UK Donor blood tests
Additional
Category B
UN3373
Infectious substance that does not meet criteria for Cat A
Packaging should have 3 components: primary receptacle, secondary packaging, and outer packaging (MUST BE RIGID).
Absorbent material in the secondary packaging.
Category A
UN2814 or UN2900(Animals)
Pathogens when exposure occurs, capable of causing permanent disability, life-threatening or fatal disease to humans or animals.
Packaging should have 3 components: leak-proof primary receptacle, leak-proof secondary packaging, and outer packaging (MUST BE RIGID).
Absorbent material in the secondary packaging.
Itemised list of contents between 2nd and outer packaging.
HCID PPE
filtering face piece 3 (FFP3) respirator
hood
longer-length visor
long rear-fastening fluid-resistant surgical gown tied to the side
medium thickness apron
inner gloves
middle gloves taped to the gown with microporous tape
outer gloves
wellington boots
HAIRS
Human Animal Infections and Risk Surveillance (HAIRS) group
Monthly meeting for risk assessment
HAIRS is chaired by the Department for the Environment, Food and Rural Affairs (Defra), with secretariat functions provided by UKHSA’s Emerging Infections and Zoonoses team.
The group includes representatives from:
UKHSA
Defra
the Department of Health and Social Care (DHSC)
the Animal and Plant Health Agency (APHA)
the Food Standards Agency
Public Health Wales
Welsh Government
Public Health Scotland
Scottish Government
Public Health Agency of Northern Ireland
the Department of Agriculture, Environment and Rural Affairs for Northern Ireland
the Department of Agriculture, Food and the Marine
Health and Safety Executive
Republic of Ireland, Infrastructure, Housing and Environment
Government of Jersey
Isle of Man Government
the States Veterinary Officer, Bailiwick of Guernsey
Multi-step process for risk assessments
VHF scenario AtoZ
The Control of Substances Hazardous to Health (CoSHH) Regulations requires employers to assess risk to their employees in the workplace.
LOW POSSIBILITY
HIGH POSSIBILITY OF VHF
CONFIRMED VHF
SABTO/JPAC/NHSBT screening & contra-indications
Bone marrow & Cord blood - MUST NOT donate if taking Oseltamavir/Zanamavir or had symptoms suggestive of flu in the preceding 7 days.
Other organs may be offered, and the final decision lies with the transplanting surgeon weighing the balance of risks for therecipient.
Donation may be considered 6 months after recovery from infection with Chikungunya virus.
For asymptomatic organ donors returning from affected areas, an individual risk assessment is required before donation.
Known Zika virus infection: is a contraindication to donation of solid organs for transplantation except in exceptional circumstances is a contraindication to tissue donation
Donation may be considered 6 months after recovery from infection with Zika virus.
For asymptomatic organ donors returning from affected areas, an individual risk assessment is required before donation.
For asymptomatic donors returning from affected areas, an individual risk assessment is required before donation.
Donor transmission may occur from an asymptomatic individual or from a donor who died of unrecognised and therefore undiagnosed West Nile neuroinvasive disease
IF ALREADY TRANSPLANTED:
In cases where NAT testing is positive for WNV and the organs have been used, the details of the positive test should be communicated immediately to NHSBT Organ Donation and Transplantation (ODT) Duty Office (0117 975 7580) who will inform all centres that received organs and/or tissue from the donor. ODT will liaise with appropriate health authorities and all concerned transplant centres.
Removal of the transplanted organ (even if possible) will not prevent transmission.
Temporary reduction of immunosupppression has been suggested as it may allow the recipient to mount an immune response to WNV. However, there is no direct evidence to support this as an effective intervention.
ODT will seek advice from an NHSBT Consultant Virologist on screening and management of donors/recipients prior to disseminating the advice to relevant stakeholders.
5. JCV: Previous JC virus infection is not a contraindication to donation of tissues or organs.
A confirmed diagnosis of progressive multifocal leukoencephalopathy is an absolute contraindication to donation of tissues or organs
Careful consideration of benefits from transplant is required.
Acute disease is an absolute contraindication to donation of tissues unless life preserving.
Symptomatic gamete donor
The donor should be deferred if, at the time of donation or in the preceding 7 days, the donor has a new continuous cough or a temperature greater than 37.8°C. The donor can donate after 28 days from full recovery.
Asymptomatic gamete donor
If the donor is asymptomatic, government advice about those who should self-isolate should be considered including the implications this may have on the donation process.
