Laboratories are under continuous pressure to do more with less while improving overall patient care and clinician satisfaction. A close examination of current laboratory status is required to achieve such goals
Eyal Schwartzberg, Director of Laboratories and
Pharmacy, Hillel Yaffe Medical Center, Hadera, Israel
The laboratory process is generally divided into three parts: preanalytical, analytical and post-analytical. The reanalytical stage includes test transport, aliquoting, decapping, entrifugation, labelling, specimen collection and test ordering. The analytical stage includes quality control and measurement. Finally, the post-analytical stage encompasses test results and validation, reflex testing, recapping and specimen archiving. In terms of time utilisation, the pre- and post-analytical stages are the most consuming. Thus, when considering solutions to improve the laboratory process, it is important to concentrate on those stages.
Change management is beyond the scope of this article, but it is important to examine and search past and current relevant literature and learn from other organisations’ experience so one does not attempt to “reinvent the wheel”, and to use evidence-based strategies to implement change. One should understand the need for change and enlist a core change team, preferably a multidisciplinary one consisting of stakeholders; develop vision and strategy, motivate and create a sense of urgency, communicate the vision, take action and consolidate gains.
Other topics that need to be considered are: structure, systems, leadership, culture, external and internal politics. Special consideration should be given to the human factor. The fear of change and natural desire to remain within one’s “comfort zone”, decreasing qualified labour pool due to introduction of automation and new technologies, decreased job satisfaction – all could be obstacles to the required change.
Consolidation and integration
Before we can consider changes to the laboratory process, their implementation and potential benefits, we need to define two key concepts regarding new practice. Consolidation can be defined as combining different analytical modalities or strategies in one instrument or in a group of connected instruments. An example of such a process would be transferring the entire serum work area (SWA), including biochemistry, acute tests, immunoassay and therapeutic drug monitoring and serology, from a standalone working station configuration into modular or integrated working islets.
Integration is linking an analyser or groups of instruments with pre- and post-analytical devices.
When looking at consolidation and integration there are two main options available: closed systems or open systems.
Closed systems can be defined as analytical devices that possess closed channels and are cable of using reagents, used in the measurement reaction, usually from only one company – in most cases the device manufacturer. Another definition of a closed system would be inability to integrate other analysers with pre- or post-analytical devices.
Open systems allow both the integration of several devices as well as the utilisation of nonproprietary specific reagents. When considering laboratories, consolidating open systems would be an advantage as it offer flexibility as well as the ability to tailor organisation-specific needs.
What are the advantages of laboratory consolidation and automation?
- Concentrating all or most SWA laboratory activity on one site.
- Decreased expenditures due to streamlining of labour force (in some organisations this could be as much as 70% of total budget).
- Decreasing the number of analysers and reduction of duplications, which will lead to further expenditure reduction.
- Ability to perform most tests with one tube with no need to split the tests in different laboratories.
- Maximise throughput.
- Improving quality and reliability while reducing turnaround time.
- Reducing human errors.
- Increasing safety in laboratory work.
What factors will help you choose the right solution for your organisation?
As a rule of thumb the process can be divided into three stages:
- Preliminary work.
- General strategies.
- Overall criteria for selecting a consolidated laboratory system.
Preliminary work should consist of developing a clear vision for your laboratory and creating a plan. Next you should visit as many sites as possible and carefully study their entire operation. It should be borne in mind that some solutions, although working in other institutes, might not fit your organisation. You should be able to separate facts from emotions and decide which factors are most important to your operation.
Following this stage you should prepare a document with a ranking of the most important features for your operation. Do not make a selection based solely on lab automation or on instrumentation, as both are closely interlinked and should be able to potentiate one another.
Finally, it should be kept in mind that all systems meet the goals for all laboratories (local preference), and that budgetary issues should also play an important role when deciding which system is most suitable.
When considering system costs there are several methods that can be used for the acquisition: out-of-pocket money – buying the system, reagents transaction – purchasing the predetermined reagent quantities required for the system
operation and “tick on a meter” payment. Each organisation should consider what would be the most appropriate funding for such a process.
The main general strategy would be to maximise overall lab efficiency with special consideration, especially when introducing automation, to eliminating many of the so-called “3D tasks” (dull, dirty, dangerous).
You should use the same methodology across the entire system, and the results should be the same if testing is done with the same lab network.
As for cost, the larger the test volumes the lower the unit cost.
Reliability is another important issue that need to be addressed, and the instruments should function well with and without automation while producing the highest-quality results.
The system should also possess the ability to handle urgent testing (STATs) efficiently in all cases.
Finally, for the general strategy, both test consolidation and autoverification are extremely important.
When deciding on a partial or a fully automated system, make sure the track is open so other vendors’ instruments can be used. It is important to obtain written agreements with clearly defined schedules and guarantees from both instrument and automation vendors to avoid conflicts with both parties (an integrated all-in- one machine could be a solution for that).
Other issues worth remembering are: manual vs automated centrifugation, location of sample aliquoting (at the beginning or the end of the process) and automated test-tube sealing and archiving.
Finally, one should consider whether there is a need for additional space or construction work for your new system. In today’s limited resources health systems there is a constant conflict between budgetary constraints and technology expansion. Thus internal tactics, especially consolidation and integration in laboratory work as described above, can be used successfully to overcome financial restrictions while improving the quality and efficacy of the laboratory process.