The different concepts of quality in health care have implications for nature, structure and composition of health service systems. Issues of access, cost and quality of care are intricately linked with each other; for recipients, providers and policy-makers. Quality of services provided at an institution level and at systemic level, along with tangible and intangible dimensions, individual patient's interests of getting cured and larger societal interests of improved health status, make the issue of quality a complex web. This paper traces the way policy and planning have dealt with the issues, upto the present, including the NRHM, the HLEG and 12th Plan Steering committee reports.
Key words: quality in health care, historical development in India, quality assessment, accreditation, HLEG, steering committee.
Issues of Quality in Health Care for Universal Access
The discussion around Universal Health Care (UHC) offers an opportunity to seriously rethink the model of health care delivery; including opening up of core issues pertaining to the provision of good quality services. The literature on quality of health care addresses the subject at different levels: quality of care delivered to 'a patient' and quality of health service systems providing care to populations. The discourses on quality at both these levels are interdependent but involve different perspectives on initiatives for improvement. 'Quality' is often cited as one of the important reasons for the growing utilization of health care services in the private sector, and for introducing market mechanisms in the public sector through public-private partnerships.
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The shift from public provisioning of services towards purchasing of services has resulted in increased attention being given to the issue of quality. It has shaped the discourse on quality such that the emphasis is on different ways of measuring hospital performance and the quality of hospital care.  As the governments and the societies are paying more attention to health service quality, a more explicit understanding of the concepts of health care and quality of care are required. The different understanding may lead to different policy paths, strategies and active measures. 
'Quality' in health care
The definitions and notions of quality are dependent on the stakeholders (users, providers, payers), their perspectives and the intention that underlies their approach towards health care and quality improvement. For example, the management cares more about efficiency and profits whereas for the users what matters is the availability of patient-centered services that cater to their individual needs. The situation may be further complicated with the entry of insurers and purchasers along with the users and providers; all of whom have dissimilar needs and concerns leading to conflicting definitions of quality. In addition to different approaches the wide differentials in knowledge and thus power between medical professionals and patients begs the question as to whose notion of quality is considered legitimate. There are situations where the felt needs (wants) of the patient are at variance with clinically assessed needs of the patients which affect the perception of quality.
Much of the literature on quality has been derived from management studies meant for the industrial and manufacturing sector.  We have an intuitive understanding of the meaning of quality. Yet when one sets out to study and apply these concepts it becomes elusive owing to its complex and multidimensional nature. This aspect underlies the failure or degeneration of many efforts in this direction. The notion of quality is most clearly defined when it is context, time, space and activity specific. 
According to Donabedian  while assessing quality in health care all the domains of quality- structure (human resources, money, and material), process (delivery of services) and outcomes of health care must be considered. However these three domains have been addressed with differential weightage at different points of time.
Donabedian not only concentrated on the technical domain consisting of infrastructure, knowledge and skill of a provider, but also on the interpersonal relationships between patient and caregiver. With his concept the patient's perspective was taken into consideration for the first time while assessing quality. Donabedian argued that quality of care has several dimensions which he later developed into what is known as seven pillars of quality viz. Efficacy, Effectiveness, Efficiency, Optimality, Acceptability, Legitimacy and Equity. He further adds that health care professionals must take into account patient preferences as well as social preferences in assessing and assuring quality.  When the two sets of preference disagree the physician faces the challenge of reconciling them. Pursuit of each of the several attributes of quality can be both mutually reinforcing and conflicting hence achieving a balance is important.
Levels of 'Quality' in Health care
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M.I. Roemer and C. Montoya-Aguilar have analyzed the concept of quality of health care at two levels. First, at a more general level, where resources or inputs, processes and outcomes of health care are involved, quality becomes an attribute of the system as a whole in all its aspects. When appraising the quality of health care services provided to an individual it is natural to pay attention to the specific outcome where as at a population level what matters most is changes in survival, morbidity, disability, etc. "Thus quality signifies proper performance (according to standards) of interventions that are known to be safe, that are affordable by the society in question, and that have the ability to produce an impact on mortality, morbidity, disability and malnutrition". 
Yang Hui  suggests different definitions of quality at different levels, viz. one at an individual level and another at a population level and these are discussed below.
1 The definition of quality of care at the individual level:
For an individual, high quality service means conditions where one has the "ability to see the doctors and get care and treatment for the diseases, or illness". This idea can be simplified into two parts: whether individuals have access to the structure and process of health services, and whether such services are effective, the terms used to denote these are 'accessibility' and 'effectiveness'.
Accessibility: Along with obvious components like geographical/ physical access other dimensions like affordability of services, and 'soft' components like regulations, institutional and human factors are important elements of accessibility.
