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ISO series update, Part 2 - ISO 15189:2012 Medical laboratories - Requirements

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ISO SERIES UPDATE
Part 2 - ISO 15189:2012 Medical laboratories - Requirements for quality and
competence

Paulo Pereira, Ph.D.

Contributing Editor, Westgard QC, Madison (WI)
pauloarpereira@outlook.com
February 2017

Citation: Pereira P (2017). ISO series update, Part 2 - ISO 15189:2012 Medical
laboratories - Requirements for quality and competence. Madison (WI): Westgard QC.
Retrieved from: http://www.westgard.com/iso-15189-2012-requirements-1.htm.
Accessed: month, day year.

Purpose
This text is probably the most challenging on the “ISO series update” since many
reviews have been published related to ISO 15189 3rd edition [1]. Therefore, this essay
is intended to discuss some specifications briefly and to debate what is happening with
ISO 15189 implementation in the world. The standard document is focused on the
medical laboratory, and its goal could be interpreted as the satisfaction of interested
parties (4 of [1]). Stakeholders cannot be misunderstood as costumers only, such as
patients, but any internal or external involvement with the med lab, including, but not
only, professionals, suppliers, and accreditation agencies. “The customers’ satisfaction”
could be understood as the contribution of the reported results to an accurate clinical
decision. For this purpose, this international standard is based not only on a
management system but also on a set of medical laboratory technical specifications.
Despite the lab sustainability should be controlled, it is not mandatory. Such as common
in others ISO standards, “shall” stipulates a requirement, “should” specify a
recommendation, “may” instructs permission, and “can” suggests a possibility or a
capability. Only the “shall” signifies that a particular specification is compulsory.

The approach
ISO Technical Committee (TC) 212 has developed ISO 15189 (Medical laboratory
testing and in vitro diagnostic test systems) Working Group (WG) 1 (Quality and

Page 1 of 14
competence in the medical laboratory). ISO 15189 debut edition [2] was published after
a three-year hiatus from the final draft and four years after the publication of ISO/IEC
17025 first edition [3]. It quickly became a widely-accepted standard to be used for
accreditation of medical laboratory competence. The 2nd edition [4] was published in
2007 to provide the same structure as ISO/IEC 17025 intended for testing and
calibration in general laboratories for what it could be viewed as the “ISO/IEC 17025”
for medical laboratories. When a medical laboratory chooses an accreditation plan, it
should select an accrediting body that operates according to appropriate international
standards and which takes into account the particular requirements of this field. Before
2003 medical laboratories could be accredited according to the ISO/IEC 17025
approach, and they were able to change to ISO 15189 at their option. Depending on the
accrediting bodies, it may be possible for a medical laboratory to choose between
ISO/IEC 17025 and ISO 15189 or even to have both accreditations. For instance, when
a medical laboratory has ISO 15189 accredited tests and also has a calibration method
intended to calibrate not only internal devices (which does not require an ISO/IEC
17025 accreditation) but also equipment for external customers.
The difference between ISO 9001 and ISO 15189 approach that is immediately
recognized is the presence of medical-technical laboratory requirements in ISO 15189.
The framework provides a quality management system close to the ISO 9001:2008
management requirements added by specifications for technical competence that are
particular to medical laboratories.
The standard quality management model is based on the Deming TQM approach [5] [6]
[7]. Figure 1 displays a quality cycle applicable to a medical laboratory under ISO
15189 accreditation. The leadership is critical to the success of all the cycle phases.
Probably, on the next guideline revision, “customers” will be replaced by “interested
parties,” including not only the clients but others that need to verify lab practices, such
as the regulatory and accreditation agencies. This terminology is already revised in the
current ISO 9001 edition (4.2 of [8]).
ISO 15189 technical requirements are applied for personnel, accommodation and
environmental conditions, laboratory equipment, reagents, and consumables, pre-
examination processes, examination processes, ensuring the quality of testing processes
results, post-examination processes, reporting of results, the release of results, and
laboratory information management. Table 1 summarizes these stipulations.

