LR1 / Patient Safety of In Vitro Fertilization (IVF)

Bulgaria




Type of Patient Safety Practice
Clinical Practice (CP)
Related practices from PaSQ database
"Best fit" category of the reported practice
Medication / IV Fluids
Patient safety theme the SCP/clinical risk management practice is aimed at
Patient Safety of In Vitro Fertilization(IVF)
Objective of the CRM practice
In vitro fertilization [IVF] is the method of artificial fertilization of oocytes in laboratory conditions. After the fertilization of the oocytes with the spermatozoa, the retrieved embryos are transferred back to the uterus of the woman. There are three major steps: controlled ovarian [hyper] - stimulation, puncture of follicles and classical In vitro fertilization procedure. The method is conducted under the regulations of the protocol of the European good practices and it also includes the up-to-date methods and facilities. The method is conducted following the rules of Patient Safety and the WHO Surgical checklist Strategy and appropriate hand hygiene [6]. The IVF method requires additional examinations and tests that are followed under strict conditions [4].
Short description of the CRM practice, including any references for further information
There are several basic indicators in order a patient to undergo an in vitro fertilization procedure. These are tubal infertility, unexplained infertility, male infertility, endometriosis, LUF syndrome. A number of examinations are conducted in order the patient to undergo the proper treatment, if such a treatment is needed. This steps will avoid a wrong diagnosis and a condcut of a treatment that could be unhealthy or irrelevant for the patient. Patient safety has been implemented fully,at bothteam and ward levels [4].
Innovator of the SCP, country of origin
In 1965, Robert Edwards together with Georgeanna and Howard Jones at Johns Hopkins Hospital in the USA attempted to fertilize human oocytes in vitro [Edwards RG, Donahue RP, Baramki TA, Jones HW Jr. Preliminary attempts to fertilize human oocytes matured in vitro. Am J Obstet Gynecol. 1966; 15; 96:192-200]. The first IVF pregnancy was reported by the Monash research team of Professors Carl Wood and John Leeton in Melbourne, Australia. Unfortunately, this resulted in early miscarriage [dDe Kretzer D, Dennis P, Hudson B, Leeton J, Lopata A, Outch K, Talbot J, Wood C. Transfer of a human zygote. Lancet, 1973 29;2:728-9], [4].

Assoc. Prof. Atanat Shterev: http://ivf-bg.com/index.php?option=com_content&view=article&id=86%3A2009-09-09-08-04-19&catid=36%3A2009-06-11-14-03-26&Itemid=93&lang=en

Involved health care staff
Physicians, nurses, health care assistants, pharmacists, therapists, dietician/ nutritionist, clinical support, scientific staff / researches ; technical support; administrative support; clinical manager; quality manager, risk manager
Tested in which countries/health care systems, health care context(s) and/or clinical specialty/specialties, including references
Ob/Gyn Hospital “Dr. Shterev” works with a lot of foreign and Bulgarian hospitals, institutions and NGOs. For more information, check the link below.
http://ivf-bg.com/index.php?option=com_content&view=article&id=83%3A2009-09-09-06-47-24&catid=36%3A2009-06-11-14-03-26&Itemid=269&lang=en
The conduct of the procedure is quite popular and is implemented in many hospitals in Bulgaria and abroad[4].
Summary of evidence for effectiveness, including references
Patient safety is a high priority during an IVF procedure [1].
In vitro fertilization [IVF] is the method used for artificial fertilization of the oocytes in laboratory conditions. After the fertilization of the oocytes with the spermatozoa, the retrieved embryos are transferred back to the uterus of the woman.
The IVF procedure is conducted in patients with:
• tubal infertility
• unexplained infertility
• male infertility
• endometriosis
• LUF syndrome
• women with 4 inseminations with no successful pregnancy.
It is quite important to define the exact reason for the conduct of the procedure because the diagnosis is of great value for the future treatment of the patient, subject to the rules of patient safety.
Ater the conduct of examinations, diagnosis,medicaments, discussions and education, the patient and the relatives of the patient have to fill out a form, asking for an informed consent. Thus the patient complies with all the details of the procedure that will be conducted.
The following examinations and tests have to be conducted a month before the IVF procedure:
• hormones [LH, FSH, Prolactin, Estradiol]
• additional examinations / tests for the ovarian reserve – at the gynecologist discretion
• full blood count / test and erythrocyte sedimentation rate
• Thin Pap test [microbiological examination of vaginal discharge]
• sperm analysis
• AIDS, Wasserman, Hepatitis B ana C
• ultrasonographic examination
The results of the required examinations are kept in a medical record of the patient where all specialists [obstetricians, embryologists, biologists, staff from the laboratories] have access and are able to discuss the results in order to administer the right medications for the controlled ovarian stimulation[1], [4].
[2] In vitro fertilization procedure:
The embryos are stored for several days outside the body of the patient in special conditions for preservation – special incubators that maintain body temperature, certain humidity levels and concentration of CO2. Ob / Gyn Hospital “Dr. Shterev” works with up-to-date equipment that allows for the monitoring of the conditions in the incubators, together with an alarm system in cases of any deviations from the defined parameters. There are also special culture media that resembles the conditions in the fallopian tubes and the uterus.

Before the procedure there are a number of examinations that are fulfilled at special conditions in a laboratory, with labels that help for the proper processing of the samples.
There are several stages of the procedure. First, the patient undergoes a treatment with hormonal medications and their proper use is part of the proper treatment of the patient. There are specific norms that have to be followed, depending on the administered hormonal medications and the results from the examinations.
Day 1 [Zero day] – the oocytes are examined with a microscope and are classified on the basis of quality and maturity. After that the spermatozoa are added so that the oocytes could be fertilized.
Day 2 – the fertilized oocytes have started the cleavage.
Day 3-5 – development of the embryos.

