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DISTRICT COURT OF NSW MEDICAL TRIBUNAL 40026/99 15 AUGUST 2001

IN THE DISTRICT COURT OF

NEW SOUTH WALES

MEDICAL TRIBUNAL

40026 of 1999

THE MEDICAL PRACTICE ACT 1992

IN RE DR GEORGE DASKALOPOULOS

DEPUTY CHAIRPERSON HER HONOUR JUDGE M SIDIS

MEMBERS ASSOCIATE PROFESSOR J DUGGAN AM

DR C CLIFTON

MS A DEVESON AO

DATE OF DETERMINATION 15 AUGUST 2001

Pursuant to Clause 6 of Schedule 2 to the Medical Practice Act 1992 the Tribunal has made a Non Publication Order in respect of the names of or any material which may identify the patients affected by or called in the proceedings. ORDERS 1. The Tribunal finds the practitioner guilty of unsatisfactory professional conduct.

2. The Tribunal orders that the practitioner be reprimanded.

3. The Tribunal publishes its reasons.

COPYRIGHT PAGE NO 1 OF 44


DETERMINATION

Pursuant to Clause 6 of Schedule 2 to the Medical Practice Act 1992 the Tribunal has made a Non Publication Order in respect of the names of or any material which may identify the patients affected by or called in the proceedings.

NATURE OF COMPLAINT

Pursuant to the Medical Practice Act 1992 (the Act), the Tribunal is enquiring into a

Complaint1 of the Commissioner, Health Care Complaints Commission, concerning

the professional conduct of Dr George Daskalopoulos (the practitioner).

The Commissioner complains that the practitioner, being a medical practitioner

registered under the Act, has been guilty of professional misconduct or unsatisfactory

professional conduct within the meaning of ss 36 and 37 of the Act in that he

demonstrated a lack of adequate knowledge, skill, judgment or care in the practice of

medicine.

Particulars set out in the Complaint are as follows:

1. Between about the 1 February 1999 and 7 June 1999, the practitioner failed to

ensure that an appropriate order was made for contrast medium to be used

during endoscopic retrograde cholangiopancreatography (ERCP) procedures

at Canterbury District Hospital.

2. Between about 1 February 1999 and 7 June 1999, the practitioner failed to

check that the contrast medium being used was appropriate for ERCP

procedures performed by him on a number of patients at Canterbury District

Hospital.

3. Between about April 1999 and 7 June 1999 the practitioner failed to take

appropriate preventative action concerning adverse outcomes of ERCP

1 Exhibit F, Tab 1 COPYRIGHT PAGE NO 2 OF 44


procedures performed by him at Canterbury District Hospital in circumstances

when he knew or ought to have known of patients suffering a higher incidence

of complications following ERCP procedure performed by him.

Unsatisfactory Professional Conduct

The Complaint falls to be determined under Section 36 (1) (a) of the Act which

provides:

Meaning of ‘unsatisfactory professional conduct’ (1) For the purposes of this Act, unsatisfactory professional conduct of a

registered medical practitioner includes each of the following: (a) Lack of skill etc

Any conduct that demonstrates a lack of adequate knowledge, skill, judgment or care, by the practitioner in the practice of medicine.

Professional Misconduct

Section 37 of the Act defines professional misconduct as:

“....unsatisfactory conduct of a sufficiently serious nature to justify suspension of the practitioner from practising medicine or the removal of the practitioner’s name from the Register.”

The obligations of medical practitioners are encapsulated by Priestley JA in his

minority judgment in Richter v Walton2 in the following terms:

“The degree of trust which patients necessarily give to their doctors may vary

according to the condition which takes the patient to the doctor. Even in regard to the most commonplace medical matters, the trust a patient places in a doctor is considerable. In some cases, of which the present seems to be an example, the patient’s trust cannot help but be almost absolute. The doctor’s power in regard to the patient in such cases is also very great. I do not mean power in the abstract way but as a matter of fact; the extent of the power will vary according to the temperament of the patient, but the doctor with some patients and for limited periods, because of the relationship in which they are

2 NSW Court of Appeal, unreported, 15.7.93 COPYRIGHT PAGE NO 3 OF 44


temporarily placed, is in a position to do whatever the doctor wants with the body of the patient. This is one of the reasons why doctors are subject to correspondingly great obligations and are expected to maintain high standards; all this being very much in the public interest.”

The majority decision in Richter v Walton was over-ruled in Health Care Complaints

Commission v. Litchfield3 where it was stated that the dissenting judgment of

Priestley JA was entirely correct.

Onus and Standard of Proof

After reference to Rejfek v McElroy4 the Court of Appeal accepted in Bannister v

Walton5 that the standard of proof requires that the Tribunal be ‘comfortably satisfied

on the balance of probabilities’. The Commissioner bears the onus of satisfying the

Tribunal that the Complaint has been proved to this standard.

The Tribunal must have regard to the gravity and importance of the matters which it is

deciding in accordance with the principles stated in Briginshaw v Briginshaw6. At

pages 361 and 362 Sir Owen Dixon stated:

“Except upon criminal issues to be proved by the Prosecution it is enough that the affirmative of an allegation is made out to the reasonable satisfaction of the Tribunal. But reasonable satisfaction is not a state of mind that is obtained or established independently of the nature or consequence of the fact or facts to be proved. The seriousness of an allegation made, the inherent unlikelihood of an occurrence of a given description, or the gravity of the consequences flowing from a particular finding are considerations which must affect the answer to the question whether the issue has been proved to the reasonable satisfaction of the Tribunal. In such matters “reasonable satisfaction” should not be proved by inexact proofs, indefinite testimony, or indirect inferences.”

3 41 NSWLR 630 @ 639 4 (1965) 112 CLR 517 5 (1993) 30 NSWLR 699 6 (1938) 60 CLR 336 COPYRIGHT PAGE NO 4 OF 44


Preliminary Applications

Objections were raised on behalf of the practitioner to certain aspects of the evidence

presented by the Complainant on the basis that they were not particularised in the

Complainant’s letter of 19 October 20007.

For reasons given on 2 July 20008, the objection was determined in favour of the

practitioner in respect of evidence dealing with the issue of whether ERCP procedures

should have been suspended.

It was noted that some of the material of the Complainant responded to the

practitioner’s supplementary statement9 dated 2 July 2001, the first day of the

hearing, which contained information not known to the Complainant until that date.

The particulars supplied by the Complainant in October 2000 could not, of course,

have been directed to this further information.

Nevertheless, the Tribunal determined that the evidence called and questions asked

after late receipt of this information were directed at the issues raised in the

particulars provided.

At the conclusion of the evidence for the Complainant submissions were made on

behalf of the practitioner seeking the dismissal of those parts of the Complaint to

which particulars 1 and 3 related. A request was also made to amend particular 2 in

relation to the dates specified.

The Tribunal declined these requests for reasons which were delivered on 10 July

200110.

7 Part Exhibit K 8 Transcript p.15 9 Exhibit 1(b) 10 Transcript, p.188 COPYRIGHT PAGE NO 5 OF 44


PRACTITIONER’S BACKGROUND AND EXPERIENCE

The practitioner is a registered and legally qualified medical practitioner specialising

in gastroenterology. He is aged 51 years.

Qualifications

January 1975 MBBS, University of New South Wales

January 1983 Fellow, Royal Australasian College of Physicians

June 1985 Fellowship in Hepatology, University of Southern California,

USA

Memberships

Royal Australian College of Physicians

Gastroenterology Society of Australia

Since graduation the practitioner has held a number of appointments and has engaged

in private practice. He has undertaken postgraduate studies in Australia and overseas.

He regularly attends clinical meetings and conferences. He has collaborated in the

publication of numerous papers and some texts.

At the time of the incidents which are the subject of the Complaint he held the

position of Visiting Medical Officer, Gastroenterology, Canterbury District Hospital.

