Fresh_Whole_Blood_Transfusion_17_Jul_12
Contents
1. If response is Then No Proceed to Group B Question 3 Yes DEFER INDEFINITELY 3 Have you had sex with anyone who was born in or has lived in any African Country since 1977 If response is Then No Proceed to Group C Yes Was it any of these countries Cameroon Benin Central African Republic Chad Congo Equatorial Guinea Kenya Gabon Niger Nigeria Senegal Togo or Zambia If No to listed countries Proceed to Group C Yes to listed countries Document when DEFER INDEFINITELY Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 29 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline Group C 1 Have you had sex in the last 12 months even once with anyone who has AIDS or has had a positive test for the AIDS virus 2 Have you had sex in the last 12 months even once with anyone who has ever taken illegal drugs with a needle including steroids 3 Have you had sex in the last 12 months even once with anyone who has taken clotting factor concentrates for a bleeding disorder such as hemophilia 4 At any time in the last 12 months have you given money or drugs to someone to have sex with you 5 At any time in the last 12 months have you had sex with someone who has taken money or drugs in exchange for sex 6 In the past 12 months have you had a positive test for syphilis 7 In the last 12 months have you2. Email Y 2 N ote Ave you progmant now or havo you bean Y 36 N Have you over bad Chagas disease babosiosis or Leishmaniasis ya yoa group have the AIDS vires and you can give it to someone alse oven or acupanctare foal well and have a ave AIDS test Y 25 N Hayn eve given blood under another name or Social Y 40 N Le the past 12 momths haw you had close contact with a person Secantty Number with yellow jaundice or hepatitis or boen given Hepatitis B Y 26 N i thopast wosks have you gwen blood plasma or platelets Y 4 N Have you over had yellow jaundice iver disease hepatitis or a you ever aa or told mot to past you had any or vaccinations donates blood past you a scare past you a vaccination or or had close comtact with the vaccination site of alsa Y ON ae ee g e a E e p e E pee Y 4 Nia the past month hra you taken Famasteride Proscar Propecia or a tissue transplant including any you may have donated Se or Isotretincim Accutane Ammesteem Claravis Sotret or in the 6 have you ukan Deawends Y 30 N bh tho past 3 yoan have you bad malaria Y 31 N ee SS a d matar or brain covering graft Y 33 N Have you over taken Eens Togison or Acitwtin Soriatane you ever had cancer a aa problem Y 35 N Have you eve had chest pam best disease or lung diseases Use this section and reverse side of form to explain Yes answars above With the exception of questions 22 24 High Risk Oral Questions
3. AT Hour ON Date IDENTIFICATION on the patient identification tag ist VERIFIER Signature CROSSMATCH FOR THE COMPONENT REQUESTED DATE SECTION Ill RECORD OF TRANSFUSION AMOUNT GIVEN ML REACTION TEMPERATURE PULSE BLOOD PRESSURE _ None _ suspectep If reaction is suspected IMMEDIATELY have examined the Blood Component container label and this form and find all 1 Discontinue transfusion treat shock if present keep intravenous line open information identifying the container with the intended recipient matches item by item 2 Notify Physician and Transfusion Service The recipient is the same person named on this Blood Component Transfusion Form and 3 Follow Transfusion Reaction Procedures 4 Do NOT discard unit Return Blood Bag Filter Set and I V Solutions to the Blood Bank DESCRIPTION OF REACTION Tea OTHER DIFFICULTIES Equipment clots etc C YES Specify PREVIOUS RECORD CHECK TT record C vo recoro SIGNATURE OF PERSON PERFORMING TEST POST TRANSFUSION DATA TIME DATE COMPLETED INTERRUPTED C Fever Cl Pain DATE OF TRANSFUSION TIME STARTED rate hospital or medical facility O urticaria a TT OTHER Specify 2nd VERIFIER Signature PRE TRANSFUSION TT no TEMP PULSE BP SIGNATURE OF PERSON NOTING ABOVE PATIENT IDENTIFICATION USE EMBOSSER For typed or written entries give Name Last first middle grade rank SEX WA
4. 10 Jan 2010 Asked By Donor Temp pc Sp Pulse HCTHst lt 99 6 F375 C 180100 l00bpm gt 38 ar 12 Spal 3L Medications Malaria Prophylaxis Daily Doxycycline Wockly___ Mfloquin N A Your blood wil NOT be tested for viral diseases price to transfasion dus to the emergency if you any reason you feel your blood may not be safe or you could answer yes to the high risk questions please do not donate today I have read had explained to mo the high rick questions and am not in a high rick category and fal my blood is safe to donate at this time I verify that I have answered the questions bomestly and foel my blood is safe to be transfused Donor s Si Phlebotomist Start Tims Stop Time Should be lt 15 mimates Bag Mamafactarar Lo Expiration date Segment Number The Modified DD Form 572 bas boen reviewed for completeness If there are any risk factors that place the recipient at harm notify the ordering physician immediately for appropriate follow ap DD 572 WB Version 13 May 2010 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 11 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline APPROVED STATE TATTOO AND PERMANENT AND MAKE UP REFERENCE LIST Armed Services Blood Program State Tattoo and Permanent Make Up Reference List NOTICE ee eegen by non DoD personnel blood programs or individual medical institutions The use of
5. Clinical Judgment Page 21 of 43 July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline EMERGENCY WHOLE BLOOD COLLECTION SOP 7 Perform and record temperature on Modified DD Form 572 See DD Form 572 Emergency Whole Blood Donation Record If Then lt 99 5 F or 37 5 C Proceed to Step 8 gt 99 5 F or 37 5 C Stop the donation process The donor is Ineligible at this time 8 Perform and record measurements of donor pulse and blood pressure If Then BP lt 180 100 and Pulse is lt 100 Proceed to Step 9 bpm BP gt 180 100 and Pulse is gt 100 Stop the donation process The donor is bpm Ineligible at this time 9 For female donors perform and record hematocrit hemoglobin results on Modified DD Form 572 if possible Male donors do not require hematocrit hemoglobin testing If Then gt 38 or 12 5 g dL Proceed to Step 10 lt 38 or 12 5 g dL Defer donor and stop the donation process The donor is Ineligible at this time 10 Donor is physiologically acceptable to donate have the donor sign the Modified DD Form 572 and proceed to Step 11 11 A competent medical authority should review the Modified DD Form 572 to determine the eligibility of the donor If Then Acceptable Donor is Eligible Proceed to Step 12 Unacceptable Donor is Ineligible Stop donation process and do
6. Whole Blood Sample Shipping Manifest Form 148 V May 2012 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 37 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline FORM 150A EMERGENCY RELEASE LETTER OF UNDERSTANDING TESTED Provider Letter of Understanding for Emergency Non FDA Whole Blood Units I understand that Emergency Whole Blood Units are NOT FDA approved and transfusion of these units may result in unintended disease and or transfusion reactions I accept full responsibility for the units and the consequences that may follow transfusion Print Sign Date Provider Form 150a Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 38 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline FORM 150B EMERGENCY RELEASE LETTER OF UNDERSTANDING UN TESTED Provider Letter of Understanding for Untested Emergency Whole Blood Units I understand that these Emergency Whole Blood Units have not had complete Rapid Testing prior to transfusion and transfusion of these units may result in an increased risk of unintended disease and or transfusion reactions I accept full responsibility for the units and the consequences that may follow transfusion Print Sign Date Provider Form 150b Guideline Only Not a Substitute for Clinical Judgment July 2012 Page
7. anti coagulated blood to reenter the tubing Perform this procedure three times Processing Donor Units 1 Take donor unit and donor sample tubes 2 gold tops SST 2 pearl tops PPT and 1 purple top tubes to processing area Strip donor units segment tubing three times and mix so as to avoid the development of clots Perform ABO Rh type utilizing ABO Rh Testing Card and purple top tube Record results on Form 147 Write the donor blood type on the bag ABO Rh Testing Card along with date time and phlebotomist initials of collection Write the expiration of the unit which is 24 hours from collection Create product in TMDS while Rapid Testing is being performed NOTE Rapid tests should be performed and found to be negative prior to transfusion to the greatest extent possible In situations requiring whole blood available blood component inventory should continue to be transfused in lieu of whole blood until rapid testing has been performed and found to be negative Crea ting Whole Blood Units in TMDS 1 From Manage Donation tab select Donate Product 2 Enter SSN of donor and click Next LA Verify demographic information for donor is correct enter donation date and Donation ID number from bar code label and click Add Products Enter product code E0009V00 for whole blood Enter expiration date 24hrs post collection Click Add Product Verify Donat
