This document outlines the steps for developing quality standards for clinical and managerial functions of healthcare services. It begins by having organizations identify high-volume, high-risk, or problem-prone functions that would benefit from quality standards. As an example, it identifies immunization services. The next steps are to identify the inputs, processes, and outcomes of the selected function, and then define quality characteristics for key elements. Finally, standards are developed by writing statements, guidelines, algorithms, or pathways to clearly define the quality characteristics. The document provides examples of applying these steps to develop quality standards for immunization services.

1. Step 1 : Identify a Function of Service
It is of critical importance that the organizations identify
clinical and managerial function for a service(s)/system that
would require standards. For example
•Acute Respiratory Infection (ARI) case management
•Management of diarrhoea
•Immunization Services
•Family planning services
•Antenatal Care
•Emergency Obstetric Care: Performance of Caesarian
sections

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•Newborn Care
•Non-clinical functions such as record maintenance, admissions,
logistics and supply, etc.
Prioritize which of these functions and services are performed
in high volume, and/or associated with high risk and/or
problem prone
High Volume (HV) functions are the functions that are
performed frequently or affect large number of people
High Risk (HR) functions are the functions that expose the
client to a greater risk of adverse outcomes due to nature of
disease or management process.

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Problem Prone (PP) functions are the functions that have
produced problems for the client of the organization in the past
The organization identify and list all functions that meet one or
more criteria described above. The focus of this process is to
identify functions that need improvement to improve quality of
services in terms of output or outcome
Some additional criteria for deciding priorities for selection of
functions for Quality Assurance, are as follows:

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Importance of function
Ability to implement the
process
Impact
Economic feasibility
More significance than other
functions
The organization or its
personnel can implement the
changes in the inputs and
processes
The function that produces
maximum effect
Budget availability and
financial constraints

6. Example : Step 1
Let us take example of Immunization services for children.
We want to improve quality of immunization services. It is a
high volume function and also associated with high risk of
deaths due to vaccine preventable diseases among children.
If we review the additional criteria for choosing services /
function, you will find that it is a very significant function in
the health system; it is implementable and has a high impact
on health status of children. Further it is also a cost-effective
intervention.

7. Step 2: Identify Inputs, Process and Outcomes
The next step is to identify the Inputs, Processes and
Outcomes for the function or services chosen for Quality
Assurance. To do this,
•Constitute a team or panel of experts
•Identify and list elements of Inputs, Processes and Outcomes
•Identify critical elements/activities that have impact on quality

8. Example: Step 2
In Step 1, we have selected immunization services for Quality
Assurance. Let us identify elements in Inputs, Process and
Outcomes.
INPUTS
Staff
Vaccines
Equipment
(Vaccine carrier, Ice packs Syringes/needles, Sterilizer)
Electricity
Records
IEC material

9. Contt…
PROCESS
Planning of immunization sessions
Vaccine transportation and maintenance
Conducting vaccination sessions
Vaccination
Counseling

10. Contt…
OUTCOMES
Access and availability
Reduction in Morbidity due to VPDs
Reduction in Mortality due to VPDs
Higher Coverage with Vaccines

11. Step 3: Define Quality Characteristics
After Step 2, the next important step is to identify quality
characteristics for each of the element in inputs, process and
outcomes as identified. To accomplish this;
•Review all the elements for inputs, process and outcomes
for the function or service.
•Choose the key elements that are essential to achieve the
desired outcomes of the function or service;
•List the quality characteristics for the key elements and
define them appropriately

12. Example : Step 3
Once the elements in Inputs, Process and Outcomes are
Identified, the next step is to identify and define quality
characteristics for each of the element. One may decide to
choose key elements and define quality characteristics for
the selected key element(s).

13. Contt…
Elements Quality Characteristics
INPUTS
Staff
Vaccines
Equipment
(Vaccine carrier, Ice packs
Syringes/needles, sterilizer
Records
Compete at and available
Potent vaccines available in
adequate quantity
Available and functional
Completeness of records

14. Contt…
PROCESS
Planning of immunization
sessions
Vaccine transportation and
maintenance
Conducting vaccination
sessions
Vaccination
All areas to be covered
Safety of vaccine
Regularly of sessions
Aseptic and correct technique

15. Contt…
OUTCOMES
Access and availability
Reduction in Mortality due
to VPDs
Coverage with Vaccines
Immunization facilities are
easily accessible Reduction in
deaths due to VPD
High coverage

16. Step 4: Develop Standards
It is important that the standards are clearly written and
documented. Writing standards is a specialist job and requires
basic skills in written communication. However, the ground rules
for writing standards are that the standards should be written in
the form of statement and in third person. To write standards;
Statement We can write standards in the form of statement.
Generally, the input and outcome standards are written in the
statement format.
Guidelines Process standards are generally described as Clinical
Protocols or Practice Guidelines to perform particular clinical
tasks or technical procedures.

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Algorithms Process standards may be written in the form of
Algorithm describing steps. It may be done in a graphic from
outlining the process step by step and flowcharts with directions
and decision options.
Pathways This is another way to standardize the process.
Pathways are used to describing optimal sequencing and timing
for diagnosis or procedure, to be followed by the health care
provider.

