|LETTER TO THE EDITOR
|Year : 2016 | Volume
| Issue : 1 | Page : 204-205
The road to laboratory accreditation: Experience of a tertiary care oncology center
NK Chital1, VG Bhat2, PD Chavan3, PC Bhat4
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 Publication||28-Apr-2016|
V G Bhat
Department of Microbiology, Research and Education in Cancer-Laboratory Services, Navi Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None
|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
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. 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  and enhances customer confidence in results issued by accredited laboratories.
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.
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