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Purpouse
The points of the 2019 Croatian Recommendations for post-examination
processes (CR) [1] that merit revision are selected, in comparison with
SIPMeL Recommendations on informatics in the medical laboratory (SR)
[2] and the review made by Cappelletti (PC) [3] that compared IFCC [4].
This topic has become very relevant for the 2022 revision of ISO 15189.
Materials and Methods
CR, SIPMeL and PC papers were analysed.
Recommendations for laboratory results in
post-examination processes: critical points
Marco Pradella
Società Italiana di Patologia Clinica e Medicina di Laboratorio, Commissione nazionale Qualità e
Accreditamento, GdS Informatica
RESULTS in pages 2 and 3
DISCUSSION and CONCLUSIONS in page 4
REFERENCES in page 5
Results
CR [1]
PC [3]
SIPMeL GdS
-I [2]
PROCEDURE 1: Evaluation of test
results
Recommendation 1
...a)... comparison of the results
with reference intervals and/or
critical results, patient diagnosis
and previous test results (if
available); and b) confirmation of
test results.
"evaporation" of
"validation" of results
The counterpart of reference values are clinical
decision limits or clinical decision values, not
critical values. Critical values are a subset of
decision values. ISO 15189 use “decision limit”
and “clinical decision values”. See IFCC 2018 [5]
Statland BE. Clinical Decision Levels for
Laboratory Tests (Oradell 1987).
Before the definition of critical values,
agreement must be reached within the
laboratory and with physicians using the
laboratory results.
1.3.1. Sample dilution
Recommendation 6
sample dilution should be included in analytical
phase.
1.3.2. Repeat testing
Recommendation 7
Lack of concept of
postanalytic and post
-
postanalytic phases
Repeat measurement should be included in
analytical phase.
PROCEDURE 2: Decision to
release test results
Recommendation 9
... specialization in medical
biochemistry and laboratory
medicine ...
lacks in
-
depth discussion of
the different levels of
"validation" and the
different clinical situations
(emergency, urgent, POCT).
Today, almost all laboratory test results are
released by automatic selection or POCT
systems, without manual intervention.
The activities described in Recommendation 9,
such as accessing patients' histories, revoke part
or
all of the results of laboratory tests,
requesting a new test or sample
on the basis of
clinical information and previous test results,
are not routine. Rather, they are very important
consultative activities, exercisable in very
selected cases.
PROCEDURE 3: Preparation of
the laboratory test report
Recommendation 10
… minimum content and layout
requirements…
Noone
Nowadays, the results of laboratory tests are
transmitted in a way that is aimed at individual
use, without any consideration of the organised
representation in 'reports'
PROCEDURE 4: Release of the
laboratory test report
Recommendation 11
...always be possible to obtain a
printed form. Electronic … reports
must be in a “read
-
only” format ...
absence of digital
communications and smart
phone applications as well
as the direct relationship
with the "patient".
Printing of results or reports is now an obsolete
activity. security of health data is a matter for
specific technical standards. A 'read only'
indication is not sufficient.
ISO 15189 stated that "the laboratory must
verify that changes are accurately reproduced
by information systems outside the
laboratory"...
PROCEDURE 8: Post
-analytical
quality indicators
Recommendation 17
... turnaround time (TAT),
percentage of incorrect (revoked)
laboratory test reports, and
notification of critical results.
IFCC "key processes"
(TAT, incorrect reports,
notification
of critical findings),
"outcomes" (modified
findings ...) and "supporting
processes"
Noone
Laboratory results –page 2
Results
PC [3] notes the "evaporation" of "validation" of
results, the distance between CR [1] and IFCC [4] on
"additive testing", comments and "Critical Results",
the absence of digital communications and smart
phone applications, as well as the direct relationship
with the "patient".
SIPMeL [2] believes with IFCC [5] that
clinical/medical decision levels, of which the critical
values are a subset, should be used in the
comparison of the results.
CR [1] on Release decision, Preparation and Printing
of report should be revised: today almost all
laboratory results are released by automated
selection or POCT and communicated via electronic,
not paper-based systems.
Laboratory users, health data standards (such as the
International Patient Summary), clinical decision aids
and artificial intelligence systems need results, not
reports. [6].
The characteristics of the staff confirming the
results, the content and layout of the report, the
printed form and 'read only' locking are no longer
useful. CR [1] lacks the reproduction of results by
external information systems.
Laboratory results –page 3
Discussion and Conclusions
It is good that CR [1] pays attention to post-
examination processes and contains appendices full
of practical examples, but some critical points should
be updated.
Laboratory users, health data standards clinical
decision support and artificial intelligence systems
need results, not reports.
Consultation activities such as access to patient
histories and revocation of results, while important,
are not carried out before the release of each single
data.
Printing on paper is obsolete, but accurate
reproduction of results by information systems
outside the laboratory is crucial for patient safety, as
stated in ISO 15189. 'Read only' is irrelevant for the
security of data.
The fast evolution of medical laboratory
organizations must be followed by standards and
recommendations with great speed.
Laboratory results –page 4
References
1 Lenicek Krleza J et al. Post-analytical laboratory work: national
recommendations from the Working Group for Post-analytics on behalf
of the Croatian Society of Medical Biochemistry and Laboratory
Medicine. Biochem Med (Zagreb) 2019;29:020502.
https://doi.org/10.11613/BM.2019.020502
2. Pradella M. Infrastruttura informatica per i Laboratori medici (LIS) del
2020: le raccomandazioni SIPMeL. Riv Ital Med Lab 2017;13:56–62.
https://www.sipmel.it/it/riviste/articolo.php/114063
3. Cappelletti P. The post-analytical phase and the patient-laboratory
interface. Riv Ital Med Lab 2020;16:135-40.
https://www.minervamedica.it/en/journals/medicina-
laboratorio/article.php?cod=R54Y2020N03A0135
4. Ajzner É. Adding value in the postanalytical phase. EJIFCC
2016;27:166–73.
https://www.ifcc.org/media/415307/eJIFCC2016Vol27No2pp166_173.p
df
5. Ozarda Y et al. IFCC Committee on Reference intervals and Decision
Limits (C-RIDL). Distinguishing reference intervals and clinical decision
limits. Crit Rev Clin Lab Sci. 2018;55:420-31.
https://www.tandfonline.com/doi/abs/10.1080/10408363.2018.148225
6?journalCode=ilab20
6. Pradella M. Il risultato di Laboratorio nella infrastruttura informatica
sanitaria - The laboratory result in the healthcare IT infrastructure. Pisa,
December 2019 http://dx.doi.org/10.13140/RG.2.2.17549.49124
Internet resources
https://www.sipmel.it/en/lineeguida/approvate/110813
https://www.westgard.com/decision.htm
https://openlibrary.org/works/OL4973204W/Clinical_decision_levels_fo
r_lab_tests
https://labmedico.blogspot.com/2021/11/decision-limits-and-decision-
values.html
https://www.ifcc.org/ifcc-education-division/workinggroups-special-
projects/laboratory-errors-and-patient-safety-wg-leps/quality-
indicators-project/ Laboratory results –page 5
