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Risk Assessment and its Analysis in Relation to ISO 15189:2012-An Experience

of a Tertiary Care Teaching Hospital Laboratory

Article in International Journal of Chemical Sciences · January 2024

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 International Journal of Chemical and Biochemical Sciences (IJCBS), 25(13) (2024): 37-43

International Journal of Chemical and Biochemical Sciences

(ISSN 2226-9614)

Journal Home page: www.iscientific.org/Journal.html

© International Scientific Organization

Risk Assessment and its Analysis in Relation to ISO 15189:2012- An

Experience of a Tertiary Care Teaching Hospital Laboratory

Pradnya Padalkar1*, Preeti Doshi2*, Meera Modak3, Meghana Padwal4, Bharati Dalal5,
Lalna Takale6, Reena Bharadwaj7
1*
Associate professor, Department of Biochemistry, Bharati Vidyapeeth (DTU) Medical College, Pune-
411043, India.
2*
Dr Preeti Doshi, Professor, Department of Pathology, Bharati Vidyapeeth (DTU) Medical College, Pune-
411043, India.
3
Dr Meera Modak, Professor & Head of Laboratory, Department of Microbiology, Bharati Vidyapeeth
(DTU) Medical College, Pune-411043, India.
4
Dr Meghana Padwal, Professor & Head, Department of Biochemistry, Bharati Vidyapeeth (DTU) Medical
College, Pune-411043, India.
5
Dr. Bharati Dalal, Associate Professor, Department of Biochemistry, Bharati Vidyapeeth (DTU) Medical
College, Pune-411043, India.
6
Dr. Lalna Takale, Associate Professor, Department of Biochemistry, Bharati Vidyapeeth (DTU) Medical
College, Pune-411043, India.
7
Dr. Reena Bharadwaj, Professor & Head of Department of Pathology, Bharati Vidyapeeth (DTU) Medical
College, Pune-411043, India.

Abstract
Laboratory plays an important role in diagnosis; thus, test reports must be reliable and accurate. The working of laboratory
tests involves various processes which may cause errors at pre-analytical, analytical and post-analytical phases of testing. Hence the
study was planned to evaluate errors or risks and its analysis in laboratory. The format was prepared for risk assessment and shared
to various sections of laboratory to obtain data from five years to assess laboratory activities for risk assessment outlined required
control measures. The criteria for risk assessment were fixed and data was analyzed based on that and observed maximum severity
in the year 2019 for post analytical consideration category compared to others. The present study emphasizes on risk identification,
calculation of incidence and establishing protocol for control measures. This study provides guidelines for risk assessment and also
encourages laboratory to develop system for laboratory inherent risks to improve quality of testing and ultimately patient diagnosis
and prognosis.

Keywords: Risk assessments, Laboratory errors, Control measure, Post analytical considerations.

Full length article *Corresponding Author, e-mail: [email protected]; [email protected]

1. Introduction it is just new for healthcare services and medical checkup in

As per ISO 31000: 2009, Risk is an effect of uncertainty laboratory [3]. To emphasize this Donald Rumsfeld said
on objectives whether positive or negative or they can be “there are Known Knowns, there are Known Unknowns, but
referred to as unhappy outcome of unrecognized, there are also Unknown Unknowns” [2]. Evaluation of risk is
unintentional and not managed errors [1-2]. This uncertainty dependent on probability of harm and severity of harm. Thus,
consists of measurable and immeasurable risk as work is laboratory need to identify risks to: 1) reduce undesired
always done for measurable risk calculations which may be impact and potential failure in laboratory activities 2) achieve
“incomplete” and but it is not known how they are purpose of running laboratory and bringing about
incomplete. The concept of risk is not new in industries, but improvement by acting on opportunities [4-5]. Testing of

