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Sandro C. Esteves, MD., PhD.
Director, ANDROFERT
Andrology & Human Reproduction Clinic
Campinas, BRAZIL
The Perfect Integr...
Outline
o  What a lab SOP is and why it is needed in TQM
o  What problems can be solved by a lab SOP
o  What the key point...
Standard Operating Procedure
sequence of steps that have been
standardized to execute a task, which is
used every time a g...
Key points of a Lab SOP
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPR...
Top 10 reasons why ART
practice needs Lab SOPs
1.  Repetitive highly-complex critically
important tasks
2.  Variation must...
Top 10 reasons why ART practice
needs Lab SOPs (cont.)
6.  Many lab professionals have previous
(differing) or no experienc...
Variation often reflects misuse of
equipment, poor lab technique
and human errors 
Root causes:
• 
 Complexity of activity
...
Essential information to be
included
What problems can be solved by
Lab SOPs? 
•  Mismatching oocytes with sperm
•  Perfor...
Double-checking (DC) and
Double-witness (DW)

Example (ET SOP; Androfert):
1.  Identification by the nurse of the patient a...
Example (ET SOP; Androfert, cont.):
6. Doctor (or nurse) informs embryologist about No.
embryos for ET (and cryopreservati...
Key points
SOP defines a sequence of steps that have
been standardized to execute a task, thus
ensuring it is done the same...
How to develop and update
Lab SOPs according to
clinical perspective

ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRO...
What are the key points of a Lab
SOP from a clinical perspective?
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCT...
Basic questions:
1.  Does SOP address specific clinical
question?
2.  Does SOP post-analytical information
help determining...
Designing Lab SOPs
Clinical Needs
Determine tests/
procedures
Write SOP (if
test/procedure
done internally)
Provide the
in...
Designing a Lab SOP

Example 1
Does the patient
have high sperm
DNA
fragmentation?
SDF Testing using
Sperm Chromatin
Dispe...
Clinical decision based on Lab
SOP information
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERR...
Designing a Lab SOP

Example 2
How can I avoid
unnecessary
surgical sperm
retrieval in men
with NOA?
Semen analysis
at spe...
How can I avoid
unnecessary
surgical sperm
retrieval in men
with NOA?
Semen analysis
at sperm retrieval
day
Presence of
sp...
Clinical
decision
based on Lab
SOP
information
How to adapt Six Sigma when
designing/updating Lab SOPs
Define the process and analyze its design
Identify where SOPs are n...
What the Lab team needs to consider
when designing/updating a SOP
Key points
WHAT is a given test/procedure for? 

Clinica...
How to combine clinical
and lab perspective for
making decisions
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTI...
Lab perspective determining
clinical decision – Example 1
What to do?
Patient failed
to ejaculate
No sperm on
ejaculate
Im...
Lab perspective determining
clinical decision – Example 2
No oocytes on
FF examination
Flush follicles
Check aspiration
pu...
Clinical perspective determining 

Lab SOPs – Example 1
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC...
Clinical perspective determining
Lab SOPs – Example 2
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC -...
GnRH-agonist vs hCG 
LH trigger
Fresh autologous cycles
Moderate/
severe OHSS
OR 0.10, 
(0.01 to 0.82)
Live birth
OR 0.44
...
How to combine clinical and lab
perspectives for making decisions


Key points
Clinical
perspective
determining lab
SOPs
L...
Thank you
Rio de Janeiro, BRAZIL
The perfect integration between Lab SOP and clinical strategy
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The perfect integration between Lab SOP and clinical strategy

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The perfect integration between Lab SOP and clinical strategy