Effectiveness: It is the outcome of services provided to meet the needs and the degree of closeness to the anticipated outcome. Effectiveness has two components, clinical care and inter-personal care.
Inter-personal aspects of service provision and the nature of clinical services are critical for dispensing effective health care. An emphasis on just one of these is erroneous. The methods for measuring these aspects of quality differ greatly. Customer-centered service and communication between doctors and patients require methods that are more time-consuming, less evolved and more expensive than searching hospital clinical databases via computers for assessing effectiveness of clinical services. 
2 The definition of quality health care at a population level:
The quality of health care at a population level is defined as: 'the ability to obtain affordable service on the basis of efficiency and equity' thus highlighting the three important components equity, efficiency and cost.
'Equity' is the degree to which all the individuals from a population can obtain necessary services according to their need. Efficiency is the ratio of returns to cost, i.e., to maximize outcomes with a particular input. Efficiency could be divided into allocation efficiency (focus on the measures to maximize returns) and technical efficiency (focus on technical capacity). As for individuals, technical efficiency is more important, which allows individual users to maximize their expected outcomes. However, such maximization is neither continuous nor affordable for population health services. Allocation efficiency becomes important for population health, effectively distributing resources into the areas where health could possibly be obtained.  Resource allocation is determined by a society's choice, which could be justified by need and equity. The balance between equity and efficiency is a permanent theme for health care quality, but this does not mean that efficiency and equity are mutually exclusive. The key concern here is how to integrate economic and clinical motives with social motives.
According to Yang Hui the quality of individual health care is "the ability to obtain effective health services according to needs and aiming at maximizing the health benefits"; the quality of population health care is "the capacity to obtain effective services through efficient and equal means to optimize population health benefits".
Challenges to 'quality' assessment in health care
Baru and Kurian  argue that it is necessary to ensure that quality services are available, accessible and responsive to the felt need of different sections of the population. They categorize quality into tangible and intangible dimensions.
Tangible dimensions include availability of infrastructure, medicines, manpower, location of services, transport facilities, financial resources available, distance and the cost of health care.
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Intangible dimensions include; Functional quality (manner of services delivery i.e. issues like time taken, queues, organization of services, administrative procedures involved), Technical quality (comprehensiveness and rationality of care) and Interactive quality (reliability, responsiveness, assurance, empathy provided by caregiver).
They argue that, these dimensions of quality care are interdependent and interlinked. They show how intangible and tangible factors together, affect perceptions of quality.
It becomes evident that health care services are different from other services industries and have their own peculiarities. Quality in health services need product attributes spelt out while other industries need only to meet customer requirements. Hence standard industrial quality management approaches cannot deal with this. Each individual patient-health service interaction episode consists of an intangible, unique, highly variable and contentious process. Unlike many products and services, health care has intrinsic moral and ethical dimensions in its production as well as delivery. 
The criteria and standards used to assess quality of care come from the dimensions of care under study and values that one uses to judge them. Selection and defining the boundaries of dimension/component of care selected for setting standards, the number of dimensions selected and exhaustiveness with which performance in each dimension is explored affects the quality assessment. Judgments of quality are incomplete when only a few dimensions are used and decisions about each dimension are made on the basis of partial evidence. Some dimensions, such as preventive care or the psychological and social management of health and illness, are often excluded from the definition of quality and the standards and criteria that make it operational. The dimensions selected and the value judgments attached to them constitute the operational definition of quality in each study. 
Donabedian's work contributed to the argument that quality cannot be judged by healthcare professionals alone but must include the patient's views and preferences as well as those of society in general because 'standards' used in quality assessment are heavily influenced or rather come from three sources namely, the science of health care that determines efficacy, the individual values and expectations that determine acceptability and social values and expectations that determine legitimacy.
Quality of health care services in Indian context
The history of health service system development in independent India begins with the state envisaging a comprehensive system for care for all irrespective of their ability to pay, in the Bhore Committee Report.  The proposed design of health service system and organizational set up was internally consistent with requirements of health service delivery and was externally consistent by addressing the social determinants of health. However the system that developed is but a pale shadow of the same.
Efforts to improve health and health service delivery are evident in the recommendations of the several committees set up at different points in the post-Independence period. Though largely systemic in nature, such as about human resources and infrastructure, some of the recommendations and guidelines advocated were also applicable for improving the quality of care at the level of institutions (e.g. MCI guidelines for medical colleges).
There were no separate internal systems for quality improvement other than the departmental supervisory structure. Efforts to assess the quality of health services or improve their quality were largely undertaken through the external committees set up from time to time for review of health services development and functioning, and their recommendations provided the guidelines and pathways for further development. Often, they were set up when a particular change was already envisaged.
