tcoyle

We have a process for a new piece of hardware such as this. The lab will print a label from the printer. Attach this to the form that we use or another piece of paper. They also take a screen print from the application that label was printed. They then compare the printed label to the information in the application. It's all documented on a worksheet and kept in the work unit for the required record retention.

As far as I know, FDA currently has a draft guidance for pathogen reduced platelets. FDA recently came out with the final regarding bacterial risk and platelets. You can search for FDA guidance's any time. Copy this link https://www.fda.gov/regulatory-information/search-fda-guidance-documents

What does the manufacturer of the WB bag state in their package insert?

We have a label adherence validation that we do with the label and bag set; so we validate that the label will adhere in all conditions that it may incur. That could be anything from the blast freezer to a microwave for thawing and of course refrigerator/RT/Freezer conditions. We do this with any new label stock that we would receive prior to putting it into use. We basically test the label as it goes thru the manufacturing, storage and processing life cycle.

While not endorsing anyone, we use digitrax labels. We also have a robust pre-qualification/label adherence protocol to ensure that they will stay put in all situations. We also ensure that these labels meet the FDA regs for adhesive.

Hey Cliff, What standard/checklist item were you cited against?

31st edition of the AABB Standards 5.1.1 Change Control: The BB/TS shall have a process to develop new processes or procedures or to change existing ones. This process shall include identification of specifications and verification that the specification have been met. Before implementation, the new or changed processes or procedures shall be validated. Stand 2.12 applies. To show that your laboratory isn't changing things on the fly, it is important to have a controlled process in making changes. AABB has a section on their website under the Accreditation Member Tools a Commendable Practices link. You may be able to glean some information on how to set up a change control process for your laboratory.

Are you creating your own software?

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?