Guidance

Guidance for acceptance of cervical screening samples in laboratories and pathways, roles and responsibilities

Updated 25 August 2026

Applies to England

1. Introduction

This guidance has been updated to reflect changes relating to the implementation of primary human papillomavirus (HPV) screening, an extended screening interval for those participants aged 24.5 to 49 years, meaning all women and people with a cervix aged 24.5 to 64 years now have the same routine screening interval, and the introduction of a self-testing offer for those who are underscreened.

Laboratories providing HPV testing and cytology services must follow this guidance.

It aims to:

• improve the quality of service provided by the NHS Cervical Screening Programme (NHS CSP) by reducing the administrative and technical errors associated with cervical screening sample requests
• support the recommendations from the NHS CSP/NHS Improvement cytology improvement guidance for achieving the national 14-day turnaround time standard
• reduce the risk of potential incidents by giving the minimum requirements for processing and auditing samples that are sent to cervical screening laboratories

Recording, reporting and auditing errors is important to identify any problems in the sample taking process. It also gives an opportunity for learning and quality improvement.

Implementing this guidance will reduce:

• the risk of people receiving incorrect screening
• the time taken for all people to receive their cervical screening test results

The cervical screening programme follows a complex pathway with multiple providers. Clear roles and responsibilities are essential to make sure that high quality screening is carried out, and that appropriate action is taken where this is found not to be the case. 

2. Screening commissioner responsibilities

NHS England is responsible, via the Section 7a agreement and cervical screening service specification No. 25 to commission services across the screening pathway.

Screening commissioners should work in partnership with laboratories with regards to the sample taker register. This makes sure comprehensive feedback is provided, both by individual sample takers and by general practice or clinics, on reporting profiles, workload and error rates (for example incomplete patient identity details).

The screening commissioner is responsible for:

• agreeing with the laboratory the processes for ensuring unique personal identification numbers (PINs) for sample takers are in place
• local requirements for acceptable sample taker training (in line with national screening guidance) and what checks of training are required
• the process for oversight of sample taker performance, quality and safety
• a mechanism to report performance information to relevant parties
• the process for communication and escalation of any issues that arise so that action can be taken

These responsibilities can be discharged directly, by the screening commissioners, or by commissioning other providers. Documentation of the arrangements is required regardless of which approach or combination is determined locally.

3. Sample taking provider responsibilities

Sample taking providers are usually general practices. They can also be community clinics, sexual health services and hospitals.

The sample taking providers or employer organisations are responsible for making sure that:

• all sample takers are adequately trained as described in national sample taker training guidance
• protocols and procedures consistent with national screening guidance are in place for the:
  • completion of the screening test and its associated documentation
  • safe transport of screening specimens to the cytology laboratory

We recommend the call and recall IT system for all administration regarding the NHS CSP. This references data from the national call and recall system, so holds the master screening history records. This gives the laboratory immediate access to relevant data when reporting a test so that an appropriate next action can be specified. This in turn minimises the likelihood of rejection of invalid test results by the call and recall system and reduces delays in issuing results to people.

4. Sample taker responsibilities

The sample taker is responsible for making sure they:

• receive appropriate initial training to take cervical screening samples
• understand how the screening programme operates and their responsibilities within it
• keep themselves updated on programme developments and policy to avoid taking inappropriate tests (we recommend this is best carried out through 3-yearly updates)
• audit their practice routinely and proactively seek advice should they identify any issues

4.1 Demonstration of competence

On demonstration of competence, sample takers are issued with a PIN for carrying out unsupervised screening tests. This PIN is unique and must not be used by anyone else. It will reflect the locally agreed PIN arrangements, which may use General Medical Council (GMC), Nursing and Midwifery Council (NMC) numbers or another locally agreed unique identifier.

It may be necessary to use different numbers for the same person where personnel work in more than one practice or clinic. This is to avoid skewing any practice-based data.

4.2 Sample request forms

Should electronic requesting not be in use, sample takers should use the cervical screening test request forms available via the call and recall IT system. Only this version contains the full screening history.  A blank HMR 101 form is available from the Cervical Screening Administration Service website. This should only be used when the call and recall system is unavailable as it does not contain any pre-populated screening history. Sample takers must have knowledge of the call and recall IT system to download the correct test request form and be an authorised user. They should follow the guidelines for completion of the form.

If a non-call and recall system request form is used for a legitimate reason (for example the patient is not yet registered or the call and recall system is unavailable), explain this to the laboratory on the call and recall system request form. Also provide the person’s recent or relevant screening history.

