Hospital Resource Guide

Memorial Blood Centers Hospital Resource Guide

Memorial Blood Centers A Division of Innovative Blood Resources

We create trusted and innovative solutions to help our customers achieve their goals Table of Contents

Introduction 1 About this Hospital Resource Guide 1 Updates . 1 We invite your comments. 1 About Memorial Blood Centers, A Division of Innovative Blood Resources 2 Who We Serve 3 How We Do What We Do 4 Right Production, Right Type . 4 A Service Culture Designed to Meet all of your Hospital’s Needs 5 We’re Here When You Need Us 6 By Phone. 6 On the Web . 6

Routine Ordering and Delivery 7 Routine Orders 7 STAT and ASAP Orders 7 Definitions:. 7 Ordering Policy 7 Supply Orders 7 Routine Ordering and Delivery Times 7 Saint Paul . 7 Duluth . 7 Ordering Special Components 8 Modified Components. 8 Transportation of Blood Components 9 Memorial Blood Centers-Central (MBCM). 9 Memorial Blood Centers-Duluth (MBCD) . 10 Delivery Services . 11 Blood Hub Use 12 Blood Hub Screen Examples 12, 13 Routine Order Form 14 Handling, Storage and Return 15 Handling and Storage of Blood Components 15 Receiving Blood and Components . 15 Packing Lists . 15 Manual Packaging List. 16 Blood Component Return Guidelines . 17 Guidelines for Storage of Blood and Blood Components 18, 19 Memorial Blood Centers Policy. 18 Example Record of Return/Transfer . 19 Transferring Units 19, 20 Transferring Units to Another Memorial Blood Centers Facility. 19 Transferring Units with a Patient to:. 20 Hospitals Memorial Blood Centers Does Not Service. 20 Inventory Reconciliation 20 Guidelines for Returning and Packing of Red Blood Cells 20 Guidelines for Packing Platelets 20 Shipping Box. 21 Rev. June 2015 Table of Contents • Page ii MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Product Codes 22 Memorial Blood Centers Transfusable Blood Product Codes Manufactured at MBC 22 Whole Blood. 22 Frozen RBC . 22 Non-Leukoreduced RBC . 23–24 Leukoreduced RBC . 24-27 Apheresis Platelets. 27-28 Platelet from Whole Blood. 29 Pooled Platelets . 29 Plasma. 29-30 Memorial Blood Centers Testing Catalog 31 Donor Testing Laboratory 31 Viral Screening, Red Cell Typing, Nucleic Acid Testing. 31–39 Quality Assurance 41 Physician Services and Quality and Regulatory Affairs 41 Quarantine, Market Withdrawal, Recall, Inventory Lookback and Recipient Notification 41 If you are notified of a market withdrawal or recall, it is imperative that you: . 41 Reporting Adverse Outcomes of Transfusion 41 Communications 42 Customer Service Reports:. 42 Quality Control (QC) of Blood Components 43 Serious Outcome of Transfusion Report. 43 Suspected Transfusion Transmitted Disease Report. 44 Reference Laboratory 45 Request for Antibody Identification and Red Cell Crossmatching 45 Unit Antigen Typing 45 Antibodies in Donors 45 Platelet Crossmatching 45 HLA Matched Platelets 46 Service Fees 46 Request for Reference Lab Testing 47 Guidance for Industry 48-54 Qualifications Letter 55 Memorandum . 55 Parentage Testing 56 Common Questions & Answers 56 Why should you choose Memorial Blood Centers?. 56 How can I start testing for a parentage dispute?. 56 What type of testing is available? . 56 At what age are children able to be tested? . 56 What type of sample is collected from the individuals tested? . 56 How long does the collection take? . 56 Is there a difference in accuracy between a blood and buccal swab sample?. 57 Are these tests accurate? . 57 How long will it take to get results? . 57 Will the child and/or mother need to be re-collected if the first man is excluded? . 57 Can tests be performed when the parties involved live in different states or countries?. 57 If an Alleged Father is deceased can paternity testing still be done?. 57 Is the accuracy of a DNA test affected by drug use, illness or disease?. 57 Parentage Testing Services 58 Service Fees. 58

Rev. June 2015 Table of Contents • Page iii MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Routine Trios (Mother, Child & Alleged Father). 58 Family Studies (Motherless, Fatherless, Grandparents, Siblings, Y-chromosome, etc.). 58 Special Testing. 58 Additional Fees . 58 Expert Witness . 58 Educational Opportunities 59 Department of Training and Education. 59 American Association of Blood Banks (AABB) Audioconferences/ American Society for Clinical Pathology (ASCP) Teleconferences. 59 Student Rotations. 59 Facility Tours. 59 Volunteer Opportunities . 59 Continuing Education. 59 Current Topics and Controversies in Transfusion Medicine. 59 Reference Laboratory Workshops. 59 School Presentations. 60 “My Blood, Your Blood” . 60 Technical Advisory Meeting (TAM). 60 Medical Advisory Council. 60 Testing Services 61 Thank You 63 Addendum 64 Special Collections . 64

About this Hospital Resource Guide

Overview We invite your comments. Memorial Blood Centers is honored to be your Memorial Blood Centers strives to provide you with healthcare partner. And we are committed to ensuring the best customer service possible and we welcome that you have the resources you need to perform at your thoughts and ideas about this Hospital Resource your best as you provide the essential services that Guide. If there is important information you would save and sustain lives. This Hospital Resource Guide, like to see included or other ways we can effectively provided exclusively to our valued hospital partners, keep you up-to-date on operational changes, please has been created to help streamline the delivery of our feel free to contact us at 651-332-7108 (Metro) or 218- services to you and most effectively support you in 740-1520 (Northland). your work. It is an important reference that details our operating policies, procedures, and practices. This Hospital Resource Guide is provided for the exclusive use of Memorial Blood Centers’ hospital Please keep this resource guide in a convenient place partners. Any other distribution or use is strictly and use it as an easy-to-access tool to help answer prohibited. questions you might have. Additional information also can be quickly accessed at our website: MBC. ORG/Products-and-Testing-Services. In addition, feel free to contact Hospital Services for more information at 651-332-7108 (Metro) or 218-740-1520 (Northland).

Updates From time to time, the information contained in this Hospital Resource Guide may change or become outdated. When appropriate, Memorial Blood Centers will issue updates. Please be aware that it is the hospital’s responsibility to ensure it has the most current information and that the updated pages or sections are added and old pages are discarded.

If you are unsure if this guide contains the most current updates, please call Hospital Services for clarification or visit our website at MBC.ORG.

Who we are Memorial Blood Centers has been saving and sustaining lives for over 65 years. A Minnesota-based, independent nonprofit, we supply life-saving blood, state-of-the-art laboratory services, and biomedical expertise to area hospital and clinic partners, national blood centers, biotechnology companies, research institutions, and international clients from Australia to Switzerland.

As a mission-driven organization committed to advancing the cause of blood donation and ensuring the health and well-being of all of our citizens, in 2012 Memorial Blood Centers formalized a decade-long partnership with Nebraska Community Blood Bank (NCBB) of Lincoln, NE to form a new blood services organization. Our two community-based non-profits now operate as divisions of the newly formed entity: Innovative Blood Resources. Both are 501(c)(3) not- for-profit, charitable organizations. Each is licensed by the FDA and accredited by AABB and CLIA.

While we will continue doing business as (d/b/a) Memorial Blood Centers, all blood products collected by MBC and NCBB and shipped to our hospital partners will be labeled with the Innovative Blood Resources name.

Learn more about: Innovative Blood Resources at InnovativeBloodResources.org Memorial Blood Centers at MBC.ORG Nebraska Community Blood Bank at NCBB.ORG

Mission | To help save lives by providing blood and biomedical services

Rev. June 2015 Introduction • Page 2 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. As a national blood provider with a local focus on Who We Serve community participation to advance our mission of saving lives through blood donation, we service As a division of Innovative Blood Resources, customers with core competencies in production Memorial Blood Centers provides a comprehensive planning, blood utilization management, advanced menu of blood products, laboratory services, and Immunohematology Reference Laboratory services, technical expertise to a diverse client base of over and internationally-recognized transfusion medicine 40 partner hospitals in Minnesota, Nebraska and expertise. Visit our website at MBC.ORG/About-Us/ Wisconsin—from large, multi-unit systems to Service-Area for a current list of hospital partners. government-run Level 1 trauma centers, to tertiary hospitals and rural facilities. Additionally, we serve dozens of laboratory and blood bank customers across the United States, including the Mayo Clinic and the National Marrow Donor Program (Be The Match), and provide blood products for special manufacturing around the globe.

Blood Products Reference Lab Donor Testing International

Vision | To delight our customers and be the best blood center in America

With hospitals as our most valuable partners, our work at Memorial Blood Centers comes full circle: from donor to recipient. A two-time Minnesota Quality Award winner Our core work processes connect people to people. recognized for our commitment to continuous Beginning with generous donors, Memorial Blood improvement and customer service, Memorial Centers’ systematic, robust processes help us achieve Blood Centers maintains safety and quality at the our ultimate goal: meeting patients’ needs 100% of highest levels possible while streamlining processes the time by delivering the life-saving blood to our and maximizing cost-efficiencies to deliver hospital partners that recipients need whenever, competitively-priced blood products. wherever it is needed most.

Right production, right type— readily available at the right time

Sophisticated production planning, effective screening and manufacturing, excellent forecasting, and deployment of leading-edge technology ensure that Memorial Blood Centers efficiently meets each hospital’s unique specifications. As a result, we have built a solid reputation for dependability, reliability, and service excellence with local, regional, and national clients.

Production Collections Manufacturing Recipients Planning Donors Recruitment Testing Distribution

Strategic Approach | We create trusted and innovative solutions to help customers achieve their goals

With a 65-year legacy of serving the needs of hospitals large and small, CAH and PPS partners alike, Memorial Blood Centers has become the Partner-of- Choice for hospitals that demand:

• reliable availability and 24/7 convenience • easy online ordering and comprehensive testing services • transfusion support for cost-effective blood management • in-service training programs for hospital staff • flexibility, agility, and creative solutions to meet unique requirements

In addition to providing a comprehensive menu of blood products, Memorial Blood Centers is a nationally-recognized leader in advanced laboratory testing. Our FDA-licensed and EU-compliant advanced laboratory facilities provide a full range of testing services to help ensure a safe and stable blood supply that protects donors and recipients, while research advances the scientific study of infectious diseases that set the standard for the blood industry.

• Decades of experience performing more than 3 million blood sample tests for clients, including reproductive medicine providers, national and regional blood centers, the National Marrow Donor Program, and such world-renowned facilities as the Mayo Clinic • AABB-accredited Immunohematology Reference Laboratory • HPC-Hematopoietic Progenitor Cell Lab accredited by AABB and The Foundation for the Accreditation of Cellular Therapy (FACT) • Partner of the American Rare Donor Program

FDA registered | AABB Accredited | CLIA Licensed

Visit MBC.ORG/About-Us/Accreditations to view all current accreditations.

By Phone: On the Web:

MBC.ORG/Products-and-Testing-Services/ Key Contacts - Metro Products-and-Testing-Services-Overview General Information 1-888-GIVE-BLD (888-448-3253) 651-332-7000

Hospital Services 651-332-7108 Phone 651-332-7004 Fax 651-490-9431 Cell

Hospital Services & Lab Relations 651-332-7109 Manager Key Contacts - Northland General Information 218-723-8080 Duluth Hospital Services 218-740-1520 Phone 218-740-1521 Fax 218-591-3813 Cell

Component Services Manager 218-740-6125

Additional Contact Information Billing/Invoice Questions 651-332-7252 Accounts Receivable Donor & Patient Testing 651-332-7119 Reference Laboratories 651-332-7125 Associate Medical Director 651-332-7285 and Director, Physician Services Elizabeth Perry, M.D. Medical Director and VP, Medical & 651-332-7284 Regulatory Affairs Jed Gorlin, M.D.

Routine Orders Ordering Policy

Routine orders for blood and/or components are made Full-Service Hospitals recognize that Memorial Blood by accessing the Memorial Blood Centers website Centers is the primary source for blood and blood www.mbc.org and logging into the Blood Hub Online components. Specifically, Memorial Blood Centers Ordering System. Each Transfusion Services employee maintains a sufficient inventory to meet hospital will be entered into the Blood Hub system by the needs. In the event that Memorial Blood Centers Memorial Blood Centers Hospital Services Designee does not have sufficient inventory, Memorial Blood or the Transfusion Services assigned administrator for Centers will contact other blood centers to obtain the your facility. Blood Hub will send the user an email blood and blood components needed. If Memorial with a link to set their own password. Passwords are Blood Centers cannot meet the hospital’s need within required to be changed every 90 days. (See example of the time frame requested, the hospital may contact login screen on page 12.) another blood center or non-affiliated hospitals to obtain the required blood and/or blood components. As a back-up to the Blood Hub Online Ordering System, Memorial Blood Centers will provide a paper Supply Orders copy of the Fax Order Form. The Fax Order Form should be used only when the Blood Hub System is not functioning. (See example on page 14.) Supplies can be ordered through Blood Hub or the fax order form if Blood Hub is not functioning. For a For technical difficulties with Blood Hub, we request complete listing of supplies available from Memorial that you contact a Memorial Blood Centers Hospital Blood Centers, refer to the current service fees. Services Designee or the Transfusion Services assigned administrator for your facility. Routine Ordering and

For reasons of inventory management, Memorial Delivery Times Blood Centers reserves the right to ship ABO compatible components in lieu of the specific Saint Paul requested type. If Memorial Blood Centers requests that a substitution be made, the charge will reflect the Day Order Time Delivery Time component of lesser cost. Monday – Friday 6:30 am to 8 am 9 am to 10:30 am Morning Orders 8 am to 9 am 10:30 am to Noon STAT and ASAP Orders Monday – Friday 2 pm to 4 pm 4:30 pm to 7:30 pm Afternoon Orders The Hospital Services Department is staffed 24 Saturday and Sunday By 9 am 9:30 am to 1 pm hours, 7 days a week at the Saint Paul location and the Duluth location. To place a STAT/ASAP order, log on to Blood Hub and place your order. All STAT Duluth and ASAP phone orders must be followed-up with a submitted order through Blood Hub or via fax. Day Order Time Delivery Time Monday – Friday 7:00 am to 9 am 10 am to 11:30 am Definitions: Stock Rotation for Duluth Facilities • STAT — Orders are for an emergency need, Stock rotation occurs every 1–3 weeks for some affiliate sites on shipped in 1 hour once the component is available. predetermined dates. The hospital rotates older stock units back to • ASAP — Orders are shipped in less than 4 hours Memorial Blood Centers-Duluth in return for fresher units. once the component is available. • Routine — Orders are sent with the next scheduled note: Duluth area hospitals located out of town delivery to your facility, or in less than 24 hours. that are served by Memorial Blood Centers should • Specialty Orders — Reference Lab requests can be communicate with the Duluth Hospital Services staff placed through Blood Hub. when ordering blood/components that are not part of • Memorial Blood Centers-Central (MBCM) their routine exchange. These orders should be placed • Memorial Blood Centers-Duluth (MBCD) early enough for Memorial Blood Centers to arrange a routed courier service. Please contact Duluth Hospital Services for delivery time frame. Rev. June 2015 Routine Ordering and Delivery • Page 7 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Ordering Special Components

Modified Components To order modified components place the order using Blood Hub or the Fax Order Form can be used when Blood Hub is not functioning. Because modification of blood components can be a time consuming process for the blood center, please consider this when placing the order to ensure timely delivery. The expiration date for most modified components is shortened, which must also be considered prior to placing an order. Refer to the table below for approximate modification times and new expiration dates.

