Unattached operating theatres.
The Regulations Governing Private Hospitals and Unattached Operating Theatre Units published under Government Notice No. R. 158 of 1 February 1980 and amendments are lengthy and onerous. The regulations stipulate a number of issues for theatres in both private hospitals and unattached facilities, but there is a poor distinction between private hospital and 'unattached theatres'. They do not address the practical and legal issues pertaining to office-based surgery, endoscopy and the modern concept of ambulatory surgery centres.
* Definition: 'unattached operating theatre unit' means an operating theatre unit not owned or managed by the state, local authority, private hospital, hospital board or any other public body and not attached to a hospital or nursing home, and where a patient operated on may remain for a period not exceeding 12 hours.
* Prior approval and limited registration is provided, necessitating annual renewal.
* Detailed technical requirements for the facility, building, accommodation and equipment are contained in the regulations. Compliance with electrical specifications and provision of uninterrupted power supply (UPS, backup generators) are common problem areas.
* A list of the scope of prescribed procedures carried out in unattached operating theatre units is summarised in Table I.
Additional governance matters are addressed in the Health Act and Medical Schemes Act, their regulations and amendments, other regulations governing patient care facilities, general hygiene and infectious diseases requirements, water supply, waste disposal, facilities regulation in terms of the Occupational Health and Safety Act, applicable Local Authority bylaws, South African Bureau of Standards, Basic Conditions of Employments Act and Labour Relations Act.
Please note that these acts represent minimum standard legislation. There is a definite interaction between the abovementioned statutes, common law, legal precedents, delictual and criminal liability and HPCSA ethical rules. (1)
The Medical Protection Society (http://www.medicalprotection.org/southafrica/) issued a warning that it may not be able to assist or provide indemnity cover in respect of complaints or claims arising from procedures performed in unregistered unattached theatres.
Most office-based surgery in South Africa is currently undertaken in doctors' rooms where no formal accreditation or licensing is held. This clearly exposes the practitioner and the owner of the facility to numerous legal and ethical risks. Legislation and governance processes are antiquated or lacking.
The Department of Health list of the scope of procedures in Table I is outdated. The South African Medical Association (SAMA)'s Doctors' Billing Manual (DBM) contains a long 'list of procedures that are often done in the doctors' rooms ...', but this list simply defines procedures that may not attract extra remuneration (modifier 0004). The SAMA Private Practice Committee has expressed the need to update this list as well as to develop consensus on the scope and standards of office-based surgery practice so as to avoid legal exposure.
A much wider range of procedures are performed or could be performed in the office surgery, particularly under a combination of local and sedation or general anaesthetic techniques, e.g.:
* endoscopy: polypectomy, dilatation, stenting, placement of feeding tubes, vascular access, haemostasis and ablation of lesions, ENT endoscopic procedures
* general, orthopaedic, podiatry, neurosurgery and plastic surgery: more extensive procedures and rearrangements, liposuction, radio-frequency ablation, anorectal procedures (see the article on minor anorectal surgery in the office, p. 412 of this issue), ENT and ophthalmology
* obstetrics and gynaecology: hysteroscopy, suction biopsy, endometrial ablation, terminations, infertility procedures
* dental and maxillofacial procedures.
Practice guidelines for office-based surgery must be addressed by the national organisations representing practitioners, in co-operation with Department of Health, indemnity insurers, HPCSA and ISO Standards bodies, e.g. the International Organization of Standardization (ISO: http://www.iso.org/iso/home.htm) and their local representative, the South African Bureau of Standards (SABS: https://www.sabs.co.za/), and accreditation bodies such as the Council for Health Service Accreditation of Southern Africa (COHSASA: http://www.cohsasa.co.za/html/ accreditation.htm). In the USA there are a host of state regulatory authorities and at least four accrediting organisations that constrain practices, e.g. Medicare (http://www.medicare.gov/), Joint Commission on Accreditation of Healthcare Organizations (JCAHO: http://www.jointcommission.org), Accreditation Association for Ambulatory Health Care (AAAHC: http://www.aaahc.org) and the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF: http://www.aaaasf.org/).
These (to-be-developed) local guidelines must take cognisance of the following principles to assist practitioners who are considering or currently practise ambulatory surgery or other invasive procedures that require anaesthesia, analgesia or sedation in an office setting. While it is relatively easy to develop a set of criteria to certify a facility in which office surgery is to be performed, it is difficult to determine similar criteria or scope of practice definitions that can be used fairly and accurately to determine which physicians are qualified to use those facilities. Patients will benefit from systems based on best practice that ensure quality. (2-4) There should be a focus on quality care and patient safety in the office. Practitioners and nurses should hold a valid licence or certificate and perform services commensurate with appropriate levels of education, training and experience and the scope of practice.
* Facilities should comply with all applicable state and local laws, codes and regulations pertaining to fire prevention, building construction and occupancy, including the disabled, occupational safety and health, drug supply, storage and administration, disposal of medical waste and hazardous waste. All premises must be kept neat and clean. Sterilisation of operating materials must be adequate.
