|Year : 2015 | Volume
| Issue : 1 | Page : 19-31
Medical diagnostic laboratories provisioning of services in India
Rahi Jain, Bakul Rao
Centre for Technology Alternatives for Rural Areas, Indian Institute of Technology Bombay, Mumbai, Maharashtra, India
|Date of Web Publication||14-Jan-2015|
Asso. Prof. Bakul Rao
Centre for Technology Alternatives for Rural Areas, Indian Institute of Technology Bombay, Powai, Mumbai - 400 076, Maharashtra
Source of Support: None, Conflict of Interest: None
Context: Diagnostic services have a very important role to play in medical decision-making, which have an impact on the nation's health status. The understanding of Indian diagnostic services provisioning has certain literature gaps. Aims: This study focused on understanding the functioning of provision of diagnostic services by Indian diagnostic laboratories. Materials and Methods: Exploratory field visits and literature review were used as tools to understand the Indian health system. Results: Indian diagnostic laboratory can be classified into various categories based on the type of services provided and governance. The difference in their financing, resources, quality assurance of services and patient access to services was found in these different laboratories. Conclusions: It was concluded from the study that patient's access to laboratory services is affected by the functioning of laboratories in terms of governance, financing, resources, quality assurance of services and patient services.
Keywords: Indian diagnostic laboratories, Indian medical laboratories functioning, laboratory diagnosis in India, Indian medical laboratory services
|How to cite this article:|
Jain R, Rao B. Medical diagnostic laboratories provisioning of services in India. CHRISMED J Health Res 2015;2:19-31
| Introduction|| |
Laboratory diagnostic services play a critical role in all health-related decisions both of an individual as well as of the population.  A good understanding of country's laboratory services is needed for success in the programs related to health ,, and laboratory.  In case of India, diverse types of laboratories are present, which are either public or private sector diagnostic laboratories, which can be further classified into 'Hospital-attached' laboratory (HAL) and 'Stand-alone' laboratory (SAL) [Figure 1]. HALs are either present within the hospital ('Hospital-attached fixed' laboratory (HAFL)) or attached to the hospital ('Hospital-attached mobile' laboratory (HAML)). SALs are laboratories not attached to hospitals, run by government, individuals or corporate.
|Figure 1: Indian diagnostic laboratories classification (boxes with color background reflect the places which were part of discussion, dotted line is used to indicate examples)|
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HAFLs can either be hospital-owned laboratory or be contract private laboratories that are provided space in the hospital premises. Public HAFLs are at primary, secondary and tertiary levels of health care. At the primary health care level, laboratories can be present in sub-center (SC), primary health care center (PHC) and community health center (CHC) in rural areas and dispensaries in urban areas catering to the primary health care needs of the population. At the secondary level, laboratories can be present in sub-district hospital (SDH), maternity and child hospital (MCH) and district hospital (DH), all of which are located in urban areas. At the tertiary level, the diagnostic laboratories are present in tertiary care hospitals attached with the medical colleges. Secondary and tertiary care hospitals are expected to cater to the secondary and tertiary health care needs of both urban and rural people. In case of private sector, HAFLs are present in private hospital both standalone and those attached to private medical colleges. However, small hospitals and clinics may not have laboratories of their own and rely on the services of SALs.
Mobile laboratories in both public or private sector are either permanent (established in a vehicle (like Vans, Boats  )) or temporary (conducted as part of health camps), which are commonly used to provide primary health care services and are extensions of an existing health care institution like tertiary hospital and DH.  For example, a mobile medical unit managed by All India Institute of Medical Sciences (AIIMS), Delhi, provides some basic diagnostic facility in Ambedkar Nagar, New Delhi, on a regular basis. In another case, regular health camps are conducted by Maharashtra Institute of Medical Sciences and Research (MIMSR) College, Latur, in rural areas.
