In Vitro Fertilization Center -requirement PUBLIC
Compulsory Ethiopian StandardCESOMMENTSFiUVW Editionxx-xx-2022DRAFTFORPUBLICCIn vitro fertilization center-requirementICS: 11.020Published by Ethiopian Standards Agency ESA
ForwardENTSThis Ethiopian standard has been prepared under the direction of the Technical Committeefor Medical Science & Healthcare facility (TC 90) and published by the EthiopianStandards Agency (ESA).Application of this standard is COMPULSORY due to concerns to safeguard thepublic health & safety. A Compulsory Ethiopian Standard shall have the same meaning,Minterpretation and application of a "Technical Regulation “as implied in the WTO-TBTDRAFTFORPUBLICCOImplementation of this standard shall be effective as of xxx 2022.MAgreement.i
Table of ContentsENTSForward . 11.Scope . 42.Normative References. 43.Terminologies and Definitions . 44.IVF services . 6M5. Nursing services . 126. Anesthesia services . 15MClinical Laboratory Services (Optional) . 20DRAFTFORPUBLICCO7.ii
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1.Scope1.1 This Minimum requirement shall be applicable for all IVF specialty centers new andENTSexisting, governmental and non-governmental.1.2 The document covers the minimum requirements with respect to practices, premises,professionals and products or materials put into use for the IVF specialty centers.2.Normative ReferencesMThe latest editions of the following laws, regulations, directives and guidelines shall beMtaken as part and parcel of this Ethiopian requirement.Terminologies and DefinitionsC3.O CES-246 Health institutions general requirement3.1 Specialty Services requirementsICShall mean requirements which are specific/ peculiar to the IVF center as describedin thedocument.BL3.2 Infertility:A disease of the reproductive system defined by the failure to conceive after 12PUmonths ofregular unprotected sexual intercourse3.3 Intrauterine Insemination (IUI):RA the insemination of washed semen directly into the uterus3.4 In vitro fertilization(IVF):FOA fertilization of an egg by sperm in a laboratory dish3.5 Intracytoplasmic sperm injection (ICSI):TA process by which an egg is fertilized by injecting a single sperm into the egg3.6 Fertilization:AFA sperm penetrates the egg leading to a combination of genetic material resultingDRin afertilized egg3.7 Follicle: A fluid filled sac that contains an immature egg. Located in the ovaries,folliclesdevelop each cycle, one ovulates into an egg.3.8 Gamete:A reproductive cell, egg in females and sperm in males3.9 Embryo:iv
The product up to eight weeks after fertilization, later it is called a fetus3.10 Micro-epididymis sperm aspiration (MESA):Surgical collection of sperm direct from the epididymis (tube that carries sperm outENTSof thetestis). Used when a blockage in the epididymis leads to absence of sperm inthe semen.3.11 Percutaneous epididymal sperm aspiration (PESA):Collection of sperm under local anesthesia by needle aspiration of the epididymisM3.12 Testicular sperm aspiration (TESA):MMeans needle aspiration of the testis to collect sperm, usually carried out in cases3.13 Pre-implantation genetic diagnosis (PGD):Owhere PESA has been unsuccessful.CA diagnostic technique involving genetic tests on an embryo or a polar body (acell structure inside the egg). Usually done when the embryo is at the 6-8 cellICstage. One cell is removed for analysis of its DNA or chromosomes to determine ifBLthe embryo is likely to develop a genetic disease.3.14 Pre-implantation genetic screening (PGS):PUA technique to check if an embryo has the correct number of chromosomes. Usedparticularly for older women (at increased risk of chromosomal abnormalities) andfor women who have had recurrent miscarriages (often due to chromosomalRabnormalities). It is still in the experimental phase, since it is not yet evidenceDRAFTFObased.v
4.Specific requirement4.1. IVF services4.1.1.1.ENTS4.1.1. PracticeUnder the Ordinance, any IVF procedure shall be provided only to personswho are the parties to a marriage (certified under the municipality ortraditional / religious marriages). The requirement provides guidance forgood practice, as described in subsequent chapters, which aim to supportMproper clinical and scientific procedures, to safeguard the health and interestsMof service users and to protect the welfare of children born through IVF.Professionals concerned should still follow the codes of practice andOprofessional ethics of their individual disciplines. The requirement is notThe IVF center shall provide the