Indian Journal of Pathology and Microbiology

: 2018  |  Volume : 61  |  Issue : 2  |  Page : 304--305

Quality does not reside in files: Its a way of life

Nadeem Tanveer 
 Department of Pathology, University College of Medical Sciences, New Delhi, India

Correspondence Address:
Nadeem Tanveer
Department of Pathology, University College of Medical Sciences, Dilshad Garden, New Delhi - 110 095

How to cite this article:
Tanveer N. Quality does not reside in files: Its a way of life.Indian J Pathol Microbiol 2018;61:304-305

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Tanveer N. Quality does not reside in files: Its a way of life. Indian J Pathol Microbiol [serial online] 2018 [cited 2021 Apr 20 ];61:304-305
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Quality control and accreditation are the buzz words of laboratory practice these days. The emphasis on record keeping which is the backbone of quality control has resulted in new designations such as quality managers in the laboratories. A certain amount of paperwork is necessary for ensuring quality in laboratories. However, one of the ill effects of this overemphasis on documentation is that the essence of quality is lost somewhere in between the files.

The paperwork required for laboratory accreditation is very extensive. Often, it is managed by a dedicated person whose sole responsibility is to make sure that all files are in order. This has its own repercussions since the idea behind documentation is to ingrain the concepts of quality in the minds of the operator, involve staff at all levels, and promote good practices. This idea is lost if all the files are managed by one person. In other words, we need quality managers who do not manage the quality but supervise the functioning of the staff. The best quality manager would be the Lab head who has administrative control on everyone.

The main advantages of the accreditation process are:

Technologists are sure about the procedures to be followedTechnologists have better knowledge about the tests to be performedAll the test results and processes are traceable.[1],[2]

However, there are several challenges that the accreditation process has to address. These include

Discrepancies between the reality and documentsMore attention being paid to formalities than the quality of the resultsIncreased paperwork.[3],[4]

Any accreditation process involves assessment, reassessment, and surveillance at regular intervals to ensure that the commitment to quality is a continuous process. While assessment and reassessment are easier to perform, adequate surveillance is a challenge. Surprise inspections are the ideal solution, but logistic problems and increased cost to be borne by the laboratory are the main roadblocks. The accreditation bodies such as National Accreditation Board for Testing and Calibration Laboratories have done pathbreaking work in the field of quality assurance in laboratories in India. They have brought quality to center stage of laboratory practice. It is time to take their efforts to the next level.

While accreditation can definitely help in improving the standards of laboratories, it cannot perform the role of a regulator. The central government has passed the Clinical Establishment Act in 2011 to bring in its purview the diagnostic industry. However, the law has raised several concerns within the medical community. All the legitimate concerns of the medical community regarding the feasibility of the provisions need to be addressed. Moreover, it is left to the individual states to implement the Act.

Most laboratories use software called laboratory information system (LIS) to manage reports and patient data. The LIS should meet the reporting and auditing needs of the accreditation agency. The accreditation agencies can ask the laboratories to incorporate quality control data in the LIS itself wherever possible. This would help in reducing paperwork to some extent.

To conclude, the accreditation agencies should strive to reduce unnecessary paperwork and focus on surveillance through surprise inspections. This would push the laboratories to maintain the quality standards throughout the year. It would also improve the acceptance of accreditation process among laboratory personnel.[5]

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.


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