Impact of Point of Care Testing on Central Lab – Literature Review

Laboratory testing plays a very significant role in the health of a patient because the decision made by the physician on medication is largely based on lab results. Physicians have depended on laboratory results for quite a long time when it comes to decision making on how to improve patient outcomes. Traditionally, laboratory testing was carried out only in the central laboratory by qualified laboratory technicians. All samples from the patient had to be transported to the central laboratory before they could be analyzed. However, this paradigm has now shifted to a new system where tests are performed right where the patient is (Sequeira and Rathod, 2014). According to Sequeira and Rathod (2014), Point of Care testing is one of the most recognized approaches has replaced the central laboratory testing that has been in use for quite a long time. The new approach has been growing rapidly in the field of laboratory medicine.

John and Price (2013) define Point of Care testing as any test performed either close to the patient or at the patient’s bedside, and that does not require a permanent facility. Point of Care testing is normally performed outside the central laboratory where traditional testings were being carried out. In order to perform a Point of Care testing, analytical instruments must temporarily be brought at the patient’s location. All test procedures that are performed on patients must be accredited first to ensure that it meets the necessary requirements and that it will not put patients at risk. Similarly, Point of Care testing is an authorized procedure that has received accreditation from the College of American Pathologists (CAP), the Clinical Laboratory Improvement Act (CLIA) of 1998, and The Joint Commission accreditation body (Sequeira and Rathod, 2014).

Like the traditional clinical laboratory testing, Point of Care testing is performed with the aim of providing accurate and timely analyses, making important medical information available to Public Health organizations, and for providing important patient information that is useful to clinicians. Additionally, the quality requirements of central laboratory testing are similar to those of the Point of Care testing in spite of the differences in the testing site (John and Price, 2013). Although the performance goals of Point of Care testing are similar to those of the traditional clinical laboratory, the new technology has brought about significant impacts on the central lab.

Point of Care testing has made organization to make improvements on their central laboratory testing systems due to its quality and sensitivity benefits. New approaches to central laboratory testing have been developed due to the possibility of networking Point of Care testing systems. For instance, Point of Care testing allows for the transfer of central laboratory services to external provides and for the extension of various analytical spectrums. According to John and Price (2013) tests may be performed to make a range of clinical decisions including diagnosis, screening, medication, and monitoring.

Formal screening programs carried out using Point of Care testing demonstrate a difference in health outcomes from those obtained in the central laboratory. As far as diagnostic tests are concerned, Point of Care testing helps to improve the accuracy which helps in generating positive health outcomes. Moreover, Point of Care testing is considered safe and specific when it comes to generation of sensitivity of tests. Majority of healthcare organizations have decided to replace central laboratory testing with Point of Care testing because with Point of Care testing, it is possible to initiate the right treatment quicker than when tests are performed in the central lab (Price, 2001).

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Point of care testing has changed the manner in which different tests are performed in hospitals and in other health care organizations. This is with regard to various areas of analysis including blood gases and electrolyte tests, clinical chemistry, glucose analysis, lipid metabolism, bilirubin, hematology, hemostaseology, and cardiovascular diagnostic testing. With the Point of Care testing, all the listed tests can be performed close to patient’s location (Junker, Schlebusch and Luppa, 2010). Normally, blood gases and quantity of hydrogen ions are measure electrochemically. In order to effectively perform the Point of Care testing on the blood gases, the instruments for measuring gases and that for measuring pH can be integrated so that the complete analyzer is able to cover all the required parameters. In such a case, all the mechanical parts of the instruments lie with one cassette to allow easy transportation to the patient’s location. Conversely, the test instruments used in the traditional central laboratory were kept permanently in the lab (Junker, Schlebusch and Luppa, 2010).

Glucose analysis through Point of Care testing involves the use of small instruments that allow all types of reaction to occur subsequently. These reactions include enzymatic reactions and electrochemical detections. Interfering factors from blood components that may occur in these small instruments are taken care of using electrodes. The value obtained may differ depending on the types and quantities of enzymes used. Large variations can however be avoided by abiding by the German Diabetes Society guidelines for measuring blood glucose (Junker, Schlebusch and Luppa, 2010).

