Theme: Expectations , realities and challenges. What are the challenges emerged from reality and finally what are the expectations?
He talks how can we go about selecting equipment for laboratory and what are expectations from the IVD.
The lab equipment selection process is based upon expectations, reality and challenges. It is like a utopian dream of choosing the perfect lab equipment. There are certain compromises that need to be made and certain specific points selected while choosing lab equipment.
Lab physicians have some specific parameters while selecting laboratory equipment. They are
- Quality Goals
- Software Compatibility
- Throughput
- Scope/ Test menu.
Initiation of the process
The lab team/ purchase team controls the initiation of the process equipment selection process. The quality goals consist of accuracy, precision, linearity and carryover. For the selection process, the vendors move the list of equipment to the purchasing team, and then the team directs it to the lab physicians.
The lab physicians evaluate whether the equipment meets
- The quality goals
- And the throughput of the equipment since each laboratory is of different size
- Test Menu across Equipment’s: In hematology, 10-15 years back, there was only one CBC test but however now it has evolved and lot of new tests has come which can aid diagnosis of nutritional anemia’s and hemolytic anemia’s. For clinical chemistry and immunoassay, wider the test menu the better it is.
- Software capability of vendor of the lab equipment and how it can amalgamate with the existing Lab information system.
The selection of lab equipment is based on the quality goals for the equipment. Upon the arrival of any new equipment, they are kept at the laboratory and lab physicians compare those with the existing setup or existing equipment. If it is completely new technology or equipment which has nothing to be compared with, then peer laboratory methods or standard procedures are used for comparison.
Parameters for choosing laboratory equipment:
The primary parameter is accuracy. Accuracy is the true value of the experiments and what exactly is the value which is reported?
It is compared with peer laboratories, if there is an X value that is reported, then what is the acceptable value around X with other lab reports.
Next is the precision of the equipment. It consists of the repeatability variation. For example, people around the hospital or set-up keep on doing the same test, then the result determines the repeatability determination. Another aspect known as total error is defined as a combination of accuracy and precision.
International communities like CLIA in the USA, RILIBAK, and the RCPA define quality goals. They have defined various quality goals for the analytes. The laboratories have to select their best fit.
New Lab equipment is weighted based on these quality goals. Whenever new equipment comes, it is compared with an existing setup or equipment. If it is new technologies that do not have any comparator, it is compared with existing methods or if any peer has that equipment, some samples are collected from peers for evaluation.
Linearity is essential as it adds to a lot of cost savings. Linearity means the highest and lowest value reportable by the equipment or kit that can be reproducible. It is a range of a particular kit or equipment; for example, a manufacturer X measures blood sugar up to 400 mg% and another one Y measures up to 800 mg%; So if a patient value is 500 mg%, then the sample needs to be rerun in dilution on kit X whereas the values can be released on kit Y. As kit Y measures up to 800 mg %, we don’t need to repeat the test. The higher first-pass yield of results, means when we run the sample for the first time, how many times do we need to repeat it again? The greater the first pass yield of results, the shorter the turnaround time, which results in cost efficiency.
Carryover is the last assessment marker. For example, when we buy a certain vehicle, there is a specific vehicle average given by the company, but we don’t get that vehicle average. Similarly, there are commitments proclaimed by the equipment of providing certain precision and accuracy but we need to verify on our end and finally, we come to know what that equipment can achieve and also be compared with peers.
One great expectation, therefore, arises that the lab equipment must be tested in different geographies and in different ethnicities. IVD companies need to collaborate with the laboratory physicians of our country to have biological reference intervals that are relevant to our population.
Expectations of vendors for lab equipment
The most essential is laboratory throughput we have labs all across the country from seven sisters to Jammu and eastern Rajasthan, the
geographies are different and the temperature also varies. The diagnostic market is growing at a rate of 20%- 25% per year, especially from Tier 2- Tier 3 cities where the population is less than 5 lacs. Lab physicians working in Tier 2 and Tier 3 cities essentially look for throughput of the equipment whose capacity ranges from 350 tests per hour for certain equipment to 50-60 tests per hour in tier 2 and tier 3 cities. We would require the same test menu across all the laboratories as well. Whether it is smaller equipment or larger equipment, we require the same test menu so that we can serve Tier 2- Tier 3 cities. This is one of the expectations we have from a vendor which some vendors have tried to achieve.
Another important requirement is scalability, depending on the need, we should be able to scale from 200 patients to 400 patients per day.
The vendor should have the ability to scale up. They should have an efficient modular system to join equipment together or at the same time have certain equipment with the same footprint so that the lab physicians do not have to move on to a larger area.
Everyone wants to do more with less. Admin cost or rental cost is a big concern for lab physicians. Therefore, a smaller footprint with
greater throughput is always expected from the vendors.
Smaller equipment means a smaller test menu so it is devoid of tier 2 and tier 3 cities of these rarer tests which are equally essential. For an accreditation, it helps as well with the same equipment because references don’t change and it became much easier to work that way.
Software capability is another important criterion as well. Software capability is something that the analyzer or equipment itself can do, and second, what it can do with our existing software by transferring data seamlessly. Transferring data seamlessly on devices or bi-directional interfacing is a huge problem as vendors are different. Collaboration between IVD and LIS vendors is important for the seamless integration of equipment with LIS.
When we release reports, lots of alarms are not interfaced in the system. Alarms need to be interfaced so that it helps the pathologist and laboratory physicians to decide which report to release and which not to release.
There are certain middleware companies that act as artificial intelligence and help us to decide what reports to release and what not. The challenges with these companies are that have a monopoly and they work with some specific types of equipment only. There are drivers or software which is integrated with analyzer to the software.
As expansion takes place in Tier 2 and Tier 3 cities, skipping maintenance in a busy schedule can be rampant. Issue of warning alerts can also be of great help as it will then include a schedule for maintenance as required. The prospect of software aid to technicians in less developed areas is also looked into in the future.
The equipment health report is very important. As expansions are happening in tier 2 and tier 3 cities, the skill we have in these cities is not competitive enough as big cities. So we need more software support so that we can help those technicians online. The larger equipment of 300 test per hour offer online support, but smaller equipment does not provide this type of support. If a technician is stuck and these locations also do not have instrument backups. IVD companies should try to provide these software inputs in smaller equipment as well, which will be really helpful.
An equipment health report is generated every month, but due to work pressure, technicians skip weekly or monthly maintenance. If some warnings or alerts can be given by the vendors to the supervisors through auto-generated mail or intimation on mobile phones that these many maintenances have been skipped.
Generating accurate reports in minimal time with maximum efficiencies and minimum resources is what laboratory physicians expect from the IVD industry in times to come.
Note: Dr. Manish Karekar is a qualified MBBS, MD, Pathology, Six Sigma Black belt from ISI, Pune. He is the Technical assessor for
NABL ( ISO 15189:2012) AND international fellow of CAP also done Health care management and Data analytics from IIM – Kozhikode.
He is currently in Krsnaa Diagnostics Ltd. as Chief Operating Officer in Laboratory Medicine and Pathology. His job role encompasses continuous improvement across the total testing process, standardization, innovation, and sustenance of standardized processes across all laboratory services. His areas of interest are coagulation, autoimmune testing, Mitigation of risk in processes, and method verifications.