Tracking filters used with blood products

A medical director of a network of four transfusion services in the Pacific Northwest (one of which supports a 450+ bed hospital with a very busy trauma service, large NICU with ECMO, and large pediatrics population) reports that due to local practices, her transfusion service laboratories (at all four hospitals) dispense blood component administration sets (filters) along with the blood products that they issue, including leukodepletion filters (which are only rarely used because most of their leukocyte reduced products are processed by the blood collection center). The following is a comprehensive list of the blood administration sets that they dispense at their hospitals:

1. Baxter Interlink Y-Type
2. Baxter Straight Type
3. Pall 40 micron (SQ40S)
4. Braun Horizon Pump Y-type
5. Alaris Nonvented Blood Set
6. Pall High Efficiency Rapid Flow Leukoreduction Filter
7. Charter Medical Neonatal Syringe Set

The medical director reports that prior to a recent AABB assessment her hospital did NOT track lot numbers of the blood component administration sets (filters) that they dispensed along with blood products. The assessor cited her hospital for not tracking blood component administration sets (filters) lot numbers. The justification for this citation was based on AABB Standard 5.1.6.2 "Traceability of Blood, Components, and Tissue" which states 'The blood bank or transfusion service shall ensure that all blood, components.... and critical materials used in their processing...are identified and traceable.' The written report of the deficiency was reportedly "There is not a mechanism in place to track the lot number and expiration date when applicable for all filters issued by the four transfusion services."

The medical director of these four transfusion services is currently trying to figure out a simple and workable mechanism for tracking all of the various blood component administration sets (filters) so that when they dispense them, they can be in compliance. She laments that the impact of having to track all of the blood component administration sets (filters) for their four hospitals (soon to be 5) is 'huge'. However, she wonders if any other hospital has been required to do this type of tracking. She also wonders if hospitals that employ the exact same blood component administration sets (filters) are required to track them, if the blood component administration sets (filters) are obtained from nursing or ward inventories, rather than from the transfusion service inventory? If in fact the blood component administration sets (filters) do not need to be tracked if they come from inventories outside the transfusion service, her strategy might be to divest the transfusion service from maintaining and dispensing the blood component administration sets (filters), and having nursing services take over that responsibility.

Additional questions for discussion:

• Are there published data reporting the percentage of hospitals that maintain and dispense blood component administration sets from their blood bank rather than from their nursing service?
• Are there published data reporting the percentage of hospitals that track blood component administration sets, regardless of which department maintains and dispenses them?
• At institutions that currently track blood component administration sets, what protocol is followed?

The following comments have been received.

ADDENDA Jan. 8, 2005

1. A colleague in Iowa reports that his hospital tracks only one kind of blood administration filter, specifically the leukocyte reduction filters that are issued by the blood bank for bedside use for leukocyte reduction. However, all other blood administration filter sets are issued from a central supply room and managed by nursing services, which does not track the filters to the individual patients for whom the filters are used, or to the blood products that filtered by the sets. The Iowa colleague is of the opinion that if the laboratory is not issuing all of the filters, that it is important to differentiate between the laboratory's failure to track filters from a failure by nursing services or central supply to track filters. The reasons that the Iowa colleague's blood bank tracks the leukocyte reduction filters that it issues are as follows:
   1. The Iowa colleague's laboratory accrediting agency, CAP, has similar language about tracing critical materials
   2. It seems prudent to him that any thing that comes in contact with the transfused blood should be considered critical; at least as a possible contamination source.
   3. The transfusion service has control of those filters.
   Since they only track one kind of filter, a simple log of receipt and distribution dates is adequate to identify what lot number was used for a particular transfusion. They document in the log the manufacturer, lot number, expiration date, receipt date, quantity, and date of first use. Subsequent entries identify the end date of use. Should there be more than one lot number used on a particular day, a comment is recorded indicating the time or name of the patient that starts the next lot number. This system is currently recorded on paper, but could be computerized. For tracking multiple filter types (which they do not do presently) it was suggested that an entry in the computerized issue record would seem most prudent. This entry should detail: filter type, manufacturer, lot number, and expiration date. Entering the data could be manual or interpreted from the manufacturer's barcode.

