PT processes are a sequence of activities that enable the laboratory to monitor and assess test (including qualitative and quantitative methods) performance utilizing either commercially prepared products or established acceptable internal processes. Any institutional established process must meet regulatory and accreditation requirements. The PT process begins with an assessment of test methods and includes those that are:
- Nonwaived (moderately or highly complex)
- Categorized as provider performed microscopy procedures (PPMPs)
- Any additional methods requiring PT by state or accreditation agencies
- Any tests for which the laboratory director has determined the need or desire for PT to be performed on a regular basis
Test complexity levels and categorization of waived, nonwaived, and PPMPs are defined by the Food and Drug Administration (FDA).
The PT process is generic by design and each laboratory must have written policies and procedures incorporated into the standard operating procedures(SOP). Policies and procedures must include the appropriate test methods as defined by complexity and regulatory requirements for testing.
Each PT plan should include the following points:
- Selection of a PT provider/vendor from the approved CMS providers
- Proper handling, analysis, review and result reporting of PT testing materials
- Investigation and correction of problems that are identified by unacceptable, unscored, or lack of consensus results
- Investigation and correction of results demonstrating bias or trends that represent a possible problem
Selection of a PT provider and appropriate test modules should consider the following points, and the provider must be included among the CMS-approved providers:
- The PT samples are compatible with instruments and methods used in the laboratory.
- Analytes included, evaluation intervals (assigned value and deviation allowance), and performance scoring are consistent with test methods requiring evaluation.
- PT frequency meets CMS requirements.
- Reports are confidential, accurate, informative, and inclusive of all analyses, interpretations, evaluation criteria, and technical assistance (as needed).
- Have the ability of reports to be sent to compliance and accrediting organizations.
Each site must be enrolled separately based by location and test menu. The testing for each facility must be performed at the facility to which the samples are sent from the manufacturer.
