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o D REGIONAL ADVISORY COUNCIL CBRACREGIONAL WHOLE BLOOD PROGRAM MEMORANDUM OF UNDERSTANDING CBRAC Regional Whole Blood Program MOU September 2025 V.1 1 Table of Contents CBRAC REGIONAL WHOLE BLOOD*PROGRAM ................................................................................................1 MEMORANDUM OF UNDERSTANDING............................................................................................................1 BACKGROUND..............................................................................................................................................3 PROGRAMTENETS...................................................................................................................................3 EMSAgencies...........................................................................................................................................4 RegionalLTOWB Centers..........................................................................................................................5 TERM........................................................................................................................................................5 References ...................................................................................................................................................7 APPENDIX B: PREHOSPITAL BLOOD PRODUCT TRANSFUSION RECORD.......................................................9 APPENDIXC: LTOWB BLOOD PRODUCT TAG..............................................................................................10 APPENDIX D :APPROVED PRODUCTS LIST.................................................................................................11 APPENDIX E: CBRAC Inventory Management ............................................................................................14 APPENDIX F: Coastal Bend Blood Center MCI Letter..................................................................................15 Appendix G: Regional Whole Blood Change Request ................................................................................16 Appendix H: CBBC Validation Templates ...................................................................................................17 CBRAC Regional Whole Blood Program MOU September 2025 V.1 2 BACKGROUND The CBRAC Whole Blood Program was created in 2025 as a multi-disciplinary, multi-institutional consortium. This consortium is made up of regional helicopter and ground EMS agencies, regional trauma centers, the Coastal Bend Blood Center and CBRAC. It was born of like minded professionals focused on building a program to provide appropriate, timely, early resuscitation, either in the pre- hospital or rural hospital environment, using Low Titer O+ Whole Blood (LTOWB). This Consortium's objective is to manage the regional supply (donors) and demand without intentionally creating excess leading to waste; maintaining strict compliance with regulatory guidelines; and perpetuating an evidence-based system of care providing the best possible patient outcomes. CBRAC has developed this Memorandum of Understanding (MOU) to outline the agreement for program collaborators/stakeholders to work through the development, operation, and sustainment of this whole blood program. All stakeholders recognize the complexity of a regional LTOWB initiative and its potential impact to quality patient care if all parties do not develop, implement, and follow this MOU guiding each organization's behavior. For the purposes of this program: • A rotational site is an EMS agency or hospital with rotation privileges to Coastal Bend Blood Center (ensuring the LTOWB is rotated through to a higher usage rotational center). • A rotational center receives LTOWB already cycled through the prehospital or rural hospital setting. This process is intended to be free of bias, agnostic to any entity and in the best interest of those involved. This MOU is a living document and will be evaluated annually and as needed.The signatories are attesting to the commitment of their organization to follow and enforce the practices, roles, and responsibilities for their organizations as delineated in this MOU. PROGRAM TENETS All Participating Agencies and Facilities Agree to the Following: 1. Program updates and training information can be found at:cbrac.org 2. This is a regional process improvement program. All data and information shared will be used solely for the improvement of the delivery of care in the Coastal Bend Region in Texas. 3. The CBRAC Regional Whole Blood Committee will serve as the guiding body for the regional LTOWB program. Committee membership consists of EMS agencies (both air and ground), healthcare facilities and organizations contributing to supplying, administering, accounting for, and/or care of the patient receiving LTOWB in the CBRAC region. Meetings are conducted monthly. Participation is paramount. Key decisions regarding program execution and operation will be determined by consensus among all members of the CBRAC Whole Blood Program. Attendance requirement is to have a representative from each member agency/organization attend at least 9 of 12 meetings. 4. Clinical and administrative support is required to ensure program development,tracking, and sustainment is successful. This includes: a. Coastal Bend Blood Center will provide administrative training on the ordering, management, and storage of LTOWB at participating sites. b. Each agency and facility will ensure that training and validation is conducted per AABB standards. c. Each agency and facility will have a primary point of contact or designee available to address concerns and participate in discussions and decision making. 5. Coastal Bend Blood Center has its own collection, preservation, and lifecycle processes.To maintain consistency within the region,the Coastal Bend Blood Center will be the single supplier of rotational LTOWB. CBRAC Regional Whole Blood Program MOU September 2025 V.1 3 6. Agencies and facilities will provide clinical and administrative performance improvement information as requested by CBRAC. 7. Documentation of prehospital LTOWB transfusions will be done using the CBRAC Regional Prehospital Blood Product Transfusion Record (Appendix B).The transfusion record is not a substitute for the agencies electronic patient care record (EPCR).This document provides real- time communication between prehospital agencies,the receiving emergency department, and receiving facility's blood bank/transfusion services. It is imperative hospital blood banks/transfusion services receive real-time notification. It is required to utilize prehospital blood product transfusion record to include Pulsara notification as outlined that untyped & uncross- matched blood has been administered. 8. CBRAC will maintain regional program records using information from prehospital providers, Coastal Bend Blood Center, and receiving facilities. 9. Every attempt to regionally standardize LTOWB initiatives will be made to maximize opportunities for interoperability amongst member agencies.This includes: a. Distinct marking of the LTOWB blood bags to decrease the risk of misidentifying LTOWB versus packed red blood cells. See Appendix C. b. The use of only approved equipment and approved product(s) list by the CBRAC Regional Whole Blood committee. See Appendix D. c. New products for consideration will be brought to the committee for consideration. Products will be reviewed and approved by all stakeholders and the committee. 10. Any requests for changes to the agreed Memorandum of Understanding must be submitted using a CBRAC Regional Whole Blood Program Request for Change (RFC)form (Appendix G).The RFC will be evaluated by CBRAC Executive Leadership and CBRAC Regional Whole Blood Committee Executive Leadership for approval.Evaluation and decision will be required from all major program stakeholders(Coastal Bend Blood Center, CBRAC Executive Leadership,Whole Blood Committee) as well as any supporting committees possibly affected by proposed changes. Once a decision on the request for change is made (approve/reject/defer),the requestor will be informed. EMS Agencies: 1. All EMS agencies will include a searchable field for LTOWB, as an intervention, in their electronic health care record. 2. Any change in program status will be reported through the CBRAC Regional Whole Blood Committee. 3. For issues revolving around blood administration by EMS agencies,the CBRAC Regional Whole Blood committee will be the committee through which communication is shared and will assist with conflict resolution and system review. CBRAC Regional Whole Blood Program MOU September 2025 V.1 4 4. All EMS agencies will participate in continuous temperature monitoring.Temperature monitors will be decided through the committee as designated in the approved product list.Temperatures are to be monitored by the agency with access available to Coastal Bend Blood Center. 5. Requests for resupply can be coordinated through current agreements with Coastal Bend Blood Center. Regional LTOWB Centers: 1. LTOWB Centers will include "low titer o-positive whole blood"fields in their data collection to assist with future tracking and process improvement. Example:gastrointestinal bleeding patients, OB, and retroperitoneal hemorrhage. 2. For issues revolving around LTOWB administration in a healthcare facility,the CBRAC Trauma Systems Committee will be the committee through which communication is shared and will assistwith conflict resolution and system review. 