following services and perform proceduresICin intention to produce safe pregnancy.Infertility work up and treatmentb)Pre-implantation genetic screening (PGS)c)Pre-implantation genetic diagnosis (PGD)d)Intracytoplasmic sperm injection (ICSI)e)Insemination of In Vitro fertilized embryoMicro-epididymis sperm aspiration (MESA):Rf)BLa)PU4.1.1.2.Cmeant to supersede these.Percutaneous epididymal sperm aspiration (PESA):h)Testicular sperm aspiration (TESA):i)Hysteroscopy and laparoscopy (optional)j)Cryopreservation of gametes, embryo and tissuek)Laparotomy and Female genital reconstructive surgery (optional)l)Intrauterine Insemination of washed semen directly into the uterusDRAFTFOg)4.1.1.3.(IUI):m)Follow up and treatment of early pregnancyn)Referral serviceIVF centers shall devise a mechanism to ensure that relevant information isgiven to persons seeking IVF procedure.vi
4.1.1.4.Persons seeking IVF procedure shall be informed of the followinga)Explanation of the procedure;b)Possible discomfort, side effects and complications of procedures andc)Limitations and possible outcomes of the treatment;d)Any other options available; ande)Charges for services.MBecause of the ethical concerns involved in treatments which involve thelaboratory handling and manipulation of human gametes and embryos, thereM4.1.1.5.ENTStreatments.should be an ethics Committee and has to issue a report on the ethicalOconsiderations of IVF procedures.Counseling service shall be provided by doctors, nurses, social workers,IC4.1.1.7.Counseling service shall be recommended and made available to all clients.clinical psychologists or other medical professionals with suitable experienceBL4.1.1.6.CCounseling serviceand/or qualifications.Information obtained during counseling shall be kept in accordance with4.1.1.9.The IVF center shall have counseling protocol that addresses the followingPU4.1.1.8.Rprinciples of privacy and confidentiality.FOa) The success and failure rate of the procedureb) The cost of treatmentAFTc) The effect of IVF on the offspringd) The potential side effects of the treatment ande) Other related issue as it pertains to the treatment/IVFDRTreatment Method4.1.1.10. The attending clinician shall ensure that the treatment method offered is theone which best suits the couple’s particular medical indication.4.1.1.11. Indication for selecting a particular IVF procedure shall be stated in eachcase.vii
4.1.1.12. Side effects and complications arising from IVF procedure shall be recordedfor each case.ENTS4.1.1.13. Whenever possible, IVF practitioners shall take measures to reduceoccurrence of high order multiple pregnancies.4.1.1.14. For IVF techniques, no more than three embryos shall be placed at a time.If a pregnancy involving multiple fetuses should occur despite the above-mentioned precautions having been taken, and if the prognosis for the fetusesM4.1.1.15.is so unfavorable, a procedure of fetal reduction may be necessary. ParentsMshall be clearly counseled of the reasons for embryonic/fetal reduction andOthe possible risks involved, and the procedure shall not be carried out withoutCtheir consent.4.1.1.16. When pre-implantation genetic diagnosis (PGD) is used to combine IVF andICgenetic testing as a means of avoiding the transmission of a geneticabnormality or disease, the medical practitioners shall follow the principlesBLof the WHO Ethical Guidelines.PU4.1.1.17. The center shall allow access only to designated individuals in the IVF centrefor whom such access is essential for their work.4.1.1.18. The source of gametes and embryos shall be accurately recorded and labeledRin a manner which is not susceptible to unauthorized or undetectableFOalteration.4.1.1.19. IVF centers shall be responsible for maintaining the gametes and embryos ingood condition through periodic review.AFT4.1.1.20. The handling of surplus gametes and embryos shall be discussed with theclients and consent obtained.DR4.1.2. Professionals4.1.2.1.4.1.2.2.The IVF center shall be directed by a Reproductive Endocrinology andInfertility (REI) sub specialist.Andrologist or Urologist, experienced in male reproduction (andrology) maybe available if the center performs Testicular sperm aspiration (TESA),vii
