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Tool: Booklet on DEVELOPMENT OF LIST OF CRITICAL TESTS AND

PROCEDURES FOR LABORATORY. Delphi Survey. Round One.

Technical Report · January 2007

DOI: 10.13140/2.1.1611.6480

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 A PROJECT UNDER THE LETTER OF INTENT
FOR IMPROVING PATIENT SAFETY

Booklet on
DEVELOPMENT OF LIST OF
CRITICAL TESTS
AND PROCEDURES
FOR LABORATORY

Delphi Survey

Round One

To assure confidentiality, security and the integrity of the survey,

please provide your e-mail address or alternative contact details:

E-mail Address:____________________________________________________________
(preferred)

OR

Alternative contact details: __________________________________________________

Contents
section page
HOW TO USE THIS BOOKLET 4
INTRODUCTION 5
1 Demographics & definitions 7
2 LIST OF QUANTITAtiVE TESTS & CRITICAL VALUES
2.1 Chemical Pathology (Adults) 10
2.2 Haematology (Adults) 18
2.3 Chemical Pathology (Paediatrics) 20
2.4 Haematology (Paediatrics) 22
3 LIST OF QUAlitative TESTS 24
3.1 Haematology 24
3.2 Microbiology 25
3.3 Anatomical Pathology 26
4 ENQUIRies RELATing TO CRITICAL VALUE TABLES OF 27
QUANTITATIVE AND QUALITATIVE TESTS
5 PROCEDURE OF CRITICAL RESULT NOTIFICation 28
5.1 General Procedure of Critical Result Notification 28
5.2 Chemical Pathology and Haematology Tests 29
5.2.1 Step 1: Identification & Confirmation of 29
the Critical Value for Chemical Pathology
and Haematology Tests
5.2.2 Step 2: The Procedure of Notification by 30
Laboratory for Chemical Pathology and
Haematology Tests
5.3 Microbiology and Anatomical Pathology Tests 31
5.3.1 STEP 1: Identification & Confirmation of 31
the Critical Value for Microbiology and
Anatomical Pathology Tests
5.3.2 STEP 2: Procedure of Notification 31
by Laboratory for Microbiology and
Anatomical Pathology Tests
5.4 Receiving of Critical Result Notification 32
5.4.1 STEP 3: The Process of Receiving Critical 32
Result Notification by Ward / Clinic
6 List of references 33
7 OVERALL COMMENTS 35
8 contributors 35

~~
How To Use This Booklet

C ritical values have been used to decide when to notify physicians and other care givers of
potentially life-threatening situations. In order to strengthen the policy and procedure this study
aims to obtain consensus:
1) Laboratory tests to be included in the critical /panic value list and to identify
critical/panic values results for immediate notification,
2) The procedures and processes required for notification of critical/panic
values (for the laboratory and in the ward)
We are applying the Delphi Technique1 here to obtain the opinion of experts without necessarily bringing
experts together face to face. A second round will be mailed out for final consensus. The introduction
section explains further details of the development of this list, its aims and goals.
We appreciate if you would do the following:
1) Please complete the Demographics and Definitions questions (in Section 1).
2) Please review the preliminary suggested values and complete the blue boxes (in Section 2 and Section
3).
3) Please review all the tests listed and assess for missing areas/tests (in Section 4).
4) Please critique the procedures and processes we have outlined (in Section 5) for improvement.
5) Please provide us with additional references if you have any (in Section 6).
6) Please provide any additional feedback, for improvement, if any (in Section 7).
7) Please ensure that you have filled in your email or alternative contact details on the front cover for
round one of Delphi Survey.
8) Please mail back this booklet and the questionnaire to us at:
Patient Safety – Laboratory Critical Values Project
Institute for Health Systems Research
Ministry of Health Malaysia
Jalan Rumah Sakit Bangsar
59000 Kuala Lumpur
For queries, please contact the research team at
email: patologi@hkl.gov.my or sararaks.s@ihsr.gov.my or
Tel: Dr Lily Manoramah / Pn. Noor Aishah 03-26155555 ext 5634,
Dr. Tengku Norita 03-61201039 ext 4055
After this round of the Delphi Technique, the research team will compile and edit the comments and
suggestions into a summary and use this for the second round of the Delphi Technique for the Development
of List of Critical Test and Procedures for Laboratory.

Thank you for your valuable time.

From the Research Team:
Lily Manoramah (Principal Investigator) 1 , Noor Aishah Mohd Dawi 1, Tengku Norita Tengku Yazid 2,
Sondi Sararaks 3, Maimunah A. Hamid 3, Low Lee Lan 3 and Habibah Bee1
1 Kuala Lumpur Hospital, 2 Selayang Hospital and 3 Institute for Health Systems Research

1. Brown B.B. 1968. Delphi Process: A Methodology Used for The Elicitation of Opinions of Experts. Rand Document. No. P-3925.

~~
Introduction
What is a Critical Value?
Thirty years ago, George Lundberg, MD (Journal of
American Medical Association) defined a critical value
as a result indicating that the patient is in imminent
danger unless appropriate therapy is promptly
initiated.
Since Lundberg’s observations, the concept of defining
critical values and systems for reporting have been
adopted widely by laboratories throughout the world.
Why do we need Critical Values?
Reporting of laboratory critical results is a crucial
responsibility of the laboratory and is an important
laboratory outcome measurement because it reflects
operational effectiveness that affects patient safety.
The concept of critical values, defined as an imminent
life threatening laboratory result requiring immediate
physician notification has been widely adopted as a
standard of good laboratory practice.
The recent international and national focus on patient
safety has brought increased attention to the issue of
laboratory critical value reporting. For example, the Joint
Commission of Accreditation of Hospital Organization
(JCAHO) requires health care organizations to track
and improve the timeliness of reporting and receipt of
critical test results.
A study on the “Evaluation of Serum and Whole Blood
Sodium Critical Values by Joan H. Howanitz, MD; Peter
J. Howanitz, M .Am J Clin Pathol. 2007; 127(1):56-59.
American Society for Clinical Pathology found that:
• In hypernatremic and hyponatremic patients, the
lengths of stay were increased above of the 5-day
average,
• Clinicians responded to more than 50% of results
within 4 hours.
• The mortality rates of hyponatremic and
hypernatremic inpatients were 19% and 48%,
respectively.
What is our clinical and laboratory
current practice?
In order to establish diagnosis, treatment and prognosis,
clinicians often require laboratory investigation results
to support their clinical management. They either made
routine test requests or ask for urgent /STAT test
requests, by labeling the latter requests as “urgent”
and sending it immediately to the laboratory.
~~
The turnaround time for issuance of the test result for
routine test requests is based on the laboratory work
processes. However for the Urgent or STAT request, a
system is triggered to ensure that all such requests are
processed as soon as possible and the results are notified
to the responsible physicians, irrespective of whether
they normal or abnormal. For a quantitative test, the
normal or abnormal test results are usually interpreted
based on their relation to a reference range, defined
for each test based on the procedure used in each
laboratory.
Malaysian data is not available to assess the current
practices in clinical laboratories in terms of availability
of lists of tests with critical “panic” values. An attempt
to understand the current practices on immediate
notification of critical/panic values was conducted in
all 126 laboratories of the Ministry of Health hospitals
in July – August 2007. The results of the survey showed
that:
1) Only half of laboratories surveyed had a list what
they termed as critical tests.
2) Confusion exists over the definition of “critical
results”, “critical test” and “STAT” test. Many of the
laboratories in the survey assumed that the term
“stat test” equals “critical test”.
3) Justification for inclusion of tests in the critical test
list was not clear.
4) There was significant variation in the critical limits
reported by hospitals. In addition, some laboratories
did not report any critical limits; quoting instead
reference ranges.
What have we done so far?
An extensive literature search exercise was carried out
to identify what are the published critical tests, critical
values and crucial differences in critical limits for the
various tests in Haematology, Chemical Pathology,
Microbiology and Anatomical Pathology used by other
countries. The literature findings were tabled and
deliberated at several meetings involving laboratory
personnel and clinicians from various disciplines.
The following consensus on definition of terms was
reached:
CRITICAL VALUES: Test results that fall outside the
low or high of critical limits; or the presence of any
unexpected abnormal findings, cells or organisms that
may potentially cause life threatening emergencies;
and/or requires immediate medical attention. Please
note that these values may be identified from routine or
urgent test requests.
Introduction (continued)

CRITICAL LIMITS: Boundaries of the low and high life How can you be a partner in developing
threatening values of a quantitative laboratory test a national list of critical/panic values for
result. laboratory?