3. The CBRAC Trauma Systems Committee Meeting and its invited stakeholders will be the primary committee through which communication is shared and will assist with conflict resolution and system review. Any issues that cannot be resolved in the CBRAC Trauma Systems Committee will be routed to the CBRAC Executive Committee and CBRAC Whole Blood Committee for further assistance. 4. Any change in program status will be reported through the CBRAC Regional Whole Blood Committee and CBRAC Executive Committee. TERM This memorandum of understanding is in effect on the date on which it is signed and remains in effect until written notification is received revoking the Memorandum of Understanding with CBRAC. All parties reserve the right to terminate this MOU at any time, with or without cause.Thirty(30) days written notification is required for termination of the MOU. ORGANIZATION: Corpus Christi Fire Department (Indicate Hospital or Agency Name here) PRIMARY POC� Assistant EMS Director (This is a role,not a person.Example ED shift supervisor) PRIMARY POC CONTACT INFORMATION (EMAIL/PHONE): Andrewc@corpuschristitx.gov (Business URL only,NO Gmail/yahoo,etc.,personal accounts) POC FOR PROVIDING FEEDBACK (OUTCOMES DATA FOR TRAUMA AND MEDICAL): Assistant EMS Director (This is a role,not a person.Example ED shift supervisor) POC FOR PROVIDING FEEDBACK CONTACT INFORMATION (EMAIL/PHONE): Andrewc@corpuschristitx.gov (Business URL only,NO Gmail/yahoo,etc.,personal accounts) CBRACRegional Whole Blood Program MOUSeptember 2025 V.1 5 Coastal Bend Regional Advisory Council By: " `wad Hilary Watt, Executive Director Date: September 181,2025 Address: 1305 N Shoreline Blvd Corpus Christi,TX 78401 Coastal Bend Blood Center Hospital: By: By. Corey S nt, President & CEO Hospital or Systems CEO OZ Date Address: 209 North Padre Island [give Date Corpus Christi, TX 78406 Address: EMS Agency: C'� s .f--401t--hC L3y fay: � EMS Agency Leadership EMS Medical Director Date �,/ 7 Date 4f7f2026 Address: Address: 2406 Leopard Ste. 300 c-kr:a. , X `7 Corpus Christi, TX 78408 CBRAC Regionol Whole Blood Program MOUSep.ernber 2025 V.1 6 References Alarhayem, A. Q., Myers,J. G., Dent, D., Liao, L., Muir, M., Mueller, D., Nicholson, S., Cestero, R., Johnson, M. C., Stewart, R., O'Keefe, G., & Eastridge, B.J. (2016).Time is the enemy: Mortality in trauma patients with hemorrhage from torso injury occurs long before the "golden hour". American journal of surgery, 212(6), 1101-1105. https://doi.org/10.1016/m.ammsurg.2016.08.018 Braverman, M. A., Smith, A., Pokorny, D., Axtman, B., Shahan, C. P., Barry, L., Corral, H.,Jonas, R. B., Shiels, M., Schaefer, R., Epley, E., Winckler, C., Waltman, E., Eastridge, B.J., Nicholson, S. E., Stewart, R. M., &Jenkins, D. H. (2021). Prehospital whole blood reduces early mortality in patients with hemorrhagic shock. Transfusion, 61 Suppl1, S15—S21. https://doi.org/10.1111/trf.16528 Brill,J. B.,Tang, B., Hatton, G., Mueck, K. M., McCoy, C. C., Kao, L. S., &Cotton, B. A. (2022). Impact of Incorporating Whole Blood into Hemorrhagic Shock Resuscitation:Analysis of 1,377 Consecutive Trauma Patients Receiving Emergency-Release Uncross matched Blood Products.Journal of the American Collegeof Surgeons, 234(4),408-418. https://doi.org/10.1097/XCS.0000000000000086 Ciaraglia,A., Myers,J.C., Braverman, M., Barry,J., Eastridge, B., Stewart, R., Nicholson, S.,&Jenkins, D. (2023).Transfusion-related cost comparison of trauma patients receiving whole blood versus component therapy. The journal of trauma and acute care surgery, 95(1), 62-68. https://doi.org/10.1097/TA.0000000000003933 Crombie, N., Doughty, H.A., Bishop,J. R. B., Desai,A., Dixon, E. F., Hancox,J. M., Herbert, M.J., Leech, C., Lewis, S.J., Nash, M. R., Naumann, D. N., Slinn, G., Smith, H., Smith, I. M., Wale, R. K., Wilson, A., Ives, N., Perkins, G. D., & RePHILL collaborative group (2022). Resuscitation with blood products in patients with trauma-related hemorrhagic shock receiving prehospital care (RePHILL): a multicenter, open-label, randomized, controlled, phase 3 trial.The Lancet. Hematology, 9(4), e250—e261. https://doi.org/10.1016/S2352-3026(22)00040-0 Hazelton,J. P.,Ssentongo,A. E., Oh,J. S., Ssentongo, P.,Seamon, M.J., Byrne,J. P.,Armento, I. G., Jenkins, D. H., Braverman, M.A., Mentzer, C., Leonard, G. C., Perea, L. L., Docherty, C. K., Dunn,J.A., Smoot, B., Martin, M.J., Badiee,J., Luis, A.J., Murray,J. L., Noorbakhsh, M. R., ... Porter,J. M. (2022). Use of Cold-Stored Whole Blood is Associated With Improved Mortality in Hemostatic Resuscitation of Major Bleeding: A Multicenter Study.Annals of surgery,276(4), 579-588. https://doi.org/10.1097/SLA.0000000000005603 Mapp,J. G., Bank, E. A., Osborn, L.A., Stringfellow, M. L., Reininger, D. W., Winckler, C.J., & Prehospital Research and Innovation in Military and Expeditionary Environments (PRIME) Group (2020). Epidemiological and Accounting Analysis of Ground Ambulance Whole Blood Transfusion. Prehospital and disaster medicine, 35(1), 98-103. https://doi.org/10.1017/S1049023X1900517X McGinity,A. C.,Zhu, C.S., Greebon, L.,Xenakis, E.,Waltman, E., E., Epley, E., Cobb, D.,Jonas, R., Nicholson, S. E., Eastridge, B.J., Stewart, R. M., &Jenkins, D. H. (2018). Prehospital low-titer cold-stored whole blood: Philosophy for ubiquitous utilization of O-positive product for emergency use in hemorrhage due to injury. The journal of trauma and acute care surgery, 84(6S Suppl 1), S115—S119. https://doi.org/10.1097/TA. CBRACRegional Whole Blood Program MOU September 2025 V.1 7 Morris, D. S., Braverman, M. A., Corean,J., Myers,J. C., Xenakis, E., Ireland, K., Greebon, L., Ilstrup, S., & Jenkins, D. H. (2020).Whole blood for postpartum hemorrhage: early experience at two institutions. Transfusion,60Supp13,S31—S35. https:Hdoi.org/10.1111/trf. Munoz,J. L., Kimura,A. M.,Xenakis, E.,Jenkins, D. H., Braverman, M. A., Ramsey, P. S., & Ireland, K. E. (2022).Whole blood transfusion reduces overall component transfusion in cases of placenta accreta spectrum: a pilot program. The journal of maternal fetal& neonatal medicine: the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 35(25), 6455-6460. https://doi.org/lo.1080/14767058.2021.1915275 Newberry, R., Winckler, C.J., Luellwitz, R., Greebon, L., Xenakis, E., Bullock,W., Stringfellow, M., & Mapp,J. (2020). Prehospital Transfusion of Low-Titer O+Whole Blood for Severe Maternal Hemorrhage: A Case Report. Prehospital emergency care, 24(4), 566-575. https://doi.org/10.1080/10903127.2019.1671562 Weymouth, W., Long, B., Koyfman, A., &Winckler, C. (2019). Whole Blood in Trauma: A Review for Emergency Clinicians.The Journal of emergency medicine, 56(5), 491-498. https://doi.org/10.1016/m.memermed.2019.01.024 Zhu, C. S., Pokorny, D. M., Eastridge, B.J., Nicholson, S. E., Epley, E., Forcum,J., Long,T., Miramontes, D., Schaefer, R., Shiels, M., Stewart, R. M., Stringfellow, M., Summers, R., Winckler, C.J., &Jenkins, D. H. (2019). Give the trauma patient what they bleed, when and where they need it: establishing a comprehensive regional system of resuscitation based on patient need utilizing cold-stored, low-titer O+ whole blood.Transfusion, 59(S2), 1429-1438. https:Hdoi.org/10.1111/trf.15264 CBRAC Regional Whole Blood Program MOU September 2025 V.1 APPENDIX B: PREHOSPITAL BLOOD PRODUCT TRANSFUSION RECORD 6 Prehosplital Blood Product Transfusion Record Patient Name: Transporting Agency Run)Case 0: Receiving Facility Medical Record is uct Unit Number Product Type Transfusion Transfusion Transfusion Transporting (Affix sticker below,or write unit (Check One) Date&Start Complete" Reaction" MedWRN number) 0 PEW— Time Check One Check One Initials 0 PLASMA Q Yes a Yes LTOWB a Ongoing 0 No 2. 0 PRBC � PLASMA d Yes © Yes UP 0 LTOWB 0 Ongoing d No 3. 0 PRBC d Yes 0 Yes 0 PLASMA 0a LTOWB Ongoing } Na Name of Air MedicallGround Agency and Receiving Facility: Tyoe of Call(Check Oral: Aircraft ID/Medic Unit 0 Scene Call d Interfacility Transfer Reason for Transfusion: Comments: Q Trauma U OBIGYN 4 GI Bleed d Other vans fusion is ongoing at am@ orpsuent transAWospr a,document-ungiaming: 0 Female under 55 yrs old received 0+product. Mandatory Blood Product$Blond Form Tracking: Transporting crew keep White Copy;give the yellow and pink Actions to take for suspected copies to the EmergencytTrauma Team+ transfusion reaction: u STOP TRANSFUSION F-1 Emergency Department keep Yellow Copy and add to patient u Disconnect tubing from infusion site; u flush site with normal saline chart; give the Pink Copy to the Blood Bank[Transfusion Services. u Keep line open with normal saline u Fie-initiate new transfusion if deemed Transporting Crew Using the Whole Blood App, select _, clinically essential Document actions taken in "Administer to Patient'->Scan the bag ->Take a picture of Blom: Comments'section of ePCR Form-+ Click Submit. Give unused blood,tubing and form to receiving hospital Form received by at the hospital PMA196 hG Form completed by: rr !