ASSISTANT REPRODUCTION TREATMENT PRACTICES AND REPRODUCTION REGULATION ON ASSISTANT TREATMENT CENTERS

 

FIRST PART

Purpose, Scope, Basis and Definitions

Goal

ARTICLE 1 - (1) The purpose of this Regulation; It regulates the principles of the practice to be carried out for married couples who cannot have children, who are deemed medically suitable, to have children through assisted reproductive treatment methods, and the procedures and principles regarding the opening, operation and supervision of the centers that will carry out this practice.

Scope

ARTICLE 2 - (1) This Regulation covers health practice and research centers and hospitals affiliated with universities and public institutions and organizations, medical centers and private hospitals, and independent reproductive treatment centers belonging to real persons and private law legal entities, and their reproductive aids. It covers the activities and operators related to treatment methods.

Rest

ARTICLE 3 - (1) This Regulation; Article 7 of the Basic Law on Health Services No. 5 dated 1987/3359/3, subparagraph (c) of the first paragraph of Article 9 and additional article 11 and Article No. 11 dated 10/2011/663 on the Organization and Duties of the Ministry of Health and its Affiliated Organizations It has been prepared based on Article 40 of the Decree Law.

Definitions

ARTICLE 4 - (1) In this Regulation;

  1. a) Minister: Minister of Health,
  2. b) Ministry: Ministry of Health,
  3. c) General Manager: General Manager of Health Services,

ç) General Directorate: General Directorate of Health Services,

  1. d) Center: Independent reproductive treatment centers belonging to real persons and private law legal entities, health practice and research centers affiliated with universities and public institutions and organizations, and centers operating within hospitals, medical centers and private hospitals, where assisted reproductive treatment methods are applied,
  2. e) Directorate: Provincial health directorates,
  3. f) Detached center: Centers licensed independently by the Ministry, other than hospital and medical center buildings, within the scope of the Invitro Fertilization and Embryo Transfer Centers Regulation published in the Official Gazette dated 21/8/1987 and numbered 19551,
  4. g) License: The document issued stating that the detached center complies with this Regulation and can operate,

g) Assisted reproductive treatment (ART): Practices that are accepted as a medical treatment method in modern medicine, including the transfer of gametes or embryos to the expectant mother by making the expectant mother's egg and the husband's sperm more suitable for fertilization by various methods, ensuring fertilization outside the body when necessary,

expresses

SECOND PART

Establishment of the Scientific Commission, Working Method and Duties of the Commission

Formation of the scientific commission

ARTICLE 5 - (1) A Commission is established by the Ministry to provide scientific opinion on the centers and ART methods in order to develop the services of the centers and increase their quality.

(2) The Commission is chaired by the General Manager or the authorized person appointed by him;

  1. a) Three people who are gynecologists and obstetricians who are qualified to be responsible for the ART unit,
  2. b) Two people who are histology and embryology specialists or have a master's degree in reproductive medicine who are qualified to be responsible for the ART laboratory,
  3. c) A person who is a urologist,

ç) A medical geneticist or a person who has a doctorate in the field of medical genetics,

  1. d) A person who is a perinatology specialist,

It consists of a total of 9 people.

(3) Commission members are elected by the Minister. Members elected by the Minister serve for a period of two years. It is possible to be re-elected as a member. Memberships of elected members who do not attend two consecutive meetings without an excuse are terminated. A member is determined to replace the member who leaves the commission or whose membership is revoked, using the same procedure.

(4) The Ministry may call representatives from relevant institutions and organizations and non-governmental organizations when necessary.

Working method and duties of the commission

ARTICLE 6 - (1) The Commission meets upon the invitation of the Ministry. The meeting agenda is determined by the Head Office and notified to the members at least seven days in advance. The issues requested by the members to be included in the agenda are notified to the secretariat at least three days before the meeting for evaluation. The commission meets at least once a year. The Commission may be called to a meeting when the Ministry deems it necessary.

(2) The commission convenes with the 2/3 majority of the total number of members and takes decisions with the absolute majority of the attendees. In case of equality of votes, the opinion of the chairman is deemed to be accepted.

(3) The secretariat services of the Commission are carried out by the general directorate. The commission examines the agenda items and prepares the decision text. Commission decisions are advisory. Commission decisions are signed by the members. Those who do not agree with the decision sign the decisions by adding an annotation. The justification for the opposing opinion is stated under the decision or in its annex.

(4) The duties of the Commission are:

  1. a) To give opinions on the evaluation criteria of the centers' study data and pregnancy results,
  2. b) To express opinions regarding the determination of standards regarding centers and assisted reproductive treatment methods,
  3. c) To carry out the necessary studies on scientific and technical issues needed by the Ministry,

ç) To give scientific opinion on the implementation of the Regulation.

(5) If deemed necessary by the Chairman, experts may be invited to the meeting or their opinions may be taken. Experts invited to the meeting cannot participate in the voting on the work of the commission. The Commission may request scientific opinions from relevant persons and organizations when necessary.

THIRD PART

Planning of Centers, Center Staff, Authorization to Open Centers

Institutions, Center Opening Application and Licensing

Planning of centers

ARTICLE 7 - (1) In order to avoid creating idle capacity and to use resources effectively and efficiently, the Ministry makes plans for the centers to be opened within public and private hospitals according to the needs on a country, regional and provincial basis, taking into account the working performance and service quality of existing centers. In line with the planning made by the Ministry, a center can be opened within public and private hospitals.

Central staff

ARTICLE 8 - (1) Centers within private hospitals and medical centers must use private hospital and medical center staff. The presence of a center does not give a private hospital or medical center the right to vested staff.