8. donate should be deferred from donating i e heart and or lung conditions Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 34 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline FORM 145A RAPID TESTING WORKSHEET Date of Testing sg Tech Form 145a V 24 Now 2010 Guideline Only Not a Substitute for Clinical Judgment July 2012 Fresh Whole Blood FWB Transfusion Page 35 of 43 4 Date of Testing FORM 147 ELDON CARD ABO RH TYPING RECORD Eldon Card ABO Rh T Joint Theater Trauma System Clinical Practice Guideline i K i nf uf uf uf op ad ada nf uf fut uf ufuf uf uf apap uf apap ap apap ap aga al al f tf ai ff HH f f ftf l ff fl Hf Hl Hl Hl ed ed ed ed ed ee H uf uf uf vi vii uf uf vi apap apap uf apap apap apap ad adap fofofo ofa E e e dd ed E dd E ed E ed ed ed ed E ed ed Ea ed Ea ed ed ee E E 1 1 il 1i uf uf u 1i ufu uf uf uf un 1 a zl ul a vi vii vii vi tut ti vu vi vi vil apap ad apap vi vlt ap aga E ed ed ed ed ed ed REITER ed E E ed ed ed ed ed E eed ed E E Assigned Unit V 28 June 2010 Form 147 Guideline Only Not a Substitute for Clinical Judgment July 2012 Fresh Whole Blood FWB Transfusion Page 36 of 43 Joint Theater Trauma System Clinical Practice Guideline FORM 148 PRE SCREEN WHOLE BLOOD SAMPLE SHIPPING MANIFEST Prescreen
9. had syphilis or gonorrhea or have you been treated for syphilis or gonorrhea 8 In the last 12 months have you received blood or blood products 9 In the last 12 months have you been incarcerated in a correctional institution including jail or prison for more than 72 consecutive hours 10 In the last 12 months have you taken snorted cocaine through your nose 11 Female donors only In the past 12 months have you had sex with a man who had sex with another man even one time since 1977 A Yes answer to Group C isa TEMPORARY DEFERRAL for 12 months following the event Group D 1 Have you at any time since 1980 injected Bovine Beef Insulin A Yes answer to Group D is an INDEFINITE DEFERRAL Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 30 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline APPROVED STATE TATTOO AND PERMANENT MAKE UP LIST Armed Services Blood Program State Tattoo and Permanent Make Up Reference List NOTICE The ee eegen by non DoD personnel blood programs or individual medical institutions The use of this information by DoD personne is strictly for blood donor operations and must adhere to the current Service Army Navy and Air Force specific Standard Operating Procedure dealing with the screening of blood donors Allogeneic Donor Qualification were used to determine acceptability of each
10. or coagulopathy e g bleeding with associated metabolic acidosis thrombocytopenia or INR gt 1 5 when optimal component therapy e g PLTs and FFP was unavailable or stored component therapy was not adequately resuscitating the patient with immediately life threatening injuries Data Source 1 Patient Record 2 Joint Theater Trauma Registry JTTR 3 Blood transfusion databases System Reporting amp Frequency The above constitutes the minimum criteria for PI monitoring of this CPG System reporting will be performed annually additional PI monitoring and system reporting may be performed as needed The system review and data analysis will be performed by the Joint Theater Trauma System JTTS Director JTTS Program Manager and the Joint Trauma System JTS Performance Improvement Branch 8 Responsibilities It is the trauma team leader s responsibility to ensure familiarity appropriate compliance and PI monitoring at the local level with this CPG 9 References l Massive transfusion in trauma patients tissue hemoglobin oxygen saturation predicts poor outcome Moore FA Nelson T McKinley BA Moore EE Nathens AB Rhee P Puyana JC Beilman GJ Cohn SM StO2 Study Group J Trauma 2008 Apr 64 4 1010 23 Repine TB Perkins JG Kauvar DS Blackborne L The use of fresh whole blood in massive transfusion J Trauma 2006 60 S59 S69 Spinella PC Perkins JG Grathwohl JG Beekley AC Holcomb JG Warm fresh whole
11. rhythmically squeeze every 5 to 10 seconds relaxing between squeezes 16 Secure the needle to the donor s arm with tape across the hub or on the tubing near the hub of the needle This will optimize the positioning of the needle to prevent rotation of the needle or drag on the tubing which may impede blood flow An additional piece of tape may be placed across the tubing lower on the arm 17 Partially reduce the pressure by loosening the tourniquet or blood pressure cuff to approximately 20 40 mm Hg Mix blood bag several times during the collection to prevent clotting 18 Cover the phlebotomy site with sterile gauze dressing to keep the site clean and needle out of view Lift the gauze occasionally to monitor for a hematoma 19 If a hematoma is evident remove tourniquet and needle from donor s arm and place sterile gauze square over the hematoma and apply firm digital pressure while donor s arm is held above the heart level 20 Record the following in the appropriate blocks on the DD Form 572 e Time phlebotomy was started e Initials of the phlebotomist 21 Watch for the signal of a filled unit by monitoring for the completion indicator of the weighing device or visual reference point see step 3 if not using a weighing device Record stop time on the DD FORM 572 22 Seal the tubing to 2 inches below the Y segment of the tubing using a metal seal slip and a hand crimper or pu
12. starting at the center and moving outward in concentric circles at least 1 inches in all directions 4 For donors allergic to iodine follow the same procedure outlined above but substitute a chlorohexidene scrub ChloraPrep NOTE If a disinfectant is not available clean the site with alcohol or other solution if possible 5 Allow area to dry 6 Set up trip scale Manual or Electronic Perform quality control if possible to obtain a counter weight of 585 grams NOTE If no trip scale is available the Terumo Single Blood Bag can be filled with whole blood to the mark pictured below It is however recommended that weight then be checked with table top scale if available ita WE The target weight for 450 mL is 585 grams Do not use if overfilled as blood clots may develop from an incorrect ratio of whole blood to anti coagulant causing potential harm to the patient 7 Using a hemostat clamp tubing between the needle and the main bag This will prevent air contamination of blood after the needle cover is removed Place tape within reach for anchoring the needle during phlebotomy NOTE Place a loose knot in the tubing approximately 6 inches from the needle prior to uncapping needle if metal seal clips and hand crimpers are not available 8 Apply tourniquet with enough pressure If using a blood pressure cuff adjust to approximately 40 60 mm Hg 9 Twist off the needle cover and inspect the needle for bar
13. 39 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline STANDARD FORM 518 BLOOD OR BLOOD COMPONENT RELEASE 518 123 MEDICAL RECORD SECTION REQUISITION BLOOD OR BLOOD COMPONENT TRANSFUSION NSN 7540 00 634 4158 COMPONENT REQUESTED Check one Products are requested TYPE OF REQUEST Check ONLY if Red Blood Cel REQUESTING PHYSICIAN Print DIAGNOSIS OR OPERATIVE PROCEDURE DATE REQUESTED TT REO BLOOD CELLS _ FRESH FROZEN PLASMA _ TYPE ANO SCREEN IT PLATELETS Poo of units TT crossmatcH _ CRYOPRECIPITATE Pool of units O Rh IMMUNE GLOBULIN DATE AND HOUR REQUIRED _ OTHER Specify VOLUME REQUESTED If applicable REACTION Specify ML Specify REMARKS RG TREATMENT DATE GIVEN HEMOLYTIC DISEASE OF NEWBORN KNOWN ANTIBODY FORMATION TRANSFUSION IF PATIENT IS FEMALE IS THERE HISTORY OF SECTION II PRE TRANSFUSION TESTING I have collected a blood specimen on the below named patient verified the name and ID No of the patient and verified the specimen tube label to be correct SIGNATURE OF VERIFIER DATE VERIFIED TIME VERIFIED UNIT NO TRANSFUSION NO TEST INTERPRETATION ANTIBODY SCREEN PATIENT NO RECIPIENT TT crossmarcu NOT REQUIRED REMARKS ABO ABO PRE TRANSFUSION DATA INSPECTED AND ISSUED BY Signature
14. 550008T000102 Malarial Rapid Test 6550081332341 RPR Test Kit 6550015110291 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 42 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline APPENDIX C ADDITIONAL INFORMATION REGARDING OFF LABEL USES IN CPGs 1 Purpose The purpose of this Appendix is to ensure an understanding of DoD policy and practice regarding inclusion in CPGs of off label uses of U S Food and Drug Administration FDA approved products This applies to off label uses with patients who are armed forces members 2 Background Unapproved i e off label uses of FDA approved products are extremely common in American medicine and are usually not subject to any special regulations However under Federal law in some circumstances unapproved uses of approved drugs are subject to FDA regulations governing investigational new drugs These circumstances include such uses as part of clinical trials and in the military context command required unapproved uses Some command requested unapproved uses may also be subject to special regulations 3 Additional Information Regarding Off Label Uses in CPGs The inclusion in CPGs of off label uses is not a clinical trial nor is it a command request or requirement Further it does not imply that the Military Health System requires that use by DoD health care practitioners or considers it to be the