Where laboratory electronic requesting systems are in use, there must be mechanisms in place to provide the past screening history as it is on the call and recall system. This makes sure sample takers do not take unnecessary samples and laboratories are able to give correct patient management recommendations.

4.3 Taking the sample – clinician taken samples

The sample taker must establish that an individual is eligible for a test (invited from age 24.5 to 64 for routine tests) and that a test is now due (or overdue). People outside the standard screening age range can still be eligible for screening if they:

• are under surveillance or follow-up as a result of a previous abnormality
• did not respond to their last routine invitation and now wish to be tested

The sample taker should be aware of when not to take a sample, and be familiar with the guidance on assessment for young women with abnormal vaginal bleeding.

The sample taker is responsible for making sure that the sample and request submitted relate to the correct person. It is essential that the sample taker checks with the individual that:

• their details on the downloaded request form are correct
• their correspondence address is current
• the personal details relate to them and are correct (such as their full name and date of birth)

If the address is not current, advise the call and recall service of the new details as soon as possible. This will prevent downloaded results from laboratories being rejected or correspondence sent to the wrong address.

The sample taker is responsible for making sure that the person is contactable so they can be advised of any further tests or investigations needed following screening.

Take a cervical sample in accordance with programme sample taker training guidance. Check the vial to make sure that it has not passed its expiry date and that it has at least 14 days remaining. HPV testing cannot be carried out on expired vials.

It is the sample taker’s responsibility to fully visualise and sample the cervix appropriately.

Complete the test request form and vial with relevant patient information. This must comply with the guidelines outlined in section 7 below. Include previous cervical HPV, cytology and cervical histology results and treatments on the sample request form so that correct management can be determined by the laboratory.

People who are living with well controlled HIV are no longer invited annually for routine cervical screening; they are managed in accordance with national guidelines applicable to participants who are not HIV positive. People who are living with HIV that is not well controlled or have poor adherence to treatment and test hrHPV negative may be screened annually using a clinician taken cervical screening test. This will be at the request of their managing clinician for samples taken at a specialist HIV clinic and with prior agreement on a test by test basis with the laboratory, to ensure the sample is processed and not rejected. As this arrangement will take place outside the routine call and recall process, responsibility for patient selection, request for annual screen and checking recall interval issued by the laboratory rests with the requesting clinician. The number of individuals on this pathway is expected to be very low based on the evidence available.

Where a sticky label is used for the person’s details, it should not obscure the vial’s expiry date. It must also not obscure the clear area between each end of the label already on the vial; this interferes with the laboratory processor’s ability to read the level of fluid in the vial.

It is essential for the laboratory receiving the request form and vial that the 2 can be matched to each other. Provide all the appropriate information correctly to make sure that the test can be processed and reported.

Sample takers should make sure they follow correct processes so that:

• the samples they take, and their accompanying request forms, are stored appropriately in their practice or clinic
• the vials and forms are passed to the sample transport provider, making sure that this is safe, prompt and that forms and vials do not become dissociated from one another

Sample takers should make sure there is a failsafe system in place so they can assure themselves that a cervical sample result comes back for every test they take and that appropriate action is taken when necessary. Information is available in NHS CSP failsafe guidance.

4.4 Self-test samples for hrHPV

A self-testing screening offer is extended to individuals who are underscreened and meet the established criteria, initially through the NHS App. If no response is received an email/SMS invitation is sent, and again if no response is received a self-testing invitation letter will be sent as the default approach. Eligible individuals will have previously been offered routine cervical screening but did not attend. These persons remain eligible to complete screening at any time, either by performing the self-test or by attending for a clinician-collected sample.

Individuals electing to participate in self-testing may request that a test kit be delivered to their residence or a designated alternative location. Each kit is uniquely assigned to the individual and contains all necessary materials for sample collection and return, accompanied by comprehensive instructions. Typically, the sample is collected independently at home. Upon completion, the individual returns the sample to the laboratory using the pre-labelled envelope provided with the kit. At the laboratory, the sample undergoes hrHPV testing, and the results are transmitted to the NHS Cervical Screening call and recall system, in the same way as for clinician-taken samples.

Individuals invited to participate in hrHPV self-testing can find further information about the service at NHS.uk. Where an individual still needs help to do the test, they can contact the dedicated support service helpline via the contact details provided in their invitation. Sample takers may however still receive questions regarding self-testing for hrHPV and subsequently may be asked to provide assistance to individuals who need extra support with completing the self-test kit.