Apart from the central laboratory tests which determine individual clinical laboratory parameters, Point of Care systems now cover a wide range of analytical spectra at the same time. However, many organizations cannot afford these instruments because they are very expensive (Price, 2001). Organizations normally have varied reasons for using Point of Care testing, and the test procedures used in clinical chemistry for determining substrates and enzymes are always different from those used in central laboratory testing. Since modern organizations are very much concerned about accuracy, they prefer Point of Care testing to central laboratory testing when performing clinical chemistry tests (Junker, Schlebusch and Luppa, 2010).

Patients need to be screened properly to determine whether they need any antibiotic therapy. Currently, Point of Care testing is applied in most hospitals to evaluate the necessity for antibiotic therapy. These tests are carried out in automated systems which help to yield high amounts of sensitivity (Junker, Schlebusch and Luppa, 2010). This is considered as a great transformation from what used to happen in the traditional central laboratories. Unlike in the central laboratories, more integrated instruments are now used in Point of Care testing to determine different parameters of lipid metabolism, bilirubin, and various components of blood such as hemoglobin. Point of Care systems are now available for cardiovascular diagnostic testing, and the methods applied greatly differ from those used in the central laboratory. Handheld instruments are used for combined analysis of different cardiovascular markers (Junker, Schlebusch and Luppa, 2010).

Point of Care testing has assisted organizations to improve central laboratory systems despite the high costs involved. For example, self-monitoring of blood glucose is very expensive as compared to similar tests that are carried out in the central laboratory. According to Price (2001), there has been a rapid increase in the number of patients who are on warfarin therapy over the recent past. This increases the need for easy access to testing areas, especially for patients who have difficulties in monitoring their therapies. This is one area where Point of Care testing is playing a very big role. Clinics and hospitals are now implementing Point of Care systems to help speed up the testing process. These organizations are trying to avoid delays associated with sending specimens to the central laboratory. There are minimum complications observed when Point of Care testing is introduced. For this reason, Point of Care testing has helped to reduce the number of clinic visits for patients. Patients whose samples must be tested in the central laboratories must travel to the facilities or must have their sample transported there. This consumes a lot of time as the patients have to wait for a long time to obtain test results (Junker, Schlebusch and Luppa, 2010).

Turnaround time is one the key performance indicators of laboratory performance, and timeliness is very important to clinicians performing laboratory tests (Hawkins, 2007). The high level of concern on timeliness has led to the proliferation of Point of Care testing observed today in most hospitals and clinics. Additionally, many clinicians judge the quality of the laboratory based on turnaround time. Major complaints will arise from delays in turnaround time in many hospitals. Many laboratories have had problems improving their turnaround time despite several advances in technology and transportation systems. If properly implemented, Point of Care has the ability of decreasing delays in treatment, and to solve the problem of overcrowding in health care institutions (Hawkins, 2007).

Several authors highlight that there Point of Care helps to decrease turnaround time for test results in emergency setting (Rooney and Schilling, 2014). In one study, the researchers wanted to investigate the difference in turnaround times between Point of Care testing and central laboratory testing using similar samples. Even when tests were carried out in circumstances that could help minimize transportation problems, results obtained from Point of Care testing still arrived earlier than those from central laboratories (Norgaard and Mogensen, 2012). Other investigations involving pregnancy tests have revealed that Point of Care testing yields sensitive results faster than those tests carried out in the central laboratory. The main reason behind the delays in central laboratories is a lot of time spent in processing and handling samples (Rooney and Schilling, 2014).

The real life impacts of Point of Care testing and central laboratory have been observed to vary greatly in the emergency department. The degree of impact that Point of Care testing has on the central laboratory shows the nature of change that the Point of Care testing has brought to the health sector. According to Hawkins (2007), turnaround time are very beneficial in cases where the test results are needed in less than an hour and where delay in test results is the only barrier to clinical decision making. For this reason, Point of Care testing has been found to add more value to central laboratory testing especially if it is performed at pre-hospital level. The extent to which Point of Care testing adds value to central laboratory testing can be analyzed using a number of tests carried out in the emergency department.

A high percentage of attendees in the emergency department comprise of people who present with symptoms of acute coronary syndrome. About 70 percent of patients who are suspected to suffer from acute coronary syndrome are later found to suffer from different medical problems after thorough investigation. On the other hand, some patients suffering from acute coronary syndrome and mistakenly discharged, leading to more complications and even death. Ideally, any technique that can be used to make rapid and accurate assessments on patients suspected to suffer from acute coronary syndrome can help greatly in improving patient outcomes (Rooney and Schilling, 2014).

