This is a sample quality system plan to comply with AABB and CAP accreditation standards that I used at HMC Doha.
This is the policy I used at HMC Doha for screening donors for this agent.
Nipah virus NiV is a paramyxovirus that may cause a fatal encephalitis in infected patients. Transmission to humans may occur after direct contact with infected bats, infected pigs, or from other infected humans. ELISA, NAT, and direct culture may be used for confirmation of diagnosis, but there is no available licensed donor test. The geographical distribution of this virus corresponds generally to the areas of malaria exclusion used for blood donor screening. Most cases are fatal, and survivors may have neurologic sequelae.
The incubation period is 5-14 days with illness presenting 3-14 days of fever, headache, followed by drowsiness, disorientation, and confusion. These findings may progress to coma within 24-48 hours. Some patients also develop a respiratory illness. Latent infections with subsequent reactivation of the virus have occurred months to years after exposure.
- The current exclusion for travel to malaria endemic areas will be used to exclude donors with possible NiV exposure.
- Any donor with a history of Nipah virus infection will be permanently deferred.
- As per current SOP, any donor not feeling well must not donate blood or blood components.
Nipah Virus Fact Sheet, Center for Disease Control, Atlanta, GA, USA—current edition—attached.
This is an updated version of a previous post.
All donor unit mislabeling is potentially life-threatening and must be stringently investigated as soon as possible after the discrepancy is detected. Most importantly, if there is one error, there may be possibly ADDITIONAL donor unit errors (e.g. switch of donor tubes or units, etc.). All donor units processed in the same batch must be also quarantined until the discrepancies are resolved.
The following steps MUST be performed as soon as possible:
- The Component Processing Supervisor or Senior Technologist must be IMMEDIATELY notified of any discrepancy.
- The Blood Bank Supervisor will inform the Division Head, Transfusion Medicine. If the Head is not available, notify the Transfusion Medicine on-call.
- Quarantine ALL donor units collected and processed in the same batch.
- Obtain copies of all testing including photos of the gel/glass bead cards documenting the discrepancy.
- Obtain copies of all worksheets used in donor processing for the affected batch.
- Perform repeat ABO/D typing of ALL DONOR UNITS in the affected batch. Any further discrepancies must be investigated and resolved.
- All repeat testing must be entered into the Medinfo Hematos IIG computer system.
- Identify all staff who were involved in handling the donor unit (phlebotomist, blood bank technicians processing and labelling the unit). Identify those associated directly with the error.
- Submit all documents and photos to the Blood Bank Supervisor or designate.
- Prepare an occurrence/variation OVA report documenting all the data, findings, and interpretations.
- All investigations must be reviewed by the Supervisor, responsible blood bank physician, and one of the senior consultants.
- All such investigations must then be finally reviewed and approved by Head, Transfusion Medicine or his designate. Only when the issue(s) are completely resolved and investigation is approved may the donor unit be properly relabeled and released into available stock. Also, only at that time may the other units in the affected batch be released into available stock!!
- Photograph the correctly relabeled unit and attach it to the other documentation of the incident.
- If the discrepancy cannot be resolved, ALL units in the affected batch must be discarded.
- The implicated staff’s personnel record should be reviewed for previous errors. Appropriate disciplinary action should be taken and documented in the personnel record. If a verbal warning is given, it should still be documented in the written record.
- If there is a systemic cause for the error, appropriate measures should be taken to minimize reoccurrence.
Standards for Blood Banks and Transfusion Services, Current Version, AABB, Bethesda, MD, USA