Point-of-care testing – a reality
to be dealt with
Report on a seminar on 19 November 2002
Arranged by the Swedish Association
of Health Professionals and the Swedish
Institute for Biomedical Laboratory Science (IBL)
back to report intro
Where does responsibility lie in point-of-care
testing?
EQUALIS (External Quality Assurance in Laboratory Medicine
in Sweden) works towards the goal of increasing patient safety by
raising the quality and reliability of laboratory medicine activity.
Gunnar Nordin is CEO of the Uppsala-based company, which is owned
by the Federation of Swedish County Councils, IBL and the Swedish
Medical Association.
EQUALIS offers quality assurance programmes for analytical methods
for all laboratory disciplines. Participation is voluntary and is
based on professional commitment. An overall picture of the current
quality of analysis in general is obtained by compiling results
from laboratories throughout the country.
Taking part in a quality assurance programme means knowing the
frequency of control runs, the analysts included and analysis methods
of measurement it applies to and what the purpose of the programme
is. Expert groups who represent most disciplines assist EQUALIS.
There are two types of patient-based testing. One of them –
POCT – is dealt with by healthcare staff, while the other
– DAT (direct access testing) is performed by the patients
themselves. An example of the latter is weight. Instead of checking
weight, healthcare staff often take information supplied by the
patient as their basis, and set the dosage of medication according
to this information.
Several patient-based tests can now be performed by health care
workers without laboratory training and are at least as reliable
as those performed in laboratories. These include Hb (blood) HbA1c,
blood Hb, blood gases, blood glucose, plasma CRP, plasma troponin
I, plasma PK (INR) and urinary choriongonadotropin. However, it
is unclear where responsibility lies for:
purchasing and selection of method
local instructions
handling results (signing and keeping records, what has been measured?
and interpretation of results)
cost and quality follow-up.
It is important to be able to go back and see what has and has
not been done for traceability. The documentation needs to be safeguarded.
With regard to cost follow-up, the statistics need to be improved.
Norway is ahead of Sweden in this area.
A survey among Swedish healthcare centres conducted by EQUALIS
in 2000 showed which occupational groups perform CRP tests. The
analyses were performed by biomedical scientists in around a quarter
of the healthcare centres and by assistant nurses in an equal number
of centres. At other healthcare centres it was mixed. The survey
also showed that there were biomedical scientists in half of the
clinics. In an equal number of clinics there was no person medically
responsible for the analyses.
According to another survey (from 2001) relating to dipslide for
detecting UTI, 59 per cent of healthcare centres had biomedical
scientists who together with an assistant nurse or nurse interpret
dipslide results. 78 per cent did not have anyone who was medically
responsible.
There is a large and growing market for simple analytical methods
where anyone can “test if you are ill”. But how reliable
are they and what consequences do they have? What is the diagnostic
sensitivity, specificity and predictive value of these quick tests?
To take an example, 10,000 men test themselves with a PSA test,
which has 90 per cent sensitivity and 70 per cent specificity. Of
these, 500 have prostatic cancer, but the test misses 50 of them.
Of the majority who do not have the disease, 2,859 nevertheless
receive a positive, that is to say incorrect, reaction. The predictive
value of a positive test in this case is 13.6 per cent.
Several questions should therefore be answered before opting for
a quick test, including:
How good is the test? Check whether EQUALIS and/or SKUP (Scandinavian
Evaluation of Laboratory Equipment for Primary Health Care), has
reviewed the test.
When is it to be used? Check published studies and apply the “just
enough and no more” principle.
What does the test cost? Difficult to assess due to use of various
calculation methods.
So, in Norway NOKLUS and in Sweden EQUALIS work on quality assurance
of laboratory activity in primary healthcare. In Denmark the National
Health Service and the Danish Organisation of General Practitioners
have recently decided that doctors are only to receive payment for
quality-assured laboratory methods.
Website: www.equalis.se
Industry: Understanding and accepting development:
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