Page 2 of 14
 Figure 1 A quality cycle in a medical laboratory conform to ISO 15189:2012.
Interested Organization and Interested
parties management parties
Quality
management
system

Evaluation and Interested

Resource Leadership continual parties’
management
improvement satisfaction
Requirements
(including
technical
requirements Process approach
according to Pre- Post- Reported
Input Examin. Output Costumer
results examin. examin. results
intended use)

Support processes

Table 1 Summary of ISO 15189 specifications.

5.6 Ensuring quality of examination
5.1 Personnel
results
Personnel qualifications documentation, job Quality control procedures design to verify
descriptions, personal introduction to the the attainment of the intended quality of
organizational environment program, training results, quality control materials, quality
provision, competence assessment per control data, interlaboratory comparisons,
person, reviews of staff performance, analysis of interlaboratory comparison
continuing education and professional samples, evaluation of laboratory
development, and personal records of performance, and comparability of
relevant skills. examination results.
5.2 Accommodation and environmental
5.7 Post-examination processes
conditions
Laboratory and office facilities to provide an
environment appropriate for the duties to be
Review of results, storage, retention, and
undertaken, storage facilities, staff services,
disposal of clinical samples.
patient sample collection facilities, facility
maintenance, and environmental conditions.

Page 3 of 14
 5.3 Laboratory equipment, reagents, and
5.8 Reporting of results
consumables
Equipment: Documented procedure,
acceptance testing, instructions for use,
calibration and metrological traceability,
maintenance and repair, adverse indented
Report of examination results, the report
reporting, and records. Reagents and
attributes, and content.
consumables: Documented procedure,
reception and storage, acceptance testing,
inventory management, instructions for use,
adverse incident reporting, and records.
5.4 Pre-examination processes 5.9 Release of results
Documented procedures, information for
patients and users, request form information,
Documented procedures, automatic
first sample collection and handling, sample
selection and reporting of results, and
transportation, sample reception, pre-
revised reports.
examination handling, preparation, and
storage.
5.10 Laboratory information
5.5 Examination processes
management
Examination procedure selection which has
been validated for their intended use,
verification or validation of tests,
Authorities and responsibilities, and
measurement uncertainty of measured
information system management.
quantity values, biological reference intervals
or clinical decision values, and
documentation of testing procedures.

Sub-chapters 5.3, 5.5, and 5.6 require specifications for which there is not a
harmonization of practices - note that all the results are recorded, and its traceability is
assumed:

a) 5.3.1.4 Equipment calibration and metrological traceability

The medical laboratory participates in programs to calibrate and verification of trueness,
i.e., to determine and verify bias (systematic error analysis) defined as “the difference
between the expectation of the test results and an accepted reference value” (2.18 of
[9]). Measurement Precision (random error analysis) is also measured and verified. It is
defined as “the dispersion of independent results of measurements obtained under
specific conditions, is expressed such as standard deviation or coefficient of
variation”(2.15 of [9]). Preferably, traceable metrological materials should be used.
When these materials are not available, or their use is not significant to the estimate
accuracy, alternative materials could be used. See for a more in-depth discussion see
[10-12].
Page 4 of 14
b) 5.5 Examination processes requires:
 5.5.1.1 Selection of examination procedure: New tests are selecting per its
clinical purpose (intended use, fit for purpose). For instance, a screening test
selection in a blood bank should assure that a method with high diagnostic
sensitivity [13] is chosen to minimize the residual risk (2.29 of [14]) of post-
transfusion infection. ISO 15189 does not recommend any approach to select a new
test. Usually, it is based on a literature review using validation cases of state-of-the-
art methods.

 5.5.1.2 Verification of examination procedure: All tests used without

modification - “non-waived” tests - are verified using performance information data
available from the manufacturer. The verification shall evidence that the laboratory
performance claims have been met. The calculations are based on experimental data.
The methodology is presented in guides such as the CLSI EP15-A3 [15] for
quantitative tests or CLSI EP12-A2 [16] for qualitative tests.