CRITICAL  TESTS:  Tests  that  require  prompt We welcome your contribution to complete the
communication of results to the clinicians when the test following work process for the development of a
results exceed the critical limits (for quantitative tests), national list of critical/panic values.
or the presence of any unexpected abnormal findings,
cells or organisms (for qualitative tests), that have been
Search for literature on
identified to have a potential imminent danger to the Research team
critical values/tests etc
Carried out in 2007

patient unless appropriate treatments are initiated ↓

Laboratory Documentation &
immediately. This includes selected Microbiology tests representatives Recommendations Carried out in October 2007
for which prompt communication of the results is team for this meeting
↓
required, even if results are normal. Meeting of
Laboratory
Preliminary opinion &
representatives Carried out in November 2007
To elaborate the above concept on a quantitative test, with clinician
Recommendations

an example is given below for Critical Test on Sodium representatives

Lower Limit
Value: <135 mmol/L
Clinical Indication: Hyponatremia
Lower Critical Limit
Clinical Indication:
Value = 120 MEq/L (120 mmol/L)
Potential harm to cause
cerebral œdema
Value ≤ 115MEq/L (115 mmol/L)
or rapid reduction in serum
levels may lead to
coma or death
Acceptable CRITICAL 120 135
VALUE (for lower limit) =
120 MEq/L (120 mmol/L)
↓
Delphi Technique
Normal – 2 rounds (to
Higher limit
Value be circulated
Your significant contributions
Value: >145 mmol/L to all Head of Feedback from
are greatly appreciated in
Clinical Indication: Hypernatremia Departments, stakeholders/experts
these 2 stages.
both in clinical
Higher Critical Limit & laboratory
135 -145 Clinical Indication: settings)
mmol/L Value ≥158 to 160 MEq/L ↓
(158-160 mmol/L) Potential harm to Summary of results of
cause anorexia, muscle weakness, Research team
Delphi technique
nausea and vomiting, lethargy, ↓
Test: stupor and coma.
Sodium Consensus Consensus List of Tests
Meeting & Values (version 1)
Value ≥160 MEq/L
(160 mmol/L) Associated with
75% mortality in adults
How can you help?
145 160 Acceptable CRITICAL
mmol/L mmol/L VALUE (for higher Limit) =
160 MEq/L (160 mmol/L)
To list what exactly and clearly what should be done.

Based on the above consensus we have compiled Conclusion

and enclosed in the proceeding pages of this report a
preliminary list of quantitative tests and critical values
for chemical pathology and heamatology (for adults and
pediatrics) AND a list of qualitative tests for hematology,
microbiology and anatomical pathology.
The critical tests and their critical values are useless,
unless they are used effectively in patient management.
Thus, the importance of creating a procedure to
support effective use of the results. We have developed
flowcharts for the notification processes to take place
at the laboratory and ward levels and your feedback
on the practicality and applicability of the proposed
procedures is extremely useful.
The concept of critical (panic) values, defined as an
imminent life threatening laboratory test results
requiring immediate physician notification has been
widely adopted as a standard of good laboratory
practice. This is a preliminary effort to develop a national
list of critical tests and reporting procedure that we
hope to have the following characteristics:
- feasible and practical to be used in any MOH
laboratory setting
- a reporting procedure with a higher likelihood to
be successful given the current environment and
workload
- in-build continual improvement, beginning with
Version 1 of the Consensus List.
- Ownership by all involved in using the critical
values.

~~
Demographics & Definitions
A. PARTICIPANT DEMOGRAPHICS

A1 Age (in completed years) _____________ years

A2 Gender Female Male

A3 If you are a health care professional, what are your primary area of healthcare activities?
Physiotherapy
Anaesthesia Diagnostic Services Microbiology
(Physical Therapy)
Administrative
Emergency Medicine Neonatology Plastic surgery
Services

Allied Health Endocrinology Nephrology/Renal Podiatry

Anatomical
Gastroenterology Neurology Primary Care
Pathology

Dietetics General Medicine Neurosurgery Psychiatry

Breast surgery General Nursing Obstetrics Public Health

Cardiothoracic
Genetics Opthalmology Rehabilitation
Surgery

Cardiology Gynaecology Orthopaedics Radiation Oncology

Care of the elderly

Haematology Otolaryngology Rheumatology
(Geriatrics)
Speech & Language
Chemical Pathology Infectious diseases Pain services
Therapy
Clinical Immunology Thoracic/Respiratory
Intensive care Palliative Medicine
& Allergy Medicine
Dental Medicine and Maxillo-facial
Paediatrics Vascular Surgery
Surgery Surgery

Dermatology Medical Oncology Pharmacy Urology

Other (please specify):

A4 Name of Hospital: _ _______________________________________________________________________

A5 Designation:
Consultant/Specialist Medical Officer Scientific Officer

Other (please specify):

A6 Department: _ ___________________________________________________________________________

~~ Section 1
B. DEFINITIONS

We are interested in determining whether the terms and definitions for each of the classes contained within the
Conceptual Framework are clear, precise and provide an accurate representation of the nature, properties, scope
and essential qualities of the concept.

Please review the terms and associated definitions for clarity (including precision and accuracy).

B1 “CRITICAL TEST: Test that require rapid communication of results when it exceeds the critical limits that
have been set that may cause imminent danger to the patient unless appropriate treatments are initiated
promptly. This includes selected Microbiology tests for which rapid communication of the results is required,
even if results are normal.”

B1.1 Is the definition for Critical Test clear? Clear Unclear

If you answered “Unclear”, please state which aspect you do not understand:

B1.2 Please provide an explanation for why you find the term to be unclear:

B1.3 Please provide an alternative term or definition, the relevant reference(s) to the sources and your
rationale for including the alternative term/definition instead of that provided:

B2 “CRITICAL LIMITS: Boundaries of the low and high life threatening values of laboratory test results.”

B2.1 Is the definition for Critical Limit clear? Clear Unclear

If you answered “Unclear”, please state which aspect you do not understand:

Section 1 ~~
 B2.2 Please provide an explanation for why you find the term to be unclear:

B2.3 Please provide an alternative term or definition, the relevant reference(s) to the sources and your
rationale for including the alternative term/definition instead of that provided.

B3 “CRITICAL VALUE: Test result that falls outside the low and high of critical limits or the presence of any
unexpected abnormal findings, cells or organisms which may potentially cause life threatening emergencies,
and/or requires immediate medical attention.”

B3.1 Is the definition for Critical Value clear? Clear Unclear

If you answered “Unclear”, please state which aspect you do not understand:

B3.2 Please provide an explanation for why you find the term to be unclear:

B3.3 Please provide an alternative term or definition, the relevant reference(s) to the sources and your
rationale for including the alternative term/definition instead of that provided

~~ Section 1
LIST OF QUANTITATiVE TESTS AND CRITICAL VALUES
Table 2.1: Chemical Pathology (aDULTS)
Please review the preliminary suggested values and complete the blue boxes.

