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On January 1, 2016 the Center for Medicare and Medicaid Services (CMS) will no longer acknowledge Equivalent Quality Control (EQC) policies and procedures as an effective form of Quality Control (QC). Individualized Quality Control Plan (IQCP) will replace EQC as the preferred form of QC for clinical laboratories. To learn more about IQCP, read the CMS IQCP Introduction brochure and IQCP Frequently Asked Questions.
Considerations When Deciding to Develop a Plan
CMS also published a helpful brochure, Considerations When Deciding to Develop an IQCP. The document outlines the advantages of an IQCP:
- Customized QC program for your tests, systems, and unique laboratory environment
- Uncover potential sources of error in your pre-analytic, analytic and post analytic phases of testing
- Establish the appropriate QC and quality practices which reduce the chance of errors
In the second section of the brochure, they give scenarios that aid you in your decision making process. Start by reviewing the manufacturer’s instructions on quality control stated on the package insert or operator’s manual of your tests and devices. Then, follow the three scenarios listed to see which option is right for you.
Steps Towards Developing an IQCP
Time for the actual plan of action. It’s important to research each path to see if it is a good fit for your laboratory. There are a few options you can take to meet the requirements for IQCP.
Create Your Own
CMS put out a Step-By-Step Guide to help you develop your own IQCP plan. This guide helps you tailor an individualized plan for your unique testing environment by addressing the three key foundations of an IQCP. It may be helpful to copy and paste the spreadsheets found in the guide into Excel so you can easily document each step. Don’t forget to complete the Risk Assessment Worksheet (pg.15), Quality Control Plan Worksheet (pg.41), and the Quality Assessment Worksheet (pg.49). The workbook comprehensively covers the following pillars of an IQCP program:
- Risk Assessment
- Specimen Risks
- Test System Risks
- Reagent Risks
- Environment Risks
- Testing Personnel Risk
- Quality Control Plan
- What it is
- How to develop it
- Worksheet and Tips
- Quality Assessment
- What it is
- Documents to consider
Implement the CRI IQCP Program
While this approach does come with a price tag, it will save you time in the long run. COLA Resources Inc. (CRI) developed this solution, but you don’t have to be a registered COLA lab to use it. For $249 you can purchase the CRI IQCP software that provides all laboratories from small POLs, to hospitals and independent labs, a roadmap on how to perform a risk assessment and develop an IQCP. After implementing, you receive custom recommendations on how to align your QC programs with IQCP guidelines.
There is also an Implementation Guide available to assist in the application of your IQCP specific to your laboratory. The software and guide simplify CMS’ Step-By-Step Guide by offering it online; your responses are recorded, customized questions and information is given due to your answers, and a customized IQCP is formed at the end. If you are pressed for time to implement, this may be the approach for you.
This is not advised, though IQCP is voluntary. It is strongly suggested that you develop an IQCP program that ensures quality control compliance. If you chose not to participate you must at least follow CLIA’s QC requirements of performing two levels of external control on each test system for each day of testing.
While the education and transition deadline is nearing, hopefully this post steers you in the right direction towards developing an IQCP for your laboratory. Still have questions? Check out the resources below.
If you want to more know about IQCP you can:
- Visit the CMS IQCP Website
- Purchase the webinar “Everything You Wanted to Know About IQCP”
- Check out The Medicare Learning Network’s “IQCP Information and Questions”
- Take the Clinical Laboratory and Standards Institute Online Workshop: “Risk Based Tools to Meet IQCP Requirements”
- Register for the CRI IQCP Workshop Series on July 31st in Atlanta, GA