I had an employee who typed a patient wrong, resulting to transfusing the wrong unit. Luckily it was a near miss, because the patient was A pos, but typed as A neg, and transfused A neg units. We have confirmed and changed the patients type to A pos, and are currently updating our policy to make sure that all retypes on patients without history are done before transfusion. Since this wasnt vice versa, or a different type, and the patient wasnt hurt, is there any agency I have to report this to? Also any suggestions on how to deal with perfomance especially if this is the second time the employee has made the same mistake. Very competent employee by the way.

this is reported to FDA as patient was typed incorrectly. and also blood was issued. And your STATE(if required)

I'm curious as to the mechanism of the error. Lack of reagent in the tube? Just shook it too hard? Do you wD test all Rh negatives? Was it a clerical error. If this person had re-typed the patient what is the chance they would have simply duplicated the error there by making the second testing prior to transfusion worthless?

Is your policy for pts without history to be re-typed by different tech prior to crossmatch being performed, or at least prior to issue?

We require all negative reactions with Anti-D sera to be repeated. Plus we require 2 ABORh's on record prior to dispensing blood products. Either of these may have stopped this error from occuring.

I am leaning towards not reporting. The FDA would be over run unfortunately with reports. My understanding is that the FDA wants to know only about issues with devices, issues with the product purity or death or serious injuries.

Check this statement from the FDA:

1. A Transfusion Service is NOT required to report to us if the event occurs during transfusion or administration procedures, after the blood product has left the control of the transfusion service. For example, a report is not required:
   
2. If the transfusion service issued a product from the laboratory to the nursing floor, operating room, emergency room, etc., for transfusion and the product was not held at the appropriate temperature outside of the transfusion service prior to transfusion. However, the transfusion service is required to report if the product was returned and the transfusion service determined it to be unsuitable, but contrary to CGMP, applicable regulations, applicable standards, or established specifications, reissued the product.
   

• If the hospital staff, outside of the blood bank, transfused the wrong patient or transfused a patient with the wrong unit, provided the unit was labeled appropriately and the transfusion service conducted compatibility testing properly. If a complication of a transfusion was confirmed to be fatal, the facility that performed the compatibility testing must submit a fatality report to us in accordance with 21 CFR 606.170(.
  
• If the transfusion service issued a filter with the product and the hospital staff did not use the filter at the bedside.
  
• If the patient has a transfusion reaction that is not related to an event in manufacturing. Fatalities due to Transfusion Related Acute Lung Injury (TRALI) or other transfusion complications must be reported to CBER in accordance with 21 CFR 606.170(. We also accept voluntary reports of non-fatal TRALI as a serious adverse reaction to transfusions. Such voluntary reports can be submitted via MedWatch by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by US mail at MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852, or by email at http://www.fda.gov/medwatch. For additional information, see the "Dear Colleague" letter published October 19, 2001 at http://www.fda.gov/cber/ltr/trali101901.htm.
  

This is FDA Reportable. It fits into the category RT6-61-03. You can also contact the FDA and they will tell you if it is reportable or not. It is mandatory that you report - they don't give you a choice. (Although your chances of any bad thing happening to you if you don't report are low.)

"

RT-60-01 Other

RT-61-** Testing performed, interpreted, or documented incorrectly for: {use RT61** only if testing was performed, interpreted or documented incorrectly; use QC92** if testing positive or use QC93** if testing is not performed incompletely performed or not documented}

RT-61-01 Other

{includes: DAT; Hemoglobin S testing}

RT-61-02 ABO

RT-61-03 Rh

RT-61-04 ABO & Rh

Agree that it is FDA reportable. 3 required criteria for reporting were met:

1. A deviation occurred during manufacturing (which includes compatibility testing),

2. It occurred in your facility, and

3. Product was distributed.

The outcome (or even if it was transfused or not) is not part of the reporting decision tree. Also from the FDA website.......

1. Testing
   

Testing events include those that occur during the testing process, which you did not discover until after you have distributed the product. Testing includes all tests used to assure the safety, purity, and potency of a product, whether required by specific regulations or by your SOP. ........Use of an unsuitable or inappropriate sample may also be a testing deviation or unexpected event.

Under 21 CFR 606.171(, you must submit a report when there is an event (a deviation or unexpected or unforeseeable event) during testing that may affect the safety, purity, or potency of a product you distributed. Examples of reportable events associated with testing may include:

• Testing was not performed in accordance with test manufacturer's instructions, such as
  
  • Incorrect incubation time or temperature was used;
    
  • Incorrect reagent was used/licensable components from two different test kit lots were used;
    
  • Incorrect addition of reagents (incorrect sequence, volume or concentration).
    

For transfusion services, reportable events may also include:

• Patient samples were mislabeled or collected from the wrong patient, if you used the sample to crossmatch a product that you distributed. This includes samples collected by transfusion service personnel and personnel outside of the blood establishment.
  
• Mistyped or misinterpreted patient samples if the sample was used in crossmatching a product that you distributed.
  
• Immediate spin crossmatch performed when a patient's history or testing requires an indirect antiglobulin test.
  

I lean toward consulting FDA to see if they want it reported. I know that they do not require reporting of a blood product that is mislabeled where the mislabeling does not affect the purity, potency, or safety of the product (such as giving it a shorter expiration date than was required). In this case, an Rh Negative product was a perfectly acceptable product for this patient and could, under ordinary circumstances, be selected for this patient. You do need to track it in your near miss data regardless of whether it is reported and do a root cause analysis (John has provided some good questions for that).

I would say it is reportable. The important phrase is 'the potential to affect the purity....etc'. Mistyping the patient certainly has the potential to affect the safety of the transfusion. It was fortunate that the Rh neg unit was compatible and caused no harm, but the potential for harm was present.