1. INTRODUCTION:

“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives, the cumulative experience of many masters of craftsmanship. Quality also marks the search for an ideal after necessity has been satisfied and mere usefulness achieved.” William A. Foster¹

The Joint Commission on Accreditation of Health Care Organizations (JCAHO) define quality of patient care as “ the degree to which patient care services increase the probability of desired patient outcomes and reduce the probability of undesired outcomes, given the current state of knowledge” Quality in health care has two critical components: quality in practice and quality in perception. The first involves meeting own set standards, the second being meeting customer expectations.² Quality assurance is that set of activities that are carried out to set standards and to monitor and improve performance so that the care provided is as effective and as safe as possible.³ Standards and guidelines serve as the basis for measuring quality of care provided.

1.1 Objectives

The objectives of the present paper are to

1. describe standards and guidelines

2. compile the standards and guidelines related to neonatal care in India

3. analyze the current situation in India in relation to neonatal care standards and guidelines

4. identify existing problems in relation to standards and guidelines of neonatal care

5. recommend strategies to improve the existing situation

6. develop standards for neonatal nursing in India

1.2 Standards⁴

WHO defines a standard as an agreed upon level of performance (minimum set of requirements) that specifies what action should be taken. It serves as a benchmark upon which to make judgments. It must be achievable, observable, desirable and measurable. Standards of care for neonatal health should be evidence-based (supported by current scientific knowledge) and focus on the baby in the context of family and community.

Standards of care are the basis for:

· education and training curricula (preservice and inservice)

· content for training manuals, clinical care protocols and guidelines

· identification of gaps in performance for quality programs

· supervisory and management systems

· essential equipment, supplies and drug lists

· job descriptions and deployment of personnel

· essential level of care and referral criteria

· measurable outcomes

Standards allow provider training and performance to be consistent at all levels of the healthcare system and provide the means to ensure uniformity of the healthcare delivery practices needed to support quality clinical services. However, standards can be implemented consistently in a country only if there is an effective and efficient healthcare delivery system in place. Standards help to identify deficiencies in the system.

1.3 Guidelines⁴

The word “guidelines” is a generic term for various documents that describe how standards are achieved. Two broad types of guidelines exist at the national level: policy guidelines and service delivery guidelines. In addition to being evidence-based, they reflect individual client demands; the community’s perceived needs and the overall healthcare situation in the country.

Policy guidelines describe:

· which services are to be officially offered

· who may receive these services (e.g., any income restrictions)

· who will deliver the services (categories of healthcare providers)

· where these services will be delivered (at what level of the healthcare system)

· how often certain services are to be delivered ( how many antenatal care visits) and

· what the minimal acceptable level of performance is for each service offered.

Policy guidelines do not contain the technical information needed to provide services; rather they serve as a general outline for the provision of services. Service delivery guidelines are a technical tool for achieving standards, and they provide the detailed information needed to implement the national policy guidelines. Service delivery guidelines complement policy guidelines by:

· describing the components of maternal and neonatal health services

· including protocols on how to perform those services

· introducing related components needed for quality service provision

· such as the principles and procedures for infection prevention practices

· explaining how healthcare providers should relate with mothers and their babies

· recommending how neonatal services should be organized at the various levels of the country’s healthcare system and

· serving as the basis for neonatal health learning and resource materials

2. EXISTING STANDARDS AND GUIDELINES:

India is home to 20% of global births and highest number of neonatal deaths in the world. The neonatal mortality rate (NMR) of 37 per 1000 live births in India translates into at least two newborn deaths every minute in this vast country.⁵India, thus, contributes nearly 30 percent to the 3.9 million global neonatal deaths.^{6, 7}The quality of neonatal care in India varies from no care to highly advanced care comparable to any centers in the world. Similarly, the care providers vary from parents alone to highly trained and DM qualified neonatologists. The health care system in India and delivery of services are diverse in different regions of the country. Government and National Neonatology Forum are taking lot of initiatives to standardize the services delivered to the neonates. Some of the current initiatives according to structure, process and outcome are as follows.

