X-Message-Number: 2647
Date: 14 Mar 94 20:18:49 EST
From: Mike Darwin <>
Subject: SCI.CRYONICS BPI Tech Brief #6


BPI TECH BRIEF #6

What follows is a draft version of internal Biopreservation guidelines
for identification of human cryopreservation patients.  It is presented
here to both inform and to elicit coments and suggestions.  It is hoped
that this document might be used as the basis for uniform standards
within the cryonics community for routinely documenting the identity
and care of human cryopreservation patients.



IDENTIFICATION AND ASSESSMENT
OF BIOPRESERVATION HUMAN
CRYOPRESERVATION PATIENTS
by Mike Darwin


Introduction

Because human cryopreservation is free from much of the feedback
present in most other areas of human activity, it is essential that
feedback be provided in the form of meticulous documentation of the
patient's condition before and during cryopreservation.  In a routine
medical situation the patient's condition can be assessed on the basis
of behavior and responsiveness to therapeutic intervention.  As an
example, trauma to a living patient as result of mishandling (i.e.,
dropping the patient) will rapidly become apparent in the form of
sequelae such as pain, inflammation, hemorrhage and/or accompanying
alterations in behavior.

In a cryopreservation patient, such sequelae may not become apparent
until cryoprotective perfusion is carried out, if they become apparent
at all.

The importance of thorough documentation of patients' arrival
condition and subsequent handling by Biopreservation personnel was
illustrated in November of 1989 by the case of a patient who was
accepted for cryopreservation after legal death (by the Alcor
Foundation) and a reportedly "limited" post-mortem examination.
Statements from the patient's family, her physician and the coroner
who examined her indicated that post-mortem dissection had been
confined to the thorax and that no cranial autopsy had been performed.

External examination of the patient upon arrival at the Alcor facility
revealed evidence of a more extensive autopsy than Alcor had been told
had been carried out.  Since the patient arrived already frozen at a
temperature of -5 C a thorough examination (including opening the
thoracic and abdominal suture line) was not possible.  Thus, it was not
until a full body radiologic exam was performed 5 days after the
patient arrived and been cooled to -79 C that it was discovered that a
complete autopsy had been performed and that the cranial vault had
been opened and the brain removed (1).

This case raised a number of important issues and has caused extensive
discussion of the specific kinds of risks Biopreservation is exposed
to in handling patients who have been in the care of others, as well
as the broader issues of identifying patients who are not personally
known to us.

This latter issue has become a cause for concern only recently with
the restructuring which has gone on in cryonics and the unique
problems it has brought with it.  Biopreservation is now servicing two
non-profit cryonics organizations.  This means that we now have members
with cryopreservation arrangements with whom no Biopreservation staff
member has ever met or, in some cases, even communicated with by
telephone.  It is possible that we could be confronted with a situation
where we are notified that such a member is already in cardiac arrest
and is being air shipped to Biopreservation having already been packed
in ice by a local mortuary.

How do we insure that we are cryopreserving the correct patient?
During 1988 and 1989, in the neighboring community of Riverside,
California there have been at least two incidents where the wrong body
was released for burial or cremation by the local Coroner's office
(2).  Similar incidents involving local hospitals, mortuaries, and
government morgues have been reported in the news media during the
last year.  Additionally, in cases of disfiguring accident or disaster
we may receive "remains", identification of which is problematic due
to dismemberment or disfigurement.  Since we do not usually have
next-of-kin view the patient immediately after s/he comes into our
care it is possible that we could treat the wrong patient.

What is needed is a set of procedures which will minimize, if not
eliminate, the risk that the wrong patient is received and treated for
cryopreservation.  It is also of importance that the patient's
condition on arrival at Biopreservation be as well documented as the
subsequent care he or she will receive.  What follows is a series of
procedures for identifying, assessing and documenting the identity and
condition of Biopreservation cryopreservation patients.

In-Field Identification, Assessment, and Documentation

Identification

If the patient is in a hospital or nursing home and Biopreservation
personnel are present to provide immediate post cardiac arrest support
and stabilization the patient's identity should be established early
on.  This should be done by:

1) Examining the patient's medical facility I.D. bracelet and checking
the patient's appearance against his or her member file I.D. photo.  In
cases where visual identification is not possible or there is doubt
about the patient's identity (and next-of-kin or other reliable
sources are not available), finger prints should be obtained and, as
soon as possible, compared against any which may be in the member's
file or available from other sources.