Special Component Requests

Component *Approximate New Expiration Availability Description Preparation Time Date Washed Red Cell Unit 1.5 hours 24 hours M – F, 7 am –10 pm (MBCM only) Other times: on call charges apply Deglycerolized Red Cell Unit 2 hours 24 hours M – F, 7 am –10 pm (MBCM only) Other times: on call charges apply Washed Platelet Component 2.5 hours 4 hours M – F, 7 am –10 pm (MBCM only) Other times: on call charges apply Irradiation of Components 15 minutes 28 days or unit expiration 24 hours a day, 7 days a week (whichever is shorter) Volume Reduction of Platelets 1 hour 4 hours M – F, 7 am –10 pm

Other times: on call charges apply

If unit must be pooled prior to volume reduction — add 30 minutes Sterile Connection of Pediatric/ 30 minutes NA M – F, 7 am –10 pm Transfer Bags Other times: on call charges apply

Add 30 minutes if requesting Memorial Blood Center to divide into transfer bags Antigen Negative Unit Dependent upon antigen NA Refer to Reference Laboratory section requested and inventory levels

Preparation time does not include transportation time to the hospital.

For requests during non-routine hours an additional one hour must be added to preparation time. Call Hospital Services to inquire about preparation times for any components not listed above.

• Memorial Blood Centers works together with each hospital to select an appropriate delivery schedule to meet the Hospital’s inventory needs. • Memorial Blood Centers provides routine deliveries at no charge according to an established schedule. • Charges for additional deliveries, requested by the Transfusion Services, are the responsibility of the requesting Hospital.

Memorial Blood Centers-Central Telephone number: 651-332-7108 Cell number: 612-490-9431 (MBCM) Fax number: 651-332-7004 Hours of Operation: 24 hours a day Serving the Twin Cities Metro Area and Southern Minnesota Orders Routine Non-Routine Request Restocking Online ordering – see “Ordering Section” Central Business Hours: for current schedule cut-off 24 hours a day, 7 days a week Inventory Exchange Standing Order Call MBCM Hospital Services and place order through NOTE: Orders not received by the cutoff will be shipped with the next Blood Hub, the online ordering system. scheduled routine delivery. If needed earlier, the delivery charges are the responsibility of the requesting Hospital.

Delivery Schedule Monday – Friday 2 deliveries daily STAT — Request processed immediately shipped <1 Saturday, Sunday, and 1 delivery daily hour once product is available Holidays ASAP — Request shipped < 4 hours once product Inventory Exchange Every 1–3 weeks as scheduled is available Delivery Charge No Charge Requesting facility pays delivery fees. Transportation fees are billed monthly by MBC

Highway Patrol: The highway patrol is available ONLY for Critical Medical Emergency transport.

The order MUST be ready for pick-up when the Highway Patrol arrives at the sending site — communication and coordination between the sender and the receiver is crucial.

Rev. June 2015 Routine Ordering and Delivery • Page 9 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Transportation of Blood Components (continued) Memorial Blood Centers-Duluth (MBCD) Telephone number: 218-740-1520 Cell number: 218-591-3813 Serving Duluth, Northern Minnesota and Wisconsin Fax number: 218-740-1521 Hours of Operation: 2 4 hours a day

Orders Routine Non-Routine Request Restocking Online ordering by 7:30 am. Our Duluth Business Hours: 24 hours a day, 7 days a earliest courier leaves at 8:00 am. week Inventory Exchange Every 1–3 weeks as scheduled Call MBCD Hospital Services or place order through Blood NOTE: Orders not received by the cutoff will be shipped Hub. with the next scheduled routine delivery. If needed earlier, the delivery charges are the responsibility of the requesting Hospital.

Delivery Schedule Monday – Friday 1 delivery daily STAT — Request processed immediately shipped <1 hour once product is available Inventory Exchange Every 1–3 weeks as scheduled ASAP — Request shipped < 4 hours once product is available Delivery Charge No Charge Requesting facility pays delivery fees. Transportation fees are billed monthly by MBC

Highway Patrol: The highway patrol is available ONLY for Critical Medical Emergency transport.

The order MUST be ready for pick-up when the Highway Patrol arrives at the sending site — communication and coordination between the sender and the receiver is crucial.

Carrier Telephone # Service Area Service Memorial Blood Centers -Central 651-332-7108 Twin Cities Metro Area, Southern/ • Routine Northern Minnesota • ASAP • STAT Memorial Blood Centers - Duluth 218-740-1520 Duluth, Northern Minnesota and • Routine Wisconsin • ASAP • STAT Couriers Hybrid 612-308-7667 Twin Cities and Duluth • Routine • ASAP • STAT • Scheduled Quicksilver 651-484-1111 Twin Cities • Routine • ASAP • STAT MedStat 763-586-0369 Twin Cities • Routine • ASAP • STAT Velocity Express 218-726-1514 Duluth Area • ASAP • STAT Scheduled Routes in Duluth Region ZOOM 218-348-1144 Duluth Area • Routine • ASAP • STAT • Scheduled Northern Lights 218-729-5841 Duluth Area Scheduled Routes in Duluth Region Cab Red & White 612-871-1600 Twin Cities • Routine • ASAP • STAT Allied 218-722-3311 Duluth Area • ASAP • STAT Orders must be placed with a minimum of 2 hours prior to published departure times Other Greyhound Statewide Call MBC-Central for schedule Delta United States Midnight Express United States Skyline Shuttle from Duluth to St. Paul and airport Call MBC-Duluth skylineshuttle.com Fed-Ex United States Place order before 4 pm for next day delivery. Sat. delivery available

See Blood Hub training presentation and Blood Hub How to Guide links on the Blood Hub Dashboard page for full instructions for use.

Example of the Blood Hub Log in Screen

Select the Products you are ordering, blood types, and quantities

Verify that your order is correct

Complete your order

Note: An Antigen Screened order includes units that will be tagged and have antigens confirmed

Note: Do not select Antigen Screened to request “Historical” typed antigens – place a regular order for those and type “Historical” in the comment field

Click the Create Order Link, select Antigen Screened, and Shipping Options

Blood Hub allows you to place an order and tell us the Date/Time when the order is needed. Select Delivered by Date/Time under shipping options to use this feature.

Select Products, Blood Types, and Quantities. Then select the antigens to screen for

Verify the order for accuracy Complete the Order

Rev. June 2015 Routine Ordering and Delivery • Page 13 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Rev. June 2015 Routine Ordering and Delivery • Page 14 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Handling, Storage and Return

Handling and Storage of Packing Lists Blood Components Your facility will receive a packing list with each shipment of blood and/or blood components. The packing list contains a listing of each component Receiving Blood and Components contained within the shipment. There is also a listing of historical antigen typing for each red cell unit (refer Upon receipt of a shipment of blood and/or blood to Page 45 for a description of antigen testing). The components it is imperative that the receiving facility: person at your facility who receives the shipment should sign the packing list. Signed packing lists 1. Ensure the blood and/or blood components have should be maintained at your facility in accordance arrived at your facility at the proper temperature: with AABB and Food and Drug Administration Product S hipping Temperature (FDA) guidelines. • Red Blood Cells 1 – 10o C • Platelets 20 – 24o C +/-2o C In the event that the computer system at Memorial • Frozen Components Dry ice must be present Blood Centers is not functional and/or a component must be sent to your facility as an emergency release, 2. Compare the unit numbers and components on the you will receive a handwritten manual packing list. packing list against the actual numbers/components The manual packing list must be treated as your received. official packing list (as in the paragraph above). 3. Visually inspect each unit received according to your hospital policies and American Association of Examples of a computer-generated and a manual Blood Banks (AABB) guidelines. packing list are provided below and on the following page. note: Contact Hospital Services immediately if a discrepancy or problem is noted. If not contacted in writing within 10 days of receipt of shipment, your facility assumes responsibility for each component listed on the original packing list.

Rev. June 2015 Handling, Storage and Return • Page 15 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Rev. June 2015 Handling, Storage and Return • Page 16 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Blood Component Return Guidelines Discard unit, report disposition and request credit on Hospital Request Credit Report (Form-IT-005). Send Hospital Request Credit Report to your distribution These guidelines were developed to: hub by the last day of the month. Credit requests received late will be posted to the next month’s • Encourage judicious inventory management billing cycle. Policies/Guidelines are monitored for practices by Memorial Blood Centers and each effectiveness in inventory management and financial of our customers for the benefit of all customers outcomes; changes are made as necessary. served. • Allow hospitals to establish their own criteria for Modified components (washed, irradiated, volume managing their unique patient populations and reduced, etc.) are not acceptable for return and credit sharing in the cost of meeting their inventory needs will not be issued with the exception of Irradiated Red Cell Components. Irradiated Red Cells are acceptable Any component issued by Memorial Blood Centers for return if they meet the guidelines listed below. with a ‘shorted-dated’ sticker will not be charged to the hospital if the unit outdates at the hospital.

JobAid-HS-002.9 05/13

Rev. June 2015 Handling, Storage and Return • Page 17 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Component Guidelineswith each return shipment. If Blood hub is not Guidelines for Storage of functioning a Record of Return/Transfer paper BloodPlatelet Apheresis and — R eservedBlood for a specificComponents patient (by hospital Sent to hospitalcopy when (Form-HS-020) available (See example on page 19) request — yellow sticker): may be used as long as it is completely filled out. Charged to hospital if not used Each unit returned must be listed on the return Memorial Blood Centers Policy If used by alternateform individually hospital — collection with fee a return of $250 reasonplus special clearly fees (HLA, HLA-Matched cross-matching,documented. irradiation), charged to requesting hospital; receiving hospital All full-service hospitals served by Memorial Blood • The Record of Return Transfer form MUST CentersSpecial Typing may (PIA1)return blood components with an charged $250 Cross-matched be completed by an employee of the hospital accompanying Record of Return Transfer form The All fees associatedTransfusion with units Service imported to to indicatemeet a patient’s that specific the blood need are return form must be generated in Blood Hub or the passed on and/orto the hospital. blood components have been stored facilities own computer system (if the computer continuously as directed on the unit label. system generates a pre-approved return packing slip).. Returns accepted with > 48 hours to expiration UnitsPlatelet not Concentrates acceptable for reissue will be charged to the If < 48 notes:hours, (day of expiration), contact Hospital Services, St. Paul. If unit hospital unless previous arrangements for credit have can be • used, M noemorial charge, Bloodif it cannot Centers be used, will hospital NOT will beaccept charged units for been made. The following conditions apply to any Frozen Plasma Components > 3 monthsreturn to outdate without — may bea returnreturned reason and the initials of hospital returning blood components to Memorial the person shipping the units. Memorial Blood Centers physician consulted for alternative Blood Centers: • The return packing slip generated in Blood Hub will document the tech, date and time of return • The hospital must store all blood and blood If hospital chooses not to use suggested alternative, hospital charged full cost Components not available at Memorial Blood Centers of importedand component. will require checking an acceptance box components according to current AABB and FDA indicating that the units are acceptable for return guidelines If no alternative, Memorial Blood Centers assumes cost of imported • A Record of Return Transfer packing slip generated for reissue. alternative. by Blood Hub (see the example below) or the Hospitals computer system must be included Blood Hub generated return form below.

An example of a Record of Return/Transfer form Transferring Units (Form HS-020) is provided. Record of Return/ Transfer forms are provided free of charge. If you need forms, call Hospital Services and they will be Transferring Units to Another sent with a routine order. Memorial Blood Centers Facility Whenever possible, components should be returned to Component Storage Comments Memorial Blood Centers for transfer to another facility. Description Temperature However, if it becomes necessary to expedite the delivery, you may be asked to transfer blood and/or blood o Platelet Component 20 – 24 C Continuous components directly to another facility. To do this: agitation is required • Arrange for transportation from your facility to Buffy Coats 20 – 24o C DO NOT AGITATE the hospital needing the blood and/or components. Red Blood Cells 1 – 6o C Hospital Services may assist you in this effort, if Frozen Component < -18 o C necessary call them directly. • Complete the Record of Transfer in Blood Hub or the facilities Computer system and indicate which NOTE: These storage guidelines are provided to assist facility the units were transferred to. A paper your facility in the proper storage temperature for generated Record of Return/Transfer form may be components. It is the responsibility of your facility to used if Blood Hub is not functioning (see example follow all applicable storage regulations provided by on page 18. the AABB and FDA. • Notify Hospital Services by fax or phone that the units were transferred. • Instruct the receiving facility to complete the Record of Return Transfer upon receipt of the shipment and forward to Hospital Services.

Rev. June 2015 Handling, Storage and Return • Page 19 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Transferring Units with a Patient to: • Each Transfusion Service is responsible for developing processes to comply with this Hospitals Memorial Blood Centers Services requirement. If the blood and/or blood components are transferred with a patient to a hospital supplied by Memorial Blood Centers: Guidelines for Returning and Packing of Red Blood Cells • A Record of Return Transfer form must be completed Memorial Blood Center’s standard shipping box with • The blood and/or components must be received at Styrofoam inserts should be used in combination with the proper storage temperature by the receiving gel packs, which have been frozen at approximately facility -18oC. NOTE: If the receiving facility will NOT accept the Please refer to JobAid-HS-015.1 How to Pack Red units, it is your responsibility to charge the patient for Blood Cells for Return which is distributed to hospital the units. Memorial Blood Centers will charge your customers. Call Hospital Services department facility (original receiving facility) for these units. management if you do not have this JobAid at your facility. Hospitals Memorial Blood Centers Does Not Service Guidelines for Packing Platelets It is sometimes necessary to transport units with a patient to a hospital Memorial Blood Centers does 1. Memorial Blood Center’s standard shipping box with not service. Blood and/or blood components may be the Styrofoam inserts may be used only for routine in transferred to these facilities at your discretion. town shipments, which are expected to be less than 2 hours, when outside temperatures are between 40oF Memorial Blood Centers hospitals that send blood and 85oF. and/or blood components to hospitals that Memorial Blood Centers does not serve will be charged for the 2. Memorial Blood Center’s platelet shipping container units. It is then up to you to charge the receiving with molded foam sides can be used for any hospital appropriately. platelet shipment and should be used for platelet shipments expected to take >2 hours or when outside These blood components may not be returned to temperature are >85oF or <40oF. any hospital Memorial Blood Centers serves or to Memorial Blood Centers itself. The sending hospital is responsible for billing the receiving hospital for all units involved. Please contact Hospital Services with questions. Inventory Reconciliation

FDA and AABB Standards require that it be possible to trace any unit of blood or component from source (the donor or the collecting facility) to final disposition (transfused, shipped, and/or discarded).

