Over the years the clinical laboratory has slowly but surely started playing a very important role in the treatment of patients. From being used as an ancillary branch in the treatment, it is being looked upon as one of the most important foundation of overall healthcare management of patients. Its role in the final diagnosis of any medical condition cannot be overemphasized. Thus it is imperative for any laboratory to maintain the highest of quality standards at all times.
There is a huge inflow of data into the laboratory. This begins with gathering data on the patient with respect to personal details, clinical details, the type of testing required, and the details about the parameters generated subsequent to the testing process. The testing itself is done by various instruments. These vary from simple colorimeters to complex flow cytometers. The data generated can be stored manually or using computers. It is easy to see why manual methods are now becoming inconvenient and cumbersome. Many errors can be generated when one uses the manual mode of gathering, storing and divulging data.
Most laboratories however small, have now resorted to using computers to handle the data. However, most laboratories still use computers only for analytical process. Low end systems now offer basic automation like pipetting and dispensing of blood, body fluids and reagents. These also help in processing of raw data to give end results. The high end instruments offer a mind boggling array of features and are extremely user friendly. Most of these instruments can be interfaced with the laboratory information system [LIS] facilitating reporting and previous data retrieval. Computerization has significantly improved integration of laboratory instruments, facilitates communication between the laboratory and patients, laboratory and referring physicians.
The work in any laboratory can be divided into the following phases
- The pre-analytical phase: this comprises of patient identification, test request registration and billing, sample collection, labelling and transport and sample processing.
- The analytical phase: This comprises of properly calibrating the instruments, the quality control process and analysis of samples.
- The post-analytical phase: This includes all the processes that follow the testing of the samples. Namely, the validation of test results, transcription of results into the records, typing the results, printing and despatch of the results. Also, the data so generated needs to be stored. The samples also need to be stored for specified period of time.
It would hence be clear that errors can occur at any of the above mentioned phases…
Thus automation is indeed a good idea to
- Minimize errors: these include specimen mix-ups, calculation errors, and transcription errors.
- Improve the turnaround time: thus helping the patients in getting quicker results and hence quicker access to the treatment regime.
- Improve efficacy and thus make work less stressful and monotonous for the personnel
Types of automation: Automation may be of two main types
- Total Laboratory automation (TLA)
- System based automation
Total laboratory automation automates almost every step of the laboratory process. This includes such steps as automatic centrifuge, decapping, sorting of samples, testing on various instruments, post analytical processing, storage and retrieval. Needless to say, this involves considerable expense and may be in the reach of a very few sophisticated laboratories.
System based automation on the other hand gives the power to pick and choose the areas which the laboratory views as most crucial and can be customized accordingly.
Information inflow in a typical laboratory is as follows:
Patient information: When a patient is registered, the identifying information is first registered in the database. The patient is then given a unique identifying number which is used as a primary identifier. The number thus generated is used by a computer is used by all the computers on the laboratory network to access data of the particular patient. This number generated by the computer may be printed using a bar code generator. Most testing instruments these days come either with bar code readers or have provisions to attach bar code readers. Errors pertaining to sample identification are thus avoided using this type of automation.
Test request and specimen collection: After the above step test requests are entered and the time of registration and sample collection can be clocked at this time. This step allows in identification of time elapsed between collection, transport and processing of samples. Also helps in monitoring turnaround time.
Generation of worksheets: testing of blood samples may require the interaction and involvement of various departments. These departments in turn require an organized list of tests that need to be performed as more often than not multiple parameters need to be tested. This step can be automated using a computer and specialized software (generic or customized) to generate a worklist. If one sticks to a manual list it is a cumbersome process requiring personnel and time.
Automated instruments and result entry: For manual workstations performing standardized assays, an effective mode of result entry is to assign phrases and concepts to single keys on the workstation keyboard (e.g. In qualitative assessment, the use of “negative” and “positive” tests etc.)
The automated instruments with random assess test menus have provisions for a bidirectional interphase with the LIS (Laboratory information system} so that the LIS can transfer orders for each specimen directly into the instruments (bar coding is thus a very important pre-requisite)
As results are entered into the laboratory computer either from a keyboard or instrument, the computer performs validity checks; required numbers of decimal places are verified. The results are compared with the reference ranges and automatically flagged based on prior criteria given by the laboratory /user.
Result reporting: results can be reported either by computer generated hard copies or my email as required by the patient or physician.
This is just a sneak preview of how automation in a laboratory and information technology can play a pivotal role in improving the quality and provide a mainstay in the day to day running of a clinical laboratory.