Public SALs are namely public health laboratories and research institutes. These laboratories are not only involved in research and health status monitoring, but also provide the public laboratory services when needed. Private SALs are focused in providing laboratory services and can be further classified into corporate labs and non-corporate labs. Corporate labs are large scale laboratories performing tests on samples received from around the country (e.g. Metropolis, SRL Diagnostics, Dr Lal's Pathology, Thyrocare and Anand Labs).  Non-corporate laboratories are regional or local labs whose operations are limited geographically. ,
Several concerns related to Indian health care and its diagnostic services have been raised. National health programs have been unable to meet various health outcomes like disease control, malnutrition eradication and achieving Millennium development goal targets owing to the inadequate and inaccessible health services, weak preventive measures and inadequate resources. ,,,,, Secondary and tertiary institutions are overburdened with catering to primary health care need of the urban people owing to the inadequate primary health care facilities, lack of awareness in the patients and weak referral system. , Inadequate/wrong disease control often happens owing to inadequate laboratory services. ,, Laboratory diagnostic services has low market share despite its significance in decision-making. , Unorganized laboratory service providers are present catering to the unmet demand.  Better diagnostic products are demanded, which are compatible with Indian ambience. 
These concerns raised by various researchers and lack of comprehensive understanding of diagnostic laboratory functioning in providing services necessitates a need to understand the services provided by Indian laboratories before providing any intervention to address those concerns. This study focused on understanding Indian laboratory services so as to address the existing gap in India's laboratory services, thus, helping in better programmatic design.
| Materials and Methods|| |
The methodology for understanding different laboratory services can be developed into various themes, namely, laboratory governance, financing, resources and services and its quality assurance. The understanding was developed by visiting health care institutions at all levels [Figure 1] and reviewing of journal papers and gray documents. The field-based information was collected by performing open-ended and unstructured discussions with various key personnel (doctors, laboratory head and laboratory technicians) in both the public and private sectors [Table 1]. However, scope of this study did not include the legal compliance or accreditations of these institutions because the attempt was to understand the services provided by laboratories rather than legality of those institutions.
Lack of any standard questionnaire for such discussions has led to a general set of basic questions for the study [Table 2]. The use of the questions and in-depth discussions was based on the position in hierarchy system and experience of the key personnel.
| Results|| |
The study performed to understand the diagnostic services in India revealed a complex functioning mechanism of Indian laboratory in public sector and relatively simpler mechanism in private sector. The various aspects of functioning studied included governance structure, financing mechanism, resource, quality assurance system and patient services mechanism are discussed in detail hereon.
Diagnostic services provided by laboratory are dependent on the governance structure, which plays the decision-making role in funds sanctioning, laboratory administration, laboratory operations and provision of services type. Laboratories are a part of three different levels of governance structure namely health system level [Figure 2], institution level [Figure 3] and laboratory level [Figure 4].
|Figure 2: Health system-level governance structure of laboratories (dotted line is used to indicate indirect connection)|
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|Figure 3: Institution level governance structure of hospital attached public laboratories (dotted line is used to indicate example)|
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|Figure 4: A sample case study of Thane civil hospital for institutional and laboratory level organization structure|
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Health system-level governance system deals with both inter-laboratory as well as overall coordination and governance of laboratories to improve utilization and access of resources and services by differential distribution of services at different levels in health system. It is prevalent in public laboratories and some corporate SALs. In public laboratories, public SALs are part of the health system-level governance while public HALs become indirectly part of the health system-level governance through their host institutions, which are part of the health system-level governance. These laboratories are mainly under state government as health is a state subject according to the Seventh schedule of the Indian Constitution,  but central government may influence indirect control through central health funds.  In addition, various laboratories may be under the different central government ministries (like railways, defense and health), institutes (Indian Institute of Technology (IITs)) and companies (Rashtriya Chemical Fertilizers Ltd.) as shown in [Figure 2]. For example ICMR labs under Department of Health Research (DHR) (Ministry of Health and Family Welfare (MOHFW)), AIIMS and CGHS health care institutions  under MOHFW, IIT Hospital under Indian Institute of Technology Bombay (IITB), RCF hospital under Rashtriya Chemicals and Fertilizers (RCF) limited and Railway Hospitals under Ministry of Railways. A multi-tier governance structure exists for laboratories under Ministry of Railways  and State government. In case of corporate labs, two-tier hierarchy exists in certain cases where the lower-level laboratory serves the regional needs of basic, simple and common tests while the higher-level laboratory serves the national needs by providing more sophisticated and advanced tests.  The existence of multiple vertical governance structures indicates the potential duplication of the resource and efforts as well as greater challenges in horizontal coordination of these laboratories.
