Date of Official Gazette: October 27, 2014 Issue of Official Gazette: 29158
REGULATION ON TRADITIONAL AND COMPLEMENTARY MEDICINE PRACTICES
PART ONE
Objective, Scope, Basis, and Definitions
Objective
ARTICLE 1 – (1) The objective of this Regulation is to identify traditional and complementary medicine practice methods for human health, to arrange training and authorization for the individuals who will apply these methods as well as the working principles and procedures of the healthcare institutions where these methods will be applied.
Scope
ARTICLE 2 – (1) This Regulation hereby covers the healthcare institutions owned by public and private legal persons and by the natural persons and where traditional and complementary medicine practices are performed, and the individuals who will apply the methods in these institutions.
Basis
ARTICLE 3 – (1) This Regulation has been prepared based on Additional Article 13 of the Law on the Practice of Medicine and Medical Sciences no. 1219 dated April 11, 1928; the subparagraph (c) of Article 9 and Additional Article 11 of the Fundamental Law on Healthcare Services no. 3359 dated May 7, 1987; the subparagraphs (f) and (ğ) of the first paragraph of Article 8 and Article 40 of the Decree Law on the Organization and Duties of the Ministry of Health and Its Affiliates no. 663 dated October 11, 2011.
Definitions
ARTICLE 4 – (1) In this Regulation;
a) ‘Ministry’ indicates the Ministry of Health,
b) ‘Science Commission’ indicates the Science Commission on Traditional and Complementary Medicine Practices established by the Ministry,
c) ‘General Directorate’ indicates the General Directorate of Healthcare Services,
ç) ‘Directorate’ indicates the Provincial Directorate of Health,
d) ‘Healthcare institution’ indicates the hospitals affiliated to the public institutions and organizations, health practice and research centres of a faculty of medicine or a faculty of dentistry, private hospitals accredited in accordance with the Regulation on Private Hospitals which has been published in the Official Gazette dated March 27, 2002 and numbered 24708, and the healthcare institutions accredited in accordance with the provisions of the Regulation on Private Health Institutions Performing Outpatient Diagnosis and Treatment which has been published in the Official Gazette dated February 15, 2008 and numbered 26788,
e) ‘Certified physician’ indicates the physician who has a certificate of traditional and complementary medicine practices registered by the Ministry,
f) ‘Certified dentist’ indicates the dentist who has a certificate of traditional and complementary medicine practices registered by the Ministry;
g) ‘Practice’ indicates the traditional and complementary medicine practices;
ğ) ‘Practice centre’ indicates the centre which is established under the responsibility of a physician and/or dentist having a corresponding certificate and within the health practice and research centre of a training and research hospital and a faculty of medicine or a faculty of dentistry in order to perform the practices specified in this Regulation, and can provide training upon the authorization by the Ministry;
h) ‘Unit’ indicates the units which are established under the responsibility of a physician and/or dentist having a corresponding certificate and within the healthcare institution owned by public and private legal persons and by natural persons in order to perform the practices specified in this Regulation.
PART TWO
Science Commission, Its Duties and Working Principles
Establishment of the Science Commission
ARTICLE 5 – (1) A Science Commission on Traditional and Complementary Medicine Practices shall be established by the Ministry in order to receive its opinion on the practices envisaged in this Regulation, the individuals who will perform the practices, and the standards of the units and the practice centres.
(2) The Science Commission shall consist of 11 members as follows:
a) Under the chairmanship of the General Director of Healthcare Services or an authorized person appointed by him/her,
b) The relevant head of department from the General Directorate of Healthcare Services,
c) Three members to be chosen among the university professors having scientific studies in the relevant field or the physicians who are entitled to provide specialization training in the training and research hospitals affiliated to the Public Hospitals Agency of Turkey,
ç) One member from the field of pharmacognosy in the faculties of pharmacy,
d) One member from the field of pharmacology in the faculties of medicine,
e) Two certified physicians,
f) One medical oncologist who is a university professor or a lecturer,
g) One member who has received specialization training or studied for doctorate in the fields of medical ethics or medical history and deontology,
(3) The members of the Science Commission are designated by the Minister. The members serve for a two-year term.
Working Principle of the Science Commission
ARTICLE 6 – (1) The Science Commission convenes at least twice a year upon the invitation of the General Directorate. The Ministry may call a meeting with the Science Commission when necessary.
(2) The Science Commission discusses the agenda and prepares a meeting report. The members shall be informed of the agenda by the General Directorate at least seven days before the meeting.
(3) The Science Commission convenes with at least nine members and decides by absolute majority. In case there is an equality of votes, the Chairman will have a casting vote.
(4) The General Directorate conducts the secretarial works of the Science Commission.
Duties of the Science Commission
ARTICLE 7 – (1) The duties of the Science Commission shall be as follows:
a) To present opinion on determining the fields of practice and on the indications and potential side-effects of the practices,
b) To present opinion on establishing the physical standards, personnel and medical equipment required to be supplied in the units and centres where the practices will be performed,
c) To evaluate the unit and practice centre applications in terms of scientific issues, technical infrastructure and personnel, and to give opinion about their conformity,
ç) To carry out scientific and technical studies with respect to the practices which are not identified in this Regulation,
d) To carry out and make others carry out guiding, enlightening, and scientific studies on the practices,
e) To form sub-commissions in order to carry out studies in the required fields.
PART THREE
Principles of Practice, Types of Healthcare Institutions and Their Working Principles, Training
General Principles of Practices
ARTICLE 8 – (1) The practices shall be limited to the fields set out in this Regulation. The Ministry may, when necessary, request the practices performed and the new practices to be performed in the unit and practice centre to be evaluated by the Science Commission in terms of being scientific. The Science Commission shall present opinion to the Ministry on whether the practices can be applied to people upon reviewing their scientific evidences and which one of those practices deemed appropriate can be performed in the unit and practice centre.
(2) Researches for the practices not included in the appendix of this Regulation can only be conducted in the practice centres within the scope of the Regulation on Clinical Trials of Drugs and Biological Products which has been published in the Official Gazette dated April 13, 2013 and numbered 28617, and a copy of the research files shall be submitted to the General Directorate. The Science Commission shall evaluate the submitted studies in terms of the evidence level, efficiency, and development of the practices throughout the country. It is prohibited to use the submitted data and studies in a way to disclose the personal information without the knowledge of and permission by the person in question.
(3) No practice other than the ones specified in the Appendix-3 can be performed in the units. The practice centre may also perform the practices designated for the unit.
(4) It is prohibited to perform the practices in such a way that they will replace the standard treatment of the disease and will disrupt the ongoing treatment. This fact shall be made clear to the individuals and stated in the informed consent form.
(5) The healthcare professionals who are not physicians and dentists but have completed the basic training in the field of practice shall participate in the practices under the supervision of the certified physicians and dentists.
Place of practice and authorized persons
ARTICLE 9 – (1) The practices can be performed in the units and practice centres authorized by the Ministry by the physicians and dentists (only in the field of dentistry) who have a “certificate of practice” in the relevant field. The healthcare professionals who have completed the basic training in the field of practice may assist the certified physicians during the practice in the units and centres.
