InfoCard #: APBMT-GEN-002 Rev. 08 Effective Date: 01 May 2019

DukeMedicineDivision of Cellular Therapy ^AbULT AND PEDIATRIC BLOOD AND

MARROW TRANSPLANT PROGRAM

DOCUMENT NUMBER: APBMT-GEN-002

DOCUMENT TITLE:

Overview of the Collection Facility Personnel

DOCUMENT NOTES:

Document Information

Revision: 08 Vault: APBMT-General-rel

Status: Release Document Type: General

Date Information

Creation Date: 26 Mar 2019 Release Date: 01 May 2019

Effective Date: 01 May 2019 Expiration Date:

Control Information

Author: MC363

Previous Number: APBMT-GEN-002 Rev 07

Owner:

Change

JLF29

Number: APBMT-CCR-147

CONFIDENTIAL - Printed by: ACM93 on 01 May 2019 08:48:51 am

InfoCard #: APBMT-GEN-002 Rev. 08 Effective Date: 01 May 2019

APBMT-GEN-002OVERVIEW OF THE COLLECTION FACILITY PERSONNEL

1 PURPOSE

1. 1 This document serves to outline an overview of the characteristics of thepersonnel required for everyday functioning for both the adult and pediatric bloodand marrow transplant (APBMT) collection facilities.

2 INTRODUCTION

2. 1 The collection facility at Duke is a combined adult and pediatric program withdistinct sites of collection. The outpatient Adult Blood and Marrow Transplant(ABMT) clinic is located in the North Pavilion building. The Pediatric Blood andMarrow Transplant (PBMT) outpatient clinic is located on the 4th floor of theChildren's Health Center (CMC).

2.2 Both outpatient collection facilities have 'day hospital' facilities available toprotect the patient from transmission of infectious agents and designed tominimize the risk of airborne microbial contamination. The facilities allow asnecessary, for appropriate patient isolation; confidential examination andevaluation.

2. 3 The dedicated pediatric and adult collection facilities are staffed by a fullcomplement of registered nurses (RNs), hospitalists, advanced practice providers(APPs) including Nurse Practitioners (NPs) and Physician Assistants (PAs).

3 SCOPE AND RESPONSIBILITIES

3. 1 Multidisciplinary: All faculty and allied staff, as outlined in section 2, who carefor the blood and marrow transplant patient are responsible for maintaining andsupporting the characteristics of each collection unit.

4 DEFINITIONS/ACRONYMS

4. 1 APBMT Adult and Pediatric Blood and Marrow Transplant

4. 2 ABMT Adult Blood and Marrow Transplant4.3 APP Advanced Practice Provider

4. 4 CHC Children's Health Center

4. 5 ECP Extracorporeal Photopheresis

4. 6 IV Intravenous

4. 7 NP Nurse Practitioner

4. 8 PA Physician Assistant

4. 9 PBMT Pediatric Blood and Marrow Transplant

4. 10 PBPC Peripheral Blood Progenitor Cells

4. 11 PO By Mouth

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InfoCard #: APBMT-GEN-002 Rev. 08 Effective Date: 01 May 2019

4. 12 RN Registered Nurse

5 MATERIALS

5. 1 NA

6 EQUIPMENT

6. 1 NA

7 SAFETY

7. 1 NA

8 PROCEDURE

8. 1 Collection Facility

8. 1. 1 The Collection Facility is directed by the Adult and Pediatric Blood andMarrow Transplant Program Directors, Dr. Nelson Chao, MD andDr. Joanne Kurtzberg, MD, respectively. Both of these licensedphysicians have completed postdoctoral training in hematopoietic stemcell collection and transplantation. These individuals also serve as theMedical Directors of the facility. These individuals are qualified bytraining and experience to oversee the technical procedures and facilityoperations related to marrow, peripheral blood progenitor cells (PBPC)and other cellular collections.

8. 1.2 The adult and pediatric collection facilities are staffed by fullcomplements of trained support personnel. The training, continuededucation and continued competency requirements for these individualsare located in their Training Folders in their respective supervisorsoffices. The training, education and competency programs for theseindividuals are detailed in the training procedures in the overallProgram Manual.

8. 2 Adult Collection Facility Personnel

8. 2. 1 PBPC collections are performed by licensed RNs, employed by theABMT Program, trained in donor screening, trained in the operation ofthe Terumo BCT Spectra Optia, trained in blood transfusion practices,and trained in general care of the donor and transplant patient.Collections are performed in the designated apheresis area within theABMT Clinic. The RNs administer the APBMT-COMM-003 InterimDonor History Questionnaire and assess the patient during theprocedure. ABMT apheresis nurses are also trained in Extracoq3oreal

Photopheresis (ECP) using the Therakos Cellex. They are qualifiedand trained to administer premeds, calcium by mouth (PO) orintravenous (IV), and other related supportive care during theprocedure.