Confirmed C-19: No using lungs. If died of covid, no using ANY ORGANS.
Blood & BM: Must not donate if less than 14dayssince resolution of symptoms.
Outbreak investigation
More cases than expected? Problem properly diagnosed?
Multiple countries affected?
Coordinated investigation needed?
Decide on coordinator of investigation (Member State, ECDC, EC, WHO etc.);
Form outbreak control team;
Alert other networks and entities.
Agree on case definitions - confirmed, probable, possible.
3. Identify cases and obtain information
Conduct case finding by means appropriate to the outbreak;
Obtain information on disease and exposures.
4. Describe data collected
Characterize the outbreak by time (epidemic curve), place and person.
Interpret the descriptive findings;
Use information from trawling interviews or other relevant national studies;
Review available evidence on previous outbreaks;
Assess surveillance data and existing knowledge on reservoirs and presence in foods (EFSA, TESSy, EPIS and Zoonoses reports).
6. Test hypothesis: analytical studies
Collect food, water and/or environmental samples;
Determine what happened with the implicated source or vehicle;
Collect information on food distribution/traceback investigations (origin of foods).
Outbreak meeting - who should attend?
IDPS screening
3 infections - HIV, HBV, syphilis
LAB REQUIREMENTS:
The IDPS screening laboratories must:
be accredited by the UK Accreditation Service (UKAS) to ISO 15189:2012 medical laboratories – requirements for quality and competence
meet the IDPS laboratory QA evidence requirements mapped to ISO 15189:2012
participate in external quality assurance (EQA) schemes accredited to ISO 17043:2010 conformity assessment – general requirements for proficiency testing
use reference laboratories accredited to ISO 15189:2012 for confirmation of screen positive results when this is not available in-house
DOCTOR REQUIREMENTS:
have a named, discipline-specific clinical lead from a virology, microbiology or infectious diseases background, who has passed the FRCPath Part 2 by examination (or has a recognised examination if overseas-qualified), who has day-to-day responsibility for the IDPS service.
SAMPLE BOOKING:
Samples should be ‘logged’ as antenatal samples, assigned a laboratory accession number and booked for the appropriate tests according to the request within 24 hours of receipt in the laboratory.
REPORTING POS/EQUIVOCAL:
Positive or equivocal screening results must not be reported verbally (with the exception of urgent results as discussed below), in written or electronic form to the maternity service (for example screening team, specialist midwife or clinical nurse specialist) until confirmatory tests are completed on the screening sample.
Positive or equivocal screening results must only be reported on the screening sample for HIV, hepatitis B and syphilis following confirmation of the result using appropriate analytical methods.
TAT: 8 WORKING DAYS
EXPEDITED: The test turnaround time of by or before 8 working days does not apply for women without screening results who are:
in labour or who have just delivered
admitted to maternity services and have a high risk of premature labour
VERTICAL AUDIT
Antenatal screening audit
The laboratory must include in its laboratory audit schedule an annual vertical audit of an antenatal screening sample.
The audit should randomly select a confirmed screen positive sample. A different infection should be selected each year so that over a 3-year cycle confirmed screen positive samples for HIV, hepatitis B and syphilis samples are audited.
The audit should include arrival and receipt of the antenatal screening sample at the laboratory, and communication of a confirmed screen positive result by clinical services.
SAMPLE STORAGE:
When the screening tests are complete an aliquot (a suggested minimum volume of 300 microliters) from the screening sample must be stored frozen at a maximum temperature of -20 degrees Celsius for at least 2 years.
REPORTING NEG:
The phrase ‘negative now’ is being used to emphasise to women and those involved in her care that although she has tested negative in her antenatal screening sample, infection can be acquired at any time during pregnancy, after screening. Retesting may be appropriate at any stage if the woman was at risk of exposure and/or has a relevant clinical presentation. When screening is negative for all 3 infections laboratories are asked to add the following comment to reports in order to reinforce this message:
‘Negative at time the screening sample was taken. Please offer testing at any time in pregnancy if the woman has a new exposure risk or develops relevant symptoms’.
SECOND SAMPLE NEEDED TO CONFIRM
Requirements for CL3 lab - 7 things
HEPA
High-efficiency particulate air (HEPA)
Has to filter 99.97% of all particles with a diameter up to 0.3 micro metre in size.
European Standard EN 1822-1:2009.
EPP restrictions