Recipient Identification

Abstract

An identification band, fastener and pilot tube for use in blood handling procedures to minimize blood transfusion errors. The fastener and pilot tube are integrally connected to the band and the pilot tube is adapted for release through action of the fastener when forming the band into a bracelet on an extremity. The bracelet and pilot tube carry removable labels presenting like indicia.

Description

The present invention relates to an identification band. In particular the present invention relates to an integral identification band, fastener and pilot tube combination as well as to methods of use of the structure whereby chance of error in the infusion of biological fluids or other medication is substantially minimized. The structure and method, however, has particular utility in connection with blood handling and blood transfusion. Therefore, the description which follows will be specifically directed to this implementation of the invention. Nevertheless, it is to be understood that the discussion is not intended for the purpose of limitation but rather for the purpose of illustrating a preferred embodiment of the invention.

At the present time donated blood is individualized by hospitals and blood banks. Usually the individualizing is accomplished by placing on the blood bag or blood collection and storing apparatus, for example, a form of identification representing a specific donor. This is done for many reasons. Positive individualizing identification, however, of the type disclosed herein to substantially minimize the occurrence of blood infusion errors has not been utilized up to the present time in connection with the recipient.

Many systems have been and are presently employed in an attempt to provide positive recipient identification, i.e. tying together by some means the recipient, the sample blood from the recipient and the crossmatched blood from a donor or donors to be later transfused. However, these systems fail in the attempt to provide the necessary positive identification because, generally, the sole correlating or tying factor is the name of the recipient as may be found upon a hospital wrist band. Systems of this type offer a high potential for the occurrence of clerical errors during handling, even though the handling is carried out by trained personnel knowledgeable as to the danger resulting from error. Thus, the possibility always exists that Jane Smith will be infused with the wrong blood.

Blood transfusion errors are, in most instances, fatal. Errors may occur for a host of reasons. For example, a transfusion error may occur for failure to exercise utmost care in the operating suite or at bedside. In this connection there must be a determination of a direct biological correspondence between Jane Smith and the transfused blood. Errors also may occur during the handling of blood including sample typing operations and crossmatching operations during which compatible units of blood are set up for later use by the patient, as is necessary. In times of great activity and stress one of several blood samples taken substantially simultaneously may be inadvertently or accidentally intermixed on the tray by either the nurse or attendant obtaining the sample. Since there is no characterizing difference between bloods of different types this inadvertent mistake will not be rectified irrespective of the care later exercised in properly identifying the patient to whom the blood is given.

The present invention overcomes the above-described problems and the disadvantages in proper identification during blood handling and substantially minimizes the occurrence of transfusion errors. In this connection the structure described in detail below provides through utilization of the method direct cross-identification between the patient or recipient, the pilot tube carrying a blood sample from the patient to be used for typing and blood crossmatching, and the units of cross-matched blood from a donor or donors.

According to one aspect of the present invention, a band for receipt on the wrist or ankle of the patient is integrally connected to a pilot tube used to contain a sample of the patient's blood. As will hereinafter be described in detail, the pilot tube may be released from the band only when the band in bracelet fashion is securely and positively secured about the wrist or ankle. With the bracelet in place a blood sample may be obtained by implementation of the released tube. Therefore, there will never be more than a single unfilled pilot tube detached from the pilot tube-band combination at any one time.

The pilot tube is carried at one end of the band which, in the region of the pilot tube, carries identifying indicia. Identifying indicia is also carried by the bracelet forming portion of the band. The indicia within each location is identical. Thus, immediately upon separation there will be a direct cross-identification between the bracelet indicia on the patient and the indicia on the pilot tube into which the blood sample is received. The direct cross-identification between the patient and the blood filled pilot tube continues during the further handling steps, including typing and crossmatching.

According to a further aspect, the present invention provides a direct cross-identification between the patient and crossmatched blood of a donor. In this connection, the identifying indicia on the pilot tube is in the form of a plurality of pressure sensitive labels upon which like indicia is presented. Each label is individually removable. Once crossmatching of blood is complete individual ones of the labels are removed from the pilot tube and individually affixed to a like number of blood bags containing blood found to be compatible with the blood of the patient. Each blood bag contains a unit of blood and generally as a standard procedure 4 to 6 units of blood are set up prior to a patient being operated upon.

An additional aspect of the present invention relates to the structure provided whereby the proper previously set up blood is released for delivery to the recipient for infusion upon correspondence of blood bag indicia, indicia presented upon a blood request form and bracelet indicia.