He had occupied the position since 1991.

His full curriculum vitae is attached as Annexure A to his statement11.

His practice involves general gastroenterology and hepatology and procedural

gastroenterology, including endoscopic ultrasonography. The practitioner states that

he has performed 25,000 endoscopies, including, since 1980, 1600 ERCP procedures.

11 Exhibit 1(a) COPYRIGHT PAGE NO 6 OF 44


BASIS FOR THE COMPLAINT

1. The Complaint is made in respect of a number of patients treated by the

practitioner with ERCP procedures at Canterbury District Hospital (the

Hospital) between 1 February 1999 and 7 June 1999.

The Complaint arises out of the use during ERCP procedures carried out by

the practitioner at the Hospital of Phenol 10% in 60% Conray 280 as a

contrast medium.

2. There is no dispute that Phenol 10% in 60% Conray 280 was:

2.1 inappropriate for use as a contrast medium;

2.2 toxic;

2.3 a therapeutic substance, classified under the Poisons and Therapeutic

Goods Regulation 1994;

2.4 a substance that required the prescription of a medical practitioner

before it could be supplied; and

2.5 supplied for the purposes of the practitioner’s ERCP procedures by

reason of error and gross departure from protocol on the part of the

Pharmacy of the Hospital.

3. The issues in this inquiry go to the practitioner’s conduct in the process of

ordering or checking contrast medium or in taking preventative action after his

patients suffered higher than usual rates of complications following ERCP

procedures in which Phenol 10% in 60% Conray 280 was used as a contrast

medium.

4. In paragraph 7 of his statement the practitioner describes the ERCP procedure

in the following terms:

It is a procedure in which dye is put into the bile and/or pancreatic ducts, after which an x-ray is taken to visualise the blockage in the bile duct. The procedure is normally done in hospital.



A more detailed description of the procedure is set out in the report of CSAHS

Internal Review12 of October 1999 which adds the following information:

The entry point into the duodenum of the common bile duct is cannulated so that contrast medium can be injected and therapeutic manoeuvres, such as removal of a gall stone in the common bile duct, carried out. Once the contrast medium has been injected, x-rays are taken using an image intensifier. This allows immediate viewing of the x-rays and immediate decisions about any therapeutic manoeuvres that are required.

5. The contrast medium used by the practitioner prior to the events which are the

subject of this inquiry was Conray 280. It is described in the Review:

Conray 280 is an iodine containing radiographic contrast medium used to assist in the visualisation of vasculature and organs during radiographic procedures. While it is still used in the health system, it has been replaced to a large extent in recent years by ‘non-ionic’ contrast media. Its main uses were in angiography and urography, the latter because it is rapidly excreted by the kidneys after intravenous injection. Phenol was described:

Phenol is an antiseptic and disinfectant chemical, also known as carbolic acid. …It acts by denaturing protein and has antiseptic effects against a wide range of micro-organisms at concentrations of 1-2%. At concentrations of 5% and above, it is irritant to tissues and for this reason is used for disinfection of inanimate objects and surfaces. It is caustic and corrosive and should be used with due regard to occupational health and safety. … When used as intended, solutions containing higher concentrations of phenol cause sclerosis of the injected area. The specialists involved in the ongoing care of the affected patients were unable to identify any descriptions in the medical literature of the effects of phenol when injected into the bile and/or the pancreatic ducts.

12 Exhibit F, Tab B COPYRIGHT PAGE NO 8 OF 44


Phenol 10% in 60% Conray 280 was described:

Phenol 10% in 60% Conray 280 is a specialised product produced by the firm Ophthalmic Laboratories in its manufacturing facility in Sydney. It is not a registered pharmaceutical product, but it is produced under approval from the Therapeutic Goods Administration (TGA) for specific therapeutic purposes. … The only use for Phenol 10% in 60% Conray 280 is the chemical ablation of nerves in persons with chronic pain of vascular conditions. The therapeutic agent in the product is the phenol, the Conray 280 simply being added to allow accurate localisation of the injection. Phenol 10% in 60% Conray 280 has been used in hospitals in CSAHS for several years for it is recommended purpose. It had never been supplied to Canterbury Hospital until January 1999. The vial containing Phenol 10% in 60% Conray 280 is different from that of plain Conray 280. The vial size is 5mls rather than 20mls, the colour is opaque brown rather than clear and the writing is a different colour. The vial is clearly labelled ‘Phenol 10% in 60% Conray 280’ and ‘Use Under Strict Medical Supervision - Caustic Substance’. … Each box contains 10 vials. Because it is manufactured for a specific purpose, no product literature is provided with the product.

Evidence for the Commissioner

The evidence presented on behalf of the Commissioner concerning the factual

background comprised:

Exhibit C1 specimen bottle of Conray 280, 50 ml size

Exhibit C2 specimen bottle of Conray 280, 20 ml size

Exhibit D specimen vial of Phenol 10% in 60% Conray 280, 5 ml size

Exhibit E folder containing schedule of patients and operating schedules

Exhibit F folder, being Vol 1 of HCCC materials, including reports,

correspondence with the practitioner, witness statements and

other documents

Exhibits G, H, J folders, being Vols 2, 3 and 4 of HCCC materials, concerning

patients 1 - 24

Exhibit K particulars of the Complaint



Exhibit L syringe of the type used in the ERCP procedure

Exhibit M white box containing nine vials of Phenol 10% in 60% Conray

280

Exhibits N-S, W,) Operating Suite Nurses’ Reports, Endoscopy Examination

Y, Z, AA-CC ) Reports and Hospital file covers

Exhibit T The curriculum vitae of Dr Stewart

Exhibit U Letter Mr Took, solicitor to Dr Speer, 13.8.99

Exhibit V Letter Mr Brown, solicitor to Dr Byrnes, 14.1.00

Exhibit X Documents produced under summons by the practitioner

The following witnesses were called to amplify and to be cross-examined on their

statements:

Dr Stewart13

Ms Scandrett14

Ms Pasten15

Ms Nicholls16

Ms George17

Dr Makarie18

Dr McNamara19

Dr Horvath20

Evidence for the Practitioner

The evidence presented on behalf of the practitioner comprised:

Exhibit 1(a) Practitioner’s statement 8.5.00

Exhibit 1(b) Practitioner’s statement 2.7.01

13 Exhibit F, Tab B (Dr Stewart being a joint author of this report) 14 Exhibit F, Tab 11 15 Exhibit F, Tab 17 16 Exhibit F, Tab 19 17 Exhibit F, Tab 25 18 Exhibit F, Tab 37 19 Exhibit F, Tab 40



Exhibit 2 Statement of Mr Brown 9.5.00

Exhibit 3(a) Report of Dr Speer 22.9.00

Exhibit 3(b) Report of Dr Speer 10.9.99

Exhibit 3(c) Curriculum vitae of Dr Speer

Exhibit 4(a) Report of Dr Byrnes 8.8.00

Exhibit 4(b) Report of Dr Byrnes 10.10.00

Exhibit 4(c) Letter of instruction 12.7.00

Exhibit 4(d) Letter of instruction 29.9.00

Exhibit 5 Statement of Dr Ho 5.7.01

Exhibit 6 Patient list prepared on behalf of Dr Jagger

Exhibit 7 List of practitioner’s patients 1.2.99 to 7.6.99

Exhibit 8 Letter Professor Bokey to Dr Horvath 9.6.99

Exhibit 9 Draft and final form of letter Dr Horvath to Complainant 1.7.99

Exhibit 10 Letter Complainant to Dr Horvath 2.9.99

Exhibit 11 Learning Center Program, American Society for Gastrointestinal

Endoscopy Digestive Disease Week, May 1999

Exhibit 12 8 Testimonials

The following witnesses were called to amplify and to be cross-examined on their

statements:

The practitioner

Dr Ho

Dr Byrnes

Dr Speer

Dr Jagger, Director of Medical Services, Canterbury Hospital, was also called by the

practitioner in connection with a summons for the production of documents.

