Federal regulations require clinical laboratories to routinely assess the accuracy and reliability of their testing processes. But what happens when no commercial Proficiency Testing (PT) program exists for a particular analyte your lab performs? In these cases, alternative split sample assessment, also known as Alternative Proficiency Testing (ALT PT), becomes essential for meeting CLIA compliance.
This article explains why alternative split sample assessment matters, how it differs from traditional PT, and how laboratories can successfully use it to fulfill federal regulatory requirements.
The Regulatory Requirement Behind Alternative Proficiency Testing
Under the Clinical Laboratory Improvement Amendments (CLIA), laboratories are required to evaluate their testing accuracy and reliability at least twice annually for each regulated analyte they perform. In most cases, this is accomplished through participation in an approved Proficiency Testing program. These programs provide standardized samples that labs test and return for peer comparison and performance scoring.
However, not all analytes have commercially available PT programs. In these cases, CLIA allows laboratories to use what’s known as alternative assessment procedures to meet regulatory expectations. This is where Alternative Proficiency Testing comes into play.
What Is Alternative Proficiency Testing?
Alternative Proficiency Testing (ALT PT) refers to the evaluation of a laboratory’s performance on specific analytes when a commercial PT program is unavailable. Also referred to as Alternative Split Sample Assessment, this method involves the testing of shared samples (often referred to as “split samples”) across multiple laboratories to determine consistency and reliability of results.
While “Alternative Proficiency Testing” and “Alternative Split Sample Assessment” are often used interchangeably, there is a subtle difference in nomenclature:
- Alternative Proficiency Testing (ALT PT): A general term for any alternative approach taken to meet the proficiency testing requirement for non-commercial analytes.
- Alternative Split Sample Assessment: A specific method of ALT PT that involves distributing identical patient samples to multiple labs to compare performance.
Importance of Proficiency Testing for Clinical Labs
Failure to comply with CLIA’s PT or alternative assessment requirements can result in serious consequences, including loss of certification or the ability to perform certain types of testing. But beyond regulatory compliance, Alternative Proficiency Testing plays a crucial role in quality assurance and continuous improvement within the laboratory.
Here’s why participating in ALT PT and split sample testing is essential:
- Quality Verification: Confirms the accuracy of lab methods for non-commercially tested analytes.
- Operational Confidence: Helps ensure consistency in patient test results, boosting physician and patient trust.
- Documentation: Creates a traceable and reviewable record for inspections and audits.
- Peer Comparison: Provides valuable benchmarking when conducted through a coordinated network of labs.
How ALT PT Works in Practice
In a typical alternative split sample testing program, such as the one provided by Lighthouse Lab Services, laboratories receive a set of shared samples twice a year. These samples are tested using each lab’s established methods, and the results are then compiled and compared among participating laboratories.
Lighthouse further supports this process by:
- Identifying an appropriate peer group of laboratories performing the same analytes.
- Analyzing and compiling the test results.
- Providing a formal performance report for laboratory directors and personnel to review.
This added layer of analysis ensures the laboratory not only meets CLIA standards but also receives actionable feedback on its testing quality.
Common Use Cases: Toxicology and Ethanol Testing
Many labs turn to ALT PT for complex or specialty testing panels where commercial options are limited. Urine-based toxicology and ethanol testing are two such areas where alternative split sample assessments are frequently necessary.
These types of tests are often critical for pain management, behavioral health, and forensic applications, and maintaining confidence in testing accuracy is vital, especially in environments where results may impact medical or legal decisions.
Final Thoughts: Meeting CLIA Standards with Confidence
Alternative Proficiency Testing and Split Sample Assessment may not be as widely discussed as traditional PT, but it’s a vital component of laboratory quality management and regulatory compliance. Labs that perform specialized testing or work with non-commercially available analytes cannot afford to overlook this requirement.
By understanding the purpose and process behind ALT PT, laboratories can confidently maintain high standards while meeting CLIA’s expectations, even for niche or hard-to-find analytes.
Want to learn more about how your lab can stay compliant with proficiency testing? Lighthouse Lab Services offers a trusted Alternative Split Sample Assessment program for urine-based toxicology and ethanol testing.
Feel free to contact us to learn more about how the process works or see if your analytes are covered.