Padalkar et al., 2024 37

 International Journal of Chemical and Biochemical Sciences (IJCBS), 25(13) (2024): 37-43

patient sample occurs in large number and involves many considerations. The data format was shared with all the
different processes. Errors can occur at any point in the sections of laboratory for collection of data. The collected
laboratories, hence the need for careful examination of data was used for calculating incidence (%) and probability
laboratory weakness [6]. of harm. Assessment criteria or Risk matrix was set for
Laboratories therefore must take precautionary measures laboratory and circulated to all sections as follows:
to ensure that the results obtained are reliable and accurate
[6]. Laboratory cannot predict, whether small error may • Occasional/Minor (<1%)
affect less, or it will have a huge impact on the outcome of • Moderate (1-2%) and
the results. Sample analysis derives information which is used • Frequently (2-3%)
for making patient related decision, thus laboratory • Severe (>3%) depending on percentage.
information which is not accurate may result in poor outcome
[7]. Hence it is necessary for laboratory to take initiative to Benchmark for incidence was fixed at 1% and if any
establish strong and good risk assessment process which will identified risk crosses the benchmark, the respective sections
help to protect from injuries, to prevent accidents for overall was instructed to take measures for control of that particular
and safe working of the laboratory [7]. The risk management risk element.
process comprises of five important steps, which are risk
identification, risk assessment, risk control, record-keeping 3.6. Confounding factor
and review [8-9]. This knowledge emphasis on risk Communication with respective sections
management has become an essential need for taking action
and addressing risks. Therefore, this observational study was 3.7. Statistical Analysis
planned with the intend to evaluate the potential link between Categorical variable results were calculated by frequency
laboratory test results and patient safety. The aim of this study and incidence in percentage
is to assess and analyze risk in relation to ISO 15189: 2012 in
a tertiary care hospital. 4. Results
As per statistical suggestions results were obtained from
2. Objectives all the sections for observing the various laboratory activities.
• To find the incidence of risk in the various After identification of risk from each section, the requirement
laboratory activities. with frequency of the risk parameter was analysed for each
• To obtain data from each laboratory section in section. Incidence and probability were considered as per
shared format given criteria in our study: occasional/Minor (<1%),
• To establish a protocol to control the identified risk moderate (1-2%) and frequently but not severe (2-3%) and
in laboratories. severity (>3%). Number of errors mentioned under
occasional, moderate, frequently and in severe section is
3. Materials and Methods against total number of samples. There number of parameters
which showed severe risks were less in the year 2018; they
3.1. Study setting belong to the category of other post analytical considerations
A medical college with accredited hospital laboratory in the sections of Microbiology, clinical biochemistry and
(As per ISO 15189) of a tertiary care hospital. clinical pathology section. The reason of the severe risk
documented is because of all the sections include critical alert
3.2. Study Design reporting and turnaround time under other post analytical
Observational study process. The occurrence of severity was found to be
maximum in the year 2019 compared to remaining 4 years
3.3. Ethics approval data. It was found more in biochemistry section, which
Institutional ethics committee approval was taken for involves all processes of laboratory except result
scientific and ethical content (EC No 166). interpretation and result reporting. In the haematology
section two moderate risks were observed under specimen
3.4. Study population requirement and other post analytical considerations and one
In this study five-year data of risk assessment was used each in cytology and clinical pathology section was under
for analysis other post analytical considerations. Table 3 of 2020 shows,
severe risk category which was found in other post analytical
3.5. Methodology considerations in hematology and cytology sections
The observational study was conducted by analyzing respectively and moderate risk was observed under specimen
data from 2018 to 2022 at tertiary care hospital laboratory. ordering, requirement and processing in hematology,
All the sections (hematology, cytology, clinical pathology, cytology and microbiology sections. Table 4, shows
histopathology, clinical biochemistry, microbiology) of observations for the year 2021 severe risks category was
laboratory were selected for the present study as a model of found under specimen testing and other post analytical
risk assessment. All activities of the laboratory were assessed considerations one in each section (microbiology and
starting with sample collection to report release. A table was cytology). Similarly moderate risk was observed for
prepared to find probability of risk. Once risk was identified specimen testing, result interpretation and result reporting in
observations were noted depending on specific laboratory microbiology, cytology, clinical pathology section. In 2022,
activity, it pertains to specimen ordering, specimen severe category was observed for other post analytical
requirement, transport, specimen handling and processing,
result interpretation, reporting and other post analytical
Padalkar et al., 2024 38
 International Journal of Chemical and Biochemical Sciences (IJCBS), 25(13) (2024): 37-43

