Appropriate and up-to-date tests help hospital laboratories to remain financially viable and remain competitive in the market while meeting the needs of doctors and patients. Laboratory staff is continually looking for new analysis to complete their in-house testing. Monitoring and maintaining new technology internally allows smaller hospital laboratories to rely less on reference laboratories to perform their tests. In order to determine whether a particular test should be carried out internally, this procedure for laboratory test was designed.

This standardized model was created in the form of a checklist to introduce new clinical laboratory tests to clinical laboratory staff. The inventory is designed to simplify the implementation of new tests. With the potential retirements of experienced lab experts, inexperienced laboratory staffs who recently graduated or recently changed professions are likely to be in positions where they will take part in the implementation of new tests. With this checklist, information that has become general knowledge for experienced laboratory staff is formed into a standard procedure that leads new people on the ground. The main implementation points were identified to create a checklist. These steps include the selection of test, testing, supplier interaction, decision making, and specific requirements.

Developing a Template for Implementing New Testing into the Clinical Laboratory

Step 1: Selection of Test

The laboratory must first decide whether the request is present for a new test. The demand analysis involves determining the cost-benefit ratio, complexity of tests and were in the hospital the test would be carried out (central laboratory, statistical laboratory, satellite laboratory or point of service). Although demand may be present, the test must be profitable to bring in-house.

One aspect that relates to profitability is the number of ordered tests (volume). It may not be cost-effective for low-volume tests that are internally controlled based on testing costs, test configurations, controls, and capability tests. However, if a sufficient volume is sent or if there is technological advancement, it may be better to carry out tests internally.

Consideration should be given to the degree of manual work to be done with a new test, especially if the laboratory automates certain test areas. Another important area for resolution is flexibility and compatibility with current instruments and the Laboratory Information System (LIS) used for electronic record results.

Step 2: Research

The next step is to examine the available test options for performing this test internally. This was done in the cooperation of experts for administration and analysis. For example, a research team could include laboratories, department supervisors, technicians, medical billing experts, and information technology (IT) representatives.

Step 3: Communicate with Suppliers

Suppliers are necessary to implement a new test. Suppliers can offer a list of laboratories using a particular product so that these laboratories can be visited during the intensive testing period, which can provide useful information. These laboratories can answer specific questions that may include their successes and disadvantages.

Vendors should be invited to show their product. Some vendors need to be interviewed, having an open mind, especially if they have a business history. The types of assistance providers in the assessment process include free test kits, equipment, validation board or training.

Step 4: Decision

Using information from each supplier will lead to the decision-making process. The question to be answered is: “Which test or more products will best meet the specific needs of the lab?” If the obvious possibility is unclear, a document can be created to organize the advantages and disadvantages of each test. It is better to make a decision by consensus with the research team and the head of the lab, enabling consideration of contrasting attitudes. The head of the laboratory must be fully engaged in the test because it is responsible for carrying out the test.

Step 5: Specific Requirements

New tests carried out by a clinical laboratory usually have common requirements as well as unique requirements. It is important to know these requirements and plan accordingly. It must be determined whether the FDA has approved or not approved the test. The FDA test has approved a new test design or a test that is different from the current product for sale is approved by the FDA based on the manufacturer’s data to prove it is safe if used correctly.