ICSI Procedure
In cases of impaired sperm parameters [low concentration, reduced to absent motility, a large percentage of sperm with abnormal morphology, etc.], Intracytoplasmic sperm injection is conducted. The procedure is close to the classical IVF procedure. The only difference is that with the assistance of a micromanipulator system, only one spermatozoon is chosen and then it is injected in the oocyte cytoplasm.
The right conduct of the conditions, should be followed strictly for a successful IVF procedure.
During the second important step of IVF procedure, the patient undergoes a mini-invasive procedure during the puncture of follicles. The oocyte retrieval is done while the patient is under an anesthesia (for not more than 10-15min), together with the assistance of an anesthetist. There are specific international safety standards that the specialists have to comply with due to patient safety in the manipulation room [5].

[3] Embryotransfer:
This procedure is the placement of the embryos in the uterine cavity. It is usually performed on the the 3rd to 5th day after the day of the puncture.
The number of the embryos that has to be transferred is between 1 and 3. The procedure lasts for around 5 minutes. The embryos are transferred in the uterus with the assistance of a special catheter into the cervix. No anesthesia is applicable for this short procedure.
The embryotransfer is the last part where the embryos are transferred back into the uterus of the womenman. For not more than 5 days the embryos are kept in special microchambers under special oxygen and temperature conditions.
The laboratory where the embryos are kept is just right to the manipulation room where the embryotransfer takes place. This helps for the fast and secure transfer of embryos.
Each patient has a medical record where all the information from the procedure is kept in a special premises for this purpose.
Stringent international standards for patient safety and rules of National standard of patient safety are observed during the whole procedure. The process is monitored by the supervisory authorities in the health care system in the Republic Bulgaria taking into acount outcomes and data colection and monitoring the patient's.
Summary of evidence for transferability (transferability across health care systems or health care contexts or clinical specialties), including references
Ob/Gyn Hospital „Dr Shterev“ works with the National Health Insurance Fund for the application of the procedure, together with the Assisted Reproduction Fund Center. There are a number of clinics who conduct in vitro fertilization procedure, but not all of them have the high professionalism of our specialists and the contemporary equipment. More information can be found: http://www.ivf-bg.com/index.php?option=com_content&view=article&id=97:-2010&catid=39:2009-06-11-14-04-16&Itemid=112&lang=en
Summary of available information on feasibility, including references
There are a number of barriers for the implementation of the procerure. There could be connected to the medical indications of the patients and also to the financial part of the procedure [especially for the region of Eastern Europe].
There is a need todevelop education modules about patient safety1], [2], [3], [4].
Existing implementation tools, including references
IVF guidelines, criteria for patient safety scientific materials as well as guidelines for patients admitted to the hospital represent several implementation tools available. The major patient safety tools is the informed consent where the patient receives full information on the procedure that is about to be conducted. The use of short-acting anesthesia also needs patient safety tools. In this case, information is the main source for sufficient patient safety. There is an obligatory appointment with an anesthesiologist before the procedure.
During the procedure there is a checklist and a medical record of the patient. These documents keep track of all the processes and actions that are undertaken by the specialists. Another place where all the information is stored is the informational system. Each week there are special meetings that gather all the specialists in the hospital where different cases and patient safety incidents are discussed.
[3], [4]. [5]. [6].
Potential for/description of patient involvement in the CRM practice, including references
Despite the fact that an international consensus regarding the patient’s collaboration in some medical activities is lacking, their involvement would contribute to their safety. The patients have a high enough level of medical culture about the effects of treatments and the recommendations of doctors and the medical team in order to make this happen.
Bibliography (for each reference: author(s), year, title, journal/internet link, page(s))
[1] Andreeva, Petya [2008]: HP-FSH [Fostimon] –A Matter of Choice in Older Women and /or Low Ovarian Responders, Journal of Obstetrics and Gynecology”, Vol. 47, ? 3: 56 – 61.
[2 ]Andreeva, Petya [2012]: Folate metabolism and its impact on several reproductive processes and disadvantages, Journal of Reproductive Medicine and Endocrinology,19: 22-36.
[3] Andreeva, Petya, Horiuchi, I, Koyama, K, Kyurkchiev, S, Shterev, A, Resistance index S/D of uterine blood flow has a predictable value for successful embryo implantation. Journal of Reproductive medicine and endocrinology 2010; 7 [4]: 341.
[4] www.ivf-bg.com, website of Shterev Hospital, Sofia, BG.
[5]. www.mh.government.bg,Standard of Anesthesiology;
[6]. WHO, Surgical checklist strategy;
[7].http://www.ivf-bg.com/index.php?option=com_content&view=article&id=97:-2010&catid=39:2009-06-11-14-04-16&Itemid=112&lang=en
[8]. Assoc. Prof. Atanas Shterev: http://ivf-bg.com/index.php?option=com_content&view=article&id=86%3A2009-09-09-08-04-19&catid=36%3A2009-06-11-14-03-26&Itemid=93&lang=en
Reviewer
M.Vladimirova,NCPHA,BG, B.Tsvetkova,ObGyn Hospital Dr.Sterev
Organisation
The National Center of Public Health and Analyses (NCPHA), Bulgaria and ObGyn Hospital
Any additional information on the CRM (e.g. implementation barriers and drivers)
Barriers:
• Development of a new Codex for Patient Safety at national level;
• Financial resources of the patient;
• Climate and environmental issues and changes affecting health equality;
Overcome Barriers:
• Enhance the culture and education of patients
• Support national levellegislative and community initiatives related to patient safety.
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