considerations in Microbiology, clinical biochemistry and then started to develop procedure for monitoring activities.
cytology sections. Control measures were documented and implemented at that
However, moderate risk was found for specimen time; therefore, laboratory must initiate long term practices
requirement and other post analytical considerations only in regarding risk analysis and monitoring its control measure.
hematology section. The results of this present study demonstrate three major
finding as the outcome of study. First, identified processes for
5. Discussion risk assessment are valid for obtaining appropriate data.
The biomedical laboratories monitored and assessed Second high percentages of risks were found to occur for
under physical, ergonomic, chemical, biological, and other post analytical consideration which involves critical
electrical areas. The risk assessment in the medical laboratory reporting and turnaround time. This observation forced
is gaining more attention day by day. Literature search laboratory staff to take appropriate measures to control these
indicates that more research in this area is necessary to spread errors which then showed improvement over the next three
awareness and to inculcate environment in the laboratories years. The third major finding was use of effective vehicle
for risk estimation as per NABL (National accreditation (taking control measure) for controlling laboratory errors.
board for laboratory testing and calibration) guidelines [4]. Wasaif Alshammari et al., also carried out observational
Risk is inherent in all laboratory tests and processes. In study to evaluate risk in two educational laboratories to
addition, because of the many steps involved in laboratory highlight risk and results were used to improve laboratory
testing, the risk of error can be high. Therefore, it is important quality and safety by taking control measures [8]. The control
to evaluate and prioritise risks and determine the acceptable measures needed, such as on-going training, adhering to
level of risk in the clinical lab [6]. Every laboratory has their standard precautions according to laid down protocol, and
own weakness during sample processing but understanding establishing quality indicators, must be implemented to
that weakness is the first step to move ahead for quality goal minimize risk parameters [8]. Rasoul Yarahmadi and Pravin
based on risk management. Thus, the present study was aimed Moridi et al., had similar observations in laboratory fields.
to evaluate the different risks encountered in a medical They elaborated, communication with the respective section
laboratory setup. The risks were observed and analyzed under and the probability occurrence tool were considered sufficient
following procedures (11). A cause or a result is never totally and hence were included for assessment and analysis of risk
predictable. Risk is not a fixed measurement; and variable as they enable for identification and implementation of
depending on various by events and is therefore susceptible actions to be taken in the future [13-14].
to change. NABL document and few other authors mentioned Fabiane Rodrigues da Silva et al., in their study stated that,
following Risk Matrix in their article: 1-5: LOW, 6-10: for each risk, the impact of the proposed measures should also
MEDIUM-LOW, 11-15: MODERATE, 16-20: be assessed, taking into account (or not taking into account)
MODERATE-HIGH, 21-25: HIGH [2,3,11-12]. Following events that occurred during the period which may have been
this matrix increases the likelihood of errors, and therefore associated with that risk [13-15].
we established our own benchmark for risk assessment and
its analysis. As a result, our lab has made progress which 6. Limitations
appears to be satisfying in terms of lowering the risk matrix • Impact of outcome has to be analyzed.
and developing new benchmarks. Indicators of outcome are: • Control measures were taken for specific error or
• Incidence risk. Laboratory need to prepare protocol to review
• Probability of harm of the control measures initiated.
• Control measure. • Risk mitigation need to be analyzed.
Risk can be estimated by factors like: 1) detectability 2) • Missed information if any from sections as LIS do
severity 3) occurrence. In present study frequently occurring not catch the errors.
and severe risk parameter were observed under other post
analytical considerations as shown in Table 1,2,3,4, & 5. In
2019, clinical biochemistry and overall, many other sections
of the laboratory accounts for maximum observations under
severe risk in most of the activities or processes, found in
table 2 when compared to table 1. This could be due to prompt
observation of all the errors under laboratory activities or
breach of established protocol for observing and monitoring
error or over sighting of errors by laboratory staff about
processes. Table no 3,4, & 5 show that data of the year 2020,
2021 and 2022 which showed a decreased error rate or risk as
compared to 2018 and 2019. This reflects that the
identification of the risks and control measures taken after
2019 were sufficient to reduce or eliminate risks occurring in
the laboratory. Though maximum severe risk were found
under post analytical considerations category, specimen
ordering, specimen requirement, specimen processing and
specimen testing activities cannot be ignored because
moderate risk was observed in these areas too. The laboratory

