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International Accreditation of Healthcare Facilities

Ambulatory Clinic Standards · Standard 11

Oncology & Infusion Therapy

ASF-AMB-STD3-v3.0  ·  Published  ·  12 September 2026  ·  287 pages  ·  27 chapters

STANDARD 11

Oncology & Infusion Therapy

OPTIONAL ENDORSEMENT

Requires Standards 1–7 verified first

4 criteria

  Standard 11.1 NON-NEGOTIABLE · Standard 11: Oncology & Infusion Therapy
Cytotoxic Drug Handling Follows a Verified Safe-Handling Standard
ASSESSMENT
ASF-AMB-STD11-v3.0
CR N/A TR FULL SM FULL ST FULL
11.1
NON-NEGOTIABLE
L1
THE STANDARD
Cytotoxic Drug Handling Follows a Verified Safe-Handling Standard
Preparation, administration, and disposal of cytotoxic and other hazardous drugs follows a defined, verified safe-handling standard — appropriate personal protective equipment, engineering controls, and disposal procedures — not informal practice that varies by individual staff member.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Is appropriate personal protective equipment — including chemotherapy-rated gloves and gowns — used consistently for every stage of handling?
Consistent use at every stage, not only during administration.
Doc: PPE protocol and observation record
YES PARTIAL NO
2 Are hazardous drugs prepared and stored using the required engineering controls, not standard pharmacy equipment?
Specific, required controls, not general pharmacy practice assumed to be sufficient.
Doc: Engineering control documentation
YES PARTIAL NO
3 Is hazardous waste disposed of through a defined, compliant pathway, not general medical waste?
A specific, separate disposal pathway matched to the actual risk.
Doc: Waste disposal record
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
OBSERVE
PPE and handling observation
Observes actual handling practice across preparation, administration, and disposal stages.
DOCUMENT
Engineering control review
Reviews documentation of required engineering controls for hazardous drug preparation and storage.
DOCUMENT
Waste disposal pathway review
Reviews the defined hazardous waste disposal pathway and compliance records.

REFERENCES

  1. [57] Established hazardous drug handling standards, recognized in various forms across many countries' pharmacy and occupational safety guidance, require defined personal protective equipment, engineering controls, and procedures for the receipt, storage, compounding, administration, and disposal of hazardous drugs.
  Standard 11.1 · Standard 11: Oncology & Infusion Therapy
Guidance & Learning
GUIDANCE
ASF-AMB-STD11-v3.0
WHY THIS STANDARD EXISTS

Hazardous drug exposure risk extends beyond the patient to every staff member who prepares, administers, or disposes of these medications, and the risks — including reproductive and long-term health effects from repeated exposure — are serious enough that international standards exist specifically to govern every stage of handling, not administration alone.

The evidence: [57] Established hazardous drug handling standards, recognized in various forms across many countries' pharmacy and occupational safety guidance, require defined personal protective equipment, engineering controls, and procedures for the receipt, storage, compounding, administration, and disposal of hazardous drugs.
WHAT GOOD LOOKS LIKE
✓ PPE is used consistently and correctly at every handling stage.
✓ Required engineering controls are documented and in place.
✓ A defined, compliant hazardous waste disposal pathway is followed.
WHAT FAILURE LOOKS LIKE
✗ PPE use is inconsistent or limited to administration only.
✗ Standard pharmacy equipment is used without required hazardous drug controls.
✗ Hazardous waste is disposed of as general medical waste.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 PPE is used correctly during administration but less consistently during preparation.

Every handling stage carries real exposure risk, not administration alone.

2 Engineering controls exist but staff weren't specifically trained on their correct use.

Correct equipment without correct training doesn't provide the intended protection.

3 Waste disposal follows the correct pathway for most hazardous drugs but not all categories on the hazardous list.

The full hazardous drug list is broader than chemotherapy alone, and each category carries the same real handling requirement.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Review current handling practice against required PPE, engineering controls, and disposal standards.

Week 2 Address any gaps in PPE use or engineering controls.

Week 3 Establish or verify a compliant hazardous waste disposal pathway.

