X-Message-Number: 2332
Date: 08 Jul 93 03:09:34 EDT
From: Mike Darwin <>
Subject: CRYONICS Response to Tanya Jones' CRYOMSG# 2323
From: Mike Darwin
Date: 5 July, 1993
Re: Response to Tanya Jones' CRYOMSG #2323
1) Tanya (and Charles Platt) have stated that they feel the issue of
the care A-1399 received should be covered in the political section of the
net (i.e., File 14). I disagree. I can think of no more basic issue than
the quality of care that Alcor and other cryonic organizations deliver to
their members/clients. The issues at stake here (chlorine bleach
contamination of the perfusate being only one) are primarily technical and
procedural.
While I would be the first to grant that the root of the problems is
managerial/interpersonal/political, that does not alter the primary
issues: the level of care a patient received, the level of care subsequent
patients are likely to receive, and the way this care is documented and
problems with it are handled.
I can think of no issues more critical to those interested in
cryonics either personally or peripherally. If the information is
damaging to the promotion of cryonics or to its image, then that is
unfortunate, but not nearly as important as insuring that: 1) problems are
corrected, 2) there is open discussion, and 3) that members and potential
members are aware of the reality of the situation, however adverse to
member recruitment or retainment that may be.
2) Tanya states that her article is "objective" and "comprehensive"
with the aim of providing her (sic) with methods for future improvement.
She also states "The entire tone of my article is one of encouragement,
because in its entirety (as opposed to dissecting details) it answered
an essential unknown. This suspension demonstrated that Alcor is able to
perform cryonic suspensions without the services of Mike Darwin, and even
the mistakes which surfaced during suspensions with Mike's participation
were largely avoided. ... If this isn't encouraging news to Alcor's
membership, I'm at a loss for what to say."
My response to this is to review the care this patient received.
Please be advised that the problems I detail below are ones of which I
have become aware by reading Tanya's incomplete article in CRYONICS and by
talking with several people who were present. I have not had the
opportunity to review the case notes, go over the lab data, or talk in an
extensive way with the principals. Tanya and Hugh were invited (and were,
according to Steve Bridge) going to come over to Biopreservation and go
over this data with me, however this never occurred. This
notwithstanding, this is what I do know went wrong:
a) Despite the presence of clear agonal signs the team leader (Tanya)
and other skilled personnel were not summoned back to the hospital. This
reportedly occurred because personnel left attending the patient were not
competent to determine that skin color changes in the extremities
(cyanosis and mottling) were an agonal sign. Further, according to a
principal present at the scene, when Tanya left, there was no clear
delegation of responsibility. This resulted in a very poorly organized
response to cardiac arrest. Further, despite a prior positive California
court ruling, a decision was made to accede to the hospital's unreasonable
demand that respiratory and circulatory support be withheld from the
patient until he was off hospital premises. The net result was that this
patient experienced a potentially avoidable period of 15 to 20 minutes of
ischemia at near normothermia.
b) No samples were taken during initial cardiopulmonary support.
There was very little sample taking during MALSS support (apparently only
one sample at the beginning and one at the end). This makes it difficult
to assess the quality of this support and further, to assess when
hypochlorite contamination occurred and to what extent.
There were, according to Hugh Hixon, no blood gases done and few
samples taken during cryoprotective perfusion. One reason that blood
gases were not done was that the blood gas unit was down at the time of
the suspension; a condition in which it had been for at least 6 weeks
prior to the time this patient deanimated (I know this because Hugh asked
me about disposables and parts and we discussed the problem). Because
there is no blood gas data it is now not possible to tell what impact the
bleach contamination had on the patient's metabolism. If metabolism was
still intact (as indicated by oxygen utilization and carbon dioxide
generation) things would be considerably more hopeful.
c) According to one observer present, a cannula and line were
improperly anchored in the operating field and were pulled out of the
patient during cryoprotective perfusion. The photo which appears on the
bottom of page 19 of CRYONICS shows what appear to be cannulae in place
without the conductive tubing anchored to the tubing holder. This is a
violation of one of the cardinal rules of cardiopulmonary bypass. This
incident was not mentioned in the case report: it is thus impossible to
assess whether it was an arterial or venous cannula and whether or not (if
it was the aortic root cannula) appropriate steps were taken to insure
that air was not perfused upon reinstituting circulation.
