Standard 46: Fertility Clinic (Version 11)

Why it matters. Fertility treatment is costly, emotional and often uncertain. A patient who is given a success rate that is inflated, or only half the options, makes a decision they cannot undo. Clear written and verbal information protects them.

Sample. Review the information record and the price list for 30 patients who started treatment in the last 6 months, chosen at random.

1. Each patient receives written and verbal information before treatment.

Method. Check each sampled record for the written and the verbal information, with dates.

Evidence to show. Treatment information and options record ( FRT-FRM-001 ).

Pass when. At least 95% of records show both, given before the first treatment step.

2. Success rates are stated with their basis.

Method. Check the information given for each success rate and its stated basis.

Evidence to show. Treatment information and options record.

Pass when. Every success rate given has its basis stated.

3. Risks, costs and alternatives are covered.

Method. Check each record for the risks (including multiple pregnancy and ovarian hyperstimulation), the costs and the alternatives.

Evidence to show. Treatment information and options record.

Pass when. Every record covers all three.

Immediate fail (any one means the criterion is not met)

• Treatment starts with no written information given to the patient. A success rate is published with no basis stated.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. Consent for fertility treatment is not one signature. Each stage, including the storage and use of gametes and embryos, needs its own informed decision, because each raises different questions.

Sample. Review the consent records for 20 patients in treatment, covering each stage they have reached.

1. Consent is obtained for each stage separately.

Method. Check each stage reached by a sampled patient for its own consent record.

Evidence to show. Stage-specific consent record ( FRT-FRM-002 ).

Pass when. Every stage reached has its own signed consent.

2. Consent covers handling, storage, future use and disposal of gametes and embryos.

Method. Check each consent record for these four items.

Evidence to show. Stage-specific consent record.

Pass when. Every record covers all four items.

3. A change or withdrawal of consent is recorded and acted on.

Method. Check the records for any change or withdrawal and the action taken.

Evidence to show. Stage-specific consent record.

Pass when. Every change or withdrawal is recorded and acted on at once.

Immediate fail (any one means the criterion is not met)

• A stage starts with no consent for that stage. Material is used after the patient has withdrawn consent.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. A gamete or embryo in the wrong place, or matched to the wrong patient, cannot be undone. Identification and traceability from collection to use or disposal is what prevents it.

Sample. Trace 20 gametes and 20 embryos at random from collection to their current location or use, using the traceability register.

1. Every gamete and embryo has a unique identifier.

Method. Check each sampled item in the register for a unique identifier.

Evidence to show. Gamete and embryo traceability register ( FRT-REG-001 ).

Pass when. Every sampled item has a unique identifier.

2. Two identifiers are checked at each handling step, with a witness.

Method. Check each recorded step in the sample for two identifiers and a witness.

Evidence to show. Traceability register.

Pass when. At least 95% of steps record both.

3. Each movement can be traced without a gap.

Method. Trace each sampled item from collection to its current location.

Evidence to show. Traceability register.

Pass when. Every sampled item traces without a gap.

Immediate fail (any one means the criterion is not met)

• A gamete or embryo is used or moved with no identifier check. A gamete or embryo cannot be traced to its patient.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. A storage failure can destroy years of work. Monitored storage with alarms, a defined response and a back-up is the only protection against a silent failure.

Sample. Review the storage monitoring log and the alarm record for the last 6 months, and the back-up test log for the same period.

1. Storage is monitored at all times with alarms.

Method. Check the monitoring log for continuous readings and alarm settings for each storage unit.

Evidence to show. Storage monitoring and alarm log ( FRT-REG-002 ).

Pass when. Monitoring is continuous with alarms set for every unit.

2. Every alarm is answered within the set time, and the response is recorded.

Method. Check each alarm for its response and the time taken.

Evidence to show. Storage monitoring and alarm log.

Pass when. At least 95% of alarms are answered within the set time, and every response is recorded.