2.1 Structure Standards

2.1.1 Facility Standards and Guidelines

· Indian Public Health Standards (IPHS):

Indian Public Health Standards (IPHS) are a set of standards envisaged to improve the quality of health care delivery in the country under the National Rural Health Mission (NRHM) constituted by a task group under Director General of Health Services (DGHS). With Accredited Social Health Activists (ASHA) in place, there is bound to be a groundswell of demands for health services and the system needs to be geared to face the challenge. In order to ensure availability and quality of services, and to provide a yardstick to measure the quality of services being provided, IPHS for Community Health Centres (CHCs), Primary Health Centres (PHCs) and Sub Centres (SCs) are established. The guidelines include specifications regarding objectives of IPHS for CHC, PHC and SC; service delivery in CHC, PHC and SC; minimum requirements in CHC, PHC and SC; equipments, drugs, manpower, physical infrastructure, capacity building, quality assurance in service delivery, documentation, monitoring; and accountability. With complete implementation of IPHS the quality of care delivered to rural population is expected to improve drastically. Newborn will be a key beneficiary and the programme would help to reduce neonatal mortality and morbidity. ^8-10

· Accreditation Guidelines for Level II and Level III Neonatal units: Based on birth weight and gestational maturity the above a three tier system of neonatal care is recommended for developing countries.

Level I care is provided for neonates weighing above 2000 grams or having gestational maturity of 37 weeks or more. Over 80% of the neonates require minimal care or primary level care which can be provided by their mothers under the supervision of basic health professionals.

Level II care is provided for neonates weighing between 1500-2000 grams or having gestational maturity of 32-36 weeks. Equipment for resuscitation, maintenance of thermo neutral environment, intra venous infusion and gavage feeding, phototherapy and exchange blood transfusion services are provided.

Level III Care is required for babies weighing less than 1500 grams or those born before 32 weeks of gestation. Apex institutions, medical colleges or regional perinatal centres equipped with centralized oxygen and suction facilities, servo controlled incubators, vital sign and transcutaneous monitors, ventilators and infusion pumps etc are best suited to provide intensive neonatal care ^1,9

The national neonatology forum has established guidelines for level II and level III neonatal units based on which accreditation is conducted from time to time. The guidelines include specifications regarding physical facilities, staff requirements, neonatal resuscitation requirements, neonatal transport, thermoregulation, nutrition, infection control, monitoring, ventilation and therapeutic facilities, investigative facilities, neonatal follow-up guidelines, teaching and administration policies.^11-15

2.2 Process Standards

2.2.1 Case Management Guidelines

· Integrated Management of Neonatal and Childhood Illnesses (IMNCI): IMNCI guidelines represent an evidence based, syndromic approach to case management that includes rational effective affordable use of drugs and diagnostic tools. The IMNCI strategy includes both preventive and curative interventions that aim to improve practices in health facilities, the health system and at home. The strategy includes three main components:

· Improvements in the case-management skills of health staff through the provision of locally-adapted guidelines on imnci and activities to promote their use

· Improvements in the overall health system required for effective management of neonatal and childhood illness

· Improvements in family and community health care practices.

IMNCI guidelines recommend case management procedures based on two age categories, young infants age up to two months and children age two months up to five years. Neonatal case management included under young infants is described in figure1. ^{11, 16-18}

· Home Based Neonatal Care (HBNC): Home-based Neonatal Care includes a package of home based interventions delivered by a village-level worker in reducing mortality of neonates and young infants. The action pathway in HBNC based on the Gadchiroli SEARCH trial is mentioned in figure-2.

HBNC Intervention Package includes the following aspects;

· Selection and training of a village health worker in each village

· Ensuring cooperation of community, traditional birth attendants (TBA) and the health services

· Making a list of pregnant women in community, and updating it regularly

· Health education

§ Group health education: using audio-visuals and group games

§ To individual mother, by home visiting, twice during pregnancy and once on the second day after delivery.

