The Pediatric Cardiac Surgery Inquest Report

 

 

The draft interim report

The draft interim report was presented to the committee members near the end of the August 10, 1994 meeting. The minutes of the meeting state:

The Interim Report which had been compiled by the Chairman was presented to the Committee and discussed briefly. It was the general consensus that this report was representative of the Committee's position at the present time. (Exhibit 20, Document 278G)

Wiseman prepared the report on his own initiative. He testified that at the meeting before its presentation to the committee, there had been some discussion to the effect that the committee ought to be reporting back to the three department heads. The key recommendation of the report was that the program be returned to full service in a staged manner.

By the time the report was prepared, the committee had met ten times. All but one of the open-heart cases had been reviewed. According to the report:

As a result of the frank and open discussion which occurred a large number of problems [sic] areas were discovered and specific recommendations were made to improve the overall function of the team. Areas where problems appeared to arise included many items relating to team communication. A significant amount of discussion was devoted to improved communication between nursing, surgery, anaesthesiology, and bypass technology. It was felt that this frank discussion resulting [sic] in paving the way for a much improved communication in the future. (Exhibit 20, Document 278F)

In addition, a large number of technical details concerning the intra-operative and peri-operative management of individual patients were discussed and solutions were recommended. Some of the specific areas where changes were recommended included:

  1. The effective use of invasive monitoring lines so as to satisfy the requirement of both anesthesiology and to meet the needs for postoperative monitoring.
     
  2. Specific technical details concerning team communication relating to the going on cardiopulmonary bypass and coming off cardiopulmonary bypass.
     
  3. Methodology and communication concerning the administration of anti-coagulation agents and agents for reversal of anticoagulation.
     
  4. Details relating to transfer of patients from operating room to Intensive Care Unit and with respect to this the timing of a postoperative radiogram.
     
  5. Details concerning the use of cardio-plegia solutions.
     
  6. Specific recommendations concerning the timing and ordering of blood products for use at the conclusion of cardiopulmonary bypass. Products to be ordered from the Red Cross for availability immediately coming off of bypass.
     
  7. The recognition that the operating room assistant is a major component to the smooth and safe conduct of the surgical procedure. A group of such assistants familiar with the Children's Hospital personnel and operating theatre is to be gradually developed.
     
  8. The need for an operating room call-back system in the event of re-operation taking place in the Intensive Care Unit. As well the need for instrumentation for re-operation under emergency circumstances in the Intensive Care Unit.
     
  9. The need to recognize that specific cases of greater complexity be not be [sic] undertaken during the early experience of the Program. It was the consensus of the Committee that the early experience included cases of an order of complexity which exceeded the program maturity at its onset. (Exhibit 20, Document 278F)

The report also stated that, by continuing to undertake straightforward cases during the period of the review, the team was able to "work together to gain confidence and during this period of time, significant success was met." (Exhibit 20, Document 278F)

This listing is impressive for what it does not deal with, namely the program's morbidity and mortality. There is no assessment of the program's mortality rate. Nor is there a discussion of the specific issues that led to mortality or morbidity. Soder, one of the consulting witnesses who appeared before this Inquest, cited surgical factors as playing a role in the deaths of four children during the period under review. Other consulting witnesses raised serious questions about the length of surgery and whether or not repairs were properly done. None of these questions were addressed by the report, which was the committee's only report before the program went back to full service.

Most of the issues on the list of matters discussed were of peripheral concern to the anaesthetists, who had called for the slowdown, and to the nurses who had enthusiastically supported the slowdown. The final point, number nine, flirts with these issues when it states that cases at the outset exceeded the program's maturity.

The report lacks concrete recommendations and is maddeningly vague. For example, it is unclear from point 9 as to whether or not the committee had concluded that the team was, in August 1994, sufficiently mature to handle those cases that had exceeded its maturity a few months earlier.

The draft report concluded with the following statement:

It was generally agreed that the Program proceed with cases generally falling into the low and medium risk category, and that at the present time, cases in the high-risk category be deferred. This is recommended to continue for a period of 4 to 6 months. (Exhibit 20, Document 278F)

While this paragraph appears to indicate that the program slowdown would continue for a considerable period of time, the statement in fact opened the way to a rapid return to full service. In the final draft of the interim report, the last sentence reads, "This is recommended to continue for a period of 3 to 6 weeks." (Exhibit 19, Document 246) McNeill testified that the committee had agreed that four to six months was too long a time, although she thought the period was going to be shortened to six to eight weeks, not three to six weeks.