20 Exhibit F, Tab 2 COPYRIGHT PAGE NO 11 OF 44


FACTUAL BACKGROUND

1. The practitioner performed ERCP procedures on a regular basis at the Hospital

between 1991 and 1999. Some patients came from wards within the Hospital,

others were treated through the Day Procedure Unit on the basis that they were

to be discharged on the same day. However, if they suffered complications

they were admitted to the Hospital.

2. Until 1996 ERCP procedures were carried out in the X-ray Department at the

Hospital. The X-ray Department supplied the contrast medium.

In the course of redevelopment work at the Hospital the practitioner and his

unit were transferred to Concord Hospital Radiology Department. On transfer

back to the Hospital in July 1998, the ERCP procedures were undertaken in

the operating theatre suite. The evidence suggests that this was done because

it was considered that there were better facilities in the operating theatre suite

for recovery of patients after a procedure. The practitioner stated that he

objected to this change because he preferred the better quality images

available from the equipment in the X-ray Department.

3. At the same time responsibility for the supply of contrast medium was

transferred from the X-ray Department to the Pharmacy at the Hospital. The

practitioner stated that he was not informed of this system change and that he

remained unaware of it until 7 June 1999.

4. The contrast medium initially used was Urografin. This was changed to

Conray 280 in 1996, again, according to the practitioner, without reference to

him and without his knowledge until some months later.

5. There is evidence of a protocol21 for the ERCP procedure dated April 1992.

On the evidence this protocol has never been updated. It contains reference to

the X-ray Department of the Hospital and under the heading Drugs, there is



reference to Urografin. The practitioner denied any knowledge of or

responsibility for this document, except that he was aware that such a protocol

must have existed because the Hospital had been and in 1999 remained

accredited22.

6. There is evidence of a surgeon’s preference sheet23 which is undated. This

document bears the name of the practitioner as the surgeon and refers to

Conray, with no reference to type or bottle size. The statement of Ms Jones24

indicated that this document is surgeon specific and is updated by the theatre

nurses annually. The practitioner denied any knowledge of or responsibility

for this document, stating that it was prepared by theatre nurses for their own

use25.

7. In late 1998 there was a change in Pharmacy staff at the hospital. A new

Pharmacy clerk, Ms Toubia, was employed in November 1998. She was given

some training by the retiring clerk. Her responsibilities included ordering

stock on receipt of requisitions placed by theatre staff.

According to Ms Toubia26, she received an order for Conray for which she

could find no catalogue number. She therefore searched in the Hospital

computer under its Oracle system. Ms Toubia had no password with which to

access this computer system. She was permitted to use the password issued to

Mr Fung, the Hospital’s chief pharmacist. The only reference which

Ms Toubia could find to Conray in the Oracle system was to Phenol 10% in

60% meglumine iothalamate. She placed an order for this substance.

Ms Toubia proceeded with other orders. When the computer screen was full

with orders she asked the pharmacist to approve the order. This was done by

entering a password.

21 Exhibit F, Tab 39c 22 T.200-202 23 Exhibit F, Tab 39d 24 Exhibit F, Tab 20 25 T200-202



The materials ordered were delivered next day and placed on the Pharmacy

shelves.

8. According to Ms Nicholls, she first used this contrast medium on the

22 March 1999. She stated that she was told of the change by Ms Naicker.

Ms Naicker had since November 1998 held the position of Acting Floor

Manager (Nursing Unit Manager, level 2) of the operating theatre at the

Hospital.

Ms Naicker’s statement27 contained no reference to her giving any advice to

Ms Nicholls concerning a change in contrast medium. She was not called to

give evidence before the Tribunal.

9. Ms Nicholls also stated that she questioned the size of the bottle in which the

contrast medium was provided because of the difficulty she encountered in

drawing the material into the syringe. The evidence of Ms Naicker and of the

Pharmacy staff confirmed that such an inquiry was made. The response to the

inquiry was that this was the only size in which the medium was supplied.

10. Ms Nicholls worked with the practitioner as his instrument nurse for a period

of four years. She said that during that period the practitioner did not ask to

check the bottles from which the contrast medium was drawn. She said the

bottles were always in the view of the practitioner.

11. The evidence of the practitioner and other medical experts indicated that

complication rates resulting from ERCP procedures of up to 20%- 25% were

not unusual.

26 Exhibit F, Tab 34 27 Exhibit F, Tab 29 COPYRIGHT PAGE NO 14 OF 44


12. Operating Suite Nurses’ Reports were completed after each procedure. A

number of those reports specifically referred to 10% Phenol in 60% Conray.

The reports are signed by the practitioner, the instrument nurse and the scout

nurse. There was a conflict on the evidence concerning the purpose of and the

use which was made of these reports.

13. Ms George was the scout nurse on 22 March 1999. She stated that in the

course of setting up in preparation for the procedure on patient 7 she read

aloud in the presence of Ms Nicholls: Phenol 10% in 60% Conray 280

and said: the label says caustic. According to Ms George, Ms Nicholls

responded: Yes.

Ms George stated that the practitioner was in the operating theatre at the time

but was a number of metres away. She did not check the contrast medium

with him. The ERCP procedure was then carried out on patient 7 without

apparent complication.

A procedure was carried out on patient 8 later on the same day. On this

occasion, according to Ms George, she did not check the contrast medium with

the practitioner because she had previously checked it with Ms Nicholls and

the practitioner had not asked Ms Nicholls or Ms George to show him the

vials or the syringe. Again there was no record of complications.

14. Ms George identified a white box28 as similar to the container in which the

Phenol 10% in 60% Conray 280 had been packed in 2 rows of bubble

wrapped vials. She stated that there were no labels on the white boxes which

she retrieved from a non-secure medications cupboard close to the operating

theatre. In particular the boxes were not marked as containing therapeutic

medication. Had they been so marked, it would have been necessary to keep

them in a secure cupboard. There was no information sheet concerning the

medication in the box.



15. In the course of her duties as scout nurse, Ms George completed the following

Operating Suite Nurses’ Reports:

patient 7, 22 March 199929

patient 8, 22 March 199930

patient 13, 3 May 199931




In each case she entered into the space marked medications the words Phenol

10% in 60% Conray 280, with the exception of the report in respect of patient

14. In that case nothing has been entered into the report concerning

medications.

Ms George stated that her practice was to complete her entries into the reports

in the early stages of each procedure and before the report was signed by the

practitioner.

16. Statements of other scout nurses assisting Ms Nicholls indicate that a similar

process was adopted up to 7 June 1999. In no case prior to that date was the

contrast medium checked with the practitioner.

17. On 3 May 1999 four patients were treated by the practitioner. Annexure C2 to

the practitioner’s statement35 of 8 May 2000 indicated that all of these patients

suffered complications and were admitted to the Hospital.

18. On 7 June 1999 after completing an ERCP procedure in respect of patient 24

the practitioner became aware that Phenol 10% in 60% Conray 280 had been

28 Exhibit M 29 Exhibit N 30 Exhibit O 31 Exhibit P 32 Exhibit Q 33 Exhibit R 34 Exhibit S 35 Exhibit 1(a) COPYRIGHT PAGE NO 16 OF 44


used as a contrast medium. The circumstances in which he was alerted to the

situation are in dispute.

19. Ms Nicholls confirmed that the practitioner had not seen the vial from which

the dye had been taken prior to the procedure on 7 June 1999. She said he did

not ask to see it and it had not been his practice to do so in the four years that

she had been working with him on ERCP procedures.

