NEXTCLINIC IVF Zentren Prof. Zech - Bregenz

Safety

Safety for our Patients
- FAQs

We attach particular attention to the safety and quality of all therapies that we provide and aim to live up to the trust our patients have placed in us. Our treatments are based on legally regulated, scientifically proven and advanced medical procedures. The well-being of our patients and the safety and health of all persons involved are always at the forefront of all our activities.

Quality Management

(1) What importance do the IVF Centers Prof. Zech attach to a well-functioning quality management system?
(2) Where to find the legal provisions governing the requirements with regard to quality?
(3) What is covered by the professional quality management system in place at the IVF Centers Prof. Zech?
(4) How often and by whom are the IVF Centers Prof. Zech audited?
(5) What is meant by "ISO Certification"?
(6) Do the employees receive targeted training?

Patient Treatment: Identification and Documentation

(7) How do the IVF Centers Prof. Zech ensure a continuous documentation of processes and treatments?
(8) How is it ensured that the patients are properly identified?
(9) What is an identification code?
(10) What measures are taken to rule out any risk of specimen mix-up in the laboratory?
(11) What steps are required in order for embryos to be released for transfer?
(12) Details on how to collect a sample of freshly ejaculated semen.
(13) Instructions on how to proceed in case a semen sample is produced elsewhere and brought to our laboratory.
(14) What steps are involved in the release procedure of oocytes and sperm that have been donated by a third party?
(15) What measures are taken to rule out any risk of identification error or mix-up when performing embryo transfer or insemination?

Safety related to the freezing and storage of tissues and cells (cryopreservation)

(16) How safe is the storage of cells and tissues at our centers?
(17) How should cells and tissues be stored?
(18) What steps are required in order for cells and tissues to be released for cryopreservation?
(19) How to terminate the storage of cryopreserved material?
(20) What happens upon expiry of the legally stipulated maximum storage period of 10 years (applicable in Austria)?




Quality management

(1) What importance do the IVF Centers Prof. Zech attach to a well-functioning quality management system?
At the IVF Centers Prof. Zech, an effective quality management forms the basis for professional therapies. In the process, we do not only strictly adhere to national legal provisions and international guidelines, but set ourselves even stricter standards. Thanks to the complete documentation and control of all processes and procedures, we are able to guarantee maximum patient safety.

(2) Where to find the legal provisions governing the requirements with regard to quality?
In Austria, the legal framework is provided by the Law on Reproductive Medicine (FMedG) as well as the Tissue Safety Act (GSG), which entered into force in 2008, specifying the quality and safety criteria to be met when comes to the procurement, processing, storage and distribution of human cells and tissues intended for human applications. Before then, this was governed solely by the Austrian Law on Reproductive Medicine (1992). Even though in the early days of "artificial insemination" there was no such thing as a legally required quality management system, the IVF Centers Prof. Zech have developed their own documentation and monitoring system. In this respect, we took on the role of a pioneer in Europe. This also becomes evident, for instance, through the first voluntary ISO certification of our Bregenz-based IVF Center in 1997.

(3) What is covered by the professional quality management system in place at the IVF Centers Prof. Zech?
All IVF Centers Prof. Zech are subject to a central quality management system, which comprises:

  • an in-house quality-management-team
  • consistent quality management
  • ongoing advanced training and knowledge tests for all employees
  • valid certifictions
  • use of a documentation software

(4) How often and by whom are the IVF Centers Prof. Zech audited?
The IVF Centers Prof. Zech undergo an annual monitoring audit in accordance with ISO 9001:15. Every two years, they are subjected to a two-day audit by the Austrian Agency for health and Food Safety (AGES) and regular inspections by the state of Vorarlberg. These three statutory inspection bodies have repeatedly confirmed that the IVF Centers Prof. Zech can guarantee the availability of appropriate resources in the form of qualified staff, spatial, operational and technical equipment – namely in accordance with the latest acknowledged scientific and technological standards. In addition, the IVF Centers Prof. Zech carry out self-inspections at regular intervals.

(5) What is meant by "ISO Certification"?
The ISO certificate officially confirms the application and development of an effective quality management system. In 1997, the IVF Centers Prof. Zech were the first IVF unit certified according to ISO 9001. All our locations are subject to an annual renewal of the ISO certification. To this end, they are audited by an official certification body once a year.

(6) Do the employees receive targeted training?
Our employees are the key to a functioning quality management. All our employees are required to regularly attend in-house and external training programs. The knowledge of our staff is subject to constant review and assessment.