On the question of the pace at which the program would be accelerated, the draft interim report read as follows:

After considerable Team discussion and with a [sic] some degree of trepidation it was recommended that the overall approach to the Cardiac Program occur with the development of a staging system based upon complexity and risk involved with individual cases. (Exhibit 20, Document 278F)

In the final copy of the report, the word "trepidation" was replaced with the word "reservations" (Exhibit 19, Document 246).

This clearly reflects the lack of consensus over returning to full service. The report stated that patients could be considered as either low, medium or high-risk. It was only at this point in the committee's history, when the program was on the point of returning to full service, that it set about defining risk categories. Low-risk patients included many of the closed procedures, as well as simple open-heart procedures with short bypass times. These included atrial septal defects and Glenn shunts. Moderate-risk cases included ventricular septal defects, Tetralogys and incomplete atrioventricular canals, and "patients undergoing primary repair of anomalies which occur with a reasonable frequency and are not usually associated with high mortality." (Exhibit 20, Document 278F) The high-risk cases included both complex neonatal repairs and reoperations on patients with previous palliative repairs. With such a list developed, it was agreed that cases would not be vetted through the committee.

McNeill, Ullyot and Youngson were somewhat taken aback by the presentation of Wiseman's draft report. They felt it was presented without any prior discussion and did not represent their views. Yet it became adopted as the committee's interim report, apparently with their approval. This gives rise to some questions about decision-making in the committee.

In her testimony, McNeill gave this description of how consensus was determined in the committee:

It was sort of, we would all discuss something, and then perhaps one or two people would reiterate the idea or express sort of an encapsulation of what we had just said. And somebody may have been arguing against it or critical of it, or having a different opinion, but at the point that the idea is summarized, if they then don't say anything, that summary becomes the consensus. (Evidence, page 13,312)

In many instances, McNeill said she felt that statements became consensus not because everyone agreed with them, but because they had stopped arguing against them and were simply prepared to let them stand.

Youngson, McNeill and Ullyot had felt almost from the outset that the committee process was not adequately addressing the concerns they had about the program. They had felt that the major issue was the ability of the surgeon, but had not been able to raise that concern about his abilities very strongly because of their lack of surgical expertise. Youngson recalled the manner in which McGilton's questioning of the suturing of the eustachian valve in the KZ case had brought about such a strong reaction from both Odim and Giddins and how McGilton's views had been dismissed as coming only from a nurse.

McNeill had also felt all along that Giddins, Odim and, to a certain extent, Wiseman had viewed her as being obstructionist and unco-operative in her assessment of the levels of care the program was able to provide for cardiac patients. She, too, felt that even though she was a trained anaesthetist, she was unable to argue forcefully that there were valid surgical issues that had not been addressed during the process up to that time.

She had felt that the committee suffered from a lack of members with pediatric cardiac surgical experience who could assess and comment on any of the surgical issues that were raised or needed raising. At the meetings, whenever a surgical matter had been raised, she felt that Odim's view was invariably accepted and that there was little room for dissent, especially since no one at the table could match Odim's credentials in matters of pediatric cardiac surgery.

Youngson, Ullyot and McNeill were not confident at all that the program was ready to proceed to operating on all children. However, they were all hesitant to speak out against the contents of the interim report, since their true concern was their lack of confidence in the surgeon-a position they felt unable to express at the committee or to articulate convincingly.

McNeill testified:

I think that we didn't sometimes actually speak clearly, forthrightly and critically about incidents that we felt were-that had occurred or we had concerns about.

Question: Why not? Why not?

McNeill: On my part, I think that, or I know that it was a combination of feeling that there was expectations of me to be part of a healing process almost, if you will. There was a definite intent that was reiterated by the people who set up the committee and by department heads that this should be a mechanism for improving the general tenor of relationships.

So with that sort of background and that message being delivered to me, I felt that if I had an issue that I wanted to discuss, I should try to do it in as least a confrontational manner as possible, and if possible, to avoid being directly and personally critical and try to address the issue from a more unbiased and perhaps from a farther back perspective. So I had the sense of expectation of my behavior, if you will.

