Definition of Quality Assurance, Quality Control  & Quality Standards

Quality Assurance= The process of building quality control measures into a system which will ensure a consistently high standard of performance.

Quality Control = The set of measures designed to ensure the accuracy of interpretation and reporting of cervical smears.

Quality  Standards= Measurements of laboratory performance agreed  at local, national or international levels which reflect good cytology practice.

Types of quality assurance

Quality Assurance systems may be internal or external

• Internal Quality Assurance systems (IQA) are applied  by  the laboratory on a daily basis such as in regular checks on data entry and introduction of  tiered screening.
• External Quality Assurance systems (EQA) are applied by an outside regulatory body e.g. proficiency testing schemes, accreditation.

Model cytology workflow

Internal quality assurance (IQA) measures to be taken on a daily basis

Errors encountered		IQA measures
Specimen reception
	Errors at the point of reception are usually due to mismatching of smears and request forms.	Ensure receptionist/clerk checks name on slide with patient data on request form. laboratory manager should carry out regular checks of accuracy of computer data entry. Introduce barcode system for labeling request form and slide.
Specimen processing
	Poor quality staining and fixation is the single most likely cause of errors of reporting cervical smears.	Introduce standard operating procedures (SOP) to ensure staining protocols are followed exactly Keep daily record of topping up stains and fixatives Select optimal cover slip size (24x50mm) Daily check by supervisor for intensity of stain, nuclear/ cytoplasmic contrast, dehydration and clarity of mountant
Specimen interpretation
	The commonest error is false negative reporting	Adequate training and continuing professional education of all cytotechnologists involved in examining cervical smears. Control  of the number of smears examined  by each screener (suggested maximum 50 / day ,7000 per year) Screener checks PID on slide and request form before screening. Screener carries out systematic assessment of smear adequacy. Introduction of tiered screening (random re-screening, rapid review, automated, semi-automated review) Ensuring that all borderline and abnormal smears are reexamined and reported by a pathologist or authorised person. Supervisory review of all cases with selected clinical characteristics e.g. post coital or post menopausal bleeding, previous abnormal smear, past history of pre-invasive or invasive cancer.

The analysis of cervical smears is a skilled repetitive task requiring intense concentration by the screener who is required to detect a relatively small number of abnormal cells among the many thousands of normal epithelial cells in the smear. Consequently the risk of false negative reporting is high. Quality assurance measures to reduce the risk of false negative reports must be in place every cytology laboratory.