�1C:.V d 7UJP1 The clinical situation was sufficiently urgent to require release of blood before completion of compatibility testing- OR AV[RT PVRPOSiES ENS Physician PRMTEO NAME src;.va rukf Version 1 Aug 2025 CBRACRegional Whole Blood Program MOUSeptember 2025 V.1 9 APPENDIX C: LTOWB BLOOD PRODUCT TAG 4 t w30 f R0161 �r � �2�i�rrr���� Ill1{ti�1{Iti{1�1II{1M1II{�1 s,ao pw rr,oa cane., Mom,r.mn,r ten�ea qY 11 Rh POSITIVE r.a ,0LURiE11ERI16i11{{N6DIIR 11111111111,111MI+ 1I�I f�o�r I ,^ • �IIII�11�I��1f� �`�I :7772359 16 MAR 2025 „�a000 COAL BEND BLOOD CENTER 309 Noah Padre liland Duvr Rh: 351.R55.4943 CarpusChnsti,TX 794616 Fax, 361.955.3945 t Low Titer Whole Blood Initials. Date. Da meal ID YN 014 Rev'I a a a° CBRAC Regional Whole Blood Program MOU September 2025 V.1 10 APPENDIX D : APPROVED PRODUCTS LIST All items used in this program are to be FDA approved to ensure program integrity.This approved products list allows the Regional Whole Blood Program to maintain the highest standards and promote interoperability withing our region.When considering a new product for inclusion to this list,approval will be sought by authorized representatives of the major stakeholders of this program—Coastal Bend Blood Center and CBRAC Whole Blood Committee. Contact the manufacturer or distributor directly for most recent pricing.Costs listed below are to provide an estimate of costs to start a program. LOW TITER 0+WHOLE BLOOD,LIQUID PLASMA(LP), PACKED RED BLOOD CELLS(LRBC): Coastal Bend Blood Center is the only authorized vendor of blood products in this program. BLOOD COOLERS: Blood cooler products are to be approved by the CBRAC Whole Blood Committee, It is the responsibility of the EMS agency to perform the validation and/or revalidation of the blood coolers at defined intervals. Pelican Credo Cube w/Thermal Isolation Chamber System(TIC) NAME:Credo PROMED Series 4,2L STANDARD TAN BAG w/inserts Contact vendor for purchasing "Need to purchase 2 Thermal Isolation Chambers(TIC).This will allow one to remain in the freezer at all times, ready for easy swap out at change of shift. �p Delta Development Delta ICE 2L SMART Blood Cooler F „ Email: sales@deltadevteam.com or contact vendor I 160 CBRAC Regional Whole Blood Program MOU September 2025 V.1 11 Delta Dev Autonomous Portable Refrigeration ■ Unit(APRU) 6L Email:sales@deltadevteam.com - - " BLOOD WARMERS: The prehospital industry is exploding with new devices.The program recommends identifying which one is best for your agency or mission. Of note:when price comparing,a device may be cheaper on the outset,but the expendable items(proprietary blood tubing) may be very pricey. To facilitate the program's emphasis on standardization for the continuity of care,CBRAC recommends the use of the QinFlow warmer for all rotation sites and rotation centers participating in the regional whole blood program.QinFlow has adopted a new"Unplug-Replug"strategy to create a seamless patient handoff for the entire continuum of emergency care.The disposable tubing in their warmer can be used with their prehospital focused equipment and hospital-based equipment in addition to facilitating patient handoff,this inter-operability strategy supports a regional mass casualty incident response in which blood and blood warmers will besent to the point of need. QinFlow Quantum LifeWarmer http://ginflow.com/Products https://www.lifewarmer.com Warrior Portable Warmer System Item#35-0006 Item:Q1110000OU Wamm " Belmont Buddy Lite https://www.beImontmedtech.com/products/the- belmont-buddy-lite belmont-buddy-lite Prices not publicly available. . '. CBRAC Regional Whole Blood Program MOU 12 CONTINOUS TEMPERATURE MONITORING: Because this program considers the blood to be in storage, it must be maintained at a temperature between 1-6 degrees Celsius. A device to continuously monitor the temperature in the blood cooler is required. This product is to be monitored by the EMS Agency. Temp Stick: This is a Wi-Fi based option. https://tempstick.com/?gclid=EAlalQobChMlzJfPlrH35glVxkXVChOenAAtEAAYASAAEgJKAvD BwE MISCELLANEOUS Filtered Blood Tubing: Y-type Blood/Solution Set with Standard Blood Filter Pressure Bags:Any standard pressure bag will work. (these spike into blood bag and connects into You may already have these on your vehicles. Useful proprietary warmer tubing) if LTOWB will be given through an IO. CBRAC Regional Whole Blood Program MOU 13 APPENDIX E: CBRAC Inventory Management App 12:269 ... - Inventory Management 6 Options Inventory Maiwgomem 1. Initial Receipt 2. Inventory Check 3. Inventory Transfer 4. Return to STBTC PA 5. Unusable 6.Administer to Patient www.blood.strac.org Option How to Use Administer to Patient Scan Unit Number Bar Code; Take photo ofcompleted Blood Form; click submit Initial Receipt Select only when picking up units from Coastal Bend Blood Center. scan all 4-unit barcodes; click submit Inventory Done DAILY; Scan Unit Number Bar Code;click submit Inventory Transfer Select only if handing off YOUR unit to another agency but is not currently being transfused. Return to Select when returning unused unit to CBBC.Scan Unit Number Bar Code; click Unusable Select only if unit is rendered unusable due to temperature variance, damage to bag prior to use, or unsafe to use due to clot, froth, or debris in bag. 14 APPENDIX F: Coastal Bend Blood Center MCI Letter LTOWB ♦Whole Blood: Contains all components(RBCs, , COASTALPLTs,and PLSM). ♦Group O: Is collected from a donor with blood type 0,which is considered a universal donor for RBCs. • Low Titer: refers to the donor having a low level BENDof ABO antibodies(anti-A and anti-B)at the time of donation. ♦ RhD Positive: LTOWB is typically RhD positive, meaning it contains the D antigen. BLOOD WHY IS LTOWB USED? ♦ Universal Transfusion: Group O blood doesn't contain A or B antigens;it can be transfused into patients of any blood type without causing a major transfusion reaction. CENTER ♦ Emergency Situations; LTOWB is particularly useful in emergency situations,such as trauma or massive hemorrhage,where time is critical. WHAT IS LOW TITER 0 WHOLE BLOOD KTOWBI: LTOWB is type O-Positive Whole Blood that has low levels of anti-A and OTHER PRODUCTS USED? anti-B antibodies(titer< 1:256). LT0W13 can be transfused to patients of ♦ RED BLOOD CELLS(LEUKOCYTES REDUCED) any blood type. ♦ LIQUID PLASMA ♦ LTOWB is collected in a CPD bag allowing for a 21-day shelf life. WHO IS ELIGIBLE TO DONATE ♦ LTOWB is unmodified and contains Red Blood Cells,Platelets,and Plasma. LTOWB? ♦ LTOWB is non-leukoreduced and averages around 500 mLs(approx.). Whole Blood for allogeneic transfusion will be from Reference AABB Standards. donors who are: ♦Type O Male Donors TAGS USED FOR LTOWB: ♦Type O Female Donors who have never been pregnant ILWREND euwucR.TFN ♦Type 0 Female Donors who test negative for HLA 2419 Nosh Pack Id.0 D— Ph. 3618554943 C.q-Ck,,A TX 784% F. 3618553945 antibodies and have not been pregnant since �«a1W testing are eligible to donate Low Titer Whole Blood . HLA(Human Leukocyte Antigen)antibodies are proteins produced by the immune system F"aioi1D�� 01 R" I in response to foreign HLA antigens. LTOWB STORAGE: FOR ADDITIONAL INFORMATION PLEASE CALL 361.855.4943 OR EMAIL ♦ LTOWB, Red Blood Cells,and Liquid Plasma must be stored in a SERVICE@COASTALBENDBLOODCENTER.ORG continuously monitored temperature-controlled refrigeration system U Coastal Bend Blood Center between l°C and 6°C. Givingw that others may live ADDITIONAL FACTS: 209 North Padre Island Drive Corpus Christi,TX 78406 CBRAC Regional Whole Blood Program MOU 15 Appendix G: Regional Whole Blood Change Request COASTAL BEND Regional Advisory Council Regional Whole Blood Program Change Request Form REQUEST FOR CHANGE FORM Validation and Testing:(outline any validation or testing procedures to be conducted to ensure the Requestor Name and Agency: Date of Submission: successful implementation of the change) CHANGE INFORMATION Reason For Change(circle one): Equipment Process Is the change for existing equipment/process or new addition to equipment/process?(circle one) Tracking Requirements:(specify any training needs resulting from the change.Identify who needs to Existing New be trained and the training methods to be used) Description of Proposed Change: EQUIPMENT INFORMATION Manufacturer Information:(to include POC) Cost:(Per unit,consumables,bulk discount, installation cost) Documentation:(procedures,forms,policies and agreements requiring change) Warranty:(yes/no,how long,extra cost) FDA Listed(Yes/No) FDA Number: Other Impacts-Include Health&Safety,Functionality,Quality/Compliance SUBMITTER INFORMATION Name: Phone: CHANGE IMPLEMENTATION PLAN Email: Describe the steps required to implement the change:(including responsibilities,timelines,and any necessary resources) Signature: Date: 1 Appendix H: CBBC Validation Templates Title: T AS Blood Storage Equipment and Process Validation Plan 1.0 General Information Validation Title: Transfusion Administration Service (TAS)Blood Storage Equipment and Process Validation Category of Validation (check all that Equipment Process Computer System apply): New Repair Relocation Revalidation Type of Validation: Other 2.0 Introduction Reason for Validation: To validate the blood product storage equipment and processes used by(add organization/department)to store and handle blood products for transfusion are validated for use and comply with the following AABB Standards for Emergency Prehospital and Scheduled Out-of-Hospital Transfusions, current revision: • AABB Std. 3.0 Equipment: The organization shall define and control critical equipment. • AABB Std. 3.2 Qualification of Equipment: All critical equipment shall be qualified for its intended use. Equipment shall be requalified, as needed, after repairs and upgrades. AABB Std.3.3 Use of Equipment: Equipment shall be used in accordance with the manufacturer's written instructions. • AABB Std. 3.4 Unique Identification of Equipment: Equipment shall have unique identification. • AABB Std.3.5 Equipment Monitoring and Maintenance: Equipment shall be monitored and maintained in accordance with the manufacturer's written instructions. 3.5.1 Calibration and Accuracy of Equipment: Calibrations and/or adjustments shall be performed using equipment and materials that have adequate accuracy and precision. At a minimum, calibrations and/or adjustments shall be confirmed as described below unless otherwise indicated by the manufacturer: 1. Before use. 2. After activities that may affect the calibration. 3.At prescribed intervals. 0 3.5.1.1 Calibration of equipment shall include details of equipment type,unique identification,location, frequency of checks, check method, acceptance criteria, and specified limitations. 