Stupid "FDA Reportable" Question

[Kreotc]

If an occurrence is noted in a transfusion service (i.e. issuing units for a patient with a positive antibody screen and no antibody identification is performed) and classified as reportable to the FDA by Quality, is reporting voluntary or required?

If an occurrence is never reported and discovered during an inspection/investigation, what kind of repercussions will that have?

[Cliff]

If an occurrence is noted in a transfusion service (i.e. issuing units for a patient with a positive antibody screen and no antibody identification is performed) and classified as reportable to the FDA by Quality, is reporting voluntary or required?

Required

If an occurrence is never reported and discovered during an inspection/investigation, what kind of repercussions will that have?

No response, this is not something I would ever consider.

[Kreotc]

That's how I read the guidance for industry document. Any conjectures as to where the idea that deviation reporting is voluntary came from? Thanks for the response.

[Cliff]

Here is an excerpt of the

regulation:

¹The new regulation at 21 CFR 606.171, effective May 7, 2001:

Previously, FDA regulations required licensed blood and plasma establishments to report promptly to FDA errors and accidents in manufacturing that may affect the safety, purity, or potency of a product (Title 21 Code of Federal Regulations (21 CFR) 600.14(a) (1999)). On March 20, 1991, we, FDA, issued a memorandum entitled, " Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood & Blood Components" requesting voluntary reporting from unlicensed registered blood establishments and transfusion services.In the Federal Register of November 7, 2000 (65 FR 66621), we issued a final rule amending the CGMP (current good manufacturing practice) regulations for blood and blood components. The new rule required all establishments involved in the manufacture of blood and blood components, including licensed manufacturers, unlicensed registered establishments and transfusion services, to report product deviations in manufacturing (21 CFR 606.171).

[*=left]Expands the reporting requirement to include all unlicensed blood establishments, including transfusion services and registered blood banks;

[Eman]

If an occurrence is never reported and discovered during an inspection/investigation, what kind of repercussions will that have?

Best case is you'll be cited for it during the inspection and told to report it. A discovery like that would likely inspire an inspector/assessor to dig deeper for anything else you might have missed.

If it's obvious you knew about the occurence and chose not to report it an FDA inspector could issue a 483.

[SMILLER]

Why don't you call the FDA and ask them?

Seriously, I am pretty sure that your regular Lab regulators and the FDA would freak if they found out you knew about a reportable and did'nt report it. Even if it was an honest mistake, I am pretty sure you would have citations in store. Self-reporting is the cornerstone of regulation for the FDA.

That's why we pull out the regs for pretty much any incident that occurs due to a protocol error in BB--to ensure that we do or do not have to send it into the FDA.

Scott

[Mabel Adams]

I have asked them several times if something is reportable if I am not clear on how the BPDs apply to our situation. They are very helpful in telling me what code to use and if something is reportable.

[Eman]

Also, if you report an event that FDA considers to be not reportable you'll get a statement from to that effect and the deviation report will be rejected. Those are handy references for when the same/similar event occurs again.

[bj5826023]

If an occurrence is noted in a transfusion service (i.e. issuing units for a patient with a positive antibody screen and no antibody identification is performed) and classified as reportable to the FDA by Quality, is reporting voluntary or required?

If an occurrence is never reported and discovered during an inspection/investigation, what kind of repercussions will that have?

Was this the first time the antibody screen is positive? If it's not and the antibody was identified before, it'd sound less "severe" and reporting is questionable, especially in case of emergency and if you don't know if it needs to be reported. Also, I don't see why it's such an issue, especially when you're only dealing with a very small volume of residual plasma. Worst case we've seen w/transfusion is having a positive DAT.

[SMW]

Was this the first time the antibody screen is positive? If it's not and the antibody was identified before, it'd sound less "severe" and reporting is questionable, especially in case of emergency and if you don't know if it needs to be reported. Also, I don't see why it's such an issue, especially when you're only dealing with a very small volume of residual plasma. Worst case we've seen w/transfusion is having a positive DAT.

Sorry bj5826023, but according to the FDA and in the US, if your procedures specifiy you will perform an antibody identification if the antibody screen is positive and you do not do this, it IS reportable. If it is an emergency and there is not time to perform the antibody ID but this is documented and approved BEFORE the products are issued (according to your policies and procedures), then it would not be reportable.

I don't understand the comment about the small volume of residual plasma unless you confusing an antibody screen result from a donor unit vs a patient sample? Even so, this would also be Reportable. The risk of the misstep or if there was an adverse outcome is not part of the algorithm for determining if an event is FDA reportable or not. You are required to report if the event:

1. Either
   
   1. 
      
   2. Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of that product; or
      
   3. Represents an unexpected or unforeseeable event that may affect the safety, purity, or potency of that product; and
      
      
   4. Occurs in your facility or a facility under contract with you; and
      
   5. Involves a distributed blood or blood component.
      
      
      So in the original example provided referencing a patient sample, if you did not follow your procedure to perform an antibody ID (1.1), it occurred in your facility (2) and you issued the product (3), it IS reportable. The same would apply if it was a donor unit.

[Barbarakym]

Also, I don't see why it's such an issue, especially when you're only dealing with a very small volume of residual plasma. Worst case we've seen w/transfusion is having a positive DAT.

Over the years and working as tech in several BBs, my personal experience screams out for caution. For missed antibody (no antibody id done or error in id) I have seen severe hemolysis ( new to us Anti K, hidden in an Anti Fya ABS, ID not pursued) and re-hospitilization (delayed transfusion rexn due to missed Jka showing dosage...other ab taken care of by ag neg blood)... both patients needing much more supportive care. All caused by no proper AB ID.

I was not supervisor or in chain of discepline then so don't know if proper follow up was done.. but to me a VERY BIG DEAL.

[labgirl153]

Have seen recently where a patient with negative screen was given one unit of antigen positive packed cells...but only because it was later discovered that the history was missed (anti-e) due to the Admissions Dept. giving a different birthdate and medical record number to that patient from what they'd originally had. The patient suffered no repercussions. We do an alpha search on the name and if different med. record numbers pop up we check DOB and SS#s to ensure they're one and the same person. BUT if DOB differs, it might get missed. Am guessing my lab made this FDA reportable but heard nothing about it.

[bj5826023]

Sorry bj5826023, but according to the FDA and in the US, if your procedures specifiy you will perform an antibody identification if the antibody screen is positive and you do not do this, it IS reportable. If it is an emergency and there is not time to perform the antibody ID but this is documented and approved BEFORE the products are issued (according to your policies and procedures), then it would not be reportable.

I don't understand the comment about the small volume of residual plasma unless you confusing an antibody screen result from a donor unit vs a patient sample? Even so, this would also be Reportable. The risk of the misstep or if there was an adverse outcome is not part of the algorithm for determining if an event is FDA reportable or not. You are required to report if the event:

1. Either
   
   1. 
      
   2. Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of that product; or
      
   3. Represents an unexpected or unforeseeable event that may affect the safety, purity, or potency of that product; and
      
      
   4. Occurs in your facility or a facility under contract with you; and
      
   5. Involves a distributed blood or blood component.
      
      
      So in the original example provided referencing a patient sample, if you did not follow your procedure to perform an antibody ID (1.1), it occurred in your facility (2) and you issued the product (3), it IS reportable. The same would apply if it was a donor unit.
      I did indeed misread the post, thinking the issue was to transfuse a donor unit w/a known antibody previously identified. Agreed that it's FDA reportable, but if you fail to report it, what would be the repercussion? If this unit is transfused to a patient, what's the worst outcome reported?