Ongoing Train staff periodically and audit handling practice.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Observe preparation and disposal, not only administration.

Attention often concentrates on administration, leaving earlier and later stages less consistently observed.

Ask to see the actual hazardous waste disposal pathway and its documentation.

A specific, verifiable pathway is the real evidence of compliant disposal.

E-LEARNING academy.gmj.ge/amb-std11-1-hazardous-drug-handling — 30 min · complete before self-assessment
  Standard 11.2 NON-NEGOTIABLE · Standard 11: Oncology & Infusion Therapy
Chemotherapy Dose Is Verified by Independent Two-Person Check
ASSESSMENT
ASF-AMB-STD11-v3.0
CR N/A TR FULL SM FULL ST FULL
11.2
NON-NEGOTIABLE
L1
THE STANDARD
Chemotherapy Dose Is Verified by Independent Two-Person Check
Every chemotherapy dose, drug, route, and infusion rate is independently verified by two qualified individuals before administration, each forming their own judgement separately — not a single check followed by a second signature.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Does every chemotherapy dose undergo independent verification by two qualified individuals before administration?
Two people, every dose, without exception for perceived routine cases.
Doc: Independent double-check record
YES PARTIAL NO
2 Does each person form their own separate judgement, not simply confirm the first person's check?
Genuine independence, not sequential confirmation of the same conclusion.
Doc: N/A — tested directly
YES PARTIAL NO
3 Does verification specifically cover drug, dose, route, and infusion rate together, not dose alone?
All four elements, since an error in any one carries real risk.
Doc: Verification checklist content
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
OBSERVE
Independent check observation
Observes an actual double-check for genuine independence between the two verifiers.
DOCUMENT
Verification record review
Reviews records confirming two-person verification for a sample of recent administrations.
ASK
Verification content interview
Asks staff what specifically gets verified during the double-check.

REFERENCES

  1. [58] Neuss MN, Gilmore TR, Belderson KM, Billett AL, Conti-Kalchik T, Harvey BE, et al. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology. J Oncol Pract. 2016;12(12):1262-1271 — mandates independent verification by two qualified individuals of chemotherapy drug, dose, route, and infusion rate prior to administration.
  Standard 11.2 · Standard 11: Oncology & Infusion Therapy
Guidance & Learning
GUIDANCE
ASF-AMB-STD11-v3.0
WHY THIS STANDARD EXISTS

Chemotherapy dosing errors carry genuinely serious consequences, and a single point of verification means a single point of failure — the independent double-check exists specifically because two people forming separate judgements catch errors that one person, however careful, can miss.

The evidence: [58] Neuss MN, Gilmore TR, Belderson KM, Billett AL, Conti-Kalchik T, Harvey BE, et al. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology. J Oncol Pract. 2016;12(12):1262-1271 — mandates independent verification by two qualified individuals of chemotherapy drug, dose, route, and infusion rate prior to administration.
WHAT GOOD LOOKS LIKE
✓ Every dose undergoes genuine, independent two-person verification.
✓ Each verifier forms their own separate judgement.
✓ Verification covers drug, dose, route, and infusion rate together.
WHAT FAILURE LOOKS LIKE
✗ Verification happens for some doses but not consistently for all.
✗ The second check simply confirms the first person's conclusion.
✗ Verification covers dose alone, missing route or infusion rate.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 Independent verification is strong for new regimens but becomes routine and less rigorous for familiar ones.

Familiarity can quietly erode the genuine independence the check depends on.

2 Verification happens together, side by side, rather than separately before comparing.

Checking together risks one person's read of the order influencing the other's, undermining genuine independence.

3 Infusion rate verification is inconsistent compared to drug and dose verification.

An incorrect rate carries real risk distinct from an incorrect dose or drug.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Review current verification practice for genuine independence between checkers.

Week 2 Retrain staff on separate, independent verification before comparing conclusions.

Week 3 Confirm the verification checklist covers drug, dose, route, and infusion rate together.

Ongoing Audit verification records and observe practice periodically.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Observe an actual double-check, watching specifically for separate, independent review.

