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International Accreditation of Healthcare Facilities

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.

8
criteria
12
documents
6
e-learning courses
10
references

Criteria on this page

19.119.219.319.419.519.619.719.8

How to read the colours
Red: Must. Required in every setting. Criteria that protect life are always red.
Green: Medium. Required, adapted to what a transition setting can realistically do.
Yellow: Minimum. The lowest acceptable level in a humanitarian setting, where resources are very limited.

Each criterion is shown in three settings: Humanitarian settings, Transition and fragile, and Standard. In standard settings, every criterion is Must.

Reference, not a requirement. Every policy, SOP, form and course on this page is a draft to help you. Adapt it to your hospital, write your own, or upload your own documents. What the assessor checks is that the standard is met and that you can show how.
Training colours: red means essential, green recommended, yellow optional. Each course shows its level for each setting: humanitarian, transition and fragile, and standard.
19.1Each Specimen Is Correctly Identified at CollectionHumanitarian settings: MustTransition and fragile: MustStandard: Must

Each specimen is labelled at the point of collection, in front of the patient, with the date and time, and the collector’s identity.

Humanitarian settings
Must
Transition and fragile
Must
Standard
Must

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.

Staff responsible

Role Responsibility Level
Nurse (ISCO 2221) Labels each specimen in front of the patient Must
Manager (ISCO 1342) Checks labels against request forms in audits Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
SPC-FRM-001 · Specimen labelling and collection record Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Patient Identification, Informed Consent and Patient Rights (T-07) Nurse; Manager

References

  1. WHO Western Pacific Regional Office (2026). Strengthening clinical diagnostic stewardship in the Western Pacific Region: a practical manual. Used for: specimen collection, identification and laboratory use. https://news.gmj.ge/guideline/strengthening-clinical-diagnostic-stewardship-in-the-western-pacific-region-a-practical-manual/
19.2Collection Is Done CorrectlyHumanitarian settings: MustTransition and fragile: MustStandard: Must

Collection follows defined procedures for each specimen type, including the right container, the correct timing, and the right preservation.

Humanitarian settings
Must
Transition and fragile
Must
Standard
Must

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.

Staff responsible

Role Responsibility Level
Nurse (ISCO 2221) Collects each specimen by the written procedure Must
Manager (ISCO 1342) Approves the collection procedures and reviews audits Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
SPC-POL-001 · Collection procedures by specimen type Chief executive (ISCO 1120) Governing body members N/A Chief executive (ISCO 1120) Secretary (ISCO 3344)
SPC-FRM-002 · Collection audit record Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Pre-Examination: Specimen Pathway (LAB-06) Nurse; Manager

References

  1. WHO Western Pacific Regional Office (2026). Strengthening clinical diagnostic stewardship in the Western Pacific Region: a practical manual. Used for: specimen collection, identification and laboratory use. https://news.gmj.ge/guideline/strengthening-clinical-diagnostic-stewardship-in-the-western-pacific-region-a-practical-manual/
19.3Sharps and Waste Are Handled SafelyHumanitarian settings: MinimumTransition and fragile: MustStandard: Must

Sharps and clinical waste are handled and disposed of safely at the collection point, in line with the infection-control rules.

Humanitarian settings
Minimum
Transition and fragile
Must
Standard
Must

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.

Staff responsible

Role Responsibility Level
Nurse (ISCO 2221) Segregates sharps and waste at collection Must
Manager (ISCO 1342) Checks sharps containers and disposal records Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
WST-FRM-001 · Waste contract and disposal record Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Hand Hygiene and Standard Precautions (T-06) Nurse; Manager; Secretary

References

  1. World Health Organization (2020). Minimum requirements for infection prevention and control programmes. Used for: safe handling of sharps and waste in health facilities. https://news.gmj.ge/guideline/minimum-requirements-for-infection-prevention-and-control-programmes/
  2. Pan American Health Organization (2020). Recommendations on Public Environmental Health in Health Care Facilities. Used for: waste and sharps management in health care facilities. https://news.gmj.ge/guideline/recommendations-on-public-environmental-health-in-health-care-facilities/
  3. World Health Organization (2021). Laboratory Biosafety Manual, 4th edition. Used for: biosafety when handling and transporting clinical specimens. https://news.gmj.ge/guideline/laboratory-biosafety-manual-4th-edition/
19.4Specimens Are Transported Safely and on TimeHumanitarian settings: MinimumTransition and fragile: MustStandard: Must

Specimens are transported to the laboratory within the time and temperature set for each specimen type, in packaging that meets transport rules.

