It appears that there is still some confusion among laboratory personnel in differentiating QC from QA, and that this uncertainty has been compounded by the introduction and implementation of the Individualized Quality Control Plan (IQCP). These are different concepts, and it is important to understand these differences—both from the practical standpoint of what you are trying to accomplish, as well as how you get there.
Basically, laboratory quality control is designed to detect, reduce and correct deficiencies in a laboratory’s internal analytical process prior to the release of patient results in order to ensure the quality of the results reported by the laboratory. Quality control is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. Laboratory quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after calibration and whenever patient results seem inappropriate. The effectiveness of quality control is assessed on a per-test basis.
On the other hand, quality assessment is more broadly focused; it is an on-going program for auditing an organization’s processes and systems. It involves setting quality goals, deciding whether or not these goals have been achieved and implementing corrective action if these goals have not been reached. It includes auditing the effectiveness of your policies and procedures, encompasses all phases of testing and general administration. There are no limits for quality assessment audits—going well beyond the more test-specific focus of quality control.
The CLIA regulations (Subpart K) address specific quality assessment requirements. The Code of Federal Regulations (42 CFR 493) states that laboratories “must establish and follow written policies and procedures for a comprehensive quality assurance program that is designed to monitor and evaluate the ongoing and overall quality of the total testing process.” The QA program must:
- Assess the effectiveness of the lab’s policies and procedures.
- Identify and correct problems.
- Assure the accurate, reliable and prompt reporting of test results.
- Assure the adequacy and competency of the staff.
But now we have the Individualized Quality Control Plan (IQCP), which is the new alternative QC option permitted by CMS and is based on risk assessment. As such, the process of determining the appropriate IQCPs for your laboratory involves many of the elements of the traditional quality assessment process to determine the most effective QC based on examining all aspects of the laboratory operation to determine risk.
In effect, this brings the QC/QA relationship full circle, from where the traditional (analytic phase focused) QC is a key part of QA to where QA processes are utilized to determine the best QC to use. However, the one constant is that QA remains process and systems focused, while QC/IQCP is still utilized for use on a per-test basis.