IMPART Dubai, 2013. Workshop on Quality Management System in ART Center.

1. IMPART, Dubai, 2013
Quality Management System
in ART Centers
Fabiola C. Bento, BA, MBE
Quality Manager, ANDROFERT
Andrology & Human Reproduction Clinic - Campinas,
Brazil

2. Nice to Meet You!

3. 1996 – Androfert Foundation
2000 – First IVF cases
2002 – Moved to own headquarters
2006 – Started QMS
2010 – ISO Certification
2013 – Recertification
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 3
2013 DECEMBER

4. 2010 – Started book
Fabiola Bento
Sandro Esteves
Ashok Agarwal
End of 2012 – Published
• Practical Guide
• Show international
experience
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 4
2013 DECEMBER

5. What is management?
It can be summarized as the group of people
that interact in a physical or virtual
environment and have the same goal.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 5
2013 DECEMBER

6. What is Quality?
Characteristic; nature; essential character;
something that distinguishes.
Definitions from various dictionaries.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 6
2013 DECEMBER

7. Quality is very subjective…
Individual; Influenced by personal feelings;
Existing only in the mind; Imaginary.
It varies from person to person
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 7
2013 DECEMBER

8. In the administration, QUALITY is:
1- Compliance with guidelines and
established patterns and expected results.
2- Meeting client’s needs and expectations
3- Continuous improvement
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 8
2013 DECEMBER

10. Workshop Overview
Establishing a QMS: A Practical Guideline
PART 1
Implementation of QM in Reproductive
Laboratories
PART 2

11. PART 1:
Establishing a QMS: A Practical Guideline
• Mission Statement
• Quality Management Focus
(quality policy, objectives and indicators)
• Processes and Procedures
• Non-Conformities or Improvement
Opportunities
• Registering Quality Actions
(corrective, preventive and improvement)
• Auditing
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 11
2013 DECEMBER

12. PART 2:
Implementation of QM in Reproductive Laboratories
• Laboratory scope, structure, personnel
and resources
• Laboratory manuals
• Quality Control X Quality Assurance
• Pre-analytical, analytical, and post-analytical
• Quality assurance report
• Monitoring and enhancing performance
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 12
2013 DECEMBER

14. What’s your main occupation?
a) Gynecologist
b) Urologist
c) Laboratory Director
d) Embryologist
e) ART Clinic Director

15. Where do you work?
a) Private Office
b) ART Clinic

16. Does your ART Clinic
already have a QMS?
a) Yes
b) No

17. If you answered yes, is it certified?
a) Yes
b) No

18. What do you expect from this workshop?
a) Implement a QMS.
b) Improve the QMS you already have.
c) I’m still not convinced about the
importance of a QMS and want to
learn more about it.
d) None of the above.

19. Why are most people afraid of a QMS?
a) It seems too complicated.
b) It will be expensive because I’ll have to
hire an external consultant to develop my
QMS.
c) It’s time-consuming and too much
paperwork.
d) I don’t see the benefits of having a QMS.

20. 1- Show the importance of a QMS
2- Show that it’s not as complicated as it
sounds like.
3- Show that you can do it yourself, and
therefore internally and at a low cost.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 20
2013 DECEMBER

22. PART 1:
Establishing a QMS: A Practical Guideline
• Mission Statement
• Quality Management Focus
(quality policy, objectives and indicators)
• Processes and Procedures
• Non-Conformities or Improvement
Opportunities
• Registering Quality Actions
(corrective, preventive and improvement)
• Auditing
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 22
2013 DECEMBER

23. STEP 1:
Mission Statement
Define who your patients or clients are:
couples, men, women, doctors, etc.
WHO
Define the services you provide:
Diagnostic, Counseling, IUI, IVF, etc.
WHAT
Define how you do it:
Technology used, philosophy, objectives,
etc.
HOW

24. Exercise 1
Mission
Read the Mission Statements
and define:
• WHO (clients)
• WHAT (service)
• HOW
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 24
2013 DECEMBER

25. Exercise 2
Scope
SCOPE OF ACTIVITIES = all
services offered by your ART Center
Check the items that apply
to your ART Center
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 25
2013 DECEMBER

26. Exercise 3
Mission
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 26
2013 DECEMBER

27. STEP 2:
Quality Management Focus
Brief, simple and direct statements that
define the focus of your quality
management system
Quality
Policy
Objectives of each statement of your
quality policy (they have to be
measurable)
Quality
Objectiv
es
How you monitor your quality objectives,
or in other words, the tools used to check
if your objectives and consequently policy
is being achieved.
Quality
Indicator
s

