CP-HEM-A303 Lymphoma Leukemia Panel Selection (HEM)__uncontrolled_copy.pdf

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W81K00-22-Q-0109 - Solicitation Amendment 0001 – Cost-Per-Test- Flow Cytometry Testing: Reagents and Instrumentation
Solicitation number
832022
Issued by

About this file

This solicitation amendment extends the closing date for solicitation number 832022 to August 3, 2022. The purpose of the amendment is to incorporate a revised statement of work, include answers to questions received, and attach additional documentation regarding medical device assessment and lymphoma/leukemia panel selection. The solicitation seeks cost-per-test flow cytometry testing services including reagents and instrumentation from the Department of the Army Medical Command. Responses are due by 4:00 PM Central Standard Time on the newly extended closing date of August 3, 2022.

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CP-HEM.A303 Lymphoma Leukemia Panel Selection (HEM)

Copy of version 3.0 (approved and current)

Last Approval or Periodic Review Completed 4/5/2021

Next Periodic Review Needed On or Before 4/5/2023

Effective Date 4/19/2021

Uncontrolled Copy printed on 26-Jul-2022 12:41

Organization Brooke Army Medical Center

(BAMC)

Approval and Periodic Review Signatures

Type Description Date Version Performed By Notes

Approval Captured outside MediaLab

Lab Director 4/5/2021 3.0 Samantha Butler

Recorded on 12/14/2021 by Jeremy Hershfield when document added to MediaLab

Periodic review Captured outside MediaLab

Designated Reviewer 4/5/2021 3.0 Samantha

Butler Recorded on 12/14/2021 by Jeremy Hershfield when document added to MediaLab

Signatures from prior revisions are not listed.

Approvals and periodic reviews that occurred before this document was added to the MediaLab Document Control system may not be listed.

Version History

Version Status Type Date Added Date Effective Date Retired

3.0 Approved and Current First version in Document Control 12/14/2021 4/19/2021 Indefinite

Linked Documents

• CP-HEM.303 Leukemia / Lymphoma Panel (HEM)

CP-HEM.A303 Lymphoma Leukemia Panel Selection (HEM). (version 3.0) Approved and current. Effective starting 4/19/2021.

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Lymphoma/Leukemia Panel Selection:

Defer to resident or staff pathologist to determine which panels to run if

1. WBC count is <0.3 x 103/ul and/or volume is <1 ml

2. Two of the following clinical history components are given (ie: CLL and monocytosis)

3. Clinical history is not legible or is otherwise unclear

Clinical History: Panels to Run:

Lymphocytosis Lymphoma + K/L CD5 tube Chronic lymphocytic leukemia (CLL/SLL), Mantle Cell lymphoma, Diffuse large B-cell lymphoma

Lymphoma + K/L CD5 tube

Lymphadenopathy Lymphoma + K/L CD5 tube

Hodgkin lymphoma Lymphoma + K/L CD5 tube LGL Large granular lymphocytes Lymphoma + K/L CD5+ LGL tube Multiple Myeloma, Plasma cell myeloma, or Plasma cell dyscrasia

Lymphoma + K/L CD5 + Plasma cell tube + cytoplasmic K/L

Waldenstroms, Lymphoplasmacytic lymphoma, or marginal zone lymphoma

Lymphoma + K/L CD5 + Plasma cell tube + cytoplasmic K/L

New acute leukemia Leukemia + K/L CD5 tube+ cMPO/TdT/CD19/CD3

If Flow detects: Then add on:

>10% monocytes Monocyte tube CD5-CD10- monoclonal B-cell population in blood or bone marrow

Hairy cell tube + Plasma cell tube + cytoplasmic K/L

CD5-CD10- monoclonal B-cell population in lymph node or mass forming lesion

Plasma cell tube + cytoplasmic K/L

>5% CD34+ or CD117+ blasts cytoplasmic MPO/TdT/CD19/CD3

CP-HEM.A303 Lymphoma Leukemia Panel Selection (HEM). (version 3.0) Approved and current. Effective starting 4/19/2021.

Uncontrolled copy printed by Ronnie Heflin on 26-Jul-2022 12:41 (CDT). Page 2 of 2

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