Requirements for Procedures Related to the Collection, Processing, Storage and Issue of HUMAN Haemopoietic Progenitor Cells (Third Edition 2009)

Introduction

Up to Accreditation

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The Requirements for Procedures Related to the Collection, Processing, Storage and Issue of Human Haemopoietic Progenitor Cells is a primary National Pathology Accreditation Advisory Council (NPAAC) document which may be used by bodies evaluating the competence of haemopoietic progenitor cell (HPC) transplant facilities seeking accreditation. It describes the minimum requirements for competence and quality to be met by facilities and individuals preparing HPCs and/or lymphocytes for infusion, and for providing assured safety and quality of the product.

Any manufacturing and use of products will still be subject to regulatory oversight by the Therapeutic Goods Administration (TGA). If clinical trials are required, then the usual ethics approval from the relevant institution must be obtained in addition to a clinical trial notification or exemption approval from the TGA.

This document replaces the existing NPAAC document Guidelines for Laboratory Procedures Related to the Processing, Storage and Infusion of Cells for Transplantation or Cell Therapy (2004). Substantial change in the new document includes the incorporation of requirements for collection (apheresis procedures).

Top of pageThe following principles apply to this document:

• Failure to meet these minimum requirements poses a potential risk to patient safety.
• Facilities involved in collection, processing, storage and issue or disposal of cellular products must be able to demonstrate continued compliance with NPAAC requirements.

Tier 2 Standards

• Requirements for the Supervision of Pathology Laboratories
• Requirements for Pathology Laboratories

Tier 3 Standards

• All Tier 3 Standards

• A standard is the minimum requirement for a procedure, method, staffing resource or laboratory facility that is required before a laboratory can attain accreditation — standards are printed in bold type and prefaced with an 'S' (e.g. S2.2). The use of the verb 'must' in each standard within this document indicates a mandatory requirement for pathology practice.
• A guideline is a consensus recommendation for best practice and should be used if a higher level of practice is appropriate, particularly when setting up or modifying a laboratory test, or when contamination problems have occurred — guidelines are prefaced with a 'G' (e.g. G2.2) and are numbered to correspond with their associated standard. 'Should' is used to indicate guidelines or recommendations where compliance would be expected for good laboratory practice.
• The terms 'normative' and 'informative' have been used in this Standard to define the application of the appendix to which they apply. A `normative' appendix is an integral part of a Standard, whereas an `informative' appendix is only for information and guidance.
• Commentaries are placed where they add the most value, and may be either normative or informative, depending on both the content and the context of whether they are associated with a Standard or a Guideline. Note that when Comments are expanding on a Standard or when referring to other legislation, they assume the same status and importance as the Standard to which they are attached.

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