The ICL Insider

The ICL Insider
June 2015
Volume 1, Issue 1
About Dr. Shashank Tilak
In This Issue
Dr. Shashank (‘Shash’) Tilak was educated at the
University of Toronto where he pursued studies in
Biochemistry, Cell Biology and Clinical Chemistry. He
obtained a B.Sc. and Ph.D followed by the post-doctoral
training program in Clinical Chemistry and is a Certified
member of the Canadian Society of Clinical Chemists.
His professional career was launched with ICL in 1985.
Over the years Shash has enjoyed varied tasks and
responsibilities in the Laboratory, Specimen Referral
and Community Services (Specimen Collection)
Divisions. He is currently Privacy Officer, Safety Officer,
and the Laboratory and Scientific Director.
 Quality in Reference
Testing Services
 Oligoclonal Banding
 USDTL/ICL Toxicology
Partnership
www.ICLabs.ca
shashtilak@iclabs.ca
Next Issue:
Expected Release
September 2015
USDTL / ICL Toxicology Partnership
The United States Drug Testing Laboratory (USDTL) is a leader in newborn toxicology,
alcohol biomarkers and substances of abuse testing. By partnering with USDTL ICL has
expanded its’ forensic and perinatal menu to cutting-edge sample types such as breast
milk and umbilical cord, in addition to hair, fingernail, urine and meconium.
USDTL prides itself on cutting edge research and has made significant breakthroughs in
the field of analytical toxicology largely funded by agencies within the National Institutes
of Health. Beyond its’ own research programs, USDTL also partners with other
researchers to support/promote advancements in biomarkers as objective measures.
The quality of the analytical process at USDTL:
 CLIA-certified, CLIA ID Number 14D0712964.
 Accredited by the College of American Pathologists’ Laboratory Accreditation
Program
 Accredited by the College of American Pathologists’ Forensic Drug Testing
Accreditation Program
 Member in good standing of the Drug & Alcohol Testing Industry Association
Such services require numerous pre- and post-analytical considerations.
Pre-Analytical
Post-Analytical
Collection instructions
Chain of Custody
Clear reports with cut-offs
Sample ID to track results
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Quality in Reference Testing Services
Assessment and monitoring of quality are important and significant utilizers of a lab’s time and labour resources.
Analyses performed in-house undoubtedly receive the greater share of attention than tests referred out, even when
measured on a test-by-test basis.
One of the principal aims of this Newsletter is to champion quality in test referral services. The focus will be on
Quality – principally pre-Analytical and Post-Analytical Quality. As your Test Referral Resource ICL must provide you
with or assist with measurement of verifiable quality indicators such as turnaround times, specimen quality, test
ordering, specimen transport conditions, result/report quality, etc.
What Does Accreditation Require?
Accreditation schemes consider quality of lab services along the path of workflow, in pre-analytical, analytical and
post-analytical phases.
In Ontario the accreditation requirements (Version 6.0 December 2013) include:
V. Pre-analytical Process: The laboratory shall identify and document pre-analytical processes.
VI. Analytical Process: Analytical processes shall be defined to meet the needs of users and shall be
documented.
VII. Quality Assurance: Quality assurance (internal quality control and inter-laboratory comparisons such as
external quality assessment) shall provide adequate confidence that laboratory examinations fulfill the
requirements for quality, and records shall be maintained.
VIII. Post-analytical Process (Reporting): Reporting processes shall be defined in accordance with patient care
needs and regulations.
Considering tests referred to ICL, accredited ICL testing labs have oversight of and meet the requirements for Quality
Assurance (VII) and the Analytical Process (VI).
Pre-analytical Process (V) quality requirements are the shared responsibility of:
 The Referring lab (collecting and submitting orders and specimens);
 ICL (receiving /transferring the orders and specimens to the Reference labs); and
 Reference labs (receiving the specimens and orders).
Post-analytical Process (Reporting) (VIII) quality requirements are the shared responsibility of:
 Reference labs (transmitting the results to ICL);
 ICL (acquiring the results and reporting to the original referring lab); and
 Referring labs (receiving ICL reports/reporting them to the ordering person).
The parties must act in concert to monitor and improve pre- and post-analytical quality of referred-out tests.
Monitoring specimen referral, transfer, results receipt and invoicing are enabled by ICL processes. Simultaneously,
these activities are conducted more efficiently and reduced in number when ICL is used as a one-stop referral site,
with ICL responsible for the multi-site referral processes.
Referring & Reference Lab Practices
As a matter of practical efficiency, hospital labs have segregated processes for tests performed within the hospital lab
and tests referred out to ICL. Of course both processes include quality-improvement activities. In some labs,
additional processes are required when the hospital lab is a “reference lab” for external clients such as local
physicians, clinics or other hospitals and in turn refers some of these tests to ICL. Hospital lab staff might be
especially challenged in these situations to maintain adequate oversight and control.