  1. 1. Sandro C. Esteves, MD., PhD. Director, ANDROFERT Andrology & Human Reproduction Clinic Campinas, BRAZIL The Perfect Integration Between Lab SOP and Clinical Strategy Life Summit 2014 - ART TQM Forum, CHINA ISO 9001:2008
  2. 2. Outline o  What a lab SOP is and why it is needed in TQM o  What problems can be solved by a lab SOP o  What the key points of lab SOPs are for clinicians o  How to develop/update lab SOPs according to a clinical perspective o  How to combine clinical and lab perspectives for making right decisions ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 2 2014 MARCH ANDROFERT
  3. 3. Standard Operating Procedure sequence of steps that have been standardized to execute a task, which is used every time a given task is done, to ensure it is done the same way each time ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 3 2014 MARCH ANDROFERT Detailed instructions to achieve uniformity on the performance of a specific procedure Usually written and hierarchical, but also expressed as flowcharts or drawings
  4. 4. Key points of a Lab SOP ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 5 2014 MARCH ANDROFERT I. General information: •  Name of test or procedure •  Principles (goals and general information) II. Pre-analytic information: •  Patient instruction for test/procedure preparation •  Specimen collection instructions •  Specimen labeling, transport, referral •  Specimen acceptability (including rejection criteria) III. Analytic information: •  Equipment, materials and reagents •  Conditions required (e.g. laminar flow cabinet) •  Instrument calibration and verification •  Quality control (negative/positive control if required) •  Step-by-step procedure description •  Assay/procedure performance limitations •  Troubleshooting IV. Post-analytic information: •  Calculations (if required) •  Normal ranges (reference intervals or expected results) •  Policy for handling alert or panic values •  Report •  References
  5. 5. Top 10 reasons why ART practice needs Lab SOPs 1.  Repetitive highly-complex critically important tasks 2.  Variation must be controlled 3.  More than one person could perform the same task 4.  Safety risks are present 5.  Quality control needs to be ensured ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 6 2014 MARCH ANDROFERT
  6. 6. Top 10 reasons why ART practice needs Lab SOPs (cont.) 6.  Many lab professionals have previous (differing) or no experience 7.  Training is much easier with SOPs 8.  Changes can’t be made until next revision 9.  Exclude operating procedure fault when analyzing root-causes of poor outcome 10. Improve communication among team members, and with managers ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 7 2014 MARCH ANDROFERT
  7. 7. Variation often reflects misuse of equipment, poor lab technique and human errors Root causes: •  Complexity of activity •  Insufficient education and/or training •  Lack of attention ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 8 2014 MARCH ANDROFERT
  8. 8. Essential information to be included What problems can be solved by Lab SOPs? •  Mismatching oocytes with sperm •  Performing ET in the wrong patient What can go wrong? •  Controlling critical steps during whole process (patient identification, specimen labeling, gamete reception, insemination, ET) •  Avoiding risky situations (manipulation of more than one sample at a time, sharing workplaces) How can we prevent harm? Double-witnessing in critical steps, double-checking in intermediate steps, specimen processing by same operator, one case per incubator’s shelf How it can be resolved? ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 9 2014 MARCH ANDROFERT
  9. 9. Double-checking (DC) and Double-witness (DW) Example (ET SOP; Androfert): 1.  Identification by the nurse of the patient arriving at the ET room. 2.  Patient and husband fill out a form with their full names, dates of gamete retrieval and transfer. 3. Nurse and doctor performing the ET check ID info (DC). 4. Doctor explains embryos development, and give recommendation for ET. 5. Couple fill in the No. of embryos they allow to be replaced and cryopreserved (in conformity with legislation). ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 10 2014 MARCH ANDROFERT
  10. 10. Example (ET SOP; Androfert, cont.): 6. Doctor (or nurse) informs embryologist about No. embryos for ET (and cryopreservation if applicable); the latter checks info in the filled form. (DC) 7. Embryologist removes correct embryos from incubator, and loads ET catheter, witnessed by a 2nd embryologist. (DW) 8. Embryologist gives loaded catheter to doctor, tagged with patient name and No. embryos to be replaced. 9. Doctor checks catheter info (DC), witnessed by nurse. (DW) Note: Permanent record of procedure is kept (identification, type, date and time, signatures) ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 11 2014 MARCH ANDROFERT Double-checking (DC) and Double-witness (DW)
  11. 11. Key points SOP defines a sequence of steps that have been standardized to execute a task, thus ensuring it is done the same way each time Lab SOP is an integral element of ART’s processes Lab SOP intelligent design can prevent harm ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 12 2014 MARCH ANDROFERT
  12. 12. How to develop and update Lab SOPs according to clinical perspective