In the hospital, acute coronary syndrome is tested through biochemical evaluation of cardiac biomarkers. The most widely used cardiac biomarker is troponin because it has proven to be very sensitive indicator for any myocardial problem. The current guidelines for troponin tests require that test results should be made available to physicians 30 minutes after samples have been collected from the patient. This is because, when test results are availed quickly, the physician will have an opportunity of making clinical decisions on time. This may help prevent adverse outcomes that might result from delays in treatment (Rooney and Schilling, 2014).

Several technologies that can be used in Point of Care testing for cardiac tropinin are now available. These technologies can produce results within a very short time thereby reducing turnaround time. Tests carried out by Point of Care testing give results earlier than those performed in the central laboratory (Hawkins, 2007). Point of Care testing increases the speed at which cases of acute coronary syndrome can be identified. This high speed in diagnosis has been found to assist physicians to initiate treatment on time. Generally, the use of Point of Care testing in diagnosis of acute cardiac syndrome has helped to reduce the amount of time spent by patients in the emergency department (Rooney and Schilling, 2014).

Furthermore, Point of Care testing has helped reduce the time that patients with venous thromboembolic disease spend in the emergency department. Even though some samples taken from the patient may still be taken to the central laboratory, test results from Point of Care testing will be obtained faster. Venous thromboembolic disease is a very threatening condition that requires quick diagnosis for timely clinical decision making by the physician. D-dimer is the biomarker that is used to diagnose venous thromboembolic disease (Rooney and Schilling, 2014).

There exist a number of devices that can be used in Point of Care testing for venous thromboembolic disease. These devices are capable of measuring the D-dimer quickly and accurately. These devices have positive effects on turnaround time and on measures of efficiency. Perveen, Unwin, and Shetty (2013) conducted a research to evaluate the average time that Point of Care testing takes to gives results on D-dimer in an emergency setting. These researchers revealed that results on D-dimer are produced significantly faster in Point of Care testing than in central laboratory testing. For this reason, Point of Care testing helps to reduce the length of time that patients suffering from venous thromboembolic disease take in the emergency setting.

Diagnosis of severe sepsis is another area where Point of Care testing can be more useful than central laboratory testing. Since symptoms of sepsis are normally non-specific, it is important to carry out a test that can give very accurate results as fast as possible in order to prevent profound negative effects to the patient. Therefore, the best way to maximize clinical benefits is to minimize delays on tests. Lactate is used as the biomarker for testing severe sepsis in patients who have close clinical signs and symptoms for the disease (Rooney and Schilling, 2014). Treatment guidelines for severe sepsis require that the lactate fluid should be identified immediately to avoid additional risks for patients.  Levels of lactate should be measured rapidly as high lactate levels are associated with mortality which may occur within a few days. Treatment for severe sepsis should be initiated within the first three to four hours after a patient arrives at the emergency department. Quick initiation of treatment for severe sepsis has been found to reduce mortality rates by 16 percent (Rooney and Schilling, 2014).

Valid Point of Care testing technologies now exist that can be used to measure the levels of lactate in blood for quick diagnosis of severe sepsis. These technologies provide almost immediate feedback. Test results for lactate were made available 151 minutes earlier when Point of Care testing was used than when central laboratory testing was used. This helped to improve health outcomes of patients because the physician was able to make medication decisions on time. The direct relationship between quick treatment initiation and positive patient outcomes explain why it is important to implement Point of Care testing instead of central laboratory testing (Rooney and Schilling, 2014).

Point of care testing has also helped to reduce the amount of time that patients with stroke-related symptoms spend at the emergency setting. In order to reduce risks associated with bleeding in stroke patients, it is important to avoid delays in treatment as this is very crucial in the effective management of stroke. Reducing delays in diagnosis and treatment have been found to promote positive health outcomes for stroke patients, which also helps reduce mortality rate. Diagnosis of stroke involves assessment of the coagulation status of the patient. Early computer tomography scan needs to be performed in order to confirm presence of stroke. According to Hawkins (2007), delay in laboratory results is one of the major barriers to early treatment of stroke patients. Effective management of stroke can be achieved through implementation of Point of Care testing. Point of Care testing has been found to reduce the turnaround time for diagnosis of stroke by 30 to 50 minutes less than the time take when central laboratory testing is used (Rooney and Schilling, 2014).

