Message: #2647 - BPI Tech Brief #6 Date: 14 Mar 94 20:18:49 EST From: Mike Darwin <> Message-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 reliableY.Hɕrс مb2Ɂɥ́ձzх 5R4oon 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 poli"ѵсwill 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.