Percutaneous epididymal sperm aspiration (PESA) and Micro-epididymissperm aspiration (MESA) procedures.The laboratory service shall be directed by clinical embryologist orENTS4.1.2.3.professionals with MSc degree and above in laboratory technology,microbiology, veterinary medicine, medical doctor, and other related fieldstrained at least for three months and certified in maintenance of a clinicalembryology laboratory and in tissue culture techniques with a minimum ofMtable:Professional requiredNumberRemarkCS.NoThe professionals required for the IVF service is depicted in the followingO4.1.2.4.Mone years experience.Reproductive Endocrinology and Infertility (REI) subspecialist2. Andrologist or Urologist (optional)3. Clinical Embryologist / MSc degree and above inlaboratory technology, microbiology, veterinarymedicine, medical doctor4. laboratory technologist(optional)5. Anesthesiologist (optional)6. Anesthetist7. Pharmacist8. Medical doctor9. Social worker (optional)10. Clinical psychologist/GP/Nurse11. Nurses12. Midwife ( Optional)FORPUBLIC1.1111121111314.1.3. PremisesAFT4.1.3.1.The premise for IVF center shall have a minimum of the following premises set up:DRDescription/ Rooms required Reception, registration/ recording & waiting areaExamination rooms with Gynecologic couchTreatment roomMale female Toilet rooms with hand washingbasin (for client and staff )Minor Gynecologic procedure room with Clientchanging areaMinimum room# required1114Minimumrequired30sq. m12sq. m6 sq.m120 sq. mAreaix
12 sq.m11211112130sq. mo Embryology room adjacent to the ORo Andrology and cryopreservation roomX-Ray room as per radiological service standard,( optional)Medicine and medical supplies store roomMini pharmacyUltrasound room (optional)Counseling roomGeneral purpose store roomIncinerator, fixed, with ash pit11ENTS6sq. m for each6sq. m12sq. nM18sq. m12sq. mOM1C 11IC Semen collection room with toilet and showerOperation Roomo Operation theatreo Scrub areao Staff Change area with lockero Sterile supply/ Clean utility roomo Soiled utility areao Nurse stationo Janitor’s closeto Toilet with showero Recovery room ( waiting area after procedure)with 2 bedsSterilization roomEmbryology and andrology laboratory room111120 sq.m12sq.m12 sq. m6 sq. m9 sq. m9 sq. m12sq.mPU4.1.4. ProductsBL 4.1.4.1.The person responsible shall secure that proper equipment are used and4.1.4.2.Backup and/or emergency support facilities should be arranged and madeRmaintained.FOavailable for each technique practiced in the IVF center. The extent andreadiness of such facilities must be commensurate with the degree of riskinvolved.DRAFT4.1.4.3.A laboratory manual and logbook, and maintenance records of essentialequipment must be properly kept and maintained and be available for inspectionby persons from the authorized body (EFDA).4.1.4.4.The minimum equipment required for IVF centers offering IVF services includethe followinga) List of equipment and materials for IVF laboratory Laminar flow hood workstation 180cm Heated stage for laminar flow #2x
Streozoom microscope for laminar flow #2 Inverted microscope with micromanipulation system Thermo safe for inverted microscope Box co2 incubator Bench top co2 incubator Co2 gas analyzer Temperature meter Air purification system (coda air or HEPA filter) Positive air pressure (optional) Micropipette 1000ul Micropipette 20-200ul #2 Micropipette 10-100ul Striper #2 Micropipette holder Refrigerator Block warmer #2 Wall cladding (Aluminium, HGPVC, Antibacterial coated Modular) on all sides Polyvinyl flooring Entire floorPUBLICCOMMENTS Rb) List of equipment and materials for Andrology laboratory Humidified box incubator Micropipette 1000ul Micropipette 20ul Test tube rack #2 Compound microscope Centrifuge with swing out rotor Makler chamberDRAFTFOWorkstation (laminar flow hood) 120cmc) List of equipment and materials for Cryopreservation laboratory area Cryothank for storage #2xi
Cryothank (dewar) for transport Negative pressure Optional Trolley for cryothank(dewar) #2 Face shield Eye google Cryoglove Cooling rackENTSAluminum flooring Entire floorMd) List of equipment and materials for IVF operation theatreM Anesthesia Machine OR table with stirrups Oocyte aspiration suction pump Block warmer Ultrasound with transvaginal probe Minor set Transvaginal probe needle guide Wall cladding (Aluminium, HGPVC, Antibacterial coated Modular) All sides Polyvinyl flooring Entire floor Should be adjacent to IVF lab with a connecting doorRPUBLICCO FOe) Recovery areaRecovery beds with side protection resuscitation equipment including a defibrillator on trolley, oxygen source with face mask and or nasal catheterDRAFT 4.2.Nursing services4.2.1. Practice4.2.1.1.There shall be written policies describing the responsibilities of nurses for thenursing process in the specialty center. Such policies shall be reviewed atleast once every fiveyears.xii