Results from self-tests are sent to the participant’s general practitioner for inclusion in their medical record. Individuals who test positive for hrHPV are asked to attend for a clinician-collected cervical sample in primary care, which can be taken immediately. The hrHPV test is repeated on this sample, and cytology is conducted if the participant continues to test positive for hrHPV.

If a participant receives assistance from a sample taker in primary care to complete the self-test, the sample should still be sent in the provided envelope using the mail service. This process allows the sample to be tracked as a self-test on its way to the laboratory. See section 7.13 for further details.

4.5 Incidents

Sample takers should report and discuss any rejected clinician taken samples. This should always include any sample where the laboratory has rejected the test due to insufficient or conflicting information, or where it has been taken inappropriately. Reflect on the incident, formally record it internally and report it as necessary according to local clinical governance policies. Only situations that fulfil the criteria of a ‘screening incident’ should be managed in line with national screening incident guidance.

Sample takers should take responsibility for communicating events leading to rejection of a clinician taken sample to the person concerned in an honest and sensitive manner. They should advise them when another sample should be taken. Repeat samples should not be taken within 3 months of a previous test. This allows sufficient time for the cervical epithelium to regenerate, otherwise a false result may be obtained.

Self-test samples that are not processed and tested due to being out of programme must still be entered into the laboratory information system and reported to the call and recall system. This ensures that participants are appropriately informed that no result will be issued for their sample.

4.6 Summary of sample takers’ responsibilities

Sample takers should make sure:

• they are adequately trained in line with NHS CSP guidance on taking cervical samples
• they have and use a unique PIN and do not share this number
• they have adequate and up-to-date knowledge about the screening test, results and management
• they are able to access the call and recall IT system, check next test due dates and download a request form (or use any local electronic requesting system)
• they have checked that the person is eligible for a test; they may be:
  • aged 24.5 to 64 and invited by call and recall
  • aged 24.5 to 64 and overdue a test
  • aged 65 or over, and under surveillance or follow-up, or never had a test (including participants who have moved to England after the age of 64)
• a screening test is appropriate (or is referral to gynaecology or sexual health/genitourinary medicine (GUM) clinic required)
• the sample vial is in date, and has at least 14 days left before its expiry (the time period left must be at least equivalent to the average waiting time for results)
• the person’s details on the request form and vial match, are correct and that all necessary information is given (see section 6 below)
• the registration of the person’s address is correct
• the person receives the appropriate follow up and management
• adverse events and incidents are recorded, discussed and investigated
• they communicate appropriately with the person if their sample is rejected
• they have adequate and up to date knowledge on HPV self-testing in order to support underscreened individuals who may ask questions or request assistance with completing the self-test kit, record results from self-tests in the participant’s medical record, and take follow up clinician samples following an hrHPV positive self-test result, or where otherwise indicated

5. Responsibilities of the self-test kit logistics provider

The self-test logistics provider is responsible for:

• ensuring the correct kit type is sent to the appropriate laboratory
• kits are compatible with the HPV testing platforms currently used in the NHS Cervical Screening Programme
• kits are printed with unique identifiers which include the expiry date, lot number and a 2D barcode that includes participant and order information, both digitally and readable
• enabling the participant to add the sampling date to the kit
• providing clear, easy to understand instructions describing how to use and return the kit securely
• ensuring the kits have a shelf life of at least 12 months from the date of despatch to the subject
• an appropriate quality management system to manage the despatch of test kits to participants and onward transportation to the laboratory.

6. Laboratory responsibilities

The laboratory is responsible for:

• checking that all cervical screening samples are in an adequate condition when received for processing
• preparing, screening and reporting samples in accordance with national guidelines
• notifying the sample taker and GP or responsible clinician and the call and recall system of test results and recommendations for management
• promptly identifying any errors in form filling and vial/self-test labelling, and notifying sample takers accordingly for clinician taken samples, or reporting rejections to the call and recall service for self-tests, to facilitate communications to the participant and repeat kit despatch as necessary
• maintaining a suitable log of sample issues (as outlined in this document) for both clinician taken and self-tests to monitor and report trends
• promptly highlighting any sample request errors that could indicate that a screening incident has occurred, in accordance with national screening incident guidance

7. Specimen requirements

Cervical screening samples must satisfy minimum requirements and any errors that compromise the safety of the patient will result in the sample being rejected. All required fields of the test request form must be completed correctly.

