TITLE

Analysis and review of protocols and quality standards in the diagnostic process for the detection of cervical cancer.

INTRODUCTION

The effectiveness of Papanicolau cytology for screening cancers of the neck of the uterus is well-demonstrated and has been established as a strategy capable of reducing the potential mortality due to cancer of the neck of the uterus, as long as there is a high rate of participation by the public and the quality of the system is maintained at high levels.

Cytology has the advantage of being a simple, quick and non traumatic test and the disadvantage of being subject to human error, leading to false negatives when interpreting the results.

Today, there are clear recommendations about who, how, when and with what standards and quality levels the test should be made.

In the Autonomous Community of the Basque Country, early diagnoses of cervical cancer are carried out but without generally agreed criteria as to the age, frequency and quality standards.

AIMS

1. Review the scientific evidence on the cervical-vaginal cytology test process, from taking the sample to reading.
2. Review the quality standards established by scientific societies both for taking, fixing and transporting the sample and for its reading in the laboratory.
3. Review current operating protocols relating to the performance of this test in the different health centres in the Autonomous Community of the Basque Country and determine the level of compliance by professionals of these protocols.
4. Unify the type of cytology information and the way this is collected for all the health centres in the Autonomous Community of the Basque Country.
5. Establish recommendations that allow an improvement in the effectiveness of the test.

MATERIAL AND METHODS

• The search and review of the scientific evidence was carried out in the following databases: Medline, HealthStar, Cochrane Library and Best Evidence.
• A questionnaire was sent to professionals who perform cytologies as well as those who read these, in order to determine health care practice and compliance with existing protocols.
• Reports made both by the gynaecologist and/or midwife at the time the sample is collected and those issued by pathologists to the health service professionals who request these, corresponding to the period January-June 1999.

CONCLUSIONS

• The benefits of the Papanicolau test, as an early detection test of cervical cancer, depend upon the quality of the sample taken, fixed and transported as well as its reading in the laboratory.
• The criteria to be complied with in order to guarantee the quality of the test are agreed by general consensus, clearly defined and easy to comply with.
• In the Autonomous Community of the Basque Country, cytologies are performed by well-trained professionals, provided with the necessary equipment and appropriate material. This means that virtually all the samples taken are valid for diagnosis.
• There is an important contradiction between the data health service professionals recognise is relevant to determine and the gathering of this information. Most of the request reports used indicate the variables of interest to the doctor, but this are not always supplied.
• Internal quality controls are performed in all laboratories but external controls are carried out in only one of these.

RECOMMENDATIONS

• There should be only one information gathering form for the entire Autonomous Community of the Basque Country. This should include all the variables that according to scientific evidence should be collected in order to be able to interpret the sample correctly. Furthermore, the form should be a single instrument and include both information on the sample and the pathological diagnosis.
• Women should be told what preparations should be made before the test is performed (not to have sexual relations during the previous 24 hours, not be in menstruation, not to have topical vaginal treatment up to a week beforehand, etc.).
• The health service professionals who perform the test should be reminded of the importance of complying with the variables in order to facilitate the work of the person entrusted with reading the sample.
• Laboratories should be obliged to perform both internal and external quality controls.