Patient Treatment: Identification und Documentation

(7) How do the IVF Centers Prof. Zech ensure a continuous documentation of processes and treatments?
More then ten years ago, the IVF Centers in cooperation with IMA Systems - an IT company specializing in business solutions for health care - started developinga practice management software designed for healthcare providers. The software goes under the name "DynaMed“ and is tailored to the specific needs of our IVF Centers. The software complies with the state of the art in information technology as well as with the strictest data protection criteria. All data pertaining to patients and employees as well as all procedures are recorded and controlled electronically. In the absence of the correct documentation and consequent adherence to the individual process steps, treatment cannot take place. All data is stored for at least 30 years. This is necessary to guarantee full traceability. Dynamed is a unique solution and counts among the world's leading operating systems in the field. The system is currently being used by numerous other IVF units, including public hospitals, both in Austria and abroad.

(8) How is it ensured that the patients are properly identified?
Special care is required to ensure proper patient identification. The ongoing recording and monitoring of information pertaining to the identity of the patients is subject to close scrutiny:
a) Upon the initial registration, the patient's identity must be verified by a valid identity document (e.g. passport, insurance card). Subsequently, the identity is record and an identification code is defined. Depending on the technical possibilities and in line with the respective national regulations - and, of course, provided that the patient consents, a picture is taken and added to the patient file.
b) During the treatment,i.e. prior to each individual treatment step (e.g. each time biological material is collected/removed, before embryo transfer or intrauterine insemination), the staff involved will ask the patient several times to "actively" identify themselves. To this end, the employees will ask for the patient's name and date of birth. Thus they can make sure that the right patient receives the right treatment. Every time, the patient's response is checked against the already existing patient data and then recorded in the electronic database. Only then can the treatment be continued. This prevents mix-ups and increases patient safety.

(9) What is an identification code?
As early as during registration, each patient is allocated a unique identifier. The code consists of last name, first name and date of birth. All documents (e.g. consent forms, laboratory questionnaires) as well as tissue and cells of the respective patient shall be identified with and checked against that code.

(10) What measures are taken to rule out any risk of specimen mix-up in the laboratory?
Each container where a sample is contained, shall be labelled with a unique identification code. In addition, the biologists shall never work on two samples at the same time, but only on one at a time. Moreover, separate locations are used to keep sperm prior to their use, during their use and after their use. When transferring tissue and cells to a new container, the dual control principle must be applied. Patient identification, too, is verified by two members of the laboratory staff. As a matter of course, each working step must be saved to the documentation system.

(11) What steps are required in order for embryos to be released for transfer?
On the day of the transfer, a biologist first assesses the quality of the embryos to be transferred. Subsequently, a preliminary talk is held with the patient after the release of the embryos has been approved in writing. Finally, the treating doctor of the IVF Center Prof. Zech gives his final approval for the embryos to be transferred.

(12) Details on how to collect a sample of freshly ejaculated semen
Prior to producing the semen sample, the semen collection container is subjected to visual inspection for signs of damage, such as, for instance, cracks. Then the entire labeling of the semen collection container is checked against a label that bears the identification code as well as the names and dates of birth of both the woman and the man. This ensures the correct assignment of the semen sample. Before being asked to produce a semen specimen, a laboratory questionnaire is handed out to the male patient. The questionnaire has to be completed and signed by the male patient. It remains with the patient during semen collection. The questionnaire containing additional information on the male patient must be handed in directly to the laboratory together with the sample container as soon as the semen specimen has been produced. In the laboratory, everything is checked once again. In the case of incomplete labeling of the semen sample container or if the questionnaire is not filled in completely, the specimen will not be accepted by the laboratory. The laboratory questionnaire is scanned and added to the electronic patient record.

(13) Instructions on how to proceed in case a semen sample is produced elsewhere and brought to our laboratory
Where this is the case, the form “handing in spermatozoa/ejaculate” must be printed out and then signed by the couple. Then, the checks are performed the same way as for “fresh” semen samples (see question 12).

(14) What steps are involved in the release procedure of oocytes and sperm that have been donated by a third party?
In the case of third party reproduction, the third party donor as well as the receiving couple will be informed in detail. If all parties consent to the third party reproduction, they are asked to sign the necessary paperwork. Then the required examinations will be carried out. If all medical results are found to meet the requirements, the third party donor will be accepted in writing.

