Do the new IQCP requirements have you down? Let us help!
January 1, 2016 isn’t too far off and most of us are still finalizing our Individualized Quality Control Plans (IQCP) to meet the deadline. Many of you have asked how these new requirements impact your OxyPRAS Plus® and OxyPlate™ media. Rest assured we have outlined the critical elements and provided a framework for helping with your IQCP requirements.
For those interested, background information and support can also be found at:
We tried to digest the IQCP requirements as they pertain to Oxyrase, Inc. plated media below:
The approved CLSI Standard M22-A3 specifies the requirements for Quality Control of commercially prepared culture media by breaking it into two categories: EXEMPT and NONEXEMPT. EXEMPT media does not need to be retested provided that the manufacturer certifies the media has met all criteria and the laboratory has not deemed it necessary to perform complete quality control. Here’s what you want to know:
All currently available Oxyrase media is categorized as EXEMPT by CLSI.
Our Certificate of Analysis, provided with each lot, certifies that the lot has met or exceeded established performance criteria.
- Download our list of exempt media here.
The College of American Pathologists (CAP) indicates that laboratories may implement an IQCP, for commercially prepared media that is EXEMPT per the CLSI M22-A3 Standard, accepting QC performed by the media supplier. The media supplier’s records must be maintained and show that the QC performed meets the CLSI/NCCLS standard. Here’s what you want to know:
Our Certificate of Analysis provides the data from our QC testing with each lot that meets or exceeds the testing required by the CLSI Standard M22-A3.
Our lot specific Certificate of Analysis is provided with each shipment for your convenience.
Question 42 of the April 2015 revision of FAQ’s for IQCPs found here on the CMS website states in part: “laboratory documentation showing visual quality checks of media are acceptable in house data. The laboratory may also include manufacturer’s quality certificates as part of the information considered in its risk assessment.”
The College of American Pathologists (CAP) states that a Quality Control Plan must be in compliance with manufacturer instructions and recommendations. Here’s what you want to know:
Our Certificate of Analysis, provided with each lot, certifies that the lot has met or exceeded established performance criteria.
Our recommendations for user QC can be found in our Product Inserts online here. They also indicate that each lot is tested and performed acceptably according to Oxyrase, Inc.’s specifications which include CLSI Standards M22-A3. We do not require end user QC unless the specific laboratory has deemed it necessary.
Any alerts or product updates are supplied directly to customers, for their records, as needed.
An acceptable IQCP needs at least 3 elements – Risk Assessment, Quality Control Plan, and Quality Assessment. Here’s what you need to know:
Risk Assessment – Indicate potential failure modes that can impact diagnosis and quality of results. Determine the frequency of occurrence and the severity should error occur. Include any procedures that minimize the risk or control the process.
Quality Control Plan – List how you will control the quality of the media you are using. Indicate the procedure, process, etc.
Quality Assessment – Indicate how will you monitor and assess the effectiveness of your Quality Control Plan on an ongoing basis.
We have included an example Individual Quality Control Plan for our media in the attached pdf to aid in the development of your own IQCPs. (Please note this is ONLY an example and has not been approved by CMS).
For your convenience we have also attached the IQCP example from ASM for Exempt Media.
You will see several updates to our Certificates of Analysis and Product Inserts rolled out by the end of September 2015 to help support your IQCP efforts. Always feel free to contact our Customer Service and Technical Support for any additional help you may need.
Thank you
Oxyrase, Inc.
**A special thank you to the following folks for their outstanding presentations on IQCP background and guidelines:
Yvette S. McCarter, PhD, DABMM
Director, Clinical Microbiology Laboratory
UF Health Jacksonville
Professor of Pathology
University of Florida College of Medicine-Jacksonville
Susan E. Sharp, PhD, DABMM, FAAM
Director, Airport Way Regional Laboratory
Director, Regional Microbiology and Molecular Infectious Diseases Laboratories
Department of Pathology
Kaiser Permanente
Portland, Oregon
