Indian Journal of Pathology and Microbiology

LETTER TO EDITOR
Year
: 2018  |  Volume : 61  |  Issue : 3  |  Page : 461--463

Current status and way forward for National Accreditation Board for Testing and Calibration Laboratories Accreditation of Laboratories in Government Organizations


Madhu Sinha1, Sneha Saini1, Poonam Gupta2, Natasha S Gulati1, Abhijit Das1, Ashok Kumar3, Man Mohan Mehndiratta3, Chandra Shekhar4,  
1 Department of Pathology, Janakpuri Super Specialty Hospital Society, New Delhi, India
2 Department of Microbiology, Janakpuri Super Specialty Hospital Society, New Delhi, India
3 Department of Neurology, Janakpuri Super Specialty Hospital Society, New Delhi, India
4 Department of Surgery, Dr. B. S. A. Medical College and Hospital, New Delhi, India

Correspondence Address:
Madhu Sinha
Department of Pathology, Janakpuri Super Specialty Hospital Society, C-2B, Janak Puri, New Delhi - 110 058
India




How to cite this article:
Sinha M, Saini S, Gupta P, Gulati NS, Das A, Kumar A, Mehndiratta MM, Shekhar C. Current status and way forward for National Accreditation Board for Testing and Calibration Laboratories Accreditation of Laboratories in Government Organizations.Indian J Pathol Microbiol 2018;61:461-463


How to cite this URL:
Sinha M, Saini S, Gupta P, Gulati NS, Das A, Kumar A, Mehndiratta MM, Shekhar C. Current status and way forward for National Accreditation Board for Testing and Calibration Laboratories Accreditation of Laboratories in Government Organizations. Indian J Pathol Microbiol [serial online] 2018 [cited 2019 Oct 16 ];61:461-463
Available from: http://www.ijpmonline.org/text.asp?2018/61/3/461/236622


Full Text



 Introduction



The medical laboratories are an integral part of the health-care system. To ensure timely, accurate diagnosis, treatment, and care to a patient, quality assurance in laboratory reporting is mandatory. International standardization of laboratory services is essential, and formal recognition is awarded by authoritative bodies such as National Accreditation Board for Testing and Calibration Laboratories (NABL), National Accreditation Board for Hospitals and Healthcare (NABH), College of American Pathologists, and Joint Commission International are required. NABL is a signatory to Asia Pacific Laboratory Accreditation Co-operation and International Laboratory Accreditation Co-operation through mutual recognition agreement since 2000.[1]

Accreditation is the procedure by which an accreditation body awards formal recognition that a body (laboratory) or person (signatory authority) is competent to carry out scope of tests.[2] This procedure imparts authorization and registration of a laboratory that it has demonstrated its competence and capability to carry out its specific scope.[3] The process involves assessment, re-assessment, and surveillance at regular intervals so as to ensure that commitment to quality and has to be continuous process.[4] Further accreditation reinforces and reassures quality by creating an opportunity to analyze the pitfalls which eventually creeps into the system as soon as we take our eyes off it.[2],[5]

Our hospital is an autonomous organization under the Government of NCT of Delhi since September 2013, established under Society Act 1861, having vision to match the existing super-specialty hospitals in both the public and private sectors and be a leading super-specialty tertiary care center. To achieve this, our institute decided to pursue the NABL accreditation for the diagnostic services in 2013, when Director was appointed in this Institute in January 2013. Under his vision in July 2014, our hospital got NABH certification for laboratory services, and then, we pursued NABL accreditation and we received it successfully in November 2015.

During the accreditation process, Organization appointed a quality manager to oversee the plan for accreditation and quality-related activities in coordination with the laboratory key personnel. Accordingly, quality policy endeavor was to provide the patients with accurate and precise diagnostic laboratory tests' reports of the highest quality for the satisfaction of patients and clinicians. To meet the objectives, the management ensured that all systems and processes required for the above are in place.

Quality objectives of our hospital

Issue accurate and precise reportsEnsure timely delivery of reportsCompliance to standard operating procedures (SOPs) and protocolsPatient satisfaction and careMaintenance and regular calibration of equipmentRegular training of staffQuality check by running internal controls and participating in External Quality Assurance Scheme (EQAS)Continual enhancement of quality by monitoring the quality indicators.

A step-wise approach was implemented.

