Interpretative Commenting

Samuel Vasikaran
Department of Core Clinical Pathology and Biochemistry, PathWest Laboratory Medicine WA, Royal Perth Hospital, Perth,
WA 6000, Australia.
For correspondence: Dr Samuel Vasikaran e-mail: [email protected]

Summary
• Clinical laboratories should be able to offer interpretation of the results they produce.
• At a minimum, contact details for interpretative advice should be available on laboratory reports.
• Interpretative comments may be verbal or written and printed.
• Printed comments on reports should be offered judiciously, only where they would add value; no comment preferred to
inappropriate or dangerous comment.
• Interpretation should be based on locally agreed or nationally recognised clinical guidelines where available.
• Standard tied comments (“canned” comments) can have some limited use.
• Individualised narrative comments may be particularly useful in the case of tests that are new, complex or unfamiliar to
the requesting clinicians and where clinical details are available.
• Interpretative commenting should only be provided by appropriately trained and credentialed personnel.
• Audit of comments and continued professional development of personnel providing them are important for quality
assurance.

Introduction The provision of interpretative comments on reports varies

Medical laboratories offer diagnostic services that are essential widely between labs. It may be determined by the management
to patient care. In addition to analysis of patient samples, philosophy which ranges from the view that a request to
validation and reporting of those results, a diagnostic service perform a laboratory test is an implied request for specialist
may offer advice on appropriate test selection, interpretation opinion to the view that clinicians who order tests only want
as well as advice on further appropriate investigation.1-3 the raw data and know how to interpret the results themselves.
In fact the provision of interpretative comments on reports In fact they may resent as an intrusion into their territory any
is an essential role of the diagnostic laboratory service and interpretative comments by laboratory personnel. In reality
should be guided by the needs and requirements of users most laboratories offer some form of interpretative comments
which should be established in consultation with them.4 As a on a fraction of the Biochemistry reports they produce. The
minimum, reports should carry contact details of laboratory type of interpretative comment attached to the reports may
personnel who are available to discuss the results and offer vary in depth and degree of individualisation to the particular
interpretative advice.4 result depending on the complexity of the test, the requesting
doctor, the requester’s perceived ability to interpret the test
The typical Clinical Biochemistry laboratory today is highly results, and the expertise available within the laboratory.
automated and produces a large amount of numerical data and
a much smaller volume of qualitative results. The ability of Guidelines for commenting
the laboratory to give meaning to these data by interpreting The RCPath (UK) ‘guidelines for the provision of interpretative
the results is limited by a number of factors including; comments on biochemical reports’5 state that whether a
1. Lack of knowledge of the context in which the tests comment is required will depend on:
were requested, i.e. the clinical question. • the clinical details provided
2. Lack of knowledge of patient factors which may • the clinical implication of the results
influence the results e.g. medication. • the likely familiarity of the requesting clinician with the
3. The sheer volume of tests (that may to some extent tests and their interpretation.
be amenable to expert systems which are dealt with
elsewhere in this Supplement).

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The guidelines suggest that comments might be appropriate Table 2. Examples 2 and 3.
when:
- a decision on management or treatment is indicated by the Pregnancy test (hCG) in serum
results in combination with the clinical details provided
- a result is unexpected Comment: A pregnancy test is considered positive if hCG
- a specific question has been posed but it is not obvious >25 U/L. HCG values between 5 and 25 U/L are equivocal
whether the results provide the answer and should be repeated. In the first 8-10 weeks of a normal
- a clinician has requested a test with which they are not likely pregnancy hCG doubles every 3 days.
to be familiar.5,6
Troponin request for acute chest pain
Brevity of comments is vital as clinicians are busy, they see
large number of reports and will be put off from reading Comment: Troponin I >0.40 µg/L in association with
longwinded comments. At the same time the message should ischaemic symptoms or ECG changes is compatible with
be clear and unambiguous.4 MI. Troponin between 0.10 and 0.40 may suggest increased
risk in the setting of Acute Coronary Syndrome.
Given below is a spectrum of comments that may be used by
the laboratory.
Taken one step further, the comment can relate the result to
the cut-off, and the personnel commenting can choose the
Analytical quality and pre-analytical interference are dealt
appropriate comment from a list of options (as has been done
with elsewhere in this Supplement. Suffice to mention here
in Table 3). These sorts of comment can also be automatically
that personnel commenting on results should always consider
generated by computer.
pre-analytical and analytical artefacts which may account for
the results; comments specifically related to such artefacts are
beyond the scope of this review. Table 3. Examples 4 and 5.