(2) Only the practices in the field of dentistry can be performed in the dentistry practice and research centres, dental hospitals, and oral and dental health centres as well as the dental outpatient clinics.
Working principles and procedures of the practice centres and units
ARTICLE 10 – (1) The practice centre or the unit can be opened within the scope of healthcare institution/facility planning of the Ministry; therefore, the corresponding permissions do not constitute an additional entitlement for opening a new private healthcare institution or capacity increase. The healthcare institutions owned by public and private legal persons and by natural persons who intend to open a practice centre or a unit shall apply to the Ministry with the documents stated in the Appendix-1. The applications for opening a practice centre and/or a unit shall be evaluated by the Science Commission in terms of compliance with the standards and whether there is a need for such practice centre and unit in the province of application. Provided that the applications which have been deemed appropriate by the Science Commission are also approved by the Ministry, the permission to open a practice centre and/or a unit shall be granted. The unit and practice centre as well as the practices to be performed there shall be registered to the license or operating permission certificate of the healthcare institution.
(2) A department can be founded, within the scope of planning, for the practices approved by the Ministry on condition that they will be applied to those who stay in the facility and have only received acute treatment in the accommodation facilities licensed by the Ministry of Culture and Tourism. A department can be opened within accommodation facilities, with an exception from planning, by the private hospitals and private health institutions under the Regulation on Private Health Institutions Performing Outpatient Diagnosis and Treatment in the province where the accommodation facility is located, on condition that they use their own staff and capacity. The applications for such departments shall be submitted to the directorate by the director in charge of the private health institution, and the private health institution to which such departments are affiliated shall be responsible for their activities.
(3) A patient file about all the practices performed shall be prepared in the unit and practice centre. In the event that the patient and practice data is requested on an electronic medium, they have to be sent to the Ministry by taking into consideration the privacy of personal health data.
(4) Any undesired effect occurring in the patients related to the performed practices shall be regularly reported to the directorate on a monthly basis and this information shall be submitted to the Ministry.
(5) An “Information and Consent Form” shall be prepared for the practices in accordance with the Regulation on Patient Rights which has been published in the Official Gazette dated August 1, 1998 and numbered 23420 and the consent of all the patients on whom the practice will be performed shall be requested.
Charging
ARTICLE 11 – (1) The fee tariff of healthcare services shall be determined and announced by the Ministry for the practices to be performed by the public healthcare institutions.
Promotion and Information
ARTICLE 12 – (1) The units and practice centres operating under this Regulation have to comply with the information and promotion legislation determined by the Ministry. In case of a breach of the information and promotion provisions determined by the Ministry, the relevant legislation provisions to which the healthcare institution is subject shall be applied.
(2) The legislation provisions on the medical product promotion shall be applied for the promotions of the medical products related to the practices within the scope of this Regulation.
Training
ARTICLE 13 – (1) The certified trainings within the scope of this Regulation shall be provided by the centres which are authorized by the Ministry to provide training under the Regulation on Certified Training of the Ministry of Health which has been published in the Official Gazette dated February 4, 2014 and numbered 28903.
PART FOUR
Compulsory Departments, Medical Equipment and Drugs for Units and Practice Centres at Minimum
Compulsory departments for the units and practice centres at Minimum
ARTICLE 14 – (1) The following departments shall be provided at minimum in the units and practice centres:
a) Examination and practice room of at least 12 square meters surface area where minimum medical materials and equipment required for examination and practice are kept.
b) Patient admissions and waiting room.
c) Archive.
(2) The patient admissions and waiting room and the archive room can be jointly used in the healthcare institutions.
(3) Provided that the units or practice centres within a healthcare institution are established outside the service building of the institution, the areas such as the patient admissions and waiting room, and the archive room shall be arranged according to the minimum physical conditions set out for the healthcare institutions in the Regulation on Private Health Institutions Performing Outpatient Diagnosis and Treatment.
(4) The units and practice centres licensed by the Ministry can perform the practices specified in the Appendix-3 on condition that they receive the required permission from the Ministry. The units and practice centres have to receive permission from the Ministry for each new practice specified in the Appendix-3. The places which will operate within the scope of this Regulation shall supply drugs and equipment compulsory according to the relevant legislation.
Medical equipment and drugs
ARTICLE 15 – (1) The units and practice centres have to supply minimum medical devices, tools, materials and drugs specified in the Appendix-2 as well as the medical devices, tools, materials and drugs required for each practice.
PART FIVE
Audit, Other Requirements, Prohibitions, and Administrative Sanctions
Audit
ARTICLE 16 – (1) The units and practice centres shall be annually audited by the Directorate with a team of at least 3 members including at least one specialist from the internal branches and one specialist from the surgical branches with the exception of complaints, investigations, or extraordinary audits to be conducted by the Ministry. The audit shall be carried out by using the audit form in the Appendix-5. One copy of the form to be drafted in duplicate shall be kept in the institution or organization where the unit or the practice centre is located.
Other requirements and prohibitions
ARTICLE 17 – (1) It is required to comply with the following requirements in the units and practice centres:
a) It is prohibited for the unit and practice centre to deliver service without the permission of the Ministry.
b) The units and practice centres have to incorporate minimum compulsory departments specified in this Regulation and the appendixes hereof.
c) It is prohibited for the units and practice centres to operate beyond their preliminary purpose.
ç) It is prohibited for the unauthorized people to utilize any activity area or department in the unit and practice centre.
d) It is prohibited for the units and practice centres to employ a physician, dentist and other healthcare personnel who do not have a certificate in the relevant field and the required work permit in accordance with the relevant legislation provisions by the Ministry.
e) It is prohibited for the physicians and dentists to practice outside the field for which they have been authorized by a certificate of practice.
Administrative sanctions
ARTICLE 18 – (1) The administrative sanctions in the Appendix-4 shall be imposed on those who do not abide by the principles and procedures specified in this Regulation.
(2) In the absence of provisions regarding the units and practice centres, the administrative sanctions applied to the relevant healthcare institution where the practice will be performed and the other administrative sanctions specified in the relevant legislations shall be applied.
PART SIX
Miscellaneous and Final Provisions
Situations for which there are no provisions
ARTICLE 19 – (1) In the situations for which there are no provisions regarding the physical standards, service delivery, and administrative sanctions of the units and practice centres in this Regulation, other relevant legislation provisions shall be applied.
Annulled regulation
ARTICLE 20 – (1) The Regulation on Private Health Institutions Practicing Acupuncture Treatment and Practice of This Treatment, which has been published in the Official Gazette dated September 17, 2002 and numbered 24879, has been annulled.
Harmonization process for practicing acupuncture
PROVISIONAL ARTICLE 1 – (1) The institutions authorized by the Ministry to practice acupuncture have to comply with this Regulation until January 1, 2016. The authorization certificate of the noncompliant institutions shall be deemed invalid at the end of the given date.
Entry into Force
ARTICLE 21 – (1) This Regulation shall enter into force on the date of publication.
Enforcement
ARTICLE 22 – (1) The provisions of this Regulation shall be enforced by the Minister of Health.