The study focused on Maharashtra state as a case study to understand state-level governance structure, state public laboratories governance structure was understood based on reference to secondary literature like NRHM document  as well as the interactions with biochemistry lab head of MIMSR Medical College, Thane civil hospital head and deputy director of Maharashtra State Public Health Laboratories, and is shown in [Figure 3]. The laboratory governance comes under two different state ministries, namely, Directorate of Medical Education and Research (DMER) and Directorate of Health Services (DHS). In DMER, Director of Medical Education and Research is responsible for the governance of the laboratories in the medical colleges. The rest of the health system is the responsibility of the State Public Health Minister. Deputy Director of Public Health Laboratories is responsible for the governance of the various public health laboratories present within the state. Deputy Director of Health Services governs all the primary- and secondary-level health care institutions of the state. Primary-level health care institutions of a district are governed through the head of the public health office at the district level while secondary-level health care institutions of a district are governed through the head of the DH.
The institution-level governance is needed for the HALs as shown in [Figure 4], which plays the role of maximizing the utilization of the existing diagnostic services as well as providing new services, which are deemed important. Head of the institution is responsible for the overall governance of the institution (including the laboratories), which may/may not have departments. The institutions that do not have separate para-clinical departments, head of the laboratory and head of the institution can be same like PHC and SC, or it can be different with head of laboratory directly under head of institution like Powai hospital, Mumbai. In cases, where institutions have separate departments, like CHC, secondary health care and tertiary health care institutions, the diagnostic laboratories can be considered as a separate department led by its own department head. For example, Thane Civil Hospital, where radiology and biochemistry departments were separate, each with its own head [Figure 5]. In such cases, head of the laboratory and head of the department are same.
|Figure 5: State public laboratories governance structure for Maharashtra state|
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In other institutions like AIIMS and Pt. Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), a group of laboratories along with other facilities (treatment, research, teaching, wards and patient consultation) were clubbed under a single department to provide more focused and specialized health care service . In case of AIIMS, diagnosis of different bacterial diseases is performed in Department of Bacteriology, which has many different specialized bacteriology laboratories. Pharmacology laboratory in AIIMS is under Department of Pharmacology, which also has pharmacology education, training and research facility. In case of PGIMS, Casualty Department is meant to cater to the emergency health care needs (both treatment and diagnosis) of the people and has its own set of laboratories like clinical biochemistry laboratory. Outpatient Department of PGIMS caters to the general health care needs (both treatment and diagnosis) of the people and has its own set of laboratories like pathology and biochemistry laboratory. In cases, when laboratory is a separate section of the department, a laboratory section head is appointed who may be different from the Head of department; such increase in the number of layers of governance hierarchy between the head of institution and head of laboratory could be critical for access of resources and funds as discussed in sections 3.3 and section 3.4.
At the laboratory level, the governance is important for systematic operations in laboratory services. The laboratories are headed by a Doctor/PhD (microbiology/pathology/biochemistry) (except in SC, where Auxiliary Nurse Midwife (ANM) heads the laboratory as no doctor is assigned to SC  ) with lab technicians mainly responsible for performing tests. Labs may have some additional junior doctors to perform more specialized tests. In addition, laboratories have administrative staff as well as cleaning staff that are either completely dedicated to the laboratory or are shared with other departments/facilities present in the same health care institution. A sample governance structure of Thane civil hospital is shown in [Figure 4].
Financing mechanism determines the stakeholders with decision-making power as well as ease and reliability of funds access, which plays an important role in making decisions related to the services provided by the laboratory. Based on the study, financing mechanism of existing Indian laboratories were classified as, user-pay model and government-pay model. Among the Indian laboratories, private laboratories have only user-pay model and public laboratories have both user-pay model and government-pay model. In case of user-pay model, users provide the funds by paying for the services used either directly or indirectly through agencies like insurance, government and employer. Since, in this model funds are received only when services are used, the model is dependent on the user's needs and funds are highly dynamic due to high day-to-day variability in user's needs. In case of government-pay model, government provides funds to the laboratories in the form of budgetary allocation at the start of the financial year, which are released only once or twice a year. The budgetary allocation of fund will depend on the expected user demand for the services, which is dependent on the expected user's needs. However, funds obtained from this model as compared to user-pay model are not dynamic and only have yearly/five-yearly variability based on the period of time for which the funds have been sanctioned.
