QUALITY ASSURANCE

Step 1
Planning Quality

Step 10 Step 2:
Implement Solution, Monitoring & Evaluating Set Standards

Step 9
Choose, design & develop Solution Step 3:
& corrective action Communicate Standards

Step 8
Analyze & Study Problem Step 4
(collection of data to analyze root cause) Monitoring Quality

Step 7 Step 5
Identify who will Identify & Prioritize Opportunities
Work on problem for Improvement

Step 6:
Define Problem
1. Planning For Quality

• It is impossible to improve quality in all areas, hence may

be initiated in few critical areas.
• High priority to high volume or problem prone services to
start with.
• Begins with defining Organization’s mission and
assessment of opportunities and constraints along with
internal strengths and weakness.
• Opportunities: MCH services, treatment of patient, cost
reduction, client/ staff satisfaction etc
• Sources to identify areas of improvement: Interviews,
suggestion boxes, supervisors/ managers, staff, service
statistics, organizational assessment.
2. Setting Standards and Norms
• Standard is a statement of the quality that is expected.
• A statement of expectations for the inputs, process,
behavior and outcomes of the health system.
• The statements for levels of achievements wrt inputs,
process and outcomes in healthcare.
• Includes practice guidelines, clinical protocols,
administrative procedures, operating procedures,
specifications and performance standards.
 Guidelines

• The steps described by experts for recommended or

suggested procedures.
• Are used to standardize the process of service delivery/
performing tasks.
• Generally available in the form of Manual describing set of
activities and methods to be undertaken to deliver services
or perform a task.
 Protocol

• More precise and detailed plan for a process.

• It more stringent than guidelines.
• Also used for research activities aiming at testing new
services or interventions, efficacy of drugs and vaccines,
etc
 SOP

• Statement of expected way the staff would follow for

certain activities that are more relevant to administrative
procedures.
• May include admission/ registration process, billing for
services, wait-listing etc.
 Specification

• Product characteristics/ material inputs.

• Detailed description of characteristics/ measurements of
product, service or outcomes.
• Generally used for drugs, equipments and other supplies.
 Performance Standards

• To measure the outcome of service delivery and activities.

(measure compliance with the guidelines).
Standards is an authoritative statement of
• Minimum levels of acceptable performance or results
• Excellent levels of performance or results
• The range of acceptable performance or results

Standards tell us what we expect to happen to have high

quality services

Standards are vehicles by which organizations can hold

people ACCOUNTABLE to their part (Patient, Provider,
Manager, Support System)
Characteristics of Standards
Input, process and outcome standards should posses certain
characteristics :
• Standards should be valid - i.e. it should represent the
expected result.
• Standards should be reliable i.e. give same results each
time when used.
• Standards should be clear and unambiguous
• Standards should be realistic and applicable.
• Standards can be explicit statements written as
Guidelines, Protocols, SOPs & Specifications; and can also be
derived from commonly accepted community practices &
conventional wisdom in health care
• Should reflect the perspective of community expectations
and health care providers
 Purpose of Standards

• Necessary for Assessment and measurement of

quality.
• Important for reducing variation.
• Provide benchmark for monitoring .
HOW STANDARDS ARE DEVELOPED
Step 1
Identify functions or system - clinical and non-clinical,
which require standards, like

• Acute Respiratory Infection (ARI) case management

• Immunization Services
• Ambulatory family planning services
• Antenatal Care
• Performance of Caesarian sections
• Newborn Care
• Non-clinical functions such as record maintenance,
admissions
Prioritize these functions:

• High Volume functions

The functions that are performed frequently or affect large
number of people
• High Risk functions
Conditions or functions that expose the client to a greater
risk of adverse outcomes due to nature of disease or
management process
• Problem prone functions
The functions that have produced problems for the client or
the organization in the past
Additional criteria for deciding priorities:

• Importance:
More significance than other functions
• Ability to implement:
Any changes made could be carried out by organization or
personnel
• Impact:
The function that produces maximum effect
• Economic feasibility:
Budget availability and financial constraints
Step 2
Identify the Inputs, Processes and Outcomes
• 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

E.g. Immunization services for Quality Assurance

 INPUTS
 Staff
 Vaccines
 Equipment (Vaccine carrier, Ice packs, syringes/ needles, Sterilizer)
 Electricity
 Records
 IEC material
PROCESS
 Planning of immunization sessions
 Vaccine transportation and maintenance
 Conducting vaccination sessions
 Vaccination
 Counseling
OUTCOMES
 Access and availability
 Reduction in Morbidity due to VPDs
 Reduction in Mortality due to VPDs
 Higher Coverage with Vaccines
Step 3
Define the Quality Characteristics
•Review all the elements for inputs, process and outcomes
for the activity
•Choose the key elements that are essential to achieve the
desired outcomes of the function or system
•List the quality characteristics for the key elements and
define them appropriately.
 Elements Quality Characteristics
Inputs  Staff Competent and available
 Vaccines Potent vaccines available in
adequate quantity
 Equipment Available and functional
 Records Completeness of records