APPENDIX-1
Documents Required for the Application of License to Open a Unit and Practice Centre
- The name or commercial title of the healthcare facility operator and a signed letter of application requesting to start the proceedings related to opening a unit/practice centre
- A list of equipment to be used and of practices to be performed
- A copy certified by the General Directorate of the practice certificate registered by the Ministry for physicians and dentists in relation to their fields of practice
- The training certificate(s) of healthcare professionals to work at the unit/practice centre
- A list of healthcare professionals to work at the unit/practice centre and a statement of their Turkish Republic ID numbers and two photographs
- For private hospitals, the project which is the basis of the license obtained from the Ministry for the centre; for public and university hospitals, the project outlining all the sections and facades of the entire building at a scale of at least 1/100 and three blueprint copies of the floor plans to be certified by their editors and the provincial directorate of environment and urban planning
- The survey report of the General Directorate about the project
- The joint technical report to be complied after the on-site survey by the General Directorate.
APPENDIX-2
Compulsory Equipment for Units and Centres at Minimum |
Examination coach | 1 piece |
Sphygmomanometer | 1 piece |
Stethoscope | 1 piece |
Laryngoscope | 1 piece |
Bag valve mask | 1 piece |
Airway | In various sizes and adequate number of |
Endotracheal tube | In various sizes and adequate number of |
Portable oxygen cylinders | 1 piece |
Oxygen mask | Adequate number of |
Various injectors | Adequate number of |
Intravenous cannula | In various sizes and adequate number of |
Portable lamp | 1 piece |
Mobile aspirator | 1 piece |
Aspiration catheter | Adequate number of |
Compulsory Drugs for Units and Centres at Minimum |
1 | Isoptin ampoule | 3 pieces |
2 | Corticosteroid ampoule | 3 pieces |
3 | Antispasmodic ampoule | 3 pieces |
4 | Polyvinyl pyrrolidine iodine solution 500cc. | 1 piece |
5 | 5% dextrose 500cc. | 2 pieces |
6 | 0,9% Sodium Chloride (NaCl) 500cc. | 2 pieces |
7 | 20% mannitol 500cc. | 2 pieces |
8 | 1/3 Isodex solution (3.3% dextrose＋0.3% NaCl) 500cc. | 1 piece |
9 | Adrenaline 1 mg | 5 ampoules |
10 | Atropine sulphate 0,5 mg | 5 ampoules |
11 | Dopamine | 2 ampoules |
12 | Lidocaine 2% | 2 ampoules |
13 | Antihistaminic | 5 ampoules |
14 | Aminophylline | 2 ampoules |
15 | Diazepam | 2 ampoules |
16 | Oral antihypertensive (CAPTOPRIL) | 1 ampoule |
17 | Diuretic | 5 ampoules |
APPENDIX-3
List of Practices Permitted in Units and Practice Centres
1) ACUPUNCTURE
a) Definition: It refers to a practice performed by stimulating the specific points on the body through such stimulation methods as needle, laser beams, electrical stimulation, cupping therapy, needle and magnetic pellets, thermic stimulation, acupressure and sound or electrical or magnetic vibration.
b) Personnel authorized to practice: A certified physician who has received acupuncture practice training or a certified dentist to practice in his/her own field.
c) Practicable for: Acupuncture is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Musculoskeletal mechanic pains
- Arthralgia
- Migraine and other tension-type and non-organic headaches
- Toothaches
- Neuropathic pains
- Muscle spasm, acute conservative herniated disc and chronic low back pains
- Nausea and vomiting induced by pregnancy, the side effects of drugs and motion sickness
- Functional gastrointestinal disturbances; constipation, motility disorders, reflux
- Allergic rhinitis symptoms
- Dysmenorrhea, infertility, polycystic ovarian syndrome and premenstrual syndrome, labour pain
- Extrinsic sleep disorder
- Dietary compliance of a patient diagnosed with exogenous obesity
- Itching induced by allergy, eczema and skin dehydration
- Anxiety occurred during smoking cessation
- Anxiety
- Non-organic nocturnal enuresis
- Nausea, vomiting, pain and xerostomia induced by chemotherapy and radiotherapy
- Non-organic vertigo
- Geriatric patients
- Raising the quality of daily life for patients with chronic respiratory disorders
- Helping people to provide and sustain general well-being.
In Practice Centres:
- Nerve root irritations with no progressive neurological deficit and no cauda equina syndrome detected
- Relieving distresses to be occurred during the treatment of alcohol addiction
- Paediatric respiratory distress after extubation
- Enhancing the patient’s compliance to treatment in chronic eye diseases
- Raising the quality of life for patients with dysmnesia and memory troubles
- Attention deficit and hyperactivity disorders
- Xerophthalmia induced by idiopathic and Sjögren’s syndrome
- Muscle contractures or weakness in stroke-induced hemiplegia.
d) Impracticable for: Acupuncture cannot be applied on patients with bleeding diathesis, on lower abdomen during the first trimester of pregnancy, on upper abdomen and lumbosacral regions during the second and third trimesters, on the pregnant woman’s body points with intense stimulus and in case of emergency. The Ministry can impose additional prohibitions after consulting the Science Commission in the case of unforeseen conditions arising out of practices and researches.
e) Compulsory Equipment: Sterile disposable steel needle.
f) Elective Equipment: Electro-acupuncture, ear and body detector, laser acupuncture device, silver and golden needles.
2) APITHERAPY
a) Definition: Apitherapy is a practice performed by using bees and bee products as a complementary and supportive method in the treatment of some diseases.
For bee venom, the following items are used:
- Living honey bees
- Ampoules containing extracts of bee venom
- Ointments containing bee venom
Bee venom is used in an intradermal and subcutaneous way, while other bee products are applied orally and topically. Orally applied bee products are chemically analysed and they must abide by the Turkish Food Codex Regulation which was published in Official Gazette dated 29/12/2011 with 3rd reiterated number 28157.
It is tested before practicing apitherapy if the client is allergic to bee venom and bee products. It is compulsory to supply a life support unit and authorized personnel to perform medical intervention for emergency cases in the workspace.
b) Personnel authorized to practice: Certified physician.
c) Practicable for: Apitherapy is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Honey, pollen, bee resin and royal jelly can be used to support the immune system in cases of immune deficiency.
In Practice Centres
- Bee venom can be used to help reduce such symptoms as musculoskeletal pain, erythema and tenderness and boost muscular force in cases of muscle contraction in legs and muscle weakness.
- Honey can be used topically to support healing chronic skin wounds.
d) Impracticable for: Apitherapy cannot be applied on clients allergic to bees and bee products and on children, namely no bee venom on children aged under 18 and no other bee products on infants aged under 1. Bee venom cannot be used in cases of decompensated heart failure, renal failure, respiratory failure, systemic/local infections, liver dysfunction, beta blocker intake, severe psychiatric disorders affecting the compliance to treatment, right before and right after meals and on pregnant women and nursing mothers. The Ministry can impose additional prohibitions after consulting the Science Commission in the case of unforeseen conditions arising out of practices and researches.
e) Compulsory Equipment: Living bees and bee products, medical dressing sets, light source, sterilizer, defibrillator-compressed nebulizer or atomizer fit for oxygen cylinder, large-lumen catheters, medical kits required for establishing large vascular access, 3 pieces of H2 receptor blocker, 3 nebulas of aerosol beta-2 agonist.
