personnel received these calls. For tailored uniquely to the suggestions or requirements of each
inpatients, registered nurses received almost 40% of the physician. Rather, a generic policy that covers all patients
calls, compared with the clerk or other office staff, who is what we favor, as it is easiest for technologists to imple-
received slightly more than 30%. For outpatients, office staff ment and causes no errors in judgment by the technologists.
and clerks received more than 40% of the calls, registered Such a policy should require that all values exceeding the
nurses slightly greater than 20%, and physicians 17%. Crit- critical value limits require notification of the appropriate
ical value calls are costly for laboratories in that extensive caregiver. For example, although nephrologists know their
time is required to handle reporting. For inpatients, these patients on dialysis have elevated serum urea nitrogen and
calls took an average of 6.1 minutes, whereas for outpa- creatinine values, it may be difficult for a technologist to
tients they took 13.7 minutes. One of the reasons outpatient ascertain that the elevated renal function results just veri-
calls took more time was that approximately 17% of out- fied are those of a patient on dialysis because of missing,
patient reports were received by physicians, and it took an incorrect, or hard-to-find demographic information. At the
average of 19 minutes to reach the physician on call. same time, we believe laboratories must develop policies
At what point do laboratorians give up on reaching a not to annoy physicians needlessly with values they know
person with notification of a critical value? We suspect that previously are elevated, and we suggest that only the first
this determination is related to many variables, including of a series of values within 24 hours should require notifi-
the availability of personnel who make these calls. For out- cation. Although we chose 24 hours for the first series of
patients, calls were abandoned, on average, after 46 min- values, others may feel more comfortable with a longer time
utes. This time expenditure was far longer than for inpa- frame, such as only the first of a series of values within 48
tients when the result occurred during the night shift (9 hours as requiring notification.
minutes), the evening shift (25 minutes), or the day shift Laboratory productivity has increased remarkably dur-
(24 minutes). For some outpatients, laboratorians tried to ing the past 30 years because of the use of automated
reach an appropriate physician for almost 2 hours. Unfor- equipment. The primary means of critical value notifica-
tunately, a small percentage of calls (5.4%) were aban- tion in most institutions is the use of telephone calls to the
doned. However, from our own practices we have realized physician and nursing personnel responsible for the pa-
the futility of continuing to try to find someone for an tient’s care. The use of electronic devices automatically di-
extended period of time to assume responsibility for the aling the physician’s beeper offers opportunities to reduce
critical value, even when time may be important in treat- laboratorians’ time on the telephone with clinicians, and
ing a patient who has a potentially lethal condition. at the same time improves the likelihood that the physi-
It is unfortunate that any calls are abandoned; hence, cian or another person charged with the patient’s care re-
we recommend that a fail-safe mechanism be implement- ceived the result. Some instruments have been introduced
ed to assure that all life-threatening values are fully eval- that provide automatic notification of preprogrammed
uated, and if in fact critical, then proper care can be start- critical value results,22,23 and others have discussed the po-
ed for patients. The following policy was established with tential value of laboratory information systems automati-
great success in the laboratories of one of the authors, and cally delivering results to physician pagers.12 Automated
we recommend it as simple, effective, and practical. If no e-mails or faxes to physicians require other newer tech-
one can be found by the laboratory personnel to accept nologies that can be used, although mechanisms are es-
the critical value after a short period of time, then a phy- sential to assure receipt of this notification.
sician representing the laboratory should determine the Laboratorians generally believe critical values lists are
significance of the result and determine whether further important and have worked with others to help design
effort is required. When further evaluation of the patient the lists. The perceived lack of importance of a critical
is needed, we believe it should be performed by a physi- value list to nursing supervisors was surprising. Not only
cian able to provide immediate care for the patient. In our were most of these supervisors in the emergency de-
experience, this procedure works best if the patient’s avail- partment, intensive care unit, and other nursing units
able medical record is brought to the physicians in the unaware of the critical values lists, they did not think
emergency department, who, after receiving the patient’s they were a valid indicator of the patients’ conditions and
available record, may contact the patient and discuss the reported they did not think the calls were helpful. In
results with the patient. If the patient requires immediate contrast, the overwhelming majority of physicians sur-
attention, it can be provided either as a patient in the veyed were aware of the lists, thought they were a valid
emergency department or as an inpatient. If the patient indicator, and almost all thought the calls were helpful.