Lower Critical Limit

Your agreement
No Test Preliminary (please  in the box)
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
5,13,18,23,24,
2.5
44,54,55
2.7 29

7,9,1416,26,31, Probability of
2.8
32,42, 43,46,51 Ventricular
Potassium
1 cardiatachy is 2.8 mmol/L
(mmol/L)
2.9 21 0.7 at 2.5 at 3.0
is 0.6 (57)
7,9,14,16,26,31,
3.0
32,42, 43,46,51

115 5,30
119 23
7,9,13,14,16,21,
24,25,29,26,28,
120
31,32,41,42,43,
44,46,54 Severe
121 51 hyponatremia
2 Sodium (mmol/L) link to cerebral <125 mmol/L
124 18,55
oedema, coma &
125 22,27,52 death (41)

130 8

mmol/L mg/dL
7,9,18,13,22,23,
2.2 40
28,29,43,54
2.4 23 8
7,9,18,13,22,23,
2.5 45
28(O),29, 43,54
2.6 46 14,26,31,51
21,25,10,28,
2.8 50 2.8 mmol/L,
42,44,46,55
3 Glucose 3.3 60 25 50
mg/dL

mmol/L mg/dL MEq/L Hypocalcaemia-

1.48 5.9 2.96 23 frequently occur
7,9,18,21,22,29, in critically
1.50 6.0 3.0 ill, causes
42,46,54,55
hypotension, 1.5
1.53 6.1 3.06 25 heart failure mmol/L,
1.62 6.48 3.24 51 (40), mortality of 6.0
4 Calcium
hypocalcaemic mg/dL,
1.63 6.5 3.26 16,27,40,43
significantly 3.0
1.65 6.6 3.3 26, 31 greater than MEq/L
normo-calcaemic
1.75 7.0 3.5 13,24,28
Hypocalcaemic
1.80 7.2 3.6 52 can lead to
2.15 8.6 4.3 8 tetany and death

Section 2 ~ 10 ~
 Upper Critical Limit
Your agreement
Preliminary (please  in the box) Comments
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree

5.8 30

5.9 21
5,13,22,23,16,
6.0 24,25,2752, Hyperkalaemia
43,54 Conduction 6.0
7,9,14,26,31, block & asystole mmol/L
6.2
32,42 (57)

6.4 51

6.5 18,25, 28,44,55

8.0 18,25, 28,44,55
145 8
150 30 Hypernatremia
may lead to
stupor and
152 24 coma, serious
complication
155 41,52 occurs when
>155
reach 160,
156 18,31,51,55 mmol/L
assoc. With
158 26,32 longer LOS and
5,7,9,13,16, higher mortality
160 21,22,27,29,28, (56% 0f pt with
42,4,44,54 range 155-159
161 23 died. (41)
165 25
mmol/L mg/dL

16.7 300 55

19.4 350 23

19.5 351 18

20 360 52

22.2 400 21,22,25,10 20

mmol/L,
24.7 445 51 360
24.75 446 7,9 mg/dL
25 450 27
26.7 484 8,26
26.9 485 14,26
13,24,25(I),28,
27.7 500
42,43,44,54
27.8 501 1,16
38.9 700 29
mmol/L mg/dL MEq/L
2.62 10.48 5.24 8
18,22,28,40,
3.0 12.0 6.0
42,52
3.0
3.17 12.68 6.34 51 mmol/L,
3.22 12.9 6.44 25,26,32 12.0
13,21,24,27, mg/dL,
3.25 13.0 6.5
29,44 6.0
3.27 13.1 6.54 23 MEq/L
3.5 14.0 7.0 16,43,54,55
3.53 14.1 7.06 16
Table 2.1: Chemical Pathology (aDULTS) – continuation
Please review the preliminary suggested values and complete the blue boxes.

Lower Critical Limit

Your agreement
No Test Preliminary (please  in the box)
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
mmol/L mg/dL MEq/L
0.75 3.00 1.50 42,54,55
0.78 3.12 1.56 24,29 Not to be
5 Calcium (ionized) 0.80 3.20 1.60 27,16 included in
0.82 3.24 1.64 31 critical list
0.85 3.40 1.70 22
0.88 3.50 1.75 10
mmol/L mg/dL MEq/L
0.30 0.73 0.60 52
0.37 0.90 0.74 18,23
1,10,21,22,25,
0.41 1.00 0.82 26,27,28,32,42,
46,1,7,26
0.45 1.10 0.90 51
0.49 1.20 0.98 24
0.50 1.22 1.0 16,43,55
0.57 1.40 1.14 9
0.41
mmol/L,
1.00
6 Magnesium
mg/dL,
0.82
MEq/L

µmol/L mg/dL
0.30 0.9 52
0.32 1.0 24,18,29,46
0.35 1.1 16,43 0.32
To look for
µmol/L,
7 Phosphate 0.36 1.1 16 evidence for
1.0
0.39 1.2 31 justification
mg/dL
0.42 1.3 21,31, 51
0.48 1.5 44
0.65 2.0 55
µmol/L µmol/L
4.4 9 No preliminary
8 Ammonia value. Need
expert opinion.

No preliminary
9 Lactate value. Need
expert opinion.

7.1 16,43
28,1,10,22,29,
7.2 9,31,27,42,
10 pH 7.2
44,55

7.21 26,31

Section 2 ~ 12 ~
 Upper Critical Limit
Your agreement
Preliminary (please  in the box) Comments
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
mmol/L mg/dL MEq/L
1.5 6.0 3.0 10
1.54 6.16 3.08 16 Not to be
1.55 6.2 3.1 31,54,22 included in
1.57 6.28 3.14 29 critical list
1.58 6.32 3.16 24
1.6 6.4 3.2 27,42
mmol/L mg/dL MEq/L
1.23 3.00 2.46 28
1.27 3.10 2.54 18

1.43 3.50 2.46 27

1.64 4.00 3.29 10

1.72 4.20 3.44 24
1.77 4.30 3.54 51
1.80 4.40 3.61 22
1.85 4.50 3.70 25 2.0
1.91 4.64 3.82 7 mmol/L,
1.93 4.70 3.86 42 4.86
mg/dL,
2.0 4.86 4.0 1
4.0
2.01 4.89 4.02 1,26,32 MEq/L
2.02 4.91 4.04 26
2.05 5.0 4.10 10,23,28
2.09 5.10 4.19 18
2.45 5.96 4.90 16,43
2.50 6.08 5.00 9
2.75 6.69 5.50 55
3.04 7.40 6.08 26
3.08 7.50 6.16 21
3.28 8.0 6.57 29
4.11 10.0 8.22 22
µmol/L mg/dL
2.58 8.0 18
2.87 8.9 31,51
3.23 10 55 2.87
µmol/L,
4.20 13 26,31
8.9
mg/dL

mmol/L µmol/L mg/L

44 44 74 9 No preliminary
value. Need
59 59 100 1 expert opinion.
109 109 185 51
mmol/L mg/L
3.4 30.6 26,31 5.0
mmol/L,
4.1 36.9 31
45
5.0 45 1,28,55 mg/L
68 612 31
7.55 28,22

7.59 16, 26,31,43

7.55

1,10,29,9,27,
7.60
42,55
Table 2.1: Chemical Pathology (aDULTS) – continuation
Please review the preliminary suggested values and complete the blue boxes.

Lower Critical Limit

Your agreement
No Test Preliminary (please  in the box)
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
mmHg kPa
40 5.2 29,43,55
40.7 5.3 9 <60,
43 5.6 1,26 mmHg,
11 pO2
43.8 5.7 26 <7.8
45 5.8 22 kPa
50 6.5 28,27,44
60 7.8 10
mmHg kPa MEq/L
15 1.95 10 55
16 2.08 26 dropped during
12 pCO2 November
19 2.47 1 2007 meeting
20 2.60 29,28,22,43,44
60 7.8 9
mOsmol mmol
/kg /kg 250
250 250 22,24,26 mOsmol/kg,
13 Serum Osmolality
253 253 51 250
mmol/kg

mg/dL mmol/L
20 1.11 24
30 1.67 22
30.6 1.7 51,31 dropped during
14 CSF-Glucose November
31 1.72 55 2007 meeting
37 2.05 31
37.8 2.10 31,26
40 2.2 16,42
CSF-Prot
15
(mg/dL)

Lithium
16
(mmol/L)

Digoxin
17
(ng/mL)

Phenytoin
18
(ug/mL)

Pheno-barbitone
19
(ug/mL)

Carba-mazepin
20
(ug/mL)

Section 2 ~ 14 ~
 Upper Critical Limit
Your agreement
Preliminary (please  in the box) Comments
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
mmHg kPa
71 9.3 3
111 14.8 9
dropped during
November
2007 meeting

mmHg kPa
60 8.0 28 70
65 8.6 27,22 mmHg,
67 8.9 1,26 9.3
70 9.3 29,43,55 kPa

mOsmol mmol
/kg /kg 325
318 318 51 mOsmol/kg,
325 325 22 325
326 326 26 mmol/kg
350 350 24
mg/dL mmol/L
300 16.7 22
438 24.3 31,26
dropped during
November
2007 meeting

dropped during
150 55 November
2007 meeting
1.4 46
1.5
1.5 52,21,44,54
mmol/L
2.0 22,24,23
2.0 19,22,28(I),1,54
2.1 46 need to
discuss
18,21,43,28(O), further with
2.5
42,44 pharmacist
3.0 24
20 21
22 22 need to
25 28 discuss
18,24,42,52,44, further with
30 pharmacist
43,54,55
40 46
40 44
45 18,22 need to
50 21,28 discuss
55 23 further with
60 24,42, 46,54,55 pharmacist
70 43
10.1 18
12 21, 46 need to
14 24 discuss
15 28,22,44,54 further with
18 42 pharmacist
20 52,44,55
Table 2.1: Chemical Pathology (aDULTS) – continuation
Please review the preliminary suggested values and complete the blue boxes.

