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FACT facility record retention


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FACT requires 10 year record retention for "Facility Records", some of which are global records and policies relating to safety, maintenance, mechanical systems, and construction that are beyond our control. Our facility maintains these records per JCAHO requirements, which I believe is 3 years.

How have other facilites handled this?

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Good question. We were cited. The draft third edition of standards states 5 years, still not in line with JCAHO.

Our policy is to keep all records indefinitely; however, we currently only have the last couple of years.

One thing we did was create a form for housekeeping for our department. They sign the form each night checking off the daily activities. That way the form is in our control.

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We created a separate housekeeping form for housekeeping to sign off on also, Cliff. When we reopened our HPC lab last year, the first thing I noticed that wouldn't fly was that there were dead bugs in the fluorescent light covers. We had housekeeping go over our lab the same way they would clean an operating room, and they now keep it that way. They use disposable mop heads so that each cleaning is done with new equipment.

BC

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Is there a good reason for retaining records longer than AABB and JCAHO requires (other than to meet FACT requirements)?

While I am on the topic of FACT, can anyone explain to me what is meant by a Collection Facility SOP for "Release and Exceptional Release"? We only collect autologous HPC by apheresis for immediate cryopreservation. I may be hung up on terminology. To me "release" is making the product available for use (infusion). This question makes sense to me as a processing facility question, for example an SOP for releasing a product that failed QC or was somehow compromised would be an "exceptional release". What is an "exceptional release" for the collection facility?

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Mabel,

You know how it goes when someone from the "rest" of the lab begins preparing for a CAP inspection, and you don't do anything because you are AABB inspected, and if you meet AABB standards then you are safe against the world? And when that person asks you why you are so calm, you say, "CAP? We don't need no stinkin' CAP!"? Well, it's like that for those of us with stem cell labs. "AABB? We don't need no stinkin' AABB!" Instead, we march to the beat of the Foundation for Accreditation of Cellular Therapy (FACT), whose guidelines make AABB look tame. Oh, AABB has standards for stem cell labs, but FACT accreditation is much more important.

BC

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Our blood bank performs peripheral blood HPC collections by apheresis and keeps all our apheresis instrument maintenance and repair records for 10 years. The actual collections are not performed in the Blood Bank apheresis area. They are performed in the areas FACT designates the "Clinical Facility" (hematology outpatient infusion area). If the patient is an inpatient at the time of collection, they are in one of the transplant rooms, also part of the Clinical Facility. Is it sufficient to say in our SOP for Collection Facility records retention that the Clinical Facility retains the cleaning, maintenance, and repair records for these areas?

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You can always ask FACT, but as long as you can put your hands on those records in a timely manner when asked for them, I don't think it matters who keeps the records. We do keep ours close at hand, though. We also do most of our collections in Hem/Onc. Our HPC processing lab is completely different from our donor center processing lab.

BC

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