EDITOR'S NOTE: In addition to the August MLO Continuing Education story on “IQCP: a new option for Quality Control,” we are pleased to present the following article by Irwin Rothenberg, Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI). It’s late August, and the deadline of January 1, 2016, draws ever nearer: here’s a roadmap to get from here to there.
In just a few months, the Individualized Quality Control Plan (IQCP) will be the only acceptable Equivalent Quality Control (EQC) alternative to CLIA QC requirements. We are in the last quarter of what has been a two-year education and transition period to understand IQCP: why it was developed; the processes that define it; and how it is to be implemented, assessed, and monitored.
Whether you have already begun the development of your IQCP, or are still thinking about it, time is of the essence if you want to be fully “IQCP-operational” by January 1, 2016.
IQCP: The key word is the first one: Individualized. IQCP is the new EQC option that allows your laboratory to create a QC plan that is customized to its specific environment. Quality Control is most effective when it takes into consideration all the circumstances that are unique to a specific laboratory. IQCP provides the flexibility to adapt to new and future technologies while still meeting CLIA compliance. But note: A separate IQCP must be developed for each test performed in your laboratory. If IQCP is properly implemented, potential sources of error in the pre-analytic, analytic, and post-analytic phases of testing will be examined, and the appropriate QC and quality practices will be established. This should reduce the likelihood of errors occurring in your laboratory.
The IQCP process
The three steps of the IQCP process are Risk Assessment (RA), Quality Control Plan (QCP), and Quality Assessment (QA).1
A Risk Assessment identifies and evaluates potential failures and sources of errors in the testing process. It must include, at a minimum, an evaluation of the following five components (for each phase of each test system): Specimen; test system; reagent; environment; and testing personnel.
A Quality Control Plan describes practices, procedures and resources needed by a laboratory to ensure the quality of a testing process. The QCP includes measures to assure the accuracy and reliability of test results, and ensures that the quality of testing is adequate for patient care. The QCP must provide for immediate detection of errors that occur due to test system failure, adverse environmental conditions, and operator performance. It must also monitor, over time, the accuracy and precision of test performance that may be influenced by changes in the specimen, test system, reagent, environment, or variance in operator performance.
Lab leaders should create a plan that includes activities to reduce the likelihood of failures and errors identified from their risk assessment. They must consider the amount of QC necessary based on the frequency and volume of patient testing.
A Quality Assessment is the continuous process of monitoring the effectiveness of the QCP. Practices, processes, and resources to consider for monitoring effectiveness of a QCP may include, but are not limited to, QC reviews, PT performance reviews, chart reviews, specimen rejection logs, turnaround time reports, and complaint reports.
Implementation timetable
There is still time for your lab to meet the deadline. Here is a possible schedule to take you from here to there:
8/1 – 9/15: Complete your RA processes.
• Gather and review information already available to your lab about the testing process, such as manufacturer’s information, data obtained through verification or the establishment of performance specifications, historical QC, calibration, PT data, personnel training and competency records, records of complaints and corrected reports.
• Break down each phase of testing into individual steps, so that potential failures and errors and their impact can be assessed and identified. Process mapping and fishbone diagrams are useful tools for this process.
• Evaluate your ability to detect or prevent these errors. Formulate ways to control potential errors that are not being detected by existing activities. This is your risk mitigation.
9/15 – 10/15: Write your QCP. It’s possible that you may find your customized QCP will be less rigorous than the CLIA control requirements. However, at a minimum, your QC Plan must not be less stringent than the manufacturer’s instructions for testing QC. As with traditional QC plans, your plan must:
• Detect immediate errors that occur due to test system failure, adverse environment conditions, and operator performance.
• Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance.
• Meet all applicable regulatory requirements. In addition to the federal CLIA regulations, your laboratory may be subject to more stringent requirements such as state laws or Accrediting Organization criteria.2
10/1 – 11/1/: Train your staff and finalize your QCP. Ensure that all staff involved are trained to your QCP, gather feedback, and create a revised version of your QCP.
11/1—12/31: Initiate implementation.
If you have already completed any of these phases, you have additional time for staff training, reviewing feedback about implementation, and most importantly, beginning the third step of the IQCP process: Quality Assessment. Monitoring your IQCPs must be part of your laboratory’s overall Quality Assessment Plan.
REFERENCES
1. CMS: Individualized Quality Control Plan Manual—A Step by Step Guide. www.cms/gov/…/Individualized_Quality_Control_Plan_IQCP.html.
2. Individualized Quality Control Plan (IQCP) Implementation Guide. IQCP Evaluation and Monitoring. COLA Resources, Inc. 2013. p.49.
Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI). CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with industry organizations.