8. 2.2 Prior to collection, the donor is assessed by a Physician or NursePractitioner. The Transplant Coordinator administers and reviews theAPBMT-COMM-002 Adult Donor Health History Questionnaire and

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InfoCard #: APBMT-GEN-002 Rev. 08 Effective Date: 01 May 2019

identifies any exemptions. These are then reviewed by the physician.If the donor is cleared for donation, written informed consent isobtained and the donation(s) are scheduled.

8. 3 Pediatric Collection Facility Personnel

8. 3. 1 PBPC collection procedures are performed by licensed RNs, employedby the APBMT Program, trained in donor screening and trained in theoperation of the Terumo BCT Spectra Optia. They are assisted bylicensed RNs employed by the CHC. The CHC RN staff carry out thetreatment room responsibilities on the 4th floor of the CHC. TheCHC RNs take vital signs and assess the patient/donor during theprocedure and administer premeds, calcium PO or IV, and other relatedsupportive care during the procedure, as ordered. The APBMTapheresis RN administer the PBMT-COLL-007 Interim PediatricDonor History Questionnaire and monitors the machine throughout thecollection.

8. 3. 2 Prior to collection, the donor is assessed by a Physician or NursePractitioner and Nurse Coordinator. The Nurse Coordinatoradministers and reviews the PBMT-COLL-001 Pediatric Donor HealthHistory Qiiestionnaire and identifies any exemptions. These are thenreviewed by the physician. If the donor is cleared for donation, writteninformed consent is obtained and the donation(s) are scheduled.

8.4 Training and Competency

8. 4. 1 Training, competency, and continuing education are performed on aregular basis. Standard requirements of the collection facility nursingstaff training are detailed in the APBMT-COLL-002 Apheresis NurseTraining.

RELATED DOCUMENTS/FORMS

9. 1. 1 APBMT-COLL-002 Apheresis Nurse Training

APBMT-COMM-003 Interim Donor History Questionnaire

APBMT-COMM-002 Adult Donor Health History Questionnaire

PBMT-COLL-007 Interim Pediatric Donor History Questionnaire

PBMT-COLL-001 Pediatric Donor Health History Questionnaire

APBMT-COLL-002 FRM1 Optia Competency Based Orientation

ABMT-COLL-002 FRM5 Photopheresis (ECP) - Cellex CompetencyBased Orientation

9. 1.

9. 1,

9. 1.

9. 1.

9. 1.

9. 1.

.2

.3

.4

.5

.6

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10 REFERENCES

10. 1 NA

11 REVISION HISTORY

Revision No. Author Description of Change(s)

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InfoCard #: APBMT-GEN-002 Rev. 08 Effective Date: 01 May 2019

08 M. Christen Document re-formatted into SOP format with

information distributed to each appropriate section header.Section 1: Updated Purpose to reflect current practices.Section 8.3: Updated to reflect current practices in thePBMT collection facilities and staffing.Section 8.4: Updated trainingSection 9: Added related documents

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InfoCard #: APBMT-GEN-002 Rev. 08 Effective Date: 01 May 2019

Signature Manifest

Document Number: APBMT-GEN-002

Title: Overview of the Collection Facility PersonnelRevision: 08

All dates and times are in Eastern Time.

APBMT-GEN-002 Overview of the Collection Facility Personnel

Author

] Name/Signature ; TitleMary Beth Christen (MC363)

Date | Meaning/Reason24 Apr 2019, 04:47:32 PM Approved

Management

Name/Signature

Nelson Chao (CHA00002)

Title

Medical Director

Date

25Apr2019, 01:42:42PMMeaning/Reason

Approved

Name/Signature Title

Joanne Kurtzberg(KURTZ001)

Quality

Date

25 Apr 2019, 02:43:07 PM

Meaning/Reason

Approved

[ Name/SignatureBing Shen (BS76)

Document Release

Title.

'. Pal?..... .. _------. __ Meaning/Reason25 Apr 2019, 07:27:06 PM Approved

Name/Signature Title Date Meaning/ReasonBetsy Jordan (BJ42) 26 Apr 2019, 08:30:52 AM Approved

Quick Approval

Approve Now

I Name/Signature

Betsy Jordan (BJ42)

I Title I Date [ Meaning/Reason26 Apr 2019, 09:12:49 AM Approved

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