Laboratories performing sperm banking must hold current accreditation as per the regulations in their country of operation, and must be aware of and comply with any relevant laws in their country of operation. For example in the state of Victoria, Australia, this laboratory is inspected and accredited by NATA (National Association of Testing Authorities) to assess adherence of standard operating procedures (SOPs) against the Australian Standard (Medical laboratories-Requirements for quality and competence; AS ISO 15189–2013) and must comply with Victorian legislation (Assisted Reproductive Treatment Act 2008 and Assisted Reproductive Treatment Amendment Act 2013).

The assessment of the overall security of premises should take into account the local conditions and surrounding environment, not simply guarding against access by unauthorised personnel or intruders. It is essential to perform a realistic evaluation of the potential local risks associated with extreme weather events, earthquakes and major accidents. For example, it would not be wise to establish a storage facility in the basement of a building prone to flooding in the event of extreme weather conditions (for example, the basement of a NY State University building flooded during Katrina—unfortunately the backup generator was in the basement and the resulting malfunction resulted in freezers thawing and loss of hundreds of precious research samples; personal communication). The Christchurch earthquake in 2011 caused major damage to Christchurch Hospital functionality and infrastructure, including basement flooding and loss of power, as detailed in a paper delivered at the 2012 conference of the New Zealand Society for Earthquake Engineering (NZSEE) titled “The Impact of the 22nd February 2011 Earthquake on Christchurch Hospital” [1]: http://​www.​nzsee.​org.​nz/​db/​2012/​Paper124.​pdf

It is important to factor into the risk assessment that sperm banks often require continuity of service over decades and also that extreme weather events are predicted to increase in frequency over coming decades due to global warming.

In Australia minimum staff qualifications are stipulated in various publications such as the following from NPAAC (National Pathology Accreditation Advisory Council) and RTAC (Reproductive Technology Advisory Council), respectively:

NPAAC Requirements for supervision of pathology laboratories (2007) [2]: http://​www.​health.​gov.​au/​internet/​main/​Publishing.​nsf/​Content

RTAC code of practice for assisted reproductive treatment units (2014) [3]: http://​www.​fertilitysociety​.​com.​au/​wp-content/​uploads/​RTAC-COP-Final-20141.​pdf

Each country or jurisdiction will have its own qualification requirements; however it would generally be accepted that a person working as a scientist performing unsupervised sample processing in a sperm bank facility should have a minimum qualification of a bachelor of science and that the scientist in charge of a facility would have a higher degree such as a master’s degree, PhD or equivalent fellowship of a relevant professional body. Supervised technical personnel may have lower qualifications such as relevant diplomas or be studying towards a bachelor’s degree or have accepted long-term laboratory experience.

In order to monitor the ongoing competency of staff and the suitability of methodology, all laboratories must participate in an external quality assurance (EQA) programme and perform regular internal quality control (IQC) comparisons between staff and also use other means of monitoring the quality of laboratory output (see WHO Manual 5th edition, 2010 [4]). For example, weekly or monthly means charts can be a convenient way to detect drift in laboratory results [5].

Risk assessment/management for patients/donors should focus on any potential physical hazards and their rectification, for example, provision of wheel-chair access and railings for partially disabled patients and installation of an emergency buzzer in the specimen collection area. It should also be a priority to maintain a pleasant environment including efficient but friendly staff in order to minimise patient/donor anxiety/discomfort during their visit.

All staff should undergo regular emergency procedure training and competency assessment, chemical spill-kit training and thorough liquid nitrogen handling training and risk awareness. Storage facilities must be adequately ventilated and have oxygen depletion meters installed and two people should work together for safety reasons. The following links provide some good training material to consider:

https://​www.​ehs.​wisc.​edu/​bio/​LiquidNitrogenTr​aining.​pdf

http://​www.​offices.​research.​northwestern.​edu/​ors/​training/​video/​cryogen.​html

Detailed risk assessments based on the approach outlined in Figs. 16.1 and 16.2 and comprehensively described in Janssens and Cheung (2008) [6] must be performed for all SOPs and it is imperative that properly maintained laminar-flow cabinets should be used for sample processing. Laminar-flow cabinets should be serviced annually by certified technicians and the service records retained by the laboratory for at least 3 years beyond the active life of the cabinet.