Memorial Blood Centers uses several different processes to meet this requirement:

• Memorial Blood Centers will involve Transfusion Services in a periodic reconciliation of physical inventories and inventory records. • Transfusion Services staff is responsible for assisting Memorial Blood Centers staff in the reconciliation of any discrepancies. • Transfusion Services may be asked to provide final disposition information to Memorial Blood Centers to complete the blood center records. Rev. June 2015 Handling, Storage and Return • Page 20 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Memorial Blood Centers Standard Shipping Box

1. Place 1 additional Styrofoam sheet on the bottom of the shipping box

2. Ensure plastic liner is inside the shipping box

3. Place 1 three pound room temp gel pack on the bottom of the box

4. Place component(s) on top of the gel pack

5. Place 1 additional three pound gel pack on the top of the component(s)

6. Wrap plastic liner securely around the components(s)

7. Place 2 Styrofoam sheets on the top of the gel packs

Memorial Blood Centers Platelet Shipping Box

1. Ensure plastic liner is inside the shipping box

2. Place 1 three pound room temp gel pack on the bottom of the box

3. Place components(s) on top of the gel pack

4. Place 1 additional three pound gel pack on the top of the component(s)

5. Wrap plastic liner securely around the component(s)

6. Place foam insert on the top of the units and gently push to secure

Memorial Blood Centers Transfusable Blood Product Codes Manufactured at MBC

Rev. June 2015 Product Codes • Page 23 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Non-Leukoreduced RBC MBC ISBT Product Product Description Code Code E5249*** E5249 RED BLOOD CELLS|CP2D>AS3/XX/refg|Irradiated|LowVol:anticoag adj E5553*** E5553 RED BLOOD CELLS|CP2D/XX/refg|Irradiated|LowVol:anticoag adj

Leukoreduced RBC MBC ISBT Product Product Description Code Code BC E3732 LEUKOCYTES|CPD/500mL/rt

E1237 Thawed Apheresis FRESH FROZEN PLASMA|ACD-A/XX/refg

E0773 Thawed FRESH FROZEN PLASMA|CPD/XX/refg

E5275 Pooled Thawed Plasma, Frozen Within 24 Hours After Phlebotomy, from CPD Whole Blood

E5298 Pooled Thawed FFP from CPD Whole Blood

E5308 Pooled Thawed Plasma

E5309 Pooled Thawed Fresh Frozen Plasma

E6097 Pooled Thawed FFP, from ACD-A Apheresis

GR* E3676 Apheresis GRANULOCYTES|NaCitrate-HES/XX/rt|Open

GRI* E3677 Apheresis GRANULOCYTES|NaCitrate-HES/XX/rt|Open|Irradiated

DGAP* E2528 PLASMA|CPD/XX/<=-18C

DGAP2D* E2592 PLASMA|CP2D/XX/<=-18C

DGAPA1* E2560 PLASMA|CPDA-1/XX/<=-18C

Memorial Blood Centers Testing Catalog

Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

MBC.ORG/Products-and-Testing-Services/Products-and-Testing-Services-RelatedDocs MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Hepatitis B Virus

Specimen Requirements: Glass Tubes Hepatitis B Virus Surface Antigen • Serum (HBsAg) • Plasma (EDTA, sodium heparin, sodium citrate, CPDA-1 and ACD anticoagulants) Plastic Tubes

Test Code(s): • Serum, serum separator tubes • Plasma (EDTA, lithium heparin, and sodium citrate)

HBsAg - Neutralization performed on Repeat Reactive Cadaveric - serum (glass or plastic) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. samples

Specimen Volume: 1.5 ml HBsAg (No Reflex) – No further testing performed (excluding the red cell volume) Manufacturer: Storage Instructions: • 2-8ºC for 7 days BioRad • ≤ -20ºC after 7 days (specimens should be removed from the clot or red blood cells prior to freezing) • 5 Freeze/Thaw cycles Methodology: Shipping Requirements: Ship at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to 7 days, and upon arrival should be EIA Screening stored at 2-8ºC. For transit times greater than 7 days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC).

Days Set Up: Monday thru Saturday

CPT Code: 87340 Specimen Requirements: Glass Tubes Hepatitis B Virus Surface Antigen • Serum Neutralization • Plasma (EDTA, sodium heparin, sodium citrate, CPDA-1 and ACD anticoagulants) Plastic Tubes (HBsAg Confirmatory) • Serum, serum separator tubes • Plasma (EDTA, lithium heparin, and sodium citrate) Test Code: Cadaveric - serum (glass or plastic) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. HBsAg Neutralization Specimen Volume: 1.0 ml (excluding the red cell Manufacturer: volume) BioRad 2-8ºC for 7 days Storage Instructions: • • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) Methodology: • 5 Freeze/Thaw cycles EIA Confirmatory Shipping Requirements: Ship at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to 7 days, and upon arrival should be stored at 2-8ºC. For transit times greater than 7 days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC).

Days Set Up: Monday/Tuesday, Wednesday, Friday

CPT Code: 87341

CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 1 of 17 08/2015

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Hepatitis B Virus – continued

Specimen Requirements: • Serum Antibody to Hepatitis B Virus • Plasma (EDTA or NA and LI heparin) Surface Antigen • Do not use hemolyzed or heat-inactivated specimens NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. (Anti-HBs) Sent to ViroMed for testing Specimen Volume: 100 µl (excluding the red cell volume)

Test Code:

ADVIA Centaur Anti-HBs Storage Instructions: • Specimens should be removed from the cells within 2 hours from collection.

• 8 hours at Room Temperature (15-28ºC) • 2-8ºC for 3 days Manufacturer: ADVIA Centaur • ≤ -20°C after 3 days (specimens should be removed from the red blood cells prior to freezing) • Avoid Multiple Freeze/Thaw cycles

Methodology: Shipping Requirements: Specimens should be removed from the red blood cells and shipped frozen.

Direct, chemiluminometric technology Days Set Up: Monday thru Friday

CPT Code: 86317 Specimen Requirements: • Serum Antibody to Hepatitis B Core • Plasma (EDTA, heparin or citrate-based anticoagulants) Antigen, Total NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.

(Anti-HBc Total) Specimen Volume: 0.5 ml (excluding the red cell Test Code: volume)

Anti-HBc Total Storage Instructions: • 2-8ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • 5 Freeze/Thaw cycles Manufacturer: Ortho Clinical Diagnostics Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to six days, and upon arrival should be stored at 2-8ºC. For transit times greater than six days, the serum or plasma Methodology: must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC).

EIA Screening Days Set Up: Monday thru Saturday

CPT Code: 86704

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Hepatitis B Virus – continued

Antibody to Hepatitis B Core Specimen Requirements: • Serum • Plasma (EDTA) Do not use hemolyzed or heat-inactivated specimens Antigen IgM NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. (Anti-HBc IgM) Specimen Volume: 1.0 ml Sent to ViroMed for testing (excluding the red cell volume) Test Code: Storage Instructions: • 2 days at Room Temperature (15-28ºC) IMMULITE Anti-HBc IgM • 2-8ºC for 3 days • -20ºC after 3 days (specimens should be removed from the red blood cells prior to freezing) • 2 Freeze/Thaw cycles Manufacturer: IMMULITE 2000 • Specimens which are not tested with in 24 hours should be removed from the cells

Shipping Requirements: Specimens should be removed from the cells prior to shipping. Specimens may be shipped at 2-8ºC for up Methodology: to 3 days; and upon arrival should be frozen at ≤ -20°C. For transit times greater than 3 days, the specimen Immunochemiluminometric assay (ICMA) should be kept frozen at ≤ -20°C.

Days Set Up: Sunday thru Friday

CPT Code: 86705

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Hepatitis C Virus

Antibody to Hepatitis C Virus Specimen Requirements: • Serum, SST • Plasma (EDTA, lithium heparin, CPD, CP2D, CPDA-1, ACD or 4% citrate anticoagulants) (Anti-HCV) • Cadaveric - Serum, SST or EDTA tubes NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. Test Code(s): Specimen Volume: 1.0 ml (excluding the red cell Anti-HCV - Repeat Reactive samples sent out for a PRISM HCV volume)

Anti-HCV (No Reflex) - No further testing performed Storage Instructions: • 2-8ºC for 10 days • ≤ -20ºC after 10 days (no longer than 4 weeks; specimens should be removed from the red blood cells prior to freezing) Manufacturer: • 5 Freeze/Thaw cycles Ortho Clinical Diagnostics Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to seven days, Methodology: and upon arrival should be stored at 2-8ºC. For transit times greater than seven days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC) EIA Screening Days Set Up: Monday thru Saturday

CPT Code: 86803

Antibody to Hepatitis C Virus Specimen Requirements: • Serum, SST • Plasma (EDTA, potassium oxalate, sodium citrate, ACD-A, ACD-B, CP2D, CPD, or CPDA-1 (Anti-HCV) anticoagulants or collected from segmented tubing) Alternate Methodology • Cadaveric – Serum NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. Sent to Indiana Blood Center for testing Specimen Volume: 1.0 ml Test Code: (excluding the red cell volume) PRISM HCV Storage Instructions: • 2-8ºC for 14 days

Manufacturer: • ≤ -20ºC after 14 days (specimens should be removed from the red blood cells prior to freezing)

Abbott Laboratories Shipping Requirements: Specimens may be shipped at 30ºC or colder for a period not to exceed 7 days. If shipping the sample frozen, remove the serum or plasma from the clot or red blood cells prior to shipping. Methodology: Abbott PRISM HCV (ChLIA) Days Set Up: Monday thru Saturday

CPT Code: 86803

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Human Immunodeficiency Virus (HIV)

Specimen Requirements: • Serum, SST Antibody to Human • Plasma (EDTA, sodium & lithium heparin, sodium citrate, CPD, CPDA-1, and ACD) Immunodeficiency Viruses Type 1 • Cadaveric - Serum NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. and 2 plus O (Anti-HIV-1,2+O) Specimen Volume: 600ul (excluding the red cell volume) Test Code(s):

Storage Instructions: Anti-HIV-1,2 plus O – Western Blot performed on • 2-8ºC for 7 days

Repeat Reactive samples • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • 5 Freeze/Thaw cycles Anti-HIV-1,2 plus O (No Reflex) – No further Shipping Requirements: testing performed Specimens may be shipped refrigerated (2-8ºC) or at ambient temperature (≤37 ºC) for up to 7 days. For shipments that are in transit for more than 7 days, the serum or plasma must be removed from the clot or red

Manufacturer: blood cells and should be kept frozen, (≤ -20ºC).

BioRad Days Set Up: Monday thru Saturday

Methodology: CPT Code: 86703 EIA Screening

Specimen Requirements: • Serum Antibody to Human • Plasma Immunodeficiency Virus Type 2 NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.

(Anti-HIV-2) Specimen Volume: 200 µl (excluding the red cell Test Code(s): volume)

Anti-HIV-2 – HIV-2 Immunoblot performed on Repeat Storage Instructions: • 2-8ºC for 7 days Reactive samples • ≤ -15ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • 5 Freeze/Thaw cycles Anti-HIV-2 (No Reflex) – No further testing performed Shipping Requirements: Specimens may be shipped refrigerated (2-8ºC) for up to 7 days. For transit times greater than 7 days, the serum or plasma must be removed from the clot or red blood cells and kept frozen, (≤ -15ºC). Manufacturer: BioRad Days Set Up: Monday/Tuesday, Wednesday, Friday

Methodology: CPT Code: 86702 EIA Screening

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Human Immunodeficiency Virus (HIV) – continued

Antibody to Human Specimen Requirements: • Serum • Plasma (EDTA, heparin, sodium citrate, CPDA-1, and ACD) Immunodeficiency Virus Type 1 NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.

Western Blot Specimen Volume: 100 µl (HIV-1 Western Blot) (excluding the red cell volume)

Test Code: Storage Instructions: • 2-8ºC for 7 days

HIV-1 Western Blot • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing)

• 5 Freeze/Thaw cycles

Manufacturer: Shipping Requirements: Specimens may be shipped refrigerated (2-8ºC) or at ambient temperature (≤37 ºC) for up to 7 days. For BioRad shipments that are in transit for more than 7 days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC).

Methodology: Days Set Up: Monday/Tuesday, Wednesday, Friday BioRad – Western Blot CPT Code: 86689

Antibody to Human Specimen Requirements: • Serum • EDTA Plasma Immunodeficiency Virus Type 2 NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing

Immunoblot Specimen Volume: 100 µl (HIV-2 Immunoblot) (excluding the red cell volume) Sent to ViroMed for testing Storage Instructions: • 2-8ºC for 7 days Test Code: • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing)

HIV-2 Immunoblot Shipping Requirements: Specimens may be shipped refrigerated (2-8ºC) for up to 7 days. For shipments that are in transit for more than 7 days, the serum or plasma must be removed from the clot or red blood cells and should be kept Manufacturer: frozen, (≤ -20ºC). Laboratory developed assay using analyte specific reagents Days Set Up: Tuesday, Thursday, Saturday

CPT Code: 86689

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Human T-Lymphotropic Virus (HTLV)

Antibody to Human T-Lymphotropic Specimen Requirements: • Serum, SST • Plasma (EDTA, heparin, citrate, CPD, CPDA-1 anticoagulants or collected from segmented tubing) Virus Type I and II NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. (Anti-HTLV I/II) Specimen Volume: 0.5 ml (excluding the red cell Test Code(s): volume)

Avioq HTLV-I/II - Repeat Reactive samples sent out Storage Instructions: • 2-8ºC for 14 days for a PRISM HTLV-I/II • ≤ -20ºC after 14 days (specimens should be removed from the red blood cells prior to freezing) Avioq HTLV-I/II (No Reflex) – No further testing • 1 Freeze/Thaw cycle

performed Shipping Requirements: Specimens may be shipped at ambient temperature, refrigerated (2-8ºC) or frozen ( -20ºC). Prior to ≤ Manufacturer: freezing, serum or plasma must be removed from the clot or red blood cells.

Avioq Days Set Up: Monday thru Saturday

Methodology: CPT Code(s): 86687 / 86688 EIA Screening

Antibody to Human T-Lymphotropic Specimen Requirements: • Serum, SST Virus Type I and II • Plasma (EDTA, potassium oxalate, sodium citrate, ACD-A, ACD-B, CP2D, CPD, or CPDA-1 anticoagulants or collected from segmented tubing) (Anti-HTLV I/II) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.

