L.S. 458.23 Regolamenti dwar Liċenzji għal-Kliniċi Mediċi Privati

(1)An application for a licence for a clinic shall be made to the Minister in writing and sent or delivered to the Ministry: Licensing. Provided that where an application for a licence is already pending before the coming into force of these regulations, such application shall be deemed to have been made under these regulations.

(2)In making an application for a licence for a clinic, an applicant shall furnish such particulars as are specified in the First Schedule and such other information as the Minister may require.

(3)Any application for a licence, including the renewal of a licence, for a clinic shall be accompanied by a fee payable to Government as the Minister may from time to time by notice in the Gazette prescribe. 5.

(1)The Minister may refuse to issue or renew, or may withdraw a licence in respect of a clinic if he is satisfied (

1. a)that the applicant, or any person employed or proposed to be employed by the applicant to assume responsibility for the clinic is not of good conduct; or Refusal of licence. 2 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS (
2. b)that for reasons connected with the physical location, construction, state of repair, accommodation, staffing or equipment, the clinic is not fit to be used as a clinic; or (
3. c)that the clinic is, or any premises used in connection therewith are, used, or proposed to be used, for purposes which are not related to the clinic or which are in any way improper, unethical or not lawful; or (
4. d)that the clinic or any premises to be used in connection therewith consist of or include works executed in contravention of the Development Planning Act; or Cap. 552. (
5. e)that the arrangements for the management and control of the services provided at the clinic are not adequate.

(2)Where a licence has been refused or is not renewed or has been withdrawn, the applicant or licensee, as the case may be, may within thirty days of receipt of notice of refusal, non-renewal or withdrawal of licence, appeal to a tribunal to be appointed by the President of Malta and made up of a person who has, for at least seven years, been in possession of a warrant to practise the legal profession in Malta as chairman, and two other members, one from among the medical profession and the other who shall be a representative of the department. Licence to specify number of patients to be kept. 6.

(1)The licence certificate shall specify the number of patients in beds which may be kept at the clinic.

(2)The type of surgical operations which can be carried out in a clinic shall be those listed in the Second Schedule and subject to any conditions specified therein.

(3)The licence certificate issued under the Act in respect of any clinic shall be kept affixed in a conspicuous place in the clinic.

(4)The tariff of fees chargeable at the clinic in respect of services, other than professional services provided at the clinic, shall be kept affixed in a conspicuous place in the clinic.

(5)It shall be the duty of the licensee to ensure that all patients asking for or receiving a service are informed of the fees chargeable at the clinic and can receive a copy of the relative fees charged, which copy shall be given to any person on request. Licence conditions. 7.

(1)Where the licence for a clinic is issued on behalf of a company, it shall be the duty of the licensee to inform the Minister in writing of any change in the name of the persons running the company with seven days from such change.

(2)(

1. a)No licence for the running of a clinic shall be granted, transferred or renewed unless the clinic is in the charge of a medical practitioner or a registered nurse, hereinafter referred to as "the person in charge". (
2. b)It shall be the duty of the licensee to make adequate arrangements, to the satisfaction of the Superintendent, for the running of the clinic while he, or, if he is not the person in charge of the clinic, the person in charge, is LICENSING OF PRIVATE MEDICAL CLINICS [ S.L.458.23 3 absent from such clinic, and moreover to ensure that the name of any person at any time in charge of such clinic is fixed at all times in a conspicuous place and visible to the public when the clinic is providing a service. This information is to be communicated forthwith to the Superintendent. (
3. c)If at any time during the absence of the person in charge there is no person designated as being in charge, the clinic shall during such time be deemed to have been operated without a licence. (
4. d)It shall be the duty of the licensee to inform forthwith the Superintendent in writing, and where possible and practicable in advance, of any change, other than aforesaid, of the person in charge of the clinic. (
5. e)There must be a clear distinction and definition of the roles and responsibilities of the person in charge and the licensee in all those instances where these functions are not carried out by the same person. 8. It shall be the duty of the licensee to ensure that at all times in-patients are receiving treatment at the clinic, there is available resident medical coverage for such patients to the satisfaction of the Superintendent, taking into consideration the number and condition of such patients and the service being provided at the clinic: Presence of medical practitioner. Provided that where the surgical operations to be carried out at the clinic are limited to those listed in Part I of the Second Schedule, the presence of a registered nurse shall be sufficient. 9.

