IMPORTANCE OF EFFICIENT MEDICAL COLD CHAIN SOLUTIONS TO PREVENT ERRORS IN LABORATORY REPORTS

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IMPORTANCE OF EFFICIENT MEDICAL COLD CHAIN SOLUTIONS TO PREVENT ERRORS IN LABORATORY REPORTS

Dr. Abhik Banerjee MBBS, MD (Pathology), MBA – Healthcare Management Zonal Technical Chief, East
Zone, Apollo Diagnostics, Regional Reference Laboratory, Kolkata

Preanalytical errors have been reported to account for more than two-thirds of all errors in medical
laboratories. Preanalytical variables can occur from the time when the test is ordered by the physician until
the sample is ready for analysis. Many things can go wrong in the preanalytical arena. These often result in
sub-optimal specimen quality, the implications of which will be “errors in patient test results” and the
possibility of wrong decisions related to patients’ management on the part of the physician.

Modern laboratories around the world are now enjoying the benefit of decades of technological
development. State-of-the-art instrumentation, walkway, highthroughput analysers, stringent quality
control measures, participation in various external quality control programs and many more processes
have combined to deliver high standards of analytical performance within laboratories. However, the
situation is less favourable in the preanalytical phase of the testing process and hence it is high time that,
laboratories concentrate more on the improvement of preanalytical quality.

Maintaining the cold chain from the point of collection until the analysis in the laboratory is of prime
importance to ensure the stability of the patients’ samples. A cold chain breakdown, a critical preanalytical
variable, may directly impact the sample quality and therefore compromise the accuracy of laboratory test
results. The collection centres or sample collection facilities (SCF) must have refrigerators to preserve
samples until they are picked up by the logistics services. This is especially important for samples like urine
and body fluids which deteriorate quickly if not processed at the earliest. For a reference laboratory, it is
often practically impossible to process the samples within 1 or 2 hours of collection. Therefore, preserving
the samples at 2°C to 8°C is mandatory in this interim period. It is a harsh reality that in our country cold
chain maintenance, especially in sample collection centres, is not at all satisfactory and needs serious
attention from laboratory medicine practitioners and healthcare providers.

Similarly, a medical laboratory in its testing facility must have appropriate cold chain solutions as per legal
requirements. Any negligence or casual approach in this aspect may grossly compromise the reporting
quality of the laboratory. In a medical laboratory, refrigerators are basically used for two purposes: to store
reagents (including internal quality controls and calibrators) and for sample retention purposes, be it
pre-test (to protect sample integrity before testing) or post-test as per laboratory’s sample retention
criteria. Post-test sample retention is required as sometimes the laboratory may need to reanalyse the
sample as a part of a quality control exercise (APA or alternate performance assessment) or in a case of a
complaint or litigation. Apart from samples and reagents, sometimes other laboratory consumables may
also need refrigeration. An example of this are SSTs (serum separator tubes or gel tubes) which if not stored
in a refrigerator or cold room during extreme summer (common in India) may show melting of barrier gels
leading to inadequate separation of serums from fibrin and cells.

A comprehensive cold storage solution may vary between laboratories depending on the workload, various
types of tests performed (scope or activity menu of laboratory) and complexity of testing. A large medical
laboratory covering various areas should ideally have at least a cold room (inventory management and
specimen preservation), a deep freezer (-80°C to-20°C), and refrigerators (2°C to 8°C). For example,
lyophilized controls (IQC) or calibrators (until reconstituted) and extracted DNA/RNA (PCR-based testing in
a molecular biology laboratory) need to be preserved at-20°C or-80°C as per the guidelines from the
manufacturer. There are many reagents which can be stored either at 2°C to 8°C or at-20°C, but their
shelf-life will be longer if stored in a deep freezer. Therefore, laboratories should be careful during the
selection of cold storage solutions and look for a vendor which can provide customized and cost-effective
solutions as per individual requirements but also without compromising their products’ quality.
India’s diagnostic healthcare market is made up of large diagnostic companies, standalone laboratories,
and hospital-based laboratories with variable infrastructure, capacities, and workloads. Moreover, there is
an asymmetry in the distribution of laboratories between rural and urban areas in India. Most of the large,
good quality and better-equipped private and public laboratories are situated in urban areas, whereas rural
locations are mostly dependent on either small public facilities or unregulated, small, standalone private
laboratories. Therefore, it is important that all types of laboratories, irrespective of their location, should
have at least a basic cold chain so that people from different socioeconomic backgrounds can get quality
reports without limiting these benefits to the customers of larger laboratories in bigger cities.

The government also has a big role to play here. Reducing the cost of high-end cold storage facilities and
-20°C/-80°C freezers with the “Make in India” initiative will help laboratories, irrespective of their size and
location, to adopt at least the basic-level cold storage solution and ensure accurate, error-free laboratory
reports by improving preanalytical quality.

It is good to see that laboratory accreditation bodies like NABL (National Accreditation Board for Testing
and Calibration Laboratories) is also very vigilant regarding reagent and sample storage facilities in
laboratories and collection centres. Improper and inadequate cold chain maintenance is a common
non-conformity raised during audits and inspections. Such vigilance is crucial and will certainly deliver the
greatest incremental gains in the overall quality of clinical laboratory services.

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