Standards › ASF Health Standards v10 › Standard 19
Standard 19
Specimen Collection Point
Specimen collection point: labelling at collection, correct collection, sharps and waste, safe transport, rejection, trained staff, results to the requester and consent.
Each specimen is labelled at the point of collection, in front of the patient, with the date and time, and the collector’s identity.
Why it matters. A specimen without a correct label is a result that cannot be trusted, and it may be linked to the wrong patient. Labelling at the point of collection, in front of the patient, is the moment the link is made.
How the surveyor verifies this criterion
Sample. Review 20 labelled specimens with their request forms, and observe 5 collections.
1. Each specimen is labelled at collection, in front of the patient.
Method. Observe 5 collections for the label written in front of the patient.
Evidence to show. Specimen labelling and collection record (SPC-FRM-001).
Pass when. Every observed collection labels the specimen in front of the patient.
2. Each label carries the date, time and the collector’s identity.
Method. Check each sampled specimen label for the four items.
Evidence to show. Specimen labelling and collection record (SPC-FRM-001).
Pass when. Every sampled label has all four items.
3. The label matches the request form.
Method. Match each sampled label to its request form.
Evidence to show. Specimen labelling and collection record (SPC-FRM-001).
Pass when. Every sampled label matches its request form.
Immediate fail (any one means the criterion is not met)
- Tubes are labelled later in a batch, away from the patient.
Documents
No documents yet.
E-learning
References
- International Organization for Standardization. ISO 15189:2022 Medical laboratories: requirements for quality and competence. Geneva: ISO; 2022.
Collection follows defined procedures for each specimen type, including the right container, the correct timing, and the right preservation. The procedures are those of the receiving laboratory, and Standard 33 applies to that laboratory.
Why it matters. Each specimen type needs its own container, timing and handling. Collecting it wrongly gives a result that is false, even though the sample looks fine.
How the surveyor verifies this criterion
Sample. Review the collection procedure for each specimen type, and audit 10 collections against it.
1. Each specimen type has a written collection procedure.
Method. Check the procedure list against the specimen types collected.
Evidence to show. Collection procedures by specimen type (SPC-POL-001).
Pass when. Every specimen type collected has a written procedure.
2. Each collection uses the right container, timing and preservation.
Method. Audit each sampled collection against its procedure.
Evidence to show. Collection audit record (SPC-FRM-002).
Pass when. At least 95% of audited collections match the procedure.
3. Departures are recorded and acted on.
Method. Check each departure for the action taken.
Evidence to show. Collection audit record (SPC-FRM-002).
Pass when. Every departure has an action recorded.
Immediate fail (any one means the criterion is not met)
- A specimen is collected in the wrong container.
Documents
No documents yet.
E-learning
- Pre-Examination: Specimen Pathway (LAB-06)
References
- International Organization for Standardization. ISO 15189:2022 Medical laboratories: requirements for quality and competence. Geneva: ISO; 2022.
Sharps and clinical waste are handled and disposed of safely at the collection point, in line with the infection-control rules.
Why it matters. Needles and contaminated waste injure staff and spread infection. The collection point is where the risk starts, so safe handling must be in place there.
How the surveyor verifies this criterion
Sample. Review the sharps and waste procedure, the monthly audit record, and walk through the collection point.
1. Sharps and clinical waste are segregated at the point of collection.
Method. Walk through the collection point and check the segregation.
Evidence to show. Waste contract and disposal record (WST-FRM-001).
Pass when. Sharps and waste are segregated at the point of collection.
2. Sharps containers are not overfilled.
Method. Check each sharps container at the walk-through.
Evidence to show. Waste contract and disposal record (WST-FRM-001).
Pass when. No sharps container is overfilled.
3. Disposal is recorded.
Method. Check the disposal record against the collection volumes.
Evidence to show. Waste contract and disposal record (WST-FRM-001).
Pass when. Every disposal is recorded.
Immediate fail (any one means the criterion is not met)
- A sharps box is overfilled and left on the bench.
Documents
No documents yet.
E-learning
References
- World Health Organization. Safe management of wastes from health-care activities, 2nd edition. Geneva: WHO; 2014.
Specimens are transported to the laboratory within the time and temperature set for each specimen type, in packaging that meets transport rules.
Why it matters. A specimen that is slow or too warm when it reaches the laboratory may give a false result, and the patient must then be collected again. Transport within the set time and temperature protects the result.
How the surveyor verifies this criterion
Sample. Review the dispatch and arrival register for the last 30 days, and the transport procedure.
1. Each specimen is dispatched within the time set for its type.
Method. Check each dispatch time against the set time.
Evidence to show. Specimen dispatch and arrival register (SPC-REG-001).
Pass when. At least 95% of specimens are dispatched within the set time.
2. The transport temperature is recorded where the type requires it.
Method. Check each record for the temperature where required.
Evidence to show. Specimen dispatch and arrival register (SPC-REG-001).
Pass when. Every required temperature is recorded and in range.
3. Packaging meets the transport rules.
Method. Check the packaging of each dispatch at the walk-through.
Evidence to show. Specimen dispatch and arrival register (SPC-REG-001).
Pass when. No unsealed packaging is dispatched.
Immediate fail (any one means the criterion is not met)
- A specimen waits for hours on a bench before transport.
Documents
No documents yet.
E-learning
- Pre-Examination: Specimen Pathway (LAB-06)
References
- International Organization for Standardization. ISO 15189:2022 Medical laboratories: requirements for quality and competence. Geneva: ISO; 2022.
Specimens that cannot be used, such as those mislabelled, leaking or delayed, are rejected and recorded, and the requester is told.
