2. Learning Objectives
• Understanding of the standards under “Quality Management”.
• How these standards are distributed in different checklists.
• What is the importance and weightage of these standards
• Things to be kept in mind while assessing these standards.
3. Level –wise Arrangement of Standard
Area of Concern G- Quality Control
DH CHC PHC UPHC HWC(SC)
StandardG1 The facility has established organizational framework for quality
improvement
StandardG7. The facility has defined Mission, values, Quality policy and objectives,
and prepares a strategic plan to achieve them
StandardG3. Facility have established internal and external quality assurance
programs wherever it is critical to quality.
Standard G6. The facility has established system of periodicreview as internal
assessment , medical & death audit and prescription audit
StandardG2 Facility has established system for patient and employee satisfaction
StandardG4. Facility has established, documented implemented and maintained
Standard Operating Procedures for all key processes and support
services.
StandardG8. Facility seeks continually improvement by practicing Quality method and
tools.
StandardG5. Facility maps its key processes and seeks to make them more efficient by
reducing non value adding activities and wastages
StandardG9 Facility has defined, approved and communicated Risk Management
framework for existing and potential risks.
StandardG10. Facility has established procedures for assessing, reporting, evaluating
and managing risk as per Risk Management Plan
The facility has established system of periodic review of clinical, support
and quality management processes
4. Standard
G1
The facility has established organizational
framework for quality improvement
ME G1.1
Quality
Team
ME G1.2
Review
Meetings
The facility has a quality team in place.
The facility reviews quality of its
services at periodic intervals.
General/Admin
General/Admin
5. Standard
G2
Facility has established system for patient and
employee satisfaction
ME G2.1
Patient
Feedback
ME G2.2
Feedback
Analysis
Patient satisfaction surveys are
conducted at pe.
riodic intervals.
The facility analyses the patient
feedback, and root-cause analysis.
All department
except ICU,
Emergency, LR &
OT
General/Admin
ME G2.3
Feedback
Action Plan
The facility prepares the action plans for
the areas, contributing to low satisfaction
of patients
General/Admin
6. Patient Satisfaction
• Both for OPD & IPD (Separately)
• In LaQshya – Separate for
Maternity ward & Post Surgical
Ward
• Mera Aspataal
• Sample Size
• Root Cause Analysis of Lowest
performing factor
• Regular Measurement
&continuous Improvement
10. Standard
G3
ME G3.1
Internal
Quality
Assurance
ME G3.2
External
Quality
Assurance
Facility has established internal quality
assurance program at relevant departments
Facility has established external assurance
programs at relevant departments
Applicable to all
the departments
& special focus on
lab services
Applicable to
Diagnostic &
Pharmacy Services
ME G3.3
Use of
Checklist
Facility has established system for use of check
lists in different departments and services
Applicable to all
departments
Facility have established internal and external quality
assurance programs wherever it is critical to quality.
11. Internal Quality Assurance
Quality Control-
Less than 40 per day - at least one level QC once a day.
Between 40-80 per day - apply two level QC at least once a day.
More than 80 per day - apply two level QC at least twice a day for
such analyses.
If controls are not available-
• Retesting of any randomly chosen specimen/s
• Replicate test of specimen by different method, different machine
and different person, wherever applicable
12. External Quality assurance process for
CMC Vellore Register on
http://home.cmcvellore.ac.in/clinqc/ab
outRegistration.aspx
Fill the form and send it with
demand draft of requisite fee
CMC will send the
lypophelized sample every
month
Run the samples and upload
the values on portal
Download the report at end
of month
Analyze the results and take
corrective actions
13. Interpretation of VIS
VIS Performance
< 100 Very good
100 -150
150 -200
> 200
good
satisfactory room for improvement
Not acceptable
•If VIS of >200 on two or more occasions for the same analyte, them
check your standardization procedures & calibration
• Indicates an accuracy problem (systematic error / bias )
14.