§ To mothers of high-risk neonates

· Attending delivery, along with the TBA.

§ Encouraging the family and the TBA for referral when necessary

§ Taking charge of the baby immediately at birth.

§ Assessment, and if necessary, management of asphyxia by following an algorithm, and using bag and mask

· Initiation of early and exclusive breast feeding, and supporting/teaching mother to breastfeed successfully

· Injection vitamin K 1 mg, on the day of birth.

· Thermal care of the neonate

· Assessing for high-risk status. If present, extra care

· Repeated home visits (8−12) during neonatal period to ensure breast-feeding, thermal care, hygiene, and to monitor the baby for any infection — superficial or systemic (sepsis).

· Early diagnosis and treatment of neonates with sepsis, including administration of two antibiotics, co-trimoxazole and gentamicin

· Home-based care of LBW or preterm neonates.

· Weekly weighing, problem solving, advising and helping mother.

· Referral when necessary.^19-22

2.2.2 Clinical Standards and Guidelines

Clinical standards and guidelines refer to the policies and protocols for neonatal units. There are no National guidelines for the same. Individual units develop guidelines policies and protocols for the care provided in their units.²³ Some of them include neonatal protocols for Neonatal Resuscitation

· Newborn care

· Breastfeeding

· Thermoregulation

· Jaundice

· Phototherapy

· Respiratory distress

· Oxygen therapy

· Fluid administration

· Sepsis management

· Drug administration

· Ventilation

· Management of asphyxia

· Fluid and electrolyte management

· Management of IUGR infants

· Minimal Enteral Nutrition

· Seizures

· Polycythemia

· Retinopathy of Prematurity

· Apnea in the Newborn

· Hypoglycemia

· Hypocalcemia

These protocols may be evidence based and standardized but there is no uniformity throughout the country and only a few units in the country develop and follow the guidelines. Majority of neonatal units presently follow the Neonatal Resuscitation Protocol by NNF adapted from American Academy of Pediatrics (AAP) guidelines.^24,25

2.2.3 Neonatal Nursing Standards and Guidelines:

Nursing care is a core area in newborn survival. Standards for neonatal nursing practice are established on international basis by various countries. India does not have such standards for neonatal nursing established at National level. Neonatal nursing practice is expected to be based on the practice standards for nurses in India developed by the Indian Nursing Council(INC). Some neonatal units in the country have their own guidelines and protocols for nursing care but are not uniform throughout the country.

2.3 Outcome Standards

Outcome standards refer to the standards set to evaluate the outcomes of the care provided for the neonates at different levels of health care. The neonatal outcome standards may include Neonatal Mortality Rate (NMR) and morbidity rates, length of hospital stay, family satisfaction, expected improvement in clinical parameters like temperature, vital signs, hyperbilirubinemia etc. Outcome standards are very essential for the evaluation of delivery of health services. India does not have set outcome standards as well at regional or national levels.

Figure 2: Pathways of action of the home-based neonatal care ¹⁹

3. EXISTING PROBLEMS

Standards and guidelines are very essential for quality assurance. Government of India and National Neonatology Forum are taking immense efforts to improve the quality of care provided for the neonates. There are problems existing, which come in way of the delivery of quality services to the newborn as described below.

3.1 Lack of uniformity in the system

The health care system in India and delivery of services are diverse in different regions of the country. The rural setting is having an organized system of health care delivery; the three tier system and majority of Indian population dwell in the rural areas. But the health system constitutes private sector and NGO’s as well. The inadequate number of accredited level II and level III units in the country is not able to meet the increasing demands of the neonatal community. There is no integration or uniformity between the public, private sectors and NGO’s in health care delivery for newborns. This lack of uniformity is a big barrier for implementation of set standards or guidelines.^{26, 27}

3.2 Poorly communicated guidelines

The standards and guidelines existing presently in the country emerged in the latter half of the last decade. The guidelines are being implemented only in some states and districts in the country. The guidelines are not disseminated to all providers uniformly. There is no standardized way of communicating the guidelines to all providers hence further reducing chances of implementation.

