the perfect integration between lab sop and clinical strategy
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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
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
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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
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Detailed instructions to achieve uniformity on the performance of a specific procedure
Usually written and hierarchical, but also expressed as flowcharts or drawings
Key points of a Lab SOP
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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
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
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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
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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
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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?
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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).
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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)
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Double-checking (DC) and Double-witness (DW)
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
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How to develop and update Lab SOPs according to
clinical perspective
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What are the key points of a Lab SOP from a clinical perspective?
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IV. Post-analytic information: • Normal ranges (reference intervals or expected results) • Policy for handling alert or panic values • Report
clinical interpretation and decision
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
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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?
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Designing a Lab SOPExample 1
Does the patient have high sperm
DNA fragmentation?
SDF Testing using Sperm Chromatin Dispersion Test
(SCD)
High SDF if results >30%
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What does the doctor need to
know? Determine test
Lab SOP with post-analytical info for clinical
decision
Clinical decision based on Lab SOP information
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Designing a Lab SOPExample 2
How can I avoid unnecessary
surgical sperm retrieval in men
with NOA?
Semen analysis at sperm retrieval
day Presence of
sperm for ICSI
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What does the doctor need to
know? Determine test
Lab SOP with post-analytical info for clinical
decision
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
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What to do next? eg.: Centrifugation
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 needed and assess relevant clinical question/needs
Design and implement Lab SOPs
Control (verify conformity)
Improve (update SOPs)
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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
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How to combine clinical and lab perspective for
making decisions
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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
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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?
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Clinical perspective determining Lab SOPs – Example 1
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0%
10%
20%
30%
40%
50%
60%
fresh I warming II warming
Live
birt
h ra
tes
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
Clinical perspective determining Lab SOPs – Example 2
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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
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)
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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
How to combine clinical and lab perspectives for making decisions
Key points
Clinical perspective
determining lab SOPs
Lab SOPs determining
clinical decision
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Effective communication as per TQM guidance is the key to integrate both sectors, and will determine
best strategy to meet patients’ needs
Thank you
Rio de Janeiro, BRAZIL
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