Padalkar et al., 2024 39

 International Journal of Chemical and Biochemical Sciences (IJCBS), 25(13) (2024): 37-43

Table 1: Data format shared with all the sections of laboratory for collection of data.

Sr. Process/ Probability of Measures for

Requirement Risk Incidence
No Requirement harm control
1 Specimen ordering Exam number, Lab number.
Specimen As Specified in Primary
2
requirement Sample Collection Manual
3 Specimen transport Safe transport
Specimen
Correct entry of patient details.
4 processing
Sample check before run.
&handling
Calibrated instrument. 'Pass'
before sample run. IQC
5 Specimen testing
acceptable. EQA satisfactory.
Proper storage of reagents.
Knowledge and Competence
Result
6 about interpreting machine
interpretation
printout.
Correct entry of results.
7 Result reporting Dilution, Reporting within
time.
Other post
Alert critical values
8 analytical
information, Turnaround Time.
consideration

Table 2: Risk management data for the year 2018.

Year Criteria Clinical Clinical

Microbiology Hematology Histopathology Cytology
Biochemistry Pathalogy

2018 Occasional/
7 7 6 8 8 7
Minor
2(specimen
Moderate 0 0 requirement & other 0 0 0
post analytical

Frequently 0 0 0 0 0 0

1 (other Post 1 (other Post 1 (other Post

Severe 0 0 0
analytical) analytical) analytical)

Table 3: Risk management data for the year 2019.

Clinical Clinical
Year Criteria Microbiology Hematology Histopathology Cytology
Biochemistry Pathalogy
Occasional/
2019 7 2 6 8 7 7
Minor
2(specimen
requirement &
Moderate 1 0 0 0 0
other post
analytical
Frequently 0 0 0 0 0 0
1(other post 1 (other Post
Severe 0 6 0 0
analytical) analytical)

Padalkar et al., 2024 40

 International Journal of Chemical and Biochemical Sciences (IJCBS), 25(13) (2024): 37-43

Table 4: Risk management data for the year 2020.

Clinical Clinical
Year Criteria Microbiology Hematology Histopathology Cytology
Biochemistry Pathalogy

Occasional/
2020 7 8 6 8 6 8
Minor

1(Result 1(specimen 1 (specimen

Moderate 0 0 0
reporting) ordering) processing)

Frequently 0 0 0 0 0 0

1(other post 1(other post

Severe 0 0 0
analytical) analytical)

Table 5: Risk management data for the year 2021.

Clinical Clinical
Year Criteria Microbiology Hematology Histopathology Cytology
Biochemistry Pathalogy

Occasional/
2021 6 8 8 8 6 7
Minor
1 (Result
1(Result 1 (specimen
Moderate 0 0 0 interpretation
reporting) testing)
& Reporting)

Frequently 0 0 0 0 0 0

1(specimen 1(other post

Severe 0 0 0 0
testing) analytical)

Table 6: Risk management data for the year 2022.

Clinical Clinical
Year Criteria Microbiology Hematology Histopathology Cytology
Biochemistry Pathalogy

Occasional/
2022 7 7 6 8 8 7
Minor
2 (specimen
requirement
Moderate 0 0 0 0 0
& other post
analytical)

Frequently 0 0 0 0 0 0

1(other post 1(other post 1(other post

Severe 0 0 0
analytical) analytical analytical)

Padalkar et al., 2024 41

 International Journal of Chemical and Biochemical Sciences (IJCBS), 25(13) (2024): 37-43

Figure 1: A process map showing key steps in the clinical diagnostic testing process [6,9-11].

7. Conclusions References
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