Based on the above described impacts of Point of Care testing on central laboratory, it is important for healthcare organizations to understand how Point of Care testing can be set up without interfering with patient’s outcomes. For example, before setting up a Point of Care testing system, an organization should evaluate any alternative Point of Care instruments and systems to minimize variations that may occur with central laboratory systems. Point of Care instruments comprise of handheld devices portable and highly expensive. The correlation between Point of Care testing methods and central laboratory testing methods need to be obtained to ensure that the differences in the two different testing methods do not bring about significant impacts on patient outcomes (Sequeira and Rathod, 2014).

Additionally, any health organization that is willing to set up a Point of Care testing system should use professionals from different disciplines within the healthcare sector to manage the system. Point of Care testing sites work best if they are effectively managed either by individuals or a team. When a responsible person is in charge, he or she will assist with timely reporting of any system malfunctions. This will allow appropriate action to be taken to prevent any likely delays in testing. The presence of a trained professional at the site will help ensure that no unauthorized person tampers with the Point of Care instruments. Furthermore, the person will enforce policies, assign responsibilities, make appropriate decisions, and provide administrative support concerning how the Point of Care instruments should be handled (Sequeira and Rathod, 2014).

Another thing that must be put into consideration when setting up a Point of Care testing site is availability a competent person to perform the Point of Care testing. This is different from the person in charge of the site described above. The person must be trained on all phases of the testing process including the responses of various tests. Additionally, this person must be taught to distinguish between different types of samples. The analytical phase is also very important in the Point of Care testing and the person charged with responsibility of performing the testing must be conversant with the analytical procedures. Again, he or she must understand the post-analytical issues such as presentation of results, verification of result, communicating this information to the relevant person (Sequeira and Rathod, 2014).

There must also be a properly written procedure to be followed by the person performing the Point of Care testing. The manual should document how samples are prepared for testing, the procedure used to collect test samples, the criteria used to identify the best assay method, quality control procedures, as well as methods of reporting. The procedure outlined in the manual must adhere to the recommended guidelines. The procedures must also be easy to follow to give the person performing the tests easy while at the testing site (Sequeira and Rathod, 2014).

For Point of Care testing to continue giving more accurate results than those obtained from central labs, any organization setting up the Point of Care testing must ensure that the testing instruments are frequently calibrated using quality control samples that must be run on the machines at regular intervals. Some Point of Care testing instruments have been designed in such a way that they will prevent any form of reporting incase inappropriate collaboration. Furthermore, the person performing the Point of Care resting must be document test results of all patients and the relationship between the test results and the quality control measures must be clearly stated. Abnormal patient results must also be documented for evaluation purposes. These results can either be transmitted to a computer or be handwritten in charts so long as the method chosen is appropriate for record keeping purposes (Sequeira and Rathod, 2014).

Although an organization may be willing and ready to set up a Point of Care testing system to either support or replace its central laboratory testing, it is likely to be faced by a number of challenges. Organizations must be conversant with these challenges in order to learn how to overcome them. Most Point of Care testings are performed by staff with limited qualification (Rooney and Schilling, 2014). Additionally, Point of Care testing normally places additional burden on nurses who are sometimes not ready for the responsibilities. Organizations can ensure that tests are performed according to the quality test requirements and guidelines by cooperating with central laboratory personnel. Moreover, nurses must be allowed to undergo regular training for them to meet the quality assurance purposes and to be prepared to perform any type of task assigned to them (Rooney and Schilling, 2014).

Another challenge is the high costs associated with Point of Care testing instruments. The cost per analysis involved in Point of Care testing devices is higher than the cost per analysis for tests performed in a central laboratory (John and Price, 2013). Despite the numerous steps that have to be followed when carrying out tests in a central laboratory, the total cost involved in Point of Care testing is still extremely higher than that incurred in central laboratories (Rooney and Schilling, 2014). The costs are even higher if the Point of Care testing devices produce inaccurate results. When implementing the Point of Care system, internal quality control methods must be used to ensure that devices are producing consistent and accurate results. If an organization is using Point of Care system with network access, it can integrate quality control measurements to a central data management system for accuracy reasons. As advancements in Point of Care testing continue to expand, modern health care organization should consider shifting from the traditional central laboratory testing system to the Point of Care testing system for accurate and consistent results (Rooney and Schilling, 2014).

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