Reporting and Management Guidelines

CLINICAL MANAGEMENT GUIDELINES

The Australian Government Department of Health commissioned and funded Cancer Council Australia to develop the National Cervical Screening Program: Guidelines for the management of screen-detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding (the Guidelines) to offer guidance to health professionals and women as to best practice in the clinical management of women with positive oncogenic HPV test results and abnormalities detected on subsequent LBC. The Guidelines are available as a wiki at: https://wiki.cancer.org.au/australia/Guidelines:Cervical_cancer/Screening
 

NEW GUIDELINES FOR INTERMEDIATE RISK CERVICAL SCREENING RESULTS

Revised guidelines for the clinical management of women with intermediate risk in the NCSP will come into effect from 1 February 2021.

Women with a 12-month follow up HPV (not-16/18) result with LBC prediction negative, pLSIL or LSIL (Intermediate risk result)

should be recommended to undertake a further HPV follow up test in 12 months’ time following their previous HPV test instead of referral to colposcopy.

These changes will soon be outlined in the NCSP Guidelines, Chapter 6: Management of oncogenic HPV test results. The changes are based on a review of national clinical program data, showing women at intermediate risk whose follow-up test is HPV (not-16/18), and reflex LBC prediction negative, pLSIL or LSIL, will have a low likelihood of histologically confirmed HSIL or worse, and an extremely low likelihood of cervical cancer. As a result, these women will now be managed more conservatively.

Women who may be at higher risk of harbouring a high-grade abnormality should be referred to colposcopy if HPV is detected at 12 months, regardless of the result of reflex cytology. This includes the following groups:

  • Women two or more years overdue for screening at the time of the initial screen
  • Women who identify as being of Aboriginal or Torres Strait Islander descent
  • Women age 50 years or older

There are other groups of women who fall outside the new recommendation with separate guidance outlined in the NCSP Clinical Guidelines. These groups include:

  • Immune deficient women.
  • Women exposed to DES in utero
  • Women currently undergoing Test of Cure following treatment of histological HSIL
  • Women aged 70+ (attending for an exit test)
  • Women who screen using self-collection

Pathology laboratories will consider the information provided at the time of request to develop their summary line and recommendation for this pathway. As laboratories may not be provided with the patient’s complete clinical or demographic information, they may choose to include a statement such as:

“The summary line/risk category and recommendation are based on the information provided at the time of reporting. Should your patient belong to a higher risk group such as Aboriginal or Torres Strait Islander women, or immune deficient, then referral to colposcopy should be considered. For more information, please refer to the NCSP Guidelines.”
 

ADDITIONAL GUIDANCE FOR LABORATORIES REPORTING CERVICAL SCREENING TESTS (CSTs)

The Cancer Council Australia Clinical Guidelines Network provides comprehensive information on the NCSP as above. Included is guidance to assist with interpretation of what kind of data to report under each of the mandatory fields, to align with the NCSP performance and monitoring reporting and with the NPAAC requirements as appropriate.

The following information is complimentary to the clinical guidelines, providing additional information relating to the practical implementation of the guidelines by laboratories. It is provided to assist with reporting of the more complicated cases and to encourage consistency of reporting across Australia. These recommendations stem from issues identified by the RCPAQAP and from feedback from laboratories relating to areas of uncertainty and inconsistency. Specifically addressed are guidance on Summary Line and Recommendations in the following scenarios: symptomatic patients; patients presenting with inappropriately premature follow up of intermediate risk; negative results in patients with previous AIS, DES exposure or immune deficiency; and women undergoing test of cure. Guidance for the Summary Line and Recommendations for patients undergoing surveillance of previous cancers (outside the NCSP) are also included.

Restricting the summary to a risk category describing a cervical abnormality may not be appropriate based on the clinical history or the test result. The ‘Summary Line’ has been adopted to encompass what has frequently been used by laboratories as the 'risk category'. The broader Summary Line allows for additional terminology when appropriate. In these cases, the terms ‘Symptomatic ‘, ‘Abnormal finding’ and ‘No Risk Category Assigned’ are used as appropriate.

The terminology will be adopted by the RCPAQAP during the 2021 surveys.
 

Guidance on Summary Line* and Recommendation for patients with co-test for investigation of signs or symptoms of cervical cancer.

* The default summary line is "Symptomatic" in these cases except if testing shows "High Risk" results.  High risk results,  for example pHSIL or features of a non-cervical abnormality, trump this more generic summary and terminology used is as appropriate for the abnormality.

Clinical Scenario HPV Result LBC Result Summary Line Recommendation Rationale
Symptomatic Neg Neg Symptomatic  Clinical correlation and Referral if clinically appropriate All symptomatic patients require some clinical correlation and/or investigation as per Flowchart 18.1
Symptomatic Neg Non-cervical abnormality Abnormal Finding Referral  All symptomatic patients require referral for any positive finding as per Flowchart 18.1
Symptomatic Neg pHSIL or more Higher risk for significant cervical abnormality Referral All symptomatic patients require referral for any positive finding as per Flowchart 18.1
Symptomatic HPV 16/18 Any Higher risk for significant cervical abnormality Referral All symptomatic patients require referral for any positive finding as per Flowchart 18.1
Symptomatic HPV other Not pHSIL or more  Symptomatic  Referral All symptomatic patients require referral for any positive finding as per Flowchart 18.1
Symptomatic Invalid Neg Symptomatic  Clinical correlation and Referral if clinically appropriate All symptomatic patients require some clinical correlation and/or investigation as per Flowchart 18.1. Consider comment relating to repeat HPV test at referral may be warranted
Symptomatic Invalid Non-cervical abnormality Abnormal Finding Referral All symptomatic patients require referral for any positive finding as per Flowchart 18.1
Symptomatic Invalid pHSIL or more Higher risk for significant cervical abnormality Referral All symptomatic patients require referral for any positive finding as per Flowchart 18.1
Symptomatic Invalid pLSIL/LSIL Symptomatic  Referral All symptomatic patients require referral for any positive finding as per Flowchart 18.1
Symptomatic Neg Invalid Symptomatic  Clinical correlation and Referral if clinically appropriate All symptomatic patients require some clinical correlation and/or investigation as per Flowchart 18.1. Consider comment relating to repeat cytology at referral may be warranted
 