4.2.1.2.The Specialty center shall have established guidelines for verbal and writtencommunication about client care. Verbal and/or written communication: reporting to treatingENTSphysician(s); nurse-to- nurse reporting; communication with otherservice units (laboratory, pharmacy, X-Ray, social work service).4.2.1.3.There shall be a procedure for standardized, safe and proper administration of4.2.1.4.Nurses’ documentation shall include:Mmedications by nurses or designated clinical staff.Ma. Medication/ treatment/ other items ordered by authorized attendingb.Long-term goals and short-term goals,Cc. The psycho- social needs of the patient,Implementation of infection prevention procedures and provision ofIC4.2.1.5.information on IP practices to clients as appropriate shall be done by theBLnurses;Informed consent shall be sought before carrying out any procedure ifPUappropriate.4.2.1.7.Client discharge instructions shall be documented in the patient’s medical4.2.1.8.R4.2.1.6.Ophysician ifordered4.2.1.9.There shall be a mechanism in place to ensure that assistance is provided forrecord and verbal instruction shall be given procedure if appropriateFOAllergies shall be listed on the front cover of the client’s card or highlightedon the screen in a computerized system.Tclients who require assistance.DRAF4.2.1.10. There shall be a policy for reporting and documenting medication errors andadverse drug reactions by attending nursing personnel immediately to theprescriber and/or Pharmacist.4.2.2. Premises4.2.2.1.The specialty center shall have the following premises for nursing services:a. Nurse station roomxii
b. Nurse changing room with cabinet, chairs, cupboard (optional) can sharechangingroom with other staffs.4.2.3. ProfessionalNursing care service at different service delivery areas shall be directed by a4.2.3.2.The center shall have in place a nursing workforce plan that addresses nurse4.2.3.3.All nursing staff shall receive orientation, training and/or update at leastlicensedBSC nurse with two years of work experience.Mstaffing requirements including, at a minimum:Mannually including at least:a. Center’s policies and procedures,Routine nursing procedures,Ob.Cc. Emergency procedures andd.Infection prevention and control.IC4.2.4. ProductsThe following products shall be available for nursing care services.a. Rubber Sheetsb. client Chart /FoldersPUc. Vital Sign EquipmentsBL4.2.4.1.ENTS4.2.3.1. Trolley for vital sign monitoring as necessary Thermometer,R BP apparatus,FO stethoscope, sphygmomanometer attached with stethoscope (optional),AFT wrist watch/ wall clock, weighing scale Pulseoxymetry (optional)DRd. Nursing procedure equipments: Dressing trolley as appropriate, Dressing set as appropriate, Minor set as appropriate , Enema set as appropriate,xi
IV stand, Suction machine: electrical/pedal as appropriate,ENTS Waste basket, Safety boxes, Bed screens, Kidney basin, 475ml x 5 Bed pan and urinal as appropriateM Mobile Examination light,M Plastic apron, Drapes,Oe. Soiled utility room:C Soiled linen trolley Bin with lidIC Worktable with laminated topBL Wash tube General purpose trolley, two traysf. Furniture and fixtures;PU Table Chair, stackable, without armrestsR Basket, waste-paper, metal CabinetFO Patient chart holder, Refrigerator (optional),T Bedside cabinet,AF4.3.Anesthesia servicesDR4.3.1. Practices4.3.1.1.There shall be a written policy about administration of sedation, regional andgeneral anesthesia in the center,xv
4.3.1.2.Anesthesia services shall be administered in accordance with writtenpolicies and procedures that are reviewed at least every three to five years,following:ENTSand revised more frequently as needed. They shall include at least thea) Anesthesia care, which includes moderate and deep sedation, is planned anddocumented in the patient’s record.b) hetistorManesthesiologist prior to the induction of anesthesia.byMc) The client shall be reassessed immediately prior to induction of anesthesia by ananesthesiologist or anesthetist. The plan shall be consistent with the clientOassessment and shall include the anesthesia to be used and the method ofCadministration.d) Prior to administration of any pre-anesthesia medication, a written informedICconsent for the use of anesthesia shall be obtained and documented in the medicalrecord.BLe) Each client’s physiologic status shall be continuously monitored during anesthesiaor sedation administration and the results of the monitoring shall be documentedPUin the client’s medical record on an anesthesia form, a minimum of :Pulse rate and rhythm. Blood pressure. Oxygen saturation.Respiratory rate.FO R End-tidal carbon dioxidef) The anesthesia record includes:Fluids administered. Medications administered. Blood or blood products administered. Estimated blood loss. The actual anesthesia used. Any unusual events or complications of anesthesia. The condition of the client at the conclusion of anesthesia. The time of start and finish of anesthesia.DRAFT xv