3) PHYTOTHERAPY
a) Definition: Phytotherapy is a method of medical treatment administered by using traditional herbal medical products and herbal drugs.
It can be practiced upon the suggestion of a certified physician within the term of the licence of phytotherapy products in accordance with their indications specified by receiving the consent of the Science Commission. Issues relating to licensing and selling medical products and herbal drugs to be used within the scope of phytotherapy shall be regulated by the Turkish Medicines and Medical Devices Agency.
b) Personnel authorized to practice: Certified physician and dentist.
4) HYPNOSIS
a) Definition: Hypnosis is a practice designed for or resulted in bringing about a change in the consciousness and awareness, body, emotions, feelings, opinions, memory or behaviours of a person through suggestion.
b) Personnel authorized to practice: Certified physicians and dentists, and clinical psychologists and other psychologists who have a certificate of authority to conduct psychological medical interventions (all psychologists have to work under physician supervision).
c) Practicable for: Hypnosis is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Overcoming preoperational anxiety and coping with fears and pains
- Overcoming postoperative pain, nausea, vomiting and anxiety
- Relieving intraoperative pain and anxiety
- During all diagnostic and interventional procedures
- Quelling anxiety and enhancing the compliance to treatment in emergency medicine
- During infertility treatments
- During pregnancy and delivery and in gynaecological diseases
- Obesity
- Eating disorders
- Smoking cessation
- Treatment of alcohol addiction (can only be practised by a psychiatrist)
- Depression (can only be practised by a psychiatrist)
- Anxiety and stress disorders
- Extrinsic sleep disorders
- Non-organic sexual dysfunctions
- Functional bowel disorders
- Acute and chronic pains
- In dentistry for dealing with phobias, pains, bruxism (teeth grinding), temporomandibular joint dysfunction, trigeminal neuralgia and intraoral problems and for helping anaesthesia and compliance to treatment & dental prosthesis
- Such non-organic types of itching as atopic dermatitis, seborrheic dermatitis and urticaria
- Allergic rhinitis, allergic asthma
- Enhancing the immune system.
In Practice Centres:
- Relieving pain and anxiety in burn treatment
- During delivery
- Intraoperative pains and in anaesthetizing
- Coping with pains, vomiting, anxiety and side effects of drugs for cancer patients.
d) Impracticable for: Hypnosis cannot be applied on patients with schizophrenia, psychopathic problems, alcohol or drug intoxication and dementia and on clinically depressive persons with suicidality (except for psychiatrists). The Ministry can impose additional prohibitions after consulting the Science Commission in the case of unforeseen conditions arising out of practices and researches.
5) LEECH THERAPY (HIRUDOTHERAPY)
a) Definition: It is a practice performed by using sterilized leeches. It is stipulated to provide the “medicinal leeches” called “Hirudo medicinalis” and “Hirudo verbena”, which will be used in the therapy, from the place of manufacture and businesses procuring sterilized leeches. The eradication procedure of leeches shall be applied in accordance with the Medical Waste Control Regulation which was published in Official Gazette dated 22/07/2005 with the number 25883.
b) Personnel authorized to practice: Certified physician and healthcare professional under physician supervision.
c) Practicable for: Leech therapy is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly. ,
In Units:
- Degenerative joint diseases (osteoarthritis)
- Relieving pain in varicose veins of lower extremity
- Relieving pain in such diseases as lateral epicondylitis.
In Practice Centres:
- Venous insufficiencies after flap surgery and after replantation and revascularization.
d) Impracticable for: Leech therapy cannot be applied on children (aged under 18), during chemotherapy and radiotherapy, before surgical operations, and in cases of haemorrhagic diathesis (like haemophilia), the presence of active focal bleeding points, severe anaemia, anticoagulant intakes, pregnancy and breastfeeding, allergy against leeches or other creatures, severe psychiatric disturbances which affect compliance to treatment, leukaemia, bone marrow suppression, gastrointestinal bleeding, cancer, cirrhosis of the liver, dialysis patients, the presence of cardiac pacemakers, menstrual cycle and infection (HIV positivity, etc.). The Ministry can impose additional prohibitions after consulting the Science Commission in the case of unforeseen conditions arising out of practices and researches.
e) Compulsory Equipment: Sterilized leech, water distiller, and sterilizer, sterilized distilled water (for bathing leeches after pre-use sterilization), sterilized jars in which the leech stock will be kept and capped jars for transporting leeches during usage.
6) HOMOEOPATHY
a) Definition: Homoeopathy is a kind of holistic practice method aiming to improve the health status through the homeopathic medicines exclusively selected for a person.
Issues regarding the licensing and sale of medicines to be used in the homeopathy practice shall be regulated by the Turkish Medicines and Medical Devices Agency.
b) Personnel authorised to practice: Certified physician and dentist.
c) Practicable for:
In Units:
- Non-organic headaches such as tension-type headache and migraine headache
- Strengthening the immune system
- Non-organic insomnia
- Chronic fatigue syndrome, fibromyalgia, irritable bowel syndrome
- Eczema, allergic asthma, allergic rhinitis
- Such cases as arthritis, chronic pain, xerostomia etc. which are induced by rheumatic diseases
- Such cases as nasal discharge, nasal congestion, coughing, fever, difficulty swallowing (dysphagia), stomatitis etc. which are induced by respiratory tract diseases
- Such cases as nausea, vomiting, stomatitis, xerostomia etc., which are the side effects of chemotherapy
- Supporting the treatment of those diagnosed with attention deficit and hyperactivity
- Gastro-oesophageal Reflux induced by digestive system diseases, gastritis-related stomach ache and heartburn, and such cases as nausea, vomiting, diarrhoea etc.
- Premenstrual syndrome, dysmenorrhoea, infertility
- Postoperative hematoma of varicose veins and alleviating pain etc.
- Mechanical pain of musculoskeletal system
- Toothache.
In Practice Centres:
- Urolithiasis pain
- Labour pain
- Nerve root irritation
- Supporting children during the perioperative period
- Supporting addiction treatment
- Reducing the side effects of chemotherapy and radiotherapy such as nausea, vomiting, pain, xerostomia, anxiety, radio-dermatitis
- Reducing the complaints of postoperative pain, agitation, oedema, wound healing
- Shortening the recovery process of traumas
- Anxiety.
d) Impracticable for: It can only be used for palliative purposes in serious and chronic diseases such as cancer. It can only be used as a supportive method in case of physical trauma and injury. The Ministry can impose additional prohibitions after consulting the Science Commission in case of unforeseen conditions arising out of practices and research.