* The procedure should be of a duration and degree of complexity that will permit the patient to recover and be discharged from the facility. Patients with co-morbidities may be at undue risk for complications and should rather be referred to an appropriate facility for the procedure and the administration of anaesthesia.
* The necessary equipment and personnel to manage emergencies resulting from the procedure and/or anaesthesia should be available. A written protocol must be in place for the safe and timely transfer of patients to a pre-specified alternative care facility when extended or emergency services are needed to protect the health or well-being of the patient. Pre-existing arrangements for definitive care of the patient shall be established, e.g. hospital admitting privileges or referral to appropriate specialist care.
In South Africa office-based surgery is a 'grey' area, largely devoid of formal practice standards. Accreditation guidelines are under development as this burgeoning 'ugly duckling' comes of age.
1. Boshoff MC. Study Guide: the Occupational Health and Safety Act and the Responsibilities of Management. South African Labour Guide 2008 LG/MR 002. www.labourguide.co.za
2. Wheeland RG. The pitfalls of regulating office-based surgery by state legislatures and boards of medical examiners. Semin Cutan Med Surg 2005; 24 (3); 124-127.
3. The Joint Commission's Office-Based Surgery (OBS) Accreditation, USA. (accessed June 2009).
4. The Australian Day Surgery Council (Royal Australasian College of Surgeons. Guidelines for the accreditation of office-based surgery facilities. http://www.surgeons.org/Content/NavigationMenu/ WhoWeAre/Affiliatedorganisations/AustraliaDaySurgeryCouncil/ Appendix_D_Guideline.htm. (accessed June 2009).
ANDRE (JA) POTGIETER, MB ChB, MMed (Chir), FCS (SA) Vascular/General Surgeon in private practice, Table View, Cape Town
STEPHEN GROBLER, MB ChB, MMED (Chir) (Cert Gastroenterol) Specialist Surgeon and Gastroenterologist, Universitas Netcare Private Hospital and Part-time Consultant Surgeon, Department of Surgery, Universitas Hospital, Bloemfontein
Corresponding author: Andre Potgieter (email@example.com)
Table I. Scope of prescribed procedures carried out in unattached operating theatre units * No prescribed procedures shall be carried out in unattached operating theatre units unless the necessary facilities, equipment and assistance are available for such procedures, for resuscitation and for postoperative care. A. DENTISTRY: restorative dentistry, removal of teeth, minor oral procedures B. GENERAL SURGERY: stitch wound & tendon; drain or remove superficial abscess, haematoma, nail, foreign body, tumour; sigmoidoscopy, colonoscopy; inject piles & varicose veins; paracentesis; minor anal surgery C. PSYCHIATRY: ECT, narcoanalysis, electrostimulation, LP D. ORTHOPAEDICS: reduction simple fractures, dislocations; manipulations, aspiration, injections; arthrography; carpal-tunnel release; suture tendon, nerve; remove ganglion E. ENT: laryngoscopy; DPP; grommets, toilet of ears; cauterisation, remove foreign body, polyp; reduction nose fracture; tonsillectomy & adenoidectomy (no longer sanctioned); tracheotomy F. O & G: EUA; incision, cauterise, biopsy vulva, cervix, endometrial; IUD; D&C; hysterosalpingogram; hormone implant, laparoscopy, sterilisation; Shirodkar; external version; other minor procedures G. OPHTHALMOLOGY: EUA; corneal foreign body; probe tear duct; incision meibomian cyst; remove pterygium H. DERMATOLOGY: diathermy, curettage, biopsy, removal warts, skin or mucous membrane lesions I. UROLOGY: cystoscopy, urethral dilation, vasectomy, spermatocoele, testis biopsy, meatotomy, circumcision J. THORACIC SURGERY: pleural aspiration, biopsy; intercostal block; remove superficial tumour; bronchoscopy, oesophagoscopy, dilatation K. NEUROSURGERY: EUA; LP, spinal drug administration, drainage; myelogram, angiogram, air encephalogram; nerve block; drain ventricle via existing burr hole or fontanelle; bone biopsy L. PLASTIC SURGERY: plastic excision, repair small wound, scar, small skin grafts (under local anaesthetic) M. MEDICINE: gastroscopy, bone marrow trephine/biopsy, paracentesis pleura/peritoneum * Adapted from: Updated regulations governing private hospitals and unattached operating theatre units (published under Government Notice No. R.158 in Government Gazette No. 6832 of 1 February 1980 and amendments).
|Printer friendly Cite/link Email Feedback|
|Title Annotation:||More about ... office-based surgery|
|Author:||Potgieter, Andre "JA"; Grobler, Stephen|
|Publication:||CME: Your SA Journal of CPD|
|Date:||Sep 1, 2009|
|Previous Article:||Office-based plastic surgery--Beverley Hills Dr 90210?|
|Next Article:||Sedation and analgesia by non-anaesthesiologists.|