20. The Hospital administration was notified immediately.

21. Professor Richard Smallwood, Head of Medicine, Austin & Repatriation

Medical Centre, was commissioned to review the medical care provided to

patients affected by the administration of the incorrect contrast medium. His

report is dated 16 August 1999 and is appended to the CSAHS Internal

Review. It states:

Of the 17 Group B patients, some did appear to show evidence of acute damage to bile ducts and/or the pancreas after ERCP, and a significant proportion of these remain unwell and/or showing abnormalities of liver function tests and serum amylase. All patients remain under the surveillance and care of gastroenterologists except for the patient who received no injection: she has been referred back to her family practitioner.

…continued surveillance and care by experts will be required into the future,

since the natural history and long-term consequences of any damage to bile ducts or pancreas which might have resulted from the injection of the phenol are unknown.

ASSESSMENT

1. The unusual circumstances of this case raise a number of serious issues. They

were circumstances where numerous preventable errors were made within the

Hospital system. The result of those errors was the supply to the practitioner’s

operating theatre as contrast medium of Phenol 10% in 60% Conray 280. The

qualities of this substance have already been noted in this Determination.

They are such that, on the evidence of each of the three experts called as peer

reviewers, a proceduralist would not in his or her wildest dreams expect to



find Phenol 10% in 60% Conray 280 supplied in lieu of a true contrast

medium.

2. The CSAHS Internal Review identified ten potential check points in the

process of ordering, supply and use of pharmaceutical products in the Hospital

theatres:

2.1 on ordering of drugs by theatre using the imprest requisition system 2.2 on filling of the imprest order by pharmacy

2.3 on ordering of drugs by pharmacy, through PSS, using the Oracle

system 2.4 on resupply of stock to pharmacy by PSS 2.5 on resupply of stock to PSS by the manufacturer 2.6 on restocking of the Theatre Imprest Store by a Recovery Nurse 2.7 on the removal of the product from the Imprest Store by a nurse for use 2.8 on checking by the instrument nurse with the scout nurse that the

correct product has been provided 2.9 on the checking by the instrument nurse with the doctor performing the

procedure that the correct product has been provided 2.10 on completing and signing the Operating Suite Nurses’ Report.

3. Aside from these check points there were other factors present which

contributed to delay in discovering the error in supply. They include the

transfer of ERCP procedures from the X-ray Department to the operating

theatre suite; the transfer of responsibility for the supply of contrast medium

from the X-ray Department to the Pharmacy, particularly in circumstances

where the practitioner was not informed or consulted on the change; the

employment of an instrument nurse who had not been trained to the standards

of the Gastroenterological Nurses Society of Australia (GENSA); the high

turnover of other nursing staff within the operating theatre and the engagement

on frequent occasions of agency nursing staff with the result that many were



unfamiliar with the specialised procedures of endoscopy generally and of

ERCP in particular.

Finally, there was the failure on the part of the apparently experienced

instrument nurse, Ms Nicholls, to question the practitioner about the

appropriateness of the use of Phenol 10% in 60% Conray 280 when it was

supplied in smaller 5 ml bottles which were brown rather than clear, when it

was differently described from Conray 280 and when the bottles were labelled

Use Under Strict Medical Supervision - Caustic Substance.

4. However, in considering what the practitioner did or might have done, it

seemed to the Tribunal that it was necessary to put to one side the enormity of

the errors on the part of the Hospital and its staff. The focus its inquiry was

required to be the conduct of the practitioner in the circumstances where the

use of Phenol 10% in 60% Conray 280 in ERCP procedures lead to the result

that patients treated by him developed higher than usual rates of

complications.

5. The Complainant argued that the evidence established that there were a

number of clues which ought to have alerted the practitioner to the need to

investigate the contrast medium as a source of the increased complication rate.

Those clues included:

5.1 Operating Suite Nurses’ Reports

Review of a number of these reports as early as 22 March 1999 at the

time of signature by the practitioner or in the course of investigation of

the reasons for repeated cases of complication would have revealed in

many cases that Phenol 10% in 60% Conray 280 had been used as the

contrast medium.

The reports were each signed by the practitioner. He stated that his

signature validated only the information appearing above it, relating to



the procedure undertaken and the item count, and that he was not

concerned with and never paid attention to the information appearing

on the report below his signature.

The reports were placed on the Hospital files for each patient. The

practitioner agreed that those files were readily available to him but he

did not refer to them in the course of his deliberations.

The practice of not referring to Hospital records, including Operating

Suite Nurses’ Reports, when investigating problematic cases was

confirmed by Dr McNamara, peer reviewer called on behalf of the

Complainant, and by Dr Byrnes and Dr Speer, called on behalf of the

practitioner.

Dr Speer, in particular, stated that in such a situation, his practice

would be to rely on his memory of his treatment of the patient since

Hospital files recorded findings rather than the actual procedures

undertaken. All expert reviewers stated that they paid no regard to the

nurses’ records. All stated that they would disregard the material in

the Operating Suite Nurses’ Reports which appeared below the line of

the practitioner’s signature.

This attitude, being unanimously expressed, is of course accepted by

the Tribunal as that which prevails amongst the medical profession.

The nursing profession appears to take a different view of the effect

and purpose of the Operating Suite Nurses’ Reports.

Ms Jones36, Nurse Manager, Theatres, stated her view that the

surgeon’s signature on the report indicated acceptance by the surgeon

that the material contained in the report was correct.



The CSAHS Review37 recorded as a firm view of the authors of the

document that in signing the report the practitioner acknowledged and

approved its accuracy, including the approval of any medications listed

as having been administered.

The Tribunal noted that the ambiguities concerning the effect of the

purpose of obtaining the surgeon’s signature and the position of that

signature on the Operating Suite Nursing Report was one of the

criticisms raised by the Complainant with the CSAHS38 and that

recommendations have been made to remedy these ambiguities.

Having made these comments, the practitioner’s failure to review all of

the material on the Operating Suite Nurses’ Reports at the time of

signing them or in the course of investigation of the incidence of

increased complications is regrettable but does not of itself or in

conjunction with other factors lead the Tribunal to any finding against

the practitioner.

5.2 The size and colour of the bottle or vial in which Phenol 10% in

60% Conray 280 was supplied

Exhibits C1 and C2 are specimen bottles of Conray 280 in 50ml and

20ml sizes respectively. The bottles are manufactured from clear

glass. There was evidence that contrast medium was drawn up in 20

ml syringes and that the practice of supplying Conray in 50 ml bottles

was changed to 20 ml bottles to guard against the possibility of

infection through the need to draw repeatedly from the larger bottle.

The bottle or vial containing Phenol 10% in 60% Conray 280 is

markedly different in appearance. It is manufactured of brown glass

and supplies only 5 ml of its contents so that it is much smaller in size.

36 Exhibit F, Tab 20 37 Exhibit F, Tab, 6.2.10



There was evidence that the change in size of the bottle was drawn to

the practitioner’s attention on about 19 April 1999 when Ms Nicholls

was required to draw up more contrast medium in the course of an

ERCP procedure. She commented that it was harder to draw up

because of the smaller size of the bottles.

In addition, according to Ms Nicholls, the bottles were retained in the

operating theatre and were in the view of the practitioner, although he

did not ask to see them.

The practitioner stated that it was the responsibility of the instrument

nurse, Ms Nicholls, to check the contrast medium with the scout nurse,

prior to drawing it up. Ms Nicholls confirmed that it was her practice

to check the contrast medium with the scout nurse.

There was a suggestion in the evidence that this practice was not

universally adopted.

On 7 June 1999 Ms Scandrett was the scout nurse working with Ms

Nicholls. She had been engaged through an agency providing theatre

nursing staff. Ms Scandrett said that it had been her practice and her

experience when using contrast medium or any other substance

whether it be saline, water or local anaesthetic, to show the container

to the surgeon prior to the commencement of the procedure.

The CSAHS Internal Review stated that it is accepted practice for the

surgeon involved in the procedure to check any product being

administered by viewing the vials or by having the product name read

out to her or him before administration of the product. Dr Stewart who

was called for cross-examination on this Review stated that this

information was provided by a co-author, Associate Professor Englert.