0 3.5.1.2 Equipment used for calibration,inspection,measuring, and testing shall be certified to meet nationally recognized measurement standards. Certification shall occur before initial use, after repair, and at prescribed intervals.Where no such measurement standards exist,the basis for calibration shall be described and recorded. 0 3.5.1.3 Equipment shall be safeguarded from adjustments that would invalidate the calibration setting. • AABB Std. 3.5.4 Investigation and Follow-Up: Investigation and follow-up of equipment malfunctions,failures, or adverse events shall include: 1. Assessment of products or services provided since the equipment was last known to be functioning per the manufacturer's written instructions or organization-defined specifications. 2. Assessment of the effect on the safety of individuals affected. 3. Removal of equipment from service,if indicated. 4. Investigation of the malfunction, failure, or adverse event, and a determination if other equipment is similarly affected, as applicable. 5. Requalification of the equipment. 6. Reporting the nature of the malfunction, failure, or adverse event to the manufacturer,when indicated. • AABB Std. 3.6 Equipment Traceability: The organization shall maintain records of equipment use in a manner that permits: 1. Equipment to be uniquely identified and traceable. 2. CBRAC Regional Whole Blood Program MOU 17 Tracing of any given product or service to all equipment associated with the procurement, processing, storage, distribution, and administration of the product or service. • AABB Std. 3.8 Storage and Transport Devices for Blood and Blood Components: Storage and transport devices shall have the capacity and design to ensure that the proper temperature is maintained. Standard 5.1.9 applies. 3.8.1 Alarm Systems: Storage devices shall have alarms and shall conform to the following standards: 0 3.8.1.1 The alarm shall be set to activate under conditions that will allow enough time for proper action to be taken before products reach unacceptable conditions. 0 3.8.1.2 Activation of an alarm shall initiate a process for immediate action, investigation,and appropriate corrective action. • AABB Std. 5.1.2 Quality Control: A program of quality control shall be established that is sufficiently comprehensive to ensure that products, equipment,materials, and analytical functions perform as intended. • 5.1.2.1 Quality control results shall be reviewed and evaluated against acceptance criteria. • 5.1.2.2 Quality control failures shall be investigated before release of test results,products, or services. 5.1.2.3 The validity of test results and methods and the acceptability of products or services provided shall be evaluated when quality control failures occur. • AABB Std. 5.1.9 Handling, Storage and Transportation: The organization shall ensure that products or services are handled, stored, and transported in a manner that prevents damage, limits deterioration, and provides traceability. Reference Standard 5.1.9A Requirements for Storage, Transportation,and Expiration applies. 5.1.9.1 The TAS shall ensure all containers are validated for the handling, storage, and transport of blood and blood components to ensure that temperatures are maintained within the acceptable range for the expected duration of transport, storage, or shipping. Standard 3.5.1 applies. 5.1.9.2 The TAS shall ensure blood and blood components remain within the acceptable temperature range during storage and transport. Reference Standard 5.1.9A,Requirements for Storage, Transportation, and Expiration applies. 5.1.9.3 For storage of blood and blood components,the temperature shall be monitored continuously and recorded at least every 4 hours. Reference Standard 5.1.9A: Requirements for Storage, Transportation,and Fxnirnti Item Component Storage Transport Expiration No. 1 Whole Blood 1-60C 1-10°C CPD/CP2D: 21 days CPDA-1: 35 days ACD/CPD/CP2D: 21days RBCs CPDA-1: 35 days 7 Leukocytes 1-60C 1-10°C Additive solution(AS): 42 Reduced days Open system: 24 hours CPD or CP21): The expiration for Liquid Liquid Plasma is 26 days 21 CFR 29 Plasma 1-60C 1-10°C If whole blood is stored in 610.53 b CPDA-1,the Liquid Plasma expiration date is 40 days 3.0 Purpose/Scope CBRAC Regional Whole Blood Program MOU 18 EguiUment Storage equipment used specifically for storing (add applicable products), (add cooler make, model, size specifications, etc.)will be validated to ensure a temperature of 1°C-6°C for(add storage time). A packing protocol for each product type will be validated, and the maximum allowable time for which products can be stored in the new coolers will be determined based upon validation studies. The final decision as to the maximum allowable time products can be stored in the coolers will also take into consideration customer service needs. After this time has been determined,applicable SOPS will be developed/implemented. Equipment will be given unique identification. Alarm Svstems, Alarm Systems used for monitoring the storage of(add applicable products), (add temperature monitoring equipment make, model, size specifications, etc.)will be validated to ensure the alarm will activate under conditions that will allow proper action to be taken before blood products reach unacceptable conditions. Quarterly checks of alarm function will be included in the quality control procedure. EoUiDment Monitoring an Maintenance an litj Control The process for scheduled monitoring,maintenance quality control and calibration of equipment(storage and temperature monitoring equipment)will be validated to ensure frequency of checks, check methods, acceptance criteria, and actions to be taken for unsatisfactory results are all in compliance with applicable regulations and manufacturer's written instructions. The quality control program established will be validated to verify it is sufficiently comprehensive to ensure that equipment and methods perform as expected,that the acceptability of products are evaluated when quality control failures occur, and that quality control failures will be investigated prior to release of products. Traceability The process for tracking storage and issue of blood components will be validated to ensure that documentation of receipt and issue of blood products,including patient record documentation, are identified and traceable and in compliance with applicable regulations. Handling. rage.and TransUortation The process and equipment to monitor the temperature of stored blood products shall be validated to ensure that temperature is monitored continuously and recorded at least every 4 hours and that access to storage areas and authorization to remove contents shall be controlled. 4.0 Deliverables and Responsibilities Task Responsible Person(s) Validation Plan: User/Functional Requirements: Risk Assessment: IQ Protocol: N/A OQ Protocol: N/A PQ Protocol: N/A Validation Summary Report: Other: N/A Other: N/A 5.0 Risk Assessment Risk Assessment Summary: CBRAC Regional Whole Blood Program MOU 19 6.0 Validation Strategy IQ: The temperature monitoring devices will be assigned a unique identification number and programmed to activate at established limits. Typically for blood products stored at PC-6°C the alarms are set to activate at 1.5°C and 5.5°C. The devices used will be assigned a unique identification number. Storage Equipment OQ: Using coolers of the same size,model,manufacturer,and design(add manufacturer/model)purchased for(add organizationldepartment), one/all cooler(s)will be tested. The coolers will be packed according to a proposed packing protocol (or manufacturer recommended protocol) with minimum and maximum quantities of blood products as detailed in each test case. The first/each cooler will be packed with(add amount)unit(s) of(add product type);the second cooler will be packed with(add amount)unit(s) of(add product type), (add additional cooler details as needed)- constituting (add amount) separate Test Cases. This sample size represents each possible routine packing protocol as(add amount) (add product type)per cooler,Expired or mock products will be used. The test cases will be executed using the packing details as described above. The temperature of each cooler will be monitored and recorded by (add monitoring methodology) over the course of an(add time)time frame. The decision to open the cooler to take temperatures on an hourly(or other time interval)basis creates a"worst case scenario"in how these coolers may be handled by the client while at the client's facility. Testing under these conditions will prove that the cooler can maintain appropriate temperatures despite multiple events of introduction of room temperature air and multiple events of manipulating the contents of the cooler. A continuous temperature monitoring device may be used for this validation. If a continuous monitoring device is used,attach a certificate from the manufacturer showing that the equipment certification is current. One run for each test case will sufficiently demonstrate that temperature will be maintained appropriately because the two variables that can affect the temperature (packing protocol and container)will be consistent with each use. It is not the intention of the validation plan to test each cooler in use by(add organization/department). Rather,the performance qualification will determine whether the specified cooler type,when packed in accordance with (add SOP#)will provide adequate refrigeration capacity to store the units at the required temperatures as detailed in the purpose/scope of this plan. The coolers will be validated at(add temperature of the extreme possible environments in which the coolers will be tested,for example, stored within a vehicle during summer months when the