TGA Project Implementation Status – June 2004

Executive Summary

This document is an outline of estimated costs required for NSW public hospitals to comply with new licensing requirements by the Therapeutic Goods Administration (TGA).

Summary of Key Issues

· The TGA has signalled its intention to regulate all facilities providing bone marrow transplantation and / or haematopoietic progenitor cell (Bone Marrow Stem Cell or HPC) collection, storage or processing services.

· TGA implementation has now commenced with the following actions already undertaken:

o Establishment of a National Advisory Group to recommend the national implementation timetable and strategy

o Registration of all Laboratories in public hospitals

o An audit of current stocks of cryo-preserved HPCs

· 8 public hospital sites with Bone Marrow Stem Cell Laboratories are affected.

· 13 public hospital sites with Apheresis Services are affected.

· 4 sites will require major infrastructure works to achieve compliance.

· A further 5 sites will require moderate infrastructure works to achieve compliance.

· $1.34m in additional recurrent costs will be required to maintain compliance.

Recommendations

· The appointment of a BMT Network NSW Statewide Quality Manager to oversee the process changes for HPC processing laboratories and Apheresis sites.

· The implementation of a Statewide Quality Management System for Bone Marrow Stem Cell Laboratories.

· Commissioning of a detailed Implementation Planning Study

Background

In early 2003 the Therapeutic Goods Administration (TGA) signalled its intention to remove the exemption for licensing currently enjoyed by Public Hospitals and their laboratories who are involved in the collection, storage and processing of Haematopoietic Progenitor Cells (HPCs or Bone Marrow Stem Cells). Public Hospital facilities involved in Bone Marrow Transplantation activities will now be required to meet licensing requirements using the Foundation for the Accreditation of Cellular Therapy (FACT) Standards. Some sites conducting higher risk procedures (Gene Therapy and In Vivo Expansion) will be subject to the much more stringent Australian Code of Good Manufacturing Practice (GMP) - Human Blood and Tissues standard.

Current TGA Activities

The TGA has now established stakeholders for progressing the regulatory outcomes, and has called for the formation of a Working Committee to advise the TGA on implementation strategies as follows:

· Two Clinicians from the Bone Marrow Transplant Society of Australia and New Zealand (BMTANZ)

· Two Scientists from the Bone Marrow Transplant Scientists Association of Australasia (BMTSAA)

· One representative from the Australian Bone Marrow Donor Registry (ABMDR)

· An Apheresis Nurse

· A representative of the Hospital Based Bone Marrow Transplant Coordinators

· A nominee from the Manufacturing Assessment Section of the TGA

Anticipated Funding Implications for NSW Public Hospitals

There are three key areas affected by this process – physical infrastructure, including scientific equipment, Information Technology, and human resources.

Physical Infrastructure

There are eight sites with Laboratories that will be affected and 13 sites where apheresis units in ward settings may be affected. The extent of initial infrastructure upgrading will vary from site to site. A brief Gap Analysis has been completed on each of these sites for modifications that are anticipated in order to comply. The results are shown in Table 1 for Infrastructure requirements.

Information Technology

The BMT Network has evaluated six Quality Management Applications for state wide deployment, in conjunction with the Enterprise Architecture Committee in NSW Health and the Health Data Operations Centre (HDOC). The application Q-Pulse has been identified as the strongest application and HDOC has provided quotes on hosting and ongoing maintenance. The proposed State BMT Network Quality Manager will be responsible for System Administration of Q-Pulse.

Human Resources

1. Laboratories.

TGA Licensing under FACT Guidelines will require a significantly expanded Quality Management strategy. The BMT Network NSW strongly recommends a state wide approach by the provision of a State Quality Manager and the purchase of a robust State Wide Quality Management software application. The BMT Network has already commenced this strategy with the temporary appointment of a State BMT Network Quality Manager. With the expiry of the temporary funding in July 2004 this process will slow significantly until recurrent funding can be obtained. The costs are shown in Table 2.