Alternate Methodology Specimen Volume: 1.0 ml Sent to Indiana Blood Center for testing (excluding the red cell volume) Test Code: Storage Instructions: • 2-8ºC for 14 days PRISM HTLV-I/II • ≤ -20ºC after 14 days (specimens should be removed from the red blood cells prior to freezing)

Manufacturer: Shipping Requirements: Specimens may be shipped at 30ºC or colder for a period not to exceed 7 days if removed from clot or cells. Prior to freezing, serum or plasma must be removed from the clot or red blood cells. Abbott Laboratories Days Set Up: Monday thru Saturday Methodology: Abbott PRISM HTLV-I/II (ChLIA) CPT Code(s): 86687 / 86688

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Human T-Lymphotropic Virus (HTLV) – continued

Antibody to Human T-Lymphotropic Specimen Requirements: • Serum, SST Virus Type I and II Immunoblot • Plasma (EDTA, heparin, citrate anticoagulants) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. (HTLV I/II Immunoblot) Sent to ViroMed for testing Specimen Volume: 0.5 ml (excluding the red cell volume) Test Code:

Storage Instructions: • 2-8ºC for 7 days HTLV-I/II Immunoblot -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • ≤ • 3 Freeze/Thaw cycle

Manufacturer: Shipping Requirements: Specimens may be shipped refrigerated (2-8ºC) for up to 7 days, or frozen (≤ -20ºC). Prior to freezing, serum Innogenetics or plasma must be removed from the clot or red blood cells.

Methodology: Days Set Up: Tuesday, Thursday Line Blot CPT Code: 86689

RUO - Research use only, not for diagnostic purposes

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Trypanosoma cruzi (T.cruzi)

Antibody to Trypanosoma cruzi Specimen Requirements: • Serum, SST • Plasma (EDTA, lithium heparin, CPD, CP2D, CPDA-1, ACD or 4% citrate anticoagulants) (Anti-T.cruzi) • Cadaveric – Serum, SST or EDTA NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. Test Code(s): Specimen Volume: 1.0 ml Anti-T.cruzi - Repeat Reactive samples sent out for a (excluding the red cell PRISM Chagas volume)

Anti-T.cruzi (No Reflex) - No further testing Storage Instructions: • Up to 37ºC for 24 hours performed • 2-8ºC for 10 days • ≤ -20ºC after 10 days up to 4 weeks (Can be stored for 6 months with 1 freeze/thaw cycle) Manufacturer: • 5 Freeze/Thaw cycles Ortho Clinical Diagnostics Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to 7 days, and upon arrival should be stored at 2-8ºC. For transit times greater than seven days, the serum or plasma must Methodology: be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC). EIA Screening Days Set Up: Monday thru Saturday

CPT Code: 86753

Antibody to Trypanosoma cruzi Specimen Requirements: • Serum, SST • Plasma (EDTA, potassium oxalate, sodium citrate, ACD-A, ACD-B, CP2D, CPD, or CPDA-1 (Anti-T.cruzi) anticoagulants or collected from segmented tubing) Alternate Methodology • Cadaveric – Serum only

Sent to Indiana Blood Center for testing NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.

Specimen Volume: 1.0 ml Test Code: (excluding the red cell volume) PRISM Chagas Storage Instructions: • 30ºC or colder for up to7 days Manufacturer: • 2-8ºC or -20ºC or colder for up to, but may not exceed, 14 days (specimens should be removed from the Abbott Laboratories red blood cells prior to freezing)

Shipping Requirements: Specimens may be shipped at 30ºC or colder for up to 7 days, or 2-8°C or -20°C or colder for up to 14 days. Methodology: Prior to freezing, serum or plasma must be removed from the clot or red blood cells. Abbott PRISM Chagas (ChLIA) Days Set Up: Monday thru Saturday

CPT Code: 86753

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Serologic Test for Syphilis (STS)

NEO Treponema Pallidum System Specimen Requirements: • Serum • Plasma (EDTA) for detection of Syphilis NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. (Syphilis TPHA) Specimen Volume: 2.0 ml (excluding the red cell Test Code(s): volume) Syphilis TPHA – Syphilis MHA-TP performed on repeat reactive samples Storage Instructions: • 1-10ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the clot or red blood cells prior to Syphilis TPHA (No Reflex) - No further testing freezing) performed • 3 Freeze/Thaw cycles Manufacturer: Shipping Requirements: Immucor Specimens may be shipped refrigerated (1-10ºC) for up to 7 days, or frozen (≤ -20ºC). Prior to freezing, serum or plasma must be removed from the clot or red blood cells. Methodology:

Hemagglutination Days Set Up: Monday thru Saturday **Primary method for Non-Blood Donors** CPT Code: 86780 – STS – Treponema Pallidum Specimen Requirements: • Plasma (EDTA) PK Treponema Pallidum System for • Serum NOTE: Specimens collected with an improper ratio of specimen to anticoagulant cannot be used for testing. detection of Syphilis (Syphilis MHA-TP) Specimen Volume: 2.0 ml (excluding the red cell volume) Test Code: Storage Instructions: • 2-8ºC - up to 5 days Syphilis MHA-TP • ≤ -20ºC after 5 days (specimens should be removed from the clot or red blood cells prior to freezing) Avoid repeat Freeze/Thaw cycles Note: On Blood Donor samples (and when this assay is • used as a backup for the NEO), a Syphilis TPHA is Shipping Requirements: Serum should be removed from the clot or red blood cells within 5 days from collection and ship frozen.

performed on repeat reactive samples Days Set Up: Monday thru Saturday Manufacturer: CPT Code: 86780 – STS – Treponema Pallidum Beckman Coulter 86780 – FTA-ABS

Methodology: Microhemagglutination

**Primary method for Blood Donors**

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Serologic Test for Syphilis (STS) – continued

Fluorescent Treponemal Antibody Specimen Requirements: • Serum Absorption Test Specimen Volume: 1.0 ml (FTA-ABS) Sent to ViroMed for testing Storage Instructions: • 2-8ºC - up to 5 days -20ºC after 5 days (specimens should be removed from the clot or red blood cells prior to freezing) • ≤ • 3 Freeze/Thaw cycles Test Code: Syphilis FTA-ABS Shipping Requirements: Specimen should be removed from the clot within 5 days from collection and ship frozen.

Days Set Up: Monday thru Friday Manufacturer: MarDX CPT Code: 86780 – FTA-ABS

Methodology: Indirect Fluorescent Antibody (IFA)

Rapid Plasma Reagin Specimen Requirements: • Serum (RPR)

Sent to ViroMed for testing Specimen Volume: 0.5 ml (excluding the red cell volume) Test Code: Syphilis RPR Storage Instructions: • 2-8ºC - up to 5 days • ≤ -20ºC after 5 days (specimens should be removed from the clot or red blood cells prior to freezing) Manufacturer: • 3 Freeze/Thaw cycles

BD Macro-Vue Shipping Requirements: Serum should be removed from the clot or red blood cells within 5 days from collection and ship frozen.

Methodology: Days Set Up: Daily Charcoal Flocculation CPT Code: 86592 – RPR

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Nucleic Acid Testing (NAT)

COBAS TaqScreen MPX Test Specimen Requirements: • Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and 4% Sodium Citrate) *EDTA is the recommended specimen, the other anticoagulants have more stringent storage (HIV/HCV/HBV PCR) requirements that are difficult to comply with when shipping specimens for testing. Please call the lab for the requirement if needed. Test Code(s): NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.

MPX – sent out for discriminatory testing by HIV-PCR, Specimen Volume: 1 full 7 ml EDTA plasma tube HCV-PCR, and HBV-PCR if reactive. Storage Instructions: EDTA only MPX (No Reflex) – no discriminatory testing Specimens should be removed from the red blood cells prior to freezing. performed • 2-30ºC for 72 hours This test is for the eligibility determination of Donors of • 2-8ºC for 5 days blood and blood components and human cells, tissues and • 2-8ºC for days 6-12 if separated from cells cellular tissue based products (HCT/Ps). • ≤ -18ºC for days 12-30 This test is not intended to be used for routine clinical or • 3 Freeze/Thaw cycles diagnostic evaluation. Shipping Requirements: EDTA plasma samples should be shipped within the storage specifications. Manufacturer: Days Set Up: Monday thru Saturday Roche CPT Code(s): HIV PCR – 87535 Methodology: HCV PCR – 87521 Roche RNA Polymerase Chain Reaction HBV PCR – 87516

Specimen Requirements: • Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and 4% Sodium Citrate) COBAS AmpliScreen HIV-1, HCV, *EDTA is the recommended specimen, the other anticoagulants have more stringent storage HBV Individual Tests requirements that are difficult to comply with when shipping specimens for testing. Please call the lab for the requirement if needed. (HIV-PCR/HCV-PCR/HBV-PCR) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. Sent to Indiana Blood Center for testing Specimen Volume: 1.0 ml for 1 test or 2.0 ml’s for 2-3 tests

(excluding the red cell Test Code(s): volume) HIV PCR HCV PCR Storage Instructions: EDTA only Specimens should be removed from the red blood cells prior to freezing. HBV PCR • 2-30ºC for 72 hours • 2-8ºC for 5 days This test is performed individually. It is used as the • 2-8ºC for days 6-12 if separated from cells discriminatory testing if the MPX test is reactive. • ≤ -18ºC for days 12-30 This test is not intended to be used for routine clinical or 3 Freeze/Thaw cycles • diagnostic evaluation.

Shipping Requirements: EDTA plasma samples should be shipped within the storage specifications.

Manufacturer: Days Set Up: Monday thru Saturday Roche

CPT Code(s): HIV PCR – 87535 Methodology: HCV PCR – 87521 Roche RNA Polymerase Chain Reaction CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 12 of 17 08/2015

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

HBV PCR – 87516

Nucleic Acid Testing (NAT) - continued

COBAS Taqscreen WNV Test Specimen Requirements: • Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and 4% Sodium Citrate). (WNV PCR) *EDTA is the recommended specimen, the other anticoagulants have more stringent storage requirements that are difficult to comply with when shipping specimens for testing. Please call the lab for the requirement if needed. Test Code: NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. WNV PCR Specimen Volume: 1 full 7 ml EDTA plasma tube

This test is for the eligibility determination of Donors of Storage Instructions: EDTA only blood and blood components. Specimens should be removed from the red blood cells prior to freezing.

• 2-30ºC for 24 hours followed by 24 hours at 2-25 ºC OR 2 days at 2-25 ºC This test is not intended to be used for routine clinical or • 2-8ºC to 5 days diagnostic evaluation. • 2-8ºC for days 6-12 if separated from cells • ≤ -20ºC for days 12-30 Manufacturer: • 3 Freeze/Thaw cycles Roche Shipping Requirements: EDTA plasma samples should be shipped within the storage specifications. Methodology: Days Set Up: Monday thru Saturday Roche RNA Polymerase Chain Reaction CPT Code: 87798

MBC Testing Catalog Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Cytomegalovirus (CMV)

Antibody to Cytomegalovirus Specimen Requirements: • Serum – Samples collected in a tube containing a neutral gel separator are NOT acceptable.( False positive results may occur.) (Anti-CMV Total(IgG+IgM Antibody)) • Plasma (EDTA, ACD, CPD, CPDA-1 or CP2D) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. Test Code(s): Specimen Volume: 1.0 ml Capture-CMV Total (IgG / IgM Reflex) – CMV (excluding the red cell IgG and CMV IgM are performed on reactive samples volume)

Capture-CMV Total (IgM Reflex) – CMV IgM is Storage Instructions: • 1-10ºC for 7 days (Serum, EDTA, ACD, CPD) performed on reactive samples • 1-10ºC for 42 days as whole blood (CPDA-1, CP2D) • ≤ -20ºC after 7 days (specimens should be removed from the clot or red blood cells prior to freezing) Capture-CMV Total (No Reflex) – No further testing is performed • Avoid repeat Freeze/Thaw cycles

Manufacturer: Shipping Requirements: Samples should be shipped within the storage specifications. Immucor Days Set Up: Monday thru Saturday Methodology: Immucor Capture-CMV – solid phase – automated CPT Code: 86644

Cytomegalovirus IgM Antibody Specimen Requirements: • Serum (Anti-CMV IgM) Specimen Volume: 0.5 ml (excluding the red cell Test Code: volume)

CMV IgM EIA Storage Instructions: The serum should be removed from the clot. • 2-8ºC for 48 hours Manufacturer: • ≤ -20ºC after 48 hours BioRad • Avoid multiple Freeze/Thaw cycles

Methodology: Shipping Requirements: Samples should be shipped within the storage specifications. EIA Days Set Up: Monday, Wednesday, Friday

CPT Code: 86645

Memorial Blood Centers Testing

Donor Testing Laboratory Viral Screening, Red Cell Typing, Nucleic Acid Testing

Hepatitis B Virus Hepatitis B Virus Surface Specimen Requirements: • Serum Antigen (HBsAg) • Plasma (EDTA, sodium & lithium heparin, sodium citrate, CPDA-1 and ACD anticoagulants) Test Code: • Cadaveric serum specimen HBsAg (Neutralization performed on Reactive Specimen Volume: 3 ml samples for confirmation) Storage Instructions: • 2–8º C for 7 days Methodology: • ≤ -20º C after 7 days BioRad – EIA Screening • 5 Freeze/Thaw cycles

Shipping Requirements: Ship at ambient temperature (up to 37º C) or refrigerated (2–8º C) for up to 7 days, and upon arrival should be stored at 2–8º C. For transit times greater than 7 days, the specimens should be kept frozen (≤ -20º C).

Days Set Up: Monday through Saturday

CPT Code: 87340

Hepatitis B Virus Surface Specimen Requirements: • Serum Antigen Neutralization • Plasma (EDTA, sodium & lithium heparin, sodium citrate, CPDA-1 (HBsAg Neutralization) and ACD anticoagulants) • Cadaveric serum specimen Test Code: HBsAg Neutralization Specimen Volume: 2 ml

Methodology: Storage Instructions: • 2–8º C for 7 days BioRad – EIA • ≤ -20º C after 7 days • 5 Freeze/Thaw cycles

Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37º C) or refrigerated (2–8º C) for up to 7 days, and upon arrival should be stored at 2–8º C. For transit times greater than 7 days, the specimens should be kept frozen (≤ -20º C).