With this quality policy and quality objective in mind, quality manual was prepared fulfilling compliance with ISO15189:2012 (Medical laboratories–particular requirements for quality and competence) and NABL 112 document (specific criteria for accreditation of medical laboratories)[2]Deputy quality managers and technical managers from Pathology, Microbiology, and Biochemistry departments were assigned to look into the accreditation-related functions of their respective sections in coordination with their key personnel and quality managerVarious documents such as quality system procedures, safety manual, SOP in various sections along with sample collection manual were preparedAccordingly, base-level documents such as forms, format, worksheets, and various other records were prepared for monitoring of the quality assurance [Figure 1]Automated analyzers and laboratory information system were placed through tender process for better quality of reporting, to enhance turn-around time and to decrease preanalytical, analytical, and postanalytical errors of laboratory services.{Figure 1}

NABL Accreditation process for a laboratory give insights for improvement and quality assurance to the concerned authorized signatory as well as laboratory personnel through various work activities which include the preanalytical, analytical, and postanalytical aspects. These all include as follows.

SOP for various testsInternal quality control monitoringEQAS participation with corrective and preventive measures The laboratory participated in EQAS activity for Microbiology, Biochemistry, and Hematology Laboratory by Sir Ganga Ram Hospital New Delhi; CMC Vellore; and AIIMS New Delhi, respectively.Maintenance of turnaround timeIntra- and inter-laboratory comparisonsCritical value reporting with proper communicationQuality indicator monitoringComplaint handling [Table 1].

Frequent internal audits were performed for each section of laboratory done by a competent person who has not authorized signatory for the same section but within the organization.

It helped us understand the deficiency of respective sections of laboratories against the set standards for accreditation. A gap analysis was performed through management review meeting with administration, account, and purchase departments of the hospital. It is mandatory for the continual improvement of the laboratory.

At present, of 867, approximately 85 (9.8%) accredited laboratories all over India are in government organizations [Table 2][6] including HIV testing laboratories. Of 85 accredited laboratories, HIV testing laboratories are 69 (81.1%), which are accredited by National AIDS Control Society. Hence, effectively only 16/867 (1.8%) laboratories in government organizations are accredited, out of which fair number of laboratories have only one/two section effectively included under NABL scope, whereas 782 (90.2%) private sectors are accredited.[6] It represents personal interest of a person leading the section involved with accreditation. In India, NABL accreditation is voluntary; there is a need for pressurization by government to implement it equally both in government and private organizations; benefits of accreditation are beyond expenses of accreditation [Table 3][7].{Table 2}{Table 3}

In 2009, mandatory NABL accreditation for CGHS empanelment gave a push for accreditation, but it mainly helped accreditation of private organizations.

In many developed countries, accreditation is mandatory, whereas accreditation scheme in India is voluntary. Under clinical establishment act, accreditation must be mandatory for registration of practicing health services and is essential for quality practice.

The outcome of successful accreditation resulted from the vision of organization “We may do less, but qualitative and quantity will follow.” Well-directed planning and effort, implementation, and active support from key personnel and management are necessary. As our hospital being a government organization successfully achieved, it continues to expand scopes of accreditation.

 Conclusion



In India, there is a need for emphasis by the government to implement NABL accreditation in government organizations to achieve international standards of quality services. Although it requires a great effort to implement but it is achievable. Proper dedicated quality assurance team and adequate government funding are required for accreditation and commitment to enduring quality services.

Acknowledgment

We would like to acknowledge the technical staffs of our department for technical help.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References

1General Information Brochure (NABL 100; Issue No: 01, Issue Date: 10/07/2017, Amendment No: 0). Available from: http://www.nabl-india.org/nabl/index.php?c=publicaccredationdoc&m=index&docType=both.
2Wadhwa V, Rai S, Thukral T, Chopra M. Laboratory quality management system: Road to accreditation and beyond. Indian J Med Microbiol 2012;30:131-40.
3Kanagasabapathy AS, Rao P. Laboratory accreditation-procedural guidelines. Indian J Clin Biochem 2005;20:186-8.
4Kapil A. Accreditation of microbiology laboratories: A perspective. Indian J Med Microbiol 2013;31:217-8.
5Heigrujam RS, Singh NB. Accreditation of medical laboratories: A perspective. J Med Soc 2014;28:1-3.
6Directory of Accredited Laboratories (NABL 600; Issue No: 07, Issue Date: 01.07.2017, Amendment No: 0). Available from: http://www.nabl-india.org/nabl/index.php?c=publicaccredationdoc&m=index&docType=both.
7Specific Criteria of Accreditation of Medical Laboratories (NABL 112; Issue No: 03, Issue Date: 09.05.2016, Amendment No: 0). Available from: http://www.nabl-india.org/nabl/index.php?c=publicaccredationdoc&m=index&docType=both.