ADDENDA Jan 9, 2005

2. 2. A Quality Manager at a blood bank in Spain reports that "Lot Control" can be burdensome, even if you have a computer program to do it. The following points were made:
   • Control of key elements in one's practice is required by all quality management systems (i.e. ISO, EFQM - European Foundation for Quality Management). Transfusion sets are an important part of transfusion, and in the Spaniard's opinion should be controlled as such, particularly because some kind of filters have produced adverse reactions in the recipients.
   • At all the hospitals that the reporting Spaniard knows in Spain, the transfusion service issues the transfusion filters with the components. However burdensome to the transfusion service, this is more practical for lot control. In their experience, nursing units are already too stressed to take care of lot control, particularly if they don´t transfuse blood products often. New staff can choose the wrong filter, people tend to "over stock" in order to avoid running out of filters, expiration dates are forgotten, etc.
   • From the Spaniard's experience:
     • Blood component administration set suppliers should market a limited number of product lots each year.
     • If one works at a decentralized hospital system, with different transfusion labs, in the Spaniard's experience the best thing is to keep track of lots at each separate center, even if purchases are centralized. They faced this problem and discovered that keeping centralized control was a nightmare.
     • Reduce the different kinds of transfusion sets to a minimum, particularly if the blood center already offers prestorage leukoreduction.
     • Try to modify transfusion service software so that this data can be recorded with the products transfused.
     • If it is not possible to use computerized tracking, develop a lot control system, simply inspecting the containers upon receipt and labelling them with "new lot number - 1,2 3, etc". When a lot is started, you record the time and the patient. With the last filter of that lot, you also record the time and the patient.

ADDENDA Jan 11, 2005

3. A transfusion service supervisor at a university hospital in Southern California reports that her institution does not track either the lot numbers or the type of blood component administration sets that are used for each individual blood component transfusion. Their procedures of the nursing service do address the administration of blood products, but make no mention of documenting the lot number or type of administration set that is used. The procedure does outline which types of blood component sets are appropriate to use for various blood components.

ADDENDA Jan 14, 2005

4. The laboratory medical director of an academic institution in the New England area reports that his laboratory's transfusion service does not distribute any of the blood component administration sets that are used during blood product transfusions. Any administration sets that are needed are stocked on the wards. He reports that he is certain that "they do not keep track of lot numbers!"
   
   
5. A transfusion medicine physician in the greater Chicago area reports that his transfusion service records the starting and ending dates of use for each lot of "bedside leukoreduction filters" that they issue from their blood bank for patients who need to receive leukocyte-reduced components, when pre-storage leukocyte reduced components are not available. They do not record each filter's individual lot number upon issue. In addition, they do not believe that the nurses are recording lot numbers of the blood administration sets that they obtain from inventory management. The inventory management department does not keep records of the lot numbers, but if there were a recall of past lots, they would obtain lot numbers from the supplier to see what had been used. This question has never come up in their past inspections, assessments or surveys.
   
   
6. A Transfusion Medicine Fellow at an academic institution in Pennsylvania reports that blood component administration sets (filters) and other critical supplies are tracked, provided these supplies are dispensed by or used in the blood bank. This tracking includes leukocyte reduction filters. Their tracking protocol includes recording the manufacturer, date of receipt, expiration date, dates the lot was put into and taken out of use. In this way they can "figure out" what lot was used for a particular patient based on the date of a transfusion event. Their current tracking system is "paper", but they are looking into a new laboratory information system that would allow them to computerize this application. They do not track any of the blood component administration sets that are dispensed by the hospital's central storeroom.
   
   
7. A transfusion medicine physician at an academic institution in Ohio reports that at her hospital they use the following kinds of blood component administration sets:
   • Baxter Interlink Y-Type
   • Alaris Nonvented Blood Set
   • Neonatal: Hemapediatric (Abbott) 20 micron
   The blood component administration sets (filters) are distributed through their hospital stores. She reports that they do not track any lot number, nor do they track the expiration dates.

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