Genuine independence is visible in practice in a way records alone cannot confirm.

Ask two different verifiers separately what they checked.

Consistent, specific answers from both reveal genuine independent verification.

E-LEARNING academy.gmj.ge/amb-std11-2-dose-verification — 30 min · complete before self-assessment
  Standard 11.3 NON-NEGOTIABLE · Standard 11: Oncology & Infusion Therapy
Extravasation Is Recognised and Managed Immediately
ASSESSMENT
ASF-AMB-STD11-v3.0
CR N/A TR FULL SM FULL ST FULL
11.3
NON-NEGOTIABLE
L1
THE STANDARD
Extravasation Is Recognised and Managed Immediately
Staff administering vesicant or irritant chemotherapy agents are specifically trained to recognise early signs of extravasation, with a defined, immediate management protocol and appropriate antidotes genuinely available on-site.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Are staff specifically trained to recognise early signs of extravasation for the agents actually used here?
Specific to the actual agents administered, not generic infusion complication awareness.
Doc: Extravasation recognition training record
YES PARTIAL NO
2 Is there a defined, immediate management protocol for suspected extravasation?
A specific, known protocol, not improvisation in the moment.
Doc: Extravasation management protocol
YES PARTIAL NO
3 Are appropriate antidotes for the specific vesicant agents used genuinely available on-site?
Immediately available and in date, matched to the actual agents in use.
Doc: On-site antidote stock record
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
DOCUMENT
Recognition training review
Reviews training records for extravasation recognition specific to agents actually used.
DOCUMENT
Management protocol review
Reviews the defined immediate management protocol for completeness.
OBSERVE
Antidote stock check
Physically confirms appropriate antidotes are on-site, matched to agents used, and in date.

REFERENCES

  1. [59] Extravasation recognition and immediate management protocols, including agent-specific antidote availability, are established as a distinct and essential component of safe chemotherapy administration, separate from general infusion site monitoring.
  Standard 11.3 · Standard 11: Oncology & Infusion Therapy
Guidance & Learning
GUIDANCE
ASF-AMB-STD11-v3.0
WHY THIS STANDARD EXISTS

Extravasation of a vesicant chemotherapy agent can cause severe, sometimes permanent tissue damage, and the difference between a manageable event and lasting harm often comes down to how quickly it's recognised and correctly managed, not the event itself.

The evidence: [59] Extravasation recognition and immediate management protocols, including agent-specific antidote availability, are established as a distinct and essential component of safe chemotherapy administration, separate from general infusion site monitoring.
WHAT GOOD LOOKS LIKE
✓ Staff are specifically trained on extravasation recognition for the actual agents used.
✓ A defined, immediate management protocol exists.
✓ Appropriate antidotes are genuinely on-site and in date.
WHAT FAILURE LOOKS LIKE
✗ Training is generic, not specific to the agents actually administered.
✗ No defined protocol exists beyond general awareness that extravasation can occur.
✗ Antidotes aren't on-site or are expired.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 Recognition training happened at hiring but hasn't been refreshed as new agents were introduced.

Training needs to stay current with the actual agents in use, not reflect an earlier point in time.

2 A protocol exists but doesn't specify agent-specific management steps.

Different vesicant agents may require different specific management approaches.

3 Antidote stock exists but expiry dates weren't recently verified.

Expired antidotes provide no real protection when actually needed.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Review current extravasation training against the specific agents administered.

Week 2 Update or establish an agent-specific management protocol.

Week 3 Confirm on-site antidote stock and expiry dates for all vesicant agents used.

Ongoing Refresh training whenever new agents are introduced.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask about a specific agent used here, not extravasation in general.

Specificity reveals whether training genuinely reflects current practice.

Physically check antidote stock and expiry dates.

Physical verification is the only real evidence of genuine on-site availability.