It is important to use reagents and disposable items which have been tested for sperm toxicity, either by the manufacturer or in the laboratory itself. Some manufacturers provide results of testing on each new batch of their product whilst other products require in-house evaluation prior to use. Initially, a new product in the laboratory should be tested against several semen samples, whilst new batches of the same product might be tested against only one or two semen samples to check for a defective batch prior to use.

Storage dewars should preferably be kept in a dedicated, locked room fitted with oxygen monitors and appropriate signage about risks associated with liquid nitrogen. All dewars should also be kept locked when not being accessed by authorised personnel.

During initial sample processing for testing and cryopreservation the relevant SOP should stipulate that only one semen sample should be processed per scientist per cabinet to minimise the risk of cross-contamination or sample mix-up. Sterile disposable pipette tips and test tubes should be used when processing storage samples. All sample containers and test tubes must also be labelled on their lids with a sample number which corresponds with the number on the actual container or test tube to guard against swapping of lids resulting in cross-contamination. In addition, double-checking of all paperwork, storage code/ID number assignment and labelling by a second individual prior to freezing and placement of samples in the storage inventory are vital to avoid mistakes with potentially serious consequences for patient welfare.

Holding-time checks must be performed on all liquid nitrogen dewars and dry shippers prior to commissioning for clinical use (Appendix 1). There are multiple aspects to consider when performing a risk analysis/management/mitigation exercise around sample security during liquid nitrogen storage as per the process sketched out in Fig. 16.2. For example, it would not require much reflection to identify dewar failure as a known potential risk to sample security and that the risk analysis/prevention arm should be followed initially. In order to minimise the risk of total sample loss in case of a single dewar failure, particularly in the absence of remote alarms, samples should be split for storage into at least two dewars. However, this would just be the first stage of the process. Some patients have only one vial or straw stored and we ideally don’t want to risk loss of any samples, so how can we mitigate this risk? This risk could be essentially eliminated by having all dewars remotely alarmed with SMS/email alerts sent to on-call staff, with an appropriate staff response time to allow a significant chance of recovery of samples prior to actual thawing. Dewar temperature may have risen significantly prior to recovery, but this would be unlikely to significantly affect the sperm if the dewar temperature remained below −130° C. In the case of a dewar reaching higher temperatures, it is worth noting early reports of normal pregnancies and babies born after using sperm stored on dry ice at −79° C for periods up to approximately 1 year [7], despite the fact that some degree of recrystallisation would be occurring at such relatively high temperatures. Initial investigation in my laboratory indicated that sperm stored in liquid nitrogen could be transferred to dry ice (−79° C) for 4–18 h with no change in post-thaw motility or velocity. Sperm transferred from liquid nitrogen to dry ice for 5 h and then into liquid nitrogen vapour for 18 h also showed no difference in post-thaw results compared to sperm thawed directly from liquid nitrogen.

In an alternative scenario, the samples may have thawed, but if they had not been at room temperature for any significant amount of time, they could be refrozen with high likelihood of subsequently being successfully used in IVF/ICSI treatment procedures [8]. In their introduction, the authors of the study just cited state: “It is common practice in ART laboratories to offer at least one repeated freezing cycle to patients to maximize the use of donor or partner sperm for various reasons”. This approach has also been used many times at the Royal Women’s Hospital and at Melbourne IVF in Melbourne, Australia. However, in the context of inadvertent sperm thawing due to dewar or human failure, this process of recovery would be classed as “restoration ” (Fig. 16.2). It is important to note that early studies showed that human sperm can be thawed at widely different rates (1 to 60° C/min) with no apparent difference in post-thaw motility recovery [9, 10], so the trajectory of thawing in the case of either a dewar failure or a human failure to replenish a dewar with liquid nitrogen would be unlikely to significantly affect the success of a refreeze procedure.