(1)It shall be the duty of the licensee to ensure that there are present at all times at the clinic a sufficient number of nurses to e n s ur e p r op e r c a r e o f t he p a t i e n ts i n t he c li n ic t a k i ng i n to consideration the following: (

1. a)the number and category of patients accommodated; (
2. b)the number of floors and the number of patients on each foor; (
3. c)the overall layout of the building; (
4. d)the facilities provided; (
5. e)the number of additional part time staff and of other staff capable of providing nursing support.

(2)(a) Without prejudice to the generality of the above and to the provisions of subregulation

(5), there shall be at least one registered nurse on duty in each ward or special unit at all times patients are receiving a service in such ward or special unit. For the purposes of this paragraph, no ward or special unit shall be considered as one such ward or unit unless it is wholly situated on one floor. (

1. b)If a children’s ward or special unit is incorporated within the clinic there shall be, at all times children are Duties incumbent on licensee. 4 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS receiving treatment, a registered sick children’s nurse or a registered nurse with significant experience in the nursing of children. (
2. c)Where, in any clinic, surgery is carried out there must additionally be present at all times such surgery is carried out and for a reasonable period before and after such event, a registered nurse with operating theatre experience: Provided that patients recovering from an anesthetic shall be attended to by a qualified anesthetist or by a suitably trained registered or enrolled nurse.

(3)(

1. a)No patient may be left in the sole charge of a person who is not authorised to practise as a nurse. (
2. b)The number of temporary or casual nurses on duty shall not exceed the number of permanently employed nurses on duty and no temporary or casual nurse shall be in sole charge of a patient unless a permanently employed registered nurse is present on the premises and can be called upon immediately.

(4)The person in charge of a clinic shall maintain a roster of duties of nurses and such roster shall be available to nurses and on request to an authorised person.

(5)It shall be the duty of the licensee, having regard to the number, age, sex and condition of patients treated at the clinic, to (

1. a)provide adequate professional, technical, ancillary and other supporting staff; (
2. b)provide for each patient in the clinic adequate accommodation and space, including, where appropriate, day room facilities; (
3. c)provide adequate furniture, bedding, curtains and, where indicated, suitable bed screens and door coverings in rooms occupied or used by patients; (
4. d)provide adequate medical, surgical and nursing equipment and adequate treatment facilities, including an efficient nurse/patient call system; (
5. e)provide for the use of patients adequate wash hand basins and baths or, where acceptable, showers, supplying hot and cold water and a suitable number of water closets and sluicing facilities; (
6. f)provide adequate lighting, heating and ventilation in all parts of the clinic occupied or used by patients; (
7. g)keep all parts of the clinic in good structural repair, clean and reasonably decorated; (
8. h)ensure that adequate facilities exist, and take adequate precautions, against the risk of fire, including the provision of adequate means of escape in the event of a fire, as well as make adequate arrangements for LICENSING OF PRIVATE MEDICAL CLINICS [ S.L.458.23 detecting, containing and extinguishing a fire, for notices regarding procedure to be used in case of fire and for the giving of warnings, for the evacuation of the patients and staff, for the maintenance of fire fighting equipment, and for such other arrangements as may in any case be required by law, and, in the absence of any such law, as may, at any time, be directed by the Commissioner of Police; (
9. i)provide adequate kitchen equipment, crockery and cutlery and adequate facilities for the preparation and storage of food; (
10. j)supply adequate food for every patient in accordance with such patient’s dietary requirements; (
11. k)arrange appropriate laundering facilities; (
12. l)make adequate arrangements for the disposal of swabs, soiled dressings, instruments and similar substances and materials as well as for any other hazardous wastes; (
13. m)make adequate arrangements, as may be indicated, in respect of long stay patients; (
14. n)make adequate arrangements for the recording, safekeeping, handling and disposal of drugs; (
15. o)provide adequate arrangements for the prevention of infection, toxic condition, or the spread of infection in the clinic; (
16. p)take adequate precautions against the risks of accidents; (
17. q)provide for adequate insurance coverage of patients treated, and of employees working, at the clinic and for insurance of third parties in each case in respect of accident or other mishap.

(6)The number at domestic staff shall be sufficient to ensure a high standard of cleanliness in all parts of the premises and the licensee shall ensure that such staff is supervised by a person with knowledge of cleaning methods and materials applicable to a clinic.

(7)There shall be a supply of wholesome drinking water at suitable points.

(8)Every clinic shall be provided with adequate telephone facilities. Similar facilities shall also be available for private use by patients.