15. Z-Score
Interpretation of Robust Z-scores:
Z score less than 2 - Satisfactory
Z score 2 but less than 3 - Questionable performance
Z score more than 3 – Unsatisfactory
Both ZB & ZW should be < 2
Using only one Z-score may misleading
ZW < 2 ZB > 2 = Higher bias i.e low reproducibility
ZB < 2 ZW > 2 = low precision (i.e., low repeatability)
For assessing laboratory's technical competency, both ZW and ZB value
should be low at the same time.
16.
17. The facility has established, documented implemented and
maintained Standard Operating Procedures for all key processes
and support services.
ME G4.2
SOP
Adequacy
Departmental standard operating
procedures are available .
.
Standard Operating Procedures adequately
describes process and procedures .
All Departments
All Departments
ME G4.3
SOP
Training
Staff is trained and aware of the procedures
written in SOPs
All Department
ME G4.3
Work
Instructions
Work instructions are displayed at Point of use All department
Standard
G4
ME G4.1
SOP
Availability
18. Hierarchy of Documents
QP
& QO
Quality
Manual
Procedures
Work instructions
Records & formats
Defines overall intent
Defines policies
Define what, when &
Who
Define How
Define results
19. 1. A background of the Organization
2. Quality Policy
3. Scope of services to be covered
4. Services excluded from scope
5.Statutory / Regulatory requirements applicable to the
organization
6. Interaction of various processes and control
7. Area of concern wise interpretation and application of the standard
8. Responsibilities & Authorities of Key Persons
9. Responsibility Matrix- who will be responsible for which
clause of the standard
10.General Process flow diagram of the
services
11. Services provided
12. Hospital Wide Policies
12. Abbreviation & Definitions used in the manual
Quality Manual
• Mission- Vision –Quality Policy
& Objectives
• SOP for Internal & External
assessments
• Quality Team
• MOM
• Measurement & Improvement
based on KPIs & results of
Assessment
20. (a) To be approved for adequacy prior to use
(b) To be Reviewed & updated as necessary & re approved
(c) To be ensured that the changes & current revision status are identifiable
(d) Ensure that the relevant versions are available at the point of use
(e) Ensure that the docs remain legible & readily identifiable
(f) Ensure that the documents of external origin are identified and their
distribution are controlled
(g) Prevent the unintended use of obsolete documents
20
Control of Documents
21. Standard
G5
The facility maps its key processes and seeks to make them more
efficient by reducing non value adding activities and wastages
ME 5.1
Process
Mapping
ME G5.2
Non Value
Adding
Activities
The facility maps its critical processes .
The facility identifies non value adding
activities / waste / redundant activities
All departments
All departments
ME G5.3
Process
Improveme
nt
Facility takes corrective action to improve
the processes
All departments
22. Value adding
⚫The activity transforms the patient and moves them
towards the next defined outcome
⚫The activity is something that the patient cares about
Non-value adding
⚫Do not serve any purpose (aim to remove these)
Necessary non-value adding
⚫Do not directly benefit patient but are necessary
e.g. completion of forms, logging patient details onto
systems, numerous checks of details
VALUE / NON-VALUE ADDING
STEPS
23. WASTE IS A SENSITIVE ISSUE
• Its critical to eliminate “waste”
• Its also critical to recognise that the non value adding activities may
have been a core part of someone job for many years
• It’s the activities that are non value adding not the person
24. Wastes in Hospitals (MUDAS)
1. Confusion
2. Motion/conveyance.
3. Waiting
4. Over processing
5. Inventory.
6. Defects
7. Over production.
28. Standard
G6
The facility has established system of periodic review as
internal assessment , medical & death audit and prescription
audit
ME 6.1
Internal
Assessment
ME G6.2
ClinicalAudits
The facility conducts periodic internal
assessment
The facility conducts the periodic
prescription/ medical/death audits
All departments
All Clinical
Departments
ME G6.3
Control of
Non
Compliances
The facility ensures non compliances are
enumerated and recorded adequately
All departments
29. Standard
G6
The facility has established system of periodic review as internal
assessment , medical & death audit and prescription audit
ME G6.4
Action Plan
ME G6.5
Quality
Improvement
Action plan is made on the gaps found in
the assessment / audit process
Planned actions are implemented through
Quality improvement cycle (PDCA)
All departments
All departments
31. Take Action & Make Improvement
1. Low performing attributes need to
identify
2. Do the root cause Analysis –using
Brainstorming &Why –why analysis
etc.
