Jump to content

Recommended Posts

Is there already a discussion on here on developing an ICQP for the Transfusion Service?  I am not able to find one.

Share this post


Link to post
Share on other sites

From AABB Weekly, May 5, 2017

AABB Accreditation to Accept IQCP
Beginning Oct. 1, facilities that use AABB as their provider under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) will be able to use an individualized quality control plan (IQCP) for limited testing of bacteriology. This is a change in AABB’s accreditation practice regarding the requirements under CLIA, for which AABB has been granted deemed status. Beginning in October, facilities that are accredited by AABB under CLIA that use either the BacT/Alert or Verax system for bacterial contamination testing may use an IQCP or continue to follow the quality control requirements set forth in the Code of Federal Regulations. An IQCP will only be accepted for this limited testing in the specialty of bacteriology. An IQCP will not be accepted for any other specialty for which AABB has been granted deemed status. Additional information about IQCP is available from the Centers for Medicare and Medicaid Services.
 
And there was this additional information in the AABB News June 2017

Anne Chenoweth, MBA, MT(ASCP)CM, CQA(ASQ), senior director of accreditation and quality at AABB, told “AABB News” that this change will be beneficial for those facilities that are affected. “Once the Centers for Medicare and Medicaid Services [CMS] removed the CLSI guidance from their interpretative guidelines, AABB realized that the burden for quality control of culture bottles would fall to the facility,” Chenoweth said. “We worked with CMS to ensure that we could recognize IQCP for limited use in bacteriology. IQCP is not required, but this will give facilities that use AABB as their CLIA provider a choice for bacteriology quality control.”

 

 

Share this post


Link to post
Share on other sites
19 hours ago, tcoyle said:

From AABB Weekly, May 5, 2017

AABB Accreditation to Accept IQCP
Beginning Oct. 1, facilities that use AABB as their provider under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) will be able to use an individualized quality control plan (IQCP) for limited testing of bacteriology. This is a change in AABB’s accreditation practice regarding the requirements under CLIA, for which AABB has been granted deemed status. Beginning in October, facilities that are accredited by AABB under CLIA that use either the BacT/Alert or Verax system for bacterial contamination testing may use an IQCP or continue to follow the quality control requirements set forth in the Code of Federal Regulations. An IQCP will only be accepted for this limited testing in the specialty of bacteriology. An IQCP will not be accepted for any other specialty for which AABB has been granted deemed status. Additional information about IQCP is available from the Centers for Medicare and Medicaid Services.
 
And there was this additional information in the AABB News June 2017

Anne Chenoweth, MBA, MT(ASCP)CM, CQA(ASQ), senior director of accreditation and quality at AABB, told “AABB News” that this change will be beneficial for those facilities that are affected. “Once the Centers for Medicare and Medicaid Services [CMS] removed the CLSI guidance from their interpretative guidelines, AABB realized that the burden for quality control of culture bottles would fall to the facility,” Chenoweth said. “We worked with CMS to ensure that we could recognize IQCP for limited use in bacteriology. IQCP is not required, but this will give facilities that use AABB as their CLIA provider a choice for bacteriology quality control.”

 

 

We are neither AABB nor CAP (we were for many, many years but our new lab director dropped them both).  We are inspected by the Joint Commission only.  Does the Transfusion Service have to develop an IQCP Plan?  There was a thread on here when IQCP first came about but I am not able to find it.

Share this post


Link to post
Share on other sites

According to the CMS guidelines you do not need to develop one, as long as you are performing the required QC.  This is a snippet from that additional information link:

I HAVE ALWAYS FOLLOWED MANUFACTURER’S INSTRUCTIONS FOR QC IN MY LABORATORY WHICH IS LESS THAN THE CLIA REQUIREMENT OF 2 LEVELS OF QC EACH DAY OF TESTING. WHY DO I NEED TO CONSIDER DOING AN IQCP?

Effective as of January 1, 2016, if you wish to continue your current QC practice you will need to perform an IQCP. During test system development, manufacturers challenge their tests in many ways to identify possible failures and build in features to reduce the risk of those failures. However, manufacturers’ instructions for QC may not address all the risks, potential errors and variables that are specific to your laboratory’s situation. Developing an IQCP will address the risks that are specific to your laboratory and help you determine the appropriate QC for your patient testing.

Share this post


Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now

  • Advertisement

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.