2) Obtaining visual identification from next-of-kin or close friends
of the patient's identity.  If the transport personnel or area
Coordinator personally knows the patient, s/he may be relied upon to
provide visual identification.

3) If the patient has been in the control of a coroner, medical
examiner, or hospital morgue, the hospital I.D. bracelet or morgue toe
tag should also be checked to help confirm the patient's identity.

4) If the patient is a coroner's case and there is any reason to doubt
the patient's identity, the patient's Member File photograph and
finger prints (if the latter are available) should be checked against
those made by the Coroner or Medical Examiner.  Careful note taking
should document any procedures undertaken to establish the patient's
identity including what was done, when, where and who was responsible
for carrying them out.

5) After the patient's identity has been established, affix a red
Biopreservation patient identification bracelet to one of the
patient's wrists or ankles as appropriate.

Physical Assessment

Regardless of the circumstances (coroner, nursing home, hospital...)
the patient's condition should be assessed as completely as possible
as soon as Biopreservation personnel take custody or have access to
the patient:

1) Document the time of cardiac arrest, ischemic interval, temperature
at the time of cardiac arrest (or as soon thereafter as it can be
measured), medications given, start of external cooling and so on
(these parameters are to be logged on the Transport Data Collection
Sheet).

2) It is also important to document the presence of any scars, marks
tattoos, incisions, punctures, lesions or evidences of trauma as soon
as it possible to do so by sketching them on a body diagram (see
Figure 1.) and by photographing them if possible.  Examination of the
dorsal surface of the body may have to be deferred until after the
conclusion of Transport (cardiopulmonary support and cooling), and
immediately prior to air or ground transport.

Clearly, it will probably not be practical to completely assess the
patient until Transport is well underway and the patient has been
moved to a local mortuary or to the Biopreservation facility.  However,
as soon as it is possible to do so, the patient should be given a
thorough external exam from head to toe and any abnormal or unusual
findings recorded.

3) If the patient is being received from a hospital, Coroner's or
Medical Examiner's morgue, s/he should be thoroughly evaluated both
visually and by palpation for signs of dissection and/or trauma as
soon as possible.  It is especially important that the scalp be
carefully examined for incisions or a suture line concealed by hair in
order to rule out the possibility of a cranial autopsy.  Keep in mind
that the autopsy protocol and Coroner's report will probably not be
available to Biopreservation for a period of several weeks to several
months.

Additionally, the pathologist who performed the autopsy may be
unwilling to speak with Biopreservation personnel.  Thus, a rapid but
reasonably thorough external examination of the patient is critical.
It is important to be aware of the possibility that the patient may
have been dropped or mishandled during transportation to the morgue or
while there.  Be sure to check for bloodless cuts or anatomical
deformation (such as might result from blunt, post-mortem trauma if
the patient were dropped and his/her skull fractured or nose broken).
If an autopsy has been performed what is its extent and where are the
suture lines?

4) The presence and character of any secretions or exudate from any
body orifice or wound should also be carefully noted.  Is the patient
"purging" (passing blood or blood tinged fluid from nose or mouth)?

5) If a camera is available in the field the patient's external
condition should be documented as well as possible without
compromising rescue efforts.  If a heart-lung resuscitator is in place
its position and the overall set-up in the mortuary or other facility
where rescue is taking place should be also be documented by
photography (Note: photography should not be allowed to interfere with
delivery of good acute care during rescue/transport operations).

Similarly, photographic documentation of other aspects of the in-field
care should be undertaken where possible.  Thus, if total body washout
is being undertaken the pump set up and cannula connections should be
photographed.  Finally, the air shipment set-up should be photographed
with particular reference to documenting the quantity and position of
ice bags, packing and/or insulation in the shipping container.

Note: All photographic documentation must be given to Biopreservation.
Area Coordinators or in-field staff may not retain copies.