2. Apheresis.

Apheresis is currently performed at 13 sites in NSW public hospitals. A cost estimate for the staffing requirements is shown in Table 3. The impact on staffing will be felt in two respects:

A. By the significantly increased quality monitoring and related documentation which will be required. Generally the extent of the increase required is proportional to the size of the service.

B. By moving to comply with the licensing requirement of one operator per patient on an apheresis machine, as is now the case with the ARCBS.

TABLE 1. PHYSICAL INFRASTRUCTURE IMPACT ASSESSMENT

Facility	None	Minor	Moderate	Major	Comments
Laboratories
Royal North Shore				4	Complete renovate. Still has absorbent benches, not sealed, inadequate air filtration.
Royal Prince Alfred		4			Approved Temperature Controllers (2). Transport Data Logger.
Westmead	4
Prince of Wales		4			Approved Sterile Welder Required at $15K.
St Vincent’s	4
St George	4				Purchase dry shipper and trolley bag sealer approx $12K
Liverpool		4			Minor repair work only required
Newcastle Mater				4	Complete renovate. Still has absorbent timber benches, not sealed, no aircond.
Apheresis Units (Ward or Outpatient Based)
Royal North Shore		4			Minor approved equipment purchases
Royal Prince Alfred			4		Heat Sealer @ $8K. Construction of walled off area to become low traffic area.
Westmead				4	Establishment of low traffic area, Creation of dedicated bed space and extra storage
Prince of Wales			4		Establishment of low traffic area and creation of dedicated bed space required
Sydney Children’s	4				Relocation currently being planned
St Vincent’s			4		Establish low volume traffic area – major work
St George			4		Remodelling of Apheresis Work Area and purchase of approved Heal Sealer - $30K
Liverpool			4		Temperature controlled storage Area, low traffic apheresis area required.
The Children’s Hospital WM		4			Heal Sealer and Stripper. Walling to create low traffic area. Temp controlled storage.
Concord		4			Minor fixed screening required to establish low traffic area.
Newcastle Mater		4			Heat Sealer.
Wollongong	4
Nepean				4	Complete relocation of Unit required – currently in a high traffic area
Gosford		4			Environmental Monitoring Equipment required

TABLE 1a. STATEWIDE QUALITY MANAGEMENT PROGRAM INITIATIVE

Initiative	Set up Year 1	Recurrent Costs (Commence Year 1)
BMT Network NSW Quality Manager	$22,000	$94,000 (Grossed up)
Purchase and Licences Q-Pulse	$21,000	$11,000
HDOC (NSW Health) hosting costs	$20,000	$16,000
TOTAL	$63,000	$121,000

TABLE 3. APHERESIS STAFF IMPACT ASSESSMENT

Facility	Ý FTE	Comments
Royal North Shore	0.2	Additional Documentation and monitoring will require additional nursing hours
Royal Prince Alfred	1.5	Additional Documentation and monitoring will require additional nursing hours
Westmead	1.5	Additional Documentation and monitoring will require additional nursing hours.
Prince of Wales	2.0	Additional Documentation and monitoring will require additional nursing hours. Additional staff required if single operator needed
Sydney Children’s	0.2	Additional Documentation and monitoring will require additional nursing hours.
St Vincent’s	3.5	Currently do not practice dedicated practitioner. Large unit with significant impact for additional documentation.
St George	0.2	Additional Documentation and monitoring will require additional nursing hours.
Liverpool	1.5	Additional Documentation and monitoring will require additional nursing hours.
Sydney Children’s	1.0	Additional Documentation and monitoring will require additional nursing hours.
The Children’s Hospital Westmead	1.0	Additional Documentation and monitoring will require additional nursing hours
Newcastle Mater	1.0	Additional Documentation and monitoring will require additional nursing hours.
Concord	1.0	Additional Documentation and monitoring will require additional nursing hours.
Wollongong	0.4	Additional Documentation and monitoring will require additional nursing hours
Nepean	0