The general structural premise for any competency assessment is to include specific activities for evaluation of each test method included in the competency assessment process.
In the process of evaluating competency, constructing an inclusive process to incorporate in the evaluation must include meaningful steps and be inclusive of the entire process being evaluated.
Each test method, instrument, or laboratory process that is included in the evaluation may include the following specific steps. This list is not all inclusive, but serves as a generic guideline:
- Follows institution specific policy and procedure or the package insert for all test methods. NOTE; This may be broken down into specific steps as a part of the competency assessment process.
- Follows manufacturer's instructions for use of all instrumentation. Note: This may be broken down into specific steps as a part of the competency assessment process.
- Correctly labels all reagents, controls, and kits with received date, open date, and altered expiration date as required by the manufacturer.
- Collection of correct sample type and sufficient amount of the patient sample.
- Correctly process the specimen used for the testing.
- Correctly perform the testing process by adding in the proper order and correct amount(s) of patient specimen and reagent(s).
- Correctly prepares controls and reagents as directed by the manufacturer.
- Test kits are maintained intact and uses only test solutions and reagents from the same test kit and lot number.
- Completes all logs and required documentation as defined by institution specific policy and procedure.
- Completes and maintains records of the patient testing results.
- Treats proficiency testing (PT) samples in the same manner as patient specimens and follows institution specific policy and procedure related to PT.
- Adheres to the laboratory’s quality control (QC) policies and documents QC activities as defined in institution specific policy and procedure.
- Adheres to institution specific policy and procedure and manufacturer's requirements for instrument calibrations and maintenance activities.
- Follows the laboratory’s corrective action policies and procedures when a test system fails to meet the laboratory’s acceptable level of performance.
- Identifies problems that may affect test performance or reporting test results and either corrects the problem or notifies appropriate personnel as required by institution specific policy and procedure.
- Documents all corrective action taken when there is a test system failure as required by institution specific policy and procedure.
- Completes patient test reports correctly, using the appropriate test units of measurement.
Activities to be included in the competency assessment for POCT may be evaluated throughout the assessment period (six months or 12 months). All necessary activities and all required testing must be assessed during this period.