(15) What measures are taken to rule out any risk of identification error or mix-up when performing embryo transfer or insemination?
Vor jedem Embryotransfer bzw. vor jeder Insemination kontrolliert zuerst der medizinische Dienst bei der Ankunft der Patienten deren Identität. Anschließend bestätigen die Ärzte und zusätzlich die Biologen durch aktives Erfragen des Namens und des Geburtsdatums, dass der richtige Patient behandelt wird. Das Schälchen mit dem Embryonen wird von einem Biologen aus dem Brutschrank geholt. Er oder sie spricht laut den Familien- und Vornamen der Frau aus. Der Gynäkologe kontrolliert das Schälchen, indem er erneut den Familien- und Vornamen der Frau abliest und ebenfalls laut gegenüber dem/der Biologen/ Biologin ausspricht. Jeder einzelne Schritt muss von allen beteiligten Mitarbeitern im Dokumentationssystem eingetragen und mittels Fingerabdruck bestätigt werden – wie bei einer Checkliste. Erst wenn ein Schritt abgeschlossen ist, kann der nächste erfolgen. Erst wenn alle Behandlungsmaßnahmen richtig gesetzt wurden, dürfen der Embryo bzw. die Embryonen zum Transfer bzw. die Samen zur Insemination aufgezogen werden.



Safety related to the freezing and storage of tissues and cells (cryopreservation)

(16) How safe is the storage of cells and tissues at our centers?
In allen IVF Zentren Prof. Zech werden regelmäßig Test durchgeführt, um bestmöglich auf alle Situationen vorbereitet zu sein. Unsere relevanten Geräte werden 24h überwacht und im Falle eines Ausfalls des öffentlichen Stromnetzes verfügt jedes Zentrum über ein eigenes Notstromaggregat. Alle relevanten Geräte werden laufend elektronisch auf Temperatur und die Einhaltung der C02-Werte überwacht, die Brutschränke sind sogar mit zwei unabhängigen Systemen gesichert. Hierfür ist das Alarmsystem direkt an die Mobiltelefone der verantwortlichen Mitarbeiter gekoppelt. Zusätzlich gibt es behördlich genehmigte Evakuierungspläne für Notfallsituationen wie beispielsweise Brandgefahr, um die Zellen und Gewebe zu schützen. Damit Funktion und Unversehrtheit der Zellen und Gewebe nicht beeinträchtigt werden, stehen spezielle Behältern und Tanks für den Transport zur Verfügung.

(17) How should cells and tissues be stored?
Die Lagerung von Zellen und Gewebe entspricht bei den IVF Zentren Prof. Zech dem neuesten Stand der Wissenschaft und Technik. Sämtliche Lagerungsprozesse werden rund um die Uhr überwacht. Die Brutschränke werden sogar doppelt mit zwei unabhängigen Systemen gesichert. Zudem finden laufend Kontrollen statt, welche die Funktion und Unversehrtheit der Zellen und Gewebe garantieren.

(18) What steps are required in order for cells and tissues to be released for cryopreservation?
Bei medizinischen Problemen oder bei Folgeversuchen besteht die Möglichkeit, je nach Gesetzeslage, Zellen und Gewebe einzufrieren. Wenn der Patient hierfür die Freigabe erteilt, gibt der behandelnde Arzt eine schriftliche Anweisung an das Labor weiter. Diese erfolgt automatisch in der elektronischen Karteikarte des Patienten im Dokumentationssystem. Das Labor kontrolliert, ob eine Kryokonservierung möglich ist. Falls ja, gibt es die Zellen und das Gewebe zur Kryokonservierung frei.

(19) How to terminate the storage of cryopreserved material?
Das kryokonservierte Material darf erst dann nicht mehr gelagert werden, wenn der Patient den ausdrücklichen Wunsch dafür äußert. Und zwar schriftlich in Form einer unterschriebenen Auftragserteilung zur Beendigung der Kryolagerung. Nur wenn diese Freigabe vorliegt, dürfen die Biologen des IVF Zentrums Prof. Zech im Vier-Augen-Prinzip die Lagerung beenden.

(20) What happens upon expiry of the legally stipulated maximum storage period of 10 years (applicable in Austria)?
In Österreich dürfen Embryonen maximal zehn Jahre gelagert werden. Vor Ablauf der Frist werden die Patienten von den IVF Zentren Prof. Zech kontaktiert und über den Ablauf der Frist informiert. Wenn daraufhin die Patienten keine Rückmeldung geben, entscheidet die verantwortliche Person des Zentrums, wie mit dem kryokonservierten Material weiter verfahren wird.