In-House Identification, Assessment and Documentation

1) When the patient arrives at the facility, videotaping and color
still photography should be used to document arrival conditions.  If
the patient has been air shipped, the opening of the transport
container and conditions inside it (quantity of ice, arrival
appearance of the patient) should be documented by both still and
video photography).

2) The patient's temperature should be measured upon arrival using
either the probes placed in the field or probes inserted immediately
after arrival.  If field-placed probes are being used to evaluate
arrival temperature, their correct position should be verified before
readings are made and recorded.

3) Biopreservation staff should check the patient's medical facility
I.D. bracelet and/or toe tag to verify the patient's identity.  The
patient's fingerprints should be also be taken at this time.

4) If the patient has arrived from a local transport (i.e., within 500
miles of the LA basin) or via air ambulance and is on life support of
some kind (i.e., heart-lung resuscitator or Mobile Advanced Life
Support System (MALSS) extracorporeal support) this should be
documented with both still and video photography.

5) When the patient is to be transferred to the operating table from
the shipping container, MALSS, or Portable Ice Bath (PIB), there
should be a careful external examination of both the dorsal and
ventral body surfaces with accompanying still and video photography.
(Note: the patient should be cleaned up as necessary to insure
accurate photographic documentation.) Special photographic attention
should be given to any area where an incision or abnormality is
discovered and an appropriate notation should be made on the body
diagram in the patient record.  If the patient has been autopsied the
external evidence of the autopsy should be carefully noted.

6) If the patient is a whole body patient s/he should be weighed at
this time.

Coroner's Cases

If the patient has been in the custody of a Coroner, Medical Examiner
or hospital morgue the following procedures must be carried out and
documented by note taking, still and video photography:

1) The patient should be thoroughly examined externally both visually
and by palpation in an attempt to determine if there has been any
unreported dissection, mishandling or trauma.

2) If there is any evidence of trauma or dissection there must be an
immediate radiologic examination of the area involved.

3) If an autopsy has been carried out, the autopsy incisions should be
opened and the patient's body cavities examined for the quantity and
condition of viscera present.  If the brain has not be separated from
the viscera and given to Biopreservation personnel, it should be
located and separated at this time.

4) Care must be taken throughout these procedures to minimize
rewarming if the patient has been cooled.  If the patient arrives
frozen, no attempt should be made to thaw in order to carry out an
internal examination.  Expeditious cooling to dry ice temperature
should be carried out and arrangements made for 1 mm interval CT
scanning so that, if possible, 3-dimensional CT scans can be made in
order to determine the location and condition of the patient's
viscera.

5) If it has not previously been done and the patient is not going to
be perfused (i.e., has been autopsied or the ischemic interval is
judged too long), 4 each of 10 ml blood samples should be drawn from
the femoral vessels, heart or aorta (as the patient's condition
dictates) using a syringe and 14 gauge needle: two in a red top tube
and two in a gray top (sodium fluoride) tube and promptly refrigerated
in crushed ice (Note: always draw the red stopper tube first so that
fluoride contamination does not interfere with enzyme studies).

Pre-perfusion Identification Labeling

1) Once the patient has been placed on the operating table and the
initial assessment is complete the patient's Cryonics Organization
identification number should be written with indelible ink (using a
Carter's permanent broad tip "Marks-A-Lot" felt tipped marker) on the
head (across the forehead) and abdomen (see Figure 2. for exact
location and orientation).  Before labeling, care should be taken to
insure that the skin is dry and clean, by first wiping it with solvent
soaked gauze (acetone, chloroform, etc.) to dry and de-fat it.  Care
must also be taken to insure that the marking is not smeared, by
allowing adequate time for it to dry before repacking the marked area
of the patient in ice.

2) The numbers should be no smaller than 1" in height and should be
clearly printed in block style.  It is important that the ID be printed
on both the head and abdomen to accommodate the contingency of future
emergency neuroconversion with subsequent disposal or separate storage
of the head and body.

3) Two 4 square millimeter skin tissue samples should be taken
specifically for the purpose of DNA typing.  Both samples should be
treated with 15% (v/v) glycerol in base perfusate and frozen to -196
C.  One sample should subsequently be sent out for DNA typing.  The
other should be placed with the reference effluent samples which will
placed with the patient in long term storage.

