Quality Management

1. Dr. Shilpa Bhalgat
BHMS, PGDHM, MHA, MBA,
PhD(pursuing)
shilpabhalgat@gmail.com
9552524492

2. Quality is
Appropriate application of medical knowledge with due
regard to the balance between the hazard inherent in
every medical intervention and the benefits expected
from it….
 Quality is when your customers, (in case of hospitals the
patients,) are so thrilled with your services or products
that they would go out of their way to get your services
or products from you.

3. Health care Service –
 Provider,
 Recipient,
 Organizer,

4.  To provide care as per established norms
 Adequate resources
 Self satisfaction with the final outcome
 Should contribute to enhancement of skills,
competence and add to experience

5.  Accessibility
 Affordability
 Prompt attention
 Less waiting time
 Early diagnosis and cure
 Return to Productivity as early as possible
 Humane Treatment i.e. to be treated with
dignity, respect, empathy , and concern

6.  Responsible to the Society for the funds spent
on health care
 To ensure safety of public and prevent
inappropriate or suboptimal care
 To meet the requirements of the recipient and
provider of the health care services at
Acceptable costs

8.  According to the WHO Report 2000,
improving health outcome is one of the
major objectives of the health system.
 In order to do so, service delivery or
service provision and responsiveness of
the system to people expectation are
critical determinants.
 That implies quality of health care services.

9. Quality has gained importance due to :
(1) Increased Competition
(2) Educated Customer
Hence if any organization has to survive, it
must follow
“High Quality, at Minimum Cost”

10.  TQM is a system which brings out positive
change in Quality at all levels of the
organization and organizational processes at
every step.

11.  Total Quality Control (TQC)
 Just in time (JIT)
 ISO9000
 Statistical Process Control (SPC)
 Quality Circles (QC)
 Zero Defects (ZD)
Change Systems:
 Total Quality Management (TQM)
 Process re – engineering (PR)

12.  Statistical quality sampling
 Job performance
 Financial tools and ratios
 Material usage and inventory levels
 Throughput
 Costing
 Productivity
 Efficiency

14.  Quality Management is an integral part of Management. For a
manager, ignoring quality management processes could cost a great
deal. For a product/service to be delivered successfully adopting
benchmarked quality assurance and quality control systems
becomes mandatory
 Monitoring and Controlling Quality ensures that systems and
process are on track and are progressing as per the baseline
estimations and requirements. To perform quality control various
tools and techniques are used like Inspection and Statistical
Sampling.
 While Inspection refers to ensuring if the product confirms to
specified requirements, Statistical Sampling focuses on quantitative
analysis of a sample of data to ensure conformance to the target
measurements.
 Besides these tools, there are other seven tools which are collectively
called ‘Seven Basic Tools of Quality’. The primary purpose of each
of these tools is to examine the product, service or result processes
for conformity to quantitative standards.

15.  Diagrams that define the inputs to a
process or product to identify the
potential causes of defects are known
as Cause and effect diagrams. (Std.
Def.)
 This diagram is also referred to as Fish-
bone analysis diagram or Ishikawa
diagram. This is used to determine
what may have caused a defect. This is
very helpful when we need to analyze
the root cause of a problem.
 For example, referring to diagram, we
can see that there could be a problem
of project going over budget during
the course of its execution. The given
diagram illustration simply helps us
list out the possible causes of the cost
over-run. Once the root cause is
determined, it could be handled with
appropriate resolution and may help in
damage control. It could help the
project manager save some cost during
the future phases of the project.

16.  A Control Chart is a graphical display of data
over time and against established control limits
that has a center line that assists in detecting a
trend of plotted values toward either control
limits.
 To explain it in a simple way, Control Charts
are a way of visualizing how processes are
doing over time. Control Charts measure the
results of processes over time and display the
result in graph form to show whether the
process variance is in control or out of control.
 A process is considered to be in control if the
measurements fall within the control limits. So
in a Control Chart, there is a mean, a Lower
control limit and an Upper control limit.
 It’s pretty normal to have your data
fluctuate from sample to sample. But when
seven data points in a row fall on one side of
the mean, we say that the entire process is
out of control. It is also called ‘Rule of
Seven’. The ‘Rule of Seven’ states that
seven data points trending in one direction
up or down, or falling on any one side of the
mean indicates that the process isn’t
random.