38 Exhibit 10 COPYRIGHT PAGE NO 22 OF 44


This information was apparently the basis for the finding in section 6

of the Review that the major breach was non-compliance with Hospital

policy and procedure which required that all substances used intra-

operatively be checked with the doctor performing the procedure.

Dr McNamara stated the practice adopted by the practitioner was not

unusual. Dr McNamara appended to her material protocols issued by

Manly Hospital and the Royal North Shore Hospital which she stated

indicated that those hospitals adopted the same practices.

Again Dr Byrnes and Dr Speer agreed that it had not, prior to this

incident, been their practice to check contrast media with nursing staff

before use.

Noting once more the need for the adoption of a standard practice and

for clear communication between medical practitioner and nursing

staff, the failure by the practitioner to take active steps to check the

contrast medium after having been told of the change in size of the

container in which it was supplied does not in isolation from other

factors lead the Tribunal to any finding against the practitioner.

5.3 The increasing incidence of pancreatitis following ERCP

procedures

There is evidence that Hospital Pharmacy first supplied Phenol 10% in

60% Conray 280 for the purpose of ERCP procedures in February

1999. The first evidence of its use, however, appears in Operating

Suite Nurses’ Reports completed on 22 March 1999.

The practitioner and the medical experts are agreed that complication

rates following ERCP in the vicinity of 20%-25% are not unusual.



In his response to the Complaint the practitioner relied upon what he

described as the random nature of the incidence of complications in the

patients treated where Phenol 10% in 60% Conray 280 was used. The

complication rates amongst those patients vary according to the period

of time over which the records are examined.

If 22 March 1999 is taken as the date upon which Phenol 10% in 60%

Conray 280 was first used and 7 June 1999 the last date of use, there

are 21 such procedures. Patient 24 has been excluded from

calculations because she was treated upon discovery of the error. This

leaves 20 patients of whom 9 suffered from pancreatitis and results in a

complication rate of 45%.

If the calculation is taken from 3 May 1999 there are 8 out of 12

patients affected by pancreatitis resulting in a complication rate of

75%.

It will be noted from these figures that the complication rate was

increasing as time went by.

The medical experts agreed that these figures would have caused

alarm, certainly after 3 May 1999 when all of the four patients treated

that day developed pancreatitis, although the evidence suggested that

the condition in patient 16 was mild.

6. This very high complication rate leads to an examination of the evidence

concerning the investigative steps taken by the practitioner and the views of

the medical experts on what they would have done in such circumstances.

7. Steps Taken by the Practitioner

The evidence of the practitioner was that he was well aware of the high

complication rate from early May 1999. Dr Makarie and Dr Ho gave evidence



of his level of concern and of the effort which he made to ascertain the reasons

for the adverse outcomes of so many of the ERCP procedures.

Between early May and 14 May 1999, when he went to the USA to attend a

medical conference, he stated39 that he undertook the following:

7.1 He reviewed procedures and complications by reference to textbooks.

7.2 He reviewed causes of pancreatitis by means of a Medline search,

specifically in relation to ERCP.

7.3 He researched the incidence of pancreatitis in relation to the use of

ionic and non-ionic contrast agents.

7.4 He checked with the X-ray Department’s Chief Radiology Technician

concerning problems that may have been experienced with contrast

agents in that Department. He was told there had been none. He was

unaware at that time that the X-ray Department was not supplying

contrast medium for ERCP procedures.

7.5 He checked the cleaning of the scope. A culture sample, part of the

regular quality control programme, was clear.

Whilst in the USA attending Digestive Disease Week 1999 in Florida:

7.6 He attended the Update Meeting of the American Society for

Gastrointestinal Endoscopy as well as the Learning Centre viewing a

large number of videos, displays and other presentations.

7.7 He checked all abstracts concerning the aetiology of pancreatitis.

On return to the Hospital in late May and early June:

39 Exhibit 1(a), paragraph 35 COPYRIGHT PAGE NO 25 OF 44


7.8 He took action in the performance of ERCP procedures to minimise

the number of cannulations performed and the amount of contrast

injected.

7.9 He attempted to avoid the pancreatic duct all together.

7.10 On 7 June he took a sample of bile for culture to check if infection was

being transmitted in an unexplained fashion. It was on this date that

the cause of the problem became apparent.

8. As to the extent of his knowledge of contrast medium as a potential cause of

the problem, the practitioner gave confused and inconsistent evidence.

In a letter40 to the Complainant dated 9 July 1999 he stated:

My first knowledge of a change in contrast medium was around mid April 1999, when my nursing assistant commented the new contrast was harder to draw up as the new vials were smaller. Upon inquiring about the change she commented that she had checked and this was what we have to use now. I only realised what the new contrast was when I sighted the vial when performing the ERCP on (patient 24) on 7 June 1999.

In his statement41 of 8 May 1999 the practitioner stated:

In about mid-April 1999 my nursing assistant commented to me that she was experiencing some difficulty drawing up the contrast because the new vials which had been supplied were smaller. She stated that she had made an enquiry and that this was what we were now getting and this is what we had to use.

In his supplementary statement42 of 2 July 2001 the practitioner set out in full

the material extracted above from his letter of 9 July 2000 to the Complainant

and stated:

The situation was that in mid-April my nursing assistant did comment as above. This was at a time when I was not aware of any complications and had

40 Exhibit F, Tab 4 41 Exhibit 1(a) 42 Exhibit 1(b) COPYRIGHT PAGE NO 26 OF 44


no reason to suspect that we were receiving anything other than an appropriate contrast.

In his evidence to the Tribunal43, the practitioner denied that he had been

informed by Ms Nicholls in mid-April 1999 that a new contrast medium was

being used.

9. The supplementary statement set out in greater detail the practitioner’s

evidence concerning the inquiry which he made of the X-Ray Department in

mid-May 1999. In the course of this inquiry, according to the practitioner, he

was informed that the X-Ray Department was using a non-ionic contrast

medium known as Ultravist. The practitioner stated that he regarded this as a

safe contrast medium and, apart from investigating the differences between

ionic and non-ionic media, gave no further thought to it as a possible cause of

the increased complication rates. He pointed out that Phenol 10% in 60%

Conray 280 did in fact operate as a contrast medium.

The practitioner agreed in the course of this evidence that his conversation

with Ms Nicholls most probably took place on 19 April 1999 and his inquiry

of the X-ray Department was probably made on about 10 May 1999.

10. The practitioner was tested at length concerning the veracity of this late piece

of evidence. However, the position which he maintained was that Ms Nicholls

made no mention of a new medium in mid-April and that, whatever her

comment, it was made in the course of a difficult and complex ERCP

procedure when his attention was focussed elsewhere.

11. As a result he stated (contrary to paragraph 17 of his statement of 8 May 2000)

that until mid-May 1999 he believed the contrast medium being used in mid-

April 1999 was Conray 280. After his conversation with the X-Ray

Department he believed it to have been Ultravist. He did not check with

Ms Nicholls in mid-April or mid-May 1999 to confirm what she was actually

43 Transcript p.224 COPYRIGHT PAGE NO 27 OF 44


using. He did not ask to review the ERCP procedure or surgeon’s preference

sheet to confirm that they had been updated to make reference to Ultravist. He

did not inquire of Ms Nicholls or the Hospital administration if any such

amendment had been made.

12. For reasons which are set out later in this Determination the Tribunal was

concerned with some aspects of the practitioner’s evidence which caused it to

question his credibility. The late change in this evidence was one such aspect.

After examining this evidence the Tribunal preferred the version put forward

by the practitioner in July 1999 that is, shortly after the occurrence of the

events which are the subject of its inquiry.

It appeared to the Tribunal that in seeking for the first time in evidence before

it to deny that any reference was made to a new medium in the course of the

conversation with Ms Nicholls on 19 April 1999, the practitioner was

attempting to avoid criticism for failing to inquire about the identity of the

contrast medium until about 10 May 1999.