(9)(

1. a)In respect of operations listed under Part I of the Second Schedule, the facilities and resources as well as the condition or medical fitness of the patient shall be such as to enable such operations to be carried out u n d e r c o n d i t i o n s o f g o o d s u rg i c a l a n d m e d i c a l practice, as recommended by academic colleges of anesthesiologists and of surgeons recognised by the Superintendent. (
2. b)No surgical operations as are listed or referred to in 5 6 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS Part II of the Second Schedule may be carried out at a clinic unless there are adequate operating theatre facilities, as are specified in the Third Schedule, to the satisfaction of the Superintendent. (
3. c)Where in any clinic, surgical operations are undertaken or a life support system is used, there shall be available adequate facilities for immediate electrical supply in case of interruption of the public supply as is needed to safeguard the lives of the patients.

(10)In this regulation (

1. a)"to provide" includes, where applicable, to maintain; and (
2. b)where any question arises as to suitability, acceptability or adequacy, it shall be deemed to be suitable, acceptable or adequate, as the case may be, if so considered in the opinion of the Superintendent. Natal care. 10. Where antenatal, intranatal or postnatal care is given at a clinic, the following provisions shall moreover apply:

(1)A registered midwife shall be in charge of all midwifery services and may, in respect of midwifery services only, act as person in charge for the purposes of regulation 5. In any case a practising midwife shall be present on duty at all times maternity care is provided.

(2)(

1. a)The person in charge should make certain that adequate general and specialist medical cover is provided as needed. (
2. b)Adequate arrangements shall exist for obtaining obstetric, paediatric, anesthetic and any other necessary help in an emergency situation. (
3. c)Where epidural anesthesia is to be offered to women in labour, this should be carried out by an anesthetist trained in this procedure.

(3)(

1. a)Where maternity beds are provided in a clinic they shall be so designated and shall not, unless these are single rooms, be used to accommodate any other type of patient. Maternity patients shall not share rooms with patients who are not in the clinic for obstetric care. (
2. b)No mentally disordered patient, alcoholic or drug abuser may be accommodated in the section reserved for maternity patients unless such patient requires maternity care; in such case she shall be given separate accommodation. (
3. c)Adequate sanitary and bathroom facilities reserved for the sole use of maternity patients shall be provided. Grab rails and nurse call systems shall be included, and where practicable showers and bidets. (
4. d)Nursery accommodation shall be made available as LICENSING OF PRIVATE MEDICAL CLINICS [ S.L.458.23 well as adequate facilities for the preparation as may be necessary of infant formula or other breast milk substitute. (
5. e)Single rooms shall be present for maternity cases which have special needs. (
6. f)Delivery rooms shall be adequately sound-proofed. (
7. g)Emergency electrical supplies shall extend to delivery rooms, nurseries and to any operating theatre.

(4)(

1. a)Resuscitation equipment for new-born babies shall be provided. (
2. b)When deliveries are being conducted, anesthetic and suction machines shall be available. (
3. c)Each infant shall have its own cradle of approved design, thermometer and bath. (
4. d)Each patient shall be provided with a comfortable nursing chair.

(5)The licensee shall in addition to the records referred to under regulation 11

(1), keep a case record of each child born to a patient in the clinic, which record shall include the following particulars: (

1. a)details of the weight and condition of child at birth; (
2. b)a daily statement of the child’s health; (
3. c)details of each of any of the following paediatric examinations, if carried out: (
4. i)examination for congenital abnormalities; (
5. ii)measurement of circumference of the head of the child; (iii) measurement of the length of the child; (
6. iv)screening for phenylketonuria or other screening for congenital disorder.

(6)T'he following additional particulars shall be included on the register of patients kept at the clinic in respect of maternity patients: (

1. a)the date and time of delivery of each patient, the number of children born to the patient, their sex and whether born alive or dead; (
2. b)the estimated period of gestation prior to delivery; (
3. c)the name and qualifications of the person who delivered the patient; (
4. d)the date and the time of any miscarriage occurring in the clinic, including the period of gestation prior to miscarriage; (
5. e)the date on which any child born to a patient in the clinic left the clinic; and (
6. f)if any child born to a patient died in the clinic, the date, time and cause of death. 7 8 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS

(7)The provisions of regulation 11

(2),

(3),

(4)and

(5)shall mutatis mutandis apply to these records.

(8)The provisions of this regulation and, as applicable, of the other regulations, shall apply to any premises licensed as a maternity home. Registers, receipts, case records. Amended by: L.N. 426 of 2012. 11.