 5.5.1.3 Validation of examination procedure: Modified (“waved”) or “in-house”

tests require a somewhat more complex stage. Also, “standard methods used outside
their intended scope” shall be validated. Again, these tests are validated according to
the clinical test purpose/intended use/impact of the result on the clinical decision.
Therefore, the specifications, such as the allowable total error, allowable diagnostic
sensitivity or allowable diagnostic specificity are selected accordingly. ISO 15189
does not state any approach for method validation, and it does not state any
goals/targets/claims. Identically to the non-modified tests, experimental data is
involved. The methodology is as complex as needed, and it is identical to what is
required to the manufacturer in the validation phase. CLSI guidelines referred to in
5.5.1.2 can also be used, but further studies are needed. For example, the calculation
of a clinical decision point based on representative samples of the population.

 5.5.1.4 Measurement uncertainty of measured quantity values: This requirement

is just for tests expressing quantitative results, as suggested by the subchapter title.
For qualitative results, it cannot be computed. Even if the qualitative results are
expressed on an ordinal scale according to cutoff, its determination is optional. ISO
15189 does not recommend a methodology to the measurement uncertainty
Page 5 of 14
 evaluation, regardless of be required. However, since ISO is a member of the
working groups of the Guide to the uncertainty of measurement (GUM) [17] and the
Vocabulary of international metrology (VIM) [9], it is presumed that an
“Uncertainty approach” ([17]) model is mandatory. Empirical models should be
used, preferably using data from the validation of the examination procedure phase.
It is not recommended the use of external quality assessment (EQA)/proficiency of
testing (PT) data as a primary source due to the heterogeneity of the results [18].
However, the EQA/PT is probably the most common model in medical laboratories
with tests accreditated to ISO 15189. It does not comply with the standard since
usually, this determination is not according to the results intended use (clause
5.5.1.4 of [1]). ISO 15189 2nd edition required that measurement uncertainty is
determined when its result was “relevant” and “possible” (5.6.2 of [4]) “Relevant”
could be interpreted as when the outcome has a significant clinical value, and
“possible” synonymous of the availability of a mathematical model. Such as the
total analytical error based on the “Error Approach” (also documented as Traditional
Approach or True Value Approach), measurement uncertainty is part of the
evaluation of the quality of the reported result, which could be applied to any
measurement. Target uncertainty must be defined, which can be viewed as complex.
See [19] for further details. Measurement uncertainty implementation is an
unsuccessful case in medical laboratories close to 23 years after GUM publication,
such as demonstrated by the Westgard QC 2015 survey [20]. Note that the
measurement uncertainty evaluation can be interpreted as redundancy of verification
and validation, just differing due to be used of the “Uncertainty Approach.” For
further details about models to determine measurement uncertainty in medical
laboratories see [21].

c) 5.6 Ensuring quality of examination results

 Internal quality control: A design of internal quality control scheme is applied,
but it is not recommended any approach. Most of the methods are used “the
Westgard rules,” however its application does not always fulfill its principles
[22], and there is not a harmonized practice. An alternative to the Levey-
Jennings charts could be used, such as the exponentially weighted moving
average (EWMA) chart (9.2 of [23]). Nevertheless, it is suggested a statistical
design based on the Sigma-metrics [24] principally because it relates the

Page 6 of 14
 determined total error with the allowable total error. The allowable total error is
equivalent to the error that does not significantly contribute to wrong clinical
decisions. For a depth discussion on this issue, please see [25].

Figure 2 A flowchart for activities on the examination and post-examination stages.

Selection of examination
procedures

Modified or
Non-modified
“in-house”

5.5.1
Selection, Performance specifications Examination Examination
verification, and according to method procedures procedures Reject
validation of intended use verification validation
examination
procedures
5.5.2 Biological Accept
reference intervals
or clinical decision
values Reject Rejected test

Performance specifications Measurement

according to method uncertaitny Reject
intended use evaluation

Accept

5.5 Examination Examination

Good laboratory practices
processes procedures

Result

5.6.2 Quality control

5.6.3 Interlaboratory Internal quality control result
comparisons EQA/PT
Review of results Rejected results
5.7.1 Review of Clinical information
results Previous examination results

5.5.2 Biological Accept

reference intervals or Examination results
clinical decision values Biologial reference intervals or Reported results
5.8.3 Report clinical decision values
content

 External quality assessment: Medical laboratory shall participate in programs

for EQA/PT and shall evidence corrective actions to results out of control. For
instance, when a result is out of acceptable group requirements. There are not
recommended approaches. The use of the EQA/PT approach is sometimes
misunderstood, for what some calculus based on its data could not be consistent.
For example, it could be an unreliable source for estimate bias if the group’s
results discrepancy is too large.