DRAFTFORPUBLICCOMMENTS Signature of the anesthesiologist/ or anesthetists.g) The client shall be monitored during the post-anesthesia/surgeryxv
Recovery period and the results of monitoring shall be documented in theclient’s medical record.h) The time of arrival and discharge from anesthesia recovery room shall be recorded.ENTSi) The observation at recovery room shall be done by qualified registered nurses withtraining of basic advanced cardio-pulmonary support.4.3.1.3.The anesthetist shall visit the client before the operation and assess thegeneral medical fitness of the client, receives any medication being taken, andThe anesthetist shall discuss possible plans of management with the client andM4.3.1.4.Massess any specific anesthesia problems.explains any options available, to enable the client to make an informedOchoice.Information on any medicines or treatments such as blood transfusion shall be4.3.1.6.The anesthetist shall ensure that all the necessary equipment and medicines4.3.1.7.The anesthetist shall confirm the identity of the client before inducingICdiscussed with the client.anesthesia.BLare present and checked before starting anesthesia.PU4.3.1.8.C4.3.1.5.The anesthetist shall be present in the operating theatre around the clientthroughout the operation and shall be present on-site until the client has beenFO4.3.1.9.Rdischarged.The conduct of the anesthesia and operation is monitored and recorded in linewith the monitoring standards and formats, to a minimum these shall contain:DRAFTa) A continuous display of the ECG,b) Continuous pulse oxymeter, andc) A written record of the anesthetic shall be kept as a permanentrecord in the case notes.d) End-tidal carbon dioxide4.3.1.10. Pain shall be assessed in discussion with relevant specialist and/ or the clientand pain control shall be provided.4.3.1.11. Clients shall be managed in a recovery room until overcome effect ofxv
anesthetic.4.3.1.12. The protocols and guidelines used for anesthesia service shall be availableENTSand well understood by the surgical team.4.3.1.13. Anesthetic agents administered with the purpose of creating conscioussedation, deep sedation, major regional anesthesia, or general anesthesia shallbe in accordance with anesthesia policies and procedures.Mwhen there are disabled alarms on the monitors,M4.3.1.15.There shall be a written protocol to assure that surgery shall not proceedThe general anesthesia service shall be provided in the Operation theatre(OR), together with the surgical services.C4.3.2. PremisesO4.3.1.14.4.3.2.1.There shall be central oxygen system or a system where there is a4.3.2.2.Recovery Room shall be sited within the operating suit and has a minimumBLICcontinuous supplyof charged Oxygen cylindersof:PUa) Two beds with side protection,b) Resuscitation equipment including a defibrillator on trolley (shared withOR)c) Oxygen source with face mask and or nasal catheter,FORd) Ensures ease of communication and access for anesthesia department stafffor close follow up,4.3.3. ProfessionalsT4.3.3.1.DRAF4.3.3.2.This requirement allows licensed Anesthesiologist/Msc/Bsc anesthetist tolead anesthesia service.All anesthesia providers who administer and/or supervise the administrationof general anesthesia, major regional anesthesia, or conscious sedationanesthesia shall maintain current training in Advanced Cardiac Life Support.4.3.4. Products4.3.4.1. The anesthesia service shall have the following equipments and suppliesa. Time clockb. Anesthesia machinec. anesthesia circuits with filtersxi
d. Oxygen cylinders, oxygen trolley and oxygen regulatore. Worktable with laminated topENTSf. Resuscitation equipments; Ambu bags with inflatable bag,g. Refrigerator,h. Stoolsi. ClipsMj. Weight scalek. Resuscitation trolleyMl. DefibrillatorOm. Blood gas analyzer (optional)n. Air conditioner and heater as appropriateCo. Framed boards with pencil traysq. Infusion pumps (optional)s. Suction machinesECG monitor Pulse oximeter BP apparatus with different size cuffs PU Rt. Client monitorBLr. Tourniquets, tongue depressorsICp. IV stands,End-tidal carbodioxideFOu. Intubation gadgets and airway aids4.4.Clinical Laboratory Services (Optional)T4.4.1. practicesAF4.4.1.1.The center shall have clinical laboratory services.a. The clinical laboratory shall have the following minimum test descriptions;DRHEMATOLOGY TESTS: White blood cell count Platelet Hemoglobin and Hematocrit Hemoparasite (optional)xx