Lower Critical Limit

Your agreement
No Test Preliminary (please  in the box)
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree

Valproic Acid
21
(ug/mL)

Theophyline
22
(ug/dL)

Vancomycin
23 (peak)
(ug/mL)

Gentamycin
24 (peak)
(ug/mL)

Tobramycin
25 (peak)
(ug/mL)

26 Acetame-nophen

27 Salicylate

28 CK

29 CKMB

30 Troponin I

Troponin T
31
(ug/L)

32 Uric Acid

TSH
33
(mIU/L)

34 FT4

Section 2 ~ 16 ~
 Upper Critical Limit
Your agreement
Preliminary (please  in the box) Comments
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
120 21 need to
150 22,24,46,54 discuss
further with
200 42,44,55 pharmacist
20 46 need to
discuss
25 18,44,54,55 further with
pharmacist
40 23,22,28,24 need to
50 46,55 discuss
60 54 further with
80 44 pharmacist
8 44
10 21,24,55 need to
discuss
10.5 54
further with
12 22 pharmacist
15 46
8 44 need to
10 21,46,24,55 discuss
10.5 54 further with
12 22 pharmacist
ug/mL At 4hr mg/L
25 150 25 23,55,21,42
40 At 8hr 40 42,46,54 need to
discuss
50 75 50 43
further with
150 At 12 hr 150 22 pharmacist
300 40 300 24
200 50 200 44
mg/dL Mg/L 0-17 yr
21,22,42,44, need to
30 3 30
54,55 discuss
40 4 42,46 further with
50 5 24,23 pharmacist
100 10 52
U/L mg/dL very rare, for
5000 52 neuroleptic
malignant >5000
351 18 syndrom or
muscle lysis
dropped during
>5.5% 0f Total CK 18 November
2007 meeting
ng/mL mg/dL dropped during
0.1 0.1 1 November
2007 meeting
0.5 0.5 29
dropped during
0.05 52 November
2007 meeting
µmol/L mg/dL mmol/L
286 1.7 28.6 9 dropped during
595 10 55 November
2007 meeting
761 12.79 9
773 13 1,26,31a
50 10 dropped during
November
25 52 2007 meeting
ng/L pmol/L Dropped during
November
35 45 1 2007 meeting
Table 2.2: HAEMATOLOGY (ADULTS)
Please review the preliminary suggested values and complete the blue boxes.

Lower Critical Limit

Your agreement
No Test Preliminary (please  in the box)
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
Value Do not
Agree
agree
g/dL g/L
5 50 25, 29 6
6 60 23, 46 Impaired oxygen
g/dL,
1 Haemoglobin supply to vital
6.5 65 27 60
organ
6.6 66 1, 14, 26, 31, 32 g/L
7 70 18, 21, 22, 33
L/L %
0.15 15 25
0.20
23, 26,31, 32,
0.18 18 L/L,
2 Hct 42,46
20
7,13,16,18,21, %
0.20 20
24,27
0.21 0.21 22,33
10 25,27,46
20 1,13,18,24,33,42

Platelet count 30 22 20
3 Risk of bleeding
(109/L) 109/L
37 26,31,32
40 7,23
50 16,21
0.5 4,27
1 2, 46
1.5 21, 22, 33
WBC 1,7,13,16,25,26, Risk of infection
4 2 not critical
(109/L) 28,31,32

2.5 18

g/dL mg/dL
0.5 50 25
0.70 70 18 1.0
0.75 75 22 g/dL,
5 Fibrinogen Risk of bleeding
0.8 80 1,46 100
0.88 88 26,31,32 mg/dL
7, 21, 23, 24, 27,
1.0 100
28, 33
Anti-thrombin
6 0.25 1,25 not critical
(µl/ml)

PT
7
(sec)

INR
8
(Ratio)

APTT
9
(sec)

Section 2 ~ 18 ~
 UPPER CRITICAL LIMIT
Your agreement
Preliminary (please  in the box) Comments
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
Value Do not
Agree
agree
g/dL g/L
18.0 180 33 Risk of 19.0
19.0 190 18, 21 developing g/dL,
19.9 199 26, 31,32 hyperviscosity 190
20.0 200 7 syndrome g/L
22.0 220 22, 46
%
0.55 55 46
0.60
0.607 60.7 7,21
%,
60
0.61 61 26,31,32

0.66 66 25
910 26,31,32
999 7,16
1, 13,18,21,
1000 Risk of 1000
22,25,33,46
thrombosis 109/L

25 18
30 7, 21,33
35 22
Leukemia /
will discuss
37 26, 31,32 leukemoid
with physician
reaction
1, 13, 16, 23,
50
27, 46
80 25
g/L mg/dL
7.00 700 21
7.75 775 26, 31,32

not applicable

27 26,31,32 >2.5 upper

Risk of bleeding
30 7,16 limit and
if > 2.5X the
40 18 varies from
upper normal
instrument
47.5 23 reference range
and reagent
4 28
13, 21, 23, 24, Risk of bleeding
5
27, 33, 42 especially on >5
5.5 22 OAC
6 46
60 18
68 26, 31, 32
75 1
78 7 80 sec or
>2 x upper
100 13, 16, 21, 27
reference
120 24,28 range
125 25
140 23
150 22
Table 2.3: CHEMICAL PATHOLOGY (PAEDIATRICS)
Please review the preliminary suggested values and complete the blue boxes.

Lower Critical Limit

Your agreement
No Test Preliminary (please  in the box)
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
mmol/L NB <1 wk
2.8 2.5 2.5 26(a), 51, 54, 27 Probability of
3.0 2.6 >1 wk 46, 1 Ventricular
2.8
1 Potassium cardiatachy is
2.8 3.0 51, 26(a),31 mmol/L
0.7 at 2.5 at 3.0
0-1M, >2M is 0.6 (57)
18
2.5
Sodium 121 51, 26(a) 125
2
(mmol/L) 130 21 mmol/L
mmol/L mg/dL NB
1.7 30 1.7 1
1.8 32.4 1.8 51, 26(a),31
1.94 35 0-2 D 21 No preliminary
3 Glucose 2.22 40 30 44 value. Need
expert opinion.
2.6 46.8 35 51, 26(a), 27
3.05 55 NA
>2 yrs >2D
27
55 40
mmol/L mg/dL MEq/L Hypocalcaemia-
frequently occurs
0.5 2 1.0 NA
in critically ill,
1.5 6.0 3.0 44 causes hypoten-
1.62 6.48 12.96 51, 26(a) sion, heart failure
(40), mortality of 1.7
4 Calcium 1.75 7.0 3.5 40, hypocalcaemic mmol/L
significantly greater
than normo-calcae-
NB-13 yr 2 18 mic Hypocalcaemic
can lead to tetany
and death
mmol/L mg/dL No preliminary
5 Calcium (ionized) 0.74 2.96 51 value. Need
expert opinion.
0.85 3.40 26(a)
mmol/L mg/dL
0.5
6 Magnesium 0.41 1.00 21
mmol/L
0.45 1.09 51, 26(a)
mmol/L mg/dL 0.4
7 Phosphate
0.42 1.3 51, 26(a), 21 mmol/L
No preliminary
8 Ammonia value. Need
expert opinion.
No preliminary
9 Lactate value. Need
expert opinion.
7.21 51, 26(a)
10 pH 7.2
7.25 24
mmHg NB (mmHg)
45
11 pO2 45 37 51, 26(a), 31, 1
mmHg
50 24
mmHg MEq/L
20
12 pCO2 21 10 51, 26(a), 18
mmHg
30 24

mOsmol/kg 250
13 Serum Osmolality
Mmol/kg
253 51, 26(a)
mg/dL mmol/L 1.6
14 CSF-Glucose
30.6 1.7 51, 26(a) mmol/L
Mg/L No preliminary
15 CSF-Prot value. Need
1875 51 expert opinion.