temperature is at or near 100 degrees, or in the winter when temps reach 20 degrees, this would represent the worst case scenario) during validation to simulate the storage environment of this cooler type during worst case scenarios. Upon completion of the (add time)hour validation,the temperature recordings/electronic temperature log will be reviewed by (add reviewer). Although the maximum allowable time products can be stored in these coolers will be determined based on validation data,management will establish storage time limits that are more restrictive than those validated based business needs. A final summary will be written and will detail the final determined time. Once the maximum allowable time is determined, (add organization/department)procedure will be created and implemented, and staff will be trained. Alarm System OQ: The alarm systems used for monitoring the storage of(add applicable products), (add temperature monitoring equipment make, model, size specifications, etc.)will be validated to ensure the alarm will activate under conditions that will allow proper action to be taken if the storage unit temperature approaches unacceptable conditions. Typically for blood products stored at PC -6°C the alarms are set to activate at 1.5°C and 5.5°C. The test case will demonstrate that the alarms activate at the established limits and ensure that ongoing alarm activation verification is performed by verifying that quarterly check of alarm function is included in the quality control procedure. CBRAC Regional Whole Blood Program MOU 20 Equipment Monitoring and Maintenance and Quality Control OQ: The test case will define storage and temperature monitoring equipment manufacturer's requirements for scheduled monitoring,maintenance quality control and/or calibration and verify that the process established at(add organization/department) includes frequency of checks, check methods, acceptance criteria,and actions t be taken for unsatisfactory results are all in compliance with applicable regulations and manufacturer's written instructions. The quality control program established will be validated to verify it is sufficiently comprehensive to ensu e that equipment and methods perform as expected,that the acceptability of products are evaluated when quality control failures occur, and that quality control failures will be investigated prior to release of products. Traceability OQ: The process for tracking storage and issue of blood components will be validated to ensure that documentation of receipt and issue of blood products, including patient record documentation are identified and traceable and in compliance with applicable regulations. Test cases may include: If using a paper-based system,perform document validation to confirm that the form(s)and SOP align with workflow, etc. If using an electronic system,verify that blood unit number(BUN)number and other critical data (patient usage) are maintained. Trace a unit through the process from receipt to transfusion to end hospital notification(or return to the Coastal Bend Blood Center.) Handling,Storage,and Transportation OQ: To validate the process and equipment used to monitor the temperature of stored blood products to ensure that temperature is monitored continuously or recorded at least every 4 hours,a test case will be performed to verify that(add temperature monitoring equipment make, model, size specifications, etc.)will continually monitor(and record)temperature for at least(add time). The test case will also define how(add temperature monitoring equipment make, model, size specifications, etc.)temperature record data is reviewed and stored, as well as verify that process used by(add organization/department)will ensure the data is retained for at least 10 years. (Also add any other test cases needed to test requirements/limitations of the equipment, i.e. does a battery need to be replaced periodically)and that access to storage areas and authorization to remc ve contents shall be controlled. PQ: Performance Qualification is not required for this validation because ongoing quality control and monitoring of storage and temperature monitoring equipment performance will be performed per(add organization/department)written procedure (add procedure names/#s). 7.0 Acceptance Criteria 1. Storage equipment must maintain the AABB required storage temperature for(add produ ts) of 1°C-6°C and for the allowable maximum time as determined by the validation. 2. Equipment is qualified for its intended use. 3. Equipment is used in accordance with the manufacturer's specifications. 4. Equipment has unique identification. 5. The temperature monitoring alarm is set to activate under conditions that will allow proper action to be taken before blood components reach unacceptable conditions. 6. Activation of the alarm initiates a process for immediate action,investigation, and appropriate corrective action. 7. Policies,processes,and procedures to ensure that calibration,maintenance and monitoring of equipment conforms to regulatory and manufacturer requirements, including quarterly alarm activations. 8. A program of quality control is established that ensures equipment and methods perform as expected,that the validity of test results and methods and the acceptability of products are evalua ed when quality control failures occur,and that quality control failures are investigated before release of products. CBRAC Regional Whole Blood Program MOU 21 9. A process for tracking storage and issue of blood components is established that documents receipt and issue of blood products, including patient record documentation,that is in compliance with applicable regulations. 10. The process and equipment used to monitor the temperature of stored blood products ensures that temperature is monitored continuously or recorded at least every 4 hours and temperature records are retained for at least 10 years. 8.0 Standard Operating Procedures (add SOPs) 9.0 Training Staff performing validation is required to be trained in (add SOP). 10.0 Approval to Execute Validation Plan Approver Signature and Date Department Director/Manager Department Director/Manager N/A IT Director/Manager N/A Administration N/A Medical Director Quality Assurance CBRAC Regional Whole Blood Program MOU 22 Title: Storage Container Validation Test Case Template Validation#: TAS Agency Name Make/Model: Equipment ID#: Qualification (IQ,OQ,PQ): Test Case#: 1. To validate that the coolers used by (add organization/department)to maintain 1-6°C when storing (add Function/Objective amount)unit(s) of(add product type). 2. To determine the maximum allowable time (add amount) unit(s) of(add product type) can be stored in a cooler used by (add or anization/de artment)to store (add product e). Test Case Author Signature Date Person Executing Test Case Signature Date of Validation Is preparation required prior to running test method? Yes No If yes, indicate steps here: Successful installation and operational qualification of temperature monitoring devices. Attachments Required? Yes No If yes, list attachments here: Temperature Documentation Form referencing this Validation/TC#, temp recorder records, etc. Test Method Step Action Description Expected Outcome Actual Comments Outcome Using a(add container name, model, specifications, etc.) container,pack (add amount) unit(s) of expired (add product type) or mock product in the container as follows: (Add detailed packing protocol. Ensure that none of the Temperatures are surface of the cold/frozen recorded at every 1- 1 packing materials are exposed, hour interval from the Pass so they are not in direct contact start time and are Fail with the products. You may refer within 1°C-6°C. to an attachment with pictures of acking protocol). Document the start time on (add location/specific document). Monitor the temperature for(add time) hours after the start time as follows: At CBRAC Regional Whole Blood Program MOU 23 every 1-hour interval (from the start time): open the container, remove the temperature bag, read and record the temperature on the temperature documentation form. Repeat these steps at every hour interval. Stop recording the time at(add time) after the start time. Temperatures have Management will review all been reviewed, and the temperature values to determine maximum allowable 2 the maximum allowable time time has been Pass (add amount) unit(s)of(add determined. The Final Fail product type) can be stored in the Summary includes a coolers. determined allowable time. If this test case fails,failure will be investigated and repeated.This must be documented and attached. Reviewer Review of Actual Outcome Comments Accept Reject Reviewer Signature Date of Review Title: Storage Equipment— IQ Validation Test Case #1 CBRAC Regional Whole Blood Program MOU 24 TAS Agency Name Equipment ID#: Make/Model: Qualification (IQ,OQ,PQ): IQ Test Case#: 1 To document that the (add storage device name/model)was installed according to Function/Objective the manufacturer's Operator's Manual and assigned a unique identification number. Test Case Author Signature Date Person Executing Test Case Signature Date of Validation Is preparation required prior to running test method? Yes No If yes,indicate steps here: ttachments Required? Yes No If yes,list attachments here: Step Action Description Expected Outcome Actual Comments Outcome I Review the Operator's Manual The Operator's Manual has Pass provided by the manufacturer. been reviewed. Fail Set the alarm to activate at limits that allow sufficient time The alarm is set to activate at to address out of temperature limits that allow sufficient time events. (The acceptable storage to address out of temperature 2 temperature for whole blood, events. Pass red blood