Why it matters. A specimen that is mislabelled, leaking or too old must not be tested, because the result would be wrong or unsafe. Rejecting it and recording the reason is what keeps bad results out of the chart.
How the surveyor verifies this criterion
Sample. Review the rejection log for the last 3 months, and the rejection procedure.
1. Each unsuitable specimen is rejected and not tested.
Method. Check the log against the specimens reported as unsuitable.
Evidence to show. Specimen rejection log (SPC-REG-002).
Pass when. No unsuitable specimen is recorded as tested.
2. The reason for each rejection is recorded.
Method. Check each entry for the reason.
Evidence to show. Specimen rejection log (SPC-REG-002).
Pass when. Every rejection has a reason recorded.
3. The requester is told, and the time and method are recorded.
Method. Check each entry for the notification.
Evidence to show. Specimen rejection log (SPC-REG-002).
Pass when. At least 95% of rejections show the requester told.
Immediate fail (any one means the criterion is not met)
- A leaking specimen is tested anyway.
Documents
No documents yet.
E-learning
References
- World Health Organization (2021). Global Patient Safety Action Plan 2021–2030: Towards Eliminating Avoidable Harm in Health Care. Geneva: WHO. https://www.who.int/publications-detail-redirect/9789240032705
Staff who collect specimens are trained in collection, labelling and safety, and their training is recorded. Qualification is verified as set out in the credential verification rule, and ongoing competency is evaluated as set out in 2E.1.
Why it matters. Collection is a skilled task. Staff who have not been trained in collection, labelling and safety make the errors that the other criteria exist to catch.
How the surveyor verifies this criterion
Sample. Review the training matrix for all collection staff, and the training records for 5 staff.
1. Each staff member who collects specimens is trained in collection, labelling and safety.
Method. Check the training matrix for each collection staff member.
Evidence to show. Training matrix register (WRK-REG-001).
Pass when. Every collection staff member has the training recorded.
2. Training is refreshed when due.
Method. Check each refresher date against the record.
Evidence to show. Training matrix register (WRK-REG-001).
Pass when. At least 95% of refreshers are completed on the due date.
3. Competency is evaluated, as Standard 2E requires.
Method. Check the competency evaluation record for each staff member.
Evidence to show. Training matrix register (WRK-REG-001).
Pass when. Every staff member has a competency evaluation recorded.
Immediate fail (any one means the criterion is not met)
- A staff member collects alone with no training.
Documents
No documents yet.
E-learning
References
- World Health Organization (2011). Patient Safety Curriculum Guide: Multi-professional Edition. Geneva: WHO.
The collection point confirms that each specimen reached the laboratory, and results are returned to the requester through the laboratory’s route.
Why it matters. A specimen that reaches the lab but is never linked to a result leaves the patient waiting, and no one notices. Confirming arrival and returning results is what closes the loop.
How the surveyor verifies this criterion
Sample. Review the tracking register for the last 30 days, and the follow-up of each missing result.
1. The collection point confirms each specimen reached the laboratory.
Method. Check each specimen for the arrival confirmation.
Evidence to show. Specimen tracking register (SPC-REG-003).
Pass when. At least 98% of specimens have arrival confirmed.
2. Each result is returned to the requester.
Method. Check each specimen for the result returned.
Evidence to show. Specimen tracking register (SPC-REG-003).
Pass when. At least 98% of results are returned to the requester.
3. Each missing result is followed up.
Method. Check each missing result for the follow-up and outcome.
Evidence to show. Specimen tracking register (SPC-REG-003).
Pass when. Every missing result has a follow-up recorded.
Immediate fail (any one means the criterion is not met)
- A patient never receives a result for a specimen sent a week ago.
Documents
No documents yet.
E-learning
References
- International Organization for Standardization. ISO 15189:2022 Medical laboratories: requirements for quality and competence. Geneva: ISO; 2022.
Before collection, the patient is told what will be taken and why, and their agreement or refusal is recorded. A patient’s right to decline collection is honoured, and staff can describe what happens when a patient declines. The right to refuse treatment is part of the patient rights charter in 1.7.
Why it matters. A patient has the right to know what will be taken from them and why, and to refuse. Recording the decision protects the patient and the collection point.
How the surveyor verifies this criterion
Sample. Review 10 completed consent and refusal records, and observe 5 collections.
1. The patient is told what will be taken and why, before collection.
Method. Observe 5 collections and check each record for the explanation.
Evidence to show. Collection consent and refusal record (SPC-FRM-003).
Pass when. At least 95% of records show the explanation before collection.
2. The agreement or refusal is recorded.
Method. Check each record for the agreement or refusal.
Evidence to show. Collection consent and refusal record (SPC-FRM-003).
Pass when. Every record shows agreement or refusal.
3. A refusal is honoured, and staff can explain what happens next.
Method. Check each refusal for the action taken and interview a staff member.
Evidence to show. Collection consent and refusal record (SPC-FRM-003).
Pass when. Every refusal is honoured and recorded.
Immediate fail (any one means the criterion is not met)
- A specimen is taken with no record of consent.
Documents
No documents yet.
E-learning
References
- World Health Organization Regional Office for Europe. Declaration on the Promotion of Patients’ Rights in Europe. Copenhagen: WHO Regional Office for Europe; 1994.
Additional resources: guidelines in the GMJ library
These guidelines are held in the GMJ guideline library (news.gmj.ge). WHO and PAHO are the issuing bodies; MSF guidelines are marked MSF.
- Minimum operational standards and typology for rapid response mobile laboratories · WHO · criteria: Whole standard
Global standards for rapid response mobile laboratories deployed for diagnostic surge in health emergencies.
Back to ASF Health Standards v10 · Standards Map · E-learning by standard · References