3. A back-up storage system is ready and tested.

Method. Check the back-up test log against the schedule.

Evidence to show. Storage monitoring and alarm log (back-up column).

Pass when. Back-up tests are done on schedule, with no missed test.

Immediate fail (any one means the criterion is not met)

• An alarm is not answered, and the storage failure is found only later. A storage failure happens with no back-up in place.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. A donor’s infection or genetic condition can pass to a patient or a child. Screening before use, with results recorded, is required for safe donation.

Sample. Review the donor screening record for every donation used in the last 12 months, and the record of any positive result.

1. Each donor is screened before any donation is used.

Method. Check the screening record for each donation used, and the date of use.

Evidence to show. Donor screening record ( FRT-FRM-003 ).

Pass when. Every donation used has screening recorded before the date of use.

2. Positive or incomplete results are not used.

Method. Check each positive or incomplete result for whether the donation was used.

Evidence to show. Donor screening record.

Pass when. No donation with a positive or incomplete result was used.

3. Results are valid until a set date, and rescreening follows the guidance.

Method. Check the validity date and whether rescreening was done when it passed.

Evidence to show. Donor screening record.

Pass when. Every donor is screened within the valid period.

Immediate fail (any one means the criterion is not met)

• A donation is used before the donor screening results are recorded. A donation from a donor with a positive result is used.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. An embryologist or clinician without the right credential can make a mistake that is impossible to reverse. Their qualification must be verified and current for the role.

Sample. Review the credential records for all embryologists, clinicians and counsellors in post, and the register of new staff from the last 12 months.

1. Each person holds the required credential for their role.

Method. Check each credential against the role and its registration body.

Evidence to show. Staff credential record ( STF-FRM-001 ).

Pass when. Every person in post has the required credential recorded and current.

2. Credentials are checked before work begins.

Method. Check the date each new member of staff started against the credential check date.

Evidence to show. Staff credential record and induction record.

Pass when. Every new member of staff has a credential check before their first treatment duty.

3. Training and competence are kept up to date.

Method. Check the competence record for each embryologist and clinician.

Evidence to show. Staff competence and training record ( STF-SOP-001 ).

Pass when. Every person has competence assessed in the last 12 months.

Immediate fail (any one means the criterion is not met)

• An embryologist or clinician without the required credential handles a gamete or embryo.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. Complications such as ovarian hyperstimulation are rare but serious. Recording and reviewing them, with success rates, shows whether the clinic is safe and honest.

Sample. Review the adverse event register and the yearly success rate report for the last 12 months, and every adverse event recorded in the period.

1. Each adverse event is recorded, including ovarian hyperstimulation.

Method. Check the treatment records and the register for any event, and compare them.

Evidence to show. Adverse event and success rate register ( FRT-REG-003 ).

Pass when. No event in the treatment records is missing from the register.

2. Each event is reviewed by a clinician within the set time.

Method. Check each event for its review date and the action taken.

Evidence to show. Adverse event and success rate register.

Pass when. At least 90% of events are reviewed within the set time, and every review has an action.

3. Success rates are reported yearly with the number of cycles and the basis for the calculation.

Method. Check the yearly report for the cycle count and the basis.

Evidence to show. Yearly success rate report.

Pass when. Every yearly report states the cycle count and the basis.

Immediate fail (any one means the criterion is not met)

• An adverse event is not recorded or reviewed. A success rate is published without its basis.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. Fertility treatment brings emotional strain. Offering psychological support during and after treatment, and recording the offer, makes support available when it is needed.

Sample. Review the psychological support records for 20 patients in treatment, and the record of any patient who had a loss in the last 12 months.

1. Psychological support is offered at the start, at each major stage and after a loss.

Method. Check each sampled record for the offer at each set point.

Evidence to show. Psychological support offer record ( FRT-FRM-004 ).

Pass when. Every set point has the offer recorded.

2. The offer and the patient’s answer are recorded.

Method. Check each offer for the answer and the date.