Page 7 of 14
Figure 2 represents the steps from the test selection to the reported results. The
accomplishment of the examination and post-examination phases are dependent on the
pre-examination stage.

FAQ
Which books are suggested to support the ISO 15189 quality management system?
Principally two publications: David Burnett, Ph.D. “A Practical guide to ISO 15189 in
laboratory medicine” (2013), and James Westgard, Ph.D. and Sten Westgard, M.Sc.
“Basic quality management systems” (2014).

Which references can support ISO 15189 specifications on examination and post-
examination activities?
a) Method selection
See Westgard QC lesson no. 20 Selecting a method to validate and Basic method
validation 3rd ed. (2008) book
b) Method verification and validation
Precision:
-Detection limit: See Westgard QC lesson no. 29 The detection limit experiment, Basic
method validation 3rd ed. (2008) book, and CLSI EP17
-Precision components: See Westgard QC lesson no. 22 The replication experiment,
Basic method validation 3rd ed. (2008) book, and CLSI EP15 (also EP5, EP9, and EP19)
-Bias: Proportional and constant bias: See Westgard QC lesson no. 23 The comparison
of methods experiment, Basic method validation 3rd ed. (2008) book, and CLSI EP15
(also EP9 and EP10)
- Bias: Drift and carryover: See Basic method validation 3rd ed. (2008) book, and CLSI
EP10
- Bias: Linearity: See Westgard QC lesson no. 26 The linearity or reportable range
experiment, Basic method validation 3rd ed. (2008) book, and CLSI EP6 and EP10
- Bias: Interferences: See Westgard QC lesson no. 27 Interference and recovery
experiments, Basic method validation 3rd ed. (2008) book, and CLSI EP7 and EP14
-Total error: See Westgard QC lesson no. 23 The comparison of methods experiment,
Basic method validation 3rd ed. (2008) book, and CLSI EP21

Page 8 of 14
-Qualitative assays: See Westgard QC essay Basic validation of qualitative tests,
Statistical methods in diagnostic medicine. 2nd ed. (2011) book, and CLSI EP12 and
EP24
b) Measurement uncertainty
-Modular approach: See Westgard QC essay Time to engage in MU, GUM,
EURACHEM QUAM books, and CLSI EP29
-Empirical approach: See Westgard QC essay The Hitch-hiker’s guide to MU in clinical
laboratories, Uncertainty of Measurement in Medical Laboratories chapter,
EURACHEM QUAM, NordTest TR 537, and EURACHEM Target Uncertainty books,
and CLSI EP29
c) Internal quality control
See Westgard QC lesson no. 74 Best practices for “Westgard rules”, Six Sigma quality
design and control 2nd ed. (2006) book, and CLSI C24
d) External quality assessment/proficiency testing
See Westgard QC Quality Requirements, Six Sigma quality design and control 2nd ed.
(2006) book and CLSI GP27
e) Reference intervals
See Westgard QC essay FAQ in reference intervals and biological variation, Statistical
bases of reference values in laboratory medicine (1995) book, and CLSI C28
f) Risk management
See Westgard QC Risk management essays, Six Sigma risk analysis (2011) book, and
CLSI EP18 and EP23.

Which software intended for the medical laboratory is available?

For the validation of examination, procedures are suggested Medcalc (MedCalc
Software bvba), EP Evaluator (Data Innovations), and Analyse-it (Analyse-it Software,
Ltd.). Dietmar Stöckl, Ph.D. offers a huge number of spreadsheets helpful to validation
on STT Consulting. For measurement uncertainty, it is recommended the MUKit
(SYKE). It is a freeware based on [26]. For IQC there are several software available,
some based on Web services. For an IQC statistical design based on Sigma-metrics is
proposed EZ Rules (Westgard QC).