cells, and liquid Fail High Alarm plasma is 1°C- 6°C.)Document alarm limits Low Alarm set on the device. Installation has been Perform installation according performed according to the pass 3 to the manufacturer's manufacturer's specifications. Fail specifications. See attached checklists. (as applicable.) The equipment has been 4 Assign a unique identification assigned unique identification Pass number to the equipment. number Fail Reviewer Review of Actual Outcome Comments Accept Reject CBRAC Regional Whole Blood Program MOU 25 Reviewer Signature Date of Review CBRAC Regional Whole Blood Program MOU 26 Title: Temperature Monitoring Device — IQ Validation Test Case #2 TAS Agency Name JEquipment ID #: Make/Model: Qualification (IQ,OQ,PQ): IQ ITest Case 12 To document that the (add temperature monitoring device name/model) Function/Objective was installed according to the manufacturer's Operator's Manual and assigned a unique identification number. Test Case Author Signature Date Person Executing Test Case Signature Date of Validation Is preparation required prior to running test method? Yes No If yes,indicate steps here: ttachments Required? Yes No If es,list attachments here: Step Action Description Expected Outcome Actual Comments Outcome I Review the Operator's Manual The Operator's Manual has Pass provided by the manufacturer. been reviewed. Fail Perform installation Installation has been performed according to the 2 according to the manufacturer's Pass manufacturer's Fail specifications. specifications. See attached checklists as applicable). Assign a unique The equipment has been 3 identification number to the assigned unique Pass equipment. identification number Fail Set the alarm to activate at The alarm is set to activate limits that allow sufficient at limits that allow sufficien time to address out of time to address out of temperature events (the temperature events. 4 acceptable storage Pass temperature for whole blood, High alarm setting: Fail red blood cells and liquid plasma is PC - 6°C). Document the high and low Low alarm setting: alarm activation limits set. CBRAC Regional Whole Blood Program MOU 27 Reviewer Review of Actual Outcome Comments Accept Reject Reviewer Signature Date of Review CBRAC Regional Whole Blood Program MOU 28 Title: Temperature Monitoring Device Calibration Verification— OQ Validation Test Case #1 TAS Agency Name JEquipment ID #: Make/Model: Qualification (IQ,OQ,PQ): OQ iTest Case 11 To document that the (temperature monitoring device name) monitoring device Function/Objective used to monitor the temperature of whole blood is calibrated against a NIST reference thermometer. Test Case Author Signature Date Person Executing Test Case Signature Date of Validation Is preparation required prior to running test method? Yes No If yes,indicate steps here: • Successful completion of Test Case IQ 42 of this validation. Attachments Required? Yes No If yes,list attachments here: Manufacturer's Certificate of Calibration Step Action Description Expected Outcome Actual Comments Outcome Obtain a copy of the Manufacturer's Certificate of The Manufacturer's Certificate I Calibration. Ensure the of Calibration is valid in-date Pass certification is valid and in- and attached to this test case. Fail date. Attach the certification to this test case. Reviewer Review of Actual Outcome Comments Accept Reject Reviewer Signature Date of Review CBRAC Regional Whole Blood Program MOU 29 Title: Thermometer Temperature Monitoring Device Calibration — OQ Validation Test Case #2 TAS Agency Name Equipment ID #: Make/Model: Qualification (IQ,OQ,PQ): OQ iTest Case 12 To document that the (temperature monitoring device name) monitoring Function/Objective device used to monitor the temperature of whole blood is calibrated against a NIST reference thermometer. Test Case Author Signature Date Person Executing Test Case Signature Date of Validation Is preparation required prior to running test method? Yes No If yes, indicate steps here: • Obtain a NIST Thermometer with a current valid certification. • Successful completion of Test Case IQ 42 of this validation. Attachments Required? Yes No If yes, list attachments here: • Reference Thermometer(SN: ) Certificate of Calibration • Record of Calibration Test Method Step Action Description Expected Outcome Actual Comments Outcome Verify NIST Thermometer NIST Thermometer has a has a current valid current valid certification, pass I certification. Attach the and a copy of the Fail certification to this test certification is attached to case. this test case. Assign the thermometer/ The thermometer/ temperature monitoring temperature monitoring a pass 2 device a unique identificatio unique identification Fail number. number. ID# CBRAC Regional Whole Blood Program MOU 30 Perform a three-point calibration of each thermometer/temperature monitoring device. Allow temperature to equilibrate for at least 10 minutes in each environment prior to recording the temperature. Record the temperature of the The temperature of the temperature monitoring device temperature monitoring device Pass 3 and reference the thermometer is recorded within+1°C of the Fail for each temperature point on — the attached Record of reference thermometer for Calibration form. each temperature point. If any adjustments are required to the calibration of the device, perform the adjustment and repeat the 3-point calibration on the device. Document all adjustments made on the Record of Calibration form. Review of Actual Outcome Comments Accept Reject Reviewer Signature Date of Review CBRAC Regional Whole Blood Program MOU 31 Title: Alarm Activation — OQ Validation Test Case #3 TAS Agency Name JEquipment ID #: Make/Model: Qualification (IQ,OQ,PQ): OQ iTest Case 13 Function/Objective To document that the alarm on the (temperature monitoring device name) activates when set points/limits are exceeded. Test Case Author Signature Date Person Executing Test Case Signature Date of Validation Is preparation required prior to running test method? Yes No If yes,indicate steps here: • Successful completion of test case IQ#2 and 0Q#1 of this validation. Attachments Required? Yes No If yes,list attachments here: • Alarm activation documentation form. Step Action Description Expected Outcome Actual Comments Outcome Follow the (add name) procedure (or Operator's The alarm activation is Manual) to perform the high completed successfully,and all and low temperature alarm 1 activation. Document all data required documentation is Pass associated with the alarm complete. Fail activation on form (add name o form). Alarms sound when established limits are exceeded. Ensure quarterly alarm activation is included in the Quarterly alarm activation is 2 included in the facility's Pass facility's quality control Fail procedures. quality control procedures. Reviewer Review of Actual Outcome Comments Accept Reject Reviewer Signature Date of Review CBRAC Regional Whole Blood Program MOU 32 Title: Storage & Temperature Monitoring— Performance Qualification TAS Agency Name JEquipment ID #: Make/Model: Qualification (IQ,OQ,PQ): PQ Test Case#: 1 1. To verify the performance of the (storage device name) and (temperature monitoring device name) to continuously monitor temperature and maintain 1°C- 6°C when storing whole blood for(add Function/Objective monitoring period). 2. To verify that established Standard Operating Procedures and processes in place are acceptable to support storage of whole blood and meet regulatory requirements. Test Case Author Signature Date Person Executing Test Case Signature Date of Validation Is preparation required prior to running test method? Yes No If yes,indicate steps here: • Successful completion of IQ and OQ test cases • Established Standard Operating Procedures (SOPS) • Expired Whole Blood • Successful validation of(storage device name) • Successful validation of(temperature monitoring device name) • Staff participating in validation are trained on all applicable SOPS Attachments Required? Yes No If yes, list attachments here: 1. All forms and other documentation created during the monitoring period. 2. Temperature monitoring device temperature records for the monitoring eriod. Test Method Step Action Description Expected Outcome Actual Comments Outcome Obtain all Standard SOPS are obtained and Operating Procedures (SOPS)available for all staff Pass 1 to be utilized to store and Participating in the test Fail monitor the temperature of whole blood. case. Obtain expired whole blood Expired whole blood was from Coastal Bend Blood obtained from Coastal Bend 2 Center following facility's Blood Center. Applicable Pass SOP. Complete any forms or forms and documentation Fail documentation associated associated with receipt of blood products were CBRAC Regional Whole Blood Program MOU 33 with receipt of blood completed according to -products according to SOP. SOP. Pack (add quantity to be routinely stored) unit(s) of whole blood in the validated (Add quantity to be (storage device name) routinely stored) unit(s) of according to SOP. Complete whole blood are packed in any forms or documentation the (storage device name) associated with receipt of according to SOP, all forms blood products according to or documentation associated Pass 3 SOP. with receipt of blood Fail products are completed and Storage Device: the storage device name Manufacturer Name: information is documented. Equipment ID Number: Insert the validated (temperature monitoring device name) in the (storage device name) according to SOP. Document the device information below. The validated (temperature monitoring device name) Temperature Monitoring has been inserted in the 4 Device: (storage device name) Pass Fail Manufacturer Name: according to SOP and the device information is documented. Equipment ID Number: Calibration Expiration Date: Document the start date and time below. Start date and time have Pass 5 Start Date: been documented. Fail Start Time: Allow whole blood to remain whole blood remained in in the (storage device name) the (storage device name) for(add monitoring for (add monitoring 6period). Follow SOPS for period). Temperature Pass temperature monitoring, monitoring, quality control Fail quality control and daily and daily checks were checks as documented according to SOP. CBRAC Regional Whole Blood Program MOU 34 appropriate. Document all activities according to SOP. At the end of the monitoring period: 1. Review all documentation to ensure it is complete and accurate. Perform re-training for staff as necessary to address any omissions or At the end of the monitoring errors in period: documentation. 