Indian Journal of Cancer
Home  ICS  Feedback Subscribe Top cited articles Login 
Users Online :1615
Small font sizeDefault font sizeIncrease font size
Navigate here
  Search
 
  
Resource links
   Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
   Article in PDF (205 KB)
   Citation Manager
   Access Statistics
   Reader Comments
   Email Alert *
   Add to My List *
* Registration required (free)  

 
  In this article
   References

 Article Access Statistics
    Viewed1983    
    Printed39    
    Emailed0    
    PDF Downloaded300    
    Comments [Add]    

Recommend this journal

 


 
  Table of Contents  
LETTER TO THE EDITOR
Year : 2016  |  Volume : 53  |  Issue : 1  |  Page : 204-205
 

The road to laboratory accreditation: Experience of a tertiary care oncology center


1 Quality Manager, Research and Education in Cancer-Laboratory Services, Navi Mumbai, Maharashtra, India
2 Department of Microbiology, Research and Education in Cancer-Laboratory Services, Navi Mumbai, Maharashtra, India
3 Composite laboratory, Research and Education in Cancer-Laboratory Services, Navi Mumbai, Maharashtra, India
4 Asst Med Superintendent Advanced Center for Treatment, Research and Education in Cancer-Laboratory Services, Navi Mumbai, Maharashtra, India

Date of Web Publication28-Apr-2016

Correspondence Address:
V G Bhat
Department of Microbiology, Research and Education in Cancer-Laboratory Services, Navi Mumbai, Maharashtra
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0019-509X.180858

Rights and Permissions



How to cite this article:
Chital N K, Bhat V G, Chavan P D, Bhat P C. The road to laboratory accreditation: Experience of a tertiary care oncology center. Indian J Cancer 2016;53:204-5

How to cite this URL:
Chital N K, Bhat V G, Chavan P D, Bhat P C. The road to laboratory accreditation: Experience of a tertiary care oncology center. Indian J Cancer [serial online] 2016 [cited 2019 Sep 17];53:204-5. Available from: http://www.indianjcancer.com/text.asp?2016/53/1/204/180858


Sir,

Accreditation of health care systems is increasingly seen as an approach to ensuring good health standards in both private and public organizations for better patient care. The principles of quality assurance and improvement by Joseph Juran and Edwards Deming as well as total quality management and continuous quality improvement, are finding importance into the daily processes of health care organizations globally.[1] Our hospital decided to pursue the “National Accreditation Board for Testing and Calibration Laboratories” (NABL) Accreditation for the diagnostic laboratories in 2007. Accreditation is provided for testing, calibration and medical laboratories in accordance with International Organization for Standardization (ISO) Standards. Laboratory Accreditation imparts a formal recognition of laboratories by a competent authority [2] and enhances customer confidence in results issued by accredited laboratories.[3]

Having decided upon going ahead with the accreditation process, the need of the hour was to identify elements that needed to be focused upon. Accordingly, the organization appointed a quality manager to oversee the implementation of accreditation and quality related activities in coordination with the key laboratory personnel. The responsibility of the quality manager initially was to form a team of stakeholders for achieving the said target. The mandate was to be NABL Accredited for which compliance with ISO 15189:2007 (Medical laboratories – Particular requirements for quality and competence) and NABL 112 (specific criteria for accreditation of medical laboratories) was to be achieved. Deputy quality managers from respective laboratories were assigned to look into the accreditation related functions of their respective areas in coordination with their key laboratory personnel and quality manager. Baseline audits were conducted for each prospective laboratory to be undergoing accreditation viz. Biochemistry, Hematology, Microbiology, Surgical Pathology and Molecular Pathology. Baseline audits helped to make an overall assessment of the respective laboratories against the set standards for accreditation. A gap analysis was performed to determine the “gaps” between our laboratory practices and the identified “best practices” and to try and bridge this gap.

The first level of assessment in accreditation we addressed was “system awareness.” The aim to assess system awareness was to look into the organization's consciousness towards quality assurance, liability and proper management. We felt that there was a need to increase “system awareness” at all levels. In the second level, we analyzed whether there were appropriate policies and procedures in the organization in conformity with pertinent standards. It was not surprising to experience implementation discrepancies in certain areas resulting in policies that were misconstrued, or even overlooked. One example of this was that the Laboratory staff was aware of critical values of test parameters, however, there was no system in place for “critical reporting” to the concerned clinicians. The staff was trained on the significance and procedure of “critical reporting” was implemented.

Although there were teething problems in the beginning of the accreditation drive; these were soon resolved with support from management. One major difficulty faced was during implementation of the document control procedure. That there was a need of stringent documentation of each and every aspect of the laboratory function was not initially recognized by the staff; there were at times differences in opinion regarding the need for documentation at various stages, as it seemed laborious for the staff to maintain a large amount of documentation amidst routine laboratory work. However, these staff issues were considered and duly resolved, while yet conforming to requirements. The organization mandate to achieve NABL Accreditation was strongly inculcated in the staff by conducting frequent accreditation related training programs. Finally, a regular “audit calendar plan” was established after setting the policies and procedures appropriate to the respective laboratories and the organization in place. Every laboratory area would undergo an internal audit once a year, by trained NABL Assessors from within the organization. The findings of the internal audit and the successive corrective actions to close the non-conformities helped immensely to continually improve the system. The outcome of successful accreditation resulted from the vision, well-directed planning and effort, implementation and active support from the staff and management.

 
  References Top

1.
Licensure, accreditation, and certification: Approaches to health services quality. Quality Assurance Project. Bethesda, MD 20814 USA. Available from: http://www.urc-chs.com. [Last accessed 2013 Nov 20].  Back to cited text no. 1
    
2.
Rizk K. Human and Health.;2011. p. 2-3. Available from www.sysndicateofhospitals.org.lb/magazine/jun2011/english/Accreditation.pdf. [Last accessed 2013 Oct 18].  Back to cited text no. 2
    
3.
Available from: http://www.nabl-india.org. [Last accessed 2013 Oct 18].  Back to cited text no. 3
    




 

Top
Print this article  Email this article
 

    

  Site Map | What's new | Copyright and Disclaimer
  Online since 1st April '07
  2007 - Indian Journal of Cancer | Published by Wolters Kluwer - Medknow