Page 9 of 14
Is there some guideline to support metrology requirements (subchapter 5.3.1.4)?
Yes, ISO 10012:2003 [27] is the guide to the control of monitoring and measuring
equipment. There are several other ISO guidelines for verification and validation of
equipment, such as the ISO 8655 series for pipettes. Please, search the ISO Web site.
Most of organizations on metrology have a huge number of free guidelines, such as
International Bureau of Weights and Measures (BIPM), European Association of
National Metrology Institutes (EURAMET), European Federation of National
Associations of Measurement, Testing and Analytical Laboratories (EUROLAB),
EURACHEM, Cooperation on International Traceability in Analytical Chemistry
(CITAC), National Institute of Standards and Technology (NIST), and Instituto
Portugues de Acreditacao (IPAC). Part 3 of these Westgard QC series is focused on
metrology requirements.

Is there some guideline based on audit requirements (4.13)?

Yes, ISO 19011:2018 [28] “is intended to apply to a broad range of potential users.” It
is the recommendation to support the audits, including the documented procedure. Part
4 of these series will is oriented to audit requirements [13].

Is there some guideline to support safety specifications (5.2)?

Yes, ISO 15190:2003 [29] is the complementary standard to ISO 15189. Part 5 of these
series is based on safety requirements.

What is happening with ISO 15189 implementation from a global perspective?

Currently, ISO 15189 is obligatory in Australia and Latvia. Since 2011 that all new
French medical laboratories must be accredited. All other public or private laboratories
in France must be accredited since November 1, 2016, on at least 50% of the tests, 70%
in 2018, and 100% in 2020. In the Netherlands, the CCKL accreditation has been
changing to the ISO 15189 at the aim of the Dutch ‘Raad voor Accreditatie’ (RvA)
before January 1, 2018. Thus, the implementation case of ISO 15189 at a global
perspective could be designated as unsuccessful, differently from what is happening
with ISO/IEC 17015 in other science fields. On a harmonization perspective of good
laboratory practices, this is a major concern.

Page 10 of 14
Summary
The tests’ accreditation according to ISO 15180 has several advantages.
The pros could be summed up as:
- The only global standard for the accreditation of medical laboratory results;
- Based on good laboratory practices;
- Focus on technical specifications in the medical laboratory; - Process approach
matching the pre-analytical, analytical, and post-analytical phases;
- Oriented to support accurate clinical decisions;
- Identification and traceability information of the different phases of the medical
laboratory process;
- Monitoring and measuring of devices that significantly contribute to the trueness and
uncertainty of the reported results;
- Training and competency assessment of the staff which is critical to good management
and good laboratory practices, and;
- Infrastructure to correctly support operating practices.

Nevertheless, there are a few cons to the ISO 15189:

- The accreditation is expensive when compared to the ISO 9001 certification;
- Its value is not well understood by the physician and the customers of clinical
decisions;
- It is not used by most of the medical laboratory agencies as the standard to
accreditation;
- It requires auditors with an advanced matrix of skills;
- It does not require sustainability;
- The specifications sometimes are generic;
- It does not standardize critical practices such as the validation, measurement
uncertainty, IQC and EQA/PT of examination procedures, and;
- The safety specifications are basic.

Page 11 of 14
References
1. International Organization for Standardization (2012). ISO 15189 Medical
laboratories - Requirements for quality and competence. 3rd ed. Geneva: The
Organization.
2. International Organization for Standardization (2003). ISO 15189 Medical
laboratories - Particular requirements for quality and competence. Geneva: The
Organization.
3. International Organization for Standardization (1999). ISO/IEC 17025 General
requirements for the competence of testing and calibration laboratories. Geneva: The
Organization.
4. International Organization for Standardization (2007). ISO 15189 Medical
laboratories - Particular requirements for quality and competence. 2nd ed. Geneva:
The Organization.
5. Feigenbaum, A (1956). Total quality control. Harvard Bus Rev, 34(6):93-101.
6. Deming, W (1982). Quality, productivity, and competence position. Cambridge
(MA): Massachusetts Institute of Technology, Center for Advanced Study.
7. Juran, J (1983). Upper management and quality. 4th ed. Wilton (CT): Juran Institute.
8. International Organization for Standardization (2015). ISO 9001 Quality management
systems - Requirements. 5th ed. Geneva: The Organization.
9. Joint Committee for Guides in Metrology (2012). International Vocabulary of
Metrology - Basic and General Concepts and Associated Terms. JCGM 200:2012,
JCGM 200:2008 with minor corrections. JCGM
10. EURACHEM/CITAC (2003). Traceability in chemical measurement. Europe: The
Organizations. Retrieved from:
http://www.eurachem.org/images/stories/Guides/pdf/EC_Trace_2003.pdf.
Accessed: February 13, 2017.
11. Clinical and Laboratory Standards Institute (2006). X-05R Metrological traceability
and its implementation, A report. Wayne (PA): The Institute.
12. Vesper H, Thienpont L (2009). Traceability in laboratory medicine. Clin Chem
55(6):1067-1075.
13. Pereira P, Westgard J, Encarnação P, Seghatchian J (2015). Evaluation of the
measurement uncertainty in screening immunoassays in blood establishments:
Computation of diagnostic accuracy models. Transfus Apher Sci 52(1):35-41.