17.  The depiction in a diagram format of the
inputs, process actions, and outputs of one or
more processes within a system is called a Flow
Chart.
 Flowcharts show how processes work visually.
Flowchart to show how the tasks in project
interrelate and what they depend on.
 They are also good for showing decision-
making processes.
 Flow charts are good way to analyze where in
the process could the problems occur.
 For example, referring to diagram on the right
shows a small process of decision making to get
out of the bed and what would happen if we
choose not to. If we decide not to get up, how
would the process react and what will be the
possible outcomes, until we decide to really get
out of the bed.
 The flowchart helps to see how all of the
phases relate to each other. Flowcharts help to
get a hold on the way we are working by
showing us a picture of the whole process. In
other words, flowcharts are diagrams that
show the logical steps to be carried out in order
to accomplish an objective.

18.  A bar chart showing a distribution of
variables over time, is called a
Histogram.
 Histograms gives a fair idea of how our
data breaks down. It shows the
distribution of data over various streams
ranging from resource allocation to
budget distribution.
 For example, referring to diagram , if we
found out that our product has 75
defects, we may still need a clear idea of
there severity. We cannot assume if they
were all critical. So looking at a chart like
the one below would help us get some
perspective on the data. A lot of the bugs
are high, medium or low priority. It looks
like only 10 or so are critical. Histograms
are great for helping you to compare
characteristics of data and make more
informed decisions. This product
probably isn’t ready to be delivered yet
as it still has a lot of high severity bugs,
but at least we know that the bugs aren’t
all critical!

19.  A bar chart ordered by the frequency of occurrence, that
shows how many results were generate by each identified.
 Pareto Analysis is a statistical technique used in selection of
a limited number of tasks that produce significant overall
effect. Pareto charts help us to figure out which problems
need our attention right away. They’re based on the idea that
a large number of problems are caused by a small number of
causes which is based on the Pareto Principle.
 The Pareto Principle was discovered by Vilfredo Pareto (1848
– 1923). During his research on the distribution of wealth in
Italy, he observed that 80 percent of the wealth and land
ownership was held by 20 percent of the population. In fact,
that’s called the 80/20 rule and applies to many other
disciplines and areas. It goes on to say that 80 percent of the
problems are usually caused by 20 percent of the causes.
 For example, refering to diagram , the Pareto charts plot out
the frequency of product faults and sorted in descending
order. This particular Pareto chart divides problem areas
into seven categories, which are always ordered from most
to least faults found. The right axis on the chart shows the
cumulative percentage. We observe that most of the product
problems are caused by installation issues. So, improving the
way products are installed could be one of the ways to
resolving 40% issues besides taking care of the Software
faults and shipping faults, to prevent failure of the product
in the market.
 It clearly shows that only these three categories combined
account for causing 79% of faults in the product.

20.  A run chart is a line graph of data plotted over time used
to show trends in the variation of a process.
 Run charts are often used in conjunction with Control
charts. By collecting and charting data over time, we can
find trends or patterns in the process. Because they do
not use control limits, run charts cannot tell you if a
process is stable.
 Run charts tell you about trends in your project by
showing you what your data looks like as a line chart. If
the line in the chart were the number of defects found in
your product through each quality activity, that would
tell you that things were getting worse as your project
progressed. In a run chart, you are looking for trends in
the data over time. You could check the chart to see if it
seem to be going up or down as the project progresses.
 For example, referring to diagram , as the given software
development project progressed, we observed that the
trend of fixing the bugs was slower in the initial phase of
software testing. However, as more and more bugs were
generated by the tester, the developers started focusing
on fixing more bugs to ensure delivery on-time and on-
budget.
 ‘Trend Analysis’ is another technique which is
supported by Run Charts. If we have historical data and
current data, by using mathematical statistics of business
intelligence, we could predict the future outcomes and a
representation could be made using Run Charts.