The access to the received or sanctioned funds for the laboratories is dependent on both the financing model used and sector (i.e. public sector and private sector) in which laboratory is present, as shown in [Figure 6]. In case of government pay-model for public laboratories, the released government funds trickle down to the laboratory through the multi-tier health system-level governance hierarchy. As a result, the time taken by the sanctioned funds to reach the laboratory will depend on the position of the laboratory/its institution in the multi-level hierarchy. At the institution level, in cases where laboratories are part of the institution like secondary-level institutions, tertiary-level institutions, research institutes, CHC or are under state public health laboratory, the sanctioned funds are obtained after providing the laboratory expenditure bills to the institution. In case of PHC and SC, instead of direct funds, required resources are provided to the PHC and SC by Public Health Office.
|Figure 6: Financing mechanism for Indian diagnostic laboratories (dotted line indicate multiple sub-steps)|
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In case of user-pay model for public sector, the funds collected by the laboratory or its institution are given to the government through health system-level governance structure, if allowed, with very little funds being retained by the laboratory. The funds received by the government are used to make national or state budget and may be received indirectly through the government-pay model. This provides very little incentive for the laboratories to focus on user-pay model for financing the laboratory and make them dependent on the government budgetary allocation. In case of user-pay model for private sector, the funds obtained from user are either directly retained by the laboratory or are given to the institution or laboratory headquarters. In case funds are given to the institution or corporate headquarters, the funds are returned to the laboratory for next cycle of operations.
Resources required to the laboratories are in the form of manpower, consumables and infrastructure. The amount and type of resources required by the laboratory are based on the size of the laboratory, level of automation and type of tests. Further, in terms of manpower, laboratories generally have at least one doctor/PhD (microbiology, biochemistry or pathology) and lab technician as doctor is needed to certify the tests carried out in the laboratories and lab technician is needed to perform the tests. Other types of manpower like cleaning staff, accounts staff and administrative staff presence is more flexible and are part of laboratory in case of SALs while shared with other departments in hospital attached institution.
In case of public laboratories, the resource variation is prevalent and is based on the health care level at which the laboratory is present and specialization of the laboratory, as shown in [Table 3]. SALs perform highly specialized tests, which may or may not be very skill intensive. Research institutes are of central-level SALs, and normally perform highly specialized and advanced tests like characterization of pathogens and identification of new diseases. They at least have a doctor or PhD (microbiology, biochemistry or pathology) but may have many more depending on the number of laboratories in the institute and type of the tests performed by the institutes. Similarly, state-level SALs like state public health laboratory as well as regional and lower-level public health laboratories perform limited number of highly specialized tests. It was observed that, complexity and number of tests may reduce for the laboratories while moving down the hierarchy level. The state-level laboratory had at least one PhD personnel handling the lab while lower labs were not having the PhD personnel heading the lab as they reported results to doctor rather than patients. Resources required for the state-level labs are high while that to lower-level labs are relatively medium or low.
|Table 3: Resource profile of laboratories present in different public institution|
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Tertiary-level health care institutions in public sector are generally equipped to perform a large variety of tests and contain many labs with each lab specialized in performing certain category of tests like biochemistry, pathology, bacteriology, immunology, virology and X-ray. On the basis of the tests performed, laboratory can be either highly specialized or specialized in nature with overall resource requirement for the laboratories is high, with each lab run by at least one doctor and two lab technician. Secondary-level health care institutions like DH, SDH and MCH also have labs, which are less specialized and require less funds than the labs present in the tertiary care institutions.
Laboratories in primary-level health care institutions in public sector require lower resources which decrease as the laboratory level goes down in the hierarchy. Laboratories in CHC can provide both general and specialized facilities. Dispensary and PHC-based laboratories provide very general tests and require very low resources. In case of SC, laboratory performs preliminary tests, which require least resources and minimum skills and space requirement. As a result, the tests are performed by Auxiliary Nurse Midwife (ANM).