(2) Individual center staff are recorded in the Health Institutions Management System by the Ministry. The appointment and departure procedures of physicians and specialist physicians are carried out through the system.

(3) A specialist physician with the same qualifications may be appointed to replace the person who leaves the independent center staff. A working certificate is issued for this personnel by the responsible manager and approved by the directorate within five business days at the latest. Apart from this, for healthcare professionals who will be new to the independent center, a working certificate is first issued by the responsible manager and approved by the directorate, and the personnel can work from the date the working certificate is approved.

(4) Physicians and healthcare professionals can work in private hospitals and medical centers by issuing a working certificate.

Institutions authorized to open centers

ARTICLE 9 - (1) Centers; It is opened as a unit in hospitals with gynecology and obstetrics specialization and adult and neonatal intensive care. This unit cannot be created in a separate location outside the hospital service building or campus. More than one center cannot be opened within the hospital.

(2) Centers can be opened within hospitals affiliated with public institutions and organizations and private hospitals. A detached center cannot be opened.

(3) Centers to be opened within the body of a private hospital are first processed into the project based on the license within the scope of the Private Hospitals Regulation published in the Official Gazette dated 27/3/2002 and numbered 24708. Procedures continue after obtaining permission regarding the project and planning.

(4) For centers to be opened within public hospitals, the necessary permissions are first obtained in accordance with the relevant legislation of the institutions.

(5) Licenses are issued for independent centers. Other centers are recorded in the license and/or operating permit of the hospital or medical center.

Center opening application and licensing

ARTICLE 10 - (1) Hospitals permitted by the Ministry within the scope of planning apply to the Directorate to open a center with the application file containing the documents specified in Annex-1.

(2) The application file is reviewed by the Directorate within seven business days from the application date. If a deficiency and/or non-conformity is detected in the file, the applicant is notified.

(3) If there are no deficiencies in the application file, an on-site inspection is carried out by the technical inspection team within 30 days at the latest.

(4) Under the chairmanship of the provincial health director or the deputy director to be assigned by him;

  1. a) A gynecologist and obstetrician who is qualified to be responsible for the ART unit,
  2. b) A person who has the qualifications to be responsible for the ART laboratory,
  3. c) A joint technical report is prepared as a result of the on-site examination to be carried out by a technical inspection team of four people, including an architect representative of the directorate/provincial directorate of environment and urbanization.

(5) If the members specified in subparagraphs (a) and (b) of the fourth paragraph are not available in the province where the center will be opened, a member is appointed by the Ministry.

(6) As a result of the examination, if it is determined that the application meets all the conditions, it is recorded in the license or activity permit of the center or hospital by the directorate. A working certificate is issued to employees of private hospitals/medical centers and independent centers.

(7) If deficiencies/nonconformities are detected as a result of the examination by the technical examination team of the center, the situation in the examination report prepared for their completion or elimination is notified to the applicant in writing by the Directorate. The provisions of the third paragraph shall apply as soon as the applicant notifies the Directorate in writing that the deficiency and/or non-conformity has been corrected.

(8) In cases of change of address, organization name and ownership in independent centers, the license is re-issued.

CHAPTER FOUR

Physical Standards of the Center and Issues That Must Be Met

building condition

ARTICLE 11 - (1) A detached center can be established in detached buildings or in a part of the building where all parts, starting from the entrance, have integrity and independence, including the use of elevators and stairs. If it is installed in a detached part of the building, compliance with access to fire escape stairs is required. Service units must be directly connected and adjacent to each other.

(2) Independent centers may make renovations, provided that they obtain permission from the Ministry or Directorate.

(3) There cannot be a workplace for any other purpose within the detached center, and a section within it cannot be rented or transferred in any way to third parties to operate for another purpose.

Stairs, corridors, generators and elevators

ARTICLE 12 - (1) In the centres;

  1. a) The landing dimension of the staircase must be at least 1,20 meters to allow carrying a patient with a stretcher between floors. It is mandatory to finish the stair risers with a flat surface so as not to make it difficult for disabled people to exit, and a ramp with an 8% slope must be built at the center entrance.
  2. b) The width of all corridors with patient circulation must be at least two meters. If the width of the corridors falls below two meters due to columns and similar protrusions due to the load-bearing system of the building, the two meter width requirement may not be required in these sections.
  3. c) There is a generator that is automatically activated and has the appropriate power and quality at least 70% of the installed power calculated in the electricity project.

d) In centers located outside the ground, there is a stretcher elevator in accordance with the relevant legislation, through which transportation can be easily provided. If there is more than one elevator, it is sufficient for one of them to be of this quality.

(2) Centers are heated by the central heating system. Depending on the regional and seasonal conditions, a system similar to central cooling or split air conditioning is installed. All areas used by patients and staff are properly ventilated and illuminated using sufficient sunlight and energy sources.

Departments and features of the center

ARTICLE 13 - (1) Centers are evaluated in two sections: general and application.

  1. a) Application Section: It is the section where ART applications are performed and consists of semi-sterile and sterile areas where patients and staff can enter in a controlled manner by passing through the preparation areas. At the entrance of the application area, there should be a stretcher transfer hall/semi-sterile area with a synchronized second door, a stretcher transfer point, and no space opening into it. The application section contains the following units.

1) Embryology laboratory: It is a laboratory of at least 15 m2 in size, suitable for the evaluation of oocytes as soon as possible after collection, equipped with the necessary tools and equipment, and adjacent and connected to the OPU room and the andrology laboratory. It should be air-conditioned and its temperature adjustable.

2) Andrology laboratory: It is a laboratory of at least 8 m2 in size, connected to the embryology laboratory and containing the necessary tools and equipment and a sink. This laboratory serves only the center's patients.