Days Set Up: Tuesday, Thursday and Friday

CPT Code: 87341

Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 31 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Hepatitis B Virus continued Antibody to Hepatitis B Virus Specimen Requirements: • Serum Surface Antigen Quantitation • Plasma (EDTA or heparin) (Anti-HBs) • Do not use hemolyzed or heat-inactivated specimens

100 μl Sent to ViroMed for Testing Specimen Volume:

Test Code: Anti-HBs Storage Instructions: • Room Temp for 2 days • 2–8º C for 3 days Methodology: Immulite 2000 — • ≤ -20° C after 3 days Chemiluminescent EIA • Multiple Freeze/Thaw cycles not recommended

Shipping Requirements: Shipping conditions not specified

Days Set Up: Monday through Friday

CPT Code: 86317

Antibody to Hepatitis B Specimen Requirements: • Serum Core Antigen, Total • Plasma (EDTA, heparin or citrate-based anticoagulants) (Anti-HBc Total) Specimen Volume: 600 μl Test Code: Anti-HBc Total Storage Instructions: • 2–8º C for 7 days Methodology: Ortho Clinical • ≤ -20º C after 7 days Diagnostics — EIA Screening • 5 Freeze/Thaw cycles Detects IgG and IgM antibodies. Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37º C) No additional testing required for or refrigerated (2–8º C) for up to six days, and upon arrival should confirmation of a Reactive sample. be stored at 2–8º C. For transit times greater than six days, the specimens should be kept frozen (≤ -20º C). Days Set Up: Monday through Saturday

CPT Code: 86704

Hepatitis B Virus e (envelope) Specimen Requirements: Serum — non hemolyzed Antigen (HBeAg) Specimen Volume: 1 ml Test Code: HBeAg Storage Instructions: • 2–8º C for 48 hours Methodology: Diasorin — EIA • ≤ -20º C after 48 hours • 1 Freeze/Thaw cycle

Shipping Requirements: Samples should be shipped on wet or dry ice depending on previously stated storage requirements.

Days Set Up: Monday

CPT Code: 87350

Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 32 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Hepatitis B Virus continued Antibody to Hepatitis B Specimen Requirements: Serum — non hemolyzed virus e Antigen (Anti-HBe) Specimen Volume: 600 μl

Test Code: Anti-HBe Storage Instructions: • 2–8º C for 48 hours • ≤ -20º C after 48 hours Methodology: Diasorin — EIA • 1 Freeze/Thaw cycle

Shipping Requirements: Samples should be shipped on wet or dry ice depending on previously stated storage requirements.

Days Set Up: Monday

CPT Code: 86707

Hepatitis C Virus Antibody to Hepatitis C Virus Specimen Requirements: • Serum (Anti-HCV) • Plasma (EDTA, heparin or citrate-based anticoagulants)

Test Code: Anti-HCV Specimen Volume: 700 μl — Anti-HCV (RIBA performed on Reactive samples for 600 μl — Anti-HCV — No Reflex confirmation) or Storage Instructions: • 2–8º C for 7 days Anti-HCV — No Reflex • ≤ -20º C after 7 days (No RIBA is performed if sample is • 5 Freeze/Thaw cycles Reactive) Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37º C) Methodology: Ortho Clinical or refrigerated (2–8º C) for up to six days, and upon arrival should Diagnostics — EIA Screening be stored at 2–8º C. For transit times greater than six days, the specimens should be kept frozen (≤ -20º C). Days Set Up: Monday through Saturday

CPT Code: 86803 — Anti-HCV 86803 — Anti-HCV — No Reflex Recombinant Immunoblot Specimen Requirements: • Serum Assay (RIBA) for Antibody to • Plasma (K3EDTA, sodium heparin, ACD, CPDA-1, or 4% sodium Hepatitis C Virus (RIBA) citrate)

Test Code: RIBA Specimen Volume: 500 μl

Methodology: Chiron — SIA — v. 3.0 Storage Instructions: • 2–8º C for 7 days • ≤ -20º C after 7 days • Avoid multiple Freeze/Thaw cycles

Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37º C) or refrigerated (2–8º C) for up to seven days, and upon arrival should be stored at 2–8º C. For transit times greater than seven days, the specimens should be kept frozen (≤ -20º C).

Days Set Up: Tuesday, Thursday

CPT Code: 86804

Human Immunodeficiency Virus (HIV)

Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 33 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Human Immunodeficiency Virus (HIV) continued BioRad Antibody to Human Specimen Requirements: • Serum Immunodeficiency Virus • Plasma (EDTA, heparin, sodium citrate, CPDA-1, and ACD) Type 1 rLAV EIA (Anti-HIV-1) Specimen Volume: 600 μl

Test Code: Anti-HIV-1 Storage Instructions: • 2–8º C for 7 days (Western Blot performed on Reactive • ≤ -20º C after 7 days samples for confirmation) • 5 Freeze/Thaw cycles

Methodology: BioRad — EIA — viral Shipping Requirements: Specimens may be shipped refrigerated (2–8º C) or at ambient lysate and E. coli recombinant antigen temperature for up to 7 days. For shipments that are in transit for more than 7 days, specimens should be kept frozen (≤ ).-20º C Days Set Up: Wednesday

CPT Code: 86701

Antibody to Human Specimen Requirements: • Serum (Cadaveric serum is also acceptable) Immunodeficiency Viruses • Plasma (EDTA, sodium & lithium heparin, sodium citrate, CPD, Type 1 and 2 plus O CPDA-1, and ACD) (Anti-HIV-1/2 + O) Specimen Volume: 1 ml Test Code: Anti-HIV-1,2 (Western Blot performed on Reactive Storage Instructions: • 2–8º C for 7 days samples for confirmation) • ≤ -20º C after 7 days • 5 Freeze/Thaw cycles Methodology: BioRad — EIA screening Shipping Requirements: Specimens may be shipped refrigerated (2–8º C) or at ambient temperature for up to 7 days. For shipments that are in transit for more than 7 days, specimens should be kept frozen (≤ -20º C).

Days Set Up: Monday through Saturday

CPT Code: 86703

Antibody to Human Specimen Requirements: • Serum Immunodeficiency Virus • Plasma Type 2 (Anti-HIV-2) Specimen Volume: 600 μl Test Code: Anti-HIV-2 or Storage Instructions: • 2–8º C for 7 days Anti-HIV-2 — Reflex • ≤ -20º C after 7 days • Freeze/Thaw cycles not specified (Sent to ViroMed for an HIV- 2 Immunoblot if sample is Shipping conditions not specified Reactive) Shipping Requirements:

Methodology: BioRad — EIA Days Set Up: Wednesday

CPT Code: 86702 — Anti-HIV-2 86689 — HIV-2 Immunoblot

Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 34 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Human Immunodeficiency Virus (HIV) continued Antibody to Human Specimen Requirements: • Serum Immunodeficiency Virus • Plasma Type 1 Western Blot (HIV-1 Western Blot) Specimen Volume: 500 μl

Test Code: HIV-1 Western Blot Storage Instructions: • 2–8º C for 7 days • ≤ -20º C after 7 days Methodology: BioRad — Western Blot • 5 Freeze/Thaw cycles

Specimens may be shipped refrigerated (2–8º C) or at ambient Note: Sent to Mayo Clinic for Shipping Requirements: temperature for up to 7 days. For shipments that are in transit for HIV-1 IFA testing if the blot is more than 7 days, specimens should be kept frozen (≤ -20º C). unreadable on 2 runs.

Days Set Up: Wednesday and Friday

CPT Code: 86689 — HIV-1 WB 86689 — HIV-1 IFA

Antibody to Human Immunodeficiency Virus Type 1 Immuno Fluorscence Assay (HIV-1 IFA) — See HIV-1 Western Blot Antibody to Human Immunodeficiency Virus Type 2 Immunoblot (Anti-HIV-2 Immunoblot) — See Anti-HIV-2

Human T-Lymphotropic Virus (HTLV) Antibody to Human Specimen Requirements: • Serum T-Lymphotropic Virus Type I • Plasma (EDTA, potassium oxalate, ACD, heparin, citrate, and II (Anti-HTLV I/II) CPD or CPDA-1 anticoagulants)

Test Code: Anti-HTLV I/II or Anti-HTLV I/II — EIA Reflex 500 μl (Sent to LifeSource for Specimen Volume: confirmation testing by Abbott • 2–8º C for 14 days EIA if sample is Reactive.) Storage Instructions: or • ≤ -20º C after 14 days Anti-HTLV I/II — Donor Reflex • 6 Freeze/Thaw cycle (Sent to ViroMed for HTLV Specimens may be shipped ambient, refrigerated (2–8º C), or frozen Immunoblot if sample is Shipping Requirements: (≤ -20º C). Reactive.)

Methodology: Abbott Prism Days Set Up: Monday through Saturday chemiluminescent assay (CHLIA) CPT Code: 86687/86688 — HTLV EIA Screen 86687/86688 — Alternate EIA Method Confirmation 86689 — HTLV I/II Immunoblot

Antibody to Human T-Lymphotropic Virus Type I and II Immunoblot (Anti-HTLV-I/II Immunoblot) — See Anti-HTLV I/II

Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 35 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Trypanosoma cruzi (T.cruzi) Antibody to Trypanosoma Specimen Requirements: • Serum cruzi (Anti-T.cruzi) • Plasma (EDTA, lithium heparin, CPD, CP2D, CPDA-1, ACD or 4% citrate anticoagulants) Test Code: Anti-T.cruzi Specimen Volume: 600 μl Sent to Quest for RIPA if • 2–8º C for 10 days sample is Reactive Storage Instructions: • ≤ -20º C after 10 days Methodology: Ortho — EIA Screening • 5 Freeze/Thaw cycles

Shipping Requirements: Specimens may be shipped ambient, refrigerated (2–8º C), or frozen (≤ -20º C).

Days Set Up: Monday through Saturday

CPT Code: 86753 — T.cruzi EIA Screen 86753 — RIPA Confirmation

T.cruzi Specimen Requirements: • Serum — Preferred Radioimmunoprecipitation • Plasma (EDTA) — Acceptable Assay (RIPA) Specimen Volume: 1 mL (minimum 500 µl) Se nt to Quest Diagnostics for • 2–8º C for 10 days testing Storage Instructions: • ≤ -20º C after 10 days (up to 6 months) Set up Monday & Thursday • Freeze/Thaw cycles not specified morning Results in 12+ days Shipping Requirements: Aliquot in a clean screw top vial. Specimens may be shipped Methodology: refrigerated (2–8º C) or frozen (≤ -20º C). Radioimmunoprecipitation CPT Code: 86753 — RIPA Confirmation

Serologic Test for Syphilis (STS) Macro-Vue RPR Card Test for Specimen Requirements: • Serum detection of Syphilis (Syphilis • Plasma (EDTA, heparin, potassium oxalate, potassium sequestrene RPR) or sodium fluoride (if testing samples <24 hours old) Test Code: Syphilis RPR Specimen Volume: 1.5 ml

Sent to ViroMed for confirmation Storage Instructions: • 2–8º C in original collecting tube by FTA-ABS if Reactive • ≤ -20º C • Freeze/Thaw cycles not specified Methodology: Latex Agglutination Shipping Requirements: Shipping conditions not specified

Days Set Up: Monday through Saturday

CPT Code: 86592 — STS 86781 — FTA-ABS

Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 36 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Serologic Test for Syphilis (STS) Olympus PK Treponema Specimen Requirements: • Plasma (EDTA) Pallidum System for • Serum detection of Syphilis (Syphilis TP) Specimen Volume: 1.5 ml

Test Code: Syphilis TP Storage Instructions: • 2–8º C — up to 5 days • ≤ -20º C after 5 days • Avoid repeat Freeze/Thaw cycles Sent to ViroMed for confirmation by FTA-ABS if Reactive Shipping Requirements: Shipping conditions not specified. Methodology: Microhemagglutination Days Set Up: Monday through Saturday

CPT Code: 86592 — STS 86781 — FTA-ABS

Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 37 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Nucleic Acid Testing (NAT) COBAS AmpliScreen HIV-1 Specimen Requirements: Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and and HCV Test (HIV/HCV PCR) 4% sodium citrate).

This test is for the eligibility determination * EDTA is the recommended specimen, the other of donors of blood and blood components anticoagulants have more stringent storage and human cells, tissues and cellular requirements that are difficult to comply with when tissue based products (HCT/Ps). shipping specimens for testing.

This test is not intended to be used for Specimen Volume: 1 full 7 ml EDTA plasma tube routine clinical or diagnostic evaluation. Storage Instructions: EDTA only Test Code: HIV/HCV PCR • 2–8º C for 5 days • 2–8º C for days 6–12 if separated from cells Methodology: Roche RNA Polymerase • ≤ -18º C for days 15–30 Chain Reaction • 3 Freeze/Thaw cycles

Shipping Requirements: Specimens may be shipped refrigerated (2-8ºC) or at ambient temperature for up to 3 days. Specimens over 5 days old cannot be tested unless they were centrifuged at 800–1600 × g for 20 minutes and removed from the cells. False positive results can occur from cross contamination if samples are not handled under a hood.

Days Set Up: Monday through Saturday

CPT Code: HIV PCR — 87535 HCV PCR — 87521

COBAS AmpliScreen HBV Test Specimen Requirements: Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and (HBV PCR) 4% Sodium Citrate).

This test is not intended to be used for Specimen Volume: 1 full 7 ml EDTA plasma tube routine clinical or diagnostic evaluation. Storage Instructions: EDTA only Test Code: HBV PCR • 2–8º C for 5 days • 2–8º C for days 6–12 if separated from cells Methodology: Roche DNA Polymerase • ≤ -18º C for days 15–30 Chain Reaction • 3 Freeze/Thaw cycles

Shipping Requirements: Specimens may be shipped refrigerated (2–8º C) or at ambient temperature for up to 3 days. Specimens over 5 days old cannot be tested unless they were centrifuged at 800–1600 × g for 20 minutes and removed from the cells. False positive results can occur from cross contamination if samples are not handled under a hood.

Days Set Up: Monday through Saturday

CPT Code: 87516

Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 38 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Nucleic Acid Testing (NAT) continued COBAS Taqscreen WNV Test Specimen Requirements: Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and (WNV PCR) 4% Sodium Citrate).

This test is for the eligibility determination * EDTA is the recommended specimen, the other of donors of blood and blood anticoagulants have more stringent storage components. requirements that are difficult to comply with when shipping specimens for testing. This test is not intended to be used for routine clinical or diagnostic evaluation. Specimen Volume: 1 full 7 ml EDTA plasma tube

Test Code: WNV PCR Storage Instructions: EDTA only • 2–8º C for 5 days Methodology: Roche RNA Polymerase • 2–8º C for days 6–12 if separated from cells Chain Reaction • ≤ -18º C for days 15–30 • 3 Freeze/Thaw cycles

Shipping Requirements: Specimens may be shipped refrigerated (2–8º C) or at ambient temperature for up to 3 days. Specimens over 5 days old can not be tested unless they were centrifuged at 800–1600 × g for 20 minutes and removed from the cells. False positive results can occur from cross contamination if samples are not handled under a hood.

