Standard 5 · applies to facilities that collect, test, store or issue blood
Blood Bank
Nine criteria for the blood bank: donor screening, testing, traceability, cold chain, issue against a valid request, staff competence, adverse reactions, the quality system and emergency release. Most documents are new (BLD-); the transfusion procedure, bedside check, fridge log and staff verification documents are existing, reused where the process is the same.
Two kinds of document
Means of verification. The policies, registers, forms and plans the surveyor checks. The organisation submits them.
Recommended. SOPs and guidelines that support good practice. They are held on site but are not verified.
How a surveyor reads each criterion
Why it matters→
Sample→
Method and evidence→
Pass ruleor
Immediate fail
How strict is Standard 5, by setting
Each row adds up to the total number of criteria on this page.
Non-negotiable
Donors are selected and screened by a defined process before each donation, and deferred where the criteria are not met. Each deferral is recorded.
Why this criterion matters. A donor with an infection or a condition that makes donation unsafe can put a recipient at risk. Screening before every donation, and recording each deferral, is the first barrier.
Sample. Review the donor records for the last month: 20 donations, and every deferral in the period.
How the surveyor verifies this
1. Each donor is screened by the defined process before donation.
Method. Check the questionnaire and examination record for each of the 20 donations.
Evidence to show. Donor screening record (BLD-FRM-001).
Pass when. Every sampled donation has a completed screening before donation.
2. Donors who do not meet the criteria are deferred.
Method. Check the screening record for any donor who should have been deferred.
Evidence to show. Donor screening record.
Pass when. No ineligible donor was accepted.
3. Each deferral is recorded with its reason and return date.
Method. Check every deferral in the period.
Evidence to show. Donor screening and deferral record.
Pass when. Every deferral has a reason and a return date.
Immediate fail (any one means the criterion is not met)
- A donation is taken from a donor who was not screened or who should have been deferred.
Documents
Means of verification. The surveyor checks these. Submit them.
- BLD-FRM-001 · Donor screening and deferral record
Why it is here. The screening record for each donor.
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- BLD-SOP-001 · Donor selection, screening and deferral
Why it is here. Donor screening, deferral and the return rule.
E-learning
- ISO 15189:2022 for the laboratory director and quality manager (L-01)
- Hand Hygiene and Standard Precautions (T-06)
- Planned course: Donor screening and deferral. New course planned.
References
- World Health Organization (2010). Towards 100% Voluntary Blood Donation: A Global Framework for Action. Geneva: WHO.
Non-negotiable
Each donation is tested for infectious diseases and blood group, using validated tests. Results are recorded, and unsafe donations are discarded.
Why this criterion matters. Each donation carries a risk of infections that can pass to a patient. Testing every donation with validated tests, and discarding unsafe ones, keeps those infections out of the blood supply.
Sample. Review the testing and release register for the last month: 20 donations, including every unit discarded.
How the surveyor verifies this
1. Each donation is tested for infections and blood group with validated tests.
Method. Check the test results for each of the 20 donations.
Evidence to show. Donation testing and release register (BLD-REG-001).
Pass when. Every donation has all tests recorded with validated methods.
2. Results are recorded before release.
Method. Compare the release time with the test result time.
Evidence to show. Register.
Pass when. No unit was released before its results were recorded.
3. Unsafe donations are discarded and the disposal is recorded.
Method. Check each positive or invalid result for the disposal record.
Evidence to show. Disposal record.
Pass when. Every unsafe donation was discarded and recorded.
Immediate fail (any one means the criterion is not met)
- A unit is released with a positive or invalid test result.
Documents
Means of verification. The surveyor checks these. Submit them.
- BLD-REG-001 · Donation testing and release register
Why it is here. Test results and release for each donation.
Submit the register extract for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- BLD-SOP-002 · Donation testing and disposal of unsafe units
Why it is here. Testing, release and disposal of units.
E-learning
- Internal quality control, Westgard rules and EQA (L-07)
- ISO 15189:2022 for the laboratory director and quality manager (L-01)
References
- World Health Organization (2010). Screening Donated Blood for Transfusion-Transmissible Infections: Recommendations. Geneva: WHO.