3) Sperm donation room: It is a special room with a sink and shower, created in a semi-sterile area and connected to the andrology laboratory with a sample drawer for sperm collection.

4) Observation room: It is created as two separate rooms of at least 9 m2 in size, close to the OPU room, outside the sterile area and inside the center, with a sink and minimum medical supplies and equipment determined by this Regulation, in order to prepare the patients before oocyte collection and to wake them up afterwards. . If two beds are to be placed in a room, there should be 7 m2 of space per bed and there should be appropriate separation between the beds. The patient beds to be used must be positionable, have protection bars and have wheels that can move in all directions. The rooms must have an oxygen and vacuum system and a bedside monitoring system.

5) OPU (Oocyte Pick-Up) room: It is a practice room connected to the embryology laboratory, which has a sterile area of ​​at least 20 m2 in size, which also has an ultrasonography device to obtain oocytes for the application of reproductive treatment methods only. If necessary, there are conditions suitable for general anesthesia and other equipment necessary to intervene in complications that may arise during the application. OPU room walls, ceilings and floors are made using antibacterial materials suitable for disinfection and cleaning. If there will be a fixed cabinet in the OPU room, it should be built-in or attached to the ceiling and should not contain dust.

6) TESE (Testicular Sperm Extraction) Room: A separate room with OPU room features can be created for surgical sperm extraction methods.

7) There should be a hand washing sink in the sterile corridor of the application area.

8) Freezing and storage area: It is an area of ​​at least 9 m2 sized for freezing and storing samples that need to be frozen. This area can be a unit separated by a door within the embryology laboratory, or it can be created in a separate area from the embryology laboratory, within the application area. There are embryo tanks and spare tanks in this area. For each planned additional tank, 1 m2 of area is added.

  1. b) General section: This section contains the following units:

1) Patient reception and waiting area: There is a sufficiently large and comfortably furnished patient reception area and a waiting area of ​​at least 20 m2 where patients and their relatives can wait.

2) Patient examination room: There are at least two examination rooms where patients admitted to the center for ART will be examined and followed up, equipped with an ultrasonography device and meeting the conditions of a gynecology and obstetrics examination room. At least one of them should be created within the IPC center in a way that does not disrupt the integrity of the unit. The other one can be created in the outpatient clinics section of the hospital in a way that does not affect the outpatient clinic capacity of the hospital.

3) Nurse work area: There is an open desk or room designed for nursing preparation services.

4) Patient information room: It is a room of at least 10 m2 size designed for the purpose of informing and educating patients. Arrangements are made to inform patients and their relatives. If the information is given in the patient examination room, the information room requirement is not required.

5) Archive unit: It is the unit where all patient records are archived, preferably within the center. If the archive is outside the center, it is organized separately from the general hospital archive. In detached centers, additional rooms are created.

6) Biochemistry laboratory: There is a laboratory equipped with other necessary tools and equipment where hormone studies necessary for patient follow-up can be carried out. Hospitals and independent centers that do not have a biochemistry laboratory purchase services from the biochemistry laboratory licensed by the Ministry located in the same province.

7) Personnel dressing and working rooms: Depending on the condition of the building and the staff, there are as many dressing, resting and working rooms as necessary for physicians and other staff.

8) There are separate men's and women's toilets, sinks and showers for staff and patients.

9) Material warehouse: There is a sufficient material warehouse in the centers. If the warehouse is sufficient in hospitals, a separate warehouse is not required for the center.

10) Patient preparation area: There is a private area where patients who will move to the application area can change their clothes. Two separate areas can be arranged for men and women.

11) Personnel preparation area: This is the preparation area where the personnel who will move to the application section can change their clothes. Two separate areas are arranged for men and women.

12) Sterilization unit: A sterilization unit is created within the center. In the sterilization unit, there must be a dirty material inlet-washing section, preliminary preparation-packaging section and sterilization process-sterile material exit sections. There should be only material passage between dirty areas and clean areas, and these two areas should be divided by a two-way autoclave. In cases where a one-way autoclave is used, the device must be located in the clean section. The sterilization unit is connected to both the OPU room sterile corridor and the general corridor. Entry and exit to the dirty section from the general corridor; There must be entry and exit to the clean section from the sterile corridor. If a sterilization unit is not established, sterilization service is provided through service procurement.

(2) The sections listed in subparagraphs (1), (2), (3), (4), (8), (10) and (11) of paragraph (b) of the first paragraph are arranged in a way to ensure integrity within the center, other sections can be found in different areas of the hospital.

Medical and technical equipment required at the center

ARTICLE 14 - (1) In the center;

  1. a) There are tools and equipment specified in the list in Annex-7 attached to this Regulation. This list is evaluated every year at the first meeting of the scientific commission, taking into account new medical developments.
  2. b) In OPU rooms and laboratories, a ventilation system supported by a filter system that blows fresh air and is impermeable to microorganisms is established.
  3. c) The floor of laboratories and freezing and storage areas is covered with anti-bacterial, anti-static material.

d) A central gas system is installed in the OPU room and observation rooms. The gases to be used in the OPU room and embryology laboratory are supplied from the central system if possible. If they are to be used in the form of filling tubes, they are located in a special section with locked and fixed doors and equipment with an alarm system.

Emergency services and ambulance

ARTICLE 15 - (1) In centers within private hospitals and medical centers, within the framework of the relevant legislation; In detached centers, it is mandatory to provide ambulance service to be used to transport patients in emergencies or necessary medical situations. Ambulance service is provided in one of the following ways:

  1. a) Having a fully equipped emergency ambulance with a certificate of conformity,
  2. b) By making an ambulance service purchase agreement with a private ambulance company operating in accordance with the Regulation on Ambulances and Emergency Health Vehicles and Ambulance Services published in the Official Gazette dated 7/12/2006 and numbered 26369, provided that it is undertaken to be at the center within ten minutes from the call when necessary. ,
  3. c) By documenting that if the ambulances defined in paragraphs (a) or (b) are insufficient, it can provide ambulance service through stations that can be reached within ten minutes, with the coordination of 112 emergency health command and control center, provided that it is approved in writing by the emergency health services branch directorate and the provincial ambulance service chief medical officer.