E-LEARNING academy.gmj.ge/amb-std11-3-extravasation — 30 min · complete before self-assessment
  Standard 11.4 NON-NEGOTIABLE · Standard 11: Oncology & Infusion Therapy
Infusion Reaction and Anaphylaxis Response Is Rehearsed, Not Theoretical
ASSESSMENT
ASF-AMB-STD11-v3.0
CR N/A TR FULL SM FULL ST FULL
11.4
NON-NEGOTIABLE
L1
THE STANDARD
Infusion Reaction and Anaphylaxis Response Is Rehearsed, Not Theoretical
Staff are trained and drilled — not only briefed — on recognising and responding to infusion reactions and anaphylaxis, with emergency medications and equipment genuinely available at the point of infusion, verified through a real, practiced response, not a written plan alone.
CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question.
1 Have staff actually rehearsed an infusion reaction and anaphylaxis response, not only reviewed a written protocol?
A genuine drill, not a policy document read once.
Doc: Drill record, date and participants
YES PARTIAL NO
2 Are emergency medications and equipment genuinely available at the point of infusion, not in a separate location requiring retrieval?
Immediately at hand, not requiring travel to another room during an emergency.
Doc: Emergency equipment location and stock record
YES PARTIAL NO
3 Do all staff present during infusions know their specific role in a reaction response, not just that a protocol exists?
Specific, assigned roles, not general awareness.
Doc: N/A — tested directly
YES PARTIAL NO

ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.

WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks
DOCUMENT
Drill record review
Reviews records of actual rehearsed drills, not only protocol review sessions.
OBSERVE
Emergency equipment location check
Confirms emergency medications and equipment are genuinely at the point of infusion.
ASK
Role assignment interview
Asks staff present during infusions to describe their specific role in a reaction response.

REFERENCES

  1. [60] Infusion reaction and anaphylaxis response protocols, including rehearsed drills rather than written policy alone, are identified as essential to safe ambulatory infusion practice given the narrow time window in which effective intervention determines patient outcome.
  Standard 11.4 · Standard 11: Oncology & Infusion Therapy
Guidance & Learning
GUIDANCE
ASF-AMB-STD11-v3.0
WHY THIS STANDARD EXISTS

An infusion reaction can escalate to anaphylaxis within minutes, and a written protocol nobody has actually practiced is a poor substitute for a team that has rehearsed the actual sequence of what to do, in the actual space where infusions happen.

The evidence: [60] Infusion reaction and anaphylaxis response protocols, including rehearsed drills rather than written policy alone, are identified as essential to safe ambulatory infusion practice given the narrow time window in which effective intervention determines patient outcome.
WHAT GOOD LOOKS LIKE
✓ Staff have genuinely rehearsed the response, with dated drill records.
✓ Emergency medications and equipment are immediately available at the point of infusion.
✓ Staff can describe their specific, assigned role in a response.
WHAT FAILURE LOOKS LIKE
✗ Only written protocol review has occurred, with no actual drill.
✗ Emergency equipment requires retrieval from another location.
✗ Staff are aware a protocol exists but can't describe their specific role.
MOST COMMON REASONS CLINICS SCORE PARTIAL

1 A drill was conducted once but hasn't been repeated since.

Rehearsed response capability fades over time without periodic repetition, particularly given staff turnover.

2 Emergency equipment is nearby but not genuinely at every point where infusions actually happen.

A reaction can occur at any infusion chair, and equipment needs to be immediately reachable from all of them.

3 Clinical staff know their role clearly but support staff present during infusions are less certain.

A reaction response often benefits from every present staff member knowing their part, not clinical staff alone.

HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO

Week 1 Assess current response readiness against genuine rehearsed practice, not policy review alone.

Week 2 Conduct an actual reaction response drill with all relevant staff.

Week 3 Verify emergency equipment is genuinely accessible from every infusion point.

Ongoing Repeat drills periodically, particularly after staff changes.

FOR SURVEYORS — WHAT IS NOT OBVIOUS

Ask for the date of the last actual drill, not the date the protocol was written.

A specific, recent drill date is the real evidence of rehearsed readiness.

Ask a support staff member, not just a nurse, about their role in a response.

This reveals whether readiness genuinely extends to everyone present, not only clinical staff.

E-LEARNING academy.gmj.ge/amb-std11-4-infusion-reaction — 30 min · complete before self-assessment

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