Section 2 ~ 20 ~
 Upper Critical Limit
Your agreement
Preliminary (please  in the box) Comments
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
mmol/L NB 0-1 M
6.4 6.5 8 51, 26(a), 54, 18 Hyperkalaemia
6.5 7.0 >2M 46, 21, 22 Conduction 6.0
7.7 6.5 1, 18 block & asystole mmol/L
7.8 51, 26(a),31 (57)
8 lysed 51
150 21 155
156 51, 26(a) mmol/L
mmol/L mg/dL NB
7.7 140 11.1 22
16.6 300 18 44, 1
19.5 351 18.2 18, 51, 26(a),31 No preliminary
24.7 445 200 51, 26(a), 54 value. Need
expert opinion.
324 NA
327 NA

mmol/L mg/dL MEq/L

3.0 12 6.0 NA
3.17 12.7 6.34 51, 26(a)
3.25 13 6.5 44
3.1
NB-13 yr 12 18
mmol/L

mmol/L mg/dL No preliminary

1.57 6.28 51 value. Need
expert opinion.

mmol/L mg/dL MEq/L

1.8
1.77 4.31 3.54 51, 26(a)
mmol/L

2.8
mmol/L
µmol/L ug/dL 100
109 186 51, 26(a) µmol/L
Mmol/L mg/L 3.0
4.1 36.9 51, 26(a) mmol/L
7.5 24
7.6
7.59 51,26
mmHg NB (mmHg)
125
90 24, 26(a), 31
92 mmHg
124 51, 26(a)
mmHg
70
50 24
mmHg
66 51, 26(a)
Mmol/
mOsmol/kg 310
kg
Mmol/kg
318 318 51, 26(a)

Mg/L Mmol/L 1875

1875 10.4 51 Mg/L
Table 2.3: CHEMICAL PATHOLOGY (PAEDIATRICS) – continuation
Please review the preliminary suggested values and complete the blue boxes.

Lower Critical Limit

Your agreement
No Test Preliminary (please  in the box)
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree

No preliminary
16 Bilirubin value. Need
expert opinion.

No preliminary
Uric Acid
17 value. Need
µmol/L expert opinion.

No preliminary
18 Urea value. Need
expert opinion.

No preliminary
Creatinine
19 value. Need
µmol/L expert opinion.
T4
20 3.5 24
(ug/dL)

Table 2.4: HAEMaTOLOGY (PAEDIATRICS)

Please review the preliminary suggested values and complete the blue boxes.

Lower Critical Limit

Your agreement
No Test Preliminary (please  in the box)
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
g/dL g/L
Impaired oxygen
Haemoglobin 6.6 66 1 7.0
1 supply to vital
(Paeds) g/dL
6.9 69 31, 32 organ

g/dL g/L
8.0 80 29
Haemoglobin 8.0
2 8.5 85 1
(Neonate) g/dL
9 90 18
9.5 95 21, 31, 32
Hct L/L % 0.20
3
(Paeds) 0.20 20 31, 32 L/L
L/L %
Hct 0.25
4 0.25 25 29
(Neonate) L/L
0.33 33 1, 18, 27, 31
0.5 4,27
1 2, 46
1.5 21, 22, 33
WBC 1,7,13,16,25,26, 2.0
5 2
(109/L) 28,31,32 109/L

2.5 18

Section 2 ~ 22 ~
 Upper Critical Limit
Your agreement
Preliminary (please  in the box) Comments
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
Mg/dL µmol/L NB
12 137 15 24, 54 Cause “Nerve
13 205 Infant 21 event” at 513
µmol/L Inci-
14 222 30 22, 1, 18
dence of baby
15 239 <1 D 51 with bil Neonate
30 257 8 49, 51, 26(a), 27 428µmol/L 320 mg/dL,
3-30 D 307 18 44 (250mg/L) Children
15 342 1-2D 27 may develop 250 mg/dL
brain damage
Prem 513 13 49, 27
if not promptly
15 Mmol/L D1 18 treated is
Term NB 1 0.14-0.16% (49)
239
20 222 18, 51, 26(a), 31
500
714 51, 26(a)
µmol/L
mmol/L mg/dL(Infant)
19.0
10.7 30 18
mmol/L
19.6 54.9 51, 26(a)

336 51, 26(a) 330

18

Upper Critical Limit

Your agreement
Preliminary (please  in the box) Comments
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
g/dL g/L Risk of
19.9 199 1 developing 20.0
hyperviscosity g/dL
20.8 208 31 syndrome
g/dL g/L
22.3 223 31,32
22
22.5 225 18, 21
g/dL
23 230 1

L/L % 0.40
0.62 62 31 L/L
L/L %
0.7
0.65 65 18, 21
L/L
0.71 71 1, 31, 32
25 18
30 7, 21,33
35 22
50
37 26, 31,32 109/L
1, 13, 16, 23,
50
27, 46
80 25
Table 2.4: List of HAEMaTOLOGY (PAEDIATRICS) – continuation
Please review the preliminary suggested values and complete the blue boxes.

Lower Critical Limit

Your agreement
No Test Preliminary (please  in the box)
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
10 25,27,46
20 1,13,18,24,33,42

Platelet count 30 22 50
6
(109/L) 109/L
37 26,31,32
40 7,23
50 16,21
g/dL mg/dL
0.5 50 25
0.70 70 18
0.75 75 22 0.7
7 Fibrinogen
0.8 80 1,46 g/dL
0.88 88 26,31,32
7, 21, 23, 24, 27,
1.0 100
28, 33

INR
8
(Ratio)

LIST OF QUALITATIVE TESTS

Table 3.1: HAEMATOLOGY
Please review the preliminary clinical opinion and complete the blue box.
Test/Parameter / Preliminary Clinical
No Critical Findings References Your Suggestions & Comments
Diagnosis Opinion

1 D-dimer +ve 1 not included

2 Fibrin monomer +ve 1 not included

Suspected leukemia 1, 21

Suspected aplastic crisis 1

3 Full Blood Picture

Sickle cell 1

Malarial parasites 1, 25

4 Factor VIII inhibitor Present 25

Section 3 ~ 24 ~
 Upper Critical Limit
Your agreement
Preliminary (please  in the box) Comments
Critical Values from Clinical Your suggested
Reference No. suggested Reason for your choice
Literature Significance value
value Do not
Agree
agree
910 26,31,32
999 7,16
1, 13,18,21,
1000 1000
22,25,33,46
109/L

g/L mg/dL
7.00 700 21
7.75 775 26, 31,32
No preliminary
value. Need
expert opinion.