Non-negotiable
Each donation, and each product made from it, is traceable from donor to recipient, and can be recalled. The records are kept and retrievable as set out in B2.5.
Why this criterion matters. If a donation is found to be unsafe after release, the blood bank must be able to find every product made from it and every recipient who received it. Without traceability, a recall is impossible.
Sample. Run a trace test on 5 units chosen at random from the last 3 months, from donor to recipient and back.
How the surveyor verifies this
1. Each donation and product has a unique number.
Method. Check the number on each of the 5 units through each step.
Evidence to show. Donation traceability register (BLD-REG-002).
Pass when. Every unit has a number at every step.
2. Each unit can be traced from donor to recipient.
Method. Trace each of the 5 units to its recipient.
Evidence to show. Trace record.
Pass when. All 5 units trace to a recipient or are recorded as discarded.
3. A recall can be started and closed within the set time.
Method. Check the last recall record for start and closure times.
Evidence to show. Recall record.
Pass when. The recall started and closed within the set time.
Immediate fail (any one means the criterion is not met)
- A unit cannot be traced from donor to recipient.
Documents
Means of verification. The surveyor checks these. Submit them.
- BLD-REG-002 · Donation traceability register
Why it is here. The donor-to-recipient link for each unit.
Submit the register extract for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- BLD-SOP-003 · Traceability and recall
Why it is here. Numbering, tracing and recall.
E-learning
- Document Control and the Records System (T-02)
- ISO 15189:2022 for the laboratory director and quality manager (L-01)
References
- Council of Europe (current edition). Guide to the Preparation, Use and Quality Assurance of Blood Components. Strasbourg: EDQM.
Non-negotiable
Blood and blood products are stored and transported within the required temperature range, with monitoring and records. The refrigeration and monitoring equipment is maintained as set out in 2B.4, and its power and back-up are planned as set out in 2B.9.
Why this criterion matters. Blood spoils if it is too warm or too cold, and no one may notice until it is given. Continuous temperature monitoring, with a set response to any failure, keeps products safe in storage and on the road.
Sample. Review the temperature records for the last 30 days, check the alarm log, and check the transport record for 5 deliveries.
How the surveyor verifies this
1. Blood is stored within the required temperature range.
Method. Read the temperature records for the last 30 days.
Evidence to show. Fridge temperature log (PHM-FRM-001) and blood records.
Pass when. At least 90% of readings are in range, with action recorded for every out-of-range reading.
2. Monitoring is continuous and records are kept.
Method. Check the alarm log and the readings twice a day.
Evidence to show. Alarm log.
Pass when. Every alarm is answered and recorded within the set time.
3. Transport keeps the cold chain.
Method. Check the temperature at handover for each of the 5 deliveries.
Evidence to show. Transport record.
Pass when. Every delivery is in range at handover.
Immediate fail (any one means the criterion is not met)
- A unit is issued after being out of range, or a fridge alarm is not answered.
Documents
Means of verification. The surveyor checks these. Submit them.
- PHM-FRM-001 · Fridge Temperature Log
Why it is here. The fridge temperature log (existing, reused).
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- BLD-SOP-004 · Cold chain storage and transport of blood
Why it is here. Storage, monitoring and transport of blood.
E-learning
- Equipment, calibration, maintenance and environment (L-05)
- Hand Hygiene and Standard Precautions (T-06)
References
- Council of Europe (current edition). Guide to the Preparation, Use and Quality Assurance of Blood Components. Strasbourg: EDQM.
Non-negotiable
Blood is issued only against a valid request, and the issuing is checked, with the request and issue recorded. Identity checks at the bedside are set out in A.8, where the blood bank supplies a hospital.
Why this criterion matters. Blood given to the wrong patient can kill. A valid request, a compatibility check and a recorded issue make the chain of checks visible at each step.
Sample. Review 20 issues from the last month, including emergency issues, with the request and the bedside check.
How the surveyor verifies this
1. Blood is issued only against a valid request.
Method. Check each issue for a valid, signed request.
Evidence to show. Blood request and issue record (BLD-FRM-002).
Pass when. Every issue has a valid request.