In case of private laboratories, corporate labs rely significantly on automation as the scale of operations are national level, the automation reduce the overall manpower required to perform per test but they are resource-intensive in terms of other resources namely consumables and infrastructure. In case of other private labs (including HAL and non-corporate laboratory) may or may not be as resource-intensive as corporate labs related to consumables and infrastructure owing to smaller scale of operation, but the manpower requirement per single test may depend on the level of automation of the lab and type of tests offered.
Diagnostic tests and its allied instrument form the main consumable and infrastructure component of the laboratories, which can be procured from an Indian manufacturer or imported. However, Indian manufacturers in this market are relatively less as compared to the imported, both in terms of the volume of manufacturing and the type of tests and instrument manufactured, as a result imported products have a significant presence. ,, Further, quality of resources, price at which laboratories provide services, after-sales service and ease of procuring all the resources for a particular test also determine the source of resource. Laboratories in the public sector prefer to procure resources of the Indian manufacturers if the products are cheaper and are of comparable quality as compared to the foreign manufacturers. This is because government allocates limited funds to the health sector and services are mostly offered free of cost, so the focus has been on procuring the cheap and best resources to maximize the coverage of the services.
In case of private laboratories, both the non-corporate and corporate laboratories follow similar trajectory for resource procurement, which is dependent on the target market segment. Indian market segment could be broadly classified into two parts namely price-sensitive masses and price-insensitive elites. In case of price-sensitive masses, the business model of lower prices and high volume is adopted by both non-corporate and corporate laboratories with suppliers with cheapest desirable quality products and, better after-sales services being opted. Though, the relative importance of cost and quality may vary depending on the operating price point of the laboratory and user demand. Non-corporate labs especially smaller laboratories may opt for Indian manufacturers because of more pressure to minimize the cost to maximize the customer base in its limited geographical coverage. In a corporate lab, the resources are imported in many cases because the supplier can provide the instrument along with the customized consumables to ensure better quality assurance and after-sales service. In case of price-insensitive elites, the business model of high prices and low volume is adopted by both non-corporate and corporate laboratories with imported resources highly dominating this segment owing to the need of highly customized resources with high-quality assurance and after-sales service.
Quality assurances systems a laboratory can have
In India, quality assurance system can either directly or indirectly affect the quality assurance of laboratories. Laboratories are not required to follow any quality assurance system directly. The voluntary quality accreditation system does exist for the labs, ,,, which are provided by two certification agencies namely National Accreditation Board for Testing and Calibration Laboratories (NABL) and National Accreditation Board for Hospitals and Healthcare Providers (NABH).  NABL accreditation ensures meeting of international standards ISO/IEC 17025 and ISO 15189 by the laboratory.  Out of the estimated 100,000 laboratories in India,  only 402 laboratories are NABL accredited.  Even from the field study, it was observed that only two laboratories (Accura and Thyrocare) claimed accreditation. NABH accreditation for laboratories is an intermediate-level quality assurance certification mechanism, which acts as stepping stone to promote labs to aim for NABL accreditation.  Under NABH, labs can get accredited as a part of health care institution certification or as SAL. In total, 10 government laboratories  and 40 private laboratories have been accredited under NABH. 
Apart from NABL and NABH accreditation-based quality assurance mechanism, another mechanism namely Inter-Laboratory Comparison (ILC)-based quality assurance system has been found from the field visits. In this mechanism, laboratory may compare its results with a reference laboratory and may seek accreditation from those reference laboratories. For example, biochemistry lab of MIMSR Medical College has registered with Christian Medical College (CMC), Vellore external quality assurance program and has received accreditation from CMC.
Corporate laboratories are organized and accredited while non-corporate laboratories are believed to be un-organized and without accreditation , and which was observed to certain extent in the field visits like pathology lab in Powai hospital. However, non-corporate labs can also be accredited as supported by the NABL- and NABH-accredited laboratories list provided in literature. ,,
Some of the reasons in literature, which have been attributed to the neglect of quality assurance mechanism, have been cost and tediousness of the process  and have been even been cited during field visits (like Accura, Thyrocare and RMRC). In addition, field visits (namely labs of PGIMS) indicated an additional issue of lack of adequate awareness of the existence of accreditation systems.