3. Develop the time bound action plan
4. Share the finding & action plan with
all physicians of the Hospitals
5. Improve the lowest performing
attributes using PDCA Cycles
6. Sustain the Improvement
Find the
Problem
Find the
Root
Cause
Take
necessar
y action
to make
changes
Correct
the
problem
Prevent
Future
Problem
QI For
Prescription
Audit
32.
33. Standard
G7
Facility has defined Mission, Values, Quality policy and
Objectives, and prepares a strategic plan to achieve them
ME G 7.1
Mission
Statement
ME G7.2
Core Values
ME G7.3
Quality Policy
ME G7.4
Quality
Objectives
Facility has defined quality objectives to
achieve mission and quality policy
General Admin
General Admin
General Admin
All Departments
Facility has defined mission statement
Facility has defined core values of the
organization
Facility has defined Quality policy, which is
in congruency with the mission of facility
34. Standard
G7
Facility has defined Mission, Values, Quality policy and
Objectives, and prepares a strategic plan to achieve them
ME G 7.5
Communicat
ion
ME G7.6
StrategicPlan
Mission, Values, Quality policy and objectives
are effectively communicated to staff and users
of services
Facility prepares strategic plan to achieve
mission, quality policy and objectives
ME G7.7
Review
Facility periodically reviews the progress of
strategic plan towards mission, policy and
objectives
All departments
General Admin
General Admin
36. SMART WAY TO PERFORM
QUALITY OBJECTIVES - A quality objective is a quality
oriented goal. A quality objective is something you
aim for or try to achieve.
S- Specific
M- Measurable
A- Attainable
R- Reviewable
T- Time-Bound
Tuesday, 24 August 2021 36
37. Examples of Quality objectives
Hospital
• Increasing overall patient
satisfaction by ‘p’ point in ‘Q’
months
Dept.
• Increasing OPD Access for
Vulnerable population by ‘x% ‘in ‘y’
months
Tuesday, 24 August 2021 37
38. Sr. Quality Measura Baseline Target Timeline Responsibil StatusM1 Status Status
no Objective ble ity M2 M3
Paramet
er
1 To decrease
waiting time
in OPD
Minutes 45 35 3
months
Staff
Nurse
42 40 39 Reset
2 To decrease
waiting time
in OPD
Minutes 39 30 3
months
Staff
Nurse
39 35 30 Reset
8/24/2021
39. Assignment I – Quality Objectives
Suppose you are working in MCH centre in Urban area. Yours Hospital
delivery load is 3000 patients/month. Your have 4 Gynecologist , 4
GDMOs & 7 Staff nurses. Average length of stay of your Hospital is 4
days for Normal delivery cases & 6 days for C section cases.
Derive Quality objectives for your Hospital & also describe how you
monitor Quality objectives.
40. Standard
G8
The facility seeks continually improvement by
practicing Quality method and tools.
ME G8.1
Quality
Methods
ME G8.2
Quality
Tools
The facility uses method for quality
improvement in services.
Facility uses tools for quality
improvement in services
All Departments
All Departments
41. Model for Quality Improvement
PLAN A CHANGE
FORMLATE A PLAN FOR IMPROVEMENT-
SET GOLAS, TARGETS & METHODS FOR
IMPROVEMENT
ACT
IMPLIMENT PLANNED CHANGES
NOT SUCCESSFUL, REWORK CYCLE
DO
IMPLIMENT THE PLAN
EDUCATE/TRAIN
CHECK
EVALUATE RESULTS
MODIFICATIONS NEEDED
42. Model for Improvement – Deming’s Cycle
What we are trying to
accomplish ?
