Standard 15 · applies to optical and hearing services
Optical and Hearing
Seven criteria for optical and hearing services: clinically sound tests, qualified staff for each task, products fitted and checked, device hygiene teaching, aftercare and follow-up, complaints about products, and same-day referral of urgent eye and ear conditions. Most documents are new (OPT-); equipment, credential, complaints and referral documents are existing and reused.
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 15, by setting
Each row adds up to the total number of criteria on this page.
Non-negotiable
Sight and hearing tests use validated methods and equipment. The test equipment is maintained as set out in 2B.4. Results are recorded, and any finding that needs medical review is referred.
Why this criterion matters. A sight or hearing test that uses an unvalidated method or poor equipment gives the wrong answer, and the patient is fitted with the wrong product. The test is the start of every correct fitting.
Sample. Review 30 sight and hearing test records in the last 6 months, and the calibration records for the equipment used.
How the surveyor verifies this
1. Each test uses a validated method, named on the record.
Method. Check each record for the named method.
Evidence to show. Sight and hearing test record (OPT-FRM-001).
Pass when. Every test names a validated method.
2. Test equipment is in calibration on the day of the test.
Method. Check the calibration date of the equipment used for each sampled test.
Evidence to show. Equipment inventory and service log (EQP-REG-001).
Pass when. Every test used equipment in calibration.
3. Each finding that needs referral is referred.
Method. Check each record with a referral finding for the referral made.
Evidence to show. Sight and hearing test record.
Pass when. Every finding that needs referral has a referral recorded.
Immediate fail (any one means the criterion is not met)
- A test is given with an unvalidated method or with equipment past calibration.
Documents
Means of verification. The surveyor checks these. Submit them.
- OPT-POL-001 · Clinical standards for sight and hearing tests
Why it is here. Clinical standards for sight and hearing tests.
Submit the approved policy with version and date, and evidence it is in use. - OPT-FRM-001 · Sight and hearing test record
Why it is here. The sight and hearing test record.
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- EQP-SOP-001 · Medical Equipment Maintenance and Removal from Use
Why it is here. Equipment maintenance (existing, reused).
E-learning
- Emergency Medical Equipment & AED Readiness (MED-02)
- Planned course: Sight and hearing testing with validated methods. New course planned.
References
- World Health Organization. World report on vision. Geneva: WHO; 2019.
Non-negotiable
Sight testing, dispensing and hearing aid fitting are carried out only by staff with the qualification required for that task. Each person's qualification for their task is verified and current as set out in the credential verification rule, and their ongoing competency is evaluated as set out in 2E.1.
Why this criterion matters. Sight testing, dispensing and hearing aid fitting each need their own qualification. A person without the right one can give a patient the wrong product with the wrong advice.
Sample. Review the qualification register for all staff who test sight, dispense or fit hearing aids, and the records of work done by each in the last 12 months.
How the surveyor verifies this
1. Each person is qualified for each task they carry out.
Method. Check each task in the records against the person's qualification for that task.
Evidence to show. Qualification register (OPT-REG-002).
Pass when. Every task is carried out by a person qualified for it.
2. Each qualification is verified and current.
Method. Check each entry for verification date and expiry.
Evidence to show. Qualification register.
Pass when. Every qualification is verified and current.
3. Staff without a qualification for a task are supervised.
Method. Check the supervision entry for any person without a qualification for a task.
Evidence to show. Qualification register.
Pass when. Every such task is supervised and recorded.
Immediate fail (any one means the criterion is not met)
- A person without the qualification tests sight or fits a hearing aid alone.
Documents
Means of verification. The surveyor checks these. Submit them.
- OPT-REG-002 · Qualification register for sight testing, dispensing and hearing aid fitting
Why it is here. The qualification register.
Submit the register extract for the sample period. - STF-FRM-001 · Staff Verification Register
Why it is here. The staff credential record (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
- Credentialing, Competence and the Training Matrix (T-14)
- Personnel competence, training and health (L-02)
References
- World Health Organization. World report on vision. Geneva: WHO; 2019.