7) CHIROPRACTIC
a) Definition: Chiropractic is a supportive field of practice that focuses on the biomechanical disorders of muscular, spinal and skeletal systems and the prevention of the problems on nervous system caused by these disorders. It focuses on fixing the joints of eligible patients, which have lost their normal mechanical mobility, through manual techniques.
b) Personnel authorised to practice: Certified physician and certified health professional under physician supervision.
c) Practicable for: Chiropractic is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Acute and chronic neck pain and lumbar pain
- Chronic headache induced by cervical region
- Sudden flexion/extension injury-related pains
- Early conservative treatment of lumbar spinal stenosis
- Acute and chronic soft tissue injuries
- Myofascial pain syndrome
- Occupational and sports-related recreational musculoskeletal injuries
- Musculoskeletal injury problems of geriatric age group such as osteoarthritis etc.
- Biomechanical dysfunctions caused by mechanical facet joint
- Coccyx pain
- Postural scoliosis
- Nerve root irritation without progressive motor deficit and cauda equine syndrome
- Shoulder, sacroiliac joint, temporomandibular joint, hip, knee, wrist, ankle joint dysfunctions.
In Practice Centres:
- If there is a need for sedation or anaesthesia during chiropractic intervention, it is appropriate to carry out these practices in practice centres.
d) Impracticable for: Chiropractic is impracticable for odontoid hypoplasia, unstable odontoid, acute fracture, spinal cord tumour, osteomyelitis, hematoma (spinal cord or intracanalicular), meningeal tumour, vertebral tumour, progressive neurological deficit with fragmented herniated disc, Arnold-Chiari malformation of upper cervical spine, vertebral luxation, aneurismal bone cyst, giant cell tumour of bone, osteoblastoma, osteoid osteoma, postoperative fixation/stabilization prosthesis, neoplastic diseases of muscles or other soft tissues, positive Kerning’s or Lhermitte's signs, syringomyelia, aetiology, unknown hydrocephalus, cauda equina etc. The Ministry can impose additional prohibitions after consulting the Science Commission in case of unforeseen conditions arising out of practices and research.
e) Compulsory Equipment: It is required for practice units and training centres to provide an appropriate treatment couch for the standard chiropractic manipulation.
f) Elective Equipment: Units and practice centres may utilize tilt or drop couches for different manipulative practices, electrical or manual pushing device for mechanical fixing, and superficial EMG or superficial temperature measuring devices for analysis.
8) CUPPING THERAPY
a) Definition: It refers to theDry Cupping Therapy based on creating local suction to mobilize the blood flow and the Wet Cupping Therapy (Hijama) in which blood is taken by scratching the skin superficially as well as creating local suction on specific body points.
b) Personnel Authorised to Practice: Certified physician, dentist and health professional under physician supervision.
c) Practicable for: Cupping practice is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Strengthening the immune system of patients who are not diagnosed with any kind of organic disorders
- Fibromyalgia syndrome
- Such cases as chronic pain, limitation of joint mobility, morning stiffness, fatigue etc. which are induced by rheumatic diseases
- Mechanical pains of musculoskeletal system
- Knee pain (osteoarthritis etc.)
- Non-organic headaches such as migraine headache and tension-type headache
- Such cases as nausea, vomiting, constipation etc. which are induced by digestive system diseases.
In Practice Centres:
- Neuralgia-induced pains
- Such cases as hiccup, fatigue and aphasia which are induced by stroke.
d) Impracticable for: Cupping therapy cannot be applied directly on varicose and in cases of thrombophlebitis, active wounds, surgical wounds, decompensated heart failure, anaemia (haemoglobin<9,5mg/dl), haemophilia, history of haemorrhage/coagulopathy and antiplatelet drug intake. The Ministry can impose additional prohibitions after consulting the Science Commission in case of unforeseen conditions arising out of practices and research.
e) Compulsory Equipment: Disposable cupping set, sharp object to make an epidermal incision, single-use medical gloves, examination bed appropriate for the practice, solutions which can be used to clean the practice zone. Cupping sets can be made of plastic, glass, silicone and they can be electrical, manual or pulsatile.
9) MAGGOT THERAPHY
a) Definition: It involvesthe use of sterile maggots of Lucilia (Phaenicia) Sericata in case of chronic wounds for bio-debridement purposes.
Fundamental Principles:
Within the scope of Maggot Therapy; Lucilia seritica fly, which isthe required material for the practice, shall be reproduced continuously according to the following standards:
- Within the scope of Maggot Therapy; a “climate chamber” of 12 square metersshould be set up to provide conditions under which the adult colonies of Lucilia seritica fly will be continuously reproduced in fly cages at the laboratory. To that end, a temperature of 24-27°C and a humidity of 40-60% should be maintained, and a specific lighting system should be set up in the Climate Chamber.
- Fly colonies and egg, larvae, pupa and adult of Lucilia seritica fly, which are suitable for the lifecycle of Lucilia seritica fly, should be reproduced in the climate chamber.
- There should also be a functional laboratory of about 20 square meters which contains incubator, sterilizer, laminar workbench and light microscope devices required for larvae reproduction, sterilization and independent microbiological analysis (if to be performed) to develop sterile packages.
b) Personnel Authorised to Practice: Certified Physician
c) Practicable for: Maggot therapyis used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Diabetic foot ulcer
- Venous stasis ulcers
In Practice Centres:
- Neuropathic foot ulcers which are not induced by diabetes
- Decubitus ulcer
- Traumatic non-healing wounds
- Arterial/ischemic ulcer
- Postoperative wounds
- Osteomyelitis
- Necrotizing fasciitis
d) Impracticable for: It cannot be applied on the head region, respiratory system and internal organs, endocrine glands, fistulas linked to the vital organs and haemorrhagic abscesses, and in cases of allergy against insects and a significant level of coagulopathy. The Ministry can impose additional prohibitions after consulting the Science Commission in case of unforeseen conditions arising out of practices and research.
e) Compulsory Equipment: Sterilized maggots
10) MESOTHERAPY
a) Definition: It refers to the intradermal injection of pharmacological or herbal medicines topically and in small doses using special needles and special techniques so as to heal the organ pathologies induced by mesoderm. No-needle mesotherapy is the intradermal administration of the product through the electroporation method without using needle.
b) Personnel Authorized to Practice: Certified physician and dentist
c) Practicable for: Mesotherapy is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Trigeminal neuralgia, cervicobrachial neuralgias
- Pain, stiffness, swelling and limitation of movement after joint degeneration
- Pain, erythema and limitation of movement induced by connective tissue pathology, hydro-lipodystrophy (non-inflammatory cellulite)
- Pain, erythema and limitation of movement in acute and chronic soft tissue injuries
- Myofascial pain syndrome
- Migraine headache
- Supporting oedema induced by microcirculatory disorders
- Supporting the treatment of skin pathologies such as keloid, alopecia, acne etc.
- Pains induced by spasmodic pathologies
- Strengthening the immune system
- Soft-tissue sports injuries.
In Practice Centres:
- Joint pathologies such as arthritis, rheumatoid polyarthritis, acute rheumatism etc.