1. All 2. Print/save documentation was electronically all reviewed and found temperature records to be complete and for the entire accurate. monitoring period. 2. Temperature Review the records to records for the entire verify that the monitoring period temperature for the were printed/saved duration of the electronically and monitoring period reviewed. was captured, and Temperature for the that blood products duration of the 7 were maintained monitoring period Pass Fail between 1°C -6°C. was captured, and Temperatures outside blood products were of 1-6°C will be maintained between documented, 1°C -6°C. investigated and re- 3. Feedback validation, retraining from individuals or SOP updates will participating in the be performed as validation was appropriate. obtained regarding 3. Obtain the established SOPS feedback from and processes. SOP individuals and/or process participating in the updates are not validation regarding required. the established SOPS and processes. Amend SOPS as necessary for process improvement and submit any updates to Coastal Bend Blood Center for approval. CBRAC Regional Whole Blood Program MOU 35 At the end of the monitoring period, document the date and time. 8 The stop date and time have Pass Stop Date: been documented. Fail Stop Time: If this test case fails,failure will be investigated and repeated. This must be documented and attached. Reviewer Review of Actual Outcome Comments Accept Reject Reviewer Signature Date of Review CBRAC Regional Whole Blood Program MOU 36 Coastal Bend Blood Center: AABB TAS Standard Reference Table 1AAi i Standard Number AABB Standard Description The organization shall define and control critical equipment. Guidance:The facility is required to define a list of equipment that is critical to the facility's operations.Critical equipment AABB Std.3.0 Equipment used for collection,processing and storage ofsamples should be suitable for the task and itshould be maintained appropriately.Acceptable operational limits for equipment should be defined and processes and procedures should indicate the course ofaction when these limits are not maintained(SS) 11 critical equipment shall be qualified for its intended use.Equipment shall be requalified,as ceded,after repairs and upgrades. Guidance:The intent of Standard 3.2 is to provide assurance that a device and the associated processes that employ the device are operating as designed and as intended.An important element of qualification is to provide assurance not only that the manufacturer's specifications are met but also that the equipment will work in the user's environment This includes the physical environment as well as variables such as procedures and staff.Multiple factors can influence how a piece of equipment performs.These include hardware,software,individual equipment components,device design,the manufacturing process,environment,shipping,and installation,etc.Robust installation,operational andperformance qualification(IQ, AABB Std.3.2 Qualification of Equipment OQ,and RQ)processes will give the facility confidence that the equipmentfunctions as designed and intended in the environment in which it is installed and using the facility-developed procedures and facility-trained operators. When purchasing equipment,the facility should consider the following guidance: • Inspect equipment upon arrival and install it in a suitable working environment • Qualify the equipment and maintain records ofthe qualification. • Set date for implementation after training has been conducted for all users. • Use the equipment aintain the equipment(SS) AABB Std.3.2.1 Installation Qualification Equipment shall be installed per manufacturer specifications. AABB Std.3.2.2 Operational Qualification Each piece of equipment and component of an information system shall be verified before actual use. Equipment shall perform as expected for its intended use. Guidance: When considering equipment purchase or relocation,the facility should have a documented process verifying AABB Std.3.2.3 Performance Qualification that the equipment or system can perform the expected task or controlling the activity according to written and preapproved pecifications.The equipment or system should be tested to ensure that itperforms as described in the manufacturer's pecificationis,in the operator's manual,or in accordance withfacility expectations.In this lost phase ofthe equipment qualification cycle,the facility verifies that the user requirements and specifications are met(SS) Equipment shall be used in accordance with the manufacturer's written instructions. Guidance:After selection,the equipment should then be validated to ensure that it operates as expected and that an appropriate intended output can be obtained before its use for patient care.If one chooses to deviate from the manufacturer's written instructions,evaluation ofthe impact ofthat deviation should be part ofthe validation protocol. When purchasing equipment,the facility should consider the following guidance: AABB Std. 3.3 Use of Equipment • Inspect equipment upon arrival and install it in a suitable working environment • Qualify the equipment and maintain records ofthe qualification. • Set date for implementation after training has been conducted for all users. • Use the equipment • Maintain the equipment(SS) Equipment shall have unique identification. AABB Std.3.4 Unique Identification of Guidance:This standard obligates the facility to uniquely identify the pieces of critical equipment that can affect the administration ofblood products or quality of test results.The facility is required to assign a unique identification to each Equipment piece ofcritical equipment To assist in calibration and maintenance,the facility should maintain a list ofall critical equipment A serial number can serve as the identification number.(SS) AABB Std.3.5 Equipment Monitoring and Equipment shall be monitored and maintained in accordance with the manufacturer's written Maintenance instructions. Calibrations and/or adjustments shall be performed using equipment and materials that have adequate accuracy and precision.At a minimum,calibrations and/or adjustments shall be confirmed as AABB Std.3.5.1 Calibration and Accuracy of described below unless otherwise indicated by the manufacturer: Equipment 1. Before use. 2. After activities that may affect the calibration. 3. At prescribed intervals. AABB Std.3.5.1.1 Calibration of equipment shall include details of equipment type,unique identification,location, frequency of checks,check method,acceptance criteria,andspecified limitations. Equipment used for calibration,inspection,measuring,and testing shall be certified to meet nationally AABB Std.3.5.1.2 recognized measurement standards.Certification shall occur before initial use,after repair,and at prescribed intervals.Where no such measurement standards exist,the basis for calibration shall be described and recorded. AABB Std.3.5.1.3 Equipment shall be safeguarded from adjustments that would invalidate the calibration setting. When equipment is found to be out of calibration or specification,the validity of previous inspection AABB Std.3.5.2 and test results and the conformance of potential affected products or services(including those that have already been released or delivered)shall be verified. The organization shall: 1. Define cleaning and sanitization methods and intervals for equipment. 2. Ensure that environmental conditions are suitable for the operations,calibrations, inspections,measurements,and tests carried out. 3. Remove equipment from service that is malfunctioning/out of service and communicate to appropriate personnel. AABB Std.3.5.3 4. Monitor equipment to ensure that defined parameters are maintained. 5. Ensure that the handling,maintenance,and storage of equipment are such that the equipment remains fit for use. 6. Ensure that all equipment maintenance and repairs are performed by qualified individuals and in accordance with the manufacturer's recommendations. Guidance:When equipment orsystems undergo preventive maintenance,calibration,or repairs,the facility shouldverify that the person performing the maintenance work is trained and qualified to perform the task The facility should verify that there is a record or report about the type of work performed.The maintenance workperformed should match the expectations ofthe facility,the agreement with the service provider,and the specifications ofthe manufacturer'sfoperator's manual.(SS) Investigation and follow-up of equipment malfunctions,failures,or adverse events shall include: 1. Assessment of products or services provided since the equipment was last known to be functioning per the manufacturer's written instructions or organization-defined specifications. 2. Assessment of the effect on the safety of individuals affected. 3. Removal of equipment from service,if indicated. 