4 28
13, 21, 23, 24,
5
27, 33, 42 >5
5.5 22
6 46

LIST OF QUALITATIVE TESTS

Table 3.2: mICROBIOLOGY
Please review the preliminary clinical opinion and complete the blue box.
Test/Parameter / Preliminary Clinical
No Critical Findings References Your Suggestions & Comments
Diagnosis Opinion
Microscopy result (Normal or abnormal) 7, 42, 24,1,
1 CSF C/S Accept
Positive indian Ink 22,27,13

Positive rapid antigen detection

2 CSF antigen detection Accept
(bacterial and Cryptococcus)

Positive result from gram stain 7, 42,24,

3 Blood Culture Accept
or / and culture 18,25,13

4 Sterile body fluids Positive result from Gram stain or culture 7,18,22, 27 Accept

7, 42,24,1,
5 AFB Positive smear result or / and culture Accept
22,25,13

6 Malaria (BFMP) Presence of malaria parasite 42,1,22,25 Accept

Salmonella typhi, Vibrio cholerae, Shigella

7 Stool Culture 42,1,18,25 Accept
spp, E.coli 0157:H7, Camphylobacter spp

ESBLs producer organism, MRSA, Multi-

8 Any Culture 54 Accept
Resistant Organism (MRO), VRE, VRSA

9 Antigen detection Legionella spp 42,22 Accept

Pernasal swab Bordetella pertussis

10 1,42 Accept
Throat Swab Corynebacterium diptheria

~ 25 ~ Section 3
Table 3.3: Anatomical PATHOLOGY
Please review the preliminary clinical opinion and complete the blue box.
Test/Parameter/ Preliminary Clinical
No Critical Findings References Your Suggestions & Comments
Diagnosis Opinion

Unexpected malignancy 39, 37,42 Accept

Discordance from the frozen Remove but suggest

section and permanent 39 to put ‘Alert’ stamp on
section diagnosis the report

Remove but suggest

Change in diagnosis 39 to put ‘Alert’ stamp on
the report
Unexpected or
1
Discrepant Findings
Disagreement from Remove but suggest
preliminary and final FNA 39 to put ‘Alert’ stamp on
diagnosis the report

Significant disagreement and

Remove but suggest
or change between primary
39 to put ‘Alert’ stamp on
pathologist and referral
the report
pathology consultation

Wrong organ removed Accept

Bacteria in heart valves or

39, 37 Accept
bone marrow

Organisms in an
immunocompromised patient
42, 39, 37 Accept
such as AFB, fungi, viral,
protozoa
2 Reports of infections

Organisms in Cerebrospinal
Accept
Fluid (CSF)

Unusual organisms or
organism in unusual sites e.g Accept
amoeba in the eye

Crescents in greater than

50% of glomeruli in renal 39, 37 Accept
Reports on critically biopsy specimen
3 ill patients requiring
immediate therapy
Transplant rejections 39, 37 Accept

Fat in an endometrial
39, 37, 36 Accept
currettage

Cases that have

Mesothelial cells in a heart
4 immediate clinical 39, 37 Accept
biopsy
consequences

Fat in snare colon biopsy

39, 37 Accept
specimens

Section 3 ~ 26 ~
ENQUIRIES
RELATING TO CRITICAL VALUE TABLES OF
QUANTITATIVE AND QUALITATIVE TESTS

C1 Are there any missing area/tests not identified in the Tables? Yes No

If you answered “Yes”, please answer the following questions:

(a) Please indicate which area(s) are missing:

1 _ _______________________________________________________________________________________

2 _ _______________________________________________________________________________________

3 _ _______________________________________________________________________________________

4 _ _______________________________________________________________________________________

(b) Please indicate where the area(s) should be Please provide a rationale for adding the
incorporated: suggested area(s):

C2 The List of Critical Tests is a meaningful and useful tool for improving patient safety.
(Please choose one answer most applicable.)

Strongly Agree Agree Neither Agree nor Disagree Disagree Strongly Disagree

If you indicated that you “neither agree nor disagree”, “disagree” or “strongly disagree” with the statement
above please explain why you choose your answer:

~ 27 ~ Section 4
PROCEDURE OF CRITICAL RESULT NOTIFICATION

5.1: General procedure of critical result

Laboratory Your Suggestions

performs test for Change

Critical
Step 1
Value?

laboratory
yes

The Lab staff

notifies the
Step 2 critical value to
ward / clinic staff
immediately

Ward / clinic
staff receives
Step 3 critical value
notification from
the lab

Inform doctor-
Step 4
in-charge
ward / clinic

Action taken
Step 5
by the doctor

Patient
outcome

Section 5 ~ 28 ~
5.2: Chemical pathology and haematology tests

STEP 1: Identification & confirmation of the critical value

Elaboration of the processes

CHEMICAL Your Suggestions
PATHOLOGY /
HAEMATOLOGY for Change
TESTS

How?
repeat • Refer to Critical Value Lists (Standard
Critical Values/Limits)
analysis
Critical • Verification of results
Value? • Compare with previous results
1. Same trend – phone result
2. Different trend – repeat analysis, verified,
inform result

What?
Refer to All critical tests
Standard Critical
Values / Limits When?
List Every time results fall out of the critical values
limits

Who (to verify results)

JTMP/Scientific Officer/Pathologist
Validation of results
– confirm patient’s ID Why?
on specimen and To verify/confirm that the results are truly
critical
form
– check sample
– check result
transcription (for
manual result entry)

Verification of
results – check If *No:
patient’s record (i) Check for common analytical
interferences (serum index) such as
(if available haemolysis, icteric or lipaemic samples.
e.g. LIS) Include comments on the effect of the
interference on test results (if any) and
release it to the requestor.
(ii) If the common analytical interferences
are not present, check for other
No* Record possibilities such as pre-analytical,
available? analytical and post-analytical factors
that can affect the test result. Make
corrections and include comment in the
yes test report before it is released
Examples of common pre-analytical factors
involved include:
No • Usage of wrong container
Same • Patient not fasting for tests that require
trend fasting
• Late arrival of specimen for time dependent
tests
• Specimen over exposed to light
• Formation of bubbles in the tubes
Yes, it is a • Sample taken proximal to intravenous drip
critical value Examples of possible analytical factors:
• Insufficient volume
• Wrong tube position on analyzer
Examples of possible post-analytical factors
CHEM PATH / • Wrong calculation for manual calculated
HAEM TESTS test
STEP 2 • Transcription error while transcribing the
results manually

~ 29 ~ Section 5
STEP 2: The procedure of notification by laboratory
for Chemical Pathology and haematology tests

CHEM PATH / Elaboration of the processes

HAEM TESTS Your Suggestions
Authorized laboratory personnel to
STEP 2
notify result:
for Change
• Medical laboratory technologist (MLT)
• Scientific Officer
• MO, Pathologist
The lab staff
notifies the Authorized ward/clinic personnel to
critical value receive result:
• Staff nurse
to ward
• Medical Assistant (PPP)
immediately • Sister
(within 30 • HO, MO, Specialist
minutes
after result
verification)

Verbally Yes Notification via telephone Information

notify that needs to be conveyed and
result documented
• Informer name and designation
Phone • Confirm patient destination (location)
• Patient ID (name and RN/IC)
No • Test name and result
• Sample date & time
• Result read back by recipient (Yes/No)
• Recipient name & designation
• Date and time of notification

Other mode of Immediate result dispatch by hand eg

notification Blood Gas results.
• To the ward /clinic staff waiting for the
test result in the lab.
• Record name and designation of
recipient, date and time of receipt in
Document the record book.
notification and
the relevant
information into
record book, • Lab staff informing the critical result.
LIS or standard
notification form

Document on
the result hard
copy that the
result has been
• Lab staff informing the critical result.
notified (for lab
without LIS)

Dispatch a copy
of the result

STEP 3 (page 32)

Section 5 ~ 30 ~
5.3: Microbiology and anatomical pathology tests

Step 1: Identification & confirmation of the critical value &

step 2: pROCEDURE OF NOTIFICATION BY LABORATORY
Elaboration of the processes
MICROBIO / ANAT
PATH TESTS STEP 1
Your Suggestions
for Change

Critical Value?