- Arthritis, microcirculatory problems, gynaecology and birth-related vascular pathologies
- Supporting general rehabilitation practices for diseases such as hypertension, hemiplegia, cerebral palsy etc.
d) Impracticable for: It cannot be applied on patients under anticoagulant treatment, drug-sensitive patients and pregnant women, and in cases of acute infections, deep vein thrombosis, unstable blood pressure, heart attack, episode after syncope, open wounds, end stage heart failure, diabetes mellitus and renal failure. The Ministry can impose additional prohibitions after consulting the Science Commission in case of unforeseen conditions arising out of practices and research.
e)Compulsory Equipment: Sterile disposable mesotherapy needles, injectors and gloves.
f) Elective Equipment: Mesotherapy guns,transdermal administration (no-needle mesotherapy) device, treatment couch.
11) PROLOTHERAPY
a) Definition: It refers to the injection of proliferative and irritant solutions into joint-connective tissue. Injections are generally administered into impaired, worn and weakened tendons, ligaments and joints. Specific drug mixes are topically administered with special injectors and techniques.
b) Personnel Authorized to Practice: Certified physician and dentist.
c) Practicable for: Prolotherapy is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Pain and swelling associated with sutural ligament laxity
- Partial tendon injuries and overuse syndrome
- Recurrent headache, backache, neck pain and lumber pain
- Muscle and ligament-induced chronic pains in spine, rib cage and ribs
- Migraine pains and myofascial pains
- Heel spur, plantar fasciitis pain, swelling and functional disorders,
- Soft tissue sports injuries
- Partial tears associated with muscle and ligament injuries
In Practice Centres:
- Inflammatory joint disorders, arteritis, microcirculation problems.
d) Impracticable for: It cannot be applied on patients with haemophilia, mental retardation, haemorrhagic disorder, deep vein thrombosis, unstable blood pressure, heart attack, epilepsy, open wounds, end stage heart failure, diabetes mellitus, anticoagulant treatment, renal failure, and excessive drug sensitivity. The Ministry can impose additional prohibitions after consulting the Science Commission in the case of unforeseen conditions arising out of practices and research.
e) Compulsory Equipment: Sterile disposable syringes, injector, gloves, proliferative solutions, local anaesthesia and examination couch.
12) OSTEOPATHY
a) Definition: It is a non-invasive complementary medicine practice on the efficiency of the musculoskeletal system in diseases, which focuses on total body health and helps strengthen the musculoskeletal system composed of joints, muscles, connective tissues and the spine.
b) Personnel Authorized to Practice: Certified physician, dentist and certified health professional under physician supervision.
c) Practicable for: Osteopathy is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Movement and functional disorders of spine and musculoskeletal system
- Acute and chronic pain syndromes of spine and bone-joint system
- Spinal slipped disc
- Ischialgia, brachial neuralgia, sciatica, discopathic pains.
- Joint stiffness and degeneration
- Migraine, stress-related headaches
- Postural defects
- Post-operative outpatient rehabilitation
- Post-accident pain syndromes
- Neuromuscular problems such as spasticity, cerebral palsy
- Coordination and psychomotor functional disorders in children
- Psychosomatic syndromes, anxiety, depression
- Supporting chronic neurologic diseases (Alzheimer’s disease and Multiple Sclerosis)
- Sleep disorders
- Functional disorders of the digestive system, urinary system, urogenital, respiratory and circulatory systems
In Practice centres:
- Ailments associated with viscero-somatic functional disorders
- Pain syndromes in pregnant women
- Supporting hormonal balance disorders
d) Impracticable for: Rejection of the practice due to pain, haemorrhage, prolonged haemorrhage, anticoagulant intake, acute haemorrhage/coagulopathy, haemophilia, internal fixation, presence of a total joint prosthesis; and tumour, metastatic disease, suppurative arthritis, osteomyelitis, septic arthritis, bone tuberculosis, early period in fractures, acute hematoma, Down syndrome and acute psychosis all of which can cause bone joint instability. The Ministry can impose additional prohibitions after consulting the Science Commission in the case of unforeseen conditions arising out of practices and research.
e) Compulsory Equipment: A proper treatment couch for osteopathy practice.
13) OZONE THERAPY
a) Definition: It is a practice which uses ozone-oxygen mixture topically or systemically.
Practice Methods:
- Major Autohemotherapy: The blood of the patient with an amount between 50 and 100 cc is mixed with medical ozone proportionally under normobaric conditions in a sterile environment out of the body and transfused into the patient.
- Minor Autohemotherapy: The blood of the patient with an amount between 2 and 10 cc is mixed with medical ozone in sterile conditions out of the body and injected into patient intramuscularly.
- Rectal or vaginal insufflation: The practice of giving the patient medical ozone rectally or vaginally.
- Bagging method: The procedure of applying medical ozone to extremities such as arm and leg by delivering it exteriorly in a special bag.
- Intradiscal practice: The practice of applying ozone directly into intervertebral discs by specialist doctors in company with visualization techniques in sterile conditions (C-arm scopy, fluoroscopy)
- Musculoskeletal system practices: It includes the intradermal, intramuscular, subcutaneous and intra-articular applications of medical ozone with the injection method in cases of muscle, tendon, tendon sheath, ligament, spinal, intra-articular and peri-articular problems.
b) Personnel Authorized to Practice: Certified physician and dentist
c) Practicable for: Ozone therapy is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Joint, tendon and ligament injuries
- Referred pain associated with vertebrae and disc pathologies (paravertebral injection)
- Myofascial pain, fibromyalgia
- Diabetic wounds (upon the referral of a relevant specialist)
- Gingivitis, periodontitis
In Practice Centres:
- Neuropathic pain
- Vertebral disc pathologies (intradiscal injection under scopy)
- Infected diabetic wounds
- Extremity wounds with critical ischemia for which revascularization is not practicable
Minor autohemotherapy, major autohemotherapy, rectal applications, intra-articular injections and trigger point tendon sheath injections can also be performed in unit conditions. Medical ozone applications can be performed either single-handedly or as an additional method for standard treatments.
d) Impracticable for: Intravascular injection of ozone in gas form is not performed as it may cause death as a result of air embolism. Ozone therapy cannot be performed in cases of Glucose-6-phosphate dehydrogenase deficiency, Basedow Graves-type uncontrolled hyperthyroidism, massive bleeding, malignant hypertension and serious thrombocytopenia (<50000/mm3). The Ministry can impose additional prohibitions after consulting the Science Commission in the case of unforeseen conditions arising out of practices and research.
e) Compulsory Equipment: Ozone generator, Ozone sensor.