3.3 Challenges in implementation of existing guidelines⁴

Existing guidelines related to neonatal care are not implemented properly because of the following reasons.

Policy challenges

· Pattern of frequent staff transfer

· Low staff morale

· Inconsistent posting of staff to rural areas

· Inadequate supervision and support for providers

· Inadequate logistics systems for supplies

3.3.2 Donor challenges

· Need for improved coordination among donors

· Much collaboration driven by individual personalities

· Central office agendas of donor agencies that conflict with government goals

3.3.3 Training challenges

· Healthcare providers with poor basic skills

· Training sites with low caseloads

· Extensive time required for training

3.3.4 Low demand for services

· Lack of access to rural communities

· Differing perceptions among community members about pregnancy, childbirth and illness

· Caste, class and gender differences between healthcare providers and community members

3.4 Lack of practice standards for Neonatal Nurses

India does not have established practice standards in neonatal nursing. Nurses here follow general practice standards developed by INC. Some neonatal units have guidelines, policies and protocols for specific nursing interventions but are neither standardized nor uniform. The nursing care requirements vary across the various levels of neonatal care and there is a long way to go for standardization.

4. STRATEGIES TO SOLVE THE PROBLEMS ⁴

The health system in India is a complex one that involves individuals at many levels of the health care system. Following strategies may help to improve the quality of health care delivery and to solve existing problems related to standards and guidelines of neonatal care in India.

4.1 Developing and revising National guidelines

National standards based on best practices must be accepted and introduced within a realistic framework of the country’s needs, available resources and program priorities. Revision of national policy guidelines entails adapting best practices to suit those specific needs, resources and capacities from time to time. NNF has played an important role in developing standards guidelines for neonatal care at different levels. Government of India has taken up the issue and has developed standards of care in various levels of the health care system. India has to now focus on proper implementation of IMNCI, HBNC, NRHM and IPHS.²⁶

4.2 Developing and revising national service delivery guidelines

The development of service delivery guidelines based on accepted, or soon-to-be-accepted, national standards can be a complicated process. National service delivery guidelines translate international standards into appropriate, practical instructions for skilled providers. They furnish details about how and by whom services are to be managed and delivered. Guidelines permit healthcare delivery, training, supervision, logistical support and management practices to be of consistently high quality at all levels of the healthcare system. They provide the means to standardize healthcare delivery practices needed to support quality clinical healthcare.

4.3 Endorsing guidelines to all health care sectors officially

Once reviewed and revised as needed, policy documents generally require full government approval. The need for official approval remains invariable if the standards are to be applied effectively and consistently to national healthcare provision.

4.4 Implementing guidelines

4.4.1 Disseminating policies and guidelines at National level

Dissemination of the guidelines at national level can begin by a variety of mechanisms like dignitaries launching the new guidelines at a large, formal meeting attended by a diverse audience of politicians, healthcare professionals, consumers and the media. This event has the added benefit of increasing the public’s awareness of the content, purpose and significance of the guidelines.

4.4.2 Disseminating policies and guidelines to regional and district levels

Dissemination and promotion of the completed documents to regional and district levels are the next step in the implementation process. The dissemination process works most effectively when a variety of appropriate strategies are implemented either together or sequentially to ensure both adequate distribution and understanding of the guidelines.

4.4.3 Ensure systems are in place to support quality provision of care

For national policy and guidelines to have an impact on healthcare provision, systems that support providers and help them to do their jobs effectively also have to be strengthened. These systems sustain implementation of the guidelines, and in many cases the guidelines help to sustain and strengthen the systems.