Process  Planning of immunization sessions All areas to be covered

 Vaccine transportation and Safety of vaccine
maintenance
 Conducting vaccination sessions Regularly of sessions
 Vaccination Aseptic and correct technique
Outcomes  Access and availability Immunization facilities are
easily accessible
 Reduction in Mortality due to Reduction in deaths due to VPD
VPDs High coverage
 Coverage with Vaccines
 Step 4: Develop Standards

Gather background information - Literature review, confer

with experts, Benchmark, Review past experiences
Standards are to be clearly written and documented.
Writing standards is a specialist job and requires basic skills
in written communication.
Standards should be written in the form of statement and in
third person.
To write standards; any of the following formats may be
chosen:
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.
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.
Background Information

 Before drafting the standards, it is necessary to collection

available information on standards and their formats used
elsewhere.
The information can be gathered by literature review,
discussions and consultation with experts , benchmark
used elsewhere and review past experiences.
 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.
 Elements Quality Characteristics Standards
Staff Competent and available All staff trained in
technical & Interpersonal
Communication
Vaccines Safety and availability of ALL PHC/CHC have all the
vaccine in adequate vaccines in stock for next
quantity two months which is
potent (within expire
INPUTS date)
Equipment Available and functional All the health facilities
have functional
equipments all the time as
per RCH Guidelines
Records Completeness and Records of all children are
Availability available and complete
 Elements Quality Standards
Characteristics
Planning of All areas to be All villages are covered
immunization covered with day in the immunization
passions and time pain with day and time
Vaccine All vaccines
transportation Safety and transported at optimal
and maintenance potency temperature
Conducting Regularly All sessions to be
PROCESS
vaccination conducted as planned
sessions
Vaccination Aseptic and All the staff uses right
correct technique technique (separate
needs & syringe for each
child) with aseptic
measures
 Elements Quality Standards
Characteristics

Access and The immunization All health facilities

availability facilities are have immunization
accessible and facilities within 3km
available with ease distance
OUTCOMES VPD Reduction in Measles deaths
Morbidity deaths due to VPD reduced by 50% from
the existing levels
Coverage High coverage All children<1 year of
age are fully
immunized
Step 5
Assess appropriateness of Standards

* Assess validity
* Assess reliability
* Assess standards for clarity
* Assess whether realistic and applicable
Assess Validity
Whether 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
Refers to repeatability and reproducibility.
Would be judged by observations whether the same results are
obtained using the same standard every-time.
Assess for Clarity
Whether the health managers/ providers are able interpret the
meaning in the same way and without ambiguity.
Imp: Every one explains and draws the same meaning of the standard.
Assess whether Realistic and Applicable
Doable and achievable with given resources and technology?
Setting up high and unrealistic standards may prove to counter
productive in the system.
 ARI Case Management
E le m e n t s Q u a l it y c h a r a c t e r is t ic s S ta n d a rd s

In p u ts S ta ff S ta ff c o m p e te n c e A ll s ta f f a r e fo r m a lly
( te c h n ic a l a n d t r a in e d in A R I c a s e
in te r p e r s o n a l) m a n a g e m e n t.

A ll s ta f f m e e ts
c o m p e te n c y s ta n d a r d s a t
end of A R I case
m a n a g e m e n t tr a in in g .

A n tib io tic s A v a ila b ility o f a n tib io tic s T h e r e w ill b e

u n in te r r u p t e d s u p p lie s o f
a n tib io tic s a v a ila b le a t a ll
t im e s

T im in g A v a ila b ility o f tim in g A u s a b le tim in g d e v ic e

d e v ic e d e v ic e w ill b e a v a ila b le to h e a lt h
w o r k e r s a t a ll tim e s

P a tie n ts A v a ila b le fo r N o a p p lic a b le s ta n d a r d s

e x a m in a tio n
 ARI Case Management
E lem ents Q uality C haracteristics S tan d ard s

Inputs M other/caretaker E ducated m others/caretakers A ll m others/caretak ers w ill

know th e dang er signs and
understand th e im portance of
bringing ch ildren for care

C linic record A vailability of up-to-date T he clin ic record for each

patient inform ation patient w ill b e available at th e
beginning of each p atient
appointm ent

Processes P atient history E ssentiality: C om plete A ll health w orkers w ill ask the
history-taking for essential essential qu estions described in
item s the W H O A R I C ase
M anagem en t G u idelines w hen
taking a patien t’s history

P hysical E ssentiality: C om plete W hen condu cting a physical

exam ination physical exam ination for exam in ation all health w ork ers
essential item s w ill look and listen for the
essential signs for A R I listed in
the W H O A R I M an agem ent
G uidelines.
 ARI Case Management
E le m e n ts Q u a lity C h a r a c te r istic s S ta n d a r d s

O u t- C a se m a n a g e m e n t T e c h n ic a lly c o rre c t c a se A ll c h ild re n w ill b e c o rre c tly c la ss ifie d

com es m anagem ent a n d e ith e r re c e iv e a p p ro p ria te tre a tm e n t
C lie n t sa tis fa c tio n a t th e c e n te r o r a re re fe rre d a p p ro p ria te ly .
C o rre c t re fe rra l a c c o rd in g to
C lie n t re fe rra l p ro to c o l S e v e n ty p e rc e n t o f c lie n ts a re sa tisfie d
w ith th e ir p ro v id e r.
C lie n t sa tisfa c tio n w ith
h e a lth c a re p ro v id e r
N o a p p lic a b le sta n d a rd

