Recommendations on Quality Control and Quality Assurance in Cervical Cytology

Objective: Total quality management, which basically involves pre-analytical, analytical, and postanalytical phases, is relatively more difficult in cytopathology due to descriptive reports and subjective variability. The pre-analytical phase of total quality management constitutes a major burden of errors in the laboratory and it has not been widely studied in cytopathology except in cervical Pap smears. The present study was therefore conducted to study the pre-analytical phase over 5 years from April 2013 until May 2018 at an ISO 15189: 2012-certified cytopathology laboratory, in a resource-limited setting. It was also intended to study the level of satisfaction of the patients and the training of the professionals provided in the cytology lab so as to improve and maintain high quality standards. Methods: The study included all the documents relating to the quality program used in the last 5 years in a medical institute situated in the north sub-Himalayan region of India. All the data were recorded and analysed for pre-analytical analysis of the total quality management system. Results: In total, 20,130 samples were received for cytological investigation. The total number of errors which were detected in the cytopathology lab were 1,430, constituting 7.1% of the total investigations done. The pre-analytical phase errors comprised 57% of the total errors (815/1,430), analytical errors constituted 11% (157/1,430), while postanalytical errors represented 32% (458/1,430). Incompletely filled requisition forms constituted the most common pre-analytical error (38%). There was a gradual decrease in the errors with time, but with a sudden increase between January to June 2015 due to new technicians joining during that period. Conclusion: Pre-analytical quality management is an essential component for maintaining the quality and reducing the errors in the cytopathology lab. Documentation, continuous training, and maintenance of internal and external quality control with quality charts are the key for successful quality management. The identification of non-conformance with root-cause analysis and provision of scope for continuous improvement is vital for quality improvement in the lab. Patient satisfaction is an important aspect of quality in the lab, which should be combined with the satisfaction of the personnel working in the lab.

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Study of the Pre-Analytical Phase of an ISO 15189: 2012-Certified Cytopathology Laboratory: A 5-Year Institutional Experience

Chandra

Kusum

et al. 2018

“…Nevertheless, we believe that the R10 model is the only affordable option for such large-scale projects in low-resource settings. The overall quality of cervical cytology is affected by several factors in preanalytical and postanalytical steps, including: (1) biological variability; (2) collection of samples (site and sampling method); (3) laboratory procedure, including processing; (4) primary screening (manual or computer assisted); and (5) interpretation [24,25] . It should be noted that our project involved only the primary screening phase, which is just a part of the overall quality assurance process.…”

Section: Discussionmentioning

confidence: 99%

False-Negative Rate of Papanicolaou Testing: A National Survey from the Thai Society of Cytology

Koonmee

Bychkov

Shuangshoti³

et al. 2017

Objective: To evaluate the performance of Papanicolaou smear screening in Thailand at the national level, and to propose recommendations for continuing quality control. Study Design: This study was conducted by The Thai Society of Cytology and involved 124 laboratories in 76 provinces during 2010-2014. Random sampling suggested recalling of 10% of slides defined as negative at routine screenings (10% random rescreening [R10] model) directly from the reading unit. Results: Out of 330,075 smears covered by the rescreening project throughout its 5-year duration, the rates of abnormal, unsatisfactory, and normal results were 0.63, 1.82, and 97.55%, respectively. Abnormal findings were largely represented by ASC-US (54%) and L-SIL (21%). The average false-negative rate (FNR) measured at the level of L-SIL and higher was 13.8%. Conclusion: The national project was developed to address the accuracy of cervical cancer screening and to promote internal quality assurance based on the R10, on-site surveys, and education. The major output parameters of this study (FNR and number and distribution of abnormal cases on rescreening) improved significantly in the main phase of the project (2012-2014), after revising substantial logistics issues encountered during the first 2 years of this study. This project provided objective measurable evidence related to the quality of cytology-based cervical cancer screening in Thailand.

“…Inter- and intraobserver variations in microscopic findings were determined according to the criteria previously documented [20]. …”

Section: Methodsmentioning

confidence: 99%

Eco-Pap: The Ecological Modification of the Papanicolaou Stain for Sustainable Cervical Cancer Diagnosis

Moya‐Salazar

Rojas‐Zumaran

2018

Objectives: To validate the ecological modification of the Papanicolaou stain (Eco-Pap) for the diagnosis of cervical cancer. Study Design: A prospective study was performed at the Mother and Child “San Bartolomé” Hospital, Lima, Peru. Reagent handling strategies were divided into three phases: we used (1) Harris progressive hematoxylin (for nuclear staining), (2) a polychromatic solution (a mix of EA-36/Orange G-6 to suppress the use of several alcohol baths), and (3) direct mounting (with Entellan® solution). The cellular details were analyzed by the staining quality index, an external quality control, and the Bethesda System 2014. Results: We evaluated 72,901 cervical smears stained with the Eco-Pap. The validation of the Eco-Pap against the conventional Pap stain was optimal (κ = 0.89; 95% CI: 0.87–0.92), showing a sensibility and specificity of 88.3% (95% CI: 85.1–90.0) and 98.7% (95% CI: 98–99.2), respectively. The Eco-Pap dramatically reduced the environmental pollution caused by 72 L of xylene, hydrochloric acid, and ammonia (6 L each) and mercury oxide. Conclusion: The Eco-Pap is an innovative and efficient staining method reducing the use of toxic reagents with carcinogenic potential during cervical cancer screening by exfoliative cytology.