cannot be reached by telephone, we have found that local Perhaps the supervising nurses in their administrative
police are responsive to requests to hand-carry a notice role had become out of touch with the medical care that
with the desired actions that should occur to the patient’s was being provided by their staff and physicians. Anoth-
residence. Of course, such a policy requires agreement of er interpretation of these findings is that physicians usu-
the medical staff, as well as the review of each occurrence ally see their hospitalized patients only once or twice a
when a physician cannot be reached as part of the labo- day and are further removed from emergency care than
ratory’s and institution’s quality improvement program. the nurses. Nurses are communicating among themselves
Although critical values lists are widespread and similar a number of times during the day about the patients and
among institutions, our data indicate that policies on how the patients’ critical values, hence these critical value re-
668 Arch Pathol Lab Med—Vol 126, June 2002 Laboratory Critical Values—Howanitz et al
sults represent less concerning information. However, References
1. Howanitz JH, Howanitz PJ. Laboratory results: timeliness as a quality attri-
these discrepancies suggest that laboratorians must dis- bute and strategy. Am J Clin Pathol. 2001;116:311–315.
cuss with nursing staff the value of critical limits, as a 2. Lundberg GD. When to panic over abnormal values. Med Lab Observer.
better understanding of the value of these calls should 1972;4:47–54.
3. Lundberg GD. Managing the Patient-Focused Laboratory. Oradell, NJ: Med-
reduce the time required to give the critical value report ical Economics Books; 1975.
to someone on the nursing stations. 4. Murphy J, Henry JB. Effective utilization of clinical laboratories. Hum Pathol.
1978;9:625–633.
The frequency of critical values of our participants var- 5. Lundberg GD. Critical (panic) value notification: an established laboratory
ied between 1 in 120 and 1 in 957 tests, well within the practice policy (parameter). JAMA. 1990;263:709.
range found by others of between 1 in 100 and 1 in 2000 6. Clinical Laboratory Improvement Amendments of 1988: final rule (42 CFR
Part 405, et al), 57 Federal Register 7001–7186 (1992).
tests.2,9 If one chooses the average time our participants 7. Rabinovitch A. The College of American Pathologists (CAP) Laboratory Ac-
used for notification, and a frequency of panic values of 1 creditation Checklists. Northfield, Ill: College of American Pathologists; 2000.
in 1000 tests, then in a large hospital laboratory that per- 8. Hobbs GA, Jortani SA, Valdes R. Implementation of a successful on-call
system in clinical chemistry. Clin Chem. 1997;108:556–563.
forms 5 million tests, slightly less than one full-time 9. Kost GJ. Critical limits for urgent clinician notification at US medical cen-
equivalent would be required for notification of critical ters. JAMA. 1990;263:704–707.
10. Kost GJ. Critical limits for emergency clinician notification at US children’s
values. Although this may not seem like a large resource hospitals. Pediatrics. 1991;88:597–603.
requirement for a large hospital laboratory, in a small lab- 11. Lum G. Critical limits (alert values) for physician notification: universal or
oratory where only 1 technologist may be working during medical center specific limits? Ann Clin Lab Sci. 1998;28:261–271.
12. Emancipator K. Critical values: ASCP practice parameter. Am J Clin Pathol.
some shifts, reporting a critical value may delay the re- 1997;108:147–153.
porting of other results. In 1996, the laboratory testing 13. Lum G. Evaluation of a laboratory critical limit (alert value) policy for
hypercalcemia. Arch Pathol Lab Med. 1996;120:633–636.
volume was estimated to be approximately 7.25 million 14. Kost GJ. The challenges of ionized calcium cardiovascular management
tests; when expressed in terms of the cost of laboratory and critical limits. Arch Pathol Lab Med. 1987;111:932–934.
testing in the United States, the cost of critical values sys- 15. Kost GJ, Jammal MA, Ward RE, Safwat AM. Monitoring of ionized calcium
during human hepatic transplantation: critical values and their relevance to car-
tems seems large.24 diac and hemodynamic management. Am J Clin Pathol. 1986;86:61–70.
Patient outcomes data collected in this study demon- 16. Bigger JT Jr. Diuretic therapy, hypertension, and cardiac arrest. N Engl J
strated that about 65% of critical values influenced thera- Med. 1994;330:1899–1900.