(1)Proper records are to be kept of patients treated at the clinic (

1. a)in respect of each patient, in a register showing: - - - - the name, address, date of birth and a legally valid identification document of the patient and, where the patient has no legally valid identification document, the passport number shall be included together with the country of issue, if such patient has a passport; the name, address, a legally valid identification document number and telephone number of the patient’s next of kin or of any person authorised to act on the patient’s behalf; the name and address of the patient’s medical practitioner; the date when and the time during which the patient was admitted and the date of discharge or transfer to a clinic or other place as may be applicable; if the patient died in the clinic, the date, time and cause of death; in the case of a child, where applicable, the name and address of the school he attends or has attended before being admitted to the clinic; (
2. b)a separate register of all surgical operations performed in the clinic: such register shall include in respect of each operation, the date and time of such operation, the patient’s name, a legally valid identification document or passport number as may be applicable or as provided for under the preceding paragraph, the clinic case history number, the name of the medical or dental practitioner who performed the operation, and, where applicable, the name of any other practitioner assisting him, as well as the name of the anesthetist in attendance; (
3. c)a separate case record of every patient which shall contain an adequate updated statement of the patient’s health and condition and a note of any investigation and details of surgical operations carried out and treatment given, including the anaesthetic record sheet. (
4. d)a record of each member of the staff employed, which record shall include the name, date of birth, a legally valid identification document number, grade and dates of employment at the clinic, and, in respect of nursing LICENSING OF PRIVATE MEDICAL CLINICS [ S.L.458.23 staff, details of their qualifications. Such records shall, as far as reasonably practicable, include the times when individual members of the nursing staff as well as the person or persons in charge were on duty; (
5. e)a record of the following: (
6. f)all fire practices; all fire alarm tests, results and action taken where applicable; the maintenance carried out on medical, surgical and nursing equipment in the clinic; such other records as the Minister may, from time to time, require to be kept.

(2)All records referred to in subregulation

(1), other than patient case records, shall be retained for a period of not less than two years after the last entry made therein, and shall be open for inspection by an authorised officer or by such authority as may have such power under any law.

(3)Patient case records shall be retained and shall not be destroyed except with the approval of the Minister.

(4)It shall be the duty of the person in charge of the clinic to ensure proper keeping and storage of records and, subject to the provisions of these regulations and to any other law relating to confidentiality of records, to limit disclosure only to persons entitled to access to such information.

(5)All records shall be legibly entered in full and in proper order. Any alterations, corrections or deletions shall be initialled by the person making such alteration, correction or deletion.

(6)Notwithstanding the provisions of the preceding subregulations, computer records may, under such conditions as the Minister may impose in the licence certificate, be acceptable, provided always that a hard copy of the day’s entries are made each day and filed in chronological order: Provided that such alternative shall not, in the case where the Minister directs that a copy of the entries be sent regularly to the Ministry and/or the department, be construed as any acceptance of any irregularity carried out at the clinic on the pretext that the Ministry and/or the department had been regularly informed. 12.

(1)No medical practitioner, dental surgeon, nurse, midwife, pharmacist, pharmacy technician or any other person to whom Part V of the Act refers, and who is also in the employment of Government, may, during those hours in which he is contracted to provide his services to Government, work in any medical clinic unless he is on approved leave of absence. Any breach of this provision by any such medical practitioner, dental surgeon, nurse, midwife, pharmacist, pharmacy technician or other person shall be deemed to be an offence. It shall be the duty of the licensee of such clinic to take all reasonable steps to ensure that this provision is complied with.

(2)The licensee shall require all persons to whom Part V of the Work by government personnel. 9 10 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS Act refers to register their attendance at the medical clinic, indicating date and time and whether entering or leaving the clinic, immediately on entering and immediately before leaving the clinic, in a register kept for the purpose. The licensee shall transmit the contents of such register to the Ministry or department in such manner as may be specified by the Minister. The provisions of regulation 11

(6)shall also apply to the register referred to in this provision.

(3)It shall be an offence for any licensee or person in charge of a clinic to permit on the premises any person to whom subregulation

(1)refers unless the conditions of subregulation

(2)have been complied with.

(4)Where, except in an emergency, any licensee or person in charge of a clinic is in wilful breach of any preceding provision of this regulation, such clinic shall be deemed to have been operating without a licence. Inspections. 13.

(1)Subject to the following provisions of this regulation, any authorised person, on producing if asked to do so, a duly authenticated document showing that he is so authorised, may enter and inspect any premises which are used, or which he reasonably believes to be used as a clinic and may require the production of and may inspect any register or records maintained or retained in pursuance of these regulations.

