Quality Improvement Activities in C&DST Laboratories

Quality Improvement Activities in C&DST Laboratories

Continuous Quality Improvement is defined as “a philosophy and attitude for analyzing capabilities and processes and improving them repeatedly to achieve the objective of customer satisfaction”. Quality improvement (QI) is a critical and often neglected part of the quality assurance process. The QI cycle involves four steps: Plan, Do, Check, and Act.

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Key Components of the QI Process:

Identification of non-conformities through data collection, subsequent data analysis, and creative problem-solving are key components of the QI process. This involves continual monitoring and identifying and analyzing actual and potential defects.

Identification of non-conformities:

Non-conformities may be identified in many ways, including Proficiency Testing (PT), reviewing quality indicators, reporting issues identified by staff members, and audits.

• Proficiency Testing: PT verifies that the C&DST laboratories are proficient in their testing process and can obtain accurate and reliable results. All the C&DST laboratories under NTEP receive an annual panel of 20 culture isolates from their respective National Reference laboratories (NRLs). PT helps to identify major non-conformities, allowing NRLs to target the most poorly performing C&DST laboratories for on-site supervision. PT panels may also be used to evaluate the training needs of technicians.

• Reviewing quality indicators: All C&DST laboratories should collect and analyze testing data on at least a monthly basis, using a standardized format. Targets should be set for all indicators monitored, and any unexplained change in quality indicators, such as an increase in error rates and contamination rates, a change in MTB positivity rate or rifampicin resistance rate, or a significant change in the volume of tests conducted, should be documented and investigated. Quality performance indicators should be reviewed by the laboratory manager and must always be linked to corrective actions if any unexpected results or trends are observed.

• Audit: An assessment, or audit, allows the laboratory to understand its performance when compared to a benchmark or standard. There are two types of audits- external and internal audits. 

  Audits should include the evaluation of steps in the whole laboratory path of workflow. They should be able to detect problems throughout the entire process. The value of a well-designed audit is that it will reveal weaknesses in the pre-examination, examination, and post-examination phases. During audits, information is gathered about: processes and operating procedures, staff competence and training, equipment, environment, handling of samples, quality control and verification of results, recording practices, and reporting practices.

Procedures for identifying non-conformities, determining responsibility, recalling the results associated with the non-conformities, and resuming routine testing following corrective actions must be clearly defined by all the C&DST laboratories. In addition, follow-up actions must also be implemented to prevent the same non-conformity from occurring in the future.

Resources

GLI Practical Guide to TB Laboratory Strengthening

Assessment