Understanding the processes and activities uniquely or specifically related to referred-out tests allows the lab to
manage the process effectively, maintain and improve quality. Many of these activities are similar to and
incorporated into activities related to tests performed within the lab, and some are unique to the test referral
process. Some examples of activities related to referred out tests:
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Maintaining the reference test database and making it available to those who need it, within and outside the
hospital. Persons ordering tests as well as persons implementing the orders must have appropriate
information regarding test availability, collection and reporting. While this is equally true for tests performed
within the lab, the low-volume and esoteric nature of many referred-out tests emphasizes the need for
effective presentation of the information.
o Some lab information systems link directly to ICL’s databases to achieve this quality.
o ICL Updates and notifications of significant changes are communicated via multiple processes,
including distribution via email, distribution with reports, and notations of test changes within
patient reports.
o ICL issues reports when ordered test results are unavailable because tests have been ordered
incorrectly or specimens submitted are unsuitable for analysis. Such information is vital to quality
improvement processes within the lab. ICL is developing categorized reporting of such matters to
further enhance the utility of the information.
Specimen processing activities from time of collection, designed to allow timely and accurate processing of
referred-out tests. Special attention is required to the environmental storage conditions of specimens
pending transfer. This can be a challenge when prioritizing activities to handle stat/urgent orders, routine
automated analysis within the lab, non-automated analysis and once-a-day packaging of tests referred to
ICL.
o ICL obtains relevant stability information from reference labs and makes it available in test listing in
our website. Specimen stability at ambient temperature can inform lab handling practices to ensure
timely refrigeration or freezing of specimens.
Transfer to ICL controlled to maintain specimen integrity. Environmental conditions, courier services and
transit time can present unique challenges for referred out tests compared to tests performed within the
lab.
o ICL provides feedback to labs when opportunities for improvement are noted upon package and
specimen receipt at ICL.
o ICL can establish a regular routine QA activity with hospital labs to monitor shipment environmental
conditions.
Reporting referred out tests using information systems designed primarily to capture and present results
generated within the laboratory. Interfaces can address many issues but may require special staff training.
Some labs are challenged to justify the resources required to create a seldom-ordered referred out test in
their information system.
o When interfaced-reporting is not possible ICL can fax reports to labs.
o ICL is developing a reporting option that will allow secure-email reporting of standard ICL Patient
Reports and non-standard reports such as pdf or other format image reports.
o ICL is developing a web-based secure lab portal allowing labs to access and print pdf-format reports,
to print usage statistics and to review turnaround times for referred tests.
Future issues of the ICL Insider will address pre- and post-analytical quality issues that are intrinsic to the test referral
process. Particular emphasis will be placed on ICL’s experiences and on situations in which ICL can provide guidance
and feedback to directly impact and improve the quality of the process.
Oligoclonal Banding
Specimen Collection
Oligoclonal Banding analysis requires serum and cerebrospinal fluid (CSF).
Both specimens are analyzed by isoelectric focusing to detect immunoglobulins, seen as multiple slightly diffuse
bands called “oligoclonal bands”. The bands seen only in the CSF specimen (i.e. they are not present in the serum
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specimen) may be due to Multiple Sclerosis or other central nervous system (CNS) inflammatory process. The
presence of a single “monoclonal” band is a more serious finding.
Recollection of any specimen (other than for further confirmatory testing) is an adverse quality event – and given the
nature of the collection process (i.e. lumbar puncture) extraordinary care is required to avoid the possibility of CSF
recollection.
Specimen NSQ
1 mL of each (CSF and serum) is required. This is usually easily accomplished.
However, in the event that multiple tests are being requested and the amount of CSF collected is limited due to
collection difficulty, contact ICL to determine how to deal with the possible NSQ scenario. Some of the tests might be
performed on minimal volumes, but ICL might have to transfer a single specimen from lab-to-lab to deal with the
specimen container dead-space issue. When specimens are NSQ to complete the requested tests ICL issues a report
recording the occurrence and possible remedies.
Serum Specimen Not Collected Concurrently
Detected bands are compared to reveal bands found solely in the CSF, such CSF bands being indicators of an
inflammatory process within the CNS. Bands present in both specimens are not indicative of an inflammatory process
solely within the CNS. Therefore it is important that both specimens be collected and analyzed.
It is also important that the specimens are collected at approximately the same time. Otherwise, specimens may
reflect the patient’s clinical condition at two separate times, one at the time of CSF collection and one at the time of
serum collection, thus making them non-comparable for interpretation.
In the event that the serum is not collected at the time, it is acceptable to collect the specimen within 48 hours. In
exceptional circumstances, collections within 2 weeks of the lumbar puncture may also be used if there have been no
intervening treatments that may affect clinical status from one time to the next and if there has been no obvious
change in clinical status. ICL contacts the submitting lab when unaccompanied CSF specimens are received. CSF-only
analysis is only made available upon specific request.
Plasma Collected Rather than Serum
The isoelectric focusing method has not been validated for plasma specimens and so plasma is not acceptable. ICL
and the testing lab may not be able to detect that the submitted specimen is plasma. It is important to establish
appropriate instruction and handling processes for collection teams to obtain and submit the correct specimen.
Specimens Not Frozen
Prolonged non-frozen storage of specimens may degrade immunoglobulins and compromise the results. While
immunoglobulins are fairly stable it is important to ensure the best possible specimen condition at time of analysis by
freezing specimens as soon as practical and submitting them frozen.
Specimen Age
Even frozen specimens may be prone to storage-time related immunoglobulin degradation. Adhering to submission
protocols related to time-after-collection allows the lab to establish schedules that ensure specimens are suitable for
appropriate analysis at the appropriate time. ICL provides guidance information for specimen stability.
www.ICLabs.ca
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