Non-negotiable
Spectacles, contact lenses and hearing aids are fitted to the individual's measured need. The fit is checked with the patient before they leave.
Why this criterion matters. A spectacle, contact lens or hearing aid that does not fit correctly causes headache, damage or loss of benefit. Fitting and checking each product is what makes it safe to wear.
Sample. Review 30 fittings in the last 6 months, including spectacles, contact lenses and hearing aids.
How the surveyor verifies this
1. Each product is fitted to the measured need.
Method. Check each fitting record for the measurement and the product.
Evidence to show. Fitting and fit check record (OPT-FRM-002).
Pass when. Every fitting has a measured need recorded.
2. The fit is checked with the patient before they leave.
Method. Check each fitting for the fit check and its time.
Evidence to show. Fitting and fit check record.
Pass when. At least 95% of fittings have the fit checked before the patient leaves.
3. A product that does not fit is adjusted or not given.
Method. Check each recorded misfit for the adjustment or the decision.
Evidence to show. Fitting and fit check record.
Pass when. Every misfit is adjusted or not given.
Immediate fail (any one means the criterion is not met)
- A product is given before its fit has been checked with the patient.
Documents
Means of verification. The surveyor checks these. Submit them.
- OPT-POL-002 · Fitting and checking products
Why it is here. Fitting and checking products.
Submit the approved policy with version and date, and evidence it is in use. - OPT-FRM-002 · Fitting and fit check record
Why it is here. The fitting and fit check record.
Submit the completed form for the sample period.
E-learning
References
- World Health Organization. World report on hearing. Geneva: WHO; 2021.
Standard
Patients who wear contact lenses or hearing aids are taught hygiene and care for their device, and the teaching is recorded. The teaching is checked with the patient as set out in the patient understanding rule.
Why this criterion matters. Contact lenses and hearing aids can cause infection if they are not cleaned and cared for correctly. Patients taught the right care keep themselves safe between visits.
Sample. Review the hygiene teaching records for 20 contact lens and hearing aid users in the last 6 months.
How the surveyor verifies this
1. Each user is taught hygiene and care for the device.
Method. Check each user record for the teaching.
Evidence to show. Device hygiene teaching record (OPT-FRM-003).
Pass when. At least 95% of users have the teaching recorded.
2. The teaching is checked with the patient.
Method. Check each record for the patient showing or saying back the steps.
Evidence to show. Device hygiene teaching record.
Pass when. At least 90% of records show the check.
3. The teaching is repeated at each review.
Method. Check the review records for a repeat of the teaching.
Evidence to show. Device hygiene teaching record.
Pass when. At least 90% of reviews include the repeat teaching.
Immediate fail (any one means the criterion is not met)
Documents
Means of verification. The surveyor checks these. Submit them.
- OPT-FRM-003 · Device hygiene teaching record
Why it is here. The device hygiene teaching record.
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- OPT-SOP-001 · Hygiene teaching for contact lens and hearing aid users
Why it is here. Hygiene teaching for users.
E-learning
References
- World Health Organization. World report on hearing. Geneva: WHO; 2021.
Non-negotiable
Each patient has a defined follow-up for adjustment, review and problems, and a named contact.
Why this criterion matters. A product that is fitted once is not finished. Adjustment, review and follow-up after the fitting are where most problems are found and fixed.
Sample. Review the aftercare records for 20 product fittings in the last 6 months, and each problem reported.
How the surveyor verifies this
1. Each patient has a follow-up booked for adjustment and review.
Method. Check each fitting for the follow-up booked.
Evidence to show. Aftercare and follow-up record (OPT-FRM-004).
Pass when. At least 95% of fittings have a follow-up booked.
2. Each patient has a named contact for problems.
Method. Check each record for the named contact given.
Evidence to show. Aftercare and follow-up record.
Pass when. Every patient has a named contact recorded.
3. A reported problem is seen within the set time.
Method. Check each reported problem for the time of response.
Evidence to show. Aftercare and follow-up record.
Pass when. At least 90% of problems are seen within the set time.
Immediate fail (any one means the criterion is not met)
- A patient is given a product with no follow-up booked and no named contact.