How will we know that
change is a improvement
What Changes can we
make that will result in
Improvement
The Aim
The
Measure
The Change
43. 7 Basic Quality Tools
Histogram Fishbone
Diagram
Check sheets
Control Charts Pareto Charts Scatter Plot
Run Chart
45. STANDARDS BENCHMARKS BEST PRACTICES OBJECTIVES
QUALITY MEASUREMENT (FINDING GAPS)
NQAS PSS ESS AUDITS
PROCESS MAP KPI INTERAL QC EXTERNAL QA
TEAMWORK MOTIVATION LEADERSHIP QUALITY TOOLS QUALITY
METHODS
QUALITY IMPROVEMENT (CLOSING GAPS)
ROOT CAUSE PRIORTIZE ACTION PLAN MONITOR GAP CLOSURE
46. Facility has defined, approved and communicated
Risk Management framework for existing and
potential risks
Standard
G9
ME G 9.1
Scope & context
ME G9.2
Responsibility
ME G9.3
Incident
Reporting
Risk Management Framework includes process of reporting
incidents and potential risk to all stakeholders
General
Admin
General
Admin
General
Admin
Risk Management framework has been defined including
context, scope, objectives and criteria
Risk Management framework defines the responsibilities for
identifying and managing risk at each level of functions
47. Facility has defined, approved and communicated
Risk Management framework for existing and
potential risks
Standard
G9
ME G 9.5
Training
ME G9.6
Review
Modality for staff training on risk management is defined
Risk Management Framework is reviewed periodically
General Admin
General Admin
ME G9.4
List of risks
A compressive list of current and potential risk including
potential strategic, regulatory, operational, financial,
environmental risks has been prepared
General Admin
48. Standard
G10
Facility has established procedures for assessing,
reporting, evaluating and managing risk as per Risk
Management Plan
ME G 10.1
Approval &
Update
ME G10.2
Dissemination
Risk management plan has been prepared and
approved by the designated authority and there is a
system of its updation at least once in a year.
Risk Management Plan has been effectively
communicated to all the staff, and as well as relevant
external stakeholders
ME G10.3
Assessment
Criteria
Risk assessment criteria and checklist for assessment
have been defined and communicated to relevant
stakeholders
ME G10.4
Physical Safety
Risk
Periodic assessment for Physical and Electrical
risks is done as per defined criteria
General
Admin
General
Admin
General
Admin
General
Admin
49. Standard
G10
Facility has established procedures for assessing, reporting,
evaluating and managing risk as per Risk Management Plan
ME G 10.5
Fire Safety
risks
ME G10.6
Patient safety
Risks
Periodic assessment for potential disasters
including fire is done as per defined criteria
Periodic assessment for Medication and Patient
care safety risks is done as per defined criteria
ME G10.7
Staff Safety
risks
Periodic assessment for potential risk regarding safety
and security of staff including violence against service
providers is done as per defined criteria
ME G10.8
Risk Rating
Risks identified are analyzed evaluated and
rated for severity
General Admin
Clinical
Departments
General Admin
General Admin
50. Standard
G10
Facility has established procedures for assessing, reporting,
evaluating and managing risk as per Risk Management Plan
ME G 10.9
Risk
Treatment
ME G10.10
Risk Register
Identified risks are treated based on severity and
resources available
A risk register is maintained and updated regularly to
risk records identified risks, there severity and action to
be taken
General
Admin
General
Admin
52. Risk Analysis- Qualitative Risk analysis
Infection related
practices
Likelihood of
occurrence
Severity/conseq
uences /Impact
Priority KPI for
compliance
ICC Action
Hand washing Major % compliance to
HW
Single Use
device related
Infection
Major No. of reported
infections
Decontaminatio
n
Moderate
Data collection
& Monitoring
Moderate
54. Qualitative Risk analysis
Infection related
practices
Likelihood of
occurrence
Severity
/Impact
Priority/ Risk
score
KPI for
compliance
ICC Action
Hand washing 5 5 25 % compliance to
HW
Single Use
device related
Infection
3 5 15 No. of reported
infections
Decontaminatio
n
2 2 4
Data collection
& Monitoring
3 2 6
55. Risk Analysis : Using FMEA
• Step 1- Assemble a cross sectional team with knowledge of process.