15. Joint Theater Trauma System Clinical Practice Guideline FRESH WHOLE BLOOD FWB TRANSFUSION Original Release Approval Oct 2006 Note This CPG requires an annual review Reviewed Jun 2012 Approved 17 Jul 2012 Supersedes Fresh Whole Blood FWB Transfusion updated 19 Nov 08 L Minor Changes or El Changes are substantial and require a thorough reading of this CPG or TT Significant Changes 1 Goal Provide the rationale and guidelines for FWB transfusion including but not limited to indications collection testing transfusion and documentation 2 Background Whole blood has been used extensively to resuscitate casualties in military conflicts since World War I Its use in civilian settings is limited due to the wide availability of fractionated components derived from whole blood and provided for specific deficits e g packed red blood cells RBCs for anemia fresh frozen plasma FFP to replace lost consumed clotting factors apheresis platelets PLTs for thrombocytopenia cryoprecipitate Cryo for hypofibrinoginemia However in austere conditions fractionated blood products may be in limited supply or unavailable In these settings FWB may be the only source of blood components available for the management of hemorrhagic shock and its associated coagulopathy in casualties Appendix A Blood Donor Pre Screening SOP Massively transfused casualties 10 units RBCs in 24 hours have
16. RD BLOOD OR BLOOD COMPONENT TRANSFUSION Medical Record STANDARD FORM 518 REV 9 92 Prescribed by GSA ICMR FIRMR 41 CFR 201 9 202 1 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 40 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline FORM 151 WHOLE BLOOD TRANSFUSION CHECKLIST WHOLE BLOOD TRANSFUSION CHECKLIST COMPLETE THIS CHECKLIST FOR EACH UNIT TRANSFUSED POST EVENT LOCATION OF TRANSFUSION a 1 DONOR PRESCREENED FOR TRANSFUSION TRANSMITTED DISEASE TTD MARKERS WITH FDA APPROVED TESTS WITHIN LAST 90 DAYS YES NO 2 DONORS SCREENED AT TIME OF COLLECTION USING RAPID TESTS FOR MALARIA YES NO HIV YES NO HBV YES NO HCV YES NO RPR YES NO 3 RAPID TEST RESULTS AVAILABLE PRIOR TO PRODUCT RELEASE YES NO 4 DONORS SCREENED USING DD572 amp CURRENT SOP YES NO 5 BLOOD TUBES COLLECTED AT THE TIME OF COLLECTION FOR FOLLOW UP WITH FDA TTD TESTING YES NO 6 INTERNATIONAL SOCIETY FOR BLOOD TRANSFUSION SBT LABELS USED YES MO 7 TUBES AND A COPY OF DD572 FORWARDED TO BSD YES NO 8 UNIT ACCOUNTED FOR IN TMDS YES MO 9 WAS COMPONENT THERAPY AVAILABLE WHEN YES FWB WAS GIVEN 10 PLEASE PROVIDE ANY INFLUENCING FACTORS THAT PREVENTED YOU FROM FOLLOWING THE SOP FOR THIS TRANSFUSION EVENT IF APPLICABLE INDIVIDUAL COMPLETING CHECELIST Print Name Signature This checklist is to be kept on file for a minimum
17. Whole Blood from the laboratory WBB operations are at times chaotic and do not often allow for real time updates of TMDS Provider requesting Fresh Whole Blood should sign Emergency Release Letter of understanding Form 150a or 150b as appropriate Forms should be maintained in patient transfusion records Accurate dispositions of all Whole Blood units collected MUST be properly dispositioned in TMDS Every unit must be created transfused expired or destroyed as appropriate Fresh Whole Blood should be destroyed 24 hours post collection FWB can be stored at room temperature for 8 hours and refrigerated thereafter Processing Samples for Shipment amp Testing 1 Label aliquot pour off tubes with corresponding ISBT Labels with small barcodes Position the ISBT label vertically toward top of tube as shown at left If ISBT labels are not available utilize the Donor SSN as the unit number Pour 1 Pearl Top into 1 aliquot tube and mark as Plasma Repeat for each Pearl Top tube 3ml sample requirement per aliquot Pour contents of 2 Gold Top tubes into 1 aliquot tube and mark as Serum Do not fill over full to allow for expansion from freezing The seal of capped aliquot tubes should be reinforced with para film wrap and placed into a biohazard shipping bag or rack Repeat for each series Record sample and donor demographic data on Form 148 Shipping Manifest Include a printed copy of manifest with
18. a high mortality rate 33 and have the greatest potential to benefit from appropriate transfusion strategies Large retrospective cohort studies of casualties requiring massive transfusions during Operations IRAQI FREEDOM OIF and ENDURING FREEDOM OEF demonstrate a significant survival benefit for the massively transfused casualty when RBCs fresh frozen plasma and platelets are transfused at a 1 1 1 ratio Advantages to FWB FWB provides FFP RBC PLTs in a 1 1 1 ratio For US casualties presenting in hemorrhagic shock a transfusion strategy that included FWB with RBCs and plasma has an improved survival compared to the use of stored components only FFP RBCs and PLTs Additionally FWB is available in austere conditions has no loss of clotting factor or platelet activity that is often associated with cold storage and has no red blood cell storage lesion Disadvantages to FWB Since FWB has both RBCs and plasma it must be ABO type specific There are risks associated with the use of FWB including but not limited to increased risk of transmitted blood borne diseases e g HIV hepatitis B C syphilis a period of decreased exercise tolerance in donors who are often members in the casualty s unit and an increased risk of clerical errors e g ABO typing due to the potentially chaotic activity during which FWB is requested Additionally field conditions are inherently unsanitary and are presumed to increase the risk of bacter
19. aria HBsAg and HCV test kits e Serological RPR kit e Clinical Rotator e Centrifuge e Disposable Pipettes e Adhesive Tape e Hemostats e Scissors e Strippers e Metal Clips e Gloves e Tourniquet e Biohazard Container Sharps Container e Whole Blood ISBT Labels 100 number series Records Forms Forms required modified DD FORM 572 Form 145a Form 147 Form 148 Form 150a Form 150b Form 151 and SF 518 as applicable See Enclosures Emergency Whole Blood Collection SOP Theater Medical Data Store TMDS Blood Portal Guideline Only Not a Substitute for Clinical Judgment Page 19 of 43 July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline EMERGENCY WHOLE BLOOD COLLECTION SOP Quality Control Perform QC on STAT Site M or equivalent POCT Hemaglobinometer Perform QC on ABO Rh Testing Card RPR HCV HBsAg HIV and Malaria Kits See instrument package inserts and local SOPs for procedures Medical personnel should be trained by BSD or other qualified personnel Procedure Perform the following steps when the physician request whole blood units Permission to conduct the blood drive 1 Notify Level HUT Commander DCCS and Laboratory OIC NCOIC that a physician is requesting whole blood for transfusion 2 Once the Commander DCCS grants permission initiate the emergency whole blood collection Trained medica
20. atient with immediately life threatening injuries a Facilities where full component therapy is available Due to infectious concerns the risk benefit ratio does not justify the routine use of FWB over banked blood products in non life threatening severe trauma Conversely when platelets and FFP inventories are depleted or in contingencies such as mass casualty MASCAL situation where the blood inventory may be exhausted the use of FWB remains an appropriate life saving option b Surgical Facilities where component therapy is limited e g no availability of apheresis platelets Due to risks inherent with the use of FWB it should only be used for patients with immediate life threatening injuries c Facilities where full component therapy is not available FWB should only be used when there is a threat to loss of life limb or eye sight 4 Guidelines The decision to use FWB is a medical decision that must be made by a physician who has full knowledge of both the clinical situation and the availability of compatible blood components A Walking Blood Bank WBB Program will be established based on a risk assessment and the potential for casualties Coordination with the Area Joint Blood Program Officer AJBPO is required to establish a WBB Program Appendix A Blood Donor Pre Screening SOP FWB should be collection for transfusion as outlined in Appendix B Emergency Whole Blood Drive SOP a In general the use of FWB should be limit
21. awing labeling and issuing standards required for U S FDA approved blood products d Pre screened donors in the WBB Program determined to be suitable should be utilized before using personnel who 1 are not fully suitable 2 do not have a current screening and infectious disease testing history 3 have no donation history to the greatest extent possible e Upon determining the ABO Rh status of the casualty activate the WBB Program re calling pre screened donors with the exact same ABO Rh using the TMDS gt Manage Donor gt View Donor List if available or other communication networks f Before any FWB is transfused rapid infectious disease testing i e HIV HBV HCV of donor specimens shall be performed to the greatest extent possible g Retrospective samples must be sent to a state side laboratory for FDA approved testing regardless whether the rapid infectious disease testing is performed pre or post transfusion as these tests are not licensed for donor testing h Upon the notification of confirmed positive infectious disease results a medical provider or preventive medicine personnel should be notified to ensure the donor is notified and counseled i Ifa patient receives a confirmed positive infectious disease unit the AJBPO will notify the Armed Services Blood Program immediately to initiate patient notification and a respective evaluation of both the donor and patient j In accordance with HA Policy 10 002 P
