One of the most important aspects of laboratory oversight is having a robust quality assurance (QA) program. A strong QA program that encompasses a culture of continuous quality improvement (CQI) is the cornerstone of an efficient, highly functioning laboratory.
QA Defined
QA encompasses the entire testing process—from pre-analytical through post-analytical—and puts checks, balances, and measures in place to ensure the accuracy, reliability, and consistency of test results. QA oversight requires a comprehensive program with many key components, including establishing:
-
- Standard operating procedures (SOPs)
- Validated test methodologies
- Calibrated and maintained equipment
- Staff training, continuing education, and competency assessments
- Robust quality control (QC)
- Proficiency testing (PT) compliance
- Detailed documentation and recordkeeping
- Ongoing QA review and adjustments
QA measures identify and provide an opportunity to adjust and improve procedures, continually making changes that ensure results are precise, reproducible, and compliant with established standards and regulations.
CQI Defined
One of the overarching goals of a QA program is to have a system that promotes ongoing improvement, or CQI. A strong QA program focuses on assessing, evaluating, and improving all aspects of laboratory management to enhance performance and maintain data reliability. When setting up processes to monitor as part of the QA plan, look for weak areas and put monitors in place to track and improve. When issues are uncovered, policies, procedures, or training can be adjusted to prevent that issue from reoccurring. QA measures can detect differences in performance between laboratories, test methods, and staff techniques. If a QA measure repeatedly does not uncover any issues, adopt a new measure in an area of concern.
QA Components Overview
As mentioned, a comprehensive QA program has many moving parts. Each area requires diligent oversight, review, and analysis. Below are some of the elements that should be included in a comprehensive QA program:
- SOPs: Maintain up-to-date policies and procedures for every area within the lab with documented review. In addition to procedures for day-to-day lab operations, an effective QA program should include policies for:
- Reagent handling
- Test repeat
- Split specimen analysis
- Unacceptable specimens
- Incident management
- Remedial action reporting
- QC: Develop a robust QC program to monitor the analytic phase of testing to detect errors related to test system failure, environmental conditions, or operator performance. QC is a means of determining the quality of results and should uncover issues that need resolution prior to result reporting.
- Proficiency Testing: Enroll with a CLIA-approved proficiency testing provider for external assessment of laboratory performance.
- Validation and Verification: Rigorously validate and verify laboratory methodologies to ensure reliable results. This involves evaluating factors like precision, accuracy, linearity, normal range determination, specificity, and sensitivity.
- Data Management and Recordkeeping: Ensure robust data management and document storage. Your laboratory information system (LIS) can maintain accurate and secure laboratory records. This includes proper documentation of sample handling, test results, and any corrective actions. Documentation logs may include:
-
- Incomplete Requisition Log
- Chart Correction Log
- LIS Investigation/Resolution Log
- Lab Reconciler Log
- QA Calculation Verification Log
- Result Retrieval and EMR Verification
- Lab Complaint/Investigation/Resolution Log
- Chart Correction Log
- Corrective and Preventive Actions (CAPA)
-
- Internal Audits and Annual Review: Implement internal audits to assess the effectiveness of your QA program and help find areas for improvement. Document the annual review of your QA program.
Importance of QA
A laboratory without a solid QA program is effectually operating on guesswork. QA puts tracking monitors into error-prone areas to uncover problems before they become more serious. Below are some of the benefits of a strong QA program.
- Promotes Accuracy & Reliability
QA procedures enable accurate and reliable results and reduce errors that could lead to misdiagnosis or improper treatment.
- Supports Consistency & Standardization
QA helps standardize processes and ensure adherence to regulatory standards, which in turn minimizes risk. Consistency in laboratory processes enables data comparability across personnel.
- Supports Regulatory Compliance
A QA program is an important aspect of regulatory requirements, such as CLIA.
- Evokes Trust & Confidence
Consistent reporting of accurate and timely results, supported by your QA program, fosters trust among stakeholders (e.g., patients, providers, etc.) and increases confidence in the lab’s capabilities.
- Provides Prompt Problem Resolution
Good QA measures enable early detection of issues to allow for prompt corrective actions and prevention of the same error in the future.
- Reduces Costs
Effective QA measures can decrease operational costs associated with repeat analyses, errors, and time spent investigating problems.
Summary
Your QA program is at the heart of your laboratory. Effective design and implementation of QA can protect your lab, increase the confidence providers have in your lab, and improve the overall quality of the results that you produce. It is very important to take QA seriously and invest the time it takes to create an effective program.