Types of Testing

There are different costs that are incurred during the two types of testing. There are fixed costs that are incurred regardless of which type it is; these are the costs that are not at all related to the tests that are performed. They include capital equipment acquisition, direction of the laboratory, maintenance and cleaning and the labor involved in the operations of the laboratory. There are also variable or incremental costs that are incurred and are directly to the tests that are performed. These include direct labor cost of the test performance, and also the cost of reagents and supplies (Christopher, Andrew & Jocelyn 34).

However the allocation of these costs depends on whether it is central laboratory testing or point-of-care testing. In a central laboratory, there are higher fixed costs and lower incremental costs of the test performance which include consumables and labor. In the POCT, there are lower fixed costs whereas the consumables and labor costs increase significantly depending on the number of tests. It is however complex to compare the cost levels between the two types of testing.

Point of Care Testing is also known as decentralized testing, bedside testing and ancillary testing. It is divided into two categories which are waived testing and non-waived testing. The waived testing are non-critical tests which are approved for home use by the FDA and employ all methodologies that are accurate and simple in order to render the probability of erroneous outcomes very negligible. They are also carried out so that they could pose no reasonable harm or risk to the patients in case they are incorrectly performed. These tests are however updated on the internet (Gerald 165).

The non-waived testing includes the moderately complex testing which is the test that requires minimal technical and scientific training and knowledge in order to operate accurately. The operational steps are either controlled easily or are automatically executed, and also minimum judgment and interpretation are needed. There is also the highly complex testing which is the test that requires specialized technical training, experience and knowledge in order to perform accurately. The steps of operation need very close control or monitoring, and also intensive independent judgment and interpretation are needed.

There is also the PPM (Provider-Performed Microscopy) where tests are carried out by a professional provider on patients in her or his individual medical practice, and these may include a group practice in which a professional provider is a member. There is the POCT Committee which has established standards for POCT and monitors all the POCT sites for proficiency and compliance as it is required. It also reviews all the requests of establishing POCT for approval and it also arranges for proper evaluation of the POC test kits and devices by the central laboratory ad they have to be approved before they are used for all services (James 2003 45).

All the proposals of establishing the POCT must be forwarded to the POCT Committee for correct approval. There are also minimum requirements for recorded laboratory procedures, minimum requirements for the quality control, well defined policies for reporting outcomes, recorded training for provider responsible for carrying out the testing, and finally a listing of the personnel that supervised the testing.  The personnel should have adequate orientation and training to carry out the test although they it is not a requirement to have had the formal education in laboratory testing or medical technology. There are policies that are put in place in an attempt to demonstrate very agreeable levels of competence for the testing personnel. The instructions by the manufacturers should be followed for all the tests that are carried out and these should bring out quality results. Thereafter records of all the tests should be maintained and well interpreted. All the written procedures and policies in the waived testing laboratory should address instrument calibration, issues of specimen collection and also performance practices, remedial action policies, measures of the test performance and quality control (James, 2006 56).

Frequent advances in technology have brought about complex testing to be closer to the patients and thus training and personnel qualifications to be considered much. Adherence to more formal superiority assurance practices has also become aspects that are not being recognized well by the sites of POCT. The devices need to be located on portable carts or are handheld and therefore they need to be transported to the nearest point to the patient. The devices need to be easily portable.

There are different advantages of using the Point-of-Care Testing which include reduced turn-around time; great improved outcome in the patient; cross-trained staff in order to maximize the total productivity; improved communication in the laboratory-nursing unit; decreased workload for central laboratory; and finally reduced transfusions which is secondary to very huge blood losses from possible phlebotomy. However there are also disadvantages that are connected to POCT and these include high cost of operation; reduced efficiency in the personnel; risk of duplication of the equipment that is used; very poor capability of data-management; and finally potentially dissimilar reference ranges (Price & Hicks, 30).