17. Wong KC, Schafer PG, Schultz JR. Hypokalemia and anesthetic implica-
py, the test was reordered 66% of the time when a critical tions. Anesth Analg. 1993;77:1238–1260.
value occurred, and physicians documented these results 18. Bissell MG. Laboratory-Related Measures of Patient Outcomes: An Intro-
duction. Washington, DC: AACC Press; 2000.
in the patients’ medical record 66% of the time. We know 19. Howanitz PJ. Quality assurance measurements in departments of pathol-
of no previous studies of the effects of critical values on ogy and laboratory medicine. Arch Pathol Lab Med. 1990;114:112–115.
patient care. Because critical values occur in every hospital 20. Hortin GL, Csako G. Critical values, panic values or alert values? [letter].
Am J Clin Pathol. 1990;109:496–497.
and are found in high frequency, we would recommend 21. Tate KE, Gardner RM. Computers, quality and the clinical laboratory:
that those interested in patient outcomes consider docu- a look at critical value reporting. Ann Symp Comp Appl Med Care. 1993;
193–197.
menting the value of this system in their institutions. 22. Catrou PG. How critical are critical values? Am J Clin Pathol. 1997;108:
Our study was based on critical values originating from 245–246.
the central laboratory, but with the recent trend to decen- 23. Shabot MM, LoBue M, Leyerle BJ, Dublin SB. Decision support alerts
for clinical laboratory and blood gas data. Int Clin Monitor Comput. 1990;
tralize these laboratories to point-of-care testing, consid- 27–31.
erations should be developed on how critical values 24. Steindel SJ, Rauch WJ, Simon MK, Handsfield J. National Inventory of
should be handled at these remote sites. In our own ex- Clinical Laboratory Testing Services (NICLTS): development and test distribution
for 1996. Arch Pathol Lab Med. 2000;124:1201–1208.
periences, the policies and procedures that have been es-
tablished for the central laboratory should be extended to
testing at these sites, with the required action included in Conversion From SI Units to Conventional Units
the procedure. In some situations, protocols and proce- Conversion
dures undoubtedly have been developed for such analytes Factor Conventional
as glucose, for which physicians traditionally document Analyte SI Unit (Divide by) Unit
the required responses for nurses to a variety of glucose Ammonia mmol/L 0.714 mg/dL
levels. In other cases, these values may cause problems, in Bilirubin mmol/L 17.1 mg/dL
that they may be unexpected and algorithms have not yet Calcium, ionized mmol/L 0.25 mg/dL
been developed for markedly elevated or low values for a Calcium, total mmol/L 0.25 mg/dL
Carbon dioxide mmol/L 1.0 mEq/L
specific analyte, such as calcium. Chloride mmol/L 1.0 mEq/L
In conclusion, critical values lists are widely used and Creatinine mmol/L 88.4 mg/dL
are medically important, but they also are widely vari- Fibrinogen mmol/L 29.41 g/dL
able in their content and use. Laboratorians must develop Glucose,
practices that ensure that each result is transmitted to cerebrospinal fluid mmol/L 0.05551 mg/dL
Glucose, serum mmol/L 0.05551 mg/dL
appropriate caregivers rapidly and effectively, so that Hemoglobin g/L 10.0 g/dL
quality patient care can be rendered. Medical and nurs- Lactic acid mmol/L 0.1110 mg/dL
ing staffs should be involved effectively in developing Magnesium mmol/L 0.4114 mg/dL
the laboratory’s critical value policy, as well as in partic- Phosphorus mmol/L 0.3229 mg/dL
ipating and investigating appropriate automation. A ma- Platelet count 3109/L 1.0 3103/mL
Potassium mmol/L 1.0 mEq/L
jor reduction in the time spent in critical values notifi- Sodium mmol/L 1.0 mEq/L
cation may not occur until automated systems are better Urea nitrogen mmol/L 0.357 mg/dL
used and a better understanding of the importance of the Uric acid mmol/L 0.0595 mg/dL
critical value policy is achieved among those whose ac- White blood cell
count 310 9/L 0.001 /mL
tions have an impact on patient care.
Arch Pathol Lab Med—Vol 126, June 2002 Laboratory Critical Values—Howanitz et al 669

You might also like