Autovalidation and

multistep validation of
laboratory result
B. Rina Aninda Sidharta, dr, SpPK(K)

CPD on CPLM Joglosemar – 28 April 2018

 PENDAHULUAN
Laboratorium → data pemeriksaan lab → membantu
diagnosis, monitor dan terapi.
Tanggung jawab laboratorium antara lain :
▪ Identifikasi yang benar, pengambilan & pemrosesan
sampel pasien
▪ Kinerja pemeriksaan yang akurat
▪ Pelaporan hasil tepat waktu
▪ Komunikasi dengan klinisi dan petugas kesehatan
lain
 WORKFLOW LABORATORIUM
Ada 6 tahapan utama di
laboratorium
1. Permintaan pemeriksaan
2. Pengambilan sampel
3. Pengiriman sampel ke lab
4. Pemrosesan sampel
5. Analisis sampel
6. Pelaporan hasil
 WORKFLOW LABORATORIUM

Ada 5 tahapan validasi

1. Administratif
2. Teknis
3. Sampel
4. Pasien
5. Klinis
PRE ANALITIK
CEKLIST VALIDASI PEMERIKSAAN
ANALITIK
CEKLIST VALIDASI PEMERIKSAAN
PASCA ANALITIK
CEKLIST VALIDASI PEMERIKSAAN
▪ Processes of validation and verification of
results take place in a manual form → results
are released individually, and they may reach
hundreds per shift.
▪ This task demands qualified professionals
▪ It is time consuming and highly subjective →
depending on knowledge and experience of
the professional releasing results.
▪ Autoverification → release of laboratory test results
from clinical instruments to hospital interface, or to
patients' records, with no human intervention.
▪ Verification rules are inserted in the middleware
and/or in the laboratory information system (LIS),
based on criteria established by the laboratory.
▪ It ensures that every result is consistently reviewed
in the same way, improving the entire verification
process and patient safety.
 Autoverification criteria → defined by the user and
adapted to different settings and services →
include reference values, internal quality control
results, instrument flagging, delta check
(comparison of the current exam results against
another previous result of the same patient),
reagent lot checks, demographic information about
patients, clinical information, critical values and
others
Implementing autoverification → standardized
result verification criteria,  turnaround time
(TAT), optimization of laboratory staff working
time, allowing them to focus on results that
really need a more detailed interpretation, and
discuss important cases with the ordering
physicians
Integrity the biological sample, equipment errors,
interference and quality control were set in the
middleware.
The instruments read the lipemia, turbidity and hemolysis
indices of each sample, it was possible to set the flag in the
middleware, corresponding to each interferent, if it were
present in enough quantity to interfere with the test result.
The interference limit of each of them for each test was set
in the equipment by the manufacturer, and can be sent to
the middleware. When they are present, a new sample
must be ordered.
In the LIS, values of delta check and automatic release
interval were configured.
All the results previously released in the middleware were
submitted to the LIS criteria.

Validation was done with the professionals → responsible

for result release.
Before configuring the system, rules were
applied manually in tests already released
to detect any discrepancies and possible
inadequate releases.
For each test, values within and outside the
defined release range, as well as delta
check flags, were verified.
KESIMPULAN
 Autoverification implementation led to a
more consistent reviewing process of test
results, efficiency and improved patient
safety