28. Choose the quality policies that best
apply to your ART Center.
There’s space for you to write your own quality
policies.
Exercise 4
Quality Policy
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 28
2013 DECEMBER

29. Exercise 5
Quality
Objectives
Match the quality objectives
listed with the two Quality
Policies presented.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 29
2013 DECEMBER

30. Match the quality
objectives with the quality
indicators
Exercise 6
Quality
Indicators
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 30
2013 DECEMBER

32. STEP 3:
Processes and Procedures
Complex sequence of procedures focusing
on a result. Important for defining
procedures, finding flaws, correcting
mistakes.
Process
Sequence of steps to execute a task.
Important for standardization and
replication.
Procedure

33. Flowchart Symbols
Starting or
Ending point
Decision making
Action / Procedure Data input/output
Flow or Sequence

34. Exercise 7
Process
Flowchart
Using the basic flowchart
symbols, complete the flowchart
presented with the correct forms
for each step.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 34
2013 DECEMBER

35. Secretary
answers the
phone
Is it a new
patient?
Continues…
Wants general
information?
Secretary gives
homepage and
email address
Wants to
schedule semen
test?
Secretary
verifies type of
test
Secretary
schedules
Wants to
schedule
appointment?
Secretary
verifies medical
preference
Yes
Yes
Yes
No
No
Yes
No

36. Exercise 8
Identifying
Procedures
Read the flowchart presented,
choose one “rectangle” and list
the procedures that may be part
of it.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 36
2013 DECEMBER

37. Local Diagnostic Tests and
Procedures
Diagnostic testing on semen
(standard semen analysis, antisperm antibody
assessment, sperm DNA damage testing, etc)
Ultrasound Evaluation
Blood Tests
Diagnostic PESA, TESA, TESE, micro-TESE

38. Treatments
Ovulation Induction and Control
Oocyte retrieval and Embryo transfer
Sperm retrieval techniques
Semen processing for IUI, IVF, ICSI
All IVF/ICSI procedures

39. SOP Table of Contents
I- Introduction (general information)
II- Principle of procedure (objectives)
III- Specimen collection (instructions)
IV- Equipment and Materials
V- Reagents
VI- Quality control (negative/positive control)
VII- Procedure description
VIII- Panic values
IX- Assay performance
X- References

40. Exercise 9
Identifying Parts
of an SOP
Read the SOP, write the
headings for each part, and put
them in order.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 40
2013 DECEMBER

41. Exercise 10
Identifying
Missing Parts
of an SOP
Read the SOP example and
identify what parts are missing.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 41
2013 DECEMBER

42. STEP 4:
Non-conformities or
Improvement Opportunities?
Every deviation from what is
established. Important to identify
inconsistencies, weaknesses, and
improvement opportunities.
Non-conformity
Not qualified as non-conformities because
there was no deviation, but maybe a not
well-defined (or not defined at all) process
or procedure.
Improveme
nt
opportunity

43. Read the occurrences and
define if they are non-conformities
or improvement
opportunities.
Exercise 11
NC or IO
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 43
2013 DECEMBER

44. STEP 5:
Registering Quality Actions
Actions taken to improve the service
provided.
Improveme
nt Actions
Actions taken to avoid a potential non-conformity
detected before it actually
happen.
Preventiv
e Actions
Actions taken after a non-conformity has
been detected to correct it.
Correctiv
e Actions

45. Exercise 12
Classifying
Actions
Read the situations and actions
taken and classify them as:
CA = corrective actions
PA = preventive actions
IA = improvement actions
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 45
2013 DECEMBER

46. Model (parts of the registration)
• Date/Department/
Origin/Description
• Immediate action
• Cause analysis
• Suggested action
• Action taken
• Follow-up
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 46
2013 DECEMBER

47. STEP 6: Auditing
Verify conformity!
Main
Objective
Processes, Procedures,
Documents and Records
Types

48. Exercise 13
Auditing Checklist
Read procedure, identify critical
steps, and prepare the checklist
before auditing.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 48
2013 DECEMBER

50. Coffee
Break

51. PART 2:
Implementation of QM in Reproductive Laboratories
• Laboratory scope, structure, personnel and
resources
• Laboratory manuals
• Quality Control X Quality Assurance
• Pre-analytical, analytical, and post-analytical
• Quality assurance report
• Monitoring and enhancing performance
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 51
2013 DECEMBER