However, analytical limitations or interferences inherent in an Patient: 56 year old man

assay, which may affect the interpretation of a result need to be 75 gram glucose tolerance test.
highlighted in the report. These can be attached automatically 0 minutes glucose 5.7 mmol/L
to all results produced using the particular assay (Table 1). 60 minute glucose 12.2 mmol/L
120 minute glucose 6.6 mmol/L
Table 1. Example 1. Comment: Normal glucose tolerance test. Suggest repeat
fasting glucose in 3 years time.
or
Request for thyroglobulin measurement
0 minutes glucose 6.7 mmol/L
60 minute glucose 12.2 mmol/L
Since anti-thyroglobulin antibody can interfere with
120 minute glucose 6.6 mmol/L
thyroglobulin measurement, a thyroglobulin request would
Comment: Impaired fasting glycaemia. Suggest re-test in
need to generate an anti-thyroglobulin antibody measurement
a years time. This patient is at increased risk of developing
and, if positive, the following standard comment is attached
diabetes and cardiovascular disease. Lipid testing and
to the report.
lifestyle advice may be appropriate.
Comment: The immunometric assay used for thyroglobulin
may underestimate serum thyroglobulin concentrations in
the presence of thyroglobulin antibodies.
The examples in Table 3 also highlight two issues.
1. Interpreting dynamic test results such as the oral glucose
tolerance test (GTT), the Synacthen stimulation test
Standard tied comments regarding diagnostic cut-offs and and especially more complex tests such as the water
decision levels based on recognised guidelines, while not deprivation test which have a set of results rather than a
considered interpretative comments, are used by most single result may not be straightforward. The laboratory
laboratories, and may help recipients to be reminded or should consider commenting on these tests routinely.
informed of such agreed cut-offs. These can be automatically 2. The American Diabetes Association guidelines use
generated every time such a result is reported (Table 2). a cut-off of 5.5 mmol/L for impaired fasting glucose

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whereas the Australian Diabetes Society guidelines Table 4. Example 6.

use 6.0 mmol/L; when there is a discrepancy between
guidelines national guidelines generally take precedence Thyroid Function Tests
over overseas ones. Free T4 14 pmol/L (10-23)
TSH 5.90 mU/L (0.40-4.00)
Clinical context is important in commenting and patient details The comment, depending on the context, could be:
need to be available and, if not, sought before commenting. Mild elevation of TSH may be found in patients with
Thus, in the above case, advice on additional testing and subclinical hypothyroidism or non-thyroidal illness.
management would be useful to add to the basic interpretation Thyroid antibody testing may be useful in subclinical
of the GTT result. hypothyroidism.
or
The individualised narrative interpretative comment
epitomises interpretative commenting. Components of a good Elevated TSH suggests inadequate thyroid hormone
comment may include the following: replacement if the dose has not been changed for at least
1. The absence or presence of an abnormality and its 6 weeks and the patient has been taking the medication
degree or severity. regularly. Suggest review of thyroid hormone treatment
2. Possible clinical implications of abnormality and/or a and repeat TFTs in 2-3 months.
diagnosis.
3. Suggested follow-up including further testing and
specialist referral.7 information they want in real time, and also allow other
communications, including e-mail to the laboratory.9 Of
Individualising comments is often difficult with little or course the two approaches are not mutually exclusive. The
no clinical details typically available on the request form. “hyper-linking to knowledge” approach is beyond the scope
Commenting in such instances should be restricted to what of this review, and has been reviewed elsewhere. 9
can be offered confidently based on the available information,
or such information should be sought before the comment is Table 5. Example 7.
generated. The Electronic Patient Record with data linkage
will help in accessing patient information. Table 4 shows Patient: 51 year old male.
an example of how the same result would attract different Patient Location: Presenting to Emergency Department.
comments depending on the clinical context. Inappropriate Clinical Notes on Request Form: Acute confusional state.
comments can be dangerous if acted on although, anecdotally, On risperidone.
they would often be just dismissed as such and lead to loss
of the laboratory’s credibility. Release of results (if necessary Case Details
Plasma
as an interim report) should not be delayed while they await
Sodium 108 mmol/L (136-146)
comments to be added except in the case of very complex
Potassium 4.1 mmol/L (3.5-5.5)
Biochemistry reports which cannot be interpreted without Creatinine 80 umol/L (50-110)
input from the laboratory. Urea 2.0 mmol/L (2.7-7.8)
Osmolality 227 mmol/kg (280-300)
A typical example from the Royal College of Pathologists of
Australasia (RCPA) Quality Assurance Programs (QAP) Case Urine
Report Comments Program, an educational self assessment Sodium 12 mmol/L
program for interpretative commenting, is given in example Potassium 8 mmol/L
7 shown in Table 5.8 Osmolality 0 mmol/kg

A Suggested Comment: Severe hyponatraemia and a

There is a school of thought that with electronic reporting, hypo-osmotic plasma with appropriately dilute urine and
help with interpretation of results should be offered in the no evidence of salt wasting. This pattern is in keeping
form of hyper-linking to knowledge resources (e.g. FAQs, with primary polydipsia with water intoxication. While
guidelines, laboratory handbooks available on the intra- or risperidone is not necessarily the cause of the polydipsia,
internet) rather than as added comments.9 Printed reports can an alternative atypical antipsychotic may be more effective
also have details of such sources of information. However, in improving polydipsic behaviour.
electronic hyperlinks allow clinicians to navigate to the