RBC morphology (optional) Differential count (optional) Erythrocytes Sedimentation Rate (ESR) (optional) Reticulocyte count (optional)ENTS b. CLINICAL CHEMISTRY: (optional)Glucose Bilirubin, Direct Creatinine Bilirubin, Total Blood Urea Glucose Tolerance Test (GTT) Alkaline Phosphatase γ-Glutamine Transferase Aspartate Aminotransferase (AST) Total protein, 24 hr. Urine Alanine Aminotransferase (ALT)BLICCOMM PUc. URINALYSIS AND BODY FLUID ANALYSISUrine analysis Qualitative Urine Microscopy Body fluid Analysis (optional)DRAFTFOR xx
Stool Examination Special parasitological testsENTSd. PARASITOLOGY (optional)e. BACTERIOLOGICAL EXAMINATION (optional) Gram Stain AFB Stain Special StainWidal-welifliex RPR (syphilis) HBsAg HIV/Ag/Ab (optional) H.pylori (optional)CICg. HORMONE ASSAYS (optional)OM Mf. SEROLOGICAL TESTS AND OTHER TESTSBLThe IVF center laboratory shall have written policies and procedures for the followings:a. Quality assurance and control processes,b. Inspection, maintenance, calibration, and testing of all equipment,PUc. Management of reagents, including availability, storage, and testing for accuracy.d. Statement on Normal ranges for all tests.e. Laboratory safety program, including infection control.FORf. Documentation of calibration report, refrigerator readings and so on.The IVF center laboratory shall follow standard operating procedures (SOPs)and conduct routine quality assessments to ensure reliable and cost effectivetesting of client specimens.4.4.1.3.Manuals, guidelines or Standard Operating Procedures (SOPs) shall beavailable for all tests and equipments available in the specialty clinic laboratory.DRAFT4.4.1.2.4.4.1.4.The IVF center laboratory shall have procedures (SOPs) for proper collection,identification, transport & disposal of specimen that address specific collectionrequirements.4.4.1.5.The IVF center laboratory team/ management shall review all operationalprocedures at regular intervals.4.4.1.6.The process of specimen analysis shall be specified by validated written orxx
DRAFTFORPUBLICCOMMENTSelectronic procedures maintained in the laboratory. Procedures may be writtenby the laboratory staff or may be adapted from existing published materials.xx
4.4.1.8.4.4.1.9.There shall be SOP or criteria developed for acceptance or rejection of clinicalsamples.The IVF center laboratory shall maintain a record of all samples received andtests run.ENTS4.4.1.7.IVF center laboratory staff shall test quality control materials every day forequipment requiring frequent calibration.4.4.1.11. IVF center laboratory report shall be made as follows;M4.4.1.10. IVF center laboratory shall have a procedure for storage of clinical samples thatare not examined immediately.Ma) All laboratory test results/reports shall have reference (normal) ranges specificOfor age and gender if applicable.Cb) Copies/ files of reported results shall be retained by the laboratory such that promptretrieval of the information is possible. The length of time that reported data are retainedICshall be 5 years.BLc) Reports shall be filed with the client’s medical record and duplicate copies shall be filedin the laboratory.PUd) In the case of laboratory tests performed by an outside laboratory, the original reportfrom such laboratory shall be filed in the medical record.Re) Quality assured test results shall be reported on standard forms with the followingminimum information:client identification (patient name, age, gender), Date and time of specimen collection, The test performed and date of report,DRAFTFO The reference or normal range, The laboratory interpretation where appropriate, The name and initial of the person who performed the test and the authorizedsignature of the person who reviewed the report and releases the results, and Address of the laboratory/ center.f) Laboratory results shall be legible, without transcription mistakes and reported only topersons authorized to receive them such as the ordering physician or nursing staff in