4) Cardiotomy suction was not set-up initially and it was not
discovered that the patient was losing large volumes of perfusate through
the chest wound until the recirculating perfusate volume was very low.
Recently on Cryonet, Tim Freeman asked if it was possibly the bleach that
caused the high terminal glycerol concentration. The answer is that it
was not the bleach, but the loss of a large fraction of circulating volume
to the table top, which in turn increased the steepness and terminal
concentration of the glycerol introduction ramp. This also was not
documented in Tanya's article.
d) A concentration of hypochlorite which is corrosive to skin and
metal was added to the water bath bathing the patient. This resulted in
leakage of wall water into the perfusate and denaturation of the
hemoglobin of the patient's circulating red cells strongly suggesting
exposure of the patient to toxic concentrations of hypochlorite. Even
after this incident occured no one bothered to read the product's
instructions before implemenmting a policy change. This indicates a lack
of thoroughness in dealing with the problem; both in investigating it and
in preventing its recurrence.
If the above constitutes encouraging news to Alcor members about the
quality of cryonic suspension care they are likely to receive then it is
not Tanya, but *I* who am at a loss for words.
I am insulted that Tanya equates this sorry performance with my own
work in caring for Alcor patients.
3) I do not, as Tanya states, feel that "lithium analyses...would be
a good indicator of the contamination levels in this case." I believe it
would be a good place to start. I would not have used a clinical test for
lithium since it is quite possible that lithium hypochlorite levels well
under 0.10 mEq/L (the lower end of clinical sensitivity) would be quite
damaging. The only way to evaluate the severity of this injury with
confidence is to have recourse to the animal lab.
As to Hugh's assessment that no harm was likely done: the short
answer is, who knows? Many, many variables are present in this case.
They need to be systematically evaluated by an outside group. Why? See
point #4 below.
4) Tanya states that "Hugh discarded the idea of using an external
investigator, like Mike suggests. His reasons included: that independent
investigations are usually initiated to seek out manufacturing or design
deficiencies; and that corrosion by a powerful disinfectant falls outside
the standard arena for external examination."
There is no gentle way to respond to a statement like this other than
to note that it is grossly wrong. Most medical accidents are human error
of exactly the kind that occurred in this situation. While devices are
sometimes at fault, that is not the usual case since quality control on
the people using them is usually far less stringent and objective than
that on the devices themselves. The reasons that outside agencies are
used to investigate accidents are as follows:
a) People involved in the accident and/or the people who caused it
rarely make good, objective evaluators. There is simply too much of a
tendency to try to see the accident in the best possible light and to
minimize its seriousness. This is a natural human tendency and is known
as a "conflict of interest."
b) And more to the point, even if they *were* to be objective they
lack the necessary credibility since they are *involved*. Brenda Peters
has posted a piece which all but accuses me of engaging in mud slinging
and irresponsible hysteria in my letter to the editor regarding this
incident. I do not believe that that is the case, and further, I believe
that the emotions I have expressed have been both reserved and
appropriate. However, the point here is simple: investigation by a more
objective third party would squelch such criticism from me, or at least
eliminate its credibility -- if such is justified. That is precisely the
point!
5) An excellent possibility for an investigative agency would be the
nonprofit Emergency Care Research Institute (ECRI). ECRI is
a multidisciplinary agency made up of chemists, biomedical engineers,
physicians, lawyers and allied health professionals. ECRI has strong
conflict of interest rules and has as its primary mission "to improve
safety, efficacy and cost effectiveness of health care technology,
facilities and procedures." A key function of ECRI is medical accident
and forensic investigation services. There are similar agencies to ECRI,
and further, there are technical and medical people in the cryonics
community who would probably be willing to help if asked -- believe it or
not I would have been among them had I been invited to be on the inside
rather than on the outside of this incident. It is still not too late to
do this, and I urge Alcor to follow this course of action.
6) Tanya states that "Jerry Leaf spent time documenting protocols for
cryonic suspension (over a decade ago), and those protocols were removed
from Alcor by Cryovita and weren't available for me to study when I began
learning about suspensions."