(2)Any authorised person may require the licensee or his representative to furnish information in relation to the clinic in respect of any matters mentioned in the First Schedule and such other information as may reasonably be required for the purposes of inspection: Provided that nothing in this regulation shall be deemed to authorise any person who is not a medical officer to inspect any clinical record relating to a patient in the clinic.

(3)The licensee shall permit any authorised person to interview in private any person in the clinic.

(4)The clinic shall be open for inspection by any authorised person with a view to ensuring full compliance with the provisions of these regulations.

(5)Every clinic licensed under these regulations shall be inspected at least twice in every period of twelve months. The inspecting officer or officers shall conduct a systematic review of facilities and services with a view to ensuring compliance with these regulations and with the conditions of the licence, and shall submit a report to the Minister on the results of his inspection. Staff members’ names.

1. The Ministry is to be informed of the names, addresses and qualifications of each member of the staff employed on date of issue, renewal or transfer of the licence and of any changes in staff subsequent thereto. Notice of death.
2. If a patient, or a child born to a patient dies in the clinic, the licensee shall give notice to the Superintendent forthwith and shall report to him in writing within twenty-four hours after such LICENSING OF PRIVATE MEDICAL CLINICS [ S.L.458.23 death. Such notice shall include full particulars of the patient, the circumstances and cause or suspected cause of death, and any other information which may be relevant.
3. For each service carried out on payment at the clinic, an official itemised receipt shall be issued from the clinic to the person in respect of whom such service was provided. The licensee shall moreover ensure that a register of financial accounts of the clinic is kept. Receipt for services at the clinic.
4. Nothing in these regulations shall be deemed to exempt any applic ant or lice nse e from any re quirement of t he l aw regarding any other licences which may be needed in respect of any facility or service provided at the clinic. Serving. 11 12 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS FIRST SCHEDULE [Regulation 4

(2)] Matters in respect of which a health authority may require information to be furnished by an applicant for a licence

1. The full name and address, and professional or technical qualifications (if any) of the applicant.
2. Where the application is made by a company, society, association or body, the address of its registered office or principal place of business and the full names and addresses and technical qualifications (if any) of the directors or partners.
3. The address of any other clinic in which the applicant has or had a business interest and the nature and extent of his interest.
4. The situation of the clinic and its form of construction (plan to be attached).
5. The accommodation available, and the equipment and facilities provided or to be provided in the clinic.
6. The date on which the clinic was established or is to be established.
7. Whether any other business is or will be carried on in the same premises as the clinic.
8. The type of clinic services to be provided including list of operations proposed to be carried out.
9. The number of patients (excluding staff) for whom it is proposed to be used distinguishing between different categories of patients and indicating the age-range of patients in each category.
10. The full names, ages, qualifications and experience of persons employed or proposed to be employed in the management of the clinic.
11. The arrangements for the management and control of the clinic.
12. The full names and qualifications of any employed medical practitioners.
13. The full names and (where appropriate) qualifications and grades of the nursing and other professional, technical, administrative and ancillary staff (other than staff included under paragraph 12 above) employed or proposed to be employed in the clinic.
14. The details of arrangements made or proposed to be made in respect of the provision of facilities and services.
15. The arrangements made for the supply of blood and blood products.
16. The arrangements made for the provision of pathology and radiology services.
17. The arrangements made for the insurance of patients, staff and third parties against accidents and other mishaps.
18. Whether the clinic is intended to operate as a day care clinic only (i.e. with no overnight stay) or as a clinic with overnight stay of patients. LICENSING OF PRIVATE MEDICAL CLINICS [ S.L.458.23 SECOND SCHEDULE [Regulation 9

(9)] Part I 13 Amended by: L.N. 183 of 2003. The following operations may be carried out in a clinic, as referred to in subregulation

