Developing a Standard Protocol for the Introduction of New Testing Into a Clinical Laboratory: Appendix 1

Abstract

Appropriate up-to-date testing helps hospital laboratories remain financially viable by remaining competitive in the market while serving physician and patient needs. Laboratory personnel continuously look for new analyses to supplement their arsenal of in-house testing. Staying current and maintaining new technology in-house allows smaller hospital laboratories to rely less on reference laboratories to do their testing. To ascertain if a specific test should be brought in-house, a process for laboratory test evaluation was devised. A standardized template in the form of a checklist was created to aid clinical laboratory personnel in the introduction of new clinical laboratory testing. The checklist is designed to expedite implementation of new testing. With the eventual retirement of experienced laboratory professionals, inexperienced laboratory personnel who have recently graduated or recently changed professions are more likely to be placed into positions where they will be involved in new test implementation. With this checklist, information that has become general knowledge to experienced laboratory personnel is formatted into a standard procedure to guide those individuals new to the field. Key implementation points were identified to create a checklist. These steps include: selection of test, test research, interacting with vendors, decision, special requirements (including validation), creating and maintaining documentation, establishing competency, and proficiency. ### Step 1: Selection of Test The laboratory must first decide if demand is present for a particular new test ( Appendix I: Step 1 ). Analyzing the demand includes determining the cost effectiveness, complexity of testing, and where in the hospital the testing will be performed (ie, central laboratory, stat laboratory, satellite laboratory, or point-of-care). Even though a demand may be present, the test must be cost effective to bring in-house. An aspect relating to cost effectiveness is how many tests are ordered (volume). It may not be cost effective for low-volume tests ordered to be done in-house based on the cost of …