(2) In emergencies that occur in detached centers, the patient is transported by ambulance provided within the scope of the first paragraph, after appropriate first medical intervention and other procedures are performed.

waste disposal

ARTICLE 16 - (1) In the centres, necessary precautions are taken for medical waste in accordance with the provisions of the Medical Waste Control Regulation published in the Official Gazette dated 22/7/2005 and numbered 25883. A contract is made with the relevant authority to regularly collect medical waste from the center for disposal.

Staff status

ARTICLE 17 - (1) The centers are staffed by the personnel specified in this article.

(2) Responsible manager: One of the specialist physicians working as a permanent staff in the independent center or a physician who is not on permanent staff but works full time is appointed as the responsible manager. The chief physician/manager of the hospital or medical center is also the responsible manager of the centre.

  1. a) The physician to be appointed as the responsible manager must have the following qualifications:

1) To have the right and authority to practice his profession in Turkey in accordance with the Law on the Proper Practice of Medicine and Medicine Arts No. 11 dated 4/1928/1219,

2) Being a citizen of the Republic of Turkey,

3) Not to work in any other public or private health institution/organization other than the institution for which he/she will be the responsible manager.

  1. b) The duties, powers and responsibilities of the responsible manager are as follows:

1) To carry out all kinds of transactions related to the activities of the center,

2) To ensure that the infrastructure and service quality standards defined in this Regulation and internal service operation are protected and maintained,

3) To notify the Directorate in a timely manner of any changes in the conditions for granting permits or licenses during the activity of the centre,

4) To return the working document of the healthcare worker who left his job for any reason to the Directorate within five business days at the latest,

5) To ensure that the services at the center are carried out regularly and continuously,

6) Approving relevant documents on behalf of the Center,

7) To ensure that this Regulation, other relevant legislation and the regulations prepared and announced to the employees regarding the internal functioning of the center are complied with by the relevant parties and to carry out the necessary internal audits for this purpose,

8) During inspections, providing the necessary information and documents to the authorities and assisting in the inspection,

9) To ensure the implementation of the provisions of the Medical Waste Control Regulation,

10) To ensure the sterilization of devices and materials kept in the center and the calibration of the devices,

11) Having health screenings of all personnel working in the center,

12) To notify the Directorate within fifteen business days of any changes that occur in independent centers and partners.

  1. c) The responsible manager can only practice his medical profession at the center where he is the responsible manager; It is forbidden to practice his profession freely in another healthcare institution, including a doctor's office.(1)

ç) The responsible manager is the primary interlocutor of the Directorate and the Ministry in all transactions related to the activity and supervision of the center. The responsible manager is personally responsible for administrative affairs and is responsible for medical procedures together with other physicians. The operator of the centers is responsible for the administrative work of the responsible manager, the activities of the center and the provision of infrastructure facilities required for the health services provided.

  1. d) In detached centers, in cases where the responsible manager resigns, is dismissed by the operator, loses the conditions of being a responsible manager in any way, or dies, a new responsible manager is found by the operator within fifteen business days at the latest after such a situation arises. An application is made to the Directorate with the required documents in order to issue a responsible manager certificate. In these cases, until a document is issued in the name of the new responsible manager, a physician who works at the center and meets the responsible manager requirement is notified in writing to the Directorate.
  2. e) In independent centers, if the responsible manager leaves due to illness and other acceptable compelling reasons, with the leave rights specified in the employment contract, a physician who meets the conditions of being a responsible manager and works full time at the center is appointed by the operator within three business days from the date of departure at the latest. The Directorate where he/she will act as the responsible manager is notified in writing.
  3. f) Those who are temporarily banned from the profession according to the relevant legislation cannot serve as responsible managers in an independent center during the period of this ban. The operator must appoint a physician who works full-time at the detached center and meets the conditions of being a responsible manager, within three working days at the latest from the date of implementation of the ban, to carry out the duty of responsible manager during the temporary ban from profession, and notify the Directorate in writing.

(3) ART unit manager: A gynecologist and obstetrician who has a certificate approved by the Ministry for assisted reproductive treatment is appointed as the ART unit manager. The ART unit manager works full time/permanent. She is responsible, together with other physicians, for all medical procedures performed at the center.

(4) (Change: RG-27/5 / 2023-32203) ART laboratory manager: A histology and embryology specialist who has received training on ART applications during the specialist training period, or a histology and embryology specialist who has participated in a certified training program organized by the Ministry on ART applications and is entitled to receive a certificate; If there is no histology and embryology specialist in the center, a person who has a valid ART laboratory practices training certificate approved by the Ministry is appointed as the ART laboratory responsible. The ART laboratory manager works full time.

(5) Urology specialist: Works temporarily out of staff in accordance with the relevant legislation.

(6) Anesthesiology and reanimation specialist: Works temporarily out of staff in accordance with the relevant legislation. However, OPU must be present at the bedside during application.

(7) Other personnel: There is at least one nurse, one laboratory technician, one secretary, one patient receptionist and a sufficient number of cleaning and security guards.