Different programs like RCH, NTP/RNTCP, NACP, and NVBDCP have had their own monitoring and evaluation mechanism or quality assurance mechanisms in the recent past.
Thus, in the public system, though there have been many suggestions and attempts to improve the 'health services system' (as can be indirectly interpreted from different committee recommendations) there have been few attempts to understand the issue of 'quality' of services provided at each institutions and or at the individual level. However in the recent past this has changed with the entry of health insurance and the growing importance of the private sector which has brought quality at the individual and institutional level centre stage through dedicated efforts in the form of quality assurance/management/improvement or accreditation. Private hospitals are being accredited by autonomous/independent and private organizations like National Accreditation Board for Hospitals (NABH)/ National Accreditation Board for Laboratories (NABL) and Joint Commission International/ Joint Commission on Accreditation of Healthcare Organisations. NABH has done accreditation of some of the government hospitals as well.
Under the NRHM, systemic and dedicated efforts for quality have been taken up in the formulation of Indian Public Health Standards (IPHS), and initiating a Quality Management System and Indian Standards Organization (ISO) certification of government hospitals.  With NRHM for the first time the issue of 'quality' of health service facilities is being directly attempted at both the heath service system level and at the level of institutions providing health services.
High Level Expert Group (HLEG)  and Steering Committee  recommendations for UHC: Implications for quality
The HLEG report claims allegiance to the principle of Primary Health Care (PHC). However the primary health care approach was about community ownership and participation (not as passive recipients of services or the ones just making grievances at some grievance redressal cell), sustainability i.e. ability of the community to run such services in long run, rationality and appropriate technology, accessibility, comprehensiveness, inter-sectoral coordination etc.  These were central to the process of achieving Health for All. However this is where the UHC differs in fundamental ways from CPHC. So much of the discussion in CPHC is about the 'means' and ways, principles and philosophy of achieving the end of Health for All. The HLEG report seems to match only with this end while standing divorced from the 'principles of the means', which is the spirit of the Alma Ata Declaration.
Even though the HLEG recommendations say no to insurance, the theme of their recommendation continues to remain 'public funding' and 'guarantee of financial provision'. The actual service provision is left to either the public or the contracted in private sector. In the current policy ethos one can assume that service provision through contracted in private providers will be encouraged and will result in further strengthening of private sector through public money. However one should keep in mind that there are fundamental problems with the health services being delivered based on market principles. 
The monitoring of every incident of patient interaction with every private provider (for rationality and deciding payment) would need a mammoth bureaucracy with the capacity to make an assessment and intervene in such a technological issue of health care delivery. This would mean specialist doctors who can monitor such events would be needed. Is it realistic to assume that complete control of unnecessary investigations and treatment administrations in the private sector is possible? Given that it operates on the principle of profit generation it appears near impossible to ensure strict adherence to rational treatment protocols and standard operating procedures in private institutions.
The proposition to get IPHS standards implemented for those hospitals getting contracted in raises myriad questions. First- in what proportion of private hospitals are the standards related to buildings, infrastructure, organization of service delivery and manpower standards and GOI stipulated wages being followed? How many of them will be ready to be part of the proposed arrangements to achieve UHC? (In fact HLEG recommends the standards will be applicable for non-UHC private providers also.) Many private hospitals at district and sub district levels earn their profits and are deemed viable owing to number of malpractices and unethical practices that compromise on infrastructural, material and manpower standards (less human resources, less qualification, more work hours coupled with unsatisfactory salaries). Another source of earning is through commissions earned by referring patients and through sale of medicines, drugs and other medical consumables. The proposed vision for UHC dreams that highly powerful and unregulated private hospitals will part with easy profit making avenues and opt for price regulation to get government stipulated rates of treatment!
There are no IPHS standards for hospitals having less than 30 beds, which constitutes the bulk of private sector providers. The standards constructed for hospitals with 30 beds and above are also for certain kind of composition of services with very specific mixes and balances of specialists. Additionally, will such standards be relevant and acceptable to a very powerful section of the private sector owning hospitals with more than 30 beds? The specialization and composition in terms of skill mix availability of such private hospitals is variable. The biggest chunk of the private sector consists of very heterogeneous players- includes individual general practitioners, specialist-owned hospitals, doctor couple owned nursing homes or hospitals, and private hospitals, nursing homes or polyclinics owned by groups of different types of specialists. The mix of specialization in private sector is based on social, physical, geographical, economical and other considerations and not primarily on epidemiological and public health considerations. Is it possible to even develop standards based on epidemiological rational and public health principles which will be applicable for such varied types of hospitals and permutations and combinations of skill mixes (which are concentrated in urban locations)? Secondly will they be applicable and acceptable to the private sector? Implementation of standards related to area, building, human resource standards along with their working hours and minimum wages would increase the costs of running the hospital phenomenally as compared what it is now. Will price regulations and standards be acceptable to private sector and for how long? (Capital costs, concurrent costs, costs of having trained human resources with standard salaries in the context of proposed price control and regulation would make the survival of private hospitals impossible unless there is sufficient business turnover. How is this business turnover going to be ensured and who will ensure it to all private providers?). Increasing the business turnover of such individually or couple owned hospitals would run the risk of defeating the purpose of providing quality services as there is a limit for how much workload a single doctor can handle while assuring the provision of rational and quality services.