However there are various discrepancies which may include discussions such as the discussion that reduced turn-around time does not necessarily predict expanded patient results. An example is when the central laboratory offers a glucose outcome in nearly 90 minutes for the patient whose insulin drip rate is altered every one hour, the value of the glucose is of insignificance clinical use in the decision making of whether to alter the drip with the insulin or not. In situations like this, the central laboratory requires to assess whether the time for glucose turn-around can be decreased to only less than one hour. In the case where this is not possible, a POCT program for the glucose testing at the patient’s bedside should be then considered.  This is because the mean turn-around time for the POCT glucose is only five minutes (Kiechle & Cembrowski 87).

The POCT was developed and improved due to the increasing health costs which created rising expectations from the hospitals. These include among others, reduced patient stays, transfers from the inpatient to ambulatory or also outpatient settings. The POCT was an attempt to provide quality and reliable test results and also the achievement of shorter turnaround times. There is also the reason of reduced costs because of fast discharges and the countering of personnel shortages by the hospitals.

The development of technology has made it possible for non-laboratory staff to carry out the testing although clinical laboratory scientists should be engaged to oversee and direct the overall programs. These scientists guarantee quality performances in the testing procedures. This is because the clinical laboratory scientists focus entirely on developing and maintaining the high quality of the laboratory testing across all programs related to them. These laboratories are charged with the responsibilities of developing the suitable training programs for all the non-laboratory personnel in regard to the utilization of ancillary testing equipment, review of the test results, documentation, test procedures, corrective action, equipment management, proficiency testing, and monitoring and performance of quality control. Personnel competency and its review should be built into the POCT programs. The laboratories together with the suitable medical staff should take full responsibility of defining suitable parameters and also setting up guidelines for result rejection or repeat testing (James 123).

However, the point of care testing is viewed as potential threats to the laboratory science practice although it should be viewed as an opportunity to expand their capabilities. The methodology that is utilized during POCT has positive analytical bias. Secondly there is the strategy of creation of the quality specifications that are based on how the test results are utilized. These are the quality specifications for bias and also precision in diagnosis and the monitoring the database components (Salka & Kiechle 89).

The analytical random variation should always be kept very low and this is because the alterations in the test results for a particular patient should be very significant, with very high probability. This should reflect much on the analytical random variation. Point of care testing ensures that there is close monitoring of the patient and also frequent monitoring. The patients require close monitoring because notable alterations in the serial results may be interpreted as the patient improving, worsening or pre-analytical variations (Howanitz & Jones 121).

There are two wide types of technologies that are often utilized in the point of care testing and these are the bench top analysers and the single hand held devices. The bench top analysers are small and they include electrolyte systems, blood gas systems among others. They are often referred to as small versions of the actual laboratory analysers and these bench systems have automated vulnerable operator steps that are dependent. These may include the automatic calibration of the sample after analysis, and the quality control.

The hand held devices are developed with the usage of micro-fabrication techniques and they include blood glucose tests, coagulation tests, and urine albumin tests among others. These devices are simple from the outside although they are complex on the inside and they perform various tasks. These tasks include separation of cells from the plasma, read color or any other end points and also add reagents. Many patients may conclude that the processes are not conclusive but these devices operate very well just like the big complex devices found in the central laboratories (Cembrowski & Kiechle 65).

Reliable results are only obtained when the patient is appropriately prepared and when the correct and recommended techniques are utilized. The point of care testing staff therefore should receive intensive training because they do not have the technical background. There should also be intensive and quality control from the experienced and qualified laboratory personnel.  The equipment used by the point of care testing should be connected to the main information system in the central laboratories to ensure real time supervision of overall performance and also the integration of the outcomes into the electronic record of the patient. The given approach should be able to meet the requirements that are linked with clinical governance and the clinical risk management. It should also be designed in a way that it could be able to recognize all stakeholders in POCT.  The POCT should be well guided by an overall multidisciplinary team which should include all stakeholders (Despotis, Joist & Goodnough 78).

The organization of the services offered by the point of care testing should carry out various tasks which include identifying all the clinical needs, preparing well detailed specifications, analyzing benefits and costs, surveying the technology available coupled with its performance, procuring consumables and equipment, ensuring that the available equipment could be connected to the laboratory information system, providing certification for all the operators who are competent, monitoring regularly of document performance and quality control, documenting all problems, providing continuing recertification and education and finally auditing all problems and uses and the undertaking of appropriate actions.

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