Thus, the identifying indicia on the bracelet portion of the identification band is in the form of a plurality of pressure sensitive labels. One or more of these labels, individually removable from the bracelet, are affixed to a blood request form. The form is then delivered to the blood bank. The unit or units of blood will be issued only upon a correspondence of the indicia carried by the blood bag and the indicia carried by the card. The blood is infused, only, when there is correspondence between the permanent indicia on the bracelet and the indicia on the blood bag.

The pressure sensitive bracelet labels may serve an additional function. In this connection one of the labels may be removed from the bracelet and forwarded to the hospital admitting office. Thus, a simple check that a sample of blood from the patient has been taken is provided.

In view of the foregoing the present invention seeks to individualize a patient by providing structure and methods whereby at all times there is a direct cross-identification between the patient, the pilot tube sample of the patient's blood and crossmatched donor's blood so that the chance of errors occurring in blood handling and blood transfusions is substantially minimized.

There has thus been outlined rather broadly the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject of the claims appended hereto. Those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures for carrying out the several purposes of the invention. It is important, therefore, that the claims be regarded as including such equivalent constructions as do not depart from the spirit and scope of the invention.

In the accompanying drawing, forming a part of the present invention, there is illustrated a preferred embodiment of the invention. By this drawing,

FIG. 1 illustrates generally an operative sequence wherein a blood sample is taken from a patient for typing and crossmatching with blood of a donor and the setting up of crossmatched blood for later infusion into the recipient.

FIG. 2 illustrates the component parts of the identification band assembly, and

FIG. 3 represents the identification band of FIG. 2 in place upon the wrist of the recipient.

The structure for implementing the blood transfusion procedure may be seen to best advantage in FIG. 2. The structure includes a band portion 12, a pilot tube 14 which is carried by the band at one end and a clip or fastener 16 carried by the band at the other end.

The band is of elongated length and may have a width which generally conforms to the width of other similar bands, such as watch bands and bands currently employed in hospital environments for the purpose of presenting the name of the patient, hospital, etc. The band is formed of a film material which preferably displays characteristics, such as tear strength and relative non-stretchability to prevent removal of the band from the wrist by ripping the same or stretching the band over the hand. Further, the material should display the characteristic of sturdiness thereby to support both the pilot tube and fastener. The material should also be somewhat rigid to maintain its band-like configuration while on the wrist rather than roll up into a strand, yet should be comfortable to wear. It has been found that a band formed of plastic, such as "Mylar," thin film high impact polyethylene, polypropylene and vinyl provide these characteristics. While these materials may be used with equal facility, "Mylar" is preferred.

The pilot tube 14 is an integral part of the band. The requirement of integrity between tube and band at the commencement of the procedure is an important consideration in the overall invention. Thus, as discussed, when obtaining a blood sample from the patient the pilot tube into which this sample is received will have just been released with a portion of the band upon forming a bracelet on the patient and, therefore, is the only unfilled tube that is separate from a band.

In the preferred embodiment the band and tube are connected one to the other by an adhesive system which prevents, during normal handling, the parts from separating. To provide maximum surface contact area the band may be adhered along the length of the pilot tube.

The fastener 16, carried at the other end of band 12, may be joined to the band in any acceptable manner as known to the art. In this connection the fastener may be riveted to a single or a double thickness of band material. To ensure against the band being prematurely removed from the wrist, in addition to the manner as above-described, the fastener 16 should preferably be unopenable through finger manipulation. Also, the fastener may utilize an internal compressible friction pad to provide positive securement for the band so that the received band portion cannot be pulled loose.

A series of pressure sensitive labels 18 presenting indicia in the form of numbers and/or letters are carried by the band 12 at the tube end. A second series of pressure sensitive labels 20 presenting the same indicia are carried by the band at the fastener end. Each of the labels is individually removable from the band for usage as will be discussed. Each label may readily be removable from the band material yet it is preferable that the label, once adhered to a foreign surface, be thereafter removed with difficulty. It may be preferable, however, that the label be of a "tamper-proof" variety such that once adhered to a foreign surface it cannot be readhered to a further surface. This type of a label system is well-known to the art and the label is generally formed such that the adhesive backing is stronger than the tear strength of the paper together.

FIGS. 1 and 3 represent, generally, the use of the identification structure for direct cross-identification during blood testing and handling and at the time of the patient receiving blood from a donor. These figures illustrate the individualization and direct cross-identification between the patient, the blood sample of the patient and the crossmatched blood from a donor which is ultimately set up for the patient.