52. STEP 7:
What we do & How we work
List of procedures under scope of
activities
Scope
Lab design and required equipment in
accordance to the volume and spectrum
of testing/procedures performed
Structure
and
Equipme
nt
Personnel and supplies
Resources

53. Exercise 14
Scope
Check the scope and activities
performed by your ART Center.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 53
2013 DECEMBER

54. Exercise 15
Infrastructure
Self-evaluation exercise:
Check the structure and
equipment you have at your
ART Center.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 54
2013 DECEMBER

55. Personnel & Resources
• Laboratory Director
• Clinical Consultant
• Supervisor
• Testing personnel
• Embryologist
• Nurse
• Medical Assistant
• Administrative/Support Personnel
• Quality Manager

56. STEP 8:
Laboratory Manual
Defines how to perform
procedures and routines;
describes the resources and
facilities to do it
Laboratory
Technical
Manual
SOP’s manual: written instructions
of all procedures under the scope of
the reproductive laboratory
Laboratory
Procedures
Manual

57. Exercise 16
Laboratory Manual
What should be in your laboratory
TECHNICAL manual?
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 57
2013 DECEMBER

58. Exercise 17
Laboratory Manual
Label:
• Lab manual
• IVF procedures manual
• Andrology procedures manual
• Criopreservation procedures manual
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 58
2013 DECEMBER

59. STEP 9:
Quality Control X Quality Assurance
Quality specifications for each
piece of equipment and/or
procedure, and involves ensuring
that they conform to established
limits and standards
Quality
Control
Documentation to ensure that a
product or service satisfies its
required quality characteristic
Quality
Assurance

60. Quality Control
Examples:
• Monitoring equipment’s temperature
• Using +/- controls during tests
• Equipment’s calibration
Does not measure lab performance as a
whole. It treats each element as a unit.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 60
2013 DECEMBER

61. Quality Assurance
Examples:
• Quality control activities
• Continuing education
• Enrollment in external quality proficiency
Looks at the lab as a whole. It’s the overall
surveillance.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 61
2013 DECEMBER

62. Exercise 18
Quality Control X
Quality Assurance
Read the activities and classify
them as Quality Control (QC) or
Quality Assurance (QA)
ANDROFERT
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ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 62
2013 DECEMBER

63. STEP 10: Defining pre-analytical,
analytical and post-analytical (SOP)
Patient instruction for test/procedure
Specimen collection instructions
Specimen identification, transportation
Specimen rejection criteria
Pre-analytic
Information
Name of the test or procedure
Principles (objectives, general information)
General
Informatio
n

64. Calculations (if required)
Normality intervals and expected results
Policy for handling alert or panic values
Patient report
References
Post-analytic
Information
Equipment, Materials, Reagents
Conditions required (e.g., use of safety
cabinet)
Instrument calibration and verification
Quality control (negative/positive control)
Step-by-step description
Assay limitations (sensitivity)
Analytic
Information

65. Exercise 19
Pre-analytical,
Analytical and Post-
Analytical
Classify the list of activities as:
Pre-analytical
Analytical
Post-analytical
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 65
2013 DECEMBER

66. Exercise 20
Pre-analytical,
Analytical and Post-
Analytical
Read the SOP and identify the
pre-analytical, analytical and post-analytical
phases.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 66
2013 DECEMBER

67. Quality Assurance Report

68. STEP 11:
Monitoring Quality Indicators
• Part of the Quality Improvement
• Comprehensive monitoring program to
enhance lab performance by exploring
innovation
• Focuses on the progressive increase in
quality and efficiency.
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 68
2013 DECEMBER

70. Model for Monitoring an Indicator
Indicator:
Expected Result:
Indicat
or
Objectiv
e
Monitoring every two months
Jan/Feb Mar/Apr May/Jun Jul/Ago Sep/Oct Nov/Dec
If the expected result was not achieved, justify the reasons after investigating the causes
and design an improvement plan. Add the information to the table below.
Causes or Possible
Causes
Improvement Plan
Jan/Feb
Mar/Apr
May/Jun
Jul/Ago
Sep/Oct
Nov/Dec

71. Why should we do all that?
• Standardization (compare apples to
apples)
• Replication (training)
• Quality control (eliminate variables that
can interfere with final result)
• Quality Management (monitor results/deal
with deviations in a timely manner/prevent
recurrence/design improvement
plans/enhance performance)
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
FC BENTO, 71
2013 DECEMBER

73. “The real voyage of discovery
consists not in seeking new
landscapes, but in having new
eyes.”
Marcel Proust

74. Thank You
obrigado