“Risk-assessment framework in the Test-Request-Report Cycle: Opportunities

for improvement in patient safety lie primarily in addressing issues of

specimen and patient identification.” – Leslie Burnett

Identification of Opportunities for improvement in patient safety in the Test-Request-

Report Cycle.

The Chain of Information Custody1 Guidelines of the RCPA provides a powerful

conceptual framework for analysing the processes within the Test-Request-Report
cycle:

By analysing each step of the process, it is possible to consider the relative risk of
error of that step to the patient, and to design strategies to minimise or eliminate that
particular risk. Many years of systematic improvement of laboratory operations have
focussed efforts on the intra-laboratory analytical phase of the cycle, and this phase
is closely monitored and managed in pathology laboratories.

Early attempts to quantify the residual non-analytical risk2 suggested that pre-
analytical phases contained the major residual risk, and that the pre-analytical risk
was significantly higher than the analytical risk. Using a single, small retrospective
study, the pre-analytical risk was estimated at ~1.0% of accessions. More recently,
the KIMMS Program3 has confirmed these relative analytical risks, and through
multiple large retrospective studies has quantified the residual risk as Pre-analytical

1 Chain of Information Custody for the Pathology Request-Test- Report Cycle in Australia (Guidelines for Pathology Requesters and Pathology
Providers) RCPA, Approval Date: November 2004
2 Khoury M, Burnett L and Mackay M. Error rates in Australian Chemical Pathology Laboratories. Med J Aust 1996; 165:128-130
risk (median error rate 0.6% of all accessions) and Post-analytical risk (0.05%). It
should be noted that the design of all such retrospective studies results in systematic
under-estimation of the residual risk. Available data thus confirms pre-analytical risk
is larger than post-analytical risk by a factor of 10-20:1, and is estimated to be at
least 0.6% of all accessions.

Of the sources of pre-analytical risk, specimen (and/or patient) identification

problems account for the largest single cause of pre-analytical error, accounting for
about 30% of pre-analytical risk.

From the KIMMS data, it is possible to determine the root cause/source of this
risk. The majority (65-75%) of pre-analytical errors are “imported”, in that they were
present in the specimen prior to arrival in the laboratory.

Conclusions:
1.Pre-analytical errors account for the largest residual risk to patient safety. They
are present in (at least) 0.6% of all pathology specimens.
2.The single most significant pre-analytical risk is incorrect specimen (or patient)
identification. This is present in (at least) 0.2% of all pathology specimens.
3.The majority (65-75%) of such errors are already present prior to the arrival of a
specimen in the laboratory.

Current strategies for specimen and patient identification.

Standards for specimen (and patient) identification are set by NPAAC in its
“Requirements for Pathology Laboratories (2007)” document4, under Standard 5.
The NATA Medical Testing Field Application Document5 reinforces these principles.
The RCPA Chain of Information Custody Policy1 also reinforces these principles,
and extends them to obligations on the requester.

For Transfusion related specimens, a higher standard of identification and

documentation is specified by NPAAC in its “Requirements for Transfusion
Laboratory Practice (2008)” document6. Rates of failure of transfusion-related
identification are monitored through programs such as Haemovigilance programs
(cited in [7]). Note that this higher standard may cause confusion when a specimen
is collected for non-transfusion purposes but is analysed in a transfusion laboratory
(see related item elsewhere in the current NPAAC Agenda papers).

3 Key Incident Monitoring and Management System. RCPA Quality Assurance Programs Pty Ltd. www.rcpaqap.com.au (accessed 14th April
2009). KIMMS End-of-Cycle Report December 2008 provided courtesy of RCPA Quality Assurance Programs P/L.
4 Requirements for Pathology Laboratories (2007), NPAAC, ISBN: 1 74186 162 4Online ISBN: 1 74186 163 2Publications Approval Number:
3960
5 AS 4633 (ISO 15189) Field Application Document , Medical Testing, Supplementary requirements for accreditation, National Association of
Testing Authorities, Australia (NATA), August 2007
6 Requirements for Transfusion Laboratory Practice (2008), NPAAC, ISBN: 1-74186-656-1,Online ISBN: 1-74186-657-X, Publications Number:
P3-4029
For Genetics related specimens, the RCPA has produced a Position Statement7
which analyses the risk of mis-identification in a variety of clinical scenarios, and
concludes that there is no single “correct” standard of identification. A number of
identification strategies are analysed as to risk of error, and various strategies are
found to be suitable for different purposes.

Conclusions:
1.There are a variety of standards for specimen (and patient) identification
currently in use in Australia.
2.These standards tend to vary by Discipline of Pathology, rather than by formally
calculated risk-assessment.
3.These current standards have measurable failure rates, which can be
estimated by approaches such as KIMMS (amongst others).

Summary

1. Current standards for specimen (and patient) identification, while based on

sound and tried principles, have a measurable failure rate. This failure rate
now represents the single largest residual risk of error in the test-request-
report cycle.
2. The current standards are binding on pathology laboratories, but the majority of
identification failures are occurring before arrival of the specimen in the
laboratory.
3. Current standards are based on Discipline of Pathology. Other than possibly for
Transfusion specimens, these standards are not based on risk-assessment of
the likelihood or consequence of identification errors in relation to the type of
testing being performed.
4. Data is now available on the encountered error rates for specimen (and patient)
identification errors.
5. Statistical models are now available to calculate the risk in a variety of clinical
circumstances based on the probability of an abnormal result and the
significance of that result.

Recommendation

That Council explore the desirability of developing a risk-based set of standards for
specimen (and patient) identification for the collection of pathology specimens, with a
view to developing a strategy to lower the observed incidence of identification errors.

7 Sample requirements for medical genetic testing: Do genetic tests demand a different standard? RCPA, Approval Date: November 2007