Humanitarian settings
Minimum
Transition and fragile
Must
Standard
Must

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.

Staff responsible

Role Responsibility Level
Nurse (ISCO 2221) Dispatches specimens within the set time and temperature Must
Secretary (ISCO 3344) Keeps the dispatch and arrival register Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
SPC-SOP-001 · Specimen transport Manager (ISCO 1342) Chief executive (ISCO 1120) Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
SPC-REG-001 · Specimen dispatch and arrival register Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Pre-Examination: Specimen Pathway (LAB-06) Nurse; Manager

References

  1. World Health Organization (2021). Laboratory Biosafety Manual, 4th edition. Used for: biosafety when handling and transporting clinical specimens. https://news.gmj.ge/guideline/laboratory-biosafety-manual-4th-edition/
19.5Refused or Unsuitable Specimens Are RecordedHumanitarian settings: MinimumTransition and fragile: MustStandard: Must

Specimens that cannot be used, such as those mislabelled, leaking or delayed, are rejected and recorded, and the requester is told.

Humanitarian settings
Minimum
Transition and fragile
Must
Standard
Must

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.

Staff responsible

Role Responsibility Level
Nurse (ISCO 2221) Identifies and rejects unsuitable specimens Must
Secretary (ISCO 3344) Keeps the rejection log Must
Manager (ISCO 1342) Checks that requesters are told Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
SPC-SOP-002 · Specimen rejection and requester notification Manager (ISCO 1342) Chief executive (ISCO 1120) Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
SPC-REG-002 · Specimen rejection log Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Incident Reporting, Just Culture and Open Disclosure (T-09) Manager; Nurse; Secretary

References

  1. World Health Organization (2021). Global Patient Safety Action Plan 2021–2030: Towards Eliminating Avoidable Harm in Health Care. Used for: recording and acting on unsafe care events to prevent avoidable harm. https://news.gmj.ge/guideline/global-patient-safety-action-plan-2021-2030-towards-eliminating-avoidable-harm-in-health-care/
19.6Staff Are TrainedHumanitarian settings: MinimumTransition and fragile: MustStandard: Must

Staff who collect specimens are trained in collection, labelling and safety, and their training is recorded.

Humanitarian settings
Minimum
Transition and fragile
Must
Standard
Must

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.

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.

Staff responsible

Role Responsibility Level
Nurse (ISCO 2221) Completes collection and safety training Must
Manager (ISCO 1342) Keeps the training matrix and evaluates competency Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
WRK-REG-001 · Training matrix register Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Credentialing, Competence and the Training Matrix (T-14) Manager

References

  1. World Health Organization (2025). Infection Prevention and Control Pre-Service Education and Training Curriculum: Foundational Learning for All Health and Care Workers. Used for: infection prevention and control training for all health workers, including safe sample handling. https://news.gmj.ge/guideline/infection-prevention-and-control-pre-service-education-and-training-curriculum-foundational-learning-for-all-health-and-care-workers/
19.7Results Reach the RequesterHumanitarian settings: MinimumTransition and fragile: MediumStandard: Must

The collection point confirms that each specimen reached the laboratory, and results are returned to the requester through the laboratory’s route.

Humanitarian settings
Minimum
Transition and fragile
Medium
Standard
Must

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.

Staff responsible

Role Responsibility Level
Secretary (ISCO 3344) Confirms arrival and records returned results Medium
Manager (ISCO 1342) Follows up missing results Medium

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
SPC-SOP-003 · Missing results follow-up Manager (ISCO 1342) Chief executive (ISCO 1120) Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344)
SPC-REG-003 · Specimen tracking register Secretary (ISCO 3344) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Pre-examination: patient preparation, collection, identification, transport, reception (L-04) Nurse; Secretary

References

  1. Pan American Health Organization (2020). Interpretation of laboratory results for COVID-19 diagnosis. Used for: communication of laboratory results to requesters. https://news.gmj.ge/guideline/interpretation-of-laboratory-results-for-covid-19-diagnosis/
19.8Consent or Refusal for Collection Is RecordedHumanitarian settings: MinimumTransition and fragile: MustStandard: Must

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.

Humanitarian settings
Minimum
Transition and fragile
Must
Standard
Must

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.