As a first step, within the label area 22 of band 12, it is desirable to write the name of the patient and any other suitable information, as desired. The label 22 may be forwarded to the hospital admitting office on a request or admitting card for the purpose later to be brought out. The band 12 is then fastened in bracelet fashion around the wrist (FIG. 3) or the ankle of the patient. Upon fastening the band on the patient the pilot tube is prepared for release and, with the tube indicia, may be readily separated from the bracelet by tearing the band along one side of the fastener.

A portion of the band spaced a suitable distance from the fastener to provide a bracelet of suitable opening is received between a movable closure portion 24 and a compressible pad 26 carried by the fastener. The pad may be provided with an adhesive coating to prevent the bracelet from being pulled apart. A side of the closure portion, after closing the fastener will serve as a surface against which the extending pilot tube portion of the band may be torn to release the tube. Preferably, the closure portion will also be provided with a tooth or cutting projection (not shown) to notch or cut the band edge so that with relative ease the otherwise tear resistant band may be torn, as described. The notch, at 28 (FIG. 1), will display itself to evidence the fact that the bracelet part of the band is properly attached and that the tube was released during the attaching process.

A blood sample is taken from the patient by use of the pilot tube 14. In this connection the tube is of the type which provides an internal vacuum. A plug 30 seals the tube. The plug includes a self-sealing diaphragm (not shown) disposed within thereby to close a central bore 32 through the plug. Generally the plug will be formed of an elastomeric material which is inserted into the tube bore in a somewhat compressed state to provide the necessary seal.

At the time of drawing a blood sample from the patient one of the labels 20 is removed from the bracelet. Each label 20 is distinguished from the labels 18 by an asterisk or equivalent identifying symbol. This label may be affixed to the request or admitting card and forwarded to the admitting office with the label 22 thereby to evidence the fact that a blood sample has been drawn from the patient. It also serves, at a central location, to connect the name of the patient with the identification indicia.

As generally illustrated in FIG. 1 the tube 14 is employed with a needle assembly including a double ended needle cannula for puncturing the vein of the patient as well as the self-sealing diaphragm within plug 30. Blood will flow into the tube due to the vacuum condition. If the tube is formed of a transparent or translucent material, such as glass or a plastic which is not deleteriously effected by biological fluids and which can be placed under vacuum conditions it will be possible to visually determine the sufficiency of the blood sample obtained.

The blood sample within tube 14 is thereafter typed and cross-matched with blood from a donor. Crossmatching may be accomplished in the usual manner. Thus, sample donor blood carried by a pilot tube or within an aliquot is used. The donor pilot tube or aliquot generally form a part of the blood bag assembly within which the blood from the donor is disposed. When compatible blood from a donor is found through crossmatching, one of the labels 18 (the lowest label as seen in FIG. 1) is removed from the tube and affixed to a blood bag 34. It is generally the practice to set up from 4 to 6 units of blood for each patient. Therefore all of the labels 18 may be removed from the tube and affixed to individual blood bags. It is, also, generally the practice to set up blood on a day-to-day basis and therefore the described procedure will be carried out daily.

When blood units are desired for the patient the nurse or attendant removes a bracelet label 20 and mounts this on a blood request card. Blood heretofore set up is issued upon correspondence of request card and blood bag indicia. At bedside or within the operating suite the blood is infused in the patient only upon correspondence of blood bag and permanent bracelet indicia. The permanent bracelet indicia is that indicia, through the printing process, as discussed below, which is formed within the band laminate in the "Action" paper.

In this connection the band of the present invention may be in the form of a laminated construction of, for example, opposed outer plastic layers and an interposed layer of "Action" paper. This paper may be of the type impregnated with colorless chemical constituents that are normally isolated from one another yet are capable of interacting to provide a distinct colored presentation or image. Interaction of constituents is the result of pressure impact upon microscopic chemical carrying capsules carried by the paper thereby causing rupture and chemical mixing within the area of impact. Paper of this type is described in U.S. Letters Pat. No. 2,550,473. U.S. Letters Pat. No. 3,020,171 describes a related type of "Action" paper using encapsulated ink. The preferred embodiment of the present invention utilizes "Action" paper of the former type.

The lamination may be formed by any adhesive system, i.e., pressure sensitive (rubber or acrylic base), temperature sensitive, or solvent sensitive adhesive.

