Chemistry Instrumentation Solo 1 Lecture 3 Study Guide

List three advantages that point of care testing has over central laboratory testing

More efficient workflows

Reduced turnaround time

Smaller sample volumes

List three disadvantages of point of care testing has compared to central laboratory testing

Less accuracy

Numerous operators to train

Result integration to electronic medical record (EMR) can be challenging

Defined by CLIA as a test requiring expertise beyond normal clinical automation. The test may require reagent preparation, limited pre-evaluation , and interpretation of results

High-Complexity Tests

Defined by CLIA as a test requiring basic lab knowledge and training for personnel performing the test. May require reagent preparation, limited pre-treatment of specimens, quality control, calibration, proficiency testing, some skill in troubleshooting and maintaining equipment, and some skill or judgment in interpretation of results

Moderately-Complexity Tests

The simplest complexity listing in CLIA. It involves primarily test systems approved by the FDA for home use, The requirements are that there is no reasonable risk of harm to the patient if the test is performed incorrectly. The likelihood of erroneous results is negligible; the test method is simple and uncomplicated; and is available for home use; encompasses most POCT tests; operators must follow manufacturers instructions

Waived Tests

Issued to a laboratory to perform only waived tests

Certificate of Waiver

Issued to a laboratory that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined by survey to be in compliance with CLIA regulations

Certificate of Registration

Issued to a laboratory in which a physician, midlevel practitioner, or dentist performs no tests other than the microscopy procedures. Permits the lab to also perform waived tests

Certificate of PPMPs

Issued to a laboratory after an inspection that finds the lab to be in compliance with all applicable CLIA requirements

Certificate of Compliance

Issues to a lab on the basis of the labs accreditation by an accreditation organization approved by the Health Care Finance Administation

Certificate of Accreditation

Eight key components of device design when evaluating analytical and technological considerations are:”

Operator Interface: Helps guide user through the operation

Bar Code Identification System: Identify Patient ID, reagent packs, calibration and other info

Sample and Reagent Delivery Mechanisms: Sensor strip, cassette, etc.

Reaction Cell: Location of Reaction

Sensor: Detects the reaction of the analyte with a binding molecule or some other type of recognition element

Control and Communication Systems: Coordinates all other systems to ensure that all the required processes for an analysis take place in the correct order

Data Management and Storage: Calibrations, QC Data and Patient results

Manufacturing Requirements: Must be reliable

What information should always accompany the test result across the POCT device, the middleware or LIS, and the electronic medical record

Identifiers for the patient, sample, operator, and device

Date and time of both the specimen collection and analysis

Type of specimen

Test requested and test result with appropriate units

Error messages and action messages