Indirectly, certain level of quality assurance of many laboratories is provided by regulating the quality of the diagnostic products supplied in the market for use by the diagnostic laboratories namely In vitro Diagnostics (IVDs) like kits and reagents and X-ray machines .  The products are regulated by Medical Devices and Diagnostics Division, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. The organization is led by Drug Controller General of India. , The state drug offices/State Food and Drug Administration (FDA) are then responsible for example monitoring of quality of drugs and diagnostics products manufactured by respective state units and those marketed in the state. 
The intensity of regulation of products manufactured depends on whether products are classified into notified/critical and Non-notified/non-critical devices. Critical devices are the ones used for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C Virus (HCV), blood grouping reagents and malaria tests. Rest all devices are categorized as non-critical devices. In case of critical devices, the manufacturer first submits application to Drugs Controller General of India and on approval, a test license is issued. The applicant is to send five test batches to either National Biological Laboratory (located in Noida) or National Institute of Communicable Disease (NICD) (in New Delhi) for testing the quality consistency. If approved, manufacturing license can be applied from the central authorities. An audit will be conducted in the unit, after which the manufacturing license is granted. The whole process takes 3-6 months. , For non-critical devices, the application is to be filed only with state drug offices with no requirement for applying for test manufacturing license to Drugs Controller General of India or performing test batch evaluation. 
General people can access the public health care services of the institutions, which are run by the state health ministry or MOHFW. Other public sector health care institutions run by other ministries, government institutes and government companies cater to the needs of the specific group of the people and provide restricted services as well as access to the general people. Different types of laboratories provide different services, which are different in the type of tests provided, number of tests, method of testing and process of accessing the tests and its results. The type and number of tests provided by the laboratory depends on the health care level at which it is present. A standard list of laboratory services/tests for the public secondary- and primary-level HAFLs is given by the Indian Public Health Standards (IPHS) ,,,, as shown in [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], but many laboratories functional in these institutions may not be following IPHS guidelines. , All other public and private laboratories have not been provided any fixed list and can have any number of diagnostic tests.
|Table 4: IPHS for disease specific laboratory tests in different health care institutions|
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|Table 5: IPHS for blood sample-based laboratory tests in different health care institutions|
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|Table 6: IPHS for non-blood sample (urine, stool, Sputum, vaginal discharge, bone marrow, cerebral spinal fluid and cervix samples)-based laboratory tests in different health care institutions|
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|Table 7: IPHS for medical imaging-based laboratory tests in different health care institutions|
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|Table 8: IPHS for other laboratory tests (tests which either do not need sample or need multiple sample or can be performed for different sample) in different health care institutions|
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Primary-level institutions and mobile laboratories commonly provide preventive services. Secondary- and tertiary-level health care institutions have many laboratories involved in performing diverse set of large number of tests and use advanced testing methods as compared to primary health care-level laboratories. Secondary and tertiary institutions primarily focus on providing curative services, while having capability to provide both preventive and curative diagnostic services. In general, the maximum number of tests can be performed at a tertiary-level health care institution of an area. In case of research and SALs, the tests are generally very specific in nature, which are used to provide curative diagnostics.
In case of private SALs, the focus was more on preventive diagnostic tests which had a high predictive demand. In case of corporate laboratories, additional focus was given to those tests which could be automated as it enabled standardized results and high throughput. In case of HALs, the type of the tests focused on both preventive and curative diagnostics.
Patients have different type of access facility in different laboratories. In the public laboratories at the primary-, secondary- and tertiary-level institutions, the patient has to make a visit to the doctor who would refer to the laboratory. The public laboratories are kept economically accessible for all sections of society by levying no to minimal user charges. The laboratory to which a patient is referred can be in the same or a different institution and the sampling was done in the laboratory or in the periphery (ward/clinic) from where it was sent to the laboratory. All the samples received by the laboratory are processed (like providing lab identity number, sample preparation, sample recording) and analyzed within the laboratory. Results obtained from the analysis are reported to the doctor responsible for validating the results and signing the report. Once the results are confirmed by doctor, the final report is signed and is provided to the patient or concerned doctor and the results are updated in the records. The records could be either a registers or an electronic database or both.
In case of state public health laboratories and research laboratories, the reports are directly sent to the concerned doctor or to the requesting laboratory (and never to the patient) who will validate the results. Since, results are given only to the laboratory or a doctor; these laboratories may not have a medical doctor within the laboratory for result validation.