By using a transparent film plastic the image in the "Action" paper will be visible after the labels 18 and 20 are removed, as described above. The printing operation is carried out with the several labels in place on the band laminate so that as the labels are provided with identifying indicia, the band will also be provided with the same permanent indicia which remains in the paper within the laminate. The permanent indicia is represented by the phantom letters and numbers within the bracelet portion of the band in FIG. 2.

Both the indicia segments and the adjacent plastic layer are relatively thin filmed thereby to properly transmit the printing impact. The segments may be imprinted with ink to adapt the system to automation. Thus, the segment imprinting may be magnetic, etc. to cause response in suitable scanning apparatus.

It is also contemplated that the invention may be used such that the obtained blood sample serves to allow various tests to be carried out. Thus, the tube 14 may be provided with a liquid or solid material disposed therein which suitably reacts with the blood drawn as described above. Many reactions and reacting materials for a host of tests are known in the art. To carry out this aspect of the invention the tube 14 and band 12 may be separate, one from the other, thereby to allow a proper tube, i.e. a tube containing the reacting material to perform a desired test to be integrally adhered to the band as is shown in FIG. 2. To the region opposed from the fastener 16 is provided with an adhesive to provide the integrity of the system prior to the band 12 being located on the patient as in FIG. 3.

From the foregoing it is apparent that the objects of the invention are carried out and the advantages are readily seen. Thus, the present invention provides structure and a method whereby a direct cross-identification between the patient, the blood sample of the patient and a unit or units of compatible blood from a donor is always possible and the chance that the wrong blood will be infused into the patient is substantially minimized.

Having thus described the invention with particular reference to a preferred form thereof, it will be obvious to those skilled in the art to which the invention pertains, after understanding the invention, that various changes and modifications may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

Having described the invention, what is claimed is:

1. In recipient cross-identification device for use in the infusion of biological fluid, the combination comprising an elongated strap member, a tube element for receiving and confining a sample of biological fluid from said recipient, said tube element forming with said strap member an integral assembly, fastener means carried by one end of said strap member, said fastener means adapted both to receive and securely grip an intermediate portion of said strap member as the latter in bracelet fashion is received around an extremity of the recipient and to permit release of said tube element from said integral assembly, said tube element mounted adjacent the other end of said strap member thereby being displaced from said bracelet portion; and a first and second plurality of segments each displaying like indicia carried by and individually removable from said strip member, said first plurality of segments disposed within said bracelet portion of said strap member.

2. The combination of claim 1 wherein said tube element is mounted along a portion of its length by said strap member.

3. The combination of claim 2 wherein said second plurality of segments overlie said tube element.

4. The combination of claim 1 wherein said tube element is evacuated and including self-sealing closure means.

5. The combination of claim 1 wherein said strap member is formed of a plastic material which displays tear and stretch resistance.

6. The combination of claim 5 including means on said fastener means for interacting with said strap member when closing said bracelet thereby to provide for release of said tube element.

7. A method of positive recipient cross-identification comprising the steps of fastening around an extremity of a recipient a strap member including within the bracelet forming portion thereof a plurality of removable segments carrying indicia, releasing from said bracelet forming portion a tube element including a second plurality of segments presenting like indicia, collecting a sample of blood from said recipient within said tube element, typing said recipient blood and thereafter crossmatching said typed blood sample with a sample of blood from a donor, and affixing one of said second plurality of segments to a storage container for said crossmatched donor blood whereby the same is transfused into said recipient only upon correspondence of indicia of said container segment and said bracelet.

8. The method of claim 7 comprising affixing each of said second plurality of segments to individual storage containers of donor blood.

9. The method of claim 7 comprising an indicia segment from said bracelet portion to a request card, and issuing donor blood upon correspondence of indicia of said request card segment and said container segment.

10. In recipient cross-identification device for use in the infusion of biological fluid, the combination comprising a strap member, a tube element for receiving and confining a sample of biological fluid from a recipient, said tube element supported by said strap member in position removed from the hereinafter recited bracelet portion and defining with said strap member an integral assembly, means at one strap member end for fastening said strap member in bracelet fashion around an extremity and permitting release from said integral assembly of said tube element, and means in the form of removable indicia carried by said strap member without said bracelet portion to provide correspondence between said strap member removed from said bracelet portion and at least one like means carried by said bracelet portion.

11. The combination of claim 10 wherein said last mentioned means includes a multiplicity of indicia carrying segments disposed upon said strap member.

12. The combination of claim 11 wherein each of said segments is individually removable from said strap member.

13. The combination of claim 10 wherein at least one of said means in the form of removable indicia carries a distinguishing symbol.