21.  A scatter diagram, or scatter graph is a
graphical representation of quantitative
analysis on mathematical statistics of two
variables, using Cartesian coordinates.
 Scatter diagrams show how two different types
of data could relate to each other and show the
progress of work. Scatter diagrams use two
variables, one called an ‘independent variable’,
which is an input and the other called the
‘dependent variable’, which is an output. This
relationship is also analyzed to prove or
disapprove cause and effects relationship
between the variable.
 For example, referring to diagram 7.0 below, if
the test team worked to create a bunch of new
test cases, we might use a scatter diagram to
see if the new test cases had any impact on the
number of defects we found. The chart here
shows that as more test cases pass, 10 fewer
defects are found. When the number of tests
passing goes up, fewer defects are found. The
Scatter diagram will display the relationship
between these two elements – No of Test
Cases(as the Independent Variable) and No of
Defects (as the Dependent Variable), as points
on graph. The defects are scattered on the
graph in such a way that it reflects when the
number of tests passing goes up, fewer defects
are found.
 The result shows a positive correlation between
the variables.

23.  Starting a new improvement project
 Developing a new or improved design of a
process, product, or service
 Defining a repetitive work process
 Planning data collection and analysis in order to
verify and prioritize problems or root causes
 Implementing any change
 Working toward continuous improvement

24.  Plan: Recognize an opportunity and plan a change.
 Do: Implement the planned change. Carry out a
small-scale study.
 Check: Monitor the process, analyze the results,
and identify what you’ve learned.
 Act: Take action based on what you learned in the
study step. If the change did not work, go through
the cycle again with a different plan. If you were
successful, incorporate what you learned from the
test into wider changes. Use what you learned to
plan new improvements, beginning the cycle
again.

25.  Create constancy of purpose towards
improvement of product and service
 Adopt the new philosophy
 Cease dependence on mass inspection
 End the practice of awarding business on price
tag.
 Improvement is not a one time effort but has to
be continuous one
 Institutional training and retraining
 Institutional leadership

26.  Drive out fear
 Break down barriers between department
 Eliminate slogans, exhortations and targets for
the workforce
 Eliminate numerical quotas
 Remove barriers to pride workmanship
 Institute a vigorous program of education and
retraining
 Take action to accomplish transformation

27.  Admission and Discharge protocols
 Nursing and drug administration
 Administration of indoor patients, wards
and rooms
 Laboratory and diagnostic tests
 Blood bank services
 Diet and catering services
 Vendor management
 And many more……

28.  Improves Communication
 Reduces Cost, Improves profitability
 Reduces Failures, Customer complaints
 Reduces Lead Time
 Improves Housekeeping
 Reduces “WASTE” in all processes
 Enhances confidence of customer
 Helps in getting repeat patient,References,new patients
 Helps in coming in contact with Corporates,
International patient
 Improves Medical Tourism
 Improves image of organization

29. Anything that adds COST
or TIME without adding
VALUE to it is described
by primary customer as
“WASTE”

30. Transportation
Inventory
Motion
Waiting
Overproduction
Over-Processing
Defects

31.  Accreditation of Hospitals like ISO certification /
NABH accreditation is a step towards assuring the
consumers that their institution has acquired a
certain degree of quality standards as per
international standards
 Accreditation of Hospitals is also done by National
Accreditation Board for Hospital (NABH)

32.  Commitment by Top Management.
 Preparation of Business Plan
 Finalize various processes, their interrelation
and interaction, with measurable objectives.
 Study the present system (Health check), input
/ out put for every process.
 Prepare a time bound activity schedule
defining responsibility for every activity.

33.  Train the People: Every one: Awareness,
 Clause by Clause Understanding,
Documentation, Internal Audit.
 Prepare Document (or documented procedure)
for every activity giving reference to who is
responsible and what records are maintained.
Also provide measurement criteria for the
process.
 Prepare Quality Manual.
 Start Internal Audit, preferably once in two
months.