7.1 Essential clinician taken specimen data requirements

Required data are:

• the patient’s full name (at least first name and surname)
• the patient’s date of birth
• their NHS number
• the patient’s address
• the name and address of their GP
• the name and address of sample taker (sender)
• the sample taker personal ID number (PIN)

Should electronic requesting not be in use, use of the call and recall prepopulated cervical screening test request forms will provide the necessary patient identifiers and general practice details, including the practice code and person’s area of residence (Q code).

If you use a non-call and recall system request form for a legitimate reason (for example, the person is not registered or the call and recall system is unavailable) then explain this to the laboratory on the form. The sample taker must then complete the fields listed below on the form.

7.2 Prepopulated call and recall system test requests and manually completed forms

Essential data are the:

• patient’s NHS number
• patient date of birth
• patient’s name (at least first name and surname), address and postcode
• name and address of their GP or practice
• GP’s national and local codes
• dates of last 15 tests
• results of last 15 tests (codes) and action
• the sample taker name and PIN
• clinical data including any previous cervical biopsy results and treatments
• any other appropriate clinical details
• the test date
• the reason for the current test

7.3 Patient identifiers and clinical details

Upon receipt, the laboratory checks both the form and sample for patient and clinical details. The laboratory must be confident that the form and vial can be linked together, and that they can be linked with any existing record for that individual.

There should be a minimum of 3 legible and correct patient identifiers to link a form and vial that arrive together and the patient to any existing record on the pathology system. Ideally, use the NHS number.

7.4 Minimum identifying requirement for clinician taken cervical samples

These are:

• the patient’s full name (at least first name and surname)
• the patient’s date of birth
• a further identifier (ideally the NHS number; the patient address is also acceptable)

Major labelling discrepancy

The absence of, or significant mismatch of, one or more of the essential specimen data (see section 7.2 above) – for example the first 3 items in the essential data list – constitutes a major discrepancy. In these circumstances, the laboratory cannot be certain of the patient’s identity.

Record the sample details on an electronic searchable database. Reject the sample and do not process it, as the patient’s identity cannot be confirmed with full certainty. Laboratories should keep an electronic record of all defective or rejected samples so they can undertake checks and audits to inform other interested parties of the scale of these problems (see section 8 below). Where the patient identity differs between the form and the vial, attribute the sample to the individual on the form for error recording purposes.

The laboratory must inform the sender immediately by letter advising them of the reasons for rejecting the sample, and advising them that a repeat test should be carried out in no less than 3 months’ time. If possible, the laboratory should keep records so it is possible to identify if the repeat test is taken in less than 3 months and should therefore be rejected.

If the sample taker cannot confirm with confidence which person was tested (a potential incident), the laboratory should notify the Screening Quality Assurance (QA) Service and seek advice in line with national guidance.

Minor labelling discrepancy

A minor discrepancy may be a:

• minimal spelling difference
• specimen or form labelled with the person’s maiden or previous name while the corresponding form/specimen is labelled with her current surname
• single digit error in date of birth with all other identifiers matching

In these circumstances, the laboratory is confident of the patient’s identity despite the discrepancy.

The laboratory will book in and report such samples. Check details via the call and recall system. Record the discrepancy and remedial action taken in the laboratory error log, and inform the sender of the discrepancy. Explain any discrepancy in the report using standard codes (see the example error codes provided). Laboratories can also use these to generate error reports.

Multiple minor discrepancies constitute a major discrepancy and are dealt with accordingly.

7.5 Essential self-test specimen data requirements

Self-tests for hrHPV come pre-labelled with unique barcodes for sample identification, except for the sample date, which participants fill in. A label with this information, prepared by the logistics provider, is included with the self-test kit.

Essential data are:

• order number
• NHS no.
• First name
• Surname
• DOB
• Address
• Postcode
• GP practice ODS code (optional)
• Sender code (for Self-testing in underscreened pathway)
• Sampling date
• Order date
• Sampling device expiry date (provided by the logistics provider if not provided on the device)

Patient identifier requirements, minimum identifiers for self-test kits, and labelling discrepancies should align with those outlined for clinician-taken samples in sections 7.3 and 7.4.

7.6 Out-of-programme samples

The laboratory should reject all out-of-programme clinician taken samples.

The extension to the routine call and recall interval for individuals aged 24.5 to 49 years has not been retrospectively applied; therefore people will be invited according to their existing NTDD.