Having said this, however, the Tribunal does accept the evidence that, if the

conversation on 19 April 1999 occurred in the course of an ERCP procedure,

its significance might not have registered with the practitioner as a potential

cause of the higher than usual complication rates later experienced.

THE EXPERT REVIEWS

1. The medical experts agreed that the investigative steps taken by the

practitioner were reasonable. They were also influenced by the fact that not

all patients were affected and by the fact that contrast medium was in their

view a most unlikely cause of the problem the practitioner was attempting to

solve.

They each took a different approach in their evidence of what they would have

done if facing the same circumstances.



2. In response to a question from Tribunal member, Ms Deveson, Dr McNamara

stated that after 3 May 1999 she would have taken the following steps:

2.1 discussion of procedures with Hospital staff;

2.2 checking what was actually going through the endoscope to the bile or

pancreatic duct;

2.3 checking the cleaning process;

2.4 checking changes in solutions, contrast or the condition of the patients

treated;

2.5 looking at every step of the procedure as to where there may have been

some intervention that precipitated an adverse reaction.

3. Dr Byrnes stated44 that he would have undertaken this process by 24 May

1999. Having regard to the practitioner’s absence in the USA from 14 May

1999 so that no procedures were undertaken between 10 May 1999 and 24

May 1999, Dr Byrnes position was close to that of Dr McNamara.

4. Dr Byrnes and Dr Speer would have concentrated upon the sterilisation and

disinfection of equipment. Dr Speer stated that he would have actively

involved the nursing staff in this process, checking not only sterilisation but

the integrity of the equipment used. Dr Speer, because not every patient

developed pancreatitis, would not have undertaken the step by step process

indicated by Dr McNamara.

5. In dealing with the question of whether there should have been some reaction

on the practitioner’s part to the knowledge that a new medium was being used,

either on 19 April 1999 or about 10 May 1999, each of the medical experts

was critical, although to a different degree.

6. Dr McNamara was asked a number of questions both for the purposes of her

report to the Complainant and in her evidence to the Tribunal concerning the



question of whether and in what circumstances the practitioner should have

checked the contrast medium in use. The information received by Dr

McNamara for her reports was provided piecemeal. In her report of 24 July

199945 she stated in answer to question 3:

However, when Dr Daskalopoulos was informed that the ‘new contrast was harder to draw up’ in April 1999 I would have expected Dr Daskalopoulos to check the nature of the contrast medium, since it deviated from previous orders, before ordering the nurse to inject and also the nurse to check the appropriateness of the new contrast with Dr Daskalopoulos before taking responsibility for its injection.

Therefore, in April 1999, once Dr Daskalopoulos was aware there had been a

change in contrast order from the previously accepted procedural guideline, it was inappropriate for him to order the nurse to inject without him checking the nature of the solution and giving his approval for its use.

7. Question 4(c) in the same report asked whether it was appropriate for the

practitioner to deny responsibility for ordering the contrast medium.

Dr McNamara was initially very critical of the practitioner on this aspect. On

receipt of further information she withdrew this criticism but maintained

throughout her evidence her opinion that the practitioner should have checked

the contrast medium after becoming aware in mid-April 1999 that it had been

changed.

This view was maintained notwithstanding her agreement in cross-

examination with a number of propositions put to her on behalf of the

practitioner, including the appropriateness of the practitioner’s reliance on his

nursing assistant with whom he had worked for several years; that it would be

completely unexpected that Phenol 10% in 60% Conray 280 would be

provided for an ERCP procedure; that the practitioner was not informed that

the Pharmacy had taken over the responsibility for the supply of contrast

medium, and that he had inquired of the X-ray Department and was informed

that it was not experiencing any adverse reaction to the contrast medium,

Ultravist, which it was then using.

44 Transcript, p.327 45 Exhibit F, Tab 40(e) COPYRIGHT PAGE NO 30 OF 44


Dr McNamara’s criticisms were more severe in respect of the period after

3 May 1999 when each of the four patients treated that day experienced

complications and again when, according to Dr Makarie, between mid-May

1999 and 7 June 1999 the practitioner made it clear to Dr Makarie that he had

some concerns about the contrast medium.

8. Dr Byrnes drew an analogy with an airline disaster where tragedy is the result

of a chain of events each of which could have averted the ultimate outcome at

a number of stages in its progress. He acknowledged that some of the

consequences at the Hospital could have been averted if the practitioner had

visually checked the new vials on 19 April 1999. However, he was not critical

of the practitioner’s failure to do so on the basis that the information

concerning the vials was provided to him in the course of a stressful and

technically complex procedure.

Dr Byrnes agreed that responsibility for selecting an appropriate contrast

medium should rest with the proceduralist. He stated that ordering and supply

depended upon where the procedure was performed.

9. In dealing with the responsibility of a proceduralist in ensuring that an

appropriate order was placed for contrast medium Dr Byrnes stated46 that it

would be normal practice to meet with nursing staff who would write a unit

manual. This manual would dictate everything that was required for a

particular procedure. At this stage the proceduralist would inform the nursing

staff of what was required for the procedure, including the contrast medium.

Dr Byrnes expected the unit manual, when written up, to be referred to the

proceduralist for verification that it was correct. The proceduralist would then

expect the instructions contained in the unit manual to be followed. Dr Byrnes

expected the proceduralist to be informed of any changes in the manual. He

did not regard the failure on the part of the practitioner to have the surgeon’s

preference sheet changed on becoming aware of a change in contrast medium



as a demonstrating a lack of adequate knowledge, skill, judgment or care in

the practice of medicine.

10. Dr Byrnes did go on to express some criticism of the practitioner in the course

of cross-examination. He agreed47 that there might have been an obligation

on his part to check with his instrument nurse that she was using Ultravist

after his conversation with the X-Ray Department and that it was incumbent

upon the practitioner to check with nursing staff to ensure that the documented

procedures reflected the change. Dr Byrnes agreed that this obligation was

more acute in the light of the practitioner’s prior experience of a change in

contrast medium from Urografin to Conray 280 without notice to him.

The following extract48 from the transcript is significant in summarising

Dr Byrnes’ evidence:

Q. All I'm asking you at this stage is a conversation which took place between Nurse Nicholls and Dr Daskalopoulos which on his version involved her commenting "The new contrast is harder to draw up as the new vials were smaller", and then apparently something being said upon inquiring about the change she commented that she checked and this is what we have to use now. That being said to Dr Daskalopoulos on 19 April 1999 put him on notice, didn't it, so that he should actually check the contrast medium intended to be used before carrying out procedures on 3 May 1999, isn't that so? A. That - yeah, that's correct. Q. And he should do that so that he knows what the contrast medium is that he's going to use on those patients on that day. That's so, isn't it? A. Correct. Q. And that's because, as you put it, it should be his choice as to what's being used? A. Yes. Q. So you're critical of him then, aren't you, for failing to inquire of the instrument nurse prior to the procedures on 3 May 1999 as to the identity of the contrast medium to be used, aren't you? A. In hindsight, yes.

46 Transcript p.304 47 Transcript p.315 48 Transcript p.321 COPYRIGHT PAGE NO 32 OF 44


Q. No, I'm putting to you, doctor, as you were - on the basis of what was said on 19 April, looking forward to 3 May, you were critical, blind, to the later acquired knowledge that it was in fact Phenol and Conray. That's the case, isn't it? A. Yes. Q. That's because it's professional judgment and care that the proceduralist knows what's going to be used before he causes it to be injected into patients. That's so, isn't it? A. That's correct. Q. You would be seriously critical of Dr Daskalopoulos in failing to make such an inquiry of the instrument nurse prior to 3 May 1999, wouldn't you? A. Prior to the 3rd? Q. Prior to actually doing the procedures on 3 May 1999? A. Knowing that he had been told that it was different? Q. Yes? A. Yes, I would have some criticism.