22. blood is independently associated with improved survival for patients with combat related traumatic injuries J Trauma 2009 66 S69 S76 CENTCOM FRAGO 09 1222 Joint Theater Blood Program Update 4 May 2007 Emergency War Surgery 2004 Third US Revision Chap 7 Shock and Resuscitation Theater MTF specific Standard Operating Procedures SOPs Technical Manual AABB Bethesda Maryland 16th Edition 2008 Standards for Blood Banks amp Transfusion Services AABB 25th Ed February 2008 Theater Medical Data Stores TMDS Blood Portal Standard Operating Procedures http militaryblood dod mil Staff eMOAS aspx Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 5 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline Approved by CENTCOM JTTS Director JTS Director and CENTCOM SG Opinions interpretations conclusions and recommendations are those of the authors and are not necessarily endorsed by the Services or DoD Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 6 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline APPENDIX A BLOOD DONOR PRE SCREENING SOP Materials and Use the following materials and equipment as applicable Equipment e Modified DD Form 572s e Clip Boards e Gloves e Testing Collection Set premade bags with 2x2 gauze 2 gold tops SST 2 pear
23. bs or other defects 10 Pull the skin taut below the venipuncture site 11 With the bevel up hold the needle at the hub at approximately a 30 45 degree angle and pierce the skin with a smooth quick thrust at the selected point of entry Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 23 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline EMERGENCY WHOLE BLOOD COLLECTION SOP 12 When the bevel is completely under the skin lower the angle of the needle to approximately 10 or less and with a steady push advance needle to penetrate the vein wall Thread needle approximately L inch inside the vein to maintain a secure position and to lessen the chance of a clot forming 13 Release the hemostat clamp on the collection bag tubing and observe the blood flow through the tubing and into the collection bag If blood flow Then Is impeded Try adjusting the needle with least discomfort without hurting the donor Is still impeded Seek assistance from another phlebotomist before discontinuing the phlebotomy 14 Fill sample tubes using the tube adaptor After filling sample tubes gently rock tubes to mix contents and verify once again that donation identification number on tubes corresponds to donation identification number on the collection bag and the DD FORM 572 15 Instruct donor to relax their grip and to
24. cument deferral as appropriate in TMDS 12 Issue blood bag and test collection set to donor Label bag and DD FORM 572 with Whole Blood ISBT labels Blood collection tubes 2 gold tops SST 2 pearl tops PPT 1 purple top tube should be labeled with the corresponding small ISBT labels without barcode See Illustration to the left If no labels are available bags and all samples should be labeled with donor s full name and SSN or Blood Bag Segment Number Guideline Only Not a Substitute for Clinical Judgment Page 22 of 43 July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline EMERGENCY WHOLE BLOOD COLLECTION SOP Whole Blood Collection 1 Seat donor in blood donor table or reclining chair Ask the donor their name and verify donor demographic information is correct on the Modified DD Form 572 Verify also that the labels the blood bag sample tubes and Modified DD Form 572 correctly correspond to each other and the donor NOTE If a discrepancy is noted STOP and correct before proceeding further 2 Ask donor if they are allergic to iodine or shellfish If Then Yes Skip Step 3 and proceed to Step 4 No Proceed to Step 3 3 Utilizing Frepp Sepp apply Povidone Iodine Frepp 2 Aqueous Solution Scrub vigorously for at least 30 seconds Within a 3 diameter area around venipuncture site Then Apply 10 Iodine Sepp to venipuncture site
25. e Donor is deemed fully Pre Screened Tested To minimize risk to the recipient it is recommended that pre tested population be exhausted prior to resorting to collections from the untested population A qualified interviewer will review Modified DD Form 572 for completeness and Donor Suitability Criteria following Steps 5 11 below See attached Enclosures using standards available for reference and download through Blood Portal at http rceast afghan swa army mil sites tfmeda or at http militaryblood org If Then There are all N o responses Proceed to Step 6 except for questions 22 24 There are any Y es responses Document the reason for the Y es response except for questions 22 24 Refer donor to a qualified provider to determine the donor s eligibility Defer the donor as required if necessary document Ineligible status on DD FORM 572 and in TMDS NOTE For Q 39 use State Tattoo and Permanent Make up Reference List See Enclosure to screen for acceptability Using the Direct Oral Questions See Enclosure ask the donor Group A B and C questions Record name of interviewer on Modified DD Form 572 If Then The donor answers N o to each Proceed to Step 7 group The donor answers Y es to any Defer donor for designated period of time and group stop the donation process Document donor as Ineligible Guideline Only Not a Substitute for
26. e following steps when Pre screening Donors Prepare for Donor Pre Screening Event 1 Coordinate with appropriate units contacts for times and location of event May need to conduct a site survey to ensure appropriate site i e space lighting privacy for interview etc Samples need to be sent to the blood support detachment as soon as possible after collection so prior coordination with transport assets is a must Guideline Only Not a Substitute for Clinical Judgment Page 7 of 43 July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline BLOOD DONOR PRE SCREENING SOP Conducting the Pre Screening Event 1 Medical History Provide prospective donor a Modified DD Form 572 ensure demographic info is legible and as complete as possible Interview Trained medical personnel will need to determine if the donor is eligible to donate based on the information collected Donor eligibility requirements can found on the Blood Portal at http rceast afghan swa army mil sites tfmeda If Then There are all N o responses except for questions 22 24 Proceed to Step 4 There are any Y es responses except for questions 22 24 Document the reason for the Y es response Refer donor to a qualified provider i e MD DO NP or PA to determine the donor s eligibility Defer the donor as required if necessary document Inelig
27. e into building a donor pool will make performing whole blood drives easier and safer when the time comes Your donor pool does not need to be enormous 50 people covering most of the blood types O A B is ideal for most locations REMEMBER WHOLE BLOOD MUST BE TRANSFUSED TYPE SPECIFIC References 1 AABB Technical Manual current edition AABB Standards for Blood Banks and Transfusion Services 7 JTTS Clinical Practice Guideline Fresh Whole Blood FWB Transfusion T Theater Medical Data Store TMDS Version 2 7 0 0 System User s Manual Enclosures DD Form 572 Emergency Whole Blood Donation Record Approved State Tattoo and Permanent and Make up Reference List Direct Oral Questions Form 147 Eldon Card ABO Rh Typing Record Form 148 Pre Screen Whole Blood Sample Shipping Manifest Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 10 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline DD FORM 572 EMERGENCY WHOLE BLOOD DONATION RECORD EMERGENCY WHOLE BLOOD DONATION RECORD Modified Version of the DD Form 572 Blood Unit Number D scm Dato Use Dosse SSN if ISET Not Available Rank Branch USA USAF USN USMC CIV SSN Date of Bath DDMMMYYYY Ser M F Hor ABO Eh Blood Type E0 Deployed Unit Locatica Local DSN Phone Local Cell Evening Phone Current Residence Blds Tent EMS Home Address a Home Phone Number
28. e your suitability as a volunteer blood donor Your answers to these questions will be kept strictly confidential but may result in you being asked not to donate blood either temporarily or permanently Do not respond until I have asked you the entire group of questions which at that time only give me one answer Yes or No Group A 1 Do you have AIDS or have you ever had a positive test for the AIDS virus HIV 2 Have you ever taken illegal drugs with a needle even one time including steroids 3 Have you ever taken clotting factor concentrates for a bleeding disorder such as hemophilia 4 At any time since 1977 have you taken money or drugs in exchange for sex 5 Male donors only Have you had sex with another male even one time since 1977 A Yes answer to Group A is a PERMANENT DEFERRAL Group B 1 Were you born in have you lived in or traveled to any African country since 1977 If response is Then No Proceed to Group B Question 3 Yes Was it any of these countries Cameroon Benin Central African Republic Chad Congo Equatorial Guinea Kenya Gabon Niger Nigeria Senegal Togo or Zambia If No Go to Group B Question 3 If Yes Travel Only Proceed to Group B Question 2 If Yes Born or Lived in Document when DEFER INDEFINITELY 2 When you traveled to name of country did you receive a blood transfusion or any other medical treatment with a product made from blood