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Some pitfalls to avoid with interpretative commenting of such services.1,3,4 Interpretation provided by laboratory
1. Restating the obvious; e.g. “normal sodium” “raised professionals with inadequate expertise can be clinically
potassium”. However, qualifying the degree of dangerous.7,9 In addition to formal training, personnel
abnormality may be useful e.g. “severe’’ or “life- performing interpretative commenting need to regularly audit
threatening hyperkalaemia”. their activity and be involved in continuing professional
2. Restating the clinical question; e.g. Where the clinical development which addresses such functions.6 Participation
notes on the request form state “?hypothyroid” a in relevant interpretative external quality assessment schemes
report comment “consider hypothyroidism” does not is part of continuing professional development.3,4 ISO 15189
add value. A more useful comment in this situation states “External quality assessment programmes should, as
(depending on the results) would be “results confirm far as possible, provide clinically relevant challenges ….. that
hypothyroidism”. check the entire examination process including pre- and post-
3. Commenting on reports to a doctor who has indicated examination procedures”.1 Programs addressing interpretative
(s)he does not wish to receive them. commenting in Clinical Biochemistry are offered by RCPA
4. Commenting on speciality reports to a specialist QAP and UK NEQAS.11
in the field (e.g. thyroid function tests sent to an
endocrinologist) unless specifically sought, except in Competing Interests: The author chairs the RCPA Chemical
the case of complex dynamic function tests (e.g. adrenal Pathology QAP Patient Report Comments Program.
vein sampling, water deprivation test).
5. Telling the clinician how to do his job: “Suggest clinical References
examination”; “Suggest check BP”.
1. ISO 15189:2003. Medical laboratories – Particular
6. Suggestion for invasive investigations should not be
requirements for quality and competence. Geneva,
given lightly, e.g. “Suggest liver biopsy”. Switzerland: ISO; 2003.
Proactive communications and clinical meetings 2. National Pathology Accreditation Advisory Council.
Requirements for pathology laboratories (2007 Edition).
Commenting in a vacuum by a faceless person in an
http://www.health.gov.au/internet/main/publishing.
ivory tower will be resented by clinicians. Interpretative
nsf/Content/4B4BC09A2A254FCA25728400126ED2/
commenting should go hand in hand with regular contact with $File/dhapathlabs.pdf (Accessed 26 February 2008).
clinicians to develop a dialogue about appropriate testing,
3. Code of practice for clinical biochemists (chemical
developing testing algorithms, agreeing on test protocols as
pathologists) and clinical biochemistry services.
well as diagnostic criteria (which can take the form of formal h t t p : / / w w w. r c p a t h . o r g / r e s o u r c e s / p d f / G 0 2 7 -
guidelines in some instances), and to get feedback about the ClinBioCodeOfPractice-May05.pdf (Accessed 26
comments that go out on the reports in order to improve and February 2008).
fine-tune them. At the same time, unusual and interesting 4. Clinical Pathology Accreditation (UK) Ltd. Standards for
results could be triggers for direct communication and the Medical Laboratory. http://www.cpa-uk.co.uk/files/
discussion.3 pdlabst.pdf?bcsi_scan_276FAA45874D151E=0&bcsi_
scan_filename=pdlabst.pdf (Accessed 26 February
In fact, regular and systematic communication between 2008).
laboratory staff and clinical staff is important for the effective 5. The Royal College of Pathologists. Guidelines for the
utilisation of laboratory services by clinicians as well as for provision of interpretative comments on biochemical
improvement of the laboratory service to meet the needs of reports. Bull R Coll Pathol 1998;104:25.
the end user.1,4 6. Marshall WJ, Challand GS. Provision of interpretative
comments on biochemical report forms. Ann Clin
Personnel qualified to comment Biochem 2000;37:758-63.
Pathologists and Scientists with appropriate professional 7. Vasikaran SD, Penberthy L, Gill J, Scott S, Sikaris
qualification and credentialed as specifically trained in KA. Review of a pilot quality-assessment program
commenting can perform this function adequately in a for interpretative comments. Ann Clin Biochem
Clinical Biochemistry laboratory. In addition, laboratory 2002;39:250-60.
personnel with extensive expertise and experience in a highly 8. Lim EM, Sikaris KA, Gill J, Calleja J, Hickman PE,
specialised area often perform this function in their limited Beilby J, et al. Quality assessment of interpretative
area of expertise. It is for the management of individual commenting in clinical chemistry. Clin Chem
laboratories to define the standards for such personnel, ensure 2004;50:632-7.
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able to perform these tasks and to define the responsibilities Clin Chem Lab Med 2006;44:719-23.

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10. Laposata M. Patient-specific narrative interpretations 11. Challand GS, Vasikaran SD. The assessment of
of complex clinical laboratory evaluations: who is interpretation in clinical biochemistry: a personal view.
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