Some of the research and public laboratories perform specialized activities. Some of them can act as referral laboratories, which are supported under Integrated Disease Surveillance Project (IDSP) to diagnose, monitor and track certain epidemic diseases.  In addition, certain special laboratories are being set-up under certain programs like Tuberculosis Diagnostic Laboratories under Revised National Tuberculosis Control Program (RNTCP). 
In case of private laboratories, patient can access the laboratory either directly or through the reference of the doctors, but for economically weaker sections such laboratories may not be accessible due to high charges. The sample collection can be done at lab or outside lab like in wards, home. Collected sample follow the same steps as followed by the samples given to the public laboratories. In case of large corporate-based laboratory services, where centralized laboratory exists (like thyrocare), samples from clinics/hospitals/patient house are transported to their collection center from where they are sent to the centralized laboratory. The sample is analyzed in the centralized laboratory and the results obtained are reported and sent back to the patients or doctor.
| Discussions and Conclusion|| |
The study provided an understanding on the current functioning of the different diagnostic laboratory services in India. The existence of different types of laboratories under different governance structure raises concerns regarding resource and service coordination to avoid potential resource duplication. The process to access the sanctioned/received funds for public laboratories is found to be challenging with potential time lag risks. The resource's access varies with laboratory type and equipments and consumables-based resources are found to be significantly dependent on the import and hence could increase the burden on Indian Foreign Currency Reserves. Indian regulatory system for laboratory services is almost non-existent raising concerns regarding the quality assurance of the services. The limitations on the access to services for the user were found in both the public and private sector.
The limited field work and exploratory nature of field work could have resulted in missing out of certain more institution-specific aspect of the functioning. However, the scope of the current study, which is more focused on macro-level understanding of the laboratory services functioning, so more micro-level understanding was beyond the scope of study.
| Acknowledgement|| |
We would like to acknowledge the support provided by the undergraduate students namely Gaurav Mani, Thirupathi and Nitin Chavan in performing this study who were involved in this as a part of their course Technology and Development Supervised Learning (TDSL).
| References|| |
Westgard JO, Darcy T. The truth about quality: Medical usefulness and analytical reliability of laboratory tests. Clin Chim Acta 2004;346:3-11.
Abimiku AG. Institute of Human Virology, University of Maryland School of Medicine PEPFAR Program (AIDS Care Treatment in Nigeria [ACTION]). Building Laboratory Infrastructure to Support Scale-Up of HIV/AIDS Treatment, Care, and Prevention: In-Country Experience. Am J Clin Pathol 2009;131:875-86.
Reid MJ, Shah NS. Approaches to tuberculosis screening and diagnosis in people with HIV in resource-limited settings. Lancet Infect Dis 2009;9:173-84.
Ridderhof JC, van Deun A, Kam KM, Narayanan PR, Aziz MA. Roles of laboratories and laboratory systems in effective tuberculosis programmes. Bull World Health Organ 2007;85:354-9.
Nkengasong JN, Mesele T, Orloff S, Kebede Y, Fonjungo PN, Timperi R, et al
. Critical role of developing national strategic plans as a guide to strengthen laboratory health systems in resource-poor settings. Am J Clin Pathol 2009;131:852-7.
National Rural Health Mission. Framework for Implementation (2005-2012) [Internet]. New Delhi. Available from: http://www.mohfw.nic.in/NRHM.htm
. [Last cited on 2012 Oct 17].
KPMG and CII. Excellence in Diagnostic Care: Creating a value chain to deliver an excellent customer experience; 2011.
Programme Evaluation Organisation. Evaluation Study on National Rural Health Mission (NRHM) in Seven States. Vol I. New Delhi; 2011.
Programme Evaluation Organisation. Evaluation Report on Integrated Child Development Services (ICDS). Vol I. New Delhi; 2011.
Programme Evaluation Organization. Evaluation Report On Integrated Child Development Scheme (ICDS) Jammu and Kashmir; 2009.
Planning Commission of India. Health. In: Twelfth Five Year Plan (2012-2017): Social Sectors (Volume III). p. 1-46.
Central Statistical Organization. Millenium Development Goals India Country Report 2011; 2011.
Mallya PD. Health in India: Need for a paradigm shift. Proc Soc Behav Sci 2012;37:111-22.