29. ed to casualties who are anticipated to require a massive transfusion when the physician determines that optimal component therapy is unavailable or in limited supply or in patients that are not responding to stored component therapy b The decision to initiate a FWB drive should be made in consultation with the appropriate MTF medical authority e g DCCS Trauma Director and Laboratory Blood Bank OIC c Pre screened donors registered into the WBB Program are preferably composed of active duty active reserve active National Guard and other DoD beneficiaries Coalition Forces will not be utilized routinely as donors only by exception Foreign Nationals should be used as a last resort d Donor FWB must be an ABO type specific match to the casualty If not matched a fatal hemolytic reaction may occur TYPE O whole blood is NOT universal Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 2 of 43 Fresh Whole Blood FWB Transfusion e Joint Theater Trauma System Clinical Practice Guideline The decision to use FWB that has not been completely screened for infectious agents is a medical decision that must be made after thorough consideration of risks and benefits Decision making should be adequately documented in the casualty record Prior to issuing FWB for transfusion the ABO and Rh type should be verified and approved rapid infection disease tests e g HIV HCV and HBV should be performed as outlined
30. ial contamination of the blood Recent history with gt 4000 FWB transfusions to U S personnel during OIF OEF have resulted in one Hepatitis C HCV and Human T Lymphocyte Virus HTLV seroconversion Fresh WB is not FDA approved and is not intended or indicated for routine use It is NOT appropriate as a matter of convenience to use FWB as an alternative to more stringently controlled blood products for patients who do not have severe immediately Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 1 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline life threatening injuries FWB is to be used only when other blood products are unable to be delivered at an acceptable rate to sustain the resuscitation of an actively bleeding patient when specific stored components are not available e g RBCs PLTs Cryo FFP or when stored components transfused in large volumes are not adequately resuscitating a patient with an immediately life threatening injury 3 Recommendations The use of FWB should be reserved for casualties who are anticipated to require massive transfusion 10 or more units of RBCs in 24 hours for those with clinically significant shock or coagulopathy e g bleeding with associated metabolic acidosis thrombocytopenia or INR gt 1 5 when optimal component therapy e g PLTs and FFP are unavailable or stored component therapy is not adequately resuscitating a p
31. ible status on DD FORM 572 and in TMDS NOTE For Q 39 use State Tattoo and Permanent Make up Reference List See Tattoo and Make up Reference List to screen for acceptability Using the Direct Oral Questions ask the donor Group A B and C questions Record name of interviewer on DD Form 572 See Enclosures Blood Donor Pre Screening SOP If Then The donor answers N o to each group Proceed to Step 5 The donor answers Y es to any group Defer donor for designated period of time and stop the donation process Document donor as Ineligible Register Donor in TMDS per Manage Donations Donors SOP 4 See steps below Rapid Infectious Disease Testing If performed see Emergency Whole Blood Collection SOP for instructions Perform ABO Rh Testing 1 Utilizing blood from purple top tube perform ABO Rh confirmation using Eldon Card or other FDA approved method to verify ABO listed on DD FORM 572 Refer to package inserts and approved SOPs for further instructions 2 Record Lot of reagents EXP Date and Results on Form 147 3 Record blood type in TMDS See Enclosures Blood Donor Pre Screening SOP Guideline Only Not a Substitute for Clinical Judgment Page 8 of 43 July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline BLOOD DONOR PRE SCREENING SOP Processing Samples fo
32. ican Country since 1977 If response is Then No Proceed to Group C Yes Was it any of these countries Cameroon Benin Central African Republic Chad Congo Equatorial Guinea Kenya Gabon Niger Nigeria Senegal Togo or Zambia If No to listed countries Proceed to Group C Yes to listed countries Document when DEFER INDEFINITELY Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 15 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline Group C 1 Have you had sex in the last 12 months even once with anyone who has AIDS or has had a positive test for the AIDS virus 2 Have you had sex in the last 12 months even once with anyone who has ever taken illegal drugs with a needle including steroids 3 Have you had sex in the last 12 months even once with anyone who has taken clotting factor concentrates for a bleeding disorder such as hemophilia 4 At any time in the last 12 months have you given money or drugs to someone to have sex with you 5 At any time in the last 12 months have you had sex with someone who has taken money or drugs in exchange for sex 6 In the past 12 months have you had a positive test for syphilis 7 In the last 12 months have you had syphilis or gonorrhea or have you been treated for syphilis or gonorrhea 8 In the last 12 months have you received blood or blood products 9 In the last 12 months have you been inca
33. in Appendix B Emergency Whole Blood Drive SOP to the greatest extent possible Theater Medical Data Stores TMDS Blood Portal shall be utilized to record FWB donations and infectious disease testing results 5 Precautions Transfusion of FWB in the field may be dangerous for several reasons a There is no universally compatible FWB type Transfusions of FWB must be an ABO match For female casualties of child bearing potential there must also be an Rh match Service members blood types are not always known with certainty The blood type on identification tags is occasionally incorrect last correlated data equated to about 4 and must not be relied upon routinely to determine blood type for either donors or recipients Identification tags for ABO Rh verification should be utilized as a last resort only Because it is not subject to the same infectious disease testing and strict quality controls as banked blood FWB does not meet FDA standards and has an increased risk of blood borne disease transmission e g HIV hepatitis B C syphilis In MASCAL situations particularly when more than one blood type is being collected there is an increased risk of a clerical error leading to a life threatening transfusion reaction Field conditions are inherently unsanitary and increase the risk of bacterial contamination of the blood Use of non standard blood donation material and equipment may lead to coagulation during the collect
34. in language a that the use is not approved by the FDA b the reasons why a DoD health care practitioner would decide to use the product for this purpose and c the potential risks associated with such use Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 43 of 43 Fresh Whole Blood FWB Transfusion
35. ion ID ABO Rh and expiration date then click Next Re verify all demographic and unit data then click Confirm Donation Ol aolrnst ny nm A Repeat steps 1 8 for each product collected Guideline Only Not a Substitute for Clinical Judgment Page 25 of 43 July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline EMERGENCY WHOLE BLOOD COLLECTION SOP Pre Transfusion Rapid Testing 1 Rapid tests should be performed and found to be negative prior to transfusion to the greatest extent possible In situations requiring whole blood available blood component inventory should continue to be transfused in lieu of whole blood until rapid testing has been performed and found to be negative Spin down gold and pearl top tubes Perform rapid HBsAg HCV RPR using Serum Plasma and HIV Malaria using whole blood Testing should be performed IAW Test Kit package inserts and local SOP Record reagent Name Lot Exp Date and Results on Form 145a Upon completion of rapid tests with negative results whole blood unit may be issued for transfusion When time allows rapid test results need to be entered into TMDS To do this click on Update Donation under the Manage Donation tab Issuing amp Managing Whole Blood Inventory 1 It is recommended that some sort of blood product issue document ex SF 518 be utilized to account for the issue of
36. ion process potentially causing an adversely transfusion reaction therefore only authorized equipment will be utilized Appendix B Enclosure 6 WBB Supply List with NSNs 6 Planning Since the need for FWB cannot be predicted a robust contingency operational plan should be developed by the MTF staff to include the Laboratory Blood Bank and surgical and anesthesia providers in coordination with the AJBPO The plan should be reviewed and rehearsed regularly The key elements for planning and readiness to administer FWB are knowledge and rehearsal of two SOPs Appendix A Blood Donor Pre Screening SOP and Appendix B Emergency Whole Blood Drive SOP a A contingency plan should be developed for collecting storing and transfusing FWB in MASCAL situations or when it may be deemed the current blood inventory will be exhausted prior to re supply e g when multiple type O trauma casualties are exhausting the type O RBC inventory Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 3 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline b The physical donation site should be organized in such a way as to maintain the integrity of the screening and donation process and to minimize the possibility of clerical errors This is especially important in emergency situations involving more than one casualty c Every effort should be made to adhere to the same screening dr