(8) Regarding changes made due to resignation, change of location, death and similar reasons;

  1. a) Changes in the ART laboratory manager and ART unit manager are made with the approval of the Directorate. If the ART unit manager and the ART laboratory manager leave, the Directorate is immediately notified. If there are personnel at the center who have the qualifications to be the ART unit manager and ART laboratory manager, these personnel will be temporarily responsible for the relevant laboratory/unit until the new responsible person is approved by the Directorate. If there is no personnel with these qualifications, the activities of the center will be stopped for three months. If the ART unit manager and ART laboratory manager cannot be started at the end of this period, the activities of the center will be stopped for a maximum of one year. After the center's operations are stopped, if the deficiency is corrected, the center will be put into operation again. Suspension and reactivation of the activity is carried out by the directorate and the Ministry is informed. The license of the center that does not become operational at the end of this period is canceled by the Ministry or removed from the operating permit.
  2. b) Other personnel changes of the center are notified to the directorate within five days. If at least one healthcare worker other than a specialist physician leaves the centre, and if a replacement healthcare worker cannot be found within three months, the activity of the center will be suspended for a maximum of one year until the deficiency is remedied. The license of the center that does not become operational at the end of this period is canceled by the Ministry or removed from the operating permit.
  3. c) If the activity of the center defined in paragraphs (a) and (b) of this paragraph is stopped and its license is cancelled, the procedures of the patients whose treatment is ongoing will be continued without interruption by agreement with another center or they will be directed to the centers affiliated with the nearest public institutions.

(9) In cases of building renovation, the activities of the center may be suspended for a maximum of six months. The license of the center that does not become operational at the end of this period is canceled by the Ministry or removed from the operating permit.

(10) All employees in independent centers have a photo ID card signed by the responsible manager stating their name, surname, title or profession.

Patient rights

ARTICLE 18 - (1) In the centres, necessary measures are taken to effectively implement the legislation on patient rights in order to prevent violations of patient rights and the problems arising therefrom and to effectively use legal protection methods when necessary.

SECTION FIVE

Other Principles Regarding Service Provision

Recording system

ARTICLE 19 - (1) The center has a protocol registry, surgical intervention registry and laboratory registry approved by the directorate. The patient applying to the center is recorded in the protocol book. Each physician uses the prescription bearing the name of the health institution/center he works for, and signs and stamps this prescription himself.

(2) Candidates who apply to have ART are required to be married and have the procedure done together by filling out the Informed Consent Form in Annex-8 attached to this Regulation. The originals of the spouses' identity cards and marriage certificates are seen and photocopies and photographs are taken. The process begins by checking whether these documents belong to the individuals.

(3) A patient file is prepared for each patient who applies to the center. In the patient file;

  1. a) Photocopies and photographs of the spouses' identity cards and marriage certificates,
  2. b) Information about the authorized institution and organization that referred/issued a report for the patient's application to the center, and the physician who issued and/or referred the report, previous treatments, documents regarding all diagnostic and therapeutic procedures performed at the center, and detailed anamnesis, in chronological order,
  3. c) Information and documents and forms regarding all transactions carried out at the center, information regarding the samples that need to be stored and destroyed,

c) Information showing the reproductive status of the man from the applicant couples, such as spermiogram, testicular tissue biopsy result if performed, and basal hormone values,

  1. d) Epicrisis report containing the procedures performed and the number of embryos transferred if the patient has previously received ART treatment,

takes place.

(4) The form in Annex-9 for embryo storage procedures in the centres, Annex-10 for thawing procedures and Annex-11 for destruction procedures; The form in Annex 12 is filled in for gonad tissue/cell storage procedures, Annex 13 for thawing procedures and Annex 14 for destruction procedures.

(5) Written records are kept in centers where electronic records are not secure. Medical records signed with an electronic signature in accordance with the provisions of the Electronic Signature Law No. 15 dated 1/2004/5070 are considered official records and are backed up and archived in accordance with the relevant legislation. Records can also be kept electronically. If the necessary administrative and technical measures are taken against physical, magnetic or electronic interventions and possible abuses in order to prevent the necessary records of patients' health information from being stored, changed and deleted electronically and to prevent confidentiality from being violated, written records are not required. The responsible manager is responsible for taking the necessary administrative and technical measures in this regard and periodically inspecting them. Electronic data is backed up regularly with a secure backup system. Documents that must be kept in the file are kept separately.

(6) When electronic records are requested for audit or official purposes, the data viewed on the computer screen and the previous outputs must be consistent.

(7) Centers that cease to operate shall transfer their written and/or electronic records, books and other documents to the Directorate to be kept for the period specified in the archive-related legislation.

Storage criteria for reproductive cells and gonad tissues

ARTICLE 20 - (1) It is prohibited to store reproductive cells and gonad tissues except in cases of medical necessity specified in the second and third paragraphs.

(2) Medical necessity situations that require the preservation of reproductive cells and gonad tissues in men are as follows;

  1. a) If sperm is obtained by surgical methods,
  2. b) Before treatments that damage gonad cells such as chemotherapy and radiotherapy,
  3. c) Before surgeries that will cause loss of reproductive functions (testicular removal and similar),

d) In case of very few sperm (cryptozoospermia).

(3) Medical necessity situations that require the preservation of reproductive cells and gonad tissues in women are as follows;

  1. a) Before treatments that damage gonad cells such as chemotherapy and radiotherapy,
  2. b) Before surgeries that will cause loss of reproductive functions (operations such as removal of the ovaries),
  3. c) If they have low ovarian reserve and have not given birth yet, or if their family history of early menopause is documented by a medical board report consisting of three specialist physicians.