I think another factor that played a large role in it is, it is difficult to confront somebody, it is difficult to say, I think you did or did not do this. Even in a forum that was, you know, set up with that sort of a purpose in it, it isn't always easy to do. And I know I avoided doing it at times for those reasons. (Evidence, pages 13,296-13,297)

Ullyot testified that during August, she and McNeill had concluded that a return to high-risk cases was almost inevitable.

I think we had just sort of come to the conclusion that if the push was on to increase the complexity that we weren't going to have a real problem with that in managing the cases, that we just perhaps should just let this start to happen. Even though we weren't particularly happy about it, even though we had objected to it occurring, that we weren't the only people in that committee, we weren't the only people deciding that the cases should proceed and that we should start doing medium risk cases, and that we had a responsibility to object, but that if the committee as a whole decided that's what we would be doing that we would go along with that. (Evidence, page 31,413)

Ullyot testified that she did not believe the minutes of the August 10 meeting were accurate in their statement that all the committee members had accepted the report. She said that at the August 10 meeting, she indicated her concern that the report "did not address the fundamental question of whether the mortality was acceptable." (Evidence, page 31,395) She was told that the other members of the committee were comfortable with going ahead and that the mortality and morbidity rates were acceptable, based on the reviews of the individual cases.

Odim testified that the committee discussion did not always appear to be as full and frank as the interim report suggested. While he said that the summer results had been encouraging, he testified that:

There was still certain combinations of players created the wrong chemistry and there was still some attitudinal things that still existed, but I don't think they really had any bearing on, you know, what we had to do as professionals, but my personal sense was that there was still some issues that really weren't quite resolved and I don't know whether everything was frank and open. (Evidence, page 25,325)

The people he was referring to were Youngson, Hinam, Swartz and McNeill. In short, while Odim wished to see the program return to full strength, he was developing reservations about the team's capabilities. This was reflected in his ambivalent testimony on the report's conclusion that the team had taken on cases that exceeded its maturity. At one point he rejected the conclusion, while at another point he accepted it, stating that the team was capable of performing the cases that it undertook upon startup; however, he also felt that there were problems with the team's maturity.

While Odim had a number of concerns about the chemistry of the operating-room team members and about post-operative care, he did not believe that these problems needed to be fully addressed before moving back to full service. He believed that, at that point, the program could provide acceptable care, as opposed to what he called optimal care.

In many ways, it appears that point number 9 (the statement that the team had taken on cases that exceeded its maturity) was, in large measure, offered as an appeasement to the program's critics. Odim and Giddins accepted that they had to agree with the point, if they wished to see the program return to full service. This point was made apparent when Wiseman was asked who, during the committee's work, had identified cases that were of an order of complexity greater than the team's maturity. In response, he testified:

Well, the committee, I think it's alluded to or suggested, even the terms of reference of the committee is to kind of this gradation phenomenon, the need to sort of step back and have a look. It was very clearly meant to make recognition of this fact, that's this lucidity phenomenon. That's why this-

Question: Did Dr. Odim agree that the cases at the beginning of the program had been too complex, by the time you wrote this?

Wiseman: I think insofar as the proceedings of the committee led to this conclusion, yes.

Question: Did Dr. Giddins agree that the cases selected at the beginning of the program were too complex?

Wiseman: Again, in sort of, from a retrospective perspective, I would say yes. (Evidence, page 40,626)

It was recommended that the interim report be forwarded to the three department heads.

 

 

Current Home - Table of Contents - Chapter 7 - The draft interim report
Next The interim report is distributed
Previous Forthcoming cases
Section 1 Chapter 1 - Introduction to the Issues
  Chapter 2 - Pediatric Cardiac Issues
  Chapter 3 - The Diagnosis of Pediatric Heart Defects and their Surgical Treatment
  Chapter 4 - The Health Sciences Centre
Section 2 Chapter 5 - Pediatric Cardiac Surgery in Winnipeg 1950-1993
  Chapter 6 - The Restart of Pediatric Cardiac Surgery in 1994
January 1, 1994 to May 17, 1994
  Chapter 7 - The Slowdown; May 17 to September 1994
  Chapter 8 - Events Leading to the Suspension of the Program
September 7, 1994 to December 23, 1994
  Chapter 9 - 1995 - The Aftermath of the Shutdown
January to March, 1995
Section 3 Chapter 10 - Findings and Recommendations
Appendix 1 - Glossary of terms used in this report
Appendix 2 - Parties to the Proceedings and counsel
Appendix 3 - List of witnesses and dates of testimony
Diagrams
Tables
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