37. is 585g e Under fill is less than 555g total weight e Over fill is greater than 650g total weight 4 Perform QC on the STAT Site M ABO Rh Cards HIV HCV HBsAg Malaria and RPR Kits 5 Ensure the necessary equipment to perform donor screening testing and collection are available See WBB Supply List with NSNs Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 20 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline EMERGENCY WHOLE BLOOD COLLECTION SOP Perform Donor Screening 1 To the greatest extent possible potential whole blood donors should be selected from among the pre tested and qualified population documented in TMDS This is the best practice to mitigate the risk of Transfusion Transmitted Disease TTD to the recipient Give donor Emergency Donation Record Modified DD Form 572 and instruct donor to complete demographic information and to answer questionnaire by circling Y es or N o If donor already has a pre completed DD Form 572 on file have them review the form and verify information is correct and update as necessary While donor is completing DD FORM 572 screen for donor alerts and completed FDA test results in TMDS deferrals Locate donor s name on the Donor List displayed in TMDS To the left of their name click View If all TTD results are Negative within last 90 days and there are no Donor Alerts then th
38. l tops PPT 1 purple top tube more tubes may be required if using short draw or small volume tubes e Blood Collection Needles e BD Vacutainer Hubs e Coban e Assigned Pre Screen ISBT Labels 500 number series e Sharps Containers e ABO Rh Testing Card es Eldon Military Kit or other FDA approved device e Centrifuge e Disposable Pipettes e Plastic Aliquot tubes lids 13X100mm or 12X75mm e Para Film e Biohazard Bags e Trash Bags e Leak Resistant Chucks e Disposable Lab Coats e Cold Packs e Test Tube Racks Records Forms e Modified DD FORM 572 Form 147 Form 148 See Enclosures Blood Donor Pre Screening SOP e Theater Medial Data Store TMDS Blood Portal Quality Control Perform QC on ABO Rh Testing Card See instrument package inserts for procedures Medical personnel should be trained by BSD or other qualified personnel Procedure Pre screening of a prospective emergency whole blood donor pool is mandatory Development of a pre screened donor pool should be considered a commander s priority when a level II or III facility is established or replaced It is imperative that a donor pool once established is maintained because of the frequent redeployment of units out of theatre Due diligence in establishing a pre screened whole blood donor pool will decrease the risk of transmitting infectious disease while simultaneously increasing the efficiency of the whole blood collection process Perform th
39. l be forwarded to Preventive Medicine Consultant to ensure proper donor care and follow up is initiated At no time will laboratory staff notify donors directly regarding positive testing results References AABB Technical Manual current edition AABB Standards for Blood Banks and Transfusion Services JTTS Clinical Practice Guideline Fresh Whole Blood FWB Transfusion Theater Medical Data Store TMDS Version 2 7 0 0 System User s Manual Enclosures DD Form 572 Emergency Whole Blood Donation Record Direct Oral Questions Approved State Tattoo and Permanent Make up List Acceptable Donor Worksheet Form 145a Rapid Testing Worksheet Form 147 Eldon Card ABO Rh Typing Record Form 148 Pre Screen Whole Blood Sample Shipping Manifest Form 150a Emergency Release Letter of Understanding tested Form 150b Emergency Release Letter of Understanding un tested Form 151 Whole Blood Transfusion Checklist WBB Supply List with NSNs Page 27 of 43 Guideline Only Not a Substitute for Clinical Judgment July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline DD FORM 572 EMERGENCY WHOLE BLOOD DONATION RECORD EMERGENCY WHOLE BLOOD DONATION RECORD Modified Version of the DD Form 572 Blood Unit Number D som Date Use Dosse SSN if ISET Not Available Rank Branch USA USAF USN USMC CIV SSN Date of Birth ODMMMYYYY Se
40. l personnel should oversee the process Donor Recruitment 1 REMEMBER WHOLE BLOOD MUST BE TRANSFUSED TYPE SPECIFIC Announce the whole blood drive First donors should be recruited from the pre screened donor pool who s infectious disease testing results are negative or non reactive If insufficient pre screened donors are available determine acceptability based on prospective donors 1 are not fully suitable 2 do not have a current screening and infectious disease testing history 3 have no donation history 2 Pull a pre screened donor list from TMDS Manage Donor gt View Donor List 3 Select filters for ABO Rh of the potential whole blood recipient Screened select ALL Alert select ALL Cocom select CENTCOM Highlight your facility in the Available Facilities tab and click Add Once your facility appears in the Search Facility box click Display Donor List The potential donor list for the blood type required will now appear on the screen Donor and Testing Area Preparation 1 Set up blood donor beds 2 Perform QC on weighing device i e HemoFlow or Trip Scale NOTE If no trip scale is available see section below Whole Blood Collection Step 6 3 Ensure counterweight is set at 585g One milliliter of blood equals 1 053g 450 mL of Whole Blood equals 474g The final container must weigh 425g to 520g 405 to 495 ml plus the weight of the primary blood bag with its anticoagulant The target weight for a 450mL bag
41. ld APO AE 09354 APO AE 09355 BAP 431 5446 5536 KAP 421 6171 For other deployed units Freeze samples until they can be shipped to a designated laboratory to perform FDA approved testing The BSD or unit will send all samples for FDA approved testing to designated laboratory for FDA approved testing Enter results in TMDS and forward to submitting Level II or Level III upon completion NOTE The prospective donor is NOT considered pre screened and fully qualified for FWB donation until negative or non reactive testing results are received from a testing facility Any positive testing that is received by BSD or unit will be forwarded to Preventive Medicine Consultant to ensure proper donor care and follow up is initiated At no time will laboratory staff notify donors directly regarding positive testing results Guideline Only Not a Substitute for Clinical Judgment Page 9 of 43 July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline BLOOD DONOR PRE SCREENING SOP Maintain Database TMDS 1 Transfer demographic information from the DD FORM 572 and Form 147 to Donor Management Database in TMDS This will act as a deferral list or an eligible donor list when a whole blood drive is necessary It is recommended that a hard copy of Donor Database and deferral list be printed monthly or at some regular interval for use during Emergency Whole Blood Collection when comp
42. le Blood FWB Transfusion Page 17 of 43 Joint Theater Trauma System Clinical Practice Guideline FORM 148 PRE SCREEN WHOLE BLOOD SAMPLE SHIPPING MANIFEST Prescreen Whole Blood Sample Shipping Manifest rs latin Service Natio First Form 148 V May 2012 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 18 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline APPENDIX B EMERGENCY WHOLE BLOOD COLLECTION SOP Materials and Use the following materials and equipment as applicable Equipment e Vitals Machine e Blood Collection Beds e Stethoscope e Blood Pressure cuff e Digital Thermometer and or Tempadots e Lancets e STAT Site MS or other POCT Hemaglobinometer e STAT Site M test cards e STAT Site M controls e Coban e Alcohol Pads e Electronic table top scale optional e Blood Bags Terumo Single Blood Bags preferred NOTE If an additive solution AS bag is present with a multiple bag set up the AS SHALL NOT be added to the whole blood e Blood Trip Scale with 585 2g trip counter weight and QC weights or HemoFlow e Testing Collection Set premade bags with sterile 4x4 gauze Frepp Sepp 2 gold tops SST 2 pearl tops PPT 1 purple top tubes and tube collection device e ChloraPrep Iodine alternative e Adapter MS DIR 100S Luer 100S e ABO Rh Testing Card e g Eldon Military Kit or other FDA approved device e Rapid HIV Mal
43. lling tight the loose knot in the tubing 23 Grasp the tubing on the donor side of the seal and press to remove a portion of blood in the tubing Crimp the tubing at this spot Cut the tubing between the two seals 24 Remove tourniquet or blood pressure cuff and tape strips from donor s arm 25 Place the fingers of one hand gently over the sterile gauze DO NOT APPLY PRESSURE OVER THE NEEDLE With the other hand smoothly and quickly withdraw the needle Apply firm pressure to the phlebotomy site Guideline Only Not a Substitute for Clinical Judgment Page 24 of 43 July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline EMERGENCY WHOLE BLOOD COLLECTION SOP 26 Instruct donor to apply firm pressure over the gauze Encourage donor to maintain a relaxed elevated position rather than tensing the muscle This precaution will minimize the bleeding into the venipuncture area 27 Discard the needle assembly into a sharps container 28 Using a hand stripper crimper strip all blood from the tubing into the primary collection bag This should be done ASAP after collection Stripping is pushing the blood in the tubing into the blood filled bag with the rollers on the stripper crimper device 29 Mix contents in the primary collection bag DO NOT strip the tubing and allow tubing to refill without mixing Release the stripper and allow the