Days Set Up: Monday through Saturday

CPT Code: 87798

Physician Services and Reporting Adverse Quality and Regulatory Affairs Outcomes of Transfusion

Memorial Blood Centers’ Physicians and Quality and Transfusion Services are required to have a Regulatory Affairs staff are available to answer any mechanism in place to document and track adverse questions related to quality, regulations or transfusion events related or potentially related to transfusion. medicine in general. Our highly trained staff includes The Serious Outcome of Transfusion (SOOT) Report physicians, specialists in blood banking, and medical and Suspected Transfusion Transmitted Disease technologists. Several of Memorial Blood Centers staff (TTD) Report are used to report these adverse events serve on committees, as board members or as assessors to Memorial Blood Centers. Both forms are available for professional organizations such as AABB, America’s through Memorial Blood Centers’ physicians or their Blood Centers (ABC), Foundation for the Accreditation designees in Physician Services. Current examples of Cellular Therapy (FACT), and National Marrow of both forms are located on pages 43 and 44 of this Donor Program (NMDP). A physician is available for chapter. Forms can also be found on MBC.ORG/ consultation at all times and may be contacted through Products-and-Testing-Services under Related Forms Hospital Services during non-business hours. & Docs.

Information on Memorial Blood Centers’ licensing Initial notification of a patient/recipient fatality and accreditations are available at MBC.ORG/About- should be reported to the FDA as soon as possible by Us/Accreditations. the facility that performed the compatibility tests. A written report of the investigation shall be submitted Quarantine, Market Withdrawal, to the FDA within seven days after the fatality. Please Recall, Inventory Lookback see FDA Guidance for Industry on pages 48-54. and Recipient Notification Immediate notification of the physician on call at Memorial Blood Centers allows review of records and supplies related to donor suitability, collection, Occasionally Memorial Blood Centers will request processing, storage and distribution of the that you quarantine an in-date blood component if components. it is still in your inventory. You will be notified by phone and by fax of any in-date components that need to be quarantined. If the component has already been transfused, you will receive a letter if recipient notification or tracing is necessary.

It may be necessary for Memorial Blood Centers to request the return of a unit of blood and/or blood component that was issued to your facility. When the safety, quality, purity, potency or identity of a component may be affected, a market withdrawal or recall letter will be sent directly to the physician in charge of your Transfusion Service, indicating the reason for the market withdrawal or recall.

If you are notified of a market withdrawal or recall, it is imperative that you: 1. Immediately quarantine any in-date components in inventory at your facility. 2. Complete necessary documentation and return to Memorial Blood Centers as requested so we can: • Verify that your facility received notification; • Verify that your facility received the component involved; • Complete final disposition records as required by FDA. Rev. June 2015 Quality Assurance • Page 41 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Communications

Customer Service Reports: Memorial Blood Centers strives to provide excellent time a problem is identified or when excellent or poor customer service to each of our customers. We service is provided to your facility. Please include are continuously seeking new ideas for ways to as much detail as possible so that we can follow-up improve or expand the services we provide. We appropriately. need your assistance to identify the areas where we need improvement as well as the areas where Every CSR is reviewed by the responsible department we are meeting or exceeding your expectations. To manager to determine appropriate action. These gather your feedback, Memorial Blood Centers has events are tracked by the Quality and Regulatory provided your facility with a supply of Customer Affairs department to identify opportunities for Service Reports (CSR). Please complete a CSR any continuous process improvement.

Memorial Blood Centers performs quality control on components in accordance with the requirements of the AABB and the Food and Drug Administration (FDA). A Blood Component QC Summary will be sent to your facility monthly.

If you have questions about the Blood Component QC Summary, please contact the manager of Component Services at 651-332-7117.

Rev. June 2015 Quality Assurance • Page 43 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Rev. June 2015 Quality Assurance • Page 44 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Reference Laboratory

2. Local/Metro requests for antigen negative units Request for Antibody placed after-hours, 11:00 pm Friday–2:00 am Identification and Red Monday, may be requested by the hospital to be sent out with historical typing. It is the hospital’s Cell Crossmatching responsibility to confirm the antigen type on these units. 1. Request products and testing using Memorial 3. The Reference Lab will confirm antigen typing on Blood Centers Request for Reference Laboratory units during after-hours if requested by a hospital Testing Form (sample on page 47). Form may be to do so. An after-hours service fee will be charged found on MBC’s website at www.mbc.org. to the hospital for this service.

2. Form MUST have patient identification information, hospital name, the test requested and Antibodies in Donors the date and time needed. Specimen requirements are on the reverse side of the form. When antibodies are detected in autologous donors, the hospital will receive a report stating specificity. 3. Samples must meet AABB labeling requirements. The hospital will be charged for the cost of the red cell Samples for crossmatching MUST have patient’s panels performed on autologous donors. If a hospital first and last name, identification number, draw prefers to perform the antibody identification, policy date, and identity of phlebotomist. must be established prior to donation.

4. Please send copies of any red cell panel results and any other information to aid in testing, i.e. list of Platelet Crossmatching medications, historical test results, etc. Platelet crossmatching and HLA matched platelets 5. Antibody identification is routinely performed may be beneficial to refractory alloimmunized using polyethylene glycol (PEG) as an patients with documented lack of response to pooled enhancement media. If an institution indicates a random donor platelets and/or apheresis platelets. method of testing, we will do the first red cell panel in the same media if available and time permits. 1. Request products and testing using Memorial Blood Centers Requests for Reference Laboratory 6. Hospitals will receive verbal reports from the Testing Form (sample on page 47). Form may be technologist upon completion of identification. found on MBC’s website at www.mbc.org. Final reports are usually available 1-2 business days after completion of testing, and are faxed to 2. Form must have patient identification information, the hospital when completed. Preliminary reports hospital name, the test requested and the date and can be faxed upon request if the final report is not time needed. available. 3. Samples must meet AABB labeling requirements. 7. Patient red cell genotyping is available upon Samples must have patient’s first and last name, request using the Memorial Blood Centers Request identification number, draw date, and identity of for Reference Laboratory Testing Form. phlebotomist.

4. Platelet crossmatching is performed at 12:00 Unit Antigen Typing p.m. Monday-Friday. Requests for crossmatched platelets any other time will incur an additional 1. Antigen typing is performed on all antigen STAT charge. negative units requested between 2:00 am Monday through 11:00 pm Friday. Typed units are identified with a white string tag identifying which antigens have been confirmed as negative. STAT and ASAP requests placed after 11:00 pm and before 7:00 am will incur an additional STAT charge.

Rev. June 2015 Reference Laboratory • Page 45 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. HLA Matched Platelets Service Fees 1. Reference Lab has an on-call (AFHRS) and an 1. If patient is refractory to crossmatched patients, overnight (STAT) service charge. The on-call HLA matched platelets may be considered. charge applies to testing performed Friday 11:00 pm through Sunday 11:00 pm, and on holidays. The 2. Patient HLA typing shall be requested using STAT service charge applies to testing that must Memorial Blood Centers Request for Reference be performed after 11:00 pm and before 7:00 am Laboratory Form. Sunday through Thursday. This charge also applies to platelet crossmatching performed any time other 3. Time to procure an HLA matched product for a than 12:00 pm patient will vary based on HLA type. For donors expecting ongoing transfusions, HLA matched 2. Coverage of weekends and holidays is provided by donors will be scheduled as available. an on-call technologist. He or she can be reached by contacting Hospital Services (651-332-7108). 4. If Memorial Blood Centers does not have an adequate match, other blood centers may be 3. Requests for units negative for a high frequency contacted at the hospitals request. All charges antigen or negative for multiple antigens that occur associated with imported products are passed on to in 5-percent or less of the population are assessed the requesting hospital. an additional rare (RARE) or phenotyped unit (PHUN) charge respectively. 5. Family donations may be considered if HLA matches are not available. 4. Charges associated with importing rare blood from other blood centers are passed on to the requesting facility.

5. A Platelet Compatibility Charge is applied the first time a patient is tested and after a period of remission or if no crossmatched platelets are ordered. A platelet crossmatch charge is applied to each unit sent; double platelets are charged a single crossmatch fee.

Request for Lab Phone: ( 651) 332-7125 Reference Laboratory Testing Lab Fax: ( 651) 332-7008

INSTRUCTIONS: Complete information must accompany each specimen. Identify each sample with patient’s first and last name, identifying number and date drawn ( written in ink ). Improperly labeled specimens will not be processed.

Date______When needed (date / time)______Hospital / Lab______City______State, Zip ______Phone ( _____ ) ______Fax ( _____ ) ______

TEST REQUESTED: o Antibody Identification o Platelet Compatibility o ABO and Rh typing o Crossmatch: o DAT and monospecific AHG Number of units requested ______o Elution study o Antigen negative unit ( uncrossmatched ): o ABO, Rh and antibody screening Number of units requested ______o HDN evaluation–Mother and baby o Red blood cells ( RBC ) o Kleihauer-Betke test, type of specimen o Leukocyte-reduced RBC ______o Platelets, Pheresis Reason test ordered ______o Other, specify ______o Other (specify) ______

PATIENT INFORMATION: Patient’s name ______Date of birth ______Sex____ ( Please print ) Last First MI Identifying number ______Date / time sample drawn ______Clinical diagnosis______Medications______

TRANSFUSION HISTORY: o No o Yes, date of last and quantity ______o Unavailable

OBSTETRICAL HISTORY: EDC ______Pregnancy o No o Yes, indicate number and date of last ______Has patient received Rh immune globulin in the past 6 months? o No o Yes, date received ______

HISTORY OF PREVIOUS RED CELL ANTIBODY: o No o Yes, specificity ( ies ) ______

DESCRIPTION OF REQUESTING FACILITY’S RESULTS: Blood type ______DAT ______Auto control ______FMH screen ______Red cell antibody screening (circle phase of reaction, results and method used ) Reaction phase: RT 37C IAT Reaction strength: 1+ 2+ 3+ 4+ micro Request for Method: saline albumin LISS PEG enzyme Gel card Other ______Red cell phenotype: C E c e K M N S s Fy ( a bReference ) Jk ( a Laboratoryb ) Testing Units crossmatched? o Yes, Compatible ______Incompatible ______Quantity Quantity This form should not be used when submitting hepatitis, HIV, HLA typing or parentage samples. FORM-RL-001.12 12-07 Appropriate forms ( 2-sided are available document ) from specific laboratories.

SPECIMEN REQUIREMENTS ______TEST SAMPLE REQUIRED TEST SAMPLE REQUIRED ______ABO and Rh typing 5-10mL clotted blood Elution study 7-10mL EDTA whole blood ______Antibody screen / identification, 10-20mL clotted blood** HDN evaluation Mom: 10mL clotted blood Compatibility testing or EDTA whole blood Baby: 2-5mL cord blood (red cell & platelet*) ______DAT with monospecific AHG 5-7mL EDTA whole blood Kleihauer-Betke test 5mL EDTA whole blood ______NOTE: Gel tubes are unacceptable as they can cause a false positive DAT.

* Platelet crossmatch sample must be submitted within 48 hours of collection.

** If patient has a positive direct antiglobulin test (DAT), include a 7mL EDTA tube. For recently transfused patients, include pretransfusion specimen if available.

All samples referred to Memorial Blood Centers for crossmatching and pretransfusion testing must meet the current Standards of the AABB regarding recipient blood samples. Sender will be notified if a sample is unacceptable;a new sample will be required.

DIRECTIONS FOR SAMPLE TRANSPORT MBC suggests shipping samples at ambient temperature unless temperatures are >82F or <32F. If ambient temperature is >82F, ship samples with coolant. If ambient temperature is <32F, ship samples in insulated container.

STAFFING HOURS The Reference Laboratory is fully staffed from 11:00 P.M. Sunday through 11:00 P.M. Friday. During these hours, contact the lab at (651) 332-7125 or (651) 332-7118. For after-hours requests, call the blood center at (651) 332-7108 and ask for the Reference Lab on-call technologist.

737 Pelham Boulevard • St. Paul, MN 55114 Lab Phone ( 651) 332-7125 Lab Fax ( 651) 332-7008

FORM-RL-001.12 12-07 ( 2-sided document )

Guidance for Industry

Notifying FDA of Fatalities Related to Blood Collection or Transfusion

FINAL GUIDANCE

Additional copies of this guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at http://www.fda.gov/cber/guidelines.htm.

For questions on the content of this guidance contact Lois Simmons at 301-827-6220.

U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research September 2003

Table of Contents

I. PURPOSE...... 1 II. BACKGROUND ...... 1 III. HOW TO NOTIFY FDA……………………………………………………….. 2 IV. INITIAL NOTIFICATION…………………………………………………….. 2 A. Patient/Recipient Fatalities ...... 3 B. Donor Fatalities...... 3 C. Fatalities Associated with Therapeutic Apheresis or Certain Therapeutic Phlebotomies...... 3 V. 7-DAY REPORT...... 3 A. Patient/Recipient Fatalities ...... 4 B. Donor Fatalities...... 4 C. Fatalities Associated with Therapeutic Apheresis or Certain Therapeutic Phlebotomies...... 5 VI. INQUIRIES ...... 5

Guidance for Industry

Notifying FDA of Fatalities Related to Blood Collection or Transfusion

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

I. PURPOSE

This document’s goal is to help you, a blood collection or transfusion facility, report fatalities related to blood and blood component (blood) collection or transfusion to us, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title dated June 2002.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances mean that something is suggested or recommended, but not required.

II. BACKGROUND

The current good manufacturing practice (CGMP) regulations for blood and blood components require that you report fatalities related to blood collection or transfusion to CBER (21 CFR 606.170(b)). Section 606.170(b) states:

When a complication of blood collection or transfusion is confirmed to be fatal, the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, shall be notified by telephone, facsimile, express mail, or electronically transmitted mail as soon as possible; a written report of the investigation shall be submitted to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, within 7 days after the fatality by the collecting facility in the event of a donor reaction, or by the facility that performed the compatibility tests in the event of a transfusion reaction. (Emphasis added)

Standard operating procedures for compatibility testing are required in 21 CFR 606.151 and 606.100(b)(8). Among other things, that regulation requires an establishment to have procedures both for collecting and identifying the blood samples of recipients, and for demonstrating incompatibility between the donor’s cell type and the recipient’s serum or plasma type. CBER is aware that some blood banks and transfusion services may enter into contracts with blood centers or other blood banks or clinical laboratories to perform testing on blood samples. If this is how your facility operates, the responsibility for compatibility testing is shared between the blood bank or transfusion service that collects and identifies the blood sample of the recipient, and the blood center or other blood bank or clinical laboratory that uses procedures to demonstrate incompatibility between the donated blood product and the recipient. If a transfusion-related fatality occurs, both the transfusing facility and the blood center or bank that performed the testing under contract would be responsible for reporting the death to CBER. Under these circumstances, the two facilities may make a joint report under § 606.170(b).