Samples from people under 25 years of age who have not been invited by the programme are classed as out-of-programme if they were taken more than 6 months before the person’s 25th birthday.

Accept tests from people under 25 who are being followed up in colposcopy after an incidental biopsy showing cervical intraepithelial neoplasia (CIN) or cervical glandular intraepithelial neoplasia (CGIN) but have had no prior cytology. Results from these tests are not recorded on the call and recall system and the programme next test due date is not amended.

Class samples from people 65 years of age and over as out-of-programme unless the person:

• has not had an adequate test since their 60th birthday (which should be indicated by the sample taker on the request form)
• has never had a test, which includes individuals who have moved to England after the age of 64
• is eligible for recall owing to previous screening test results (including where a clinician sample is indicated following a HPV self-test) or following treatment
• has been offered and returned a self-test sample due to being underscreened

Laboratories should check the next test due date on the call and recall system of a person aged over 65 before rejecting a sample.

The sample taker should provide relevant information on the clinician sample request form to help minimise delays caused by the need to check a person’s screening history.

Clinician taken samples taken more than 3 months before an individual’s next test due date should be considered out of programme if they are:

• a routine recall
• an early repeat test in 12 months following an HPV positive/cytology negative test
• a follow up test after colposcopy or treatment

The laboratory should reject clinician taken samples from people who have had an unavailable clinician sample HPV test repeated in less than 3 months. The laboratory should notify the sample taker. Self-tests can be accepted and tested immediately following a previous self-test reported as HPV unavailable.

Reject clinician taken samples taken within 3 months of any previous clinician taken test as they cannot be reliably interpreted cytologically. The laboratory should notify the sample taker.

Reject clinician taken samples that have been taken less than 3 months after pregnancy (vaginal delivery)  including a termination or miscarriage, unsuccessful IVF and following an IUD fitting. Individuals completing an HPV self-test are advised to avoid taking a sample in these circumstances, however the laboratory will not be able to confirm if this advice has been followed. It is the sample takers responsibility to ensure that a clinician taken sample required following a self-test in these circumstances is not taken too soon. There is no need to wait 3 months following a transvaginal scan before taking a sample.

If a participant requests a self-test kit but then attends for a clinician-collected sample, they become ineligible for the self-test. Any self-test returned after a clinician sample should not be tested and reported to the call and recall IT system so that a communication can be sent to the individual advising a result will not be issued.

Individuals who are offered a self-test may request a kit but may not complete and return the sample immediately. Should the self-test kit be returned at a later date, coinciding with the timing of their subsequent routine screening offer, the sample may be accepted provided it meets all other criteria outlined in this guidance and the kit has not expired.

Where vault cytology is required (see national guidance on colposcopy and programme management) the laboratory should accept the sample and report it back to the sample taker. These test results should not be sent to the cervical screening management system as they are classed as out of programme.

There are no circumstances where routine annual screening is indicated as part of the current NHS CSP (see national guidance on colposcopy and programme management).

Screening for people with HIV starts at 24.5 years in line with all other people. Reject tests taken outside the normal screening age range.

We advise all people on immunosuppressants to have a complete screening history, including those over 65. People who have not attended for screening should be offered another cervical screening test and remain eligible for screening.

The laboratory should reject samples from other unscheduled cervical screening tests if they have not been taken according to the recommended screening interval.

Screening for military personnel is part of the NHS CSP. Screening for people in the military starts at 24.5 years in line with all other people. Reject tests taken outside the normal screening age range or at incorrect intervals.

7.7 Cervix not visualised or no 5 x 360 degree sweep

The laboratory will accept these clinician taken samples and HPV test them.

If the sample is high-risk HPV (hrHPV) negative it must be reported as HPV-U. This is because there is no guarantee that a suitable sample has been obtained.

If the sample is If hrHPV positive, a cytology slide is prepared and examined. This must be reported as cytology inadequate unless abnormal cells are identified. The text of the report should explain to the sample taker why the sample has been reported in this way.

7.8 Sample integrity

Tests for hrHPV are extremely sensitive and could be vulnerable to contamination.

Laboratories should accept cervical screening samples with contamination of the exterior of the vial/self-test kit tube for processing for HPV testing (and cytology when appropriate).

Contamination may also arise during manual test processes, for example uncapping and pipetting. Local laboratory policies will routinely exist for management of these occurrences.

