pebiatric blood and marrow - emmes

InfoCard #: PBMT-EQUIP-003 Rev. 01 Effective Date: 01 Apr 2019

PEbIATRIC BLOOD AND MARROWTRANSPLANT PROGRAM

DOCUMENT NUMBER: PBMT-EQUIP-003

DOCUMENT TITLE:Pediatric Apheresis Supply Management

DOCUMENT NOTES:

Document Information

Revision: 01 Vault: PBMT-Equipment-rel

Status: Release Document Type: Equipment

Date Information

Creation Date: 20 Mar 2019 Release Date: 01 Apr 2019

Effective Date: 01 Apr 2019 Expiration Date:

Control Information

Author: MC363 Owner: MC363

Previous Number: None Change Number: PBMT-CCR-240

CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 12:03:15 pm


PBMT-EQUIP-003PEDIATRIC APHERESIS SUPPLY MANAGEMENT

1 PURPOSE

1. 1 This Standard Operating Procedure (SOP) describes the steps used by trainedpersonnel to receive, inspect, document and store supplies for pediatric apheresis.

2 INTRODUCTION

2. 1 Pediatric apheresis supplies are stored in the Adult Blood and Marrow Transplant(ABMT) Clinic supply room. All pediatric apheresis supplies are stored onseparate cart, to prevent mix-ups.

2.2 As part of a Quality Program for the production of cellular products, theApheresis Coordinator must ensure that all apheresis supplies and services usedconsistently meet specified requirements. This is accomplished by initialqualification and regular evaluation of suppliers, and by continuous monitoring ofcritical supplies received in the ABMT Clinic supply room. This SOP defines theprocess for assuring and monitoring the quality of critical supplies, from receipt touse.

2. 3 The Apheresis Coordinator/designee will document receipt of all supplies in thePediatric Apheresis Supply Notebook, which is located on the designated cart.This record will include stock identification, lot numbers, quantity received,expiration dates and, if applicable, a package insert and a Certificate ofAnalysis(COA) or Certificate ofConformance(COC).

2.4 The Apheresis Coordinator/designee is responsible for reviewing themanufacturer's package insert for changes. If there are changes that requirerevisions to the procedure, the appropriate revisions will be made to theprocedures and staff training will occur.

2. 5 The Apheresis Coordinator/designee is responsible for ensuring that the suppliesare used in a first in, first out order.

3 SCOPE AND RESPONSIBILITIES

3. 1 Apheresis Coordinator/designee, Quality Assurance (QA) personnel, DukeHospital Material Management personnel.

3. 2 The Apheresis Coordinator/designee is responsible for:

3.2. 1 The accurate inspection, documentation, and storage of suppliesreceived for apheresis.

3. 2.2 Maintaining current copies of package inserts, Certificates of Analysis(COA), and retaining outdated copies of same.

3.2. 3 The QSU personnel are responsible for inspecting and releasing thesupplies for use.

PBMT-EQUIP-003 Supply ManagementPBMT, DUMCDurham, NC Page 1 of 4



4 DEFINITIONS/ACRONYMS

4. 1 ABMT: Adult Blood and Marrow Transplant

4.2 ACD-A: Acid citrate dextrose formula A

4. 3 COA: Certificate of Analysis

4.4 COC: Certificate of Conformance

4. 5 NS: Normal Saline

4. 6 PDF: Portable Document File

4. 7 QA: Quality Assurance

4. 8 SOP: Standard Operating Procedure

5 MATERIALS

5. 1 Pediatric Apheresis Supply Notebook

5.2 Red Sign for Quarantine (do not use)

5. 3 Green Sign for Release (OK to Use)

5.4 Green Stickers for release (OK to Use)

6 EQUIPMENT

6. 1 NA

7 SAFETY

7. 1 NA

8 PROCEDURE

8. 1 Materials management personnel will deliver apheresis supplies to the ABMTClinic supply room. Supplies shipped directly from the supplier will be delivereddirectly to the ABMT Clinic.

8.2 Materials management personnel will place the newly delivered apheresissupplies in a designated area. They will place a red "Quarantine" sign, which isfound with the Pediatric Apheresis Supply Notebook, to identify the new suppliesdelivered.

8. 3 Materials management personnel will place the apheresis kits in designated area.The Apheresis Coordinator/designee will unbox and inspect the kits. They willplace a red "Quarantine" sign on them.

8.4 The Apheresis coordinator/designee will inspect all delivered supplies fordamage, contamination, leakage, abnormal color, cloudiness.

8. 5 If there are any unacceptable supplies (see Section 8.4 above), the PBMT-EQUIP-003 FRM3 Unacceptable Supply and Corrective Action Log will be completed.



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8. 7 QA personnel will inspect and verify that the supplies are acceptable and that allapplicable documentation is completed. After inspection and sign-off, the QApersonnel will place an "OK to Use" sign on the supplies.

8. 8 The Apheresis coordinator/designee will rotate the new stock to ensure "first infirst out rotation" of supplies.

8. 9 Storage and Disposal

8.9. 1 Pediatric apheresis supplies must be stored at appropriate temperatureand humidity ranges in a safe, sanitary and orderly manner.

8.9.2 The ABMT Clinic supply room is the area where the pediatricapheresis supplies are stored. The temperature and humidity will berecorded each day in this area by the Apheresis Coordinator/designee.

8. 9. 3 Outdated supplies will be appropriately disposed according to DukeHospital policy.

9 RELATED DOCUMENTS/FORMS

9. 1 PBMT-EQUIP-003 FRM 1 Materials Acceptance Specification Quality Checklist

9.2 PBMT-EQUIP-003 FRM2 Package Insert Review Log

9. 3 PBMT-EQUIP-003 FRM3 Unacceptable Supply and Corrective Action Log

10 REFERENCES

10. 1 AABB Standards for Hematopoietic Progenitor Cell Services, current edition

10.2 FDA Code of Federal Regulations, Title 21

10. 3 FACT-JACIE Standards for Hematopoietic Progenitor Cell Collection, Processingand Transplantation.

11 REVISION HISTORY

Revision No.

01Author

M. ChristenDescription of Change(s)

New Document




Signature Manifest

Document Number: PBMT-EQUIP-003

Title: PediatricApheresis Supply ManagementRevision: 01

All dates and times are in Eastern Time.

PBMT-EQUIP-003 Pediatric Apheresis Supply Management

Author

Name/Signature

Mary Beth Christen (MC363)

Medical Director

Title ,..,J. Date Meaning/Reason

21 Mar 2019, 10:31:44 AM Approved

Name/Signature Title Date Meaning/ReasonJoanne Kurtzberg(KURTZ001)

Quality

21 Mar2019, 11:16:21 AM Approved

I Name/SignatureBing Shen (BS76)

Document Release

Title Date J ̂/leanln9^?eason.21 Mar2019, 04:11:09 PM Approved

Name/Signature [ TitleBetsy Jordan (BJ42)

,J^!1 Meaning/Reason

22 Mar 2019, 10:44:35 AM Approved


pebiatric blood and marrow - emmes

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