This statement is so incomplete, and such a coarse distortion of
reality that I believe it constitutes an either outright lie or to be more
charitable evidence that Tanya never bothered to examined these binders
while they sat for a year at Alcor. The material Tanya is referring to
consists of blue three-ring binders containing not specific "protocols for
cryonic suspension" but basic training material covering physiology,
anatomy, sterile technique, and so on copied from standard text books.
This material was prepared by Jerry as supplemental training material for
his course.
More to the point, this material sat on the shelf at Alcor/Cryovita
for a period of nearly a year after I left, during much of which time
Tanya had full access to this material! When Paul Wakfer finally removed
it last June it was still sitting on the shelves where it had rested
undisturbed and covered with dust throughout Tanya's tenure. If she was
even slightly interested in this material (much of which is badly dated
and inappropriate to current needs) what was to prevent her from copying
it? Further, what was to prevent her from going to similar, more up to
date text books and copying it?
This is the kind of unfortunate distortion of the truth which I have
found unacceptable in dealing with Tanya in the past and it is the primary
reason why I will not work with her and do not trust her to deliver good
care to cryonics patients.
7) Tanya states that "Hugh was unable to immediately answer all of
Mike's concerns to his satisfaction." She then goes on to note that I
similarly called Steve Bridge and found his responses unsatisfactory.
It is not that Hugh was *immediately* unable to answer my concerns, it was
his attitude in dealing with them. An attitude I perceived then and
now as blase fatalism. This is the same irresponsible and uncaring
attitude which so often characterized Hugh's delivery of patient care
during the decade that I worked with him. I have not forgotten that this
is the same man who during my tenure at Alcor has walked out of the
operating room with a patient being perfused on the table, and gone to his
room (more than once) to read a science fiction book without notifying
ANYONE and in the meanwhile leaving the blood gas machine unattended. My
patience with Hugh and my confidence in his diligence in delivering good
cryonic care was exhausted long, long before this incident. I hope that I
can be forgiven for reacting as I did, but it was not because it was a
distressing new pattern, but rather because it was a distressing *old*
one.
8) Tanya then goes on to essentially agree with me stating that
"Unfortunately this isn't indicative of a fatalistic attitude, it is
indicative of a more serious problems." Please note that Tanya said this
first. And for once we agree completely. It *is* indicative of a more
serious problem. But Tanya is mistaken if she believes it is just Hugh's
problems or even mostly Hugh's problem. The reality is that it is mostly
Tanya's problem. Tanya is the Team Leader, Tanya is "Alcor Suspension
Services Manager." It is *Tanya's job* to see to it that Hugh does his
work, does it professionally, and does it in a timely fashion. If he
fails in this, it is Tanya's job to go up the chain of command and demand
appropriate action, disciplinary or otherwise, to insure that it *does*
get done.
Yes, I was disgusted at the way this incident was handled. An
undetected wall water leak into the extracorporeal circuit is usually a
major disaster. It ranks right up there with pumping air. The presence
of a visible color change in the perfusate is very ominous. In a clinical
setting such a change would mean certain death for the patient. I thought
that it deserved to be treated with gravity and to be dealt with in a
professional manner. I still feel this is the case.
9) In Tanya's CRYONICS article, she goes on at some length about
having a relaxed suspension working environment; and in her CRYOMSG #2323,
she states that she has "found profound grief and soul-searching (as
advocated by Mike) to be an unproductive combination, and have therefore
preferred to address damage assessment and solutions rather than berating
myself or poorly trained but willing volunteers."
My response to this is to note that this is at variance with
everything I have learned and seen in critical care medicine and in other
technically demanding areas such as neuro- and cardiac surgery. Jerry
Leaf himself remarked that he felt real tension and anxiety before and
during each suspension. Part of success in any such complex life-or-death
task is to have a sense of presence and awareness of what everyone else is
doing. This is especially so in when utilizing "poorly trained
volunteers." Curtis Henderson has noted that "Alcor wants happy cryonics,
and that is not possible." I agree with him. This kind of "anxious
vigilance" has been summarized by the consummate neurosurgeon Robert
Spetzler in the book THE HEALING BLADE by Edward Sylvester which documents
the work of neurosurgeons using deep hypothermia and circulatory arrest at
the Barrow's Neurological Institute in Phoenix, Arizona:
"We were talking about what a neurosurgeon does to prepare for a major
case like this. You go over the procedure, and over it again, and over it
again, he said. You simply repeat every step you are going to do and go
through every possible thing that can go wrong. And then you do it again.