Staff responsible

Role Responsibility Level
Nurse (ISCO 2221) Explains collection and records agreement or refusal Must
Manager (ISCO 1342) Checks that refusals are honoured Must

Documents: who does each step

Document Writes Approves Fills in Checks and signs Files and uploads
SPC-FRM-003 · Collection consent and refusal record Manager (ISCO 1342) Chief executive (ISCO 1120) Secretary (ISCO 3344) Manager (ISCO 1342) Secretary (ISCO 3344)

E-learning: who must take each course

Course Who must take it
Patient Identification, Informed Consent and Patient Rights (T-07) Nurse; Manager

References

  1. World Medical Association (2015). Declaration of Lisbon on the Rights of the Patient. Used for: the patient’s right to be informed and to refuse before a procedure. https://news.gmj.ge/guideline/wma-declaration-of-lisbon-on-the-rights-of-the-patient/

Who is responsible for Standard 19

Each criterion names the positions responsible for it. Every position links to its own terms of reference.

Criterion Responsible Supports
19.1 Each Specimen Is Correctly Identified at Collection Phlebotomist / specimen collector
Medical laboratory scientist
Medical laboratory technician
19.2 Collection Is Done Correctly Phlebotomist / specimen collector Medical laboratory scientist
19.3 Sharps and Waste Are Handled Safely Phlebotomist / specimen collector
Waste management officer
Occupational health and safety officer
19.4 Specimens Are Transported Safely and on Time Phlebotomist / specimen collector
Medical laboratory scientist
Patient transporter / porter
19.5 Refused or Unsuitable Specimens Are Recorded Medical laboratory scientist
Phlebotomist / specimen collector
Head of laboratory
19.6 Staff Are Trained Head of laboratory
Training and education manager
Competency assessor
19.7 Results Reach the Requester Medical laboratory scientist
Head of laboratory
Phlebotomist / specimen collector
19.8 Consent or Refusal for Collection Is Recorded Phlebotomist / specimen collector
Medical laboratory scientist
Head of laboratory

Role details: reporting, supervision and training

Training shown is the general recommendation. Role-specific training is set in the next improvement round.

Role Reports to Supervises Recommended training
Occupational health and safety officer Risk manager None Facility induction; safeguarding adults (general recommendation)
Head of laboratory Medical director Clinical biochemist, Medical laboratory scientist, Microbiologist, Blood bank technician Facility induction; safeguarding adults (general recommendation)
Medical laboratory scientist Head of department (per specialty) Medical laboratory technician, Phlebotomist / specimen collector Facility induction; safeguarding adults (general recommendation)
Medical laboratory technician Medical laboratory scientist Phlebotomist / specimen collector Facility induction; safeguarding adults (general recommendation)
Phlebotomist / specimen collector Medical laboratory technician None Facility induction; safeguarding adults (general recommendation)
Patient transporter / porter Transport supervisor None Facility induction; safeguarding adults (general recommendation)
Training and education manager Chief human resources officer Training coordinator, Staff development officer, Competency assessor Facility induction; safeguarding adults (general recommendation)
Competency assessor Training and education manager None Facility induction; safeguarding adults (general recommendation)
Waste management officer Facilities manager Waste handler Facility induction; safeguarding adults (general recommendation)

Questions and answers

The criterion text is the authority. These answers summarise it.

Who does Standard 57 apply to?

A provider that only collects specimens (blood, urine, swabs and other samples) and sends them to a laboratory. It does not analyse them. A collection point inside a laboratory is covered by Standard 33 (Laboratory).

What do the colours mean for this standard?

Red (Must) is required. Green (Medium) is recommended. Yellow (Minimum) is the lowest acceptable level in humanitarian settings. Standard setting is Must on every criterion.

Why are 19.1 and 19.2 red in humanitarian settings?

A wrong label or a wrong collection can change the result, so the patient can be harmed even in a field setting. The other criteria are yellow in humanitarian settings.

What does a surveyor check for each criterion?

Each criterion has a sample, three steps and an immediate-fail rule. Each step shows the evidence to be seen and the condition for passing. The documents for each criterion are listed in its table.

Do I have to use the documents on this page?

No. The policies, SOPs, forms and registers are drafts to help you. Adapt them to your facility, write your own, or upload your own. What the assessor checks is that the criterion is met and that you can show how.

What does In process of development mean?

That part of the standard is still being prepared. It may be a document, a course, a reference or a role table. It will be added in a later version.

Guidelines for this standard

3 guideline(s) are held in the GMJ Guidelines Library and listed here. Each link opens the full guideline on news.gmj.ge. The complete library, grouped by standard, is at Guidelines.

  1. Laboratory Biosafety Manual, 4th edition (World Health Organization)
  2. Infection Prevention and Control Pre-Service Education and Training Curriculum: Foundational Learning for All Health and Care Workers (World Health Organization)
  3. Strengthening clinical diagnostic stewardship in the Western Pacific Region: a practical manual (World Health Organization)