4.4.4 Motivate providers and ensure that they have skills

When dissemination is complete, healthcare providers should be implementing the guidelines as part of their daily practice. But for this to happen, it is critical that providers be motivated to follow the guidelines and be trained in their use. Changing attitudes and behavior is a challenging process, but it must be accomplished if healthcare providers’ performance is to reflect the standards.

4.4.5 Ensure involvement of the community

Both healthcare providers and clients must work together to make sure that standards of care are met. Community members and leaders have a vital role to play, both in developing and implementing guidelines, as part of their greater responsibilities to ensure and support healthcare.

4.5 Strengthening supporting systems to ensure implementation ⁴

4.5.1 Human resources systems

Human resources are a critical factor in implementing national guidelines. Even the best guidelines cannot have the optimal effect if there are insufficient numbers of providers delivering maternal and neonatal health services, or if well-trained providers are leaving the service at rates faster than they can be replaced.

4.5.2 Training systems

The desired result of any clinical training program, whether preservice or in service, is that providers begin using newly acquired skills to improve patient care. When guidelines are used in the development of these training programs, the skills included in the training are carefully selected as key skills called for in the guidelines and needed to improve provider performance. This allows the training to be much focused and thus makes the most efficient use of time required for training.

4.5.3 Preservice education

National training systems now recognize that the most sustainable training approach in the long term is preservice medical, midwifery and nursing education. When service delivery guidelines are used to develop preservice curricula, students learn from the start of their careers the basic principles of guidelines-based clinical practice and are taught how to apply them. When guidelines are used to develop preservice education programs, curricula are refocused to include competency-based clinical skills training, so that students graduate as qualified, proficient professionals and are able to provide the quality of care defined by the guidelines.

4.5.4 In-service training

Most healthcare professionals now in service were not trained using a guidelines-based curriculum. In-service training is therefore necessary in the short term to bring the skill level of existing health personnel up to the standards set by guidelines.

4.5.5 Supervision systems

Supervision is recognized as an essential element in the improvement of provider performance. When new guidelines are introduced, it is often the responsibility of the clinical supervisor at the healthcare delivery site to ensure that the staff and facility follow them. Supervisors can use the guidelines to support the introduction of this essential practice and coach providers to improve their skills.

4.5.6 Supply systems, logistics, drugs and equipment

Implementing guidelines requires that specific supplies, drugs and equipment be available to the provider.

4.5.7 Referral systems

Effective referral and transport systems must be in place so that the high quality care required by the guidelines can be achieved. Effective referral and transport are required to save lives. Since many, if not most, births occur outside the healthcare facility, the community is usually the initiator of care.

4.5.8 Monitoring and evaluation systems

The ultimate goal of implementing guidelines for neonatal care is the reduction of neonatal mortality. It would seem logical, therefore, that monitoring changes in maternal mortality would demonstrate whether or not guidelines have been implemented effectively. Data can be collected to assess the impact of guidelines implementation at three levels: in each facility, across all facilities and in the country’s population as a whole.

4.6 Developing and Implementing Neonatal Nursing Standards

Neonatal population in India is diverse and the type of care required for the neonates vary across different settings. Neonatal nurses are entitled to deliver specialized nursing care to neonates at different levels of health care where demands are different. Neonatal nursing provides specialized care to the newborn and family across the care continuum that promotes optimal outcomes.

An attempt is made to develop practice standards in Neonatal Nursing.

5. NEONATAL NURSING STANDARDS:

The practice standards developed here are based on and consistent with the code of ethics and practice standards for nurses in India developed by the Indian Nursing Council.¹⁷

Standard 1:

Neonatal nurses accept responsibility and are accountable for their practice

Performance criteria

1.1 Neonatal nurses work within the scope of their practice based on current nursing education, management, research, judgment, experience and competence.

1.2 Neonatal nurses demonstrate understanding of the Quality Assurance Model, evaluate the care and takes appropriate measures to improve the quality.

