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Unattached operating theatres.

Many surgical specialties currently provide their patients with cost-effective surgical procedures that are performed safely in an office-based setting. The office surgery may at times be a more 'risky' environment for patients, compared with formal hospital theatres. Governance of these matters is clearly inadequate in South Africa and exposes the office operator to legal and ethical concerns. Organisation, construction and equipment, policies and procedures Policies and Procedures are a set of documents that describe an organization's policies for operation and the procedures necessary to fulfill the policies. They are often initiated because of some external requirement, such as environmental compliance or other governmental , including fire, safety, drugs, emergencies, staffing, training and unanticipated patient transfers are among the many issues that need to be considered.

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 The rules and regulations enacted by an association or a corporation to provide a framework for its operation and management.

Bylaws may specify the qualifications, rights, and liabilities of membership, and the powers, duties, and grounds for the dissolution of an
, South African Bureau of Standards Bureau of Standards
 since 1988 U.S. National Institute of Standards and Technology (NIST)

Agency of the U.S. Department of Commerce responsible for the standardization of weights and measures, timekeeping, and navigation.
, 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 a·bove·men·tioned  
adj.
Mentioned previously.

n.
The one or ones mentioned previously.
 statutes, common law, legal precedents, delictual and criminal liability and HPCSA HPCSA Health Professions Council of South Africa  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 The South African Medical Association (SAMA) is a trade union in South Africa. It is affiliated with the Congress of South African Trade Unions. External links
  • SAMA at the COSATU.
 (SAMA sama

In Sufism, the practice of listening to music, chanting, and dancing as a means of producing a state of religious ecstasy and mystical trance. Practitioners hold that music prepares the soul for a deeper comprehension of divine realities and a better appreciation of
)'s Doctors' Billing Manual (DBM (DeciBels below 1 Milliwatt) A measurement of power loss in decibels using 1 milliwatt as the reference point. A signal received at 1 milliwatt yields 0 dBm. A signal at .1 milliwatt is a loss of 10 dBm. See deciBel and dBA. ) 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 hemostasis, haemostasis
the stoppage of bleeding or cessation of the circulation of the blood; stagnation of the blood in a part of the body. Also hemostasia, haemostasia.
See also: Blood and Blood Vessels

Noun 1.
 and ablation of lesions, ENT ENT ears, nose, and throat (otorhinolaryngology).

ENT
abbr.
ear, nose, and throat



ENT

ear, nose and throat.

ENT Ears, nose & throat; formally, otorhinolaryngology
 endoscopic procedures

* general, orthopaedic, podiatry podiatry (pōdī`ətrē, pə–), science concerned with disorders, diseases, and deformities of the feet, also called chiropody. Podiatrists treat such common conditions as bunions, corns and calluses, and ingrown toenails. , neurosurgery and plastic surgery: more extensive procedures and rearrangements, liposuction Liposuction Definition

Liposuction, also known as lipoplasty or suction-assisted lipectomy, is cosmetic surgery performed to remove unwanted deposits of fat from under the skin.
, radio-frequency ablation, anorectal a·no·rec·tal
adj.
Relating to the anus and the rectum.



anorectal

pertaining to, emanating from or affecting the anorectum.


anorectal abscess
see perianal fistula.
 procedures (see the article on minor anorectal surgery in the office, p. 412 of this issue), ENT and ophthalmology

* obstetrics and gynaecology Obstetrics and Gynaecology (often abbreviated to OB/GYN or O&G) are the two surgical specialties dealing with the female reproductive organs, and as such are often combined to form a single medical speciality and postgraduate training program. : hysteroscopy, suction biopsy, endometrial ablation, terminations, infertility procedures

* dental and maxillofacial maxillofacial /max·il·lo·fa·cial/ (-fa´sh'l) pertaining to the maxilla and the face.

max·il·lo·fa·cial
adj.
Relating to or involving the maxilla and the face.
 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 International Organization of Standardization,
n.pr a nongove-rnmental federation of worldwide bodies that publishes international agreements covering a broad range of services and technologies to promote the use of common standards across the world.
 (ISO (1) See ISO speed.

(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI.
: 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 COHSASA Council for Health Service Accreditation of Southern Africa : 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 Joint Commission on Accreditation of Healthcare Organizations,
n.pr the United States body that accredits healthcare organizations.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO/TJC),
n.
 (JCAHO JCAHO Joint Commission on Accreditation of Healthcare Organizations, see there : http://www.jointcommission.org), Accreditation Association for Ambulatory Health Care (AAAHC AAAHC Accreditation Association for Ambulatory Health Care : http://www.aaahc.org) and the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF AAAASF American Association for Accreditation of Ambulatory Surgery Facilities : http://www.aaaasf.org/).

These (to-be-developed) local guidelines must take cognisance COGNISANCE, pleading. Where the defendant in an action of replevin (not being entitled to the distress or goods which are the subject of the replevin) acknowledges the taking of the distress, and insists that such taking was legal, not because he himself had a right to distrain on his own  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.

Conclusions

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.

References

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 OBS
abbr.
organic brain syndrome


OBS Organic brain syndrome, see there
) Accreditation, USA. (accessed June 2009).

4. The Australian Day Surgery Council (Royal Australasian College of Surgeons The Royal Australasian College of Surgeons (RACS) is the body responsible for training and examining surgeons in New Zealand and Australia. The head office of the College is in Melbourne, Australia.

RACS was formed in 1927.
. 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 FCS - Frame Check Sequence  (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 (drpottie@mweb.co.za)
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).
COPYRIGHT 2009 South African Medical Association
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2009 Gale, Cengage Learning. All rights reserved.

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Title Annotation:More about ... office-based surgery
Author:Potgieter, Andre "JA"; Grobler, Stephen
Publication:CME: Your SA Journal of CPD
Geographic Code:6SOUT
Date:Sep 1, 2009
Words:1571
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