34. 1. Customer focus:
Hospital depends on their customers and therefore
should understand current and future customer
needs, should meet customer requirements and strive
to exceed customer expectations.
2. Leadership
Leaders establish unity of purpose and direction of
Hospital They should create and maintain the internal
environment in which people can become fully
involved in achieving the Hospital’s objectives.
3. Involvement of people
People at all levels are the essence of Hospital and their
full involvement enables their abilities to be used for
the Hospital’s benefit.
4. Process approach
A desired result is achieved more efficiently when
activities and related resources are managed as a
process.

35. 5. System approach to management
Identifying, understanding and managing
interrelated processes as a system contribution to
the Hospital’s effectiveness and efficiency in
achieving its objective.
6. Continual improvement
Continual improvement of the Hospital’s overall
performance should be permanent objective of the
Hospital
7. Factual approach to decision making
Effective decisions are based on the analysis of
data and information.
8. Mutually beneficial supplier relationships

36.  "A public recognition by National /
international organization for the
achievement of quality standards,
demonstrated through an independent
external peer assessment of that
organization's level of performance in relation
to the standards".

37. Thus, Accreditation is an external review of
quality with four principal components:
1. It is based on written and published standards
2. Reviews are conducted by professional peers
3. The accreditation process is administered by
an independent body
4. The aim of accreditation is to encourage
organizational development.

38.  NABH is a constituent
board of Quality Council
of India, set up to
establish and operate
accreditation
programme for
healthcare organizations.
 The board is structured
to cater desired needs of
the consumers and to set
benchmarks for progress
of health industry.

40.  QCI was set up in 1997 jointly by
 Government of India and
 3 Premier Indian Industry Associations
1. Associated Chambers of Commerce and
Industry of India (ASSOCHAM),
2. Confederation of Indian Industry (CII)
3. Federation of Indian Chambers of
Commerce and Industry (FICCI)

41.  QCI is formed to establish and operate national
accreditation structure & promote quality
through National Quality Campaign
 Establish and maintain an accreditation
structure in the country
 Provide right and unbiased information on
quality related standards
 Spread quality movement in the country through
National Quality Campaign
 Facilitate up gradation of equipments and
techniques related to quality
 Represent India’s Interest in International
forums
 Help establish brand equity of Indian products

43.  Patient Outcome
 Patient Safety
 Staff / Employee safety
 Environment and Community Safety
 Information Education and Communication

44.  In India, Heath system currently operates within
an environment of rapid social, economical and
technical changes.
 Such changes raise the concern for the quality of
health care.
 Hospital is an integral part of health care system.
 Accreditation would be the single most important
approach for improving the quality of hospitals.
 Confidence in accreditation is obtained by a
transparent system of control over the accredited
hospital
 An assurance given by the accreditation body that
the accredited hospital constantly fulfils the
Standard ethical practice.

45.  Allopathic Clinic
 AYUSH Hospitals
 Dental Clinic
Hospitals
 Medical Imaging Services
 PHC / CHC Accreditation
 Small Healthcare Organization (SHCO)
 Wellness Centre
 (many more)

46.  Accreditation Committee
 Recommending to board about grant / reject of
accreditation
 Approval of the major changes in the Scope of
Accreditation including enhancement and reduction,
 Recommending to the board on launching of new
initiatives
 Technical Committee
 Drafting of accreditation standards and guidance
documents
 Periodic review of standards
 Appeals Committee
 The Appeal Committee addresses appeals made by the
hospitals against any adverse decision regarding
accreditation taken by the NABH.
 NABH Secretariat
 The Secretariat coordinates the entire activities related to
NABH Accreditation to hospitals and healthcare

47.  NABH is an Institutional Member as well as a
Board member of
 International Society for Quality in Health
Care (lSQua).
 Accreditation Council of International Society
for Quality in Health Care (ISQua).
 Asian Society for Quality in Healthcare
(ASQua).
 International Spa Association (ISPA).