14) REFLEXOLOGY
a) Definition: It is based on the principle of the presence of directive reflex areas of all parts, organs and glands of the body in hands, feet soles and ears. Only pressure is applied to those reflex areas without using any device, material, cream and lotion. Reflexology does not cover diagnosis, treatment, or joint mobilization and manipulation of specific diseases.
b) Personnel Authorized to Practice: Certified physician and certified health professional under physician supervision.
c) Practicable for: Reflexology is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Stress, anxiety
- Irritable Bowel Syndrome
- Strengthening the immune system in people with no identified organic disorder
- Nausea, vomiting and constipation associated with digestive system diseases
- Mechanic musculoskeletal system pains
- Non-organic headaches such as migraine and tension-type
- Supporting asthma treatment by relieving anxiety
- Extrinsic sleep disorders
- Supporting urinary incontinence induced by hyperactive detrusor muscle
In Practice Centres:
- Supporting the treatments of anxiety disorders and panic attack
- Supporting general rehabilitation practices in neurological diseases such as hemiplegia, cerebral palsy and multiple sclerosis
- Supporting to mitigate adverse effects such as pain, nausea and vomiting associated with cancer and chemotherapy
- Relieving labour pains
d) Impracticable for: Reflexology cannot be practiced in cases of the history of acute infections, inflammatory diseases, active gout arthritis of the foot, deep vein thrombosis, uncontrollable blood pressure, heart attack, cardiac pacemaker, post-syncope episode, acute surgical conditions, gallbladder and kidney stone, open and closed wounds on the application area, and the first trimester of pregnancy. The Ministry can impose additional prohibitions after consulting the Science Commission in the case of unforeseen conditions arising out of practices and research.
15) MUSIC THERAPY
a) Definition: The practice in which music and musical practices are used by a licensed professional in music therapy in a clinical and evidence-based manner to meet the physical, psychological, social, and mental needs of individuals.
b) Personnel Authorized to Practice: Certified physician, certified health professional under physician supervision and assisting persons who have completed a certification programme in music therapy after receiving at least a bachelor degree in musical education.
c) Practicable for: Music therapy is used as a supportive therapeutic method in case of the following phenomena and other potentially related fields. It cannot be asserted that it will clear up or treat the disease single-handedly.
In Units:
- Anxiety disorder and stress disorders
- Social phobias
- Personality disorders
- Increasing the attention levels, facilitating the learning process and raising the awareness of their surroundings in autistic patients
- Facilitating the learning process and improving the communication with their surroundings in patients with mental retardation
- Anxiolytic practices and enhancing the compliance to treatment
- Acute and chronic pain
- Supporting rehabilitation practices in chronic organic diseases such as Multiple Sclerosis and Parkinson’s
- Supporting the rehabilitation of paralytic patients
In Practice Centres:
- Reducing pain and anxiety in burn treatments.
- Reducing pain and anxiety in Intensive Care Units.
- Reducing pain and anxiety during the labour.
- Reducing preoperative anxiety and postoperative pain.
- Coping with pain, vomiting, anxiety, and the side effects of drugs in cancer patients.
d) Elective Equipment: Musical and rhythmic instruments.
APPENDIX-4
SANCTION FORM |
Item No. | Subject | Sanctions |
1st Finding | 2nd Finding | 3rd Finding |
1 | In compliance with this Regulation, the operation of the relevant entity shall be suspended by the Governorate and a criminal complaint shall be filed in the Public Prosecution Office against persons in the case that services are provided without being granted a licence and a certificate of operation or a certificate of conformity. |
2 | In case of determining that medical operations regarded as crime by the laws of the Republic of Turkey are being performed, | The operation of the unit or the centre shall be suspended for three months. | The license of the unit or the centre shall be cancelled. |
3 | In case of violating the third paragraph of Article 8, | A criminal complaint shall be filed in the Public Prosecution Office against those concerned. The unit or the centre shall be warned. | A criminal complaint shall be filed in the Public Prosecution Office against those concerned. The operation of the unit or the practice centre shall be suspended for three days. | A criminal complaint shall be filed in the Public Prosecution Office against those concerned. The operation of the unit or the practice centre shall be suspended for ten days. |
4 | In case of violating the second paragraph of Article 9, the fourth paragraph of Article 8, | A criminal complaint shall be filed in the Public Prosecution Office against those concerned. The unit or the centre shall be warned. | A criminal complaint shall be filed in the Public Prosecution Office against those concerned. The operation of the unit or the practice centre shall be suspended for three days. | A criminal complaint shall be filed in the Public Prosecution Office against those concerned. The operation of the unit or the practice centre shall be suspended for ten days. |
5 | In case of violating the third, fourth, and fifth paragraphs of Article 10, | The unit or the centre shall be warned. | The unit or the centre shall be warned. | An administrative fine at the rate of one percent of the gross service revenue of the previous month shall be imposed. The fine shall be doubled upon the fourth finding. Upon the fifth finding, the operation of the unit or the practice centre shall be suspended for one day. |
6 | In case of violating the provisions of Article 15, | An administrative fine at the rate of one per thousand of the gross service revenue of the previous month shall be imposed. In addition, 15 days shall be granted in order to remedy the deficiency. | An administrative fine at the rate of two per thousand of the gross service revenue of the previous month shall be imposed.In addition, 15 days shall be granted in order to remedy the deficiency. | The operation of the unit or the practice centre shall be suspended for one day. |
7 | In case of violating the subparagraph (b) of the first paragraph of Article 17, | An administrative fine at the rate of one per thousand of the gross service revenue of the previous month shall be imposed. In addition, fifteen days shall be granted in order to make necessary arrangements. | An administrative fine at the rate of two per thousand of the gross service revenue of the previous month shall be imposed. In addition, 15 days shall be granted in order to make necessary arrangements. | The operation of the unit or the practice centre shall be suspended for seven days. |
8 | In case of violating the subparagraph (c) of the first paragraph of Article 17, | An administrative fine at the rate of three per thousand of the gross service revenue of the previous month shall be imposed. In addition, fifteen days shall be granted in order to make necessary arrangements. | An administrative fine at the rate of six per thousand of the gross service revenue of the previous month shall be imposed. In addition, fifteen days shall be granted in order to make necessary arrangements. | The operation of the unit or the practice centre shall be suspended for five days.In addition, fifteen days shall be granted to in order to make necessary arrangements. |
9 | In case of violating the subparagraph (ç) of the first paragraph of Article 17, | An administrative fine at the rate of three per thousand of the gross service revenue of the previous month of the unit or the centre shall be imposed. Within this scope, in case of determining that unauthorized healthcare service is provided, its operation shall be suspended for one month. In addition, a criminal complaint shall be filed in the Public Prosecution Office. | An administrative fine at the rate of six per thousand of the gross service revenue of the previous month of the unit or the centre shall be imposed. Within this scope, in case of determining that unauthorized healthcare service is provided, its operation shall be suspended for one month. In addition, a criminal complaint shall be filed in the Public Prosecution Office. | The operation of the unit or the centre shall be suspended for five days.Within this scope, in case of determining that unauthorized healthcare service is provided, its operation shall be suspended for one month. In addition, a criminal complaint shall be filed in the Public Prosecution Office. |
10 | In case of violating the subparagraph (d) of the first paragraph of Article 17, | The operation of the centre shall be suspended for ten days by the Governorate with the approval of the Ministry and a criminal complaint shall be filed in the Public Prosecution Office against persons. | The operation of the centre shall be suspended for three months. | The certificate of operation of the centre shall be revoked. |
11 | In case of violating the subparagraph (e) of the first paragraph of Article 17, | A criminal complaint shall be filed in the Public Prosecution Office against those concerned. The unit or the centre shall be warned. | A criminal complaint shall be filed in the Public Prosecution Office against those concerned. The operation of the unit or the practice centre shall be suspended for three days. | A criminal complaint shall be filed in the Public Prosecution Office against those concerned. The operation of the unit or the practice centre shall be suspended for ten days. |
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Remarks:
(1) In this regulation, among the sanctions suggested for each article, administrative fines shall be applied separately and the sanction of activity suspension shall be applied for the longest period of time, in case of more than one conflicting article at the same date.