18. Gather background information
Before drafting the standards, it is necessary to collection
available information on standards and their formats used
elsewhere. For example WHO has developed Guidelines and
Manuals for various services and programs. Similarly various
National Governments have developed manuals to standardize
the process of service delivery and provide care.
The information can be gathered by literature review,
discussions and consultation with experts , benchmark used
elsewhere and review past experiences of implementation of
Quality Assurance.

19. Draft the Standard
After a review and consultation, draft the standard. Share the
draft with the group of experts, health care administrators and
providers.

20. Example : Step 4
Elements Quality
Characteristics
Standards
INPUTS
Staff
Vaccines
Equipment
(Vaccine carrier, Ice
packs
Syringes/needles,
sterilizer
Competent and
available
Safety and
availability of
vaccine in
adequate quantity
Available and
functional
All staff trained in technical
and Interpersonal
Communication
ALL PHC/CHC have all
the vaccines in stock for
next two months which is
potent (within expire date)
All the health facilities have
functional could chain
equipment all the time as
per RCH Guidelines

21. Contt…
Elements Quality
Characteristics
Standards
INPUTS
Records Completeness and
Availability
Records of all children are
available and complete
PROCESS
Planning of
immunization
passions
Vaccine
transportation and
maintenance
All areas to be
covered with day
and time
Safety and
potency
All villages are covered in
the immunization pain with
day and time
All vaccines transported at
optimal temperature

22. Contt…
Elements Quality
Characteristics
Standards
Conducting
vaccination sessions
Vaccination
Regularly
Aseptic and
correct technique
All sessions to be
conducted as planned
All the staff uses right
technique (separate needs
& syringe for each child)
with aseptic measures

23. Contt…
Elements Quality
Characteristics
Standards
OUTCOMES
Access and
availability
VPD Morbidity
Coverage
The immunization
facilities are
accessible and
available with
ease
Reduction in
deaths due to VPD
High coverage
All health facilities have
immunization facilities
within 3km distance
Measles deaths reduced by
50% from the existing
levels
All children<1 year of age
are fully immunized

24. Step 5: Assess Appropriateness of Standards
Determine whether the standards are appropriate for the
organisation. The persons working in the orgtanisation,
especially the health managers and health care providers must
be consulted and asked whether the given standards are
workable, relevant and convergent with the goals and
objectives of the organisation. Their feedback must be
analysed and shared before finalizing standards.

25. Contt…
Asses validity of standards
Whether the given standards have relationship with the
expected change in the results or outcomes. Is there any
empirical evidence of relationship between the changed
outcome and the intervention?
Assess reliability
It refers to repeatability and reproducibility. The reliability
of standard would be judged by observations whether the
same results are obtained using the same standard every-time

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Assess standards for clarity
Clarity refers to whether the health managers and providers are
able interpret the meaning in the same way and without
ambiguity. It is important the every one explains and draws the
same meaning of the standard.
Assess whether realistic and applicable
It is doable and achievable with given resources and technology?
The standards should be applicable in the given circumstances.
Setting up high and unrealistic standards may prove to counter
productive in the system.

27. Communicate Standards
Standards are developed to improve the quality through change
in input and process at the level of health care delivery.
Therefore, it is of great importance that those who are
responsible for providing services are informed about the
standards. Communication is a vital link between development
of standard and application of standard.
How can we communicate standards? There are various
methods and approaches for communication. The health
managers need to develop a communication plan, clearly
identify the groups who need to be communicated, media
choices and source of communication, and methods. In general,
following methods be used to communicate standards.

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•Use of Job Aids
•Check-lists for inputs and process for chosen priority services
or functions
•Workshops and Review meetings
•Office circulars detailing the administrative and clinical
procedures
•Manuals and Guidelines
•On the job Training and Supervision

29. Exercise
You have gone through the most crucial step in the Quality Assurance
Cycle with your instructor, I.e. SETTING STANDARDS. Let attempt
to develop standards for functions/services in you own organisation.
1. Enlist functions that your organistion undertakes or services that are
provided.
2. Select and prioritize services for which you want to improve quality
 Develop a Matrix HV, HR and PP for each function (You may also use
additional criteria for prioritization)
3. Identify Inputs. Processes and Outcomes and elements for each of
them.
4. Identify Key Elements that would require standards.
5. Define quality characteristics for each of the key element in Inputs.
Processes and Outcomes.
6. Write Standards for quality characteristics for each key Element.

30. INSTRUCTIONS
Identify KEY ELEMENTS in INPUT, PROCESS and
OUTCOMES for the selected function or service in your
organisation, as a first step. Share and discuss this with the
Instructor and Group Members.
Next, define quality characteristics for each Key Element
in consultation with your Group Members.
Choose format and write standards for each Key Element
keeping view quality characteristic(s)
Present the entire Matrix to the Group and discuss.

31. Quality
Dimensions
Quality
Elements
Quality
Characteristics
Standards
Inputs
Process
Outcomes
Contt…