44. of one 1 year Forward a copy transfused to BSD with corresponding samples for Every unit of Whole Blood Fom 151 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 41 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline WBB SUPPLY LIST WITH NSNS Item Description Stock NSN SHARPS Container 6515014922824 Biohazard Bags 0707A950012 Leak Resistant Chucks 3583001093 Gloves SM 4352MG6001 MED 4352484802 LRG 4352MG6003 Surgical Tape 6510009268882 Sphygmomanometer 3596994215 Stethoscope 3596994510 Tempa Dots 4509005 122 Lancet F50924058510 Alcohol Pads 4725APP104 2x2 Gauze 3583001806 STAT SiteM 1750SB900900 STAT SiteM Test Cards 6550015096101 Blood Bag Scales Hemo Flow 6515015137010 Blood Bag Stand 6515004114375 Terumo Single Blood Bags 6515014802307 Frepp Sepp Kit 4335260288 4x4 Gauze 3583002634 Hand Stripper Sealer Cutter 6515011405267 Hand Sealer Clips 06814R4418 Scissors 6515003650640 Hemostats 5867097442 Adapter MS DIR 100S Luer 100S 723364902 Purple Top EDTA Plasma 0723367861 Pearl Top PPT 0723362788 Gold Top SST 723364902 Coban 5x1 4509001583 Eldon Card Rapid ABO Rh 6550015871889 individual card 6550015119294 25 ct multi test kit HIV 1 2 RA OraQuick 6550015267424 ORAQUIK HCV 6550015899845 ONSITE CTK HBSAG Hep B 6
45. olicy on the Use of Non U S Food and Drug Administration recipients of FWB shall receive follow up infectious disease testing as soon as possible 3 6 and 12 months post transfusion k A contingency plan should be developed for collecting storing and transfusing FWB in MASCAL situations or when it may be deemed the current blood inventory will be exhausted prior to re supply e g when multiple type O trauma casualties are exhausting the type O RBC inventory l Procedure See Appendix B for DD Form 572 Emergency Whole Blood Donation Record 7 Performance Improvement PI Monitoring a Intent Expected Outcomes FWB is reserved for casualties who are anticipated to require massive transfusion 10 or more units of RBCs in 24 hours for those with clinically significant shock or coagulopathy e g bleeding with associated metabolic acidosis thrombocytopenia or INR gt 1 5 when optimal component therapy e g PLTs and FFP are unavailable or stored component therapy is not adequately resuscitating a patient with immediately life threatening injuries Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 4 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline b Performance Adherence Measures 1 FWB was used for casualties who were anticipated to require massive transfusion 10 or more units of RBCs in 24 hours for those with clinically significant shock
46. owa YES Kansas YES Kentucky YES Louisiana YES Mame YES Maryland NO Massachusetts NO Michigan NO Minnesota NO Mississippi YES Missouri YES Montana YES Nebraska YES Nevada NO New Hampshire NO New Jersey YES Revised Date 14 Mar 12 BPL 12 01 BPL Date 14 Mar 12 Page20f3 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 13 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline Armed Services Blood Program State Acceptable Note New Mexico NO New York NO North Carolina YES North Dakota NO Ohio YES Oklahoma NO Oregon YES Pennsylvania NO Rhode Island YES South Carolina YES South Dakota YES Tennessee YES Texas YES Utah NO Vermont YES Virginia YES Washington YES West Virginia YES Wisconsin YES Wyoming NO Revised Date 14 Mar 12 BPL 12 01 BPL Date 14 Mar 12 Page 3 of 3 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 14 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline DIRECT ORAL QUESTIONS Preamble I am required to ask you some questions If you do not understand a question please ask me to explain it before answering The reason for asking these questions is to determine your suitability as a volunteer blood donor Your answers to these questions will be kept strictly confidential but may result in you being asked not to donate blood either temporarily or pe
47. r M F Hour ABO Eh Blood Type 110 Rodaployment Date Current Residence Bids Tent EMS Home Address a Se Home Phone Number Email you 5 have the AIDS vires and you can give it to someone alse oven or acupanctare fsal well and have a ave AIDS text Y 2 N Have you ever given blood under another name or Social Y 40 Ns Ip the past 12 months have you had close contact with a person Secarity Namber with yellow jamndice or hepatitis or boen sven Hepatitis B Teemu Globalin Y 26 N bp tho past wosk havo you given blood plasma or platelets Y 4 N Haw you over had yellow jaundice iver disease hepatitis or a itive test for itis you ever aa or told not to past you had any or vaccumshoms donate blood past you a sam a pest 5 you a waccimation or or had close comtact with the vaccination site of alia Y 29 N bp tho past 12 months have you recetved blood blood products Y 44 N In the past month havo you taken Fimasterido Proscar Propocia or 2 tissus transplant including any you may have donated for or Isotretincim Accutane Ammesteem Claravis Sotret or in the 6 have you tkan Datavends Y 30 N bs tho past 3 yoan have you bad malaria Y 32 N M mator or brain covering graft Y 33 N Have you over taken Eens Togison or Acitwtin Soriatans puss cancer a oa Y 35 N Haveymova had chest pain best Zeng or hung disease Use this section and reverse side of form to explain Yes answurs above With the e
48. r Shipment amp Testing 1 Centrifuge Gold Top and Pearl Top Tubes for 5 minutes at 4000 RPM 2 Label aliquot pour off tubes with corresponding ISBT Labels with small barcodes Position the ISBT label vertically toward top of tube as shown at left If ISBT labels are not available utilize the Donor SSN as the unit number iia Pour 1 Pearl Top into 1 aliquot tube and mark as Plasma Repeat for each Pearl Top tube 3ml sample requirement per aliquot Pour contents of 2 Gold Top tubes into 1 aliquot tube and mark as Serum Do not fill over full to allow for expansion from freezing The seal of capped aliquot tubes should be reinforced with para film wrap and placed into a biohazard shipping bag or rack If a rack is not used rubber band tubes from the same donor together Repeat for each series Record sample and donor demographic data on Form 148 Shipping Manifest Include a printed copy of manifest with shipment and e mail to BSD or designated facility if possible Maintain the pre screening DD FORM 572s at your site until the potential donor redeploys As soon as possible ship samples and Form 148 in a blood box Collins Blood Box with ice bag s to your respective blood detachment E mail a copy of manifest to BSD or designated facility if possible or call to alert incoming shipment For Afghanistan Blood Support Detachment Blood Support Detachment TF MED Bagram Airfield Kandahar Air Fie
49. rcerated in a correctional institution including jail or prison for more than 72 consecutive hours 10 In the last 12 months have you taken snorted cocaine through your nose 11 Female donors only In the past 12 months have you had sex with a man who had sex with another man even one time since 1977 A Yes answer to Group C is a TEMPORARY DEFERRAL for 12 months following the event Group D 1 Have you at any time since 1980 injected Bovine Beef Insulin A Yes answer to Group D is an INDEFINITE DEFERRAL Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 16 of 43 Fresh Whole Blood FWB Transfusion 4 Date of Testing FORM 147 ELDON CARD ABO RH TYPING RECORD Eldon Card ABO Rh T Joint Theater Trauma System Clinical Practice Guideline i K i nf uf uf uf op ad ada nf uf fut uf ufuf uf uf apap uf apap ap apap ap aga al al f tf ai ff HH f f ftf l ff fl Hf Hl Hl Hl ed ed ed ed ed ee H uf uf uf vi vii uf uf vi apap apap uf apap apap apap ad adap fofofo ofa E e e dd ed E dd E ed E ed ed ed ed E ed ed Ea ed Ea ed ed ee E E 1 1 il 1i uf uf u 1i ufu uf uf uf un 1 a zl ul a vi vii vii vi tut ti vu vi vi vil apap ad apap vi vlt ap aga E ed ed ed ed ed ed REITER ed E E ed ed ed ed ed E eed ed E E Assigned Unit V 28 June 2010 Form 147 Guideline Only Not a Substitute for Clinical Judgment July 2012 Fresh Who
50. rmanently Do not respond until I have asked you the entire group of questions which at that time only give me one answer Yes or No Group A 1 Do you have AIDS or have you ever had a positive test for the AIDS virus HIV 2 Have you ever taken illegal drugs with a needle even one time including steroids 3 Have you ever taken clotting factor concentrates for a bleeding disorder such as hemophilia 4 At any time since 1977 have you taken money or drugs in exchange for sex 5 Male donors only Have you had sex with another male even one time since 1977 A Yes answer to Group A is a PERMANENT DEFERRAL Group B 1 Were you born in have you lived in or traveled to any African country since 1977 If response is Then No Proceed to Group B Question 3 Yes Was it any of these countries Cameroon Benin Central African Republic Chad Congo Equatorial Guinea Kenya Gabon Niger Nigeria Senegal Togo or Zambia If No Go to Group B Question 3 If Yes Travel Only Proceed to Group B Question 2 If Yes Born or Lived in Document when DEFER INDEFINITELY 2 When you traveled to name of country did you receive a blood transfusion or any other medical treatment with a product made from blood If response is Then No Proceed to Group B Question 3 Yes DEFER INDEFINITELY 3 Have you had sex with anyone who was born in or has lived in any Afr
