tcoyle

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.

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.”

There was a good pod cast recently from Joe Chaffin (blood bank guy) and Anne Chenoweth discussing AABB related items. Anne discussed competency as well. It was good information and may be helpful (and you can get a free CE as well). Check it out!

Hello, are you looking to actually create physical products or just in a computer? In the past we have made physical units with card stock...yellow for yellow products, red for red cells, and then labeled with labels we have created in our validation environment.

Mabel, do you write your own reports? If so, have you seen Tableau? I'm not an expert on anything SQL, but tableau is a good software for creating your own reports. Please note: this is my opinion and not necessarily that of my employer.

I don't know of any regs or accreditation standards, however your software vendor may have a stipulation about how many versions users can be behind before they stop supporting the software. You might check with them.

Hello, are you wanting to validate the actual printer (hardware) or all the labels coming out of Hematrax?

Hello, The people have spoken and thanks for the comments! I agree that the verification of a blood sample per CAP does not state how to do this. However, AABB is quite clear that determinations of ABO group be performed with the Anti-A and Anti-B reagents and with A1 and B reagent red cells. A question to consider: isn't it safer for the patient to do the full ABO group test when actual testing is required rather than performing only the front type? With the front and back type of testing you have a built in monitor to help discover discrepancies.

Agreed! From the 31st Edition of the BBTS Standards: Standard 5.14.5 Pretransfusion Testing requires two ABO group determinations and cites Standard 5.14.1 as the precursor. 5.14.1 states the ABO group shall be determined by testing the red cells with Anti-A and Anti-B reagents and by testing the serum or plasma for expected antibodies with A1 and B reagent red cells.... TRM.40550 Forward/Reverse Typing Phase II For each patient, red blood cells are tested with anti-A, anti-B, anti-D, and serum/plasma is tested using A1 and B reagent red cells. NOTE: The ABO/Rh type of the patient's red blood cells must be determined by an appropriate test procedure. Tests on each sample must include forward and reverse grouping. CAP and AABB are in agreement.

And then a comprehensive validation to show that it would work in all situations. Best to stick with what the manufacturer requires in their directions.

That is exactly what we have at the end of our documents. If there are validations or change controls associated with the document updates, we also include those in that revision history. When the history field becomes extra-long (and it can especially if you have an SOP that has been used for many years) we will archive that revision history for except the last 3 years or so and note that in the synopsis of change.

Hello paddleking: I'm curious if you are AABB accredited or inspected by CAP or ??? Does your hospital have a patient safety reporting program? Does your laboratory have a QA unit and/or event management system? Seems like there are many processes out of control...

Yikes. We don't use Meditech but how do you get DINs with same unit number? Unless they have different product codes because of divides or component manufacture (double red/red cell + FFP). If that is the case...e.g. an FFP with an RBC, then they should also be scanning the product code.

One way to document the persons non compliance is through event management and training. Part of the training should require documented competency before they start submitting patient test results on their own and direct observation should be a part of that. If this person cannot pass their competency then you have documented evidence. If you know this person is not following SOP, you should be able to document such in your event management system. Hopefully your SOPs also out line that concurrent documentation is required. Based on the Fair and Just Culture of event management, this sounds like the Reckless behavior where the person is making these conscious choices and disregarding the risk involved. This type of behavior should not be ignored and requires corrective action. Patient Safety and the "Just Culture."  A Primer for Health Care Executives Prepared by David Marx, JD

Can you imagine what a nightmare of logistics it would be if we had to be concerned about that? As long as you issued your product on that good specimen before it expired, you are fine. We have the same practice. Our day of draw is day 0 and then our specimens expire at midnight on day 3. We could issue products on that specimen up to the minute before it expired.