Issue regrets the disaster and offers its sympathy and support to all the
                                affected couples. The circumstances are tragic in the extreme and one can
                                only imagine the shock; hurt and anger of those eouples that have lost
                                ernbryos. The blow that a loss of ones' potential children brings is immense
                                and many couples will undoubtedly suffer from delayed reactions to this.
 
                                                                                                                                                                                                                                         ISSUE' S counseling service will be at these couples disposal, as and when
     .                          they need it.

                                Patients may contact ISSUE on 01922 722888 or the help line on 01256 313171

                                Issue hopes that the crisis will,be quickly.dealt with and the affected
                                couples offered support and some form of compensation, which will address
                                their need and desire to becorne parents.

                                Tim Hedgley, ISSUE'S Chair and Dr Sammy Lee, ISSUE'S Counseling Coordinator,
                                Trustee and also a practicing clinical embryologist in London feel that the
                                disaster at the two fertility units in North Hampshire highlights a number
                                of issues.

                                1. What were the embryologist's qualifications and what where his or hers
                                background?

                                An embryologist's credentials must be impeccable; Once the eggs are
                                collected, the embryologist's look after the eggs, sperm and ernbryos until
                                the couple retum, to the clinic for the embryo transfer.

                                This role, to say the least, is a highly responsible one! In circumstances
                                where an embryologist works single-handedly, as seems to be the ease here,
                                credentials, responsibility and accountability beeome even more important.

                                2. How were records. which apparently dated back to 1996, allowed to go or
                                seemed to go unchecked, despite annual inspeetions by the govemment
                                watchdog (HFEA)?

                                All clinics are regulated by the HFEA. under the auspices of the HFE Act
                                1990. Clinics are generally inspected every 12-18% months. During these
        inspeations, issues relating to accuracy and security are supposed to be
       addressed. Indeed the Code of Practice requires units to audit their
        freezers and contents on an annual basis:

        3.How many other embryologists like this one are there?

  It is believed that the embryologist involved in the disaster was a science
  graduate. Ideally embryologists should be trained in, "established" units by
        "experienced" mentors.     .

        Training that falls short of these standards may lead to such Circumstances
        being increasingly likely in the future. Monitoring standards is definitely
  now an issue.

  4. Does single-handed practice lend itself more easily to such
  discrepancies?
 
  If a person is: poorly trained, has low moral standards, incompetent or
        negligent or all of the above; being supervised does not mean that disasters
  like this one could not have happened; but almost certainly, there would
        have been fewer cases and  the timescale of matters would have been greatly
        reduced. Single-handed practice has little to commend it!

  5.   Who is accountable for this event7

              a. The embryologist?
              b. The employers?
   c. The HFEA?

  Without doubt, the embryologist.        ,

  All embryologists are aware that to err is human. One or two missing ernbryos
        is still a disaster; but the mitigation is rather more simple, ie. a mistake, the couples still   need support; reassurance and compensation. In these situations, every embryologist will   sigh and think, "'there but for the grace of God go: I". In such cases accountability and   respansibility still lies with the embryologist, but there is an absence of malice and of   course procedures would be instigated to reduce the chances of such mistakes
        happening again. However, where forty or so couples are affected, this is
        not a mistake. Where the problem has existed for up to four years, this smacks of    something systematic...

  The employers acted in good faith, but the· checks and details of vetting (in
  this case may need to be examined.

  The HFEA is responsible for "policing"' clinic. If the embryologist involved
  has committed any negligent or criminal acts, the HFEA must be partly
        accountable for the disaster. They would have had an opportunity to check
       the embryologist's background and credentials and furthermore the person
           would have undergone at least 3 or four HFEA irispections, where there would
           have been an opportunity to ensure that he or she was keeping up to date
           with procedures and the relevant paperwork. This clearly was not done!

  Issue therefore calls for:

           a) More serious vetting of individuals employed as embryologists.

           b) Single-handed practice is to be discouraged. Where single-handed practice
           exists, a person in a supervisory role must be appointed and visits by the
           supervisor shauld be made regularly [at least ance a month].

           c) In general (and there are a few exceptions, but not many) laboratory heads
           should be graduates of high standing.  Ideally the head will possess an MSc.
          or more desirably a PhD, with of course appropriate background and
          expenence (a  PhD in history wauld not suffice).                       G

           d) The HFEA rnust re-examine their methods af policing clinics, especially
           regardmg how they audit clinics when they make inspections. Furthermore,
           this issue highlights the need for rnore random checking of patients' eggs,.
           embryos and sperm and how clinics account for them. Quality assusance
·                 (mountains of paperwork alone is clearly not enough).

         Ends:                   ·

         Dr Sammy Lee can be contacted on 07710 227645