2. The issue is checked for compatibility and the patient identity.
Method. Check the compatibility and identity record for each issue.
Evidence to show. Issue record.
Pass when. Every issue has a compatibility check and identity check recorded.
3. The bedside check is recorded at the ward.
Method. Check the bedside transfusion check (HOS-FRM-007) for each of the 20 issues.
Evidence to show. Bedside transfusion check.
Pass when. At least 90% of transfusions have the bedside check recorded.
Immediate fail (any one means the criterion is not met)
- Blood is issued with no valid request, or to a patient whose identity has not been checked.
Documents
Means of verification. The surveyor checks these. Submit them.
- BLD-POL-002 · Issue of blood against a valid request
Why it is here. Issue only against a valid request.
Submit the approved policy with version and date, and evidence it is in use. - BLD-FRM-002 · Blood request and issue record
Why it is here. The request and issue record.
Submit the completed form for the sample period. - HOS-FRM-007 · Bedside transfusion check and reaction record
Why it is here. The bedside transfusion check (existing, reused).
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- HOS-SOP-008 · Blood transfusion
Why it is here. Blood transfusion procedure (existing, reused).
E-learning
- Patient Identification, Informed Consent and Patient Rights (T-07)
- Care & Treatment: Clinical Standards for Accreditation (H-04)
References
- Council of Europe (current edition). Guide to the Preparation, Use and Quality Assurance of Blood Components. Strasbourg: EDQM.
Non-negotiable
Staff who collect, test or issue blood are qualified and credentialed for their role, with their qualification verified and current.
Why this criterion matters. Staff who collect, test or issue blood make decisions that directly affect patients. Their qualifications must be verified and current for the role they do.
Sample. Check the credentials and the verification record for every staff member who collected, tested or issued blood in the last 12 months.
How the surveyor verifies this
1. Each staff member is qualified for their role.
Method. Check each record for the qualification.
Evidence to show. Staff verification register (STF-FRM-001).
Pass when. Every staff member has a verified qualification for their role.
2. Credentials are verified and current.
Method. Check the expiry date for each credential.
Evidence to show. Staff verification register.
Pass when. No credential has expired.
3. Verification is rechecked on the set schedule.
Method. Check the recheck date for each staff member.
Evidence to show. Staff credential verification procedure (STF-SOP-001).
Pass when. Every staff member was rechecked on schedule.
Immediate fail (any one means the criterion is not met)
- A staff member without a current qualification collects, tests or issues blood.
Documents
Means of verification. The surveyor checks these. Submit them.
- STF-FRM-001 · Staff Verification Register
Why it is here. The staff verification register (existing, reused).
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- STF-SOP-001 · Staff Credential Verification and Recheck
Why it is here. Credential verification and recheck (existing, reused).
E-learning
- ISO 15189:2022 for the laboratory director and quality manager (L-01)
- Safety Training Programme & Competency Assessment (TRAIN-01)
References
- International Organization for Standardization (2022). ISO 15189:2022 Medical laboratories: Requirements for quality and competence. Geneva: ISO. Open source
Non-negotiable
Adverse reactions, in donors and in recipients, are recorded, investigated and reported. Serious incidents are investigated as set out in B2.6. Transfusion reactions at the bedside are recorded and reported as set out in A.8, where the blood bank supplies a hospital.
Why this criterion matters. A reaction to a transfusion, in a donor or a patient, is a signal that must be investigated. If reactions are not reported, the same harm happens again.
Sample. Review all adverse reaction records in the last 12 months, in donors and recipients.
How the surveyor verifies this
1. Each adverse reaction is recorded.
Method. Compare the reaction records with the transfusion records for the period.
Evidence to show. Adverse reaction report (BLD-FRM-003).
Pass when. Every reaction in the transfusion records has a report.
2. Each reaction is investigated.
Method. Check each report for the investigation and outcome.
Evidence to show. Adverse reaction report.
Pass when. Every report has an investigation and an outcome.
3. Serious reactions are reported to the national system.
Method. Check each serious reaction for the report number.
Evidence to show. Adverse reaction report.
Pass when. Every serious reaction has a report number.
Immediate fail (any one means the criterion is not met)
- A transfusion reaction is not recorded or investigated.