III. HOW TO NOTIFY FDA

Section 606.170(b) states that you may report a fatality by telephone, facsimile, express mail, or electronically transmitted mail (e-mail). We recommend that you submit the initial notification by e-mail, if possible, and if you do so, you will receive an e-mail confirmation receipt from us. If e-mail is not feasible, please notify us by telephone or facsimile. We cannot access notification outside of customary working hours unless you use e-mail or telephone. Similarly, we recommend that you submit 7-day follow up reports by e-mail, facsimile, or express mail.

• E-mail: [email protected] • Telephone/voice-mail number: 301-827-6220 • Fax number: 301-827-6748, Attn: CBER Fatality Program Manager • Express mail address: Office of Compliance and Biologics Quality/CBER Attn: Fatality Program Manager (HFM-650) 1401 Rockville Pike, Suite 200N Rockville, MD 20852-1448

IV. INITIAL NOTIFICATION

There is no required FDA form or format for notifying us of fatalities related to blood transfusion or blood collection. We recommend that you provide at least the following information so we can evaluate the potential public health significance of the event. • Date and time of the notification. • Your name, title, telephone number with area code, and fax number (if available). • Your facility's name, mailing address, and FDA registration number (if applicable). NOTE: Transfusion services that do not routinely collect or process blood or blood components are not required to register with FDA and, therefore, do not usually have a registration number.

• Age and sex of the deceased. • Date, time, and cause or suspected cause of death (briefly describe what happened). • If an autopsy was or will be performed. • Name and address of facility where the fatality occurred if different from your facility. • Please also include in the initial notification the information listed in A, B, or C below, as appropriate:

A. Patient/Recipient Fatality - Transfusion date(s), - Blood/blood component(s) and unit number(s) of product(s) that may be implicated, - Name and address of facility(ies) providing the blood, and - Brief description of events that led to the fatality – include underlying medical condition or disease and circumstances necessitating this hospitalization, reason for transfusion, how the patient initially responded to the transfusion, any medical intervention taken or response to the reaction, and time from initiating the transfusion to patient’s death.

B. Donor Fatality - Collection date, - What product was collected or attempted to be collected, - Whether this was a manual or automated collection, - If automated, the name and model of collection device and device manufacturer, and - Brief description of events that led to the fatality – include an overview of the donor’s previous donations/health history, approximate frequency of donation, any unusual events that occurred during this or any previous donation by the donor, any medical intervention taken or response to the reaction, and time from initiating the blood collection to donor’s death.

C. Fatality Associated with Therapeutic Apheresis or Certain Therapeutic Phlebotomies - Date of therapeutic apheresis (e.g., therapeutic plasma exchange) or therapeutic phlebotomy, NOTE: A report is required for a therapeutic apheresis fatality only if blood products (e.g., plasma, albumin), rather than products such as crystalloids or hydroxyethyl starch, were given as part of the procedure. A report is required for a therapeutic phlebotomy fatality only if a blood product was collected for manufacture into transfusable biologics. - Whether product was collected, and the product’s disposition, - Whether this was a manual or automated collection (if automated, include manufacturer, name, and model of collection device), - If any blood product(s) was transfused, identify the product and the unit or lot number(s), and - Brief description of events that led to the fatality – include underlying medical condition or disease and circumstances necessitating the therapeutic apheresis or

therapeutic phlebotomy, any medical intervention or response to the reaction, and time from initiating the procedure to patient’s death.

V. 7-DAY REPORT

You must submit a written report of the fatality investigation to CBER within 7 days after the fatality (§ 606.170(b)). We recommend that you identify this report as a follow-up on a fatality notification previously reported to CBER and include the initial notification date. We also recommend that this 7-day report provide any new findings or information relevant to the fatality that have become available since the initial notification, including your follow-up investigation and conclusions.

Section 606.170(a) requires that you conduct a “thorough investigation” of adverse reactions relating to blood collection or transfusion. Section 606.170(b) requires submission of a written report of such investigation within 7 days after an adverse reaction resulting in fatality. We recommend that a “thorough investigation,” and an associated written report for a fatality, include: • Discharge summary and/or death certificate, • Autopsy report (if performed), • Conclusions and follow-up actions (frequently referred to in the blood community as a corrective action plan), if appropriate, and • Either A, B, or C listed below, as appropriate.

We understand that, due to the complexity of some fatality investigations, some of this information may not be available when you submit your 7-day report. In that event, you may amend your 7-day report by filing additional information as it becomes available.

A. Patient/Recipient Fatality - Complete transfusion reaction report, including the manufacturer and lot number of the blood collection system and results of the clerical, serological, and visual re-checks performed. - Additional relevant documents, include hematology reports; clinical chemistry reports for cardiac and/or liver enzymes, albumin, and bilirubin; viral marker tests; microbiology reports; reports of anti-HLA and/or anti-neutrophil antibody testing; tryptase levels; radiology reports; and physicians’ consults/opinions. - If replacement fluid(s) was given during the transfusion, indicate which fluid(s) and the unit or lot number(s), and include any other relevant information, manufacturer’s notices, contamination warnings, or replacement fluid recalls. - If responsibility for the fatality appears to be outside the blood bank, the nurses’ and/or physicians’ notes on the patient, radiology reports, and physicians’ consults/opinions. - Results of lookback investigation, including follow-up testing on implicated donor(s) when the fatality was the result of transfusion transmitted infectious disease such as hepatitis or HIV.

- Meeting minutes or report from your transfusion committee when the fatality was reviewed and discussed. If this incident was reviewed by any other hospital oversight group(s) such as risk management or quality practices, include the report or summary of their findings.

B. Donor Fatality - The deceased’s donor record file that includes the donation just before the fatal incident and information on all donations during the past 2 years. - Lot numbers and expiration dates of collection sets or harnesses; if replacement fluid(s) was given during the collection, indicate which fluid(s) and the unit or lot number(s) and include any other relevant information, such as manufacturer’s notices, contamination warnings, or replacement fluid recalls. - Performance log for the device and any other relevant performance logs, maintenance records, manufacturer’s notices, or recalls on significant machine part(s) on the device/system during the past 2 years. - If the donor was hospitalized due to the reaction, provide any relevant documents, e.g., reports of laboratory tests, which may help determine the cause of the fatality.

C. Fatality Associated with Therapeutic Apheresis or Certain Thera peutic Phlebotomies - A summary of the deceased’s history of previous therapeutic apheresis or therapeutic phlebotomy procedures, including any previous adverse reactions related to the procedures. - Lot numbers and expiration dates of collection sets or harnesses; if replacement fluid(s) was given at any time during the procedure, indicate which fluid(s) and the unit or lot number(s) and include any other relevant information, such as manufacturer’s notices, contamination warnings, or replacement fluid recalls. - A summary of the performance log for the device and any other relevant performance logs, maintenance records, and manufacturer’s notices or recalls on any significant machine part(s) on the device/system during the past 2 years. - If the fatality followed therapeutic plasma exchange (TPE) and Fresh Frozen Plasma (FFP) was the replacement fluid, an abbreviated transfusion reaction work-up to rule out ABO incompatibility, bacterial contamination, anaphylactic reaction, or WBC antibody reaction may be useful.

VI. INQUIRIES

If you have any questions about reporting fatalities, please contact the CBER Fatality Program Manager at 301-827-6220.

June 1, 2013

Memorandum To: Memorial Blood Centers Customers

From: Quality and Regulatory Affairs Department 737 Pelham Boulevard St. Paul, MN 55114

Re: Vendor Qualifications

Memorial Blood Centers is licensed by the Food and Drug Administration (FDA) to manufacture blood and blood components (Establishment License Number 1895) and is regularly inspected by the FDA. Memorial Blood Centers follows the regulations contained in parts 600, 601, 606, 607, 610 and 640 of Title 21 of the Code of Federal Regulations and performs testing according to current Good Manufacturing Practices (cGMPs). Memorial Blood Centers has a quality assurance unit in place, as required by the FDA.

Testing in the Donor Testing Laboratory is performed using FDA-licensed test kits, if such kits are available. Tests are performed and interpreted according to the test-kit manufacturer’s instructions. Donor samples tested for investigational assays are done with prior donor consent and prior approval by an IRB (Institutional Review Board). Testing in the Immunohematology Reference Laboratory is performed using a combination of FDA-licensed reagents and reagents prepared in-house. When FDA-licensed reagents are used, the tests are performed and interpreted according to the manufacturer’s instructions. When reagents are prepared in-house, the FDA requirements for potency, contained in 21 CFR Part 660, are followed. Memorial Blood Centers laboratories are certified by the Centers for Medicare & Medicaid Services (CLIA ID Number 24D0663800).

Memorial Blood Centers is also inspected and accredited by the American Association of Blood Banks (Facility ID Number 6301). Copies of our FDA, AABB, and CLIA certificates are available at MBC.ORG.

If you would like specific information about our quality-control procedures, package inserts for test reagents or Laboratory Medicine SOPs, please do not hesitate to contact QRA at the address above, or by phone at 651-332-7000 or fax at 651-332-7001.

Common Questions & Answers

Why should you choose Amniotic Fluid or Chorionic Villi Sample: If you would like to have testing performed before the Memorial Blood Centers? child is born, your doctor may perform either an Memorial Blood Centers (MBC) is one of the oldest, amniocentesis or a chorionic villi sampling. The most respected names in parentage testing. We are amniocentesis fluid or the chorionic villi sample can committed to providing excellent customer service be used to test with buccal cell samples collected from at affordable prices. We have been accredited by the the mother and alleged father to determine parentage AABB (the national accreditation organization) since prior to birth. Please contact our customer service 1984. A reputation for reliability and a commitment office for fee schedule and more information. to education and research have set us apart from our competitors. Umbilical Cord Collection: If you know before the child is born that you would like testing performed, How can I start testing for please contact our office. We advise at least a two- a parentage dispute? week notice to ensure delivery of the collection kit on time. Many hospitals will comply with this request; Appointments can be scheduled through our however, some may elect not to participate. Please customer service office at: discuss this option with the attending Doctor or (612) 871-6636 or (800) 982-9134 Midwife before delivery. The mother and alleged father(s) should arrange to have samples collected at To schedule an appointment, you must have the our facility or at one of our collection sites. following information: • Names and birth dates of all parties involved in the Buccal Cell Collection: If cord blood is not collected, test. the child may have a buccal cell collection performed. • Approximate place, day and time you would like This procedure involves swabbing the inside of the your appointment to be scheduled. baby’s cheeks with cotton swabs similar to those What type of testing is available? used for throat cultures. Blood samples are no longer required for DNA relationship testing. Paternity: In matters of paternity, specimens are collected from the Mother, Child and Alleged Father(s). It is possible to perform testing without What type of sample is collected the mother. Motherless cases may require additional from the individuals tested? testing time and are assessed a different fee. Buccal Samples: Four swabs are collected by rubbing two swabs on the inside each cheek for approximately Family Studies: Cases to determine maternity 15 seconds. and sibling relationships are also available. We can also perform “family reconstruction” testing if an Do not drink very hot liquid immediately preceding individual is unavailable to be tested. We can do this sample collection. by testing the individual’s available family members. Please contact our customer service office for fee Blood Samples: Blood samples are no longer required schedules and more information. for DNA relationship testing.

Immigration: Immigration paternity, maternity and How long does the collection take? family studies are available. Test results can be sent to U.S. Embassies worldwide or to U.S. Citizenship Completing the forms and collecting the samples and Immigration Services (USCIS) offices in the U.S. takes about 15–30 minutes for the mother and child, Please contact our customer service office for fee and about 15 minutes for the alleged father. You will schedules and more information. need to bring identification (preferably a photo id). A photograph and thumbprint will be taken and a At what age are children able to be tested? consent form must be signed before your samples can be collected. We are able to collect samples from children prior to birth, at birth or after birth for parentage testing.

Is there a difference in accuracy between Will the child and/or mother need to be a blood and buccal swab sample? re-collected if the first man is excluded? In an individual, the DNA is the same whether a In most cases, we would not need additional samples blood sample or a buccal swab sample is collected from either the child or the mother. and will provide identical results after testing. The reliability of DNA testing is based on obtaining DNA Can tests be performed when the parties from nucleated cells, not from a specific source. The involved live in different states or countries? DNA from an individual will be the same regardless of whether it is extracted from blood or buccal cells. Yes. Memorial Blood Center can arrange sample The major difference in the types of sample collection collection nationwide and from many foreign relates to ease of collection, stability of storage and countries. If an individual is having his/her sample ease of use in the lab. Once the DNA has been collected at a facility other than ours, we will send extracted, the testing procedures are the same for all a collection kit to the appropriate hospital or lab. sample types. For individuals living in another country, Memorial Blood Center will send a collection kit to the U.S. Are these tests accurate? Embassy in that country for sample collection. Yes. A standard test will either exclude the man (say If an Alleged Father is deceased can he is not the biological father) or it will say he is paternity testing still be done? more likely to be the father of the tested child with a percentage of at least 99%. Our testing protocol Yes. DNA testing can be performed by either testing will exclude at least 99% of falsely accused males. the deceased individual’s family members or by DNA testing is the best possible means of resolving testing blood or tissue samples taken at the coroner’s parentage issues currently. DNA has been used in office during an autopsy. courts in the U.S. and around the world. Is the accuracy of a DNA test affected How long will it take to get results? by drug use, illness or disease? Maximum turnaround time from the date the last No. DNA testing is not affected by drug use, illness or sample is received is 10 business days. Results cannot disease. DNA testing may be affected if the individual be given over the telephone. Results are mailed to the has blood samples collected and has had either a representative named or to the address given at the transfusion within 90 days of sample collection or if time of sample collection. Changes in representation the individual has had an allogeneic hematopoietic or requests for additional reports must be received in progenitor (HPC) transplant. Buccal swab samples are writing. not affected.

Service Fees Effective January 1, 2008

SERVICES (Relationship Analysis — DNA Testing) FEE Testing Kits No Charge Routine Trios (Mother, Child & Alleged Father) Buccal Cell Sample $450.00 ($150.00/person) Family Studies (Motherless, Fatherless, Grandparents, Siblings, Y-chromosome, etc.) Buccal Cell Sample $225/person Special Testing Umbilical Cord Blood Sample $150.00 (must have sample from Mother) Amniotic Fluid Sample $150.00 (must have sample from Mother) Chorionic Villi Sample (CVS) $150.00 (must have sample from Mother) Products of Conception $340.00 (must have sample from Mother) Blood Sample from a Deceased Person $150.00 (if part of a Routine Trio) Blood Sample from a Deceased Person $225.00 (if part of a Family Study) Tissue Sample from a Deceased Person $340.00 Twin Testing $150.00/person Forensic Studies Consultation required — please call Additional Fees Expediting Test Results (5 business days turnaround) $50.00/person Immigration Shipping Fees (International Fed Ex) $140.00 - $210.00 Expert Witness Court Testimony $250.00/hour plus expenses Deposition Testimony $200.00/hour plus expenses

Please call 612-871-6636 or 800-982-9134 with questions.

