the perfect integration between lab sop and clinical strategy

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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ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 2 2014 MARCH

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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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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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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

the perfect integration between lab sop and clinical strategy

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