(9)of regulation 9, provided that the facilities and resources, as well as the condition or medical fitness of the patient are such as to enable such operations to be carried out under good medical, surgical and anesthetic practice in line with guidelines established by international academic colleges of surgeons and anesthesiologists recognised by the Superintendent. Where day surgery is carried out this generally demands a high standard of e x p e r t i s e , a n d s h o u l d b e u n d e r t a k e n o n l y, o r s u p e r v i s e d , b y e x pe r i e n c e d practitioners. Such operations should be clean and elective surgical procedures and should normally require a relatively short general anesthesia and should not carry the risk of postoperative complications that normally require overnight stay in a clinic and the patient is expected to recover sufficiently to return home in the early evening. In particular haemostasis must be strictly ensured and where an operation requires drainage, it may not always be suitable to be performed on a day care basis. It is understood that the facilities should be similar to those required for in-patient surgery with ward area near the operating theatre suite (including anesthetic room and recovery room of the high dependency type) and, without prejudice to the generality of this requirement, must have adequate lighting, basic equipment, piped gases and gas scavenging devices. Basic equipment includes anesthetic machine and monitoring apparatus, operating table, diathermy machine, dressing trolleys, scrub facilities as well as other equipment required in accordance with good surgical and anesthetic practice for specific operations. The elderly and infants are normally excluded and the arrangements for postoperative care outside the clinic must be satisfactory. In particular the patient must have adult attendance and it must be ensured that such patient is in close reach of the telephone for emergencies. After discharge from the clinic, the patient must be given appropriate instructions following discharge and be accompanied home. If the patient is deemed to be unfit for discharge from the clinic on the same day either on anesthetic or surgical grounds, it shall be the responsibility of the person in charge of the clinic to make appropriate arrangements for in-patient admission to a clinic where overnight stay is allowed. In every case the prudent exercise of clinical judgement by the surgeon and the anesthetist, faced with an individual problem and particularly when faced with nonideal facilities, is mandatory. A. Paediatric Surgical Operations (

