RI WITNESS

Disclosures

• Advisory Board Good Start Genetics• Advisory Board Serono• KOL speaker for Irvine Scientific

What do you mean?

• A phlebotomist mislabels a blood tube– Patient comes back and has blood redrawn– Patient may be upset

• Clinical personnel report wrong test result– Depending on test result patient may be angry– Patient may leave practice

What do you mean?

• Embryologist makes a mistake with gamete(s)– If reported early the impact can be minimized– Discard gametes prior to fertilization– Contact patient couple(s) immediately– Patients irate/distraught– Probable litigation and bad press

What do you mean?

• Embryologist makes a mistake with embryos– A minimum of two patients are involved but the

number could be as many as 8– Patient gets pregnant with the wrong embryos

and can ruin the lives of all involved– Lawsuit and bad press are a given

How can we minimize risks?

• Procedures that have safe guards built in• Procedures that are followed• Cultivate a culture that understands humans

can make mistakes so that the impact of errors can be minimized by early reporting

• Utilize available technology to protect your practice

IVF Programs

• Culture of safety• Guidelines from SART or HFEA• SOPs• IDC adapted from nursing is often used as a

standard risk reduction strategy

IDC Pitfalls

• Literature from nursing has clearly demonstrated that IDCs rarely have a clearly defined process

• Interruptions and distractions contribute to errors

• High work loads and poor staffing contribute to superficial routine performance of IDC

• Routinely 30% of IDC are not or are poorly performed

IDC Pitfalls

To ERR is human

Key Factors in Human Errors

Conscious AutomaticityInvoluntary Automaticity

Ambiguous AccountabilityStress

IDCs in the ART Laboratory

• IDCs rarely have a clearly defined process• Poor documentation or no documentation of IDC• Electronic medical records make recording IDC

documentation difficult• Interruptions and distractions contribute to poor

patient care• High work loads and poor staffing contribute to

superficial routine performance of IDC

Culture of Safety

• Minimize risk of harm to patients and practices through a system of effective environmental tools and individual performance parameters

• Multiple Strategies• Clearly defined SOPs• Proper staffing to effectively carry out the SOP

How are Gametes ID’d???

Barcodes

Barcoded Sperm

Embryo Bar Codes

Barcodes

• It is only possible to ID the brand and type of package

• Barcodes can only be read one at a time

• Ubiquitous UPC bar-code technology requires contact or line of sight for communication

• CANNOT BE LINKED

RFID Uses

• Chipped your pet with an ID tag• Used EZPass through a toll booth• Paid for gas using a SpeedPass• Transit cards

RFID

• Radio-frequency identification involves the hardware known as interrogators (readers)

• Tags or labels• RFID software or middleware• Passive or Active

Reader• A typical reader is a device that has one or more

antennas that emit radio waves and receive signals back from the tag. The reader then passes the information in digital form to a computer system.

Reader

Tags

• Integrated circuit for storing and processing info

• Antenna for receiving and transmitting

RI Witness

RI Witness

• Give confidence to technicians• Can be customized to your SOPS• Easy to use• Can put technical staff to better use• Creates a document detailing each time a

sample was handled and by whom

Report Example

Why Not?RFID is bad for embryos > No - FDA approved

Expensive > Can lead to savings– Hardware – Consumables

Equipment is cumbersome > Easy to useto use

Makes patients less comfortable with the process > Gives patients peace of (Why are you using that?) mind

RADIO WAVES

Many ART clinic labs have a radio which plays in the laboratory. I believe this is not a good practice. What is the consensus?

Embryomail January 2012

Please clarify your issues with radio play in the laboratory?  

a) Music choice may create friction among listeners? b) Music may distract workers? c) Radio waves are disturbing embryos? d) Music is disturbing patients/doctors? e) One of the laboratorians may "bust a move" creating a flash mob?

Wrong Embryo: IVF Mix-up Changes Lives

When IVF Goes Wrong• After she is implanted with embryos belonging to both herself and another couple,

a white woman in New York gives birth to two children, one black and one white. The other couple sought custody of their biological child and won when he was 7 months old. Both couples sued.

• A California woman is implanted with another couple's embryo and gave birth to a baby boy; when he was 10 months old, an anonymous tip prompted authorities to investigate. Eventually the doctor lost his license and paid Buchweitz $1 million in damages.

• A couple sues a fertility clinic for wrongful death after their embryos are accidentally destroyed, and a Chicago judge allows the charge to go forward.

• After Carolyn Savage of Ohio is mistakenly implanted with another couple's embryo, she carries the pregnancy to term and gives the baby to the other couple. Savage and her husband have hired attorneys who are now working on a case against their fertility clinic.

Easy to Use

RI Witness Pitfalls

• Litter • Constant logging in – FOBS allow auto -login• Tags and cards must be ordered from UK –

Supplies can be ordered from Origio/Cooper• Patients lose cards – Eliminated cards from

our process• Alerts interrupt other processes – that’s the

point