Undertake and document standard methods for decontamination of such vials, together with regular cleaning and decontamination of HPV test platforms (according to the manufacturer’s specification). There is no significant risk to other samples from a contaminated vial/self-test kit tube if decontamination is correctly carried out,

Routine virology practice requires full awareness of contamination risks, and all HPV test platforms have standard decontamination regimes.

Laboratories should have standard policies and procedures for all processes (specific to the liquid-based cytology (LBC) and HPV platforms in use). As a minimum these should include guidance on:

• identification of a potentially contaminated vial/self-test kit tube
• criteria for reporting for cytology in a low volume vial
• criteria for reporting for HPV in a low volume vial
• planned regular cleaning and decontamination of the HPV testing equipment in accordance with manufacturer’s instructions
• decontamination of vials/self-test kit tube believed to have surface contamination before HPV testing, to avoid contamination during analysis process
• internal quality control of HPV testing including identification of batches which may have been affected by contamination

Risks of contamination: hrHPV testing

We consider there is no significant risk of leakage occurring into a sample vial/self-test kit tube, even if (for example) there is a small defect in the lid. A sample with such a defect can be processed with no significant risk that it will test falsely positive.

Samples which have leaked and therefore potentially have HPV positive material on the outside of the vial could cause contamination of HPV testing equipment, and this could result in other samples testing falsely positive.

If a false positive HPV test falls into the category of ‘mild harm’, the person may be required to have an additional annual screen. Or, if their cytology is mildly abnormal but their HPV test should have been negative, have an unneeded colposcopy referral. Note that the rate of HPV positivity varies between platforms and a significant number of people who test positive with one system may have tested negative with another.

Contamination poses no risk of a false negative diagnosis or missed abnormality.

Risks of contamination: cytology

There is no risk of contamination involving transfer of cells. All cytology investigations are safe even in the event of significant contamination, provided there is sufficient residual volume of sample to assess adequate cellular content.

Risk of decision not to process a sample

If a sample is inappropriately rejected, the person must be offered a repeat screening test. There is good evidence that many people do not take up this invitation in a timely manner, or at all. Failure to process and report a sample therefore places a person at risk of having undetected disease or a delay in diagnosis.

Insufficient volume of sample for processing

HPV test platforms have defined minimum volumes for processing. Any sample which has insufficient volume is reported as unavailable for HPV testing (HPV-U) and appropriate management pathways should be followed in accordance with national guidance.

Liquid based cytology platforms also have minimum volumes for processing. Any sample which has insufficient volume is reported as cytology inadequate.

Condition of sample

Check the condition of the sample. Always make sure that the vial data matches that on the request form.

Check for any signs of leakage and that the volume of liquid in the vial/self-test kit (if appropriate) is adequate. For SurePath© samples, the broom head must be present in the vial. For ThinPrep© specimens, the sampling broom head should have been removed from the vial. Check that that the vial cap is screwed on hand tight.

For self-test kit samples, the swab or brush device must remain present in the tube. In cases where the self-test device has a removable head, it is important that the head is not detached into the tube, as this may complicate handling and elevate the risk of contamination. If this occurs, the sample may still be processed and tested, provided that the laboratory implements appropriate measures to mitigate contamination risk.

Samples in incorrect container, returned to incorrect laboratory, outside the recommended timescale for processing or with insufficient volume

Reject samples received in the wrong container, including self-test devices not used in the programme, or devices for tests other than hrHPV.

Where a self-test has been returned to the incorrect cervical screening laboratory, follow local protocols for managing onward transport to the appropriate laboratory. If onward transportation risks the sample becoming too old for processing and testing, the sample can be kept and tested within the receiving laboratory, if the local technology allows. In this case the test results should be forwarded to the correct laboratory for reporting to CSMS and the GP practice. If the sample date is missing use the self-test kit order/despatch date as a guide.

Self-test samples that are outside the  nationally agreed timescale for processing should be tested and hrHPV positive results reported. hrHPV negative results should be reported as hrHPV unavailable as they may not be reliable.

Follow the manufacturers guidance on what constitutes minimum acceptable volume for HPV testing or cytology - this will be HPV test platform/assay specific.

Laboratories should hrHPV test SurePath© samples with broom head missing, ThinPrep© samples with broom head present and wet self-test kits without a swab present. Report sample testing hrHPV positive as HPV positive. Report subsequent cytology (on clinician taken samples) as inadequate unless abnormal cells are found. Report samples testing hrHPV negative as HPV-unavailable, make an error log, and inform the sample taker (if a clinician taken cervical sample).