Sample collection fees are not included in the price of the testing if collected outside Memorial Blood Centers. Prices are subject to change without notice.

Department of Training and Education Volunteer Opportunities The Training and Education Department is Memorial Blood Centers is a volunteer-rich committed to providing valuable, on-going education community offering a vast array of volunteer for our staff, customers, and the community. Please opportunities with flexible scheduling to meet call Memorial Blood Centers and request the people’s interests and availability. Volunteers at appropriate department to take advantage of the Memorial Blood Centers may deliver blood to following opportunities. hospitals, staff blood drives and donor centers, represent the blood center as Ambassadors, Memorial Blood Centers — Central 651-332-7000 or provide both administrative and special Memorial Blood Centers — Duluth 218-723-8080 event staffing. Volunteers provide excellent customer service, increase Memorial Blood American Association of Blood Banks Centers connections to the community, and help save Memorial Blood Centers money. If you or (AABB) Audioconferences/ someone you know would like to volunteer or American Society for Clinical Pathology learn more about available opportunities, please contact Volunteer Services at 651-332-7228 or (ASCP) Teleconferences [email protected]. Memorial Blood Centers — Central and Duluth subscribe to several AABB audioconferences and Continuing Education ASCP teleconferences throughout the year. Our full-service hospitals are invited to attend at no extra Memorial Blood Centers’ physicians, technologists, charge. Contact Hospital Services in either Central or and educators are available to present on a variety of Duluth to receive notification of upcoming topics or topics. Listed below are several programs currently to reserve a seat. available through Memorial Blood Centers.

Student Rotations Current Topics and Controversies Memorial Blood Centers provides a quality blood in Transfusion Medicine bank rotational experience for students in all fields of Memorial Blood Centers’ physicians are available medicine. These rotations are scheduled on a regular to our constituents to provide continuing education basis. Dependent upon the availability of our staff, we opportunities on a variety of topics, dependent upon reserve the right to combine groups. Please contact current practices and/or concerns. These topics may the Training and Education Department well in include, but are not limited to: Massive Transfusions, advance of an anticipated rotation. You will be asked Age of Blood, International Transfusion Practices, to provide the number of anticipated participants and Pediatric Transfusions, or Transfusion Associated if possible, a range of acceptable dates. Risks. These are offered by prior arrangement only, so please call Training and Education well in advance of Facility Tours your preferred dates. Behind the scene tours of Memorial Blood Centers facilities and laboratories are offered on a regular Reference Laboratory Workshops basis for medical schools, as well as community Memorial Blood Centers’ Reference Laboratory offers groups. School tours are routinely scheduled on an annual workshop experience. Workshops will be the third Tuesday of every month from 9 am to presented by Central to both the Cities’ metropolitan noon. Community groups’ requests are scheduled area and Duluth — Northland hospitals. Topics based on available staffing. Please call the Training will vary and change every year but will be based and Education Department — Central or Hospital on hospital blood banking and interesting cases Services — Duluth to register a group. the reference technologists have encountered from partnering hospitals. The Reference Laboratory will send notification when workshops are scheduled.

Rev. June 2015 Educational Opportunities • Page 59 MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. School Presentations Medical Advisory Council Memorial Blood Centers’ staff members are available Physicians supervising the Transfusion Services at either Central or Duluth to present classroom supported by Memorial Blood Centers are invited to sessions, elementary through college-level, on several participate in meetings to provide input and feedback science-based themes. Educators are encouraged to Memorial Blood Centers on topics related to patient to call Training and Education to schedule these safety and product availability. These meetings will presentations. Memorial Blood Centers’ staff will visit occur once or twice a year and hospitals will be the site and provide all necessary materials. A popular notified when they are scheduled. presentation is “Blood 101.” This session helps young people understand blood components and their uses, helps them see the importance for blood transfusions, and recognize how they can help their communities through donating blood.

“My Blood, Your Blood” This educational program is designed for both elementary and secondary students. A DVD and curriculum are provided that introduce students to the human circulatory system. The program was created for America’s Blood Centers by a national team of scientists, physicians, and educators. It teaches students the importance of our blood and blood donation. Please call the Training and Education Department to request this program.

Technical Advisory Meeting (TAM) Memorial Blood Centers hosts meetings for our customers’ blood bank supervisors or designees. These meetings are sponsored by Central for Twin Cities’ metropolitan area hospitals and by Duluth for Northland affiliates. Northland meetings are all-day events in order to accommodate out-of-town attendees. TAMs are linked, at least twice a year, to an AABB audioconference. Hospitals are encouraged to submit agenda items.

Agenda items may include: • Presentations on current topics in blood banking • Announcements and discussions of upcoming changes at Memorial Blood Centers • Components • Other related services • Quality monitors • Hospital-led, round table discussions If interested but unable to attend, summary notes and handouts are generally available upon request. Please contact Hospital Services — Central or Duluth.

Test Name Test Codes CPT Code Lab Sample Requirements Storage & Shipping Methodology & Reflex Testing TAT Days Set Up Requirements ABO/Rh Typingac MTYPE/TYPE 86900 RL 5-10mL clotted blood (preferred) Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, 24 hours a day, 86901 5-10mL EDTA written report in 5 days.2 7 days a week Absorption3bc ABS 86978 RL 10-20mL clotted blood and 7mL EDTA Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, 24 hours a day, or 14-20mL EDTA whole blood written report in 5 days. 7 days a week Antibody Identificationbcf IDDN/IDDP 86900 RL 10-20mL clotted blood and 7mL EDTA Keep from extreme heat or cold. Hemagglutination tube or Gel card. Sample may require Verbal report in 8 hours, 24 hours a day, 86901 or 14-20mL EDTA whole blood separation techniques. Depending on results, additional written report in 5 days. 7 days a week 86880 methods such as adsorption, elution, titration may be 86870 performed. Antibody Screening bc ABY 86850 RL Serum or Plasma (EDTA, ACD, CPD, CPDA-1, Keep from extreme heat or cold. Hemagglutination tube or Gel card. Verbal report in 8 hours, 24 hours a day, and CP2D) 200 μl minimum volume. written report in 5 days. 7 days a week Antibody screening plus blood typeabc SCR 86900 RL 10ml clotted blood or 5ml EDTA Keep from extreme heat or cold. Hemagglutination tube or Gel card; if positive, antibody Verbal report in 8 hours, 24 hours a day, 86901 identification performed. written report in 5 days. 7 days a week 86850 Crossmatch-Red Cellabc XM 86920 RL 10-20 ml clotted blood and 7ml EDTA Keep from extreme heat or cold. Hemagglutination tube testing; antigen negative units Verbal report in 8 hours, 24 hours a day, 86921 or 14-20ml EDTA whole blood provided for patients with clinically significant antibodies. written report in 5 days. 7 days a week 86922 DAT Battery (Direct Antiglobulin Test)cf DAT 86880 x3 RL 5-7ml EDTA whole blood. Keep from extreme heat or cold. Hemagglutination tube testing using polyspecific, IgG, and Verbal report in 8 hours, 24 hours a day, C3 anti-human globulin. written report in 5 days. 7 days a week Donath-Landsteiner Test D-L 86940 RL Contact Reference Laboratory if ordering this Hemagglutination. Verbal report in 8 hours, 24 hours a day, 86941 test. written report in 5 days. 7 days a week Drug Studybc DRUG 86975 RL Contact Reference Laboratory if ordering this Varies by drug being studied. Verbal report in 8 hours, 24 hours a day, test. written report in 5 days. 7 days a week Elutionbc ELU 86860 RL 7-10 ml EDTA whole blood. Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, 24 hours a day, written report in 5 days. 7 days a week HDN Evaluation, includes: ABO/Rh, DAT on cord blood, (varies) 86900 RL Mom: 10ml clotted blood or EDTA. Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, 24 hours a day, elution on DAT positive cord blood, antibody screening and 86901 written report in 5 days. 7 days a week identification on mother's blood.abc 86880 Baby: 2-5ml EDTA cord blood. 86860 86850 HLA Matched Platelet HLA 99090 RL Contact Reference Laboratory if ordering this NA NA Varies.2 24 hours a day, product. 7 days a week Lectin Panel (Polyagglutination test)d PHEN 86999 RL 5-10mL clotted blood Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, 24 hours a day, or 7mL EDTA whole blood. written report in 5 days. 7 days a week Kleihauer-Betkee KB 85460 RL 5ml EDTA peripheral blood, amniotic fluid, Keep from extreme heat or cold. In-house acid elution method. Verbal report in 8 hours, 24 hours a day, vaginal blood/blood smears written report in 5 days. 7 days a week PLA1 Negative Platelet PLA1 99090 RL Contact Reference Laboratory if ordering this NA NA Varies.2 24 hours a day, product. 7 days a week Platelet Compatibility Panelh PLCT 86022 RL 10 ml clotted blood or EDTA, less then 48 Keep from extreme heat or cold. Solid phase. Verbal report in 8 hours, Monday-Friday hours old. written report in 5 days. 12 p.m. 1 Platelet Crossmatchh PLXM 86022 RL 10 ml clotted blood or EDTA, less then 48 Keep from extreme heat or cold. Solid phase. Verbal report in 8 hours, Monday-Friday hours old. written report in 5 days. 12 p.m. 1 Red Cell Phenotyping (patient antigen typing)ac PHEN 86905 RL 7-10ml EDTA whole blood. Keep from extreme heat or cold. Hemagglutination tube. Depending on results, may require Verbal report in 8 hours, 24 hours a day, cell seperation and/or chemical treatment. written report in 5 days. 7 days a week Rh Extended Phenotypingac RH 86906 RL 7-10ml EDTA whole blood. Keep from extreme heat or cold. Hemagglutination tube. Depending on results, may require Verbal report in 8 hours, 24 hours a day, cell seperation and/or chemical treatment. written report in 5 days. 7 days a week Sickle Cell Test (Hemoglobin S)g SQ 85660 RL 5-10 ml clotted blood EDTA Keep from extreme heat or cold. Solubility Method. Verbal report in 8 hours, 24 hours a day, written report in 5 days. 7 days a week Stroma Absorptionbc SABSS/ 86978 RL 10-20mL clotted blood and 7mL EDTA Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, 24 hours a day, SABST or 14-20mL EDTA whole blood written report in 5 days. 7 days a week

Rev. June 2013 Testing Services • Page 1 MBC.ORG © 2013 Memorial Blood Centers. Confidential and Proprietary. All rights reserved. Test Name Test Codes CPT Code Lab Sample Requirements Storage & Shipping Methodology & Reflex Testing TAT Days Set Up Requirements Titrationbc TITR 86886 RL 10 ml clotted blood or EDTA Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, 24 hours a day, written report in 5 days. 7 days a week Transfusion Reaction Workup (varies) 86078 RL Pre and Post Sample 10-20ml clotted blood Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, 24 hours a day, 86900 and EDTA. written report in 5 days. 7 days a week Includes: ABO/Rh on pre, post and donor sample; DAT on 86901 pre and post; antibody screening and identification on pre and 86880 Segments from implicated donor units post sample, elution on DAT positive samples. Other testing as 86922 indicated.abc 86850 Unit Antigen Screenabc USCR 86902 RL NA NA Hemagglutination tube. As requested.2 24 hours a day, 7 days a week Unit Antigen Typingac AGN 86902 RL NA NA Hemagglutination tube. If unable to type historical antigen As requested.2 24 hours a day, negative, may reflex to unit antigen screening. 7 days a week Unit Screening with Patient Serumbc XSCR RL 10-20 ml clotted blood and 7ml EDTA Keep from extreme heat or cold. Hemagglutination tube or Gel card. Verbal report in 8 hours, 24 hours a day, or 14-20ml EDTA whole blood written report in 5 days. 7 days a week

1 This test only occurs at 12:00 PM, Monday - Friday. Please contact Reference Laboratory for STAT requests, which may incur an additional charge. 2 Ordering a test STAT may reduce turn around time. STAT requests may incur an additional charge. 3 Absorption is a reflex test performed when antibody identification reveals an autoantibody or during absorption elution testing.

Interference with Testing Test Reagents a (antigen, abo) antibodies, reagent cells Recent transfusion, red cells coated with immunoglobulins, polyagglutination, strong cold autoantibodies, and rouleaux may interfere with testing. b (ID, screen, XM,) reagent panels, PEG, LISS, GEL, Alb, High levels of serum globulins, rouleaux, hemolysis, grossly icteric samples, and grossly lipemic samples may interfere with testing. Complement binding antibodies may not be detected using plasma. c (DAT, indirect antigen) IgG C3 PS CC Various drugs and certain disease states may interfere with testing. d (polyagglutination) Lectin panel Bacteremia may interfere with testing. e (K-B) Disease states that cause retention of fetal hemoglobin or other abnormal hemoglobin's may interfere with testing. f (DAT only) Cold antibodies may attach to complement in clotted samples and interfere with testing. g (SQ) Severe anemia, persistence of fetal hemoglobin, polycythemia, multiple myeloma, cryoglobulinemia, and other dysglobulinemia may interfere with testing. h (platelet) ABH antibodies and isoagglutinins may interfere with testing.

Special Collections Frequent (Dedicated) Memorial Blood Centers collects and Directed Collection processes the Special Collections listed in this A collection that is intended for and used section. The process for ordering each type solely by a single identified recipient. of special collection is described below. Ordering: The patient’s physician contacts Autologous Collection a MBC physician to initiate a frequent (dedicated) directed collection. A collection that is intended solely for the donor. • After consulting with a MBC physician, if collection is approved, the ordering physician Ordering: The ordering physician completes and signs Physician Order For Autologous completes and faxes Request for Frequent Blood Donation (Form-DC-032). (Dedicated) Directed Donation (Form-PS-126) to MBC. • Fax or mail a copy of the completed order form to MBC A MBC staff member will contact the donor • Give the original form to the donor/patient to schedule an appointment.

A MBC staff member will contact the donor/patient to schedule an appointment. Therapeutic Collection

Ordering: The patient’s physician completes the Physician’s Order Form for Therapeutic Directed Collection Phlebotomy (Form-DC-025). A collection that is intended for a specific patient, but • Fax the completed order form to MBC may be crossed over for allogeneic transfusion. The • Give the original form to the donor/patient donor must meet all allogeneic donation criteria. The donor/patient must call MBC Ordering: The Request for Directed to schedule an appointment. Donation form is initiated by the ordering physician (Form-DC-078). • Complete all three sections: ◆ Section I – Ordering Physician ◆ Section II – Patient ◆ Sections III – Transfusion Service • Fax the completed form to MBC

The donor must contact MBC to schedule an appointment.

Note: If ABO/Rh identical units only is marked on the order form, only donations that are ABO and Rh identical will be distributed to the transfusion service. If ABO/Rh identical units only is not marked, all compatible collections will be distributed to the transfusion service.