11. Dr Byrnes had difficulty in quantifying the extent of his criticism but

ultimately settled upon moderate criticism.

12. Dr Byrnes described the situation facing the practitioner by 24 May 1999 as a

trail of disaster and agreed49 that by this stage there was an obligation to

check everything in the exercise of professional judgment, skill, knowledge

and care, including an obligation prior to 24 May 1999 to check the vial in

which the contrast medium was delivered.

13. Dr Speer stated50 that the ERCP protocol should have been revised in 1996

when ERCP procedures were transferred to the operating theatre suite. He

described the revisionary process as one which should have been initiated by

the Hospital administration and which should have involved consultation with

nursing staff, anaesthetists, radiology, the supply department and the

practitioner as the endoscopist. In the same report he stated that it was the

responsibility of the endoscopist to ensure that the contrast medium was safe

49 Transcript p.327 50 Exhibit 3(b) COPYRIGHT PAGE NO 33 OF 44


for use at ERCP. He concluded that the incident at the Hospital had occurred

because the 1992 protocol had not been followed but he apportioned no fault

to the practitioner.

14. In his evidence to the Tribunal Dr Speer stated that because there were days

when no patients suffered from complication, he would have investigated

factors common to the list on the days when complications did arise. He said

he would have considered, as the most likely factor causing the increased

complication rate, a breach of protocol relating to cleaning or disinfection.

15. Dr Speer did not accept that upon learning of the change to Ultravist there was

an obligation on the part of the practitioner to confirm with his nurse that this

contrast medium was in fact in use. He stated51 instead that:

A. I think that it - the protocol is the most important thing here and at that stage he should be looking to hospital management to say what is the new protocol, is there a new protocol for ERCP, I haven’t been involved in a new protocol, has there been a change, who has ordered the change and he should be looking to hospital management, to the head - not to his instrument nurse - but to those involved in choosing, supplying the contrast media so his first step of contact would be the hospital management, “Have we revised the ERCP protocol”, we could to the radiology department (sic). The reality is that if contrast media is being changed it would probably change across the hospital and ERCP is a small user of contrast media and it is possible that the ERCP department, ERCP-ists will not have been informed of a global change of contrast within the hospital given that, so he may not have been involved in that process and he may just - the initial port of call would be to ask “has the hospital changed its contrast media, what is the new protocol, why haven’t I been involved in setting it up?”

16. Dr Speer agreed that the practitioner needed to be aware of the protocol for

ERCP because performance of ERCP procedures in the Hospital was governed

by that protocol stating52:

A. Safe performance of ERCP in that hospital requires everybody that’s working in the ERCP room to know what’s in the protocol, nurses, doctors, radiologists, radiographers and the people supplying the media as well.

51 Transcript p.348 52 Transcript p.350 COPYRIGHT PAGE NO 34 OF 44


Q. So the proceduralist needs to be aware of what’s in the protocol. That’s so?

A. Correct.

Q, And if he is going to seek to rely upon the process of two nurses checking, that is a critical aspect on his behalf, isn’t it, to be aware of what’s in the protocol?

A. All medical practitioners ordering drugs and contrast rely on two nurses checking for the safe delivery of the medication.

17. Dr Speer was asked if he would be critical of the practitioner for failing to

check the protocol when he thought there might have been a change in

contrast medium. He agreed that he would be critical for reasons of good

management53, because everybody at every stage in the process needed to

check that they are complying with the hospital protocols for the delivery of

health care - It’s a given54.

18. Dr Speer stated that he would be mildly critical of the practitioner only since

his comments were based on good general practice and management and not

in the context that this was a route he would have taken in the investigation of

higher than usual incidents of pancreatitis. In that context, he said, he would

not have given any thought to the contrast medium.

19. The practitioner was questioned concerning the preparation and use of

protocols both in his evidence in chief and in cross-examination. He stated55

that it had never been his role as a proceduralist or gastroenterologist to revise

a protocol. He said this was the responsibility of the Hospital administration

and in particular, in this case, the endoscopy committee in which he had never

participated. He said he had not participated in the preparation of the ERCP

protocol in 1992 and it never been suggested to him that he should do so.

53 Transcript p.355 54 Transcript p.355 55 Transcript, p.198 COPYRIGHT PAGE NO 35 OF 44


20. The practitioner stated56 that he had not seen the ERCP protocol or the

surgeon’s preference sheet until some months after 7 June 1999. He was

aware that as part of the Hospital’s accreditation process the ERCP protocol

would be in existence. He did not ask to see it prior to 7 June 1999.

21. The practitioner agreed57 that he had not communicated with Ms Nicholls

concerning the use of Ultravist after his conversation with the X-ray

Department. He denied58 that he had any responsibility to confirm the identity

of the contrast medium with her, stating:

A. No, no, the responsibility was when the protocol didn’t match that Conray was not being provided, the responsibility for Nicholls was to mention to me that there was a mismatch. That’s quite clear.

Q. It was her responsibility not yours? A. It’s quite clear from the protocol that two nurses check it. If it doesn’t match the order which was Conray, that they should notify me.

22. The practitioner agreed59 that a change in contrast medium needed to be

reflected in a change to the ERCP protocol, stating again that this was a

nursing duty. He was asked if he had any role in ensuring that the protocol

matched reality and responded:

A. No, the performing of protocols is an administrative function. It should be performed by those parts of the hospital, the section of the hospital that is responsible for upgrading their protocols. That is, in this case would have been the endoscopy committee or another committee that may have been acting in this regard.

SUMMARY AND FINDINGS

1. There is one common element in the criticisms of the medical experts. This

criticism goes to the practitioner’s failure to check the identity of the contrast

56 Transcript, p.201-203 57 Transcript, p.284 58 Transcript, p.285 59 Transcript, p.286 COPYRIGHT PAGE NO 36 OF 44


medium actually in use in his operating theatre. There were three possible

avenues of inquiry:

1.1 Ms Nicholls: according to her evidence the bottles or vials were

always available for viewing in the operating theatre;

1.2 the X-Ray Department: the practitioner did not inquire whether the

Ultravist it was using was in fact being supplied for ERCP procedures;

and

1.3 Hospital administration: the practitioner did not inquire whether the

protocol had been altered to reflect what he believed to have been a

change in contrast medium.

Any one of such inquiries would have provided the answer to the riddle

surrounding increased complication rates which the practitioner was

attempting to solve.

2. The Tribunal acknowledges the evidence of the practitioner and all medical

experts that contrast medium was a most unlikely cause of pancreatitis. The

existence of a situation which has reached crisis proportions does not in the

Tribunal’s view excuse a departure from standard processes which are

essential to good management and the delivery of safe health care.

3. The following aspects of the practitioner’s evidence are of concern to the

Tribunal:

3.1 that he had not seen the ERCP protocol;

3.2 that he appeared to take no interest in the protocol, although it was

regarded by the medical experts as significant in ensuring the safe

delivery of ERCP procedures; and

3.2 the apparent denial by the practitioner of responsibility for

involvement in the protocol when:



(a) he was the only proceduralist at the Hospital performing ERCP;

and

(b) he asserted a heavy reliance on a team approach in the

operating theatre with little evidence on his part of an

appreciation of his role as a member of that team.

4. For the practitioner an attempt was made to draw an analogy with the Court of

Appeal’s decision in Elliott v Bickerstaff60. It was claimed, quite properly,

that this decision is authority for the proposition that, where there is a team

involved in a operating theatre, each team member is responsible for the

performance of his or her duties. Further each team member is entitled to rely

on each other member of the team to perform his or her duties.

There is a distinction in this case. The Tribunal is not inquiring whether the

practitioner should be held responsible for the failure of others, that is the

Pharmacy, Hospital administration, or nursing staff, to discharge their duties.