Guidance on Summary Line and Recommendation for patients with inappropriately premature follow up (i.e. <9 months) of previous Intermediate Risk

**(NOTE: the guidelines for the follow up of Intermediate Risk is scheduled for a change in the near future)

Clinical Scenario HPV Result LBC Result Summary Line Recommendation Rationale
Premature Follow up (i.e. <9 months) of previous Intermediate Risk HPV 16/18 Any Higher risk for significant cervical abnormality Referral High risk = referral
Premature Follow up (i.e. <9 months) of previous Intermediate Risk HPV Other Not pHSIL or more Intermediate risk for significant cervical abnormality Repeat HPV test in 12 months Not enough time has been allowed for woman to clear the virus.
Premature  Follow up (i.e. <9 months) of previous Intermediate Risk Neg n/a Low  risk for significant cervical abnormality Repeat Screening in 5 years The result is in keeping with HPV clearance.**

**Note modification required in NCSR to accept this finding.


Guidance on Summary Line and Recommendation for negative results in patients with Previous AIS, DES exposure or Immune Deficiency
Clinical Scenario HPV Result LBC Result Summary Line Recommendation Rationale
Previous AIS Neg Neg Intermediate risk for significant cervical abnormality Repeat Co-Test in 12 months Patients with previous AIS remain at an increased risk compared to the baseline population, therefore regard as Intermediate Risk, regardless of negative Co-Test.(Flowchart 11.4)
Previous DES exposure Neg Neg Intermediate risk for significant cervical abnormality Repeat Co-Test in 12 months Patients with previous DES exposure are regarded as at an increased risk compared to the baseline population, therefore regard as Intermediate Risk, regardless of negative Co-Test. (Recommendation 17.1)
Routine screening in immune-deficient women Neg n/a Intermediate risk for significant cervical abnormality Repeat HPV test in 3 years Patients with immune-deficiency are at an increased risk compared to the baseline population, therefore regard as Intermediate Risk, regardless of negative HPV result (Flowchart 16.1)

Guidance on Summary Line and Recommendation for women undergoing Test of Cure
Clinical Scenario HPV Result LBC Result Summary Line Recommendation Rationale
1st Test of Cure neg neg Intermediate risk for significant cervical abnormality Repeat Co-Test in 12 months Despite negative result, patient has not yet completed the Test of Cure protocol, therefore is at increased risk compared to baseline population (Flowchart 10.1)
2nd Test of Cure neg neg Low risk for significant cervical abnormality Repeat HPV test in 5 years Patent has now completed the Test of Cure protocol and is at the same risk as the baseline population Flowchart 10.1)

Guidance on Summary Line*** and Recommendation for women undergoing Surveillance for previous cancer

*** The default summary line is "No Risk Category Assigned" in these cases except if testing shows "High Risk" results, which trump this more generic recommendation.  For example, a result of pHSIL or features of a non-cervical malignancy in a symptomatic patient.

Clinical Scenario HPV Result LBC Result Summary Line Recommendation Rationale
Surveillance following previous cancer treatment neg neg No Risk category assigned Follow up as per treating specialist advice Outside the screening program guidelines
Surveillance following previous cancer treatment HPV other Not pHSIL or more No Risk category assigned Follow up as per treating specialist advice Outside the screening program guidelines
Surveillance following previous cancer treatment HPV other pHSIL or more Higher risk for significant cervical/vaginal abnormality Referral Outside the screening program guidelines. High risk = referral if not already under specialist management
Surveillance following previous cancer treatment HPV16/18 any Higher risk for significant cervical/vaginal abnormality Referral Outside the screening program guidelines. High risk = referral if not already under specialist management
Surveillance following previous cancer treatment neg Non-cervical abnormality Abnormal Finding Referral Outside the screening program guidelines.

MANDATORY NOTIFICATION OF DATA

Under the National Cancer Screening Register Rules 2017 (the Rules), from 1 December 2017 pathology practitioners are required to notify prescribed cervical screening information to the Commonwealth Chief Medical Officer (CMO) through the NCSR within 14 days. The 14 days commences after the screening test is completed. That is;

  • HPV test and LBC test (if required) – the 14 day period commences immediately after the lab has received, tested and issued a combined report.
  • Histology – the 14 day period commences immediately after the lab has completed their testing (i.e. multiple examinations on the tissue) and issued a report.

The Rules support notification of individuals’ screening test results, results of follow-up procedures, diagnosis (or clearance) of cancer and other relevant screening information, including Indigenous status and country of origin (if known) to the NCSR to enable monitoring of NCSP program quality, safety and effectiveness.
 

HPV POSITIVITY RATES – BENCHMARKING REPORTS FOR PATHOLOGY LABS

One of the key elements of quality assessment for the renewed NCSP is for pathology laboratories to routinely assess their HPV detection rate (‘positivity rate’). The NCSR provides benchmarks that will allow laboratories to assess their detection rates against National averages. Guidance for pathology laboratories is available from the Guidelines for handling HPV positivity rate quality management process.

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06-Jan-2021
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