M o rta lity L o w m o rta lity A R I c a se fa ta lity is le ss th a n 1 %

C a se fa ta lity L o w c a se fa ta lity N o a p p lic a b le sta n d a rd s

C u re /re c o v e ry H ig h c u re /re c o v e ry A ll p a tie n ts a re c o u n se lle d fo r k e y

m e ssa g e s

M o th e r/c a re ta k e r M o th e r/c a re ta k e r k n o w le d g e A ll m o th e rs/c a re ta k e rs le a v e th e c e n tre

k n o w le d g e , o f e sse n tia l ite m s k n o w in g h o m e c a re a n d k n o w in g w h a t
a ttitu d e , a n d sig n s re q u ire im m e d ia te re tu rn fo r
p ra c tic e e m e rg e n c y c a re .

U p d a te c lin ic C o m p le te c lin ic re c o rd N ie n ty p e rc e n t o f c lin ic re c o rd e n trie s

re c o rd c o n ta in c o m p le te in fo rm a tio n fo r h isto ry ,
p h y sic a l e x a m in a tio n , a sse ssm e n t a n d
p la n
3. Communicate Standards

Communicating standards to each health provider,

supervisor, manager and support person.
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:
• 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
4. Monitoring Quality

• Selecting indicators
• Selecting information sources
• Designing a system for collecting and compiling data
• Implementing the monitoring activities
HIS is a type of monitoring system that focuses on resources
and outcomes of primary care. It includes:

• Medical Equipment at the facility

• Demographic data on the catchment area population.
• Number and the list of new cases of diseases or symptoms
seen at the health facility.
• Utilization of services and number of visits.
• New and previous patients registered.
• Outreach activities.
• Coverage rates (immunization, etc)
• Compliance of Standards
Establishing Quality Monitoring system: Major steps

1. Identify Information needs

2. Select Indicators (Numerator & Denominator):
Should be consistent with program goals and objectives.
Should be reliable, valid, realistic and measurable.
3. Collect Data: Via patient records, patient survey, interview
of healthcare providers direct observation
4. Data Storage & Retrieval: computerized database/ forms
5. Analyze and interpret data: Tabulate results & calculate
indicators, to identify the root causes of poor
performance.
6. Disseminate information: Feedback of results to staff
5. Identifying Problems and Selecting
Opportunities for Improvement

Identifying quality improvement opportunities by monitoring

and evaluating activities:

• Conduct special community/patient survey

• System diagnosis/process analysis
• Review feedback/complaints
• Generate ideas through brain-storming or group discussions
• Criteria for choosing problems and prioritization
• Technical feasibility of addressing the problem
• Potential impact for improving the quality of
health/outcomes
• Adequacy of resources
6. Defining the Problem

• The team must define it operationally -- as a gap between

actual performance and performance as prescribed by
guidelines and standards.

• Problem statement should identify the problem and how it

manifests itself.

• Problem statement should clearly states where the

problem begins and ends and how to recognize when the
problem is solved.
 Problem Statement Weakness in the Improved problem
statement statement
We do not have Contains only cause While all suspected cases
laboratory of TB should have sputum
examination at present
only 25% are being tested
We need more staff Premature solution 30% patients arriving to
clinic are sent home
without receiving care
We do not work as a team Too vague for corrective Health centre team
action members do not plan and
schedule outreach clinic
together
7. Choosing A Team

• Assign small team to address specific problem

• Team should include key-actors who contribute to inputs,
resources, beneficiaries
• The team will Analyze problem to identify the root cause,
develop solutions and actions for quality improvement
plan and implement & evaluate the quality improvement
efforts.
• Train the team in planning and facilitating meetings,
communicating efficiently, making group decisions and
resolving conflicts.
8. Collection of Data and Analyzing the
problem to identify Root Cause
Data collection instruments:
• Inventory Assessment
• Data sheets of Service Statistics
• Observations
• Questionnaire
• Interview
• Checklists
Assessment Approaches:
• Situation Analysis: SDPs – Actual gap
• Mystery Client Studies
• Client Satisfaction Studies
• Focus Group Discussion
• Operations Research
9. Developing solutions and corrective
action for quality improvement
• The team can use a technique called benchmarking to
compare the processes followed in their organization with
those of a recognized leading organization in the same
field.
• Team should develop an action plan that specifies:
 Each action to be taken
 The proposed outcomes of those actions
 The person who has the primary responsibility for
implementing each activity
 A time-table for activities, including the points at which
new data will be collected and monitored.
10. Implementing Monitoring & Evaluating
Quality Improvement Programme

• Requires careful assessment of resources, time frame, and

implementation responsibilities.
• QA team must determine whether the problem has solved.
If not, the QA cycle should be repeated, the problem should
be restudied and new actions be taken until the desired
outcome are achieved .
• If solved, the QA cycle starts again to identify and address
new area for improvement.