Rather the Tribunal’s attention is directed at the professional conduct of the

practitioner to determine whether he performed his direct responsibilities in

the circumstances of this case.

5. In respect of the particulars of the Complaint therefore the Tribunal finds as

follows:

Particular 1

Between about the 1 February 1999 and 7 June 1999, the practitioner failed to ensure that an appropriate order was made for contrast medium to be used during endoscopic retrograde cholangiopancreatography (ERCP) procedures at Canterbury District Hospital.

The evidence is that the surgeon’s preference sheet, although the practitioner

was ignorant as to its content, in fact reflected an appropriate contrast medium

60 48 NSWLR 214 COPYRIGHT PAGE NO 38 OF 44


in stating Conray. Dr McNamara agreed61 that nothing further was to be

gained by specifying Conray 280.

There is also evidence that after becoming aware of the change from Urografin

to Conray, the practitioner gave a verbal order to Ms Nicholls for the use of

Conray62.

To that point, therefore, there was an appropriate standing order for contrast

medium. The evidence established that the practitioner was alerted to the fact

that a new medium was in use on 19 April 1999 and that by 10 May 1999 he

believed he knew the identity of the medium then in use. Accepting that the

information provided on 19 April 1999 came by way of a comment in the

course of the ERCP procedure and thus may have been overlooked by the

practitioner, at least by 10 May 1999 he had information which ought to have

prompted him to advise Ms Nicholls of a change in the standing order.

The Tribunal finds that this particular of the Complaint has been established.

Particular 2

Between about 1 February 1999 and 7 June 1999, the practitioner failed to check that the contrast medium being used was appropriate for ERCP procedures performed by him on a number of patients at the Hospital.

The practitioner was alerted to Ms Nicholls’ belief that she was using a new

medium on 19 April 1999 and by 10 May 1999 certainly believed that

Ultravist was that new medium. In those circumstances, the practitioner was

obliged to check the contrast medium in fact in use for ERCP procedures

performed by him at the Hospital At the very latest this check should have

been made by the practitioner by 10 May 1999.


61 Transcript, p.119 62 Transcript, p.284 COPYRIGHT PAGE NO 39 OF 44


Particular 3

Between about April 1999 and 7 June 1999 the practitioner failed to take appropriate preventative action concerning adverse outcomes of ERCP procedures performed by him at the Hospital in circumstances when he knew or ought to have known of patients suffering a higher incidence of complications following ERCP procedure performed by him.

Appropriate preventative action would have involved the practitioner in

checking the identity of the contrast medium in use in the operating theatre at

least by 10 May 1999.

In addition, as already made clear, the Tribunal finds that it was inconsistent

with current approaches to quality control in the delivery of health care that

the practitioner was ignorant of the protocols which governed ERCP

procedures at the Hospital and, by denying that it was his responsibility, failed

to communicate with nursing staff or Hospital administration to ensure that a

change in contrast medium, apparently made without consultation with him,

was reflected in a change in the appropriate protocol.


6. Had the practitioner taken any of the steps referred to in these particulars, the

mismatch between Conray 280 and Phenol 10% in 60% Conray 280 would

most probably have become apparent at the latest by 10 May 1999.

7. The Tribunal is not persuaded that the Complaint of professional misconduct

has been made out, nor is there peer review evidence to support such a

finding.

8. The Tribunal does find evidence of:

8.1 inadequate knowledge of the need for, purpose of and the practitioner’s

role in the creation and maintenance of protocols to be followed by all



members of the operating theatre team to ensure as best as possible the

delivery of safe health care in the performance of ERCP procedures;

8.2 poor judgment on the part of the practitioner in failing to inquire

further from Ms Nicholls as to the contrast medium in use following

the comments which she made on 19 April 1999 when it appeared that

a new medium had been introduced without prior consultation or

communication with him;

8.3 poor judgment on the part of the practitioner in failing, as a matter of

good management, to deal appropriately with the information supplied

by the X-ray Department concerning Ultravist so that he could identify

the contrast medium which was being supplied and used in ERCP

procedures which he performed between 10 May 1999 and 7 June

1999.

The Tribunal finds this evidence sufficient to satisfy it comfortably that the

Complaint of unsatisfactory professional conduct is made out.

PENALTY

1. There was before the Tribunal little or no evidence of insight on the part of the

practitioner into the shortcomings in his conduct. There were no admissions,

expressions of contrition or indications of willingness to accept all of the

responsibilities of medical practice.

2. To the contrary, it has already been noted that the Tribunal had concerns

regarding the veracity of the practitioner’s evidence concerning his

conversation with Ms Nicholls on 19 April 1999. Another instance of a

conflict in the evidence in which the practitioner did not impress the Tribunal

concerned the circumstances in which he learned on 7 June 1999 that Phenol

10% in 60% Conray 280 was being used as the contrast medium for ERCP



procedures. Ms Scandrett’s evidence63 was that she, as scout nurse, showed

the empty vials to the practitioner after the ERCP procedure on patient 24 had

been completed. Ms Pasten64 confirmed her evidence. The Tribunal had no

reason to reject the evidence of these two nurses.

The practitioner’s version of events appeared to be directed at establishing that

he personally discovered the error. The Tribunal is left to speculate that the

practitioner’s reasons for putting forward this version were to attempt to place

himself in a better light. Unfortunately, the rejection by the Tribunal of this

version of events has lead to the opposite effect.

3. A similar absence of insight on the part of the practitioner was demonstrated

by his attempts to deflect responsibility to others. As an example, a

substantial period of the hearing was directed at the alleged shortcomings of

the Hospital administration and Central Sydney Area Health Service.

4. The Tribunal is charged with exercising powers to sanction members of the

medical profession for the purpose of protecting the community. The

principal consideration in the exercise of these powers is the maintenance of

the standards of the medical profession and maintaining the confidence of the

public in the profession. The public is entitled to the assurance that measures

will be taken to address breaches of acceptable standards of practice.

5. Having made these comments, the Tribunal wishes the following to be noted:

5.1 It has received no criticism of the practitioner’s technical competence

in an area of medical practice which requires high levels of skill and

dedication. It is to be regretted that his skills as a practitioner in ERCP

procedures have been suspended since June 1999.

63 Transcript, ps 3-14 64 Transcript, ps 15-22 COPYRIGHT PAGE NO 42 OF 44


Dr Makarie gave evidence of the practitioner’s genuine concern for the

patients affected by this incident.

The Tribunal received and noted testimonials concerning the

reputation and characters of the practitioner not only as a doctor but as

a member of the community.

5.2 The Tribunal is confident that, following this experience, the

practitioner’s conduct will not again fall below acceptable standards in

the same respect.

5.3 The Tribunal is well aware of the series of gross errors on the part of

Hospital administration and its Pharmacy and nursing and supply staff.

It endorses the comment of Dr Speer that those errors lead to the

passing to the practitioner of a poisoned chalice.

It is the view of the Tribunal that the practitioner’s contribution,

though at the end of the process, was of lesser significance that those

for which the Hospital was responsible.

5.4 The Tribunal is concerned that the evidence indicated an absence of

communication between the Hospital administration and the

practitioner as a visiting medical officer.

Through the medium of this inquiry the Tribunal has become aware

that decisions were made of significance to him as the sole practitioner

performing ERCP’s at the Hospital in circumstances where he had not

been consulted or informed.

Additionally, no arrangements appeared to have been made to provide

the practitioner with the opportunity for peer support or peer review

either at the Hospital or its associated teaching hospitals.



These factors left the practitioner isolated from the mainstream of the

Hospital and, in the Tribunal’s view, were significant in leading to the

errors which occurred.

6. For these reasons the Tribunal has determined that the appropriate penalty is

that the practitioner be reprimanded.

JUDGE M SIDIS ASSOCIATE PROFESSOR

J M DUGGAN AM

DR T CLIFTON

MS A DEVESON AO


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