Documents
Means of verification. The surveyor checks these. Submit them.
- BLD-FRM-003 · Adverse reaction report
Why it is here. The reaction report.
Submit the completed form for the sample period. - HOS-FRM-007 · Bedside transfusion check and reaction record
Why it is here. The bedside reaction record (existing, reused).
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- BLD-SOP-005 · Adverse reactions in donors and recipients
Why it is here. Investigating and reporting reactions.
E-learning
- Incident Reporting, Just Culture and Open Disclosure (T-09)
- Care & Treatment: Clinical Standards for Accreditation (H-04)
References
- Council of Europe (current edition). Guide to the Preparation, Use and Quality Assurance of Blood Components. Strasbourg: EDQM.
Standard
The blood bank has a quality system covering procedures, equipment, audit and staff training. The written operating plan and policies, and their follow-up in practice, are required by B2.2 and B2.3.
Why this criterion matters. A blood bank without a quality system depends on the memory of its people. A written system covering procedures, equipment, audit and training keeps the service the same from one shift to the next.
Sample. Review the quality system documents and the last annual audit, and check 5 procedures against their written standard.
How the surveyor verifies this
1. The quality system covers procedures, equipment, audit and staff training.
Method. Read the quality system and check each of the four areas.
Evidence to show. Blood bank quality system (BLD-POL-001).
Pass when. All four areas are covered in writing.
2. Procedures are current and owned.
Method. Check the review date and owner of each of the 5 procedures.
Evidence to show. Procedure register.
Pass when. Every procedure has an owner and a review date within the last 12 months.
3. Audit findings are closed.
Method. Check the audit findings and their closure dates.
Evidence to show. Audit record.
Pass when. At least 90% of findings are closed by the due date.
Immediate fail (any one means the criterion is not met)
- A procedure is in use with no owner, or the quality system has no audit in the last 12 months.
Documents
Means of verification. The surveyor checks these. Submit them.
- BLD-POL-001 · Blood bank quality system
Why it is here. The blood bank quality system.
Submit the approved policy with version and date, and evidence it is in use.
E-learning
- ISO 15189:2022 for the laboratory director and quality manager (L-01)
- Quality Management in Healthcare (A-02)
References
- International Organization for Standardization (2022). ISO 15189:2022 Medical laboratories: Requirements for quality and competence. Geneva: ISO. Open source
Non-negotiable
Where blood must be released urgently before full compatibility results are available, a written emergency release procedure applies. It names who may authorise release, the checks still made, the record kept for the patient, and how the unit is identified until the full result is known. Each emergency release is recorded and reviewed.
Why this criterion matters. Blood sometimes must be released before every test is complete, because a patient is bleeding. This is safe only when a written procedure names who may authorise it and each release is recorded and reviewed.
Sample. Review every emergency release in the last 12 months.
How the surveyor verifies this
1. A written emergency release procedure exists.
Method. Read the procedure and check the authoriser, checks and records it names.
Evidence to show. Emergency release procedure (BLD-SOP-006).
Pass when. The procedure names the authoriser, the checks, the record and the return of unused units.
2. Each release has an authoriser and a recorded reason.
Method. Check each emergency release record.
Evidence to show. Emergency release record (BLD-FRM-004).
Pass when. Every release has an authoriser and a reason.
3. Unused units are returned and tested.
Method. Check the return record for each release.
Evidence to show. Emergency release record.
Pass when. Every unused unit is returned and tested as the procedure sets.
Immediate fail (any one means the criterion is not met)
- Blood is released urgently with no named authoriser or no record for the patient.
Documents
Means of verification. The surveyor checks these. Submit them.
- BLD-FRM-004 · Emergency release record
Why it is here. The release record.
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- BLD-SOP-006 · Emergency release of blood before full compatibility
Why it is here. Emergency release rule.
E-learning
- Medical Emergency Protocol Development (MED-01)
- Patient Identification, Informed Consent and Patient Rights (T-07)
- Planned course: Emergency release of blood. New course planned.
References
- Council of Europe (current edition). Guide to the Preparation, Use and Quality Assurance of Blood Components. Strasbourg: EDQM.