Healthcare ASCT Form

HEALTHCARE ASCT INFORMED CONSENT AND AUTHORIZATION

Facility Name:    Treating Physician:

Patient Information

Date of Birth:    Gender:

Phone:    Email:

Emergency Contact

Relationship:    Phone:

Insurance Information

Policy Number:    Group Number:

Medical History

Procedure and Purpose

Procedure: Autologous Stem Cell Collection, Processing, Cryopreservation and Reinfusion (ASCT). Expected procedure date: .

Diagnosis/Indication for ASCT:

Description: I understand that autologous stem cell transplantation involves collection of my own hematopoietic stem cells, processing and storage, administration of conditioning therapy as indicated, and subsequent infusion of my stored cells. Collection may require apheresis and venous access; processing may include manipulation, cryopreservation, and testing for viability and infectious agents.

Risks, Benefits, and Alternatives

I acknowledge that my treating physician has explained the potential benefits, known risks, and reasonable alternatives. Benefits may include disease control or remission. Known risks include, but are not limited to: infection, bleeding, organ dysfunction, transfusion reactions, failure of engraftment, delayed recovery of blood counts, allergic reactions to cryoprotectants, and death. The apheresis procedure may cause transient hypotension, citrate reactions, and need for central venous access.

Alternatives include alternative medical therapy, clinical trial enrollment, or palliative care as appropriate. I have had the opportunity to ask questions and those questions were answered to my satisfaction.

I understand the risks and benefits described above and have had the opportunity to discuss them with my physician.

Collection, Processing, Storage, and Use of Cells

I authorize collection of my hematopoietic stem cells for the purpose described. I authorize processing, testing, labeling, cryopreservation, storage and release of my cells for reinfusion by the treating team or designees. I understand that processing may render cells unusable and that thawed cells may have reduced viability.

I understand cells may be retained for testing related to safety, sterility, identity, and potency. I authorize the facility to dispose of remaining biologic material in accordance with facility policy if it is no longer clinically indicated or if storage term expires.

I consent to long-term storage of my cells beyond the immediate therapeutic period until the expiration date below or until revoked in writing.

Authorization expiration date for storage:

I consent to use of de-identified samples or data derived from my cells for future research. I understand that consenting to research use is voluntary and will not affect my care.

Blood Transfusion, Anesthesia and Emergency Care

I authorize administration of blood products, sedation, or general anesthesia as deemed necessary by my treating physicians. I authorize emergency treatment and transfer to higher-level care if required to treat complications of the procedure.

I consent to receive blood products if clinically indicated.

Withdrawal of Consent and Limitations

I understand I may withdraw this authorization in writing at any time prior to collection or processing. Withdrawal after irreversible processing or after reinfusion may not be possible. I understand withdrawal does not affect actions already taken in reliance upon this consent.

HIPAA and Privacy Authorization

I authorize the facility and my treating physicians to use and disclose protected health information as necessary for treatment, payment, operations, storage, testing, and applicable research activities consistent with applicable law. I acknowledge receipt of the facility's privacy practices and understand my rights to privacy as described.

I acknowledge that I have received and reviewed the facility privacy practices regarding the use and disclosure of my health information.

Financial Responsibility

I understand that some or all components of collection, processing, storage, and reinfusion may not be covered by my insurer. I accept financial responsibility for charges not covered by insurance, except where prohibited by law or contract.

Certifications and Signatures

By signing below, I certify that I am the patient (or authorized representative) and that I have read, or had read to me, the information on this form. I understand the nature, risks, benefits, and alternatives to the proposed procedures and voluntarily consent to the actions described. I authorize release of medical information as necessary for treatment, payment and facility operations.

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