(2) The sanction of activity suspension shall take effect as of only working days (weekends and official holidays excluded). The written statement disclosing the grounds for suspending the activities of the unit or practice centre shall be hanged on the entrance of the health institution and be maintained there until the termination date of the penalty.
(3) The administrative sanctions specified in the second and third finding columns of the sanction form shall be imposed upon the second or third recurrence of the actions that require such sanctions within one year. The calculation of the one-year period is based on the calendar year.
(4) For the calculation of administrative fines, the monthly gross service revenue of the unit and practice centre shall be taken as basis for the units and practice centres established within a university’s practice research centre and a training &research hospital while the monthly gross service revenue of the health institution shall be taken as basis for other units which are located within that health institution; the monthly gross service revenue taken into consideration in both cases is the one earned in the month before the action which constituted the basis for such an administrative fine was committed.
(5) In case that the health institution is not active for the previous month, which is taken as basis for the calculation of administrative fines, or for a longer period of time, the gross service revenue of the health institution in the last operating month before its activities were suspended shall be taken as basis.
(6) An approved statement of income shall be requested by the Directorate from the relevant institution for determining the monthly gross service revenues.
(7) In case that some circumstances emerge which are thought to adversely affect the health of the community or those who receive health services, the activities of the units and practice centre shall provisionally be suspended by the Governorship until such circumstances are removed, and the Ministry shall be notified in respect thereof.
(8) With regard to the actions in this article that require administrative fines, Governors are entitled to impose administrative fines, and the Ministry of Health is entitled to inflict the penalty of suspension of activities arising out of repetition due to the regulations on administrative fines.
APPENDIX-5
TRADITIONAL AND COMPELEMENTARY MEDICINE PRACTICES AUDIT FORM |
Audited Institution / Organization’s |
Name: | |
Address: | |
Telephone: | |
Date of Audit: | |
Starting and Ending Time of Audit: | |
Item No. | Audit Questions | Appropriate | Inappropriate | Remarks |
Administrative Affairs |
S1 | Is a suitable environment provided for the audit by the Responsible Manager / Physician? Are the necessary information and documentation provided? | | | |
S2 | Do the notified members of staff perform the duties of a Responsible Manager / Physician? | | | |
S3 | Do the Responsible Managers / Physicians perform their duties? | | | |
Personnel Affairs of the Unit / Practice Centre |
S4 | Does the clothing style of the whole staff conform to the service requirements? | | | |
S5 | Do all the members of staff carry their IDs with them? | | | |
S6 | Do unauthorized persons perform medical practices that the physicians must do? | | | |
S7 | Do persons other than healthcare professionals provide healthcare? | | | |
S8 | Does the personnel employed by the private health institution or the unit / practice centre within the private health institution have insurance premium payroll / support premium payroll? Has any application been made on behalf of the members of staff who do not have those payrolls? | | | |
S9 | Have necessary precautions been taken with reference to the Employee Health and Safety? | | | |
S10 | At the unit / practice centre within the private health institution, are physicians or non-physician persons employed who do not have the right to work freelance as per the relevant legislation? | | | |
S11 | Does the staff that carries out traditional and complementary medicine practices in the unit / practice centre have certificate? | | | |
Emergency Services |
S12 | Do the drugs and equipment required for the emergency cases meet the minimum requirements? | | | |
Archive / Medical Records |
S13 | Does the medical record and archive system conform to the legislation which the unit / practice centre is subject to? | | | |
S14 | If the records are kept in electronic form, do they conform to the legislation which the unit / practice centre is subject to? | | | |
S15 | Are consent forms filled for each patient for traditional and complementary medicine practices in the unit / practice centre? | | | |
S16 | Are data that has to be notified sent within the required period of time? | | | |
Control of Medical Wastes |
S17 | Are medical wastes collected separately as hazardous and domestic wastes? | | | |
S18 | In collecting wastes, are the bags specified by the relevant Regulation used? | | | |
S19 | Are boxes and containers specified by the relevant Regulation on their technical specifications used to keep waste that may be cutting or piercing separately from other medical wastes? | | | |
S20 | Are expired and spoilt drugs and consumables disposed in accordance with the provisions of the relevant Regulation? | | | |
Patient Rights |
S21 | Is a statement of patient rights and responsibilities hung where people can see it? | | | |
S22 | Are there any contradictions to the Regulation on Patient Rights? | | | |
S23 | Are there any practices to inform about potential risks and complications that may be encountered while treating patients? | | | |
Other / General |
S24 | Do the service departments and places of the unit / practice centre conform to the provisions of the relevant legislation? | | | |
S25 | Are other traditional and complementary medicine practices than the practices permitted by the Regulation carried out in the unit / practice centre? | | | |
S26 | Is there other equipment than the notified equipment kept available in the unit / practice centre? | | | |
S27 | Are the devices, if any, maintained, controlled, and calibrated regularly? | | | |
S28 | Are the drugs kept under appropriate conditions of temperature and light? Is the temperature of the refrigerator monitored and measured daily with a thermometer and recorded? | | | |
S29 | Are the drugs, if any, subject to the green or red prescription kept in a locked place? | | | |
S30 | Do the cleaning and maintenance done in the unit / practice centre conform to the hygienic measures? | | | |
S31 | Are necessary direction and warning signs located suitably in the unit / practice centre? | | | |
S32 | Do the logos on printed documents, direction signs and promotional activities used for the unit / practice centre conform to the provisions of the relevant legislation? | | | |
S33 | Are such products as drugs and cosmetics used for traditional and complementary medicine practices sold at the unit / practice centre? | | | |
S34 | Are the conditions of heating, lighting, and ventilation in the unit / practice centre appropriate? | | | |
S35 | Are sterilization requirements met? | | | |
Other Findings (*) |
S36 | | | | |
S37 | | | | |
S38 | | | | |
Remarks |
- (*) Other points not present on the audit form but found during the audit. [Additional Items (S. No.) can be added as needed.]
- Nonconformities found during the audit shall be assessed following the audit at the Provincial Directorate of Health, and the responsible manager shall be notified of the nonconformities and be expected to submit a statement of defence in that regard. With reference to the nonconformities found during the audit, the sanctions corresponding to the relevant article and suggested in this regulation shall be imposed. If there is not any sanction suggested in this regulation, then the sanctions in the legislation applied to the relevant health institution to which the unit / practice centre is affiliated or in the other relevant legislation are imposed.
- This form can be filled manually as well as in electronic form during audits. If the form is filled in electronic form, then a printout of the form shall be taken, and a signed copy shall be submitted to the relevant centre.
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Auditor | Auditor | Auditor | Responsible Manager / Physician |
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