1. i)General Examination under anesthesia Repair of inguinal/umbilical/femoral/epigastric hernia Varicocele Ligation of communicating hydrocele Orchidopexy (unilateral or bilateral), excluding second stage operations or cases of high non-palpable testis Laparoscopy 14 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS Circumcision, meatotomy Minor hypospadias Cystoscopy Division of tongue tie Proctoscopy, sigmoidoscopy, anal stretch, examination under anesthesia Excision of local skin lesions, including biopsy Lymph node biopsy Branchial sinus, thyroglossal cyst Correction of prominent ears Excision of accessory auricles and digits Correction of syndactyly Minor revision following cleft lip and palate surgery Biopsy/excision/destruction of lesions, or removal of excess mucosa, of mouth Removal of calculi from salivary ducts (
2. ii)Orthopaedic Arthroscopy Manipulations, closed reductions of simple fractures/dislocations Change of plaster Release of trigger finger Excision of ganglion (iii) Dental Extractions/conservation dentistry Supernumerary or impacted teeth Biopsy of oral lesions, including excision Lingual or labial frenectomy Removal of fixators Enucleation of simple cysts (
3. iv)Ear, Nose and Throat Examination under anesthesia and removal of foreign body from ear, nose and throat Myringotomy and insertion/removal of tympanostomy tube Electro-cochleography Reduction for fractured nose Electro-cautery for bleeding of nose Submucosal diathermy Simple nasal polypectomy Antral puncture and washout (
4. v)Ophthalmic Correction of squint [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS 15 Electro-diagnostic tests Examination under anesthesia for ophthalmic conditions B. Adult Surgery (
5. i)General Excision of lesions of skin and subcutaneous tissue, including rodent ulcer Cautery/cryotherapy of skin Removal of foreign body in deeper tissue Dermabrasion Skin suture Insertion/removal of skin expander into tissue Repair of simple inguinal, femoral, umbilical or epigastric hernia Anal fissure, anal stretch, sphincterotomy Excision of anal fistula Removal of anal warts Repair of anal trauma Rectal polypectomy Haemorrhoidectomy Diagnostic Laparoscopy Needle biopsy of liver Oesophagoscopy and dilatation Biopsy breast, lymph node, skin, lesions of mouth Removal of salivary calculus Ligation, stripping of/other operations for, varicose veins Excision of thyroglossal cyst Excision of bronchial sinus Incision and drainage of abscess, drainage of haematoma Microdochotomy (
6. ii)Orthopaedic Note: Facilities for image intensification and application of plaster casts where necessary should be available Axthroscopic procedures, including biopsy and operation on articular cartilage Manipulation dislocations of joints, closed reduction of simple Removal of pins, plates or screws, external fixator Excision of ganglia, synovial cysts and benign synoviomata Decompression of carpal tunnel Decompression of peripheral nerve De Quervain’s release Removal of neuroma, e.g. on the hand fractures/ 16 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS Correction of minor deformity of hand/foot Minor amputation of the fingers and toes Operation on ingrowing toe nails Subcutaneous tenotomy Tendon transposition Primary repair of peripheral nerve Ulnar styloidectomy Excision of exostoses Interphalangeal fusion of the toes Hallus valgus and osteotomy of metatarsals Release of trigger finger Simple excision of palmar fascia in Dupuytren’s contracture Removal of foreign bodies Scar revision Biopsy, excision of small lesion, limited repair, of muscle (iii) Urinary System Note: Uncatheterised patients should not be sent home before they have passed urine. Percutaneous nephrostomy fine needle biopsy of kidney Nephroscopic operations on ureter Ureteroscopic extraction of calculus of ureter Endoscopic examination/insertion/removal of prosthesis, ureter Endoscopic retrograde pyelography Operations on ureteric orifice Endoscopic destruction of lesion of bladder Endoscopic hydrostatic distention of bladder Endoscopic extraction of bladder calculus or foreign body Endoscopic dilatation of, or operations on, outlet of female bladder Repair of epispadias Endoscopic operations on urethra Endoscopic examination of urethra/removal of foreign body Dilatation of urethra Endoscopic biopsy of prostate (
7. iv)Genital System External meatotomy of urethral orifice Orchidectomy and excision of spermatic cord Orchidopexy Correction of hydrocele Excision of epididymal cyst, scrotal lesion Biopsy testis LICENSING OF PRIVATE MEDICAL CLINICS [ S.L.458.23 17 Operations on varicocoele Division of preputial adhesions Circumcision Vasectomy (
8. v)Ophthalmic Operations Cataract surgery Corneal transplant surgery Procedures on the eyelid or tarsal plate Operations on the lachrymal apparatus Correction of squint Surgery for refraction Laser surgery Keratoplasty Iridectomy (
9. vi)Ear, Nose and Throat Endoscopy of nasal cavity, sinuses, pharynx, larynx, including biopsy Removal of foreign body from the nose or ear canal Removal of impacted wax Excision of lesion of external ear Myringotomy/insertion/removal of tympanostomy tube Removal of simple nasal polyps Reduction of fracture nasal or molar bone Electro-cautery of the nasal septum Submucosal diathermy of the inferior turbinates Antral puncture and washout Removal of vocal polyp Diagnostic laryngoscopy, pharyngoscopy and oesophagoscopy (vii) Endoscopic/Laparoscopic procedures of gastro intestinal tract Oesophagoscopy/oesophagostro duodenoscopy, removal/laser or diathermy destruction of lesion including biopsy/ Endoscopy and removal of foreign body/insertion of prosthesis/ dilatation/recanalisation of tumour mass Sigmoidoscopy including biopsy/removal/destruction of lesion Fibreoptic colonoscopy including excision/biopsy/destruction of lesion Endoscopic retrograde cholangiopancreatography (viii)Plastic Surgery Excision of skin lesion: direct closure, split skin or full thickness graft, local flaps (other than grafts to the lower limbs) Scar revision and soft tissue contouring Separation and inset of certain flaps Debulking and revision of flaps 18 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS Insertion and distension of tissue expanders Operations for axillary hyperhidrosis Laser and cryosurgery Excision of tattoos Blepharoplasty Rhinoplasty Mastopexy Limited Liposuction (
10. ix)Gynaecologyical Operations Note: Uncatheterised patients should not be sent home before they have passed urine Examination under anesthesia and curettage Colposcopy, cystoscopy, diagnostic hysteroscopy/laparoscopy, including biopsy and minor laparascopic surgery Biopsy/cautery of cervix, removal of cervical polyp Hormone implants Excision of vulval warts and other minor procedures to the vulva and vagina Marsupialisation of Bartholin’s cyst Endometrial ablation with laser or resectoscope Hysteroscopic resection of uterine septum Hysteroscopic myomectomy Laser treatment of cervical and vulval lesions Tubal ligation Biopsy of ovary or peritoneum Coagulation of mild endometriosis Aspiration of small ovarian cysts Lysis of mild to moderate adhesions Coagulation of moderate endometriosis Exploration of small ovarian cysts Uterine ventrosuspension Salpingectomy Salpingectomy for ectopic pregnancy (
11. x)Oral and Maxillofacial Surgery Excision of uncomplicated impacted teeth and buried roots Exposure of unerupted teeth for orthodontic treatment Biopsy of hard and soft tissues Enucleation of small cysts of jaw Division of pedicles Removal of direct bone plates and wires Minor soft-tissue surgery LICENSING OF PRIVATE MEDICAL CLINICS [ S.L.458.23 19 EUA for suspected malignancy Cryoblockade of peripheral nerves Laser and cryosurgery of small lesions Reduction of nasal and molar fractures Temporomandlibular arthroscopy Salivary ductoplasty and removal of calculi (
12. xi)Other Bronchoscopy, including biopsy and/or remwal of foreign body Oesophagoscopy and dilatation Removal of pectus bar Mediastinoscopy Chest drainage (xii) Interventional Radiology CT Scan using contrast Isotope scanning Arteriography using small arterial catheters (xiii)Pain Relief Epidural injections - cervical, lumbar or thoracic Peripheral nerve lesion - using injection, radiofrequency, cryoprobe or phenol. Part II The following operations may be carried out in a clinic where patients are kept overnight subject to the facilities referred to under regulation 9