Documents
Means of verification. The surveyor checks these. Submit them.
- OPT-FRM-004 · Aftercare and follow-up record
Why it is here. The aftercare and follow-up record.
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- OPT-SOP-002 · Aftercare and follow-up for products
Why it is here. Aftercare and follow-up.
E-learning
References
- World Health Organization. World report on vision. Geneva: WHO; 2019.
Standard
Complaints about products and services are recorded, reviewed, and acted on, including returns and replacements. The handling of complaints is set out in the complaints and records rule, which applies to every provider; this criterion adds the product-specific steps for returns and replacements.
Why this criterion matters. A complaint about a product or a service is information about what is going wrong. Recording and acting on it, and telling the patient what was done, improves the service.
Sample. Review every complaint about a product or service in the last 12 months.
How the surveyor verifies this
1. Each complaint is recorded.
Method. Compare the complaints log with the complaints received in the period.
Evidence to show. Product complaint record (OPT-FRM-005).
Pass when. No complaint is missing from the record.
2. Each complaint is reviewed and acted on.
Method. Check each complaint for the review and the action.
Evidence to show. Product complaint record.
Pass when. Every complaint has a review and an action recorded.
3. The patient is told the outcome.
Method. Check each complaint for the outcome told and its date.
Evidence to show. Product complaint record.
Pass when. At least 95% of complaints have the outcome told.
Immediate fail (any one means the criterion is not met)
Documents
Means of verification. The surveyor checks these. Submit them.
- OPT-FRM-005 · Product complaint record
Why it is here. The product complaint record.
Submit the completed form for the sample period. - INC-POL-002 · Complaints and Feedback
Why it is here. Complaints and feedback (existing, reused).
Submit the approved policy with version and date, and evidence it is in use.
Recommended. Good practice, held on site. Not verified by the surveyor.
- OPT-SOP-003 · Product complaints, returns and replacements
Why it is here. Product complaints, returns and replacements.
E-learning
References
- World Health Organization. World report on vision. Geneva: WHO; 2019.
Non-negotiable
Staff are trained to recognise sudden loss of vision or hearing, and other signs of an urgent eye or ear condition. Each such patient is sent the same day to emergency medical care through a written route that every member of staff knows.
Why this criterion matters. Sudden loss of vision or hearing can be a sign of a serious condition that needs care the same day. Staff who recognise it, and refer at once, can prevent permanent loss.
Sample. Review the urgent referral records for the last 12 months, and the staff training record for recognising urgent eye and ear conditions.
How the surveyor verifies this
1. Staff are trained to recognise sudden loss of vision or hearing.
Method. Check the training record for each clinical member of staff.
Evidence to show. Training matrix register (WRK-REG-001).
Pass when. Every clinical member of staff has the training recorded.
2. Each urgent patient is sent the same day to emergency care.
Method. Check each urgent case for the referral on the same day.
Evidence to show. Urgent eye and ear referral record (OPT-FRM-006).
Pass when. Every urgent case is referred the same day.
3. The patient is confirmed to have reached care.
Method. Check each referral for the confirmation.
Evidence to show. Urgent eye and ear referral record.
Pass when. Every referral has the confirmation recorded.
Immediate fail (any one means the criterion is not met)
- A patient with sudden loss of vision or hearing is not referred the same day.
Documents
Means of verification. The surveyor checks these. Submit them.
- OPT-POL-003 · Urgent eye and ear referral
Why it is here. Urgent eye and ear referral.
Submit the approved policy with version and date, and evidence it is in use. - OPT-FRM-006 · Urgent eye and ear referral record
Why it is here. The urgent referral record.
Submit the completed form for the sample period.
Recommended. Good practice, held on site. Not verified by the surveyor.
- PHC-SOP-003 · Referral criteria and referral tracking
Why it is here. Referral criteria (existing, reused).
E-learning
- Medical Emergency Protocol Development (MED-01)
- Safety & Emergency Preparedness (H-05)
- Planned course: Recognising urgent eye and ear conditions. New course planned.
References
- World Health Organization. World report on vision. Geneva: WHO; 2019.