(4) In mandatory cases specified in the second and third paragraphs, reproductive cells and gonad tissues and the EDTA blood sample of the donor candidate are stored in the center under appropriate conditions. For application security, DNA identification tests are performed on the blood taken before storage, this information is placed in the patient file and a sample is given to the family. In cases where sperm or testicular tissue is stored due to medical obligations specified in subparagraphs (a) and (d) of the second paragraph, DNA analysis is not required if it is used within ninety days from the date of freezing. For DNA analysis, venous blood taken from the individual belonging to the tissue to be stored in an EDTA tube is sent to a licensed genetic diseases diagnosis center within a week, provided that it is stored in the refrigerator at +4 degrees. The genetic diseases diagnosis center performs DNA identification analysis following DNA isolation. If the storage period exceeds one year, the person must apply and submit a signed petition stating that his/her consent continues. Frozen reproductive cells and gonad tissues are recorded and destroyed by the commission to be established in the directorate in cases where the person does not renew the annual protocol, requests or dies. If an electronic recording system is established by the Ministry, information about the reproductive cells and gonad tissues stored in the center will be recorded in this system.

(5) If more embryos are obtained from the candidates, the embryos are stored by freezing, with the consent of both spouses. If the storage period exceeds one year, couples must apply for the storage of the embryo every year and submit a signed petition stating that their request continues. Joint request of the spouses, death of a spouse or if the divorce is determined by decision or when the specified period expires, the stored embryos are recorded and destroyed by the commission to be established in the directorate.(3) If an electronic recording system is established by the Ministry, information about the embryos stored in the center will be recorded in this system.

(6) The samples specified in the second and third paragraphs of this article are stored in the centers for a maximum of five years. Storage for more than five years is subject to the permission of the Ministry. The evaluation, counting and destruction of the stored samples in a way that prevents their reuse is carried out by a commission to be established within the relevant directorate.

(7) Frozen embryo and/or gonad tissue/cell stored in centers,

  1. a) Spouses must apply together in writing for the embryo, and the owner of the gonad tissue/cell must apply individually to both centres.
  2. b) Notifying the directorate in writing that the embryo and/or gonad tissue/cell has been delivered and received,
  3. c) All responsibility and fee of the transfer belongs to the requester,

d) Providing the technical equipment and infrastructure for the transfer by the center where the transfer will take place,

  1. d) The tank where the transfer will take place is sealed by the center where the material to be transferred is stored, and the center from which the material is received checks the seal and records that it has been opened by them,

If necessary, it can be transferred to another center in the country.

Evaluation of center applications

ARTICLE 21 - (1) Information collected from centers regarding ART applications is evaluated by the General Directorate.

Training:

ARTICLE 22 - (1) Certified training on assisted reproductive treatment methods specified in this Regulation is given by centers authorized by the Ministry to provide training within the scope of the Ministry's certified training legislation.

(2) (Annex: RG-14/4 / 2018-30391) ART clinical applications certified training program includes gynecology and obstetrics specialist physicians, ART laboratory applications certified training program includes physicians, histology and embryology specialist physicians and those who have completed their doctoral program in the histology and embryology department of medical faculties, Official Official No. 22 dated 5/2014/29007. Healthcare professionals, veterinarians and biologists specified in the Regulation on Job and Job Descriptions of Healthcare Professionals and Other Professionals Working in Healthcare Services published in the Gazette can apply.

Invoicing

ARTICLE 23 - (1) It is mandatory to prepare a sales voucher or invoice for patients treated in the centers in accordance with the relevant legislation. A document showing the detailed breakdown and unit prices of the health services provided to the patient is prepared as an attachment to the sales receipt or invoice.

Information and promotion

ARTICLE 24 - (1) Independent centers cannot engage in behavior that misleads people, misleads people, creates demand, or creates unfair competition against other centers, contrary to the rules of medical deontology and professional ethics, and cannot make promotions of this nature.

(2) Statistical information cannot be published by centers other than scientific publications without the permission of the Ministry. Exaggerated reporting of results and success rates and any activity that leads to misinformation of patients and the public through the use of visual or written media are prohibited.

(3) It is prohibited to advertise through all press and communication tools, even for the purpose of informing, about the ICT practices specified in this Regulation and practices outside the Regulation.

(4) In naming independent centers; In order to avoid people's misperception and confusion, the names of universities and public health institutions or organizations throughout the country, regardless of the province, cannot be used verbatim or in a similar way.

(5) Information and promotional practices and sanctions of centers other than independent centers are carried out in accordance with the relevant legislation.

CHAPTER SIX

Moving of Headquarters, Merger and Change of Ownership, Headquarters

Responsibilities and Other Issues to be Compliant with and Audit

Headquarters relocation, merger and change of ownership

ARTICLE 25 - (1) Detached centers can be moved to another building within the provincial borders where they are located, meeting the physical standards defined in this Regulation.

(2) (Change: RG-25/8 / 2016-29812) Independent centers that are actively operating as of the date of the merger request may merge into a private hospital within the borders of the same province. Merger requests within the province are finalized by the Directorate and the Ministry is informed. An application is made to the Ministry for a merger request with a private hospital outside the province or a request to move out of the province. The application is evaluated within the framework of the principles determined in the Guide to Health Services Requiring Special Planning in Turkey, taking into account the minimum population foreseen for service provision and/or the health services targeted to be provided in the province, and less dense regions in terms of specialist and physician distribution. If the application is deemed appropriate, the Ministry will allow the merger or relocation. The merger or relocation process is completed within two years. During this period, the independent center can continue its activities with its current capacity or stop its activities. In this case, the organization can vacate its building by notifying the notification address to the Directorate. The independent center whose merger process has been completed cannot request separation again.

(3) In case the activity is stopped, action is taken within the scope of the fifth paragraph of Article 26 regarding the samples stored at the center.

(4) For whatever reason, an independent center that is not actively operating as of the transfer request date cannot be transferred. In case of transfer of an active independent center, an application must be made to the directorate with the documents in Annex 2/B. Upon application, a license is issued in the name of the new operator.