Refer to Standard Critical

Inform Scientific Officer / Pathologist
Values / Limits

Verify patient ID on
Check for
the request form and • sample error
specimen container / • labelling error for sample, block, slide,
blocks/slide/culture plate plate

Check the
Check processes in the • Macroscopic Appearance
laboratory • Microscopic (gram stain)
• Culture (colonies)
• Biochemical results
Call Requesting MO /
specialist or specialist- Correlate with the results eg histological /
in-charge for clinical culture / gram stain findings
information

Yes, It is critical value

MICROBIO / ANAT
PATH TESTS STEP 2

Authorized laboratory personnel to notify

result:
The Lab staff notifies the • Medical laboratory technologist (MLT)
critical value to ward/ • Scientific Officer
clinic immediately via • MO, Pathologist
phone • MO or Pathologist only for anatomic
pathology

Authorized ward/clinic personnel to receive

Inform critical results/ result:
value to doctor • Staff nurse
• Medical Assistant (PPP)
• Sister
Document the notification • HO, MO, Specialist
• MO or Specialist only for Anatomic
and the relevant
Pathology results and some of the
information into record Microbiology critical results.
book, LIS or standard
notification form

Document on the result

hard copy that the result
has been notified (for lab Notification via telephone Information that
needs to be conveyed and documented
without LIS)
• Informer name and designation
• Confirm patient destination (location)
• Patient ID (name and RN/IC)
Dispatch result • Test name and result
• Result read back by recipient (Yes/No)
• Recipient name & designation
STEP 3 (page 32) • Date and time of notification

~ 31 ~ Section 5
5.4: rECEIVING OF CRITICAL RESULT NOTIFICATION

STEP 3: The process of receiving critical result notification by

ward / clinic
CHEM PATH / HAEM /
MICROBIO / ANAT PATH
TESTS STEP 3
Elaboration of the processes
Who can receive critical results? Your Suggestions
S/n, Medical assistant (ppp), Sister, Ho, for Change
Mo, Specialist

What information to record?

Ward/Clinic staff receives
critical result notification
from the laboratory via
phone
• Patient name
• Patient r/n, id number
• Test name and result
• Sample date and time
• Laboratory staff name
• Date and time of notification
• Name of recipient

Ward/Clinic staff records Where to record? Standard form

the information received Who to record? Recipient

To read back
Read back the • Patient’s name and id
information received • Test name and result

Inform doctor-in-charge • Recipient

immediately of lab results • S/n-in-charge of the patient

Collect a copy of the test

result from lab • Ppk / porter

Carry out doctor’s • S/n-in-charge of the patient

• Recipient
instruction

Record In nursing notes, • S/n-in-charge of the patient

nursing care plan / BHT • Recipient

Paste the result and

result notification form • S/n-in-charge of the patient
• After seen and signed by doctor
in BHT

If patient has been The recipient or the S/n-in-charge will

transferred out to another inform / forward the result to staff in the
ward other ward.

If patient has been The doctor (-in-charge / referring) will

transferred out to another inform/forward the result to the doctor in
hospital the other hospital.

Doctor-in-charge (mo/specialist) will

If patient has been decide whether to
discharged • Call patient back immediately to ward/
clinic.
• Bring forward the appointment
• Phone patient and give an appointment
END date (if discharged without tca)

Section 5 ~ 32 ~
 LIST OF REFERENCES

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[ww.ifcc.org/ejifcc]
2 Kost GJ. Using critical limits to improve patient outcome – Cover Story. Medical Observer, March, 1993. [findarticles.com/p/articles/
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3 Powers Peterson MD Development of critical – Values Policy. [www.medscape.com/viewarticle/503834]
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7 Dalton-Beninato K. Critical Value Notification are Never Welcome News Laboratory News Volume 31 June 2000 [labmedicine.
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8 George S. Cembrowskia. Thoughts on quality-control systems: a laboratorian’s perspective, Clinical Chemistry 43: 886 [www.
clinchem.org/cgi/content/full/43/5/886]
9 Howanitz PJ, Steindel SJ, Heard NV. Laboratory critical values policies and procedures: a College of American Pathologists Q-Probes
study in 623 institutions. Arch Pathol Lab Med. 2002; 126: 663-9.
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[www.macoalition.org/Initiatives/docs/CTRbates.pdf ]
11 Elizabeth A. Wagar, MD; Ana K. Stankovic, MD, PhD; David S. Wilkinson, MD, PhD; Molly Walsh, PhD; Rhona J. Souers, MS Assessment
Monitoring of Laboratory Critical Values: A College of American Pathologists Q-Tracks Study of 180 Institutions Archives of Pathology
and Laboratory Medicine: Vol. 131, No. 1, pp. 44–49.
[www.atypon-link.com/WDG/doi/pdf/10.1515/CCLM.2007.288]
12 Barenfanger J. et al. Improving Patient Safety by Repeating (Read-Back) Telephone Reports of Critical Information Am J Clin Pathol
2004; 801 – 803. [http://www.arcp.com/volume_121]
13 Astion M. The Results Stopped here Laboratory Medicine June 2004. [www.webmm.ahrq.gov/case.aspx].
14 Iordace S et al. A Comprehensive Computerize Critical Laboratory Results Alerting System for Ambulatory and Hospitalized Patients.
[cmbi.bjmu.edu.cn/news/report/2001/medinfo_2001/Papers/Ch6/504]
15 Julie McDowell Critical Result Reporting. Can IT and Improved Communication Systems Help Labs Meet Patient Safety
Standards? August 2007 Clinical Laboratory News
[http://cmbi.bjmu.edu.cn/news/report/2001/medinfo]
16 Anand S. Dighe, MD, PhD; Arjun Rao, MBBS, MBA; Amanda B. Coakley, RN, PhD; Kent B. Lewandrowski, MD. Analysis of Laboratory
Critical Value Reporting at a Large Academic Medical Center Am J Clin Pathol.  2006; 125 (5):758-764. [www.medscape.com/
viewarticle/530569]
17 Critical Test Results Reporting, Washington Hospital Centre. [www.whcenter.org]
18 Follow up of Abnormal Test Results, Department of the Army US Army Medical Department Activity Arizone, MEDDAC MEMO 40-138
[rwbach.huachuca.amedd.army.mil/pubs/M40-138.pdf ]
19 Post Analytical Phase, Reference Value, EC4, University Hospital.
[www.ec-4.org/downloads/qualitymanual/9_5_interpret_consult.pdf ]
20 Policy and Procedure for Critical Results Reporting , University of California , San Diego
[irb.ucsd.edu/SOPP_2004-01-21.pdf ]
21 Northern Plains Laboratory Critical Value Policy Bismarck ND, USA. [www.northernplainslab.com/]
22 Notification of Critical Value (Laboratory Procedure, The Ohio State University Medical Centre, Department of Clinical Laboratories.
[www.pathology.med.ohio-state.edu/ext/]
23 Critical Test Result Reporting Critical (Panic) Values (Test Results) Washington Hospital Centre.
[www.whcenter.org]
24 Critical Value, University of Washington. [depts.washington.edu/labweb/PatientCare/ Reference/
CriticalR.htm depts.washington. edu/labweb/test/panic.html – 16k]
25 Critical Value (Not sure of the source)
26 Table of Critical Limits. Kost GJ Critical Limits for urgent clinician notification at US medical centre. JMA 1990;263
27 Laboratory Critical/Panic Value List. Lucile Packard Children’s Hospital, Standford Medical centre California
28 Listing of Test Critical, St. Mary Mercy Hospital, US
29 Critical values. UC Davis Health System
30 Medical Decision Levels, Statlen BE, Clinical Decision Levels for Laboratory Tests, Second Edition
31 Table of Critical Limits – Clinical and Professional Reference Guides – Illustration. By Kost GJ Critical Limits for urgent clinician
notification at US medical centres JMA 1990; 263:7004.
[goliath.ecnext.com/coms2/gi_0199-3235603/Table-of-critical-limits Clinical.html]