Gangolli LV. Review of Mumbai: Centre for Enquiry into Health and Allied Themes; 2005.
National Health Mission. National Urban Health Mission: Framework for Implementation; 2013.
Sundar S, Mondal D, Rijal S, Bhattacharya S, Ghalib H, Kroeger A, et al
. Implementation research to support the initiative on the elimination of kala azar from Bangladesh, India and Nepal - The challenges for diagnosis and treatment. Trop Med Int Health 2008;13:2-5.
Singh RK, Pandey HP, Sundar S. Visceral leishmaniasis (kala-azar): Challenges ahead. Indian J Med Res 2006;123:331-44.
Khatri GR, Frieden TR. Controlling tuberculosis in India. N Engl J Med 2002;347:1420-5.
Finpro. Diagnostic Center Feasibility Study-India [Internet]. 2008. Available from: www.finpro.fi
. [Last accessed on 2014 Mar 02].
Constitution of India. Seventh Schedule. 1949;(Article 246):264-77.
Jeffery R. Health planning in India 1951-84: The role of the Planning Commission. Health Policy Plan 1986;1:127-37.
National Rural Health Mission. Indian Public Health Standards (IPHS) Guidelines for Sub-Centres Revised 2012;2012.
Mahal A, Varshney A, Taman S. Diffusion of diagnostic medical devices and policy implications for India. Int J Technol Assess Health Care 2006;22:184-90.
Chakravarthi I. Medical technology in India: Tracing policy approaches. Indian J Public Health 2013;57:197-202.
Chakravarthi I. Medical equipment industry in India: Production, procurement and utilization. Indian J Public Health 2013;57:203-7.
Kapil A. Accreditation of microbiology laboratories: A perspective. Indian J Med Microbiol 2013;31:217-8.
QCI. Quality Council of India: Working for "National Well Being" [Internet]. Available from: http://www.qcin.org/
. [Last cited on 2014 Mar 01].
Quality Council of India (QCI). Medical Laboratory Programme: Essential Standards for Medical Laboratory Programme [Internet]. Natl Accredit Board Hosp Healthc Provid 2010;11. Available from: http://www.nabh.co/main/mlp/Standard.asp
. [Last cited on 2014 Mar 01].
National Accreditation Board for Hospitals and Healthcare Providers (NABH). Medical Laboratory Programme: Registered Government Labs [Internet]. Available from: http://www.nabh.co/main/mlp/complied_gov.asp
. [Last cited on 2014 Mar 01].
National Accreditation Board for Hospitals and Healthcare Providers (NABH). Medical Laboratory Programme: Registered Private Labs [Internet]. Available from: http://www.nabh.co/main/mlp/complied_pvt.asp
. [Last cited on 2014 Mar 01].
Central Drugs Standard Control Organisation (Medical Devices and Diagnostic Division). In-Vitro Diagnostic (IVD) Devices Frequently Asked Questions [Internet]. 2013. Available from: http://cdsco.nic.in/writereaddata/Final FAQS-IVD.pdf
. [Last accessed on 2014 Sep 25].
National Rural Health Mission. Indian Public Health Standards (IPHS) for Primary Health Centres Revised Guidelines 2012; 2012.
National Rural Health Mission. Indian Public Health Standards (IPHS) Guidelines for Sub-district/Sub-Divisional Hospitals (31-100 bedded) Revised 2012; 2012.
National Rural Health Mission. Indian Public Health Standards (IPHS) Guidelines for Community Health Centres Revised 2012; 2012.
National Rural Health Mission. Indian Public Health Standards (IPHS) Guidelines for District Hospitals (101-500 bedded) Revised 2012; 2012.
Programme Evaluation Organization. Functioning of Community Health Centres (CHCs). New Delhi; 1999.
Programme Evaluation Organization. Evaluation Study on Functioning of Primary Health Centres (PHCs) Assisted under Social Safety Net Programme (SSNP). New Delhi: 2001.
National Centre for Disease Control. Integrated Disease Surveillance Project (IDSP); 2012.
Revised National Tuberculosis Control Programme Laboratory Network: Guidelines for Quality Assurance of smear microscopy for diagnosing tuberculosis. New Delhi; 2005.
[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]
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