Perfusion Documentation

Documentation of the patient's condition and response to
cryoprotective perfusion must be carried out on several levels:

1) The Perfusion Data Collection Sheets (see Figure 3) should be used
to document the measured parameters of perfusion such as the patient's
temperature, arterial pressure, arterial flow rate, rate of CPA
concentration increase (flow rate of withdrawal pump), weight changes,
perfusate reservoir levels, and so on.

2) Photographs should also be made documenting the perfusion circuit,
general operating room set up, and surgical procedures used on the
patient.

Still and video photography should also be used to document any
unusual or significant findings or developments during the course of
perfusion.  The development of cerebral edema, cerebral dehydration,
facial or peripheral edema, leakage of perfusate from body orifices or
lesions should all be documented on both still film and videotape.

3) A minimum of two video cameras should be used to record the
perfusion.  One camera should record the surgical procedure and the
verbal observations of the surgical team, and the other camera should
record the pump/perfusion reservoir set-up and the verbal observations
of the perfusionist and perfusion data loggers (note takers).


Post Perfusion Documentation and Identification Labeling

1) Once perfusion is complete and the patient has been cleaned up in
preparation for cooling to -79 C a post perfusion set of still and
video photographs should be taken which parallel those made when the
patient arrived at the facility.  These photos should document any
incisions or suture lines made by Suspension Team personnel, the
presence of edema or dehydration, evidence of glycerolization or
cryoprotective agent (CPA) induced skin changes (i.e., glycerol or CPA
induced mottling and/or ambering of the skin) and must include a
close-up of the patient's face.


2) Medical facility, morgue and Coroner's I.D. bracelets or toe tags
should not be removed from the patient unless there is a compelling
reason to do so (i.e., it interferes with some aspect of the
suspension procedure).  If the patient's stainless steel Membership
Emergency I.D. bracelet is available it should be attached to the
patient's arm which does not have his or her medical facility I.D.
bracelet.

3) If the patient is a whole body patient, the exterior of the
sleeping bag should be clearly labeled in two places with the
patient's I.D. #: on the foot of the bag using block letters no
smaller than 3" in height so that it will be visible when the lid of
the cryogenic dewar is removed, and near the midline parallel to the
patient's navel on the front surface of the sleeping bag using block
letters no smaller than 6" in height so that it will be clearly
visible if the tray is removed from the dewar during transfer
operations.  The patient's name should also be inscribed at these two
locations although smaller letters may be used.

4) As soon as possible stainless steel or aluminum engraved I.D. tags
recording the patient's name, I.D. #, and life cycle dates should be
affixed to the exterior of the sleeping bag at the foot end.
Thermocouple probe wires should also be labeled with aluminum or
stainless steel tags engraved with the patient's name, I.D. obe #, and
location (see Figure 3 ).

5) The pods of whole body patients should have affixed to the foot end
an engraved anodized aluminum tag measuring 4" x 4" with block letters
a minimum of 4 mm wide by 4.5 mm high which records the patient's
name, I.D. #, and life cycle dates.  The lid to the thermocouple probe
box on the pod should have the patient's Biopreservation # recorded in
large (3 inch) block letters.

6) If the patient is a neuropatient, the cloth bag containing the
patient should be clearly labeled with the patient's name, life cycle
and I.D. #.

7) The securing tie to the cloth bag should also have an aluminum or
stainless steel tag bearing the patient's name, life cycle and I.D. #.

8) Additionally, as with whole body patients, each thermocouple probe
wire should be identified with an aluminum or stainless steel tag
engraved with the patient's name, I.D. #, thermocouple probe # and
location.