(9)(b) being available at the clinic:

1. All operations listed under Part I of this Schedule.
2. Any other surgical intervention other than Neonatal surgery Intracranial operations Major laryngeal surgery Surgery for kyphosis and scoliosis Cardiac surgery Aortic surgery Transthoracic oesophageal resection and other thoracic surgery excluding lobectomy and simple chest drainage Surgery for portal hypertension Organ transplantation irrespective of whether the organ is obtained from a cadaver or from a live donor Any other operation or procedure, including any operation referred to in Part I of this Schedule where there is a probability of the patient requiring intensive care after surgery or where significant amounts of blood loss are anticipated, if intensive care facilities, to the satisfaction of the 20 [ S.L.458.23 LICENSING OF PRIVATE MEDICAL CLINICS Superintendent, are not available; unless such operations are specifically approved by the Minister and a note to this effect is entered in the licence. THIRD SCHEDULE Amended by: L.N. 200 of
3. [Regulation 9

(9)] Operating Theatre facilities

(1)Facilities must include: (

1. a)two operating tables; (
2. b)a separate anesthetic room for each theatre; (
3. c)a recovery room or area; (
4. d)a cleansing room; (
5. e)a sterilising room, including facilities for sterilising equipment which cannot be autoclaved; (
6. f)a plant room or area which may or may not be integrated with the remainder of the suite; (
7. g)storage space; (
8. h)a rest/refreshments room; (
9. i)toilets, wash basins and showers; (
10. j)barrier zone; (
11. k)a theatre control office; (
12. l)facilities for infra-operative radiography including on the spot development of X-Ray films.

(2)The floor area of the operating theatres shall be of an area not less than 37 square metres, and that of the anesthetic rooms of an area not less than 16.5 square metres.

(3)The ceilings, floors and applied wall finishes of the operating suite shall be smooth, impervious and jointless. The floor of the operating theatre shall be similarly covered with material and have appropriate antistatic properties. All finishes shall be able to withstand daily cleansing with water and disinfectants.

(4)(

1. i)The operating suite shall be mechanically ventilated by a satisfactory system which shall be capable of providing and maintaining: (
2. a)temperatures (user adjustable) within a range of 15°C and 25°C; (
3. b)relative humidity of the atmosphere within the range 40%-60%. Only steam injection type humidifiers are permissible; (
4. c)sufficient fresh air for the requisite temperature and humidity control, dilution of airborne bacterial contamination and control of air movements between clean and less clean areas. (
5. ii)For the purposes of the above provisions, "satisfactory system" means a system acceptable by the international standards recognised by the Superintendent. LICENSING OF PRIVATE MEDICAL CLINICS [ S.L.458.23 21 (iii) An approved system should be included for the removal of exhaust anesthetic gases in accordance with specifications "BS 6834: 1987 Active Anesthetic Gas Scavenging Systems" or equivalent specifications.

(5)(

1. i)The operating theatre shall have clinical quality lighting capable of rendering not less than 400 lux (excluding the illumination from operating lamp). The preparation, scrubbing and recovery areas shall have lighting of not less than 250 lux while the anesthetic areas should have an illumination of not less than 300 lux. The remaining parts of the suite should have an illumination of not less than 200 lux. (
2. ii)Essential lighting and power shall be provided in the theatre suite. These shall be fed from an automatic standby power source which shall assume the load after a period of not more than 10 seconds. (iii) Emergency lighting fed from a D.C. Source shall also be available for the essential parts of the operating theatre suite. There shall be ensured a no break supply to the operating theatre lamps.

(6)Clinics carrying out surgery or admitting acutely ill medical patients shall require a cardiac monitor, a pulse oximeter, a defibrillator, a fully equipped resuscitation trolley and oxygen and suctions in all areas where acutely ill patients may be kept. More than one set of equipment may be required in hospitals handling large numbers of patients.

(7)Qualified and fully trained staff able to react and operate the cardiac emergency equipment, if so required, have to be on duty 24 hours a day.