Quality Systems in Medical Laboratory

12 essential components of quality in medical Laboratory
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Introduction to Quality 

Quality may be defined as the extent to which a product/ service / experience satisfies customer /end user expectations. In laboratory medicine, the end point of quality is to ensure quality results that contribute to patient management. Total quality management concept is useful in ensuring quality is all encompassing and organization wide. 

Internal Quality Control (IQA)

IQA are quality related activities carried out  in-house (intralaboratory) by the laboratory staff. They encompass the bulk of quality control as they are performed more regularly e.g. daily or even per batch of tests. Examples of IQA include

  • Running controls of automated analysers eg Hematology analyser every morning.
  • Calibration of test systems using manufacturers controls
  • Review of nth slide by an experienced pathologist/microscopist eg for ZN or MPS slides

IQA can be performed both for Quantitative and qualitative tests

External Quality Control (EQA)

EQA involves administration of quality tasks by an independent provider. 

This can take various forms eg:

  1. This external agency provides either samples of known values and the lab analyses and results are compared with the known value
  2. Samples with unknown values which the participating labs analyse and submit their results. Performance is gauged against peers who participate in the EQA round.
  3. Proficiency testing (PT). In PT an external agency sends out samples and kits to specific laboratory professionals. After analysing, they submit their results and the agency then returns results of either pass or fail for the professional. This has been employed widely in HIV testing.

 

Quality System Essentials

Quality essentials are the building blocks of quality system. The WHO has  recognized 12 essentials important in realization of total quality management. These are:

1.Organization

Describes key leadership responsibilities that are integral to a laboratory’s success in achieving and maintaining a systematic approach to quality and meeting regulatory, accreditation, customer, and internal requirements.

2.Customer Focus

Describes the need to design work to meet the expectation of laboratory customers. It also describes methods for seeking customer input to confirm that expectations are continually met.

3. Facilities and safety:
Accordion Content
4. Personnel:

 

Describes obtaining and retaining an adequate number of qualified, well-trained, and competent laboratory staff to perform and manage the activities of the laboratory.

5. Purchasing and inventory: 

Describes agreements that the laboratory has with customers and outside vendors to ensure that specified requirements for critical supplies and services are consistently met.

6. Equipment: 

Describes selection and installation of equipment, equipment maintenance and calibration, documentation of equipment-related problems, and record maintenance.

7.Process management:

Describes processes directly and indirectly related to the laboratories path of workflow to meet requirements and maintain efficient use of resources

8. Documents and records: 

Describes the creation, management, and retention of the policy, process, and procedure documents for the QSEs and path of workflow.

9. Information management: 

Provides guidance for managing the information generated and entered into laboratory record keeping systems (e.g., patient demographics, examination results and reports, interpretations).

10. Nonconforming event management:

Describes processes for detecting and documenting nonconformances, classifying nonconformances for analysis, and correcting the problems they represent.

11. Assessments: 

Describes the use of external and internal monitoring and assessments to verify that laboratory processes meet requirements and to determine how well those processes are functioning.

12. Continual improvement: 

Describes mechanisms for identifying opportunities for improvement and developing a strategy to continue this improvement.

Conclusion

Quality is a fundamental component of every process in the lab. In subsequent posts, We will have a more in-depth look at each of the components of quality. 

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