• Step 2- Define the scope of FMEA. ( OT Scheduled Surgery
• Step 3 – Identify the functions for scope (OT Team constituted, blood arranged,
PAC done, OT Instrument Sterilization, OT logistics arrangement, Consent etc.)
• Step 4 – For each function identify all the ways failure can happen
(Communication send to team, surgeon refuse at last time, support staff went on leave, wrong
time told , emergency case )
56. Procedure
• Step 5- For each failure mode , identify the consequences (Effects) on the function
(Surgery cancelled, delayed by half hour, delayed by 3 hours )
• Step 6- Determine how serious is this effect (S). Rate it on a scale of 1 to 10. (Surgeon did’t
turned up- Rating 8)
• Step 7 – Do a root cause analysis and assign probable causes for each of the failure
mode.
• Step 8 – For each of the causes assign a occurrence rating (O) of 1-10 based on your
experience. (Staff forgotten to convey OT schedule to surgeon Rating 5)
• Step 9- For each of the causes define the process control. (Matron checks everyday in the
event the OT schedule has been shared with surgeon)
• Step 10. Give a detection rating (D) for each cause from 0-10
• Step 11 – Calculate the risk Priority Number (RPN = SXOXD)
• Step 12 – Rank the failure mode based on risk priority no.
• Step 13. Identify recommended actions
57. Function/Proc
ess
Potenti
al Mode
Potential
Effect of
Failure
S Potential
Causes of
Failure
O Current
Process
Control
D RPN Recommended
Action
OT Team Surgeon Surgery 8 • Communic
ation Not
sent
• Emergency
Duty
• Wrong
time
communic
ated
8 OT nurse 4 256
Constitution didn’t Cancelled Checks
turned
up Duty
5 Roster 8 200
No
5 control 10 400
58. Risk Register
• Document that contain all well defined risk
Risk
Register
Contents
(for
each
Risk)
Identification Number
Name & description
Risk Category
Root Cause
Likelihood & impact score
Rank
Risk Owner
Potential Response
Current Status
Notes
59. Risk response in Healthcare setting
• Risk Treatment / Control: Implement measure to reduce with practical
approach:
• Eliminate - Auto lock syringe
• Substitute process or material with safer one- Fumigation
• Engineering Control- Fume hoods, Positive –negative pressure maintenance,
International coding for medical gases
• Administrative Control- Fire exit, Signage, Mock drills
• Reduce- Personal Protective equipment
• Retention (Acceptance) & Transfer ( Buying Insurance)
60. Risk Monitor
• Evaluate execution of risk plan
• Evaluate the effectiveness in reducing risk
• Keep track of identified risks
• Monitor trigger conditions for contingencies
• Identify new risks arising through
• Risk re assessment- update the risk when there is any change
• Risk audits- Examine effectiveness of risk responses and RM process
• Status meeting- Discuss regularly in monthly /management review meeting
61. Area of concern H: Outcome
H1
Productivity
H4
Service
Quality
H2
Efficiency
H3
Clinical Care
& Patient
Safety
4
62. Level –wise Arrangement of Standard
Area of Concern H- Outcome
DH CHC PHC UPHC HWC(SC)
Standard
H1 .
The facility measures Productivity Indicators and
ensures compliance with State/National
benchmarks
Standard
H2 .
The facility measures Efficiency Indicators and
ensure to reach State/National Benchmark
Standard
H3.
The facility measures Clinical Care & Safety
Indicators and tries to reach State/National
benchmark
Standard
H4.
The facility measures Service Quality Indicators
and tries to reach State/National benchmark
Facility endeavours to improve its
performance to meet bench marks
H1, H2,H3
& H4
H1, H2,H3 &
H4
H1, H2,H3 &
H4
H1, H2,H3
& H4