48. Initial Application including Self
Assessment as per the laid down
standards
Screening of the Application
Pre assessment survey
Assessment survey

49. Accreditation committee
Recommendations
If required Verification Visit
Approval of Accreditation by
the NABH
Re-assessment Surveys

50. 1 Application and Accreditation
Fee
Up to 100 Beds 101-300 beds 301-500 beds 501 and above
1.1 Hospitals (w.e.f 1 Jan 2017) Application fee: 40000/- Annual
fee: 1,65,000/- Plus GST @18%
Application fee: 75000/-
Annual fee: 250000/-
Plus GST @18%
Application fee:
100000/-
Annual fee: 360000/-
Plus GST @18%
Application fee:
150000/- Annual fee:
440000/- Plus GST@18%
1.2 SHCO (w.e.f 1 Jan 2017) Application fee: 25000/- Annual
fee:110000/- Plus GST@18%
Application and Accreditation
Fee
< 5000 unit per annum 5001 – 20000 unit per
annum
> 20, 000/ annum
1.3 Blood Bank Application fee: 10000/- Annual
fee: 50000/- Plus GST@ 18%
Application fee: 25000/-
Annual fee: 75000/-
Plus GST@18%
Application fee: 40000/-
/- Annual fee: 100000/-
Plus GST@18%
Application and Accreditation
Fee
Clinic/dispensary Clinic/dispensary with
additional services
1.4 Allopathic Clinics Application fee: 5000/- Annual
fee: 15000/- Plus GST @18%
Application fee: 10000/-
Annual fee: 20000/-
Plus GST@18%
Application and Accreditation
Fee
Primary Health Centre
1.5 Primary Health Centre (PHC) Application fee: 20,000/- Annual
fee: 30000/- Plus GST@18%

51. Benefits
of
Accreditatio
n
Patients/
Family
Staff -
Doctors
Hospital
TPA/
Insurance

52.  Patients are the biggest beneficiary
 Results in high quality of care and
patient safety.
 The patients are serviced by credentialled
medical staff.
 Rights of patients are respected and
protected.
 Patients satisfaction is regularly evaluated.

53.  The staff in an accredited hospital is satisfied
lot as
 it provides for continuous learning,
 good working environment, leadership and
 above all ownership of clinical processes.
 Improves overall professional development
of Clinicians and Para Medical Staff &
provides leadership for quality
improvement with medicine and nursing.

54.  Improve quality of health care
Patient safety and risk management
Evidence-based practice
Continuous learning and improvement
Continuous Quality improvement
 Stimulate and improve integration &
management of health services
 Reduce variation in care and health care costs
 Strengthen the public’s confidence in the quality
of health care
 Helps demonstrating commitment to quality care
 It also provides opportunity to healthcare unit to
benchmark with the best.

55.  Accreditation provides an objective system of
empanelment by insurance and other third
parties.
 Accreditation provides access to reliable and certified
information on facilities, infrastructure and level of
care.

56.  Consumer Protection Act
 Clinical Establishment Act
 Insurance companies regulations
 Empanelment by CGHS, ECHS,
Ayushman, MPJAY, Corporate etc.
 Community Awareness and Response
 Medical Tourism

57. 1. Accreditation
2. Certification
3. Empanelment
4. Training & Education

58. NABH 5th Edition –
April 2020
Chapters 10
Standards 100[14,20,11,8,8,7,5
,7,13,7]
Objective Elements 651

59. Chapters 10
Standards 61
Objective Elements 289

60. Chapters Std OE
Access, Assessment & Continuity of Care (AAC) 14 (96)91
Care of Patient (COP) (22)20 (151)
142
Management of Medication (MOM) (13)11 (76)70
Patient Right and Education (PRE) 8 54

61. Chapters Std OE
(Continuous Quality Improvement (CQI))
Patient Safety and Quality Improvement (PSQ)
(9)
7
(59)
49
Responsibility of Management (ROM) (6)5 (39)32
Facility Management and Safety (FMS) 7 (56)49
Human Resource Management (HRM) (10)13 (53)76

62.  Scoring on a scale of 0, 5 and 10
Compliance to the requirement : 10
Partial compliance to the requirement : 5
Non-compliance to the requirement : 0
Not Applicable : NA
 Evaluation criteria:
Regulatory / Legal Requirements : No – 0
accepted
 Average Score
 Individual Standard : not < 5
 Total Score for all standards in Chapter : > 7
 Individual Chapter : not < 7

63. ?