  1. a) In case of transfer of the detached center, in cases where there are no deficiencies and/or non-conformances in the last inspection and there is no change in the service areas, the documents in Annex-2/B are evaluated and a license is issued on behalf of the transferee, without the need for repeating the on-site inspection by the Technical Inspection Team.
  2. b) The person who takes over the detached center must apply to the directorate to obtain a license within fifteen business days from the final transfer date. Until a license is issued by the directorate on behalf of the transferee, the independent center can only continue its activities under the responsibility of its former operator and responsible manager.
  3. c) If, despite the transfer, it is determined with documentation during or after the license issuance that no application has been made within fifteen business days, the license issuance process continues on behalf of the transferee. However, following the licensing process, the activities of the independent center are suspended for one day.

d) The transferee is deemed to have assumed the responsibilities of the transferor due to the deficiencies and/or non-conformities detected during the independent center inspection. The period given to the transferor due to deficiencies and/or non-conformities detected during the audit is given again upon the request of the transferee. If the activities of the detached center are stopped, the transferee must wait for the suspension period to be completed.

Responsibilities of the center and other matters it must comply with

ARTICLE 26 - (1) Centers are responsible for the follow-up of patients who become pregnant as a result of ART until birth. In this context, the centers;

  1. a) Ensures that the pregnant woman is followed up by specialist physicians in the hospital she is in, gives birth, and provides adult and newborn care services if necessary.
  2. b) If the pregnant woman resides outside the province where the center is located, she ensures that the pregnant woman is followed up by specialist physicians in a hospital in the province where she resides, gives birth and, if necessary, provides adult and newborn care services.
  3. c) Immediately reports patients who are out of registration at any stage to the directorate.

(2) In order to ensure the follow-up of the applications; Every January, the previous year's work data and pregnancy information are regularly entered into the electronic registration system created by the Ministry, using standard forms determined by the Ministry.

(3) Centers keep the forms and documents required by this Regulation for at least thirty years and send them when requested by the Ministry.

(4) Birth cannot be given in independent centres. However, the centers administratively monitor the outcome of pregnancies resulting from ART and report it to the directorate simultaneously, stating it in their own statistics.

(5) If the operating centers are closed for any reason, the relevant information and documents regarding the patient followed in the center, cryopreserved embryo, gonad tissue or gonad cells shall be notified to the relevant directorate within three days at the latest. The relevant directorate determines the center within the hospital closest to the center and delivers a report to the center to ensure the preservation of the embryo, gonad tissue or gonad cells cryopreserved in the center and to ensure that the procedures are carried out by the designated center in order to prevent the patients from being victimised.

Prohibitions

ARTICLE 27 - (1) Acts and behaviors prohibited in independent centers are stated below.

  1. a) Operation cannot be carried out without obtaining a license/operation permit.
  2. b) Healthcare workers for whom a work certificate is not issued cannot work.
  3. c) Intern students, healthcare workers who are not authorized to work in accordance with the relevant legislation, and foreign healthcare workers who do not have the necessary permits cannot work.

ç) Other works within the company's field of activity cannot be carried out at the center. Centers cannot operate outside their purpose.

  1. d) Units in the center cannot be used by unauthorized persons.
  2. e) The doctor or staff cannot use someone else's stamp under any circumstances.
  3. f) The principles of confidentiality of patient information cannot be violated.

(2) The legislative provisions governing the institution within which the center is located shall apply to the acts and behaviors prohibited in centers other than independent centres.

Sanctions

ARTICLE 28 - (1) The sanctions in Annex-17 are applied to those who do not comply with the procedures and principles specified in this Regulation.

(2) In cases where there is no provision regarding the centres, the sanctions included in the legislation governing the relevant health institution where the application is carried out and the administrative and penal sanctions determined in other relevant legislation are applied.

Audit

ARTICLE 29 - (1) Centers, excluding examinations and investigations made upon complaints and ordinary and extraordinary inspections commissioned by the Ministry or carried out by the Ministry; It is routinely inspected every six months by the directorate teams according to the audit form specified in Annex-18 annexed to this Regulation. The audit team consists of the people with the following qualifications, headed by the relevant deputy manager.

  1. a) The relevant branch officer in the directorate,
  2. b) A gynecologist and obstetrician who is appointed by the Directorate, works in the public sector within the province, and is qualified to be responsible for the ART unit, and a histology and embryology specialist who is qualified to be responsible for the ART laboratory, if any, in the province.

Architects and mechanical engineers may also be included if necessary.

(2) In routine audits carried out by directorates through the audit form, the issues specified in Articles 19 and 26 are examined through randomly selected files and the compliance of these issues with the directorate records is determined.

(3) More than one inspection team can be formed in a province if necessary.

Issues regarding working in centers

ARTICLE 30 - (1) The following provisions apply regarding working in independent centers:

  1. a) In independent centers staff and not responsible(1) (2) Physicians and specialist physicians can work temporarily as non-staff in other private health institutions/centers within the scope of planning in the province where they are located, provided that they comply with Article 1219 of Law No. 12. Those working in private health institutions within the scope of planning and(2) Physicians and specialist physicians who meet the conditions required by this Regulation may work temporarily as non-staff in the centers in the province where they are located, provided that they comply with Article 1219 of Law No. 12. Physicians and specialist physicians as a permanent staff(2)If they leave the institution they work for, they may continue to work temporarily out of staff for a maximum of three months in order not to disrupt the physician's planning. At the end of this period, if the patient cannot start working as a permanent staff in any private health institution/center within the scope of the planning, his non-staff temporary working certificate will be cancelled.
  2. b) Physicians and specialist physicians who have retired due to age limit/lack of employment or who have reached the age limit after retirement, and physicians and specialist physicians who have retired from public institutions and organizations after reaching the age of 60 and who have not reached the age of 65, and those who meet the conditions sought in this Regulation, are subject to this paragraph (a). ) can work temporarily outside the staff in accordance with the working style of the permanent physicians and specialist physicians listed in the paragraph.
  3. c) Non-staff temporary work provisions within the scope of this Regulation are a right for physicians and specialist physicians and do not give an acquired staff right to an independent center. A working certificate is issued by the directorate on behalf of temporary out-of-staff physicians and specialist physicians. Non-staff temporary working days and hours are clearly stated in the contract made with the permanent organization/center. If the physician and specialist physician within the scope of subparagraph (b) of this paragraph wants to leave the center where they work and start working at another center, they are allowed to work in the same way.

ç) Independent centers may employ foreign physicians and non-physician healthcare professionals, provided that permission is given by the Ministry and the conditions required in this Regulation are met. Applications to be made in line with this paragraph are carried out within the framework of the Regulation on the Procedures and Principles of Working for Foreign Healthcare Professionals in Private Healthcare Institutions in Turkey, published in the Official Gazette dated 22/2/2012 and numbered 28212.

(2) Physicians and non-physician health personnel who have resigned from public service and will work in the vacant independent center staff, and physicians and specialist physicians who have left the independent center and will work in public hospitals, must be registered in the province where the institution/organization they will leave is located, thirty days in advance, in order to make plans for the institution/organization they will leave and where they will start. notifies the directorate. Those who do not notify will not be started in their independent central positions. If the planning in the province is done in a shorter period of time, the appointment of physicians and specialist physicians may be allowed before thirty days, with the consent of the directorate.

(3) Provided that they comply with Article 1219 of Law No. 12, physicians who practice their profession independently and have a certificate within the scope of this Regulation can perform the diagnosis and treatment of ART of their patients who apply to their offices in centers that meet the standards specified in this Regulation. In this case, patients are informed that their treatment expenses will be covered by them. In this case, the responsible manager reports to the directorate the number of patients treated in this way and the name of the physician at the end of each month. In addition, detailed invoices are issued to patients treated in this way.

CHAPTER SEVEN

Miscellaneous and Final Provisions

No provision

ARTICLE 31 - (1) In cases where there is no provision in this Regulation, other legislative provisions apply.

Repealed regulation

ARTICLE 32 - (1) The Regulation on Assisted Reproductive Treatment Practices and Assisted Reproductive Treatment Centers published in the Official Gazette dated 6/3/2010 and numbered 27513 has been abolished.

Determination of the status and staff of independent centers

PROVISIONAL ARTICLE 1 - (1) In independent centers that have received an operating permit/license from the Ministry until the date of publication of this Regulation, the staff of gynecologists and obstetricians, histology and embryology specialists, anesthesiologists and reanimation specialists and urologists working full time on the date of publication of this Regulation are considered as center staff. .

(2) Independent centers that have received an operating permit/license from the Ministry until the date of publication of this Regulation continue their activities with their current situation in terms of current building conditions, physical standards and healthcare professionals. In determining their current status, official records as of the date of entry into force of this Regulation are taken as basis and licenses are issued to these centers by the Directorate.

(3) In the inspection of independent centers within the scope of this article, the situation determined in accordance with the second paragraph of this article in terms of building conditions and physical standards is taken as basis.

(4) Relocation requests of independent centers within the scope of this article are evaluated and concluded by the Directorate within the scope of the standards specified in this Regulation.

Protection of acquired rights

PROVISIONAL ARTICLE 2- (Annex: RG-20/7 / 2022-31898)

(1) Rights acquired regarding certified training before the Regulation on Amendments to the Regulation on Assisted Reproductive Treatment Practices and Assisted Reproductive Treatment Centers published in the Official Gazette No. 14 dated 4/2018/30391 are reserved.

Transitional provisions

PROVISIONAL ARTICLE 3- (Added:OG-27/5/2023-32203)

(1) The rights of persons other than histology and embryology specialists who serve as ART laboratory managers on the date of publication of this article continue as long as they work in the same institution.

Force

ARTICLE 33 - (1) This Regulation shall enter into force on the date of its publication.

Executive

ARTICLE 34 - (1) The provisions of this Regulation shall be enforced by the Minister of Health.

________________________

(1)   Fifteenth Chamber of the Council of State dated 26/04/2017 and Docket No: 2014/9572; With the decision numbered: 2017/2051, it was decided to cancel the phrase "not responsible" in subparagraph (c) of the second paragraph of Article 17 and subparagraph (a) of the first paragraph of Article 30 of the Regulation.

(2) Fifteenth Chamber of the Council of State dated 10/10/2018 and Docket No: 2016/9134; With the decision numbered 2018/6847, the phrase "permanent employee and non-responsible" in the first sentence of the first paragraph of Article 30 of the Regulation, the phrase "employee and non-responsible" in the second sentence and the phrase "employee in private health institutions within the scope of planning" in the third sentence are removed. It was decided to cancel the phrase "on permanent basis".

(3) With the decision of the Tenth Chamber of the Council of State dated 31/5/2022 and numbered E.:2022/1700, it was decided to suspend the execution of the phrase "death of one of the spouses" in this sentence due to incomplete regulation.

Official Gazette in which the Regulation was published
Historical Number
30/9/2014 29135
Official Gazettes Where Regulations Amending the Regulations Are Published
Historical Number
1 25/8/2016 29812
2 14/4/2018 30391
3 20/7/2022 31898
4 27/5/2023 32203
Annexes of the Regulation

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