mcgouc

A urine specimen is not required for suspected allergic reactions.

We used 14 days. We chose that number mainly because of specimen storage space. Preadmit nurses were required to ask and document the recent transfusion and pregnancy questions in the computer on all their patients. These showed on the blood bank requisitions from preadmit and had to be answered “no” to extend the specimen. Patients signed an overall form regarding the accuracy of their history and that was part of it. Years ago, we once had an autologous unit on the shelf for a patient and the ”transfused in last 3 months” question was answered “yes”. On checking, we learned the patient lived in another state, had a unit of autologous blood drawn when he had a doctor’s appointment in our city, had returned home, and gotten a transfusion there before the surgery.

The BB supervisor sent a certified packet to the physician on record. We included a letter documenting the transfusion, a copy of the current FDA requirements for notification, and a form for them to complete and return by a certain date with the notification information. The Medical Director’s name and phone number were in the letter as the contact person for the physician. The Medical Director was copied on this info in case he was called. If the completed form were not returned, the Medical Director called the physician. Every phone call, etc, was documented. There were problems, as mentioned above. We had hospitalists who only treated the patients in the hospital who might not work there anymore or did not feel responsible for follow-up. What if the patient went to rehab and never went home? If we could not reach an end point, we sent to risk management for resolution.

Years ago, we kept the segment used for the crossmatch in a covered tube rubber banded to the patient’s specimen. When we went to the electronic issue, we switched to pulling an extra segment when we received units. It was bulky keeping the segs with the patient specimens. Plus, we did a lot of add on crossmatches and had to keep all the specimens organized and spaced in case we needed to rubber band more segments to the tube. It was about 600 beds with a busy OR. In the decades we kept the crossmatched segments, we never found one time where a crossmatched segment did not match a segment from a unit involved in a transfusion reaction. When we started pulling and keeping an extra segment on receipt, I thought we might miss keeping some segments, but we never had a problem finding a seg for a work-up. Our specimen refrigerator looked a lot neater and specimens took up less room. You could check your reaction work-ups to see if there has ever been an error found when doing the reaction work-up. If not, you could demonstrate the extra time and supplies involved in keeping the crossmatched segments was not justified. .

We inspected and checked manufacturer’s directions on receipt. For the reagents we used daily, we did “duplicate” QC on the old and new lot of any reagent expiring or running out that day and switched to the new lot. Our policy described exactly what was required from our regular QC to run on the old and new lot for each reagent to get a positive and negative control. All new lots were segregated until tested. Since we did not use the fetal screen daily, we did the double checking on arrival so we did not forget and let the old lot expire before doing it.

If you set a time, such as less than 30 minutes, and they start the transfusion at 30 minutes, you can be cited by Joint Commission or FDA if they do a trace of that unit - unless there is a deviation from policy report on file. The 30 minute start time may be in the nursing policy, but when a tracer is performed, the deviation will fall back on the transfusion service to correct. Although we did ask that the nurses do the preparation before picking up the unit, there would be a phone call saying the start of the transfusion was delayed for some reason. (IV infiltrated while picking up blood is one I remember). When we started taking temperatures of returned units, we learned they were usually only acceptable to be returned for 15-20 minutes, depending on how they were handled after leaving the Blood Bank. After much debate, we changed the policy to start the transfusion as soon as possible with the emphasis on completing the transfusion within four hours of leaving the Blood Bank. We did require them to return the unit to the Blood Bank immediately if, for some reason, the transfusion were cancelled.

When we started extending, the patient had to provide the mother’s maiden name when collected and when returning. We had that documented on our paperwork along with the no pregnancy/transfusion in three months information The extending and not requiring the bracelet to be worn continuously had to be approved by the Transfusion Committee and that was what the doctors approved. When we went to the electronic crossmatch that required a second type, we would check when we did the pre-admit work-up and order a second type for day of admit and attach a note on the chart for pre-admit to collect a type when the patient returned.

Technically, physician ordered product and pick up person brought a copy of the order. In the real world, we knew nurses were entering transfusion orders. There was a handwritten paper order form for OR to avoid delays.

Having a readily available back-up for the ABO and any antibodies, ABO discrepancies and special needs (such as irradiated) is required. Ours was done to a PC in the transfusion service in the background at 0400 every morning. It was a hassle to get IT to make that program for us, but I kept giving them documentation that the info is required to be available when the computer goes down. Had we not had the back-up, we would have had to keep making cards to check during downtime.

Many years ago, I was told by a consultant that if I modified a form, I needed a new revision number and a track of what was revised and when it went into effect. The form was an attachment in a policy so I did have the Medical Director sign off on the change. Something I considered minor might have been considered major by someone else. It would have been great to have a compliance review but I did not have that resource.

QC-97-13 - procedure for issuing not performed or documented in accordance with specifications. If your policy states the form needed to be signed prior to issuing, this is a general code to cover that. As stated above, they will let you know if it isn’t necessary.

Could the unit be a weak A or B? How was its ABO performed and confirmed? Try crossmatching with an A and B patient if you don’t have a lot of different reagents.

I had in my policy that we would review the Changes to Standards document published by the AABB and document on each change whether it affected us or not. (We did not draw donors so we just reviewed and put those changes as not applicable.). If we were already in compliance with the change, we would document no change in policy required with the policy number. If a policy had to be updated, we documented when the updates, training, etc were completed. The Medical Director signed this review and we kept it with our policies.

Our blood center could provide units with one or more bags attached. (We did not perform many neonatal transfusions and ordered these for the neonates). The empty bags had labels and our computer was set up for the aliquots. We were fortunate that this only took a few hours. If an urgent need, your process sounds acceptable.

I am retired but volunteered several years as an AABB assessor. Both CAP and AABB send the deficiencies from the previous assessment to the assigned assessor with the submitted plan of action to correct the previous deficiency. Most plan of actions have a time frame documented to correct the issue. We were supposed to make checking completion of the plan of action a priority. My first question would be if this individual had completed any work before his training records were completed. Then, I would ask for his competencies that were completed during the allowed time frames. If I performed a tracer on your FDA reportable, could you provide completed training and competency records for all the employees who worked on that patient? Your pathologist may be young, but he does not want repeat deficiencies. Document everything!