4. Investigation of the malfunction,failure,or adverse event,and a determination if other equipment is similarly affected,as applicable. 5. Requalification of the equipment. 6. Reporting the nature of the malfunction,failure,or adverse event to the manufacturer, AABB Std.3.5.4 Investigation and Follow-Up when indicated. Guidance: Appropriate calibration and maintenance include several concepts.All equipment must be properly installed and calibrated before use,with appropriate records maintained of arty problems encountered and corrected The organization must develop appropriate processes and schedules for ongoing calibration,preventive maintenance,and QC.Records of calibration,preventive maintenance,and repairs must be maintained.Defective equipment must be identified,controlled and managed to ensure that it is not used Malfunctioning equipment and/or equipmentfailures must be thoroughly evaluated to include assessing the potential impact on any patient's or donor's products associated with the equipment The evaluation or assessment should determine if there is any impact since the device%quipment was last known to be properly functioning fe,per the manufacturer's instructions or as defined in the facility's SOPs).Examples may include assessing the equipment since the last successful preventive maintenance,calibration,or validation activity,as applicable.Thefacility should evaluate and then determine if other pieces ofsimilar equipment are potentially affected as well(eg,same make and model number as the device in question or devices using the same version ofsoftware).The facility SOPS should define the criteria for evaluation and review of equipment malfunctions and for documenting the rationale for impact on other pieces o equipment A system for reporting adverse events to the manufacturer must be in place.(SS) The organization shall maintain records of equipment use in a manner that permits: AABB Std.3.6 Equipment Traceability 1. Equipment to be uniquely identified and traceable. 2. Tracing of any given product or service to all equipment associated with the procurement,processing,storage,distribution,and administration of the product or service. Storage and transport devices shall have the capacity and design to ensure that the proper temperature is maintained.Standard 5.1.9 applies. Guidance: QC testing for alarm systems needs to ensure the alarms are being activated and the temperature recording AABB Std.3.8 Storage and Transport Devices device is responding before the temperature-sensing device(probe)reaches an unacceptable temperature.An electronic for Blood and Blood alarm test that merely increases or decreases the electronic digital readout to determine if the audio alarm sounds would not Components meet the intent ofthese Prehospital and Out-of-Hospital Standards The temperature sensing device is not being tested to determine ifitis sending the signal to activate the alarm,but whether the recording device is responding to allow proper action before unacceptable temperatures are detected Ifthe electronic testis increasing and decreasing the actual temperature ofthe probe to verify 1)the probe is sending the signal to activate the alarms and 2)the recording device is documenting when inappropriate temperatures are reached then this method would meet the intent of these Prehospital and Out-of-Hospital Standards.(SS) AABB Std.3.8.1 Alarm Systems Storage devices shall have alarms and shall conform to the following standards: AABB Std.3.8.1.1 The alarm shall be set to activate under conditions that will allow enough time for proper action to be taken before products reach unacceptable conditions. AABB Std.3.8.1.2 Activation of an alarm shall initiate a process for immediate action,investigation,and appropriate corrective action. AABB Std. 5.1.2 Quality Control A program of quality control shall be established that is sufficiently comprehensive to ensure that products,equipment,materials,and analytical functions perform as intended. The organization shall ensure that products or services are handled,stored,and transported in a manner that prevents damage,limits deterioration,and provides traceability. Reference Standard 5.1.9A Requirements for Storage,Transportation,and Expiration applies. Guidance: A process must be in place to minimize the possibility ofdamage and/or deterioration ofblood and component(s) during processing storage,distribution,and transport Both storage and transport processes should be validated to ensure the ability to maintain the product(blood,blood components,tissue,derivatives,samples,and critical materials such as reagents)atprescribed temperatures and storage AABB Std. 5.1.9 Handling,Storage and conditions as specified in these Prehospital and Out-of-Hospital Standards.Monitoring is required to ensure proper Transportation conditions are maintained,and the process should be designed to enable staff to identify and manage temperature excursions,including assessing the impact ofthe excursion on the stored products.Records ofstorage temperatures shall be maintained;however,the Prehospital and Out-of-Hospital Standards does not specify the type ofinethod(eg manual method or automated temperature-monitoring device with continuous temperature monitoring).The Prehospital and Out-of-Hospital Standards does not requirefacilities to maintain an alternate or backup system for reagent storage temperature monitoring.There are both advantages and disadvantages to backup systems.The redundancy,while not required could be beneficial ifa device has a failure;however,a backup system would need to be maintained calibrated etc to ensure it isfunctioning as expected In the absence ofa redundant system,a facility could revert to manually monitoring temperatures until the primary system is functional.(SS) The TAS shall ensure all containers are validated for the handling,storage,and transport of blood and AABB Std. 5.1.9.1 blood components to ensure that temperatures are maintained within the acceptable range for the expected duration of transport,storage,or shipping.Standard 3.5.1 applies. The TAS shall ensure blood and blood components remain within the acceptable temperature range AABB Std. 5.1.9.2 during storage and transport.Reference Standard 5.1.9A,Requirements for Storage,Transportation, and Expiration applies. For storage of blood and blood components,the temperature shall be monitored continuously and recorded at least every 4 hours. AABB Std. 5.1.9.3 Guidance:Ifthe continuously monitored system does notprovide recording of temperatures,the facility must manually record the temperature every 4 hours.Ifthe continuously monitored system provides continuous recording oftemperatures, there is no need to additionally record manually every 4 hours.(SS) Item Component Storage Transport Expiration' Additional No. Criteria 1 Whole Blood 1-6C 1-10C CPD/CP2D:21 days CPDA-1:35 days ACD/CPD/CP2D:21 days 7 RBCs Leukocytes 1-6C 1-10C CPDA-1:35 days AABB Reference Std. 5.1.9A Requirements for Reduced Additive solution(AS):42 days Storage,Transportation,and Expirationl Open system:24 hours CPD or CP2D:The expiration for Liquid 29 Liquid Plasma 1-6C 1-10C Plasma is 26 days 21 CFR If whole blood is stored in CPDA- 610.53 1,the Liquid Plasma expiration Pate is 40 days The blood and blood components shall be inspected at the time of removal from the transport container and/or storage device,and it shall be verified that the following conditions are met: 1. The unit has remained in a validated transport container or storage device within the specified period. 2. The unit appearance meets visual inspection criteria. 3. The unit has an attached label or tie tag indicating the donation identification number, and compatibility testing has not been performed. Standards 5.1.9 and 5.3.10 apply. AABB Std. 5.2 Receipt of Blood and Blood Guidance:41)The TAS will have a system to validate storage or transport containers,which may include,but is not limited Components to,using the manufacturer's recommended guidelines.The blood supplier(blood collector or hospital)may also choose to complete an additional validation to meet their internal process control requirements.If a TAS decides to change the type or model ofcontainer used,revalidation will need to occur. 42)Visual inspection as per the Circular oflnformation 43)Compatibility testing refers to the patient not being tested against the donor unit The blood unit should have already undergone a first and second ABO/Rh type testing prior to being released to the TAS The blood unit type confirmation testing can be performed by either the blood center or hospital transfusion service.The second confirmatory type testing of the blood unit is not the responsibility ofthe prehospital TAS Note:Agreements between the EMS and its blood supplier should indicate where the blood supplier does not meet the standard as written(SS) AABB Std.6.2.9 Retention Records required by these Prehospital and Out-of-Hospital Standards shall be retained for a period indicated in the record retention table at the end of each chapter. AABB Std.6.2.9A Retention of Records Reference`Record Retention Table'. The TAS shall have a process for providing relevant unit and/or patient information as requested when notified by the blood collection facility and/or transfusion service.* *21 CFR 610.46 and 21 CFR 610.47 apply. AABB Std.7.3.5 Look-Back Guidance:The purpose oflook-backis to address the possibility that previously acceptable units may have transmitted disease ifthe donors were in the window period ofinfectivity or iftests were not available at the time ofdonation The process involves the tracing ofproducts to the consignee.The consignee then determines who received the product and whether or not notification and possibly,testing are indicated(SS)