Disaster management in IVF final laboratory

Presentation describes how to deal with the risks and mitigate the issues in IVF/ embryology labs.

1. Disaster Management In IVF Laboratory Dr Rachana Bajpai

2. Introduction: Disaster , any natural or human-generated calamitous event that produces great loss of  human life or destruction of the natural environment , private property, or public infrastructure .

3. Does IVF labs get affected????

4. Some other Examples: An IVF clinic in sand Diego had toxic air around the clinic for several week affecting out comes in IVF cycle as a result of nearby fire. In Arizona a toilet wall stuck fledging the laboratory with two inches of water. In New Zealand and IVF clinic below a birthing facility was inundated with water from a tab left on above them We can learn from these examples and be better prepared . All IVF programs need plans to protect fresh and cryo preserved embryo's in the event of a natural or human made disaster.

5. In case of fire & flood Fire safety norms Training of extinguishers Checking extinguishers cylinders Codes and Assembly point for staff Fireproof cabinets for documents Freeze all in case of Flood. Store all data on cloud Water and flood alarms

6. Disaster planning / Action: Communication Protocols. Staff hygiene protocols and vaccination. Between nursing staff and Embryology lab. Training of Nursing staff and Baiji’s. Train juniors and new staff before giving them work. Board check daily. Double witnessing with signature. Understand ART law. How to reduce Risk in IVF Laboratories??

7. Daily Work to ensure proper working Checking of Nitrogen dewar daily or twice a week. Not only incubators but gas cylinders ( Trigas , N2). Lab switches. QA and QC. Air conditioners Humidity

8. Contaminated samples, Processing and storage of sample known/Suspected to be contaminated, With contagious agents Always avoid Cross-contamination- in biological science it is defined as when part of one sample is transferred into another sample. S eparate cryocanes , dewars Straws I ncubators for contaminated samples. ( Hbsag + ve , VDRL, HIV…)

9. Laboratory design The embryology laboratory should have adequate space to follow good laboratory practice. More specifically: The construction of the laboratory should ensure aseptic and optimal handling of gametes and pre-embryos during all phases of the treatment. The location of storage areas and equipment such as incubators, centrifuges and cryo equipment should be logically planned for efficiency and safety within each working area. Separate office space should be provided for administrative work, such as record keeping and data entry. A general wet area in which washing of equipment, sterilization, etc., is performed, should be separate from the embryo laboratory.

10. Breakdown of equipment reasons Inappropriate wiring in labs. Power outage. Frequent breakdown of Acs. when functioning becomes too cold staff put them off. Voltage issues-Temperature dependent equipment's frequently breakdown. Delay servicing time. Equipment too old.

11. Laboratory equipment back up strategies: Adequate space for cleaning and accessibility. Critical items of equipment, including incubators and frozen embryo storage facilities, should be appropriately alarmed and monitored. Automatic emergency generator backup in the event of power failure. T wo incubators recommended. C ylinders should be placed outside or in a separate room with an automatic backup system. Nitrogen tanks should be monitored. emergency trolleys should always be ready.

12. Action Training and refresher training. Rewiring. Close supervision of staff. Service contract for equipments . Reduce waiting time by checking Availability of spare parts.

13. Mixing of Gametes Improper patient identification, multiple gamete handling at the same time negligence and ignorance of lab staff accidental. These mistakes are only apparent when a couple has a child of different color or if they go for a DNA tests or may go unnoticed . Errors in an IVF lab causes patient to suffer from the psychological stress, financial damage lose confidence in the IVF process Mistakes by one center may overall have impact on entire IVF industry

14. How to Prevent errors single gamete handling instead of multiple handling. Proper patient identification ( Incubators, loading and Embryo transfer). Cryopreservation and its location in the liquid nitrogen tank . proper labeling of samples, dishes at each and every steps. double witnessing of every step during the  IVF process. proper staffing and reducing overload in the laboratory. good communication between staff members. We can also reduce such risks by increasing the number of workstations so that work load in lab can be managed.

15. WITNESSING IS THE KEY Human witness to every procedure performed in lab. Records should be kept permanent. Who performed procedure. Date and time of procedure, witnessed Signature of both witness Embryo tagging with silicone based barcodes . These barcodes do not compromise embryo development and can be read under stereo zoom microscope. Its flaws: A double witnessing protocol is required in tagging of gametes and embryos In hatched blastocyst barcode get removed

16. Electronic Witnessing System  Modern day application in IVF practice. Electronic Witnessing System uses radio frequency identification (RFID) tags for tracking and recording patient’s information and the samples during the IVF process. Each patient is monitored at every step of the process and this system also records every information regarding the progress in IVF cycle. System doesn’t allow staff to work with two samples at a same time on same workstation. Electronic Witnessing System provides a unique ID to each embryologist and patient. offers automated cross checking and prevents human errors and provides a safe and secure environment during complete IVF process and increase confidence during each and every step of IVF process.

17. Transfer of wrong embryos Transferring the incorrect embryo into a patient is an intolerable event for all parties involved. Inadvertent embryo mix-ups can not only tarnish the reputation of the involved facility and providers; they can also lead to lawsuit damage awards that may surpass the policy limits provided by medical malpractice insurance plans.  Improper labeling or record keeping may result in the wrong embryo specimen being used in ET.

18. Loss or damage during handling Dishes containing eggs or embryos that were knocked or dropped. Pipettes that were accidently knocked whilst moving eggs or embryos. Failure to operate equipment properly. Turning off a piece of equipment mid-cycle. Operational handling

19. Human Errors

20. Clinical recommendations on reporting an incident Centers must have an internal event reporting policy . All adverse incidents should be reported to the relevant authority. This notification must include the: Contact details of the person responsible Date of the initial information or report Name of any individual affected Date and time of the serious adverse event or reaction Details of gametes or embryos involved in the incident Type of incident, including any transmission of infectious agents.

21. Staff protection- Hygiene, Rules and regulations, Protective measurements (Gloves, masks etc.), Actions upon injury Protective measures for laboratory staff to ensure aseptic conditions for tissue, gametes and embryos include: - Strict adherence to staff hygiene regulations and aseptic techniques. Use of protective laboratory clothing, preferably with low particle-shedding. Use of hairnets and non-toxic, non-powdered gloves and masks where appropriate. Use of appropriate vertical laminar flow benches for handling biological material. Use of mechanical pipetting devices. Disposal of single-use consumables immediately into proper waste containers.

22. Conti… Potentially infectious materials must be disposed of in a manner that protects laboratory workers and other staff from exposure. Viral-positive waste segregated into a separate bin , labelled and disposed of according to biosafety policies. Needles, glassware and other sharps should be handled with extreme caution and discarded into sharps containers. Disinfectants with proven compatibility and efficacy for an IVF laboratory should be used. Use of cosmetics should be minimized and perfumes should be avoided. Staff should be appropriately vaccinated and attired to diminish possible sources of contamination. All body fluids (blood, follicular fluid, semen, etc.) should be treated as potentially contaminate.