9) The lid to the neurocontainer should also be labeled with an
engraved aluminum tag measuring 4" x 4" with block letters a minimum
of 4 mm wide by 4.5 mm high giving the patient's name, life cycle, and
I.D. # (see Figure 4 )


STILL PHOTOGRAPHY

Photographic documentation is important for identification,
documentation of the patient's medical condition, for legal purposes,
and for future review and evaluation (i.e., to serve as a database for
retrospective clinical studies).  A good quality 35 mm camera with
flash attachment should be used.  Quality color print film (Kodak,
Fuji) with a 200 or 400 ASA rating should be used since it is
relatively inexpensive and easy to rapidly process in a fashion that
insures confidentiality.  Slide film or other special process film
should not be used as a primary method of documentation for several
reasons: First, it does not have the archival stability that print
negatives and prints have.  Second, it cannot usually be 1-hour
processed which means that it must be in the hands of photo laboratory
personnel without Biopreservation supervision/control.  *

* Footnote: (Many 1-hour 35 mm processing retailers are set-up in such
a way that the entire development and printing process may be
supervised by a Biopreservation staff member.  It is Biopreservation's
policy to remain on-site and supervise processing of such sensitive
film to insure that duplicate prints are not made and distributed
without Biopreservation's authorization.) Alternatively, a bonded
processor who processes film for law- enforcement may be used.

Photographs of the patient's body for documenting purposes (as opposed
to overview shots of the room or equipment set-up) should contain an
accession number identifying them and the order in which they were
taken.  This should be placed to one side of the frame, never in the
center.  Do not put rulers in the photo unless there is specific reason
to do so (such as the need to document a lesions depth).  Usually
rulers just serve to distract and make interpretation of the picture
more difficult.

External photographs of the patient's body should be clean, devoid of
blood, instruments and clutter.  When photographing injuries, lesions,
incisions and so on, two pictures will be needed: one to show where
the injury or area of interest is on the body and another closer view
to delineate its character and extent.

VIDEO PHOTOGRAPHY

Two kinds of video documentation are needed during human
cryopreservations: two stationary cameras to record the surgical
procedure and the reservoir and pump set-up* and a dynamic view of the
initial assessment of the patient provided by a hand held camera.  The
hand held camera should pause over each area of interest with an
effort made to hold the camera still and allow time for the reviewer
to absorb information of interest.  Avoid fast panning techniques and
rapid motion of the camera.  A slow, deliberate pan across the field to
be recorded is essential if the tape is to be useful in evaluating the
patient's condition in the future.

Careful attention must also be given to lighting condition so that
shadowed areas and loss of color and detail are avoided due to
inadequate light levels.

Extreme close ups should be preceded or followed by views which show
the context of the close-up shot.  A narrative should also be provided
on the audio portion of the record describing observations and
findings and explaining what is being filmed.

* Recording the reservoir and pump set-up as well as the comments of
the perfusionist and note takers is important to supplement written
notes on changes in pump settings on the cryoprotective agent (CPA)
ramp pump and to record dynamic changes in reservoir levels.  For
instance, at the start of perfusion it has often been observed that
the recalculating reservoir rapidly gains volume as the patient is
dehydrated by exposure to CPA.  It would be useful to have a complete
record of these rapid changes.



GATHERING AND EVALUATING FINGERPRINTS

Biopreservation has requested fingerprints of members from client
organizations.  One reason for doing this is to provide an alternative
source of identification in the event of severe disfiguring or
dismembering injuries.  If you have not yet provided Biopreservation
with a set of fingerprints for your member file, we urge you to do so.

Procedure For Collecting Fingerprints

The equipment required to collect fingerprints is not complex and the
procedure for reliably collecting fingerprints is relatively
straightforward and easily learned in one session (3).

The equipment required consists of printer's ink (a heavy black
paste), a roller (6" x 2", available from printers' supply houses), an
inking plate (plate glass 1/4" x 6" x 14") upon which to ink the
fingers, and a card clamp or holder (optional).  Do not use ordinary
writing or stamp-pad inks because they are too light, too thin and
take too long to dry.  Additionally, a cleansing solvent such as
acetone, denatured alcohol or trichlorethylene ("safety solvent") to
dry and de-fat the skin and remove the ink is needed.

Fingerprints should be collected on standard 8" x 8" Biopreservation
Personal Identification Cards.  Illustration 1 shows fingerprints
properly taken on one of the standard Biopreservation Personal
Identification Cards.  From this illustration one may see that there
are two types of impressions involved in the process of taking
fingerprints.