Page 12 of 14
14. International Organization for Standardization (2012). ISO 31000 Risk management
- Principles and guidelines. Geneva: The Organization.
15. Clinical and Laboratory Standards Institute (2014). EP15-A3 User verification of
precision and estimation of bias. 3rd ed. Wayne (PA): CLSI.
16. Clinical and Laboratory Standards Institute. EP12-A2 User protocol for evaluation
of qualitative test performance. 2nd ed. Wayne (PA): CLSI, 2008.
17. Joint Committee for Guides in Metrology (2008). Evaluation of measurement data -
Guide to the expression of uncertainty in measurement. JCGM 100:2008, GUM 1995
with minor corrections. JCGM.
18. Pereira P, Magnusson B, Theodorsson E, Westgard J, Encarnação P (2015).
Measurement uncertainty as a tool for evaluating the ‘grey zone’ to reduce the false
negatives in immunochemical screening of blood donors for infectious diseases. Accred
Qual Assur 21:25-32.
19. EURACHEM/CITAC (2015). Setting and Using Target Uncertainty in Chemical
Measurement. Europe: The Organizations. Retrieved from:
https://www.eurachem.org/images/stories/Guides/pdf/STMU_2015_EN.pdf.
Accessed: February 13, 2017.
20. Westgard QC (2016). MU Survey 2015: The Global Results.
http://www.westgard.com/mu-global-survey.htm. Accessed: February 13, 2017.
21. Pereira P (2016). Uncertainty of measurement in medical laboratories. In book:
Luigi Cocco (editor). New Trends and Developments in Metrology. Rijeka: InTech.
Retrieved from:
http://www.eurachem.org/images/stories/Guides/pdf/EC_Trace_2003.pdf.
Accessed: February 13, 2017.
22. Westgard J, Barry P, Hunt M, Groth T (1981). A multi-rule Shewhart chart for
quality control in clinical chemistry. Clin Chem 27(3):493-501.
23. Montgomery D (2012). Introduction to statistical quality control. 7th ed. Hoboken
(NJ): John Wiley & Sons, Inc.
24. Westgard J (1992). Charts of operational process specifications (“OPSpecs
charts”) for assessing the precision, accuracy, and quality control needed to satisfy
proficiency testing performance criteria. Clin Chem 38:7:1226-1233.
25. Westgard J (2006). Six Sigma Quality Design and Control. Madison (WI): Westgard
QC.

Page 13 of 14
 26. Magnusson B, Näykk T, Hovind H, Krysell M (2011). NordTest NT TR 537
Handbook for Calculation of Measurement Uncertainty in Environmental Laboratories.
3.1th ed. Oslo Nordic Innovation. Retrieved from:
http://www.nordtest.info/images/documents/nt-technical-
reports/nt_tr_537_ed3_1_English_Handbook%20for%20Calculation%20of%20Measur
ement%20uncertainty%20in%20environmental%20laboratories.pdf. Accessed:
February 13, 2017.
27. International Organization for Standardization. (2003). ISO 1012 Measurement
management systems - Requirements for measurement processes and measuring
equipment. Geneva: The Organization.
28. International Organization for Standardization (2003). ISO 15190 Medical
laboratories - Requirements for safety. Geneva: The Organization.
29. International Organization for Standardization (2018). ISO 19011 Guidelines for
auditing management systems. 3rd ed. Geneva: The Organization.

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