Self-test kits received with the swab external to the tube are not processed and should be reported as HPV unavailable.

Samples in expired vials/self-test devices

Reject samples received in an expired vial/self-test device. Electronically record details of such samples. Inform the sample taker if it is a clinician taken cervical sample and advise them to check for further expired stock. They should return this to the laboratory for safe disposal. For self-test devices the laboratory should report the rejected sample to the call and recall system. The laboratory should also inform the logistics supplier if they are concerned expired vials are being sent to participants, for example if the kit ordering date is later than the expiry date for the device.

Sample internal control not detected

HPV platforms with sample internal controls report an invalid result when the sample internal control (for example, β-globin) result is negative or invalid in hrHPV negative samples. A repeat test is performed starting with sample preparation. If there is still no valid result, report the sample as HPV unavailable.

Where the sample internal control is negative or invalid, an hrHPV positive result remains valid and is reported as such.

7.9 Reporting results

In all cases where the patient’s identity is not in question, but a repeat sample is required because of the quality of the sample received, book the sample onto the laboratory system and issue an HPV-U, inadequate cytology or abnormal report as appropriate. This helps to ensure:

• it is robust, failsafe
• follow-up requirements are reported in a standard manner to the sample taker and to the call and recall service
• the result is transferred electronically so that the participant gets an appropriate result letter and is recalled at the appropriate recall interval, or sent a repeat self-test device

7.10 Missing form or specimen

The procedure below is for when clinician collected cervical specimens or forms are received without the corresponding form or specimen.

1. Notify the source (general practice or clinic) of the error.
2. Advise that the specimen or form will be retained within the department for 2 working days and will arrive later if found to be separated from the corresponding form or specimen during transit.
3. If the missing items appear within the specified 2 working days, notify the sender and process the sample for reporting as usual.
4. If after 2 working days the missing component has not arrived, notify the source (general practice or clinic) and make a request to recall the person for a repeat sample to be taken in 3 months.
5. Add details of the error to the electronic laboratory error log.

Where an electronic request has been received for a screening test, but no sample arrives in the laboratory, there must be a process to alert the sender that a sample has not arrived. There is no additional requirement for laboratories to audit these samples outside of local policies.

If a self-test sample is received by the laboratory without the corresponding s labelled sample transport bag, the sample cannot be tested and reported, as the necessary patient identification information is missing. . If a labelled sample transport bag is received without the sample, the request is to be reported as HPV unavailable, and a replacement self-test kit despatched to the participant.

7.11 Sample taker details

The GP name, address and practice code must be provided for all registered people. These are automatically present if the prepopulated test request form in the call and recall system is used.

If the GP details are not provided, the laboratory should use the call and recall system to try and identify the person’s GP registration information. Book the sample in against the GP with which the person is shown to be registered, to make sure there are no delays in issuing their result. If there is any doubt about the person’s identity, follow the process for major discrepancies (see section 7.4 above).

Details of the error should be logged and reported to the sample taker. Local commissioners may also wish to be notified.

7.12 Personal Identification number (PIN) absent or invalid

The sample taker’s PIN should be present and valid as this confirms that the sample taker is appropriately trained and competent in cervical sample taking. The absence of a valid PIN on the clinician taken sample request requires investigation before it can be reported. Carry out investigation swiftly so as not to adversely affect the time the person waits for their result. If the PIN information can be confirmed, the sample can be reported.

Sample takers must not use a PIN belonging to someone else. Trainee sample takers must use a unique PIN that identifies them as a trainee.

If the sample taker PIN is invalid or cannot be provided, the sample should be hrHPV tested and reported as HPV inadequate (HPV-U) if the HPV test is negative. If the hrHPV test is positive then cytology should be examined and reported as cytology inadequate unless abnormal cells are identified.

If enquiries related to an absent or invalid PIN raise concerns that the sample taker may not be trained or does not meet the minimum requirements to be a sample taker, seek advice from the Screening QA Service in line with national screening incident guidance.

7.13 Self-tests sent via standard route for clinician taken samples

If a participant receives assistance with completing a self-test kit from a sample taker in clinic, the sample should be returned using the pre-labelled kit packaging via the mail service. In instances where the sample is inadvertently returned through the standard route designated for clinician-taken samples, the laboratory should not reject the sample on those grounds and may process it, provided that all other requirements outlined in this policy are fulfilled. The sample must still be registered using the self-testing national sender code, rather than the local sender code, to ensure proper identification and inclusion within the self-test pathway for underscreened individuals.