The upper 10 prints are taken individually: thumb, index, ring, and
little fingers of each hand in the order named.  These are called
"rolled impressions", the fingers being rolled from side to side.  The
smaller prints at the bottom of the card are taken by simultaneously
printing all the fingers of each hand, then the thumbs, without
rolling.  These are called "plain" or "fixed" impressions, and are used
as a check upon both the sequence of the rolled impressions and their
accuracy, as they may be distorted through too much pressure being
exerted when rolling the fingers.  In order to understand the
importance of taking the rolled impressions carefully, it must be
remembered that the classification of fingerprints involves
differentiation by patterns, ridge counting, and ridge tracing, and
certain focal points must be included to make classification possible.

In preparing to take a set of fingerprints, a very small daub of ink
should be placed on the inking glass and thoroughly rolled until a
very thin, even film covers the entire surface.  In taking the rolled
impressions the side of the bulb of the finger is placed upon the
inking plate and the finger is rolled to the other side until it faces
in the opposite direction.  Care should be exercised that each finger
is inked evenly from the tip to below the first joint.  By pressing the
finger lightly on the card, and rolling it in exactly the same manner,
a clear rolled impression of the finger service may be obtained.  It is
better to ink and print each finger separately, beginning with the
right thumb, and then in order, the index, middle, ring, and little
fingers.

Illustrations 2 and 3 show the proper method of holding a finger for
inking and printing a rolled impression.

To obtain "plain impressions" all the fingers of the right hand should
be pressed lightly upon the inking plate, then pressed simultaneously
upon the lower right hand corner of the card in the spaces provided.
After the same operation is completed with the left hand, the thumbs
of both hands should be inked and printed without rolling in the space
provided.

Illustration 4 shows the correct method of taking the plain
impressions.

Evaluation of Fingerprints

Whenever possible, fingerprints should be evaluated by an
identification expert.  Usually the local police department will have
available on a round-the-clock basis an individual skilled in
evaluating fingerprints.  Frequently such "identification officers"
will be willing to assist in evaluating prints while either on or off
duty.

However, the problem of evaluating a suspension member's fingerprints
will usually not be formidable.  A simple and definitive comparison of
the prints (if they are good impressions) should be possible,
providing the evaluator has even minimal pattern recognition skills.
Only in cases of mutilation, fire or other situations where the number
of prints is limited and/or partially obliterated should
identification be problematic.  In such situations it is especially
important to consult experts for a determination.

When the quality of the prints is good and the pattern matches, the
determination of Biopreservation personnel may be relied on, with
follow-up evaluation by skilled persons being done electively.

DNA TYPING

In many ways the gold standard for member identification is DNA typing
(the only exception being in the case of identical twins).  This method
of identification is not only virtually unique, it also allows for
identification of all of a member's remains, even in situations where
dismemberment or severe injury has taken place.

Currently, the costs of DNA typing are too high to allow for its
routine use.  However, in the future such costs are likely to decline
sharply as the technique comes into wider use in law enforcement,
medicine agriculture, and industry.  It would certainly seem prudent to
collect samples from patient's entering suspension (and perhaps from
Suspension Members with high risk profiles for accident) now in
anticipation of the cost effective availability of this technique in
the foreseeable future.

As this technology evolves, Biopreservation will endeavor to keep its
members appraised as to costs and availability.  Once costs come down,
we may offer DNA typing as a standard part of our sign-up procedure so
that each CRYOPRESERVATION Member's file contains a "DNA print" for
future reference and identification.


Summary

As the cryonics program continues to grow and the number of patients
in storage rises it will become more and more critical to reliably
identify patients.  This is especially true owing to the nature of
human cryopreservation: it is not possible to interrogate the patient
or subject the patient to testing which would easily establish
identity once the patient is in storage.  Transfer of patients between
service providers, transfer of patients from one storage cassette or
pod system to another during decades or longer of cryogenic storage,
and transfer and handling of administrative documents all carry the
potential for loss or confusion of patient identification.
Additionally, patients accepted from custody by law enforcement
agencies, hospitals or mortuaries may not be correctly identified and
may not be easily identified by the service provider or primary
cryonics organization.  Thus, thorough and routinely applied procedures
to establish patient identity are of critical importance.


REFERENCES

References are omitted for draft version.

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