Evidence to show. Psychological support offer record.

Pass when. Every offer has the answer recorded.

3. An accepted referral is seen within a week.

Method. Check the referral date and the first session date for each accepted referral.

Evidence to show. Psychological support offer record.

Pass when. At least 90% of accepted referrals are seen within a week.

Immediate fail (any one means the criterion is not met)

• A distressed patient is not offered support. A patient is not offered support after a loss.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. A gamete or embryo mix-up is a serious harm to patients and families. A written plan for containment, disclosure and review, rehearsed, is what the clinic must have before it happens.

Sample. Review the mix-up plan, the record of every suspected or confirmed mix-up in the last 3 years, and the disclosure record for each.

1. A written plan describes how a suspected mix-up is contained, traced and disclosed.

Method. Read the plan and check it covers containment, tracing and disclosure.

Evidence to show. Gamete and embryo mix-up response ( FRT-SOP-006 ).

Pass when. The plan covers all three, and its review date is current.

2. A suspected mix-up is reported to the senior embryologist at once.

Method. Check the time each suspected mix-up was reported.

Evidence to show. Mix-up record and incident report ( INC-FRM-001 ).

Pass when. Every suspected mix-up was reported at once.

3. The affected patients are told openly, with support.

Method. Check the disclosure record for each affected patient.

Evidence to show. Mix-up disclosure record.

Pass when. Every affected patient was told within the set time, with support offered.

Immediate fail (any one means the criterion is not met)

• A suspected mix-up is not reported at once. An affected patient is not told.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. Patients who learn the cost after treatment begins are harmed in ways that are hard to undo. Prices given before treatment protect the patient and the facility.

Sample. Review the price list, the written cost statement given to each of 20 patients who started treatment in the last 6 months, and the price list dates.

1. The price of each treatment step is published before treatment begins.

Method. Check the price list for each step, and the date it was published.

Evidence to show. Price list and cost statement ( HOS-POL-003 ).

Pass when. Every step has a published price.

2. Each patient is given a written cost statement before treatment begins.

Method. Check each sampled record for the written statement and its date.

Evidence to show. Written cost statement ( HOS-FRM-012 ).

Pass when. At least 95% of patients have a written statement given before treatment.

3. Costs are not changed after treatment has started, unless the patient agrees in writing.

Method. Check each change to a cost for the agreement.

Evidence to show. Cost change record.

Pass when. Every change after treatment starts has written agreement.

Immediate fail (any one means the criterion is not met)

• Treatment begins with no written cost statement given to the patient. A cost is changed after treatment starts with no written agreement.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course

Why it matters. An organ or tissue must be traceable from donor to recipient, through every step of handling, testing and transport. Without a chain of custody, an unsafe donation cannot be found or stopped.

Sample. Review the chain of custody records for every tissue or organ used in the last 12 months, and the record of any gap found.

1. Each tissue or organ has a documented chain from donor to recipient.

Method. Check each sampled chain for the start at donation and the close at the recipient.

Evidence to show. Chain of custody record ( FRT-FRM-005 ).

Pass when. Every sampled chain runs from donor to recipient.

2. Each step is signed with the time and condition.

Method. Check each step in the sample for signature, time and condition.

Evidence to show. Chain of custody record.

Pass when. At least 95% of steps are signed with time and condition.

3. A gap in the chain stops use until resolved.

Method. Check the records for any gap and whether use stopped.

Evidence to show. Chain of custody record and gap log.

Pass when. Every gap stopped use until it was resolved.

Immediate fail (any one means the criterion is not met)

• A tissue or organ is used or moved with a gap in its chain of custody.

Staff, training and documents

Read across each row to see who does each step. Click a document name for its full text.

Staff responsible

Which level applies to you: it depends on your setting. Humanitarian settings have the fewest essential courses; standard settings have the most. Check the colour for your setting in each criterion.

Documents: who does each step

E-learning: who must take each course