1.3 Neonatal nurses adhere to the code of ethics and professional conduct for nurses in India, demonstrates knowledge of current ethical issues and participates in ethical decision making.

1.4 Neonatal nurses perform activities within legal boundaries

1.5 Neonatal nurses maintain accurate, systematic documentation of nursing activities.

Standard 2:

Neonatal nurses are responsible for safety and well being of the newborn and family within the scope of their practice

Performance criteria

2.1 Neonatal nurses apply current nursing knowledge using a systematic (nursing process) approach to meet the holistic needs of the newborn and the family.

2.2 Neonatal nurses adhere to the practice standards and participate in the development and implementation of standards of nursing practice and quality improvement activities.

2.3 Neonatal nurses apply current evidence based guidelines and theoretical frameworks using a documented systematic approach to meet the needs of the newborn and the family.

Standard 3:

Neonatal nurses are responsible for initiating and fostering effective interpersonal relationship with the newborn, family, community and employer

Performance criteria

3.1 Neonatal nurses deliver care within a family centered framework and use expertise in all interactions with newborn and family.

3.2 Neonatal nurses maintain effective interpersonal relationship with newborn, family, community, colleagues and employer.

3.3 Neonatal nurses identify learning needs of families and community conducts and evaluates teaching activities for optimum health promotion.

Standard 4:

Neonatal nurses are responsible for safeguarding rights of the newborn and family and enhancing dignity and self esteem

Performance criteria

4.1 Neonatal nurses demonstrate respect for families and support traditional, cultural and spiritual beliefs.

4.2 Neonatal nurses mobilize the support of health team members, families and communities for the protection of the rights of the newborn.

4.3 Neonatal nurses describe and educate families about their rights.

Standard 5:

Neonatal nurses manage available resources effectively and efficiently to meet the health needs of the newborn and the family.

Performance criteria

5.1 Neonatal nurses apply appropriate management techniques based on situational analyses and initiates activities for enhancement of own managerial skills.

5.2 Neonatal nurses utilize the available resources effectively in the care of the newborn and the family.

5.3 Neonatal nurses demonstrate understanding of own role in implementation of Quality Assurance Model and involves the team members in the development and implementation of the same.

5.4 Neonatal nurses contribute to formulation and review of unit policies as per statutory regulations and communicate the policies and regulations to concerned persons and ensure compliance.

5.5 Neonatal nurses identify neonatal workforce needs, and organize training to develop appropriate knowledge and skills in care of newborns and families.

Standard 6:

Neonatal nurses are committed to professional advancement, ongoing education and professional growth of self and others.

Performance criteria

6.1 Neonatal nurses conduct research and contribute to evidence based neonatal nursing care.

6.2 Neonatal nurses maintain and expand knowledge and skills for competent practice.

6.3 Neonatal nurses seek innovative approaches to practice, to take responsibility and participate in regular evaluation and monitoring of neonatal nursing practice.

6.4 Neonatal nurses identify their own learning needs, participate in programmes designed to encourage professional development and further nursing knowledge.

6. CONCLUSION:

Standards and guidelines are essential for quality assurance in neonatal care. Development and implementation of guidelines must be tailored to suit country’s needs. Existing standards and guidelines of care needs to be applied throughout a country’s health system to ensure the provision of high quality neonatal healthcare, which would meet the national goals. The survival of newborn babies depends on the quality care provided. Neonatal nursing standards are to be developed and communicated to all practicing neonatal nurses. Indian Nursing Council and Indian Association of Neonatal Nurses can join and develop practice standards for neonatal nurses. Once standards are set, uniformly implemented, and evaluated at all levels of neonatal care, the quality of care would improve drastically, thus the neonatal survival.

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Received on 21.05.2015 Modified on 28.06.2015

Int. J. Adv. Nur. Management 3(3): July- Sept. 2015; Page 231-239

DOI: 10.5958/2454-2652.2015.00009.8