~ 33 ~ Section 6
 LIST OF REFERENCES

32 Table of Critical Limits – medical test analysis research – Statical Data. From Kost GJ, Critical Limits for urgent clinician notification at US
medical centres. JMA 1990; 263:7004.
[goliath.ecnext.com/coms2/gi_0199-5756873/Table-of-critical-limits-clinical.html]
33 UAM Haematology /Urinalysis / Body Fluids
34 Froom et al. Effect of Urgent Clinician Notification of Low Hemoglobin Values Clin. Chem. 2001; 47:63-66.
35 Shahangian S et al. Results of a survey of Hospital Coagulation Laboratories In United States 2001 Arch Pathol Med - Vol 129, January
2005
36 Telma C. Pereira, MD; Yulin Liu, MD, PhD; Jan F. Silverman, MD. Critical Values in Surgical Am J Clin Pathol 122(2): 201-205, 2004. © 2004
American Society for Clinical Pathology.
[Findarticles.com/p/articles/mi_qa3725]
37 Jan F. Silverman, MD. Critical Diagnoses (Critical Values) In Anatomical Pathology. Association of Directors of Anatomical and Surgical
Pathology. [adasp.madoryconsulting.com/papers/position/CriticalValues]
38 Pereira TC, Liu Y, Silverman JF. Critical values in surgical pathology. Am J Clin Pathol 2004; 122:201-205.
[http://arpa.allenpress.com/arpaonline]
39 Critical values in surgical pathology – survey results from ADASP (Association Washington, DC, National Academy Press, Institute of
Medicine Report, 1999.
40 Howanitz JH, Howanitz PJ. Evaluation of total serum calcium critical values. Arch Pathol Lab Med. 2006; 130:828-830
41 Joan H. Howanitz, MD; Peter J. Howanitz, MD. Evaluation of Serum and Whole Blood Sodium Critical Values. Am J Clin Pathol.  2007;
127(1):56-59.  ©2007 American Society for Clinical Pathology. Posted 02/07/2007.
42 Critical Values for Laboratory Medicine and Anatomical Pathology. UHS and UTHSCSA Department of Pathology.
43 MGH Lab Handbook – Critical Value List [http://mghlabtest.partners.org/CriticalValues.htm]
44 The University of Kansas Hospital – Critical Values. [http://www2.kumc.edu/clinlabs/CRITICALof20VALUE]
45 Rush University Medical Center Clinical Microbiology
[http://www.rush.edu/webapps/RMLClinicalMicroCV.jsp]
46 Critical Laboratory Values [http:www.medicine.uiowa.edu/path_handbook/Appendix]
47 Bloodstream Infections: A Trial of the Impact of Different Methods of Reporting Positive Blood Culture Results. Emilio Bouza, Dolores
Sousa, Patricia Munoz, Marta Rodriguez-Creixems, Carlos Fron and Juan Garcia Lechuz. CID 2004:39 (15 October)
48. Clinical impact of antibiotic susceptibility data (therapy program based on lab results).Ainsworth, Kristie. HighBeam Encylopedia.
49. Urgent Clinical Need for Accurate and Precise Bilirubin Measurements in United States to Prevent Kernicterus. Vinod K. Bhutani and
Lois H. Johnson. Clinical Chemistry 50:3 477- 480(2004)
50 The SARS Coronavirus: Rapid Diagnostics in the Limelight. Editorial, Clinical Chemistry 49, No 6, 2003
51 Critical Limits for Emergency Clinician Notification at United State Children’s Hospitals, Gerald J. Kost Pediatrics 1991; 88; 597-603,
Pediatrics Official Journal of the American Academy of Pediatrics.
[http://www.pediatrics.org]
52 Pathology Users’ Handbook-Biochemistry Department – Cumberland Infirmary,
[http://www.northcumbriahealth.nhs.uk/acute/services/pathology/handbook/biotable/info]
53 The Role of the Clinical Laboratory in Managing Chemical or Biological Terrorism, Saeed A. Jortani, James W. Snyder, And Roland
Valdes, JR. Clinical Chemistry 46:12, 1883-1893 (2000)
54 MLabs Critical Value Table, University of Michigan Health System (UMHS) http?
55 Critical Limits for Laboratory Test Values, Children’s Hospitals and Clinics of Minnessota http?
56 Deaths Associated with Hypocalcemia from Chelation Therapy – Texas, Pennsylvania, and Oregon, 2003-2005 CDC F, Morbidity and
Mortality Weekly Report [www.jama.com]
57 Importance of Potassium in Cardiovascular Disease, Domenic A. Sica, MD; Allan D. Struthers, MD; William C. Cushman, MD; Mark
Wood, MD; John S. Banas, Jr., MD; Murray Epstein, MD, J Clin Hypertens 4(3):198-206, 2002. [www.medscape.com/]

ADDITIONAL REFERENCES:

1.

2.

3.

4.

Section 6 ~ 34 ~
Overall Comments Section 7

If you have any additional comments, please write them here for us.

Thank you for answering the questions regarding participant demographics and the Conceptual Framework.
Your input is extremely valuable to us and essential to the development of List of Critical Tests and Procedures For
Laboratory in Improving Patient Safety.

Contributors Section 8

The following had contributed to the development of lists of critical tests/values and procedure.
CLINICIANS LABORATORY

Surgery Norain Karim

Abdul Jamil Abdullah Hospital Ipoh, Perak
Hospital Kuala Terengganu
Zainal Abidin Hanafiah Chemical Pathology
Hospital Raja Perempuan Zainab II, Kelantan Anasufiza Habib
Hospital Kuala Lumpur
Anaesthesia Baskaran
Lim Wee Leong Hospital Tengku Ampuan Rahimah,
Hospital Sungai Buloh Klang
Jamilah Baharom
O&G Hospital Pulau Pinang
Wan Hamilton Wan Hassan Khatijah Dawam
Hospital Serdang, Selangor Hospital Sultan Ismail, Johor
Mohd Izani Othman
Paediatrics Hospital Kangar, Perlis
Asiah Kassim Muhammad Arif Mohd Hashim
Hospital Kuala Lumpur Hospital Kuala Lumpur
Norliza Ali Munira Mohd Zain
Hospital Kuala Lumpur Hospital Putrajaya
Paediatricians from Institute of Paediatrics Nik Faizah Nik Hussein
Hospital Kuala Lumpur Hospital Raja Perempuan Zainab II,
(names not listed here) Kelantan
Norma Ibrahim
FMS Hospital Manjong, Perak
Mimiroslina Che Omar Rozita Abdullah
Poliklinik Komuniti Kelana Jaya Hospital Tengku Ampuan Rahimah,
Klang
Medicine Siti Subkhiah Satari
(none) Hospital Temerloh, Pahang
Nurses Anatomical Pathology
Arba’ainah Mohd Salleh Arni Talib
Hospital Sultanah Nur Zahirah, Terengganu Hospital Kuala Lumpur
Dominica Rose a/p J. S. Deniel Nik Hashimah Nik Yahya
Hospital Taiping, Perak Hospital Kuala Lumpur
Fu Choon Kee Nik Malihan Nik Sulaiman
Hospital Umum Sarawak Hospital Selayang
Hanifah Kahmis Razmin Ghazali
Hospital Serdang, Selangor Hospital Kuala Lumpur
Kalwant Kaur a/p Sarban Singh Raudhawati Osman
Hospital Ipoh, Perak Hospital Kuala Lumpur
Rohana Ismail
Hospital Tengku Ampuan Afzan, Pahang
~ 35 ~
Microbiology
Azizah Mustafa
Hospital Sungai Buloh
Ismail Mohamad
Hospital Dungun, Terengganu
Mohd Asri Yamin
Hospital Banting, Selangor
Mohd Sadek Yasin
Hospital Kangar, Perlis
Nurahan Maning
Hospital Raja Perempuan Zainab II,
Kelantan
Salina Abdul Rahman
Hospital Sungai Buloh
Zubaidah Abdul Wahab
Hospital Sungai Buloh
Zulkifli Muda
Hospital Tengku Ampuan Afzan,
Pahang
Haematology
Noraishah Mohd Mokhtar
Hospital Kuala Lumpur
Roshidah Hassan
Hospital Kuala Lumpur
Roswati Muhammad Noor
Hospital Tengku Ampuan Rahimah,
Klang
Salimah Abdullah
Hospital Raja Perempuan Zainab II,
Kelantan
Soo Peng Yen
Hospital Pulau Pinang
Zanariah Kassim
Hospital Sultanah Aminah, Johor
 INSTITUTE FOR HEALTH SYSTEMS RESEARCH
Ministry of Health, Malaysia

© 2007 Institute for Health Systems Research, Kuala Lumpur, Malaysia.

A Project under The Letter of Intent For Improving Patient Safety [Lab 2; Loi 4/2007(∑4)]

ISBN 978-983-42269-7-8

9 789834 226978

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