The HLEG proposes that district health managers will manage the government run health service system as well as purchasing of services from contracted-in private providers. Quality assurance, performance management (involving recruiting and deciding career trajectories), purchasing of health services etc gives a phenomenally powerful position to the health system management cadre. How will this new proposed power dynamics operate in the health sector which is currently dominated and controlled by doctors needs to be explored. These managers will be in a position for financial calculations but the technical component of 'quality', the rationality of care, would be way out of the league for the district health system managers if they are not trained medical doctors.
Allowing for dual systems where health services to the 'ordinary' coexist with luxury hospitality services will have implications for UHC in the long run. Supply generates its own demand. Over time hospitals with luxury hospitality services have changed perceptions about what constitutes good quality health care services. Are these the role models for rational, sustainable and affordable care for all? Are they not bound to increase pressure on government run health services? Will these hospitality services be part of 'quality' of health care assessment and accreditation process and in turn empanelment in to UHC? To define the boundaries of what constitutes 'necessary services' and 'hospitality services' is a difficult task since these notions are dynamic and vary with the cultural context.
The idea of defining the National Health Package/Essential Health Package (EHP) needs to reconsideration. Universal access to comprehensive services for all illness needs to be guaranteed. It is impractical to attempt defining boundaries of EHP/NHP given the existence of co-morbidities and complications associated with simple illnesses. This compartmentalized view of the human body and disease is irrational and paying the private provider for it in a transparent manner is near impossible. The HLEG and Steering Committee recommendations of encouraging public private partnerships and the idea of 'packaged' services are antithetical to the idea of 'quality' and universal access to rational services.
Many of the dimensions of quality as discussed above such as Efficacy, Effectiveness, Efficiency, Optimality, Acceptability, Legitimacy, Equity, intangible dimensions like reliability, responsiveness, assurance, relevance, empathy provided by caregiver, issues like time taken, queues, organization of services, administrative procedures, services being safe and patient centered have not even been touched upon or adequately addressed in the recommendations of the HLEG as well as the Steering Committee. While both these bodies touch upon technical domains of quality which will deal with the rationality of the treatment process the Steering Committee recommendations fail to make any concrete provisions for the same. Mechanisms for addressing the issue of quality at the systemic and at individual service delivery level are thought about in HLEG recommendations but call for further deliberation. Steering committee recommendations though project responsiveness (along with elements like choice, communication, confidentiality, dignity, amenities, prompt attention and autonomy) of the services as an important principle fail yet again to make concrete suggestions and define pathways to get there. Steering committee recommendations do not have any specific systemic or dedicated recommendation which address the issue of quality directly. It proposes that the existing NRHM governance mechanisms be continued and accommodates some other suggestions like developing a public health cadre while choosing to maintain a stoic silence on a health system management cadre and other institutional arrangements like the NHRDA along with subsidiary institutional mechanisms suggested by the HLEG report. It recommends continuation of existing public private mechanisms and has nothing new to offer the UHC except the Bachelor of Rural Health Care cadre that is being run in couple of states already. Creating competition among the public and private sector services, as in the pilots recommended to be conducted in one district of each state, may theoretically be seen as one way of forcing quality improvement in both. However, will this work on the ground?
The Way Forward
Thus it is of utmost importance that the concept of 'quality' in health care for UHC, along with its different dimensions and determinants be explicitly laid down. The objectives of that particular definition and quality improvement efforts should be deliberated upon as there is the risk of making use of quality assessment and accreditation systems for closing down public facilities and favouring corporate hospitals as against the primary and secondary level private services. This will contribute to making services more inaccessible. While increasing access to services at all levels, medical rationality and ethical practice have also to be built into quality criteria. Within the public system itself, there is a need for both the general systemic strengthening measures and a specific mechanism for facility-based quality improvement. Existing mechanisms as implemented under the NRHM should be reviewed and wide discussions held to design quality improvement systems in each state.
Acknowledgement: I would like to sincerely thank Prof. Ritu Priya for valuable comments and suggestions. Thank you, Chris and Possum for technical help and encouragement.