You go over the procedure so often it cannot leave your mind; that's
the point. Then it is the night before surgery. As you drift down to
sleep, you are in the operating room, and you cut the wrong side. Or you
see a vein or an artery, and you cut right through it. Stupid things, all
the things you prepared yourself never to do since your first day of
residency, you're doing them. And that wakes you up. And then you think
about the procedure, and as you fall asleep, it comes again. On the night
before a major case you never really *sleep*. Running things through your
mind. And then after a repose full of nightmares you go in and do the
procedure...Procedure is the key word to neurosurgery. A procedure has
specified steps that can and must be choreographed and rehearsed; it has a
beginning, a middle, and an end. *Most important, it must not have
surprises." (Emphasis mine.)
While I do not wish to be seen as advocating paralyzing grief or
depressive inaction, I feel that success depends on *all* the elements
being there. Saying "the operation was a great success but the patient
died" doesn't cut it. Saying that the shuttle launch was perfect, with
myriad things being done right except for this little problem with the O-
rings doesn't cut it either. At least not with me.
When mortality or morbidity causing errors are made in medicine, the
presence of remorse and grief in those who made them is considered healthy
and normal. It is a measure of the propriety of the value systems of
those experiencing them and a significant deterrent to a repeat of the
accident. While I do not know what Tanya is actually feeling regarding
this incident, I can only say that I do not have much evidence of these
emotions as expressed in her response.
If that is the level of care with which everyone else is satisfied, I
can live with that. And if Tanya's and Hugh's standard of performance in
this matter is considered acceptable, indeed even praiseworthy to those
who are using their services, that's fine too. But I do not consider it
acceptable for myself, my loved ones, or for the profession of cryonics as
a whole.
Further, it is my belief that in the long run people in general are
not interested in excuses or explanations, but rather in good outcome.
Period.
10) Even in the most excellent medical centers errors happen.
Highly skilled people make mistakes too. I have certainly made my share
in both clinical and cryonic medicine. It may be argued that I am the
LAST person who should be criticizing Tanya and Alcor's performance.
Perhaps this is so. But my central point when I first spoke to Steve
Bridge about this is that *I* shouldn't be in a position where this was
possible, let alone necessary. As Tanya herself points out in several
places in her response: prior to my undertaking to make an issue of this
incident NOTHING was actually being done. That, and the way in which this
matter has been handled is the *real problem.* I do not feel it
inappropriate that I took the tack that I did or that I wrote the letter I
wrote. In point of fact it appears to have been, by Tanya's own
admission, the approach which resulted in action. Certainly her approach
had not yeilded progress.
11) Finally, I wish to point out that there are a couple errors of
fact in Tanya's Cryonics article which bear correcting. This case was not
the first case in which a neuropatient's pulmonary artery (PA) was tied
off. I believe this was done in every (or almost every) suspension since
that of A-1260 and perhaps before. I know this because I personally
ligated A-1260's PA and instructed/observed our contract surgeon doing the
same in subsequent cases. The operative record sheet which contains a
diagrammatic representation of the surgery in the patients' case notes
will document this.
Readers should also be aware that it is these case notes, and the
detailed, written case histories (which are available on several of the
Alcor patients) which constitute the "protocols" which Tanya would have
profited most from studying. These have been in Alcor's custody
continuously.
Tanya also states, in her CRYONICS article, that "nerves typically
perfuse poorly when compared to other organs." To my knowledge this
statement is not correct. In fact, I would state that based on both human
and animal experience, the brain and spinal cord *perfuse* better than
many other organs, even after significant intervals of normothermic
ischemia. Similarly, the brain experiences dehydration and failure to
*equilibrate* well with perfused cryoprotectant, about as well or poorly
as many other tissues including skin, skeletal, and cardiac muscle. The
point here that vascular perfusion and equilibration of cryoprotectant
across the cell membrane are two different things.
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