7.14 Summary of non-acceptable samples

Record all non-acceptable cervical samples in an error log.

Actions are specified for each bulleted list of non-acceptable cervical samples below.

For tests that are:

• unlabelled
• with non-matching or incomplete patient details on the form and vial (major discrepancy)
• taken inappropriately from any source other than the cervix if a clinician taken sample, or vagina if a self-test sample

Action: Record clinician taken cervical samples electronically but reject and do not process. Request a repeat test. Self-test samples are not tested but reported to the call and recall system so a repeat kit can be dispatched, if it is the first occurrence.

For tests that are:

• from uninvited people under 24.5 years
• from individuals over 65 (unless they are unscreened, completing a self-test, missed their last invitation or are in follow up for a previous abnormal result)
• from individuals on routine recall taken more than 3 months ahead of schedule
• taken at an inappropriate period after an HPV negative test
• taken at colposcopy contrary to NHSCSP guidancehttps://www.gov.uk/government/publications/cervical-screening-primary-hpv-screening-implementation
• taken less than 3 months after a previous clinician taken sample
• self-tests received following recent attendance for a clinician taken sample
• vault samples from individuals with total hysterectomy who were on routine recall and had no CIN in their hysterectomy specimen
• from individuals who have undergone pelvic radiotherapy, and this is noted on the sample request form

Action: Book clinician taken cervical samples onto laboratory system (if possible) or record electronically. Reject and do not process. Self-test samples are not tested but reported to the call and recall system to enable a communication to be sent to the participant advising that a result will not be issued.

For tests that are:

• in poor condition (insufficient fluid, SurePath© sample without broom head, ThinPrep© with broom, wet self-test without swab device, with apparent bacterial/fungal growth)

Action: process and report as outlined above, and inform sender of reason.

For tests that are:

• missing a request form or specimen

Action: inform sender if a clinician taken cervical sample. Book onto laboratory system (if possible) or record electronically. Reject and do not process. Request a repeat test. Self-test devices received without a labelled sample transport bag cannot be processed and tested. Missing self-test devices, where the labelled sample transport bag is received are reported to the call and recall system so a repeat kit can be dispatched, if it is the first occurrence.

For clinician taken tests that are:

• with an invalid sample taker PIN

Action: process sample. Attempt to confirm PIN. Report if HPV positive with inadequate cytology unless abnormal cells detected if PIN not confirmed. Inform sender of reason. Report a negative HPV test result as HPV unavailable.

8. Laboratory management advice for tests requiring a repeat sample

Management advice from laboratories for clinician taken cervical screening tests requiring a repeat sample should include the following text (or similar):

‘Unable to process sample. Please repeat in no less than 3 months from initial sample. Do not repeat immediately as the cervical epithelium needs time to regenerate and the test result may be unreliable.’

State the reason for repeating the sample on the cervical screening test report. This makes sure the sample taker can clearly explain the need for the repeat test to the individual.

Laboratory management advice concerning self-tests that require a repeat sample will be communicated to participants via the call and recall system, according to the relevant result code and associated participant notification. While self-tests may be repeated immediately, the repeat self-test kit will be dispatched two weeks later to ensure the communication is received by the individual in advance.

9. Error logs and error reporting

Make reports available to commissioners as required locally. Document the provision of reports, defining their frequency, format and process for follow-up of issues.

Keep an electronic record rather than manual record of all defective or rejected samples (clinician taken cervical samples and self-test). This is so lists and audits can easily be generated to inform commissioners, sample taker providers and sample takers of the scale of these problems.

Recorded details should include the:

• date
• patient details
• clinic or sender details
• error details plus error code
• action
• resolution date

Ideally, code all errors with a relevant error code. This provides the laboratory with a means to audit and report problems back to sample takers, providers and commissioners.

Where clinician taken cervical samples are rejected, do not include these tests in the electronic download to the call and recall service or in the KC61 return or other laboratory workload data. In circumstances where the self-test is rejected, these tests must be included in the electronic download to the call and recall system to ensure the participant is aware that a result will not be issued.

Regularly audit error logs (at least quarterly). Report results to the appropriate organisation(s) as agreed locally so that appropriate action/s can be taken. Report error rates and issues at commissioner-led multidisciplinary programme board meetings (see the example audit report to commissioners provided).

Produce and disseminate audit reports for individual sample takers and, or sample taker providers at locally agreed intervals, such as annually. Refer to the example sample taker audit report provided.