process improvement of cryoprecipitate-ak...oct 07, 2019 · 5. standards for blood banks and...

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The Secrets of Cryoprecipitate: A Blood Banking Process ImprovementBy: Jessie Swanson and Michelle Soland

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Manish J. Gandhi, M.D.Associate Professor of Laboratory Medicine and PathologyDivision of Transfusion Medicine

James R. Stubbs, M.D.Associate Professor of Laboratory Medicine and PathologyChair, Division of Transfusion Medicine

Jessie A. Swanson, M.L.SClinical Laboratory TechnologistComponent Laboratory

Michelle SolandClinical Laboratory TechnologistComponent Laboratory

Transfusion MedicineDepartment of Laboratory Medicine and Pathology Mayo Clinic, Rochester, Minnesota

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Disclosures• None

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Objectives• What is cryoprecipitate?• Product storage/requirements• Indications for use• Dosage • Process improvement

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What is Cryoprecipitate?• Cryoprecipitate (cryo) is cold-insoluble proteins

that precipitates when FFP is thawed.• It is rich in plasma proteins:

• Factor Vlll• Fibrinogen• Factor Xlll• von Willebrand factor• Fibronectin

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How is it Manufactured?Frozen FFP•Same ABO

Thaw•1-6°C

Centrifuge•"heavy" spin

Separate•supernatant from precipitates

Pooling•pre-storage pool

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Thaw•1-6°C




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Thaw•1-6°C




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Thaw•1-6°C




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Thaw•1-6°C




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Thaw•1-6°C




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Thaw•1-6°C




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Product Storage

Storage and Shelf Life of CryoFrozen Thaw

Storage: ≤ -18⁰C Quick thaw: 30-37⁰CShelf life: 1 year Storage: 20-24⁰C

Shelf life: 6 hours

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Product Requirements• FDA regulations: test 4 pools per month• Each pool must contain a minimum of 80

International Units (IU) of Factor VIII and 150 mg of fibrinogen times the number of units in the pool.

• 5-pool: • Factor VIII ≥ 400 IU/pool• Fibrinogen ≥ 750 mg/pool

•

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Indications for Use• Patients that benefit from cryoprecipitate:

• Fibrinogen deficiency• Disseminated Intravascular Coagulation (DIC)• Massive transfusion with bleeding• Inherited disorder of fibrinogen• Uremic bleeding

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Selection and Administration• ABO compatible• Rh incompatible

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Standard Dose• The standard adult dose at Mayo Clinic

Rochester is 10 units, 2 pools• External blood suppliers provide blood products

to other Mayo campuses• They produce pools of 5 units at higher dosages• Allowing other Mayo sites to drop their standard

adult dose, from 10 to 5 units

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Standard Dose• Benchmark with other Mayo sites and

implement a method that produces higher fibrinogen levels

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Case Study• Middle aged man underwent a redo aorta operation• Required a long cardiopulmonary bypass run and

cooling to 18⁰C• Patient started to bleed a lot

• New graft caused fibrinogen depletion significantly

• Received 40 units of cryo

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Process Improvement

Thawing

Even thawing “Desired consistency” Time Manipulation

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Process Improvement

Thawing


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Process Improvement

Thawing


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Process Improvement

Centrifuge

Time RPM Brake

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Process Improvement

Centrifuge

Time RPM Brake

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Process Improvement

Separation

Raised shelf Coolants Single cryoweight

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Process Improvement

Separation


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Process Improvement

Separation


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Process Improvement

Pooling

Scraper No rinse Reduce heat transfer

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Implementation• Validated a process that had an average of ≥

1,450 mg/unit of fibrinogen• Implemented new process 11/5/18

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Implementation

Regulatory Requirements

AveragePre-Intervention

Results

AveragePost-Intervention

Results

GoalValues

Factor VIII (IU/pool) ≥ 400 823 782* NA

Fibrinogen (mg/pool) ≥ 750 1389 1574* ≥ 1450

*As of 6/3/19

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Process Improvement Conclusion• Help standardize the cryoprecipitate dosage

and benefit the patient, as the needs of the patient come first.

• Reduce donor exposure, increase inventory, and potentially cost saving for patients

• With continual monitoring and potential improvements the dosage change will become effective.

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Summary• Cryoprecipitate• Storage

• Frozen• Thawed

• Indications• Standard Dose• Process Improvement

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References1. McCullough, J: Transfusion medicine. Third edition. West Sussex, UK: John Wiley & Sons, Ltd. 2012.2. Menitove J., Spero J, Richards W, et al: Pre-pooled cryoprecipitate for treatment of hemophilia A. Transfusion 1983

May-Jun;23(3):265-7.3. Shaz B, Hiller C: Transfusion medicine and hemostasis: clinical and laboratory aspects. Second edition. San Diego,

CA, Elsevier Science, 2013.4. Slichter S, Counts B, Henderson R, Harker L: Preparation of cryoprecipitated factor VIII concentrates. Transfusion

16:616-626, 1976.5. Standards for Blood Banks and Transfusion Services. Thirty-first edition. Bethesda, MD: American Association of Blood

Banks, 2018.6. Taswell H, Saeed S, Committee on Quality Control: Principles and practices of quality control in the blood bank.

American Association of Blood Banks, 1980. 7. Technical Manual. Nineteenth edition. American Association of Blood Banks, 2017.8. United States, Office of Federal Register: Code of federal regulations, title 21, parts 600 to 799 food and drug.

Washington: Office of the Federal Register, National Archives and Records Administration. 2017.

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