 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 13 2014 MARCH ANDROFERT
  13. 13. What are the key points of a Lab SOP from a clinical perspective? ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 14 2014 MARCH ANDROFERT IV. Post-analytic information: •  Normal ranges (reference intervals or expected results) •  Policy for handling alert or panic values •  Report clinical interpretation and decision
  14. 14. Basic questions: 1.  Does SOP address specific clinical question? 2.  Does SOP post-analytical information help determining what to do? 3.  Does SOP provide solution for panic/ alert values? Designing/Updating Lab SOPs ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 15 2014 MARCH ANDROFERT
  15. 15. Designing Lab SOPs Clinical Needs Determine tests/ procedures Write SOP (if test/procedure done internally) Provide the information for clinical decision What does the doctor need to know? ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 16 2014 MARCH ANDROFERT
  16. 16. Designing a Lab SOP
 Example 1 Does the patient have high sperm DNA fragmentation? SDF Testing using Sperm Chromatin Dispersion Test (SCD) High SDF if results >30% ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 17 2014 MARCH ANDROFERT What does the doctor need to know? Determine test Lab SOP with post-analytical info for clinical decision
  17. 17. Clinical decision based on Lab SOP information ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 18 2014 MARCH ANDROFERT
  18. 18. Designing a Lab SOP
 Example 2 How can I avoid unnecessary surgical sperm retrieval in men with NOA? Semen analysis at sperm retrieval day Presence of sperm for ICSI ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 19 2014 MARCH ANDROFERT What does the doctor need to know? Determine test Lab SOP with post-analytical info for clinical decision
  19. 19. How can I avoid unnecessary surgical sperm retrieval in men with NOA? Semen analysis at sperm retrieval day Presence of sperm for ICSI Does SOP provide solution for panic/alert values? Panic value: No sperm ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 20 2014 MARCH ANDROFERT What to do next? eg.: Centrifugation
  20. 20. Clinical decision based on Lab SOP information
  21. 21. How to adapt Six Sigma when designing/updating Lab SOPs Define the process and analyze its design Identify where SOPs are needed and assess relevant clinical question/needs Design and implement Lab SOPs Control (verify conformity) Improve (update SOPs) ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 22 2014 MARCH ANDROFERT
  22. 22. What the Lab team needs to consider when designing/updating a SOP Key points WHAT is a given test/procedure for? Clinical objectives WHAT results (post-analytical information) provide information for clinical decision? Clinical interpretation Clinical management ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 23 2014 MARCH ANDROFERT
  23. 23. How to combine clinical and lab perspective for making decisions ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 24 2014 MARCH ANDROFERT
  24. 24. Lab perspective determining clinical decision – Example 1 What to do? Patient failed to ejaculate No sperm on ejaculate Immotile sperm only Collect again TESA Use cryopreserved specimen banked in advance ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 25 2014 MARCH ANDROFERT
  25. 25. Lab perspective determining clinical decision – Example 2 No oocytes on FF examination Flush follicles Check aspiration pump inline filter/ vacuum pressure/ flow rate Check compliance to hCG administration What to do? ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 26 2014 MARCH ANDROFERT
  26. 26. Clinical perspective determining 
 Lab SOPs – Example 1 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 27 2014 MARCH ANDROFERT 0% 10% 20% 30% 40% 50% 60% fresh I warming II warming Livebirthrates Oocyte banking by vitrification  38-40 yr  41-43 yr +  17%   +  43%   Adapted from Ubaldi, et al. Hum Reprod, 2010 Poor responder in 1st IVF cycle Lab SOP for oocyte freezing by vitrification Oocyte freezing
  27. 27. Clinical perspective determining Lab SOPs – Example 2 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 28 2014 MARCH ANDROFERT IVF cycle involving partner with high SDF Lab SOP for handling ejaculated sperm in cases of high SDF Short ejaculatory abstinence and post-processing sperm incubation Gosálbez et al. Fertil Steril 2011
  28. 28. GnRH-agonist vs hCG LH trigger Fresh autologous cycles Moderate/ severe OHSS OR 0.10, (0.01 to 0.82) Live birth OR 0.44 (0.29 - 0.68) ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 29 2014 MARCH ANDROFERT Youssef et al. Cochrane Database Syst Rev. 2011 Patients at risk of OHSS Lab SOP for embryo vitrification Freeze all embryos Clinical perspective determining Lab decision – Example 3
  29. 29. How to combine clinical and lab perspectives for making decisions

 Key points Clinical perspective determining lab SOPs Lab SOPs determining clinical decision ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 30 2014 MARCH ANDROFERT Effective communication as per TQM guidance is the key to integrate both sectors, and will determine best strategy to meet patients’ needs
  30. 30. Thank you Rio de Janeiro, BRAZIL

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