What to report?

Transfusion reactions are undesirable or unexpected events which may be related to the administration of labile blood products. Article 63 para. 2 TPO requires these events and all the relevant and available information to be reported to Swissmedic.

Art. 63 TPO requires anyone who uses or dispenses medicinal products professionally or is entitled to do so to report to Swissmedic observations of serious or previously unknown facts which endanger drug safety. Transfusion errors are defined as events in which a blood component was transfused into a patient for whom it was not intended, not suitable, compatible by chance or not necessary, or in whom transfusion was delayed.

The causes of an incorrect blood product being transfused can lie anywhere in the entire transfusion chain. An incorrect prescription, a blood sample being taken from the wrong patient or an error in the immunohaematology laboratory may be the origin of a transfusion error. Several checks, e.g. two blood group determinations from independent samples or the four-eyes principle, are incorporated into the process to prevent transfusion errors. If a transfusion error occurs nonetheless, these control mechanisms have failed.

A transfusion error must be reported irrespective of whether or not the patient experienced a transfusion reaction. If adverse reactions occur as a result of a transfusion error, both the transfusion error itself and the transfusion reaction it caused must be reported. These cases are entered in the appropriate databases.

According to Art. 59 para. 3 TPA, any person who professionally dispenses therapeutic products or administers them to humans or who is entitled to do so as medical personnel must notify Swissmedic of any serious or previously unknown adverse effects and incidents, observations of other serious or previously unknown facts and quality defects that are of significance for drug safety.

According to Art. 4 para. 1 let. a, blood and blood products are also medicinal products.

The explanatory report on the Therapeutic Products Ordinance published in September 2018 states the following: “Observations of serious facts are incorporated for the first time following the revision of Article 59 paragraph 3 TPA. This specifically addresses situations in which erroneous use of a medicinal product was avoided but which encourage errors in use and can lead to substantial damage to health. […]. Where blood products are concerned, transfusion errors that are barely avoided must also be reported.” Here the Ordinance addresses what are known as near misses. Practical experience has shown that the following cases, in particular, are likely to be near misses for haemovigilance purposes: wrong patient if names are nearly identical, wrong blood product ordered as a result of miscommunication, or blood products ordered on the basis of haemoglobin, platelet or coagulation values that are wrong due to pre-analytical factors.

These examples show that near misses are errors or deviations from regulations or guidelines which were discovered prior to transfusion and could have resulted in a transfusion error or a transfusion reaction in a recipient.

Reporting near misses also contributes to quality assurance and should protect other patients against the potential hazards identified in this way. In other words, the purpose of monitoring haemovigilance data and causes is to identify when and where in the transfusion chain errors typically occur. This enables future mistakes of this kind to be prevented by establishing specific measures.

Donor reactions

In accordance with Art. 58 para. 1 TPA, Swissmedic and the other authorities responsible for enforcing the Therapeutic Products Act monitor the legitimate manufacture, distribution, dispensing and promotion of therapeutic products within the scope of their responsibilities. They perform periodic inspections to establish whether the conditions for the corresponding licences are still being met. Swissmedic’s responsibility for inspections relating to blood and blood products is set out in Article 60 para. 2 let. b TPA.

The regional blood transfusion services (RBTS) report all Grade 1-4 donor reactions cumulatively to Swissmedic and to Swiss Transfusion SRC once a year so that the adverse effects can be assigned to a regional blood transfusion service, which is important for Swissmedic inspection purposes. Serious (Grade 3 and 4) donor reactions must be notified to Swissmedic within 15 days using the Swissmedic form.

Art. 37 para. 1 MPLO requires the person who holds a licence for activities involving blood and labile blood products to take necessary protective measures immediately, particularly if they discover that the donor did not fulfil the criteria for donor suitability during the donation, the tests for communicable diseases were not performed correctly or the donor has been discovered to have a blood-borne disease.

Reports of quality defects usually concern infection markers identified in donors who test positive. They also include the documentation of any further investigations triggered by this finding with respect to earlier donations by the same person and/or other blood donors in some cases.

The blood transfusion service uses the Swissmedic form to report the donor’s data, the positive infection markers and, if the donor is a repeat donor, the data from the last-but-one donation. The report must also state whether a look-back procedure (tracing procedure) has been started and the exposure risk must be described. In addition, the measures taken with respect to the donor must be stated and the blood products collected must be named.

However, quality defects and protective measures may also involve the users. On the one hand, Art. 37 para. 4 MPLO requires institutions (usually hospitals and doctors’ practices) which administer blood and labile blood products to patients to provide relevant information about the use of the labile blood products if requested in order to assist with the manufacturers’ investigations and on completion of the look-back procedure. On the other hand, quality defects in a product may not be identified until the product is used in a hospital. These defects must be reported to Swissmedic in accordance with Article 63 para. 1 let. c TPO. Quality defects must be reported immediately to the blood transfusion service since, in certain cases (e.g. if bacterial contamination of the blood product is suspected), further products from the donor may have to be blocked or recalled without delay.

• Donor-related look-back (DLB)
  If an infection with hepatitis B virus, hepatitis C virus, hepatitis E virus, HIV or vector-borne pathogens (e.g. malaria or Chagas disease) is identified in a repeat donor, and if the result of a confirmed positive blood sample is available, a donor-related look-back (DLB) is initiated in accordance with Art. 35 para. 2 in conjunction with Art. 37 para. 1 let. c and para. 3 MPLO. In this case the sample from the previous donor, or in specific cases from several donors, undergoes repeat testing and, if the result is positive, the recipient must be informed and also tested.
• Patient-related look-back (PLB)
  If, after a transfusion, a patient develops an infection that can be traced back to a donor, a patient-related look-back (PLB) is initiated in accordance with Art. 37 para. 1 let. d and para. 3 MPLO.
  In a look-back procedure, Art. 37 para. 4 MPLO requires users to provide the manufacturer and Swissmedic on request with relevant information about the use of the labile blood product and about the conclusion of the look-back procedure.

The look-back process for DLB and PLB was developed in cooperation with Swiss Transfusion SRC and Swissmedic. The processes are illustrated schematically and explained (in German, French and Italian) in the Swiss Transfusion SCR regulations (cf. Chapter 24).