the IVF center.ENTS4.4.1.12. No eating, drinking, smoking or other application of cosmetics in the laboratorywork area is allowed.4.4.1.13. No food and drink shall be stored in the laboratory.4.4.1.14. Temperature of the refrigerator used to store laboratory reagents shall be strictlymaintained below 8 C & daily temperature readings shall be documented.M4.4.1.15. The lab professional shall wear protective clothing of an approved design(splash proof), always fastened, within the laboratory work area and removedbefore leaving the laboratory.OM4.4.1.16. Where services are provided by an outside laboratory, the types of services &procedures available & offered shall be documented in writing and available inthe IVF center.4.4.2. premisesThe IVF center shall have a dedicated room/area for clinical laboratory4.4.2.2.The IVF center laboratory shall have the necessary space & facilities to4.4.2.3.The laboratory working environment shall be kept organized, clean, and safe4.4.2.4.The following shall be minimum space allocation for IVF center laboratory:C4.4.2.1.ICservices/can beattached in the main laboratory.PUBLcollect specimens & perform testing in a safe environment.Rfor handling specimens and waste materials.space required4 sq. m12 sq.mDRAFTFOPremises requiredSpecimen collection area,Hematology areaSerology areaurinalysis areaStore place for chemicals (wall mountedcabinets can be used)4.4.2.5.The laboratory facilities for IVF center shall meet at least the following:a) The laboratory shall have a reliable supply of running water.b) The laboratory shall be well illuminated and ventilated,c) At least one sink shall be available for hand washing in the laboratory.d) Lab bench working surface covered with appropriate materials.e) Interior of the lab
3.4 In vitro fertilization(IVF): A fertilization of an egg by sperm in a laboratory dish 3.5 Intracytoplasmic sperm injection (ICSI): A process by which an egg is fertilized by injecting a single sperm into the egg 3.6 Fertilization: A sperm penetrates the egg leading to a combination of genetic material resulting in a fertilized egg
Ventura‑Juncá et al. Biol Res () Page 3 of 13 Fig. 1 Schematic representation of in vivo and in vitro steps of mammalian fertilization.I Ovarian hormonal stimulation promotes follicle matura‑ tion and then ovulation. II ART uses different fertilization techniques to achieve fertilization, while in vivo female and male gametes interact and fuse in the female tract (infundibulum).
Human in vitro fertilization . The 2010 Nobel Prize in Physiology or Medicine is awarded to Dr. Robert G. Edwards for the development of human in vitro fertilization (IVF), a medical advance that represents a paradigm shift in the treatment of many types of infertility. The inability to conceive a child is a reproductive defect that afflicts
In Vitro Fertilization . What is In Vitro Fertilization (IVF)? A treatment in which: fertility medications are used to stimulate . human chorionic gonadotropin) as directed by the nursing team Timing of the injection is CRITICALLY important -Stop all other medications
Fertilization and cleavage in vitro of human oocytes matured in vivo. Nature 1970; 227:1307-1309. Steptoe PC, Edwards RG. Birth after the reimplantation of a human embryo. Lancet 1978; 2:366. Edwards RG. The bumpy road to human in vitro fertilization. Nature Med 2001; 7:1091-4. More information:
vitro fertilization but the major denomination, that is, Catholic and Protestants views will be delved into. The Catholic View On In Vitro Fertilization The Roman Catholic Church has long rejected any reproductive technologies that manipulate human embryos. The Catholic Church only condones procedures that 'assist' conception that
pellucida of oocytes for in-vitro fertilization applications. In this paper we describe an alternative approach to laser . The micromanipulation techniques have brought overwhelming clinical advances in human In-Vitro Fertilization (IVF). These techniques are mainly utilized to aid IVF in cases of male subfertility [1,2] to promote the .
DEVELOPMENTAL BIOLOGY 5 FERTILIZATION Introduction: Special features of the gametes for fertilization: Both egg and sperm acquire structural specializations for fertilization. Eggs are non-motile, surrounded by protective egg coverings. These serve to recognize the sperm specifically and prevent fertilization by more than one sperm (polyspermy).
learning teams, guided inquiry activities, critical and analytical thinking, problem solving, reporting, metacognition, and individual responsibility. Strategies for the successful use of learning teams are discussed, the roles of the instructor in this learning environment are described, and implementation hints