51. shipment and e mail to BSD or designated facility if possible Form 151 Whole Blood Transfusion Checklist must be submitted with shipment for every unit of whole blood transfused Copies of DD FORM 572 and for all units of whole blood collected MUST be forwarded to BSD or designated facility with specimens and Form 145a Guideline Only Not a Substitute for Clinical Judgment Page 26 of 43 July 2012 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline EMERGENCY WHOLE BLOOD COLLECTION SOP 8 As soon as possible ship samples Form 145a Form 148 Form 151 and all DD FORM 572s in a blood box Collins Blood Box with ice bag s to your respective blood detachment E mail a copy of manifest to BSD or designated facility if possible or call to alert of incoming shipment For Afghanistan Blood Support Detachment Blood Support Detachment TF MED Bagram Airfield Kandahar Air Field APO AE 09354 APO AE 09355 BAP 431 5446 5536 KAF 421 6171 Or For other deployed units freeze samples until they can be shipped to a designated laboratory to perform FDA approved testing 9 The BSD or unit will send all samples for FDA approved testing in the rear enter results in TMDS and forward to submitting Role II or Role HI upon completion NOTE This results of this testing will be viewed as pre screen for donors next donation 10 Any positive testing that is received wil
52. standard of care Rather the inclusion in CPGs of off label uses is to inform the clinical judgment of the responsible health care practitioner by providing information regarding potential risks and benefits of treatment alternatives The decision is for the clinical judgment of the responsible health care practitioner within the practitioner patient relationship 4 Additional Procedures a Balanced Discussion Consistent with this purpose CPG discussions of off label uses specifically state that they are uses not approved by the FDA Further such discussions are balanced in the presentation of appropriate clinical study data including any such data that suggest caution in the use of the product and specifically including any FDA issued warnings b Quality Assurance Monitoring With respect to such off label uses DoD procedure is to maintain a regular system of quality assurance monitoring of outcomes and known potential adverse events For this reason the importance of accurate clinical records is underscored c Information to Patients Good clinical practice includes the provision of appropriate information to patients Each CPG discussing an unusual off label use will address the issue of information to patients When practicable consideration will be given to including in an appendix an appropriate information sheet for distribution to patients whether before or after use of the product Information to patients should address in pla
53. state a application SSES b mandated use of sterile needles c one time use If the state is acceptable defer the donor for one week to ensure the site has properly healed twcook ae mg gr eon the procedure was using sterile needles and single use dye If the donor answers no or does not know he she should be deferred for 12 months Prospective donors who had a procedure performed in a state listed as No must be deferred for 12 months from the time of application Armed Services Blood Program State Acceptable Note Alabama YES Alaska YES Arizona YES Arkansas YES Califomia NO Colorado YES Comnecticut NO Delaware YES District of Columbia NO Revised Date 14 Mar 12 BPL 12 01 BPL Date 14 Mar 12 Page 1 of 3 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 31 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline Armed Services Blood Program State Acceptable Note Georgia NO Hawaii YES Idaho NO Doors YES Indiana YES Towa YES Kansas YES Kentucky YES Louisiana YES Mame YES Maryland NO Massachusetts NO Michigan NO Minnesota NO Mississippi YES Missouri YES Montana YES Nebraska YES Nevada NO New Hampshire NO New Jersey YES Revised Date 14 Mar 12 BPL 12 01 BPL Date 14 Mar 12 Page20f3 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 32 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma S
54. this information by DoD personne is strictly for blood donor operations and must adhere to the current Service Army Navy and Air Force specific Standard Operating Procedure dealing with the screening of blood donors NOTE The following criteria provided by AABB Reference Standard 5 4 1A Requirements for Allogeneic Donor Qualification were used to determine acceptability of each state a application by a state regulated entity bi mandated use of sterile needles c one time use ink required If the state is acceptable defer the donor for one week to ensure the site has properly healed eee donors should be asked if the procedure was using sterile needles and single use dye If the donor answers no or does not know he she should be deferred for 12 months Prospective donors who had a procedure performed in a state listed as No must be deferred for 12 months from the time of application Armed Services Blood Program State Acceptable Note Alabama YES Alaska YES Arizona YES Arkansas YES Califomia NO Colorado YES Comnecticut NO Delaware YES District of Columbia NO Revised Date 14 Mar 12 BPL 12 01 BPL Date 14 Mar 12 Page 1 of 3 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 12 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline Armed Services Blood Program State Acceptable Note Georgia NO Hawaii YES Idaho NO Doors YES Indiana YES T
55. uter assets are unavailable Information in database should be kept confidential 2 To enter demographic data into TMDS go to the Manage Donation tab and select Donate Product Enter the Donor SSN first name last name in appropriate fields and click NEXT 3 In product code field enter E9999V00 pre screen In the expiration date field enter date 90 days from today and click Add Product 4 Verify donation ID product code ABO Rh and expiration date are correct then click NEXT 5 Carefully Re verify all demographic data that populates on the screen then click Confirm Donation Prospective donor is now entered in TMDS 6 From Manage Donation tab select Update Donation Enter donation ID number and click NEXT T Enter ABO Rh test result and date tested from Form 147 under Rapid Testing Results In Samples sent to field select BSD or unit from pull down menu and enter date samples were sent out from your facility Now click Update Tests 8 To Register another donor select Donate Product under Manage Donation tab and repeat process above 9 Populate FDA results and forward to submitting facility Donor alerts will also be activated by BSD or unit as necessary This data once populated will be the basis by which potential donors will be deemed fully qualified for Fresh Whole Blood FWB donations should the need for a Walking Blood Bank WBB arise at your facility NOTES Investing time and car
56. xception of questions 22 24 High Rick Oral Quostions 10 Jan 2010 Asked By Donor Tap pc Sp Pulse HCDHgb OM EM 180100 l00bpm 38 ar 125 gd 31 Medications Malaria Prophylaxis Daily Doxycycline Wockly___ Mcfloquin N A Your blood yi NOT be tested for viral diseases prior to transfusion dus to the emergency if you any reason you feel your blood may not be safe or you could answer yes to the high rick questions please do not donate todzy I have read had explained to me the high risk questions and am not m a high risk category and foal my blood is safe to donate at this time I verify that I have answered the questions honestly and foel my blood is safe to be transfused Donor s Si Phlebotomist Start Time Stop Time Should be lt 15 mimates Bag Mamafactarar Lo Expiration date Segment Number The Modified DD Form 572 has boen reviewed for completaness If there are amy risk factors that place the recipient at harm notify the ordering physician immediately for appropriate follow ap DD 572 Version 13 May 2010 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 28 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline DIRECT ORAL QUESTIONS Preamble I am required to ask you some questions If you do not understand a question please ask me to explain it before answering The reason for asking these questions is to determin
57. ystem Clinical Practice Guideline Armed Services Blood Program State Acceptable Note New Mexico NO New York NO North Carolina YES North Dakota NO Ohio YES Oklahoma NO Oregon YES Pennsylvania NO Rhode Island YES South Carolina YES South Dakota YES Tennessee YES Texas YES Utah NO Vermont YES Virginia YES Washington YES West Virginia YES Wisconsin YES Wyoming NO Revised Date 14 Mar 12 BPL 12 01 BPL Date 14 Mar 12 Page 3 of 3 Guideline Only Not a Substitute for Clinical Judgment July 2012 Page 33 of 43 Fresh Whole Blood FWB Transfusion Joint Theater Trauma System Clinical Practice Guideline ACCEPTABLE DONOR WORKSHEET Document all results on DD FORM 572 Donor Weight gt 110 Ibs Donor Weight gt 110 lbs Blood Pressure lt 180 100 Pulse 50 100 bpm may be lt 50 if donor is athletic Temperature lt 99 6 F Hemoglobin gt 12 5 g dL Hematocrit gt 38 Medications Do not collect from donors currently on antibiotics to exclude anti malarial prophylaxis Donors taking medications that the competent medical authority deems may cause harm to the recipient must be deferred from donating Be advised If the purpose of the whole blood drive is derive a source of platelets for a patient then donors who have taken aspirin in the last 72 hours should be deferred Medical Any donors with an underlying medical condition that could put them at risk if they were to Conditions
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