In an effort to support blood center customers, Pall has developed an implementation package to assist blood establishments in the preparation of leukocyte-reduced blood using Pall Leukotrap^® systems. It is designed specifically for donor room/collections staff to component processing and Quality Assurance staff.

It consists of the following materials necessary to develop documentation required to comply with Food & Drug Administration (FDA) Good Manufacturing Practices (cGMPs):

• Suggested Validation, Training, and Control Guidelines
  These are suggested guidelines for process validation of Pall Leukotrap^® systems, including suggestions for training and on-going process control.
  
  
• Sample Leukotrap^® Standard Operating Procedure (SOP)
  This sample SOP can be used to integrate the new procedures into the blood center facility’s documentation for the completion of process validation. It can be easily modified to suit their needs.
  
  
• Customer User Certification for Collections and Component Lab/QA Staff
  This document provides the vehicle whereby a customer’s in-house trainer can be certified by Pall Sales/Technical staff. It may be adapted to train in-house staff.
  
  
• Product Conversion Checklist
  This detailed step-by-step checklist is designed to guide the blood center during conversion to Pall Leukotrap^® systems.
  
  
• Process Validation Worksheet
  This is used to document the performance of the Pall Leukotrap^® system for a blood center’s quality assurance program.
  
  
• Answers to Frequently Asked Questions
  Answers to product specific questions will assist the blood center staff during training.
  
  
• Product Information
  This is a packet of product inserts, brochures, and associated technical reports / performance summaries.

For more information on how to obtain your package, contact Pall.

The added value of Pall’s Scientific & Laboratory Services (SLS) offer:

• Customer Evaluations
  
  A custom evaluation is designed for the specific needs of your blood center. We evaluate your procedures, provide information for the manufacturing of leukoreduced blood components and train your personnel to initiate and complete a Process Validation.
  
  
• Process Validation
  
  A Process Validation evaluates the steps involved in operational and product preparation for the manufacturing of leukoreduced blood products. We provide a leukocyte counting workshop, as well as the tools and guidance to integrate the new procedures into your Standard Operating Procedures (SOP) for the completion of process validation.
  
  
• Statistical Process Consistency Program
  
  This program is designed to augment Process Validation by statistically comparing ongoing Quality Control data to a large reference database. This provides a useful way to confirm that your leukoreduction process is performing to manufacturing expectations.
  
  
• Counting Workshop
  
  This workshop is designed to train laboratory personnel in the use of Nageotte chambers and flow cytometry for counting leukocytes in red cell and platelet products. The workshop will emphasize good laboratory technique and correct detection and identification of leukocytes.

Pall provides the following workshops for our blood center customers:

Telephone Customer Service Training for the Blood Center

This workshop is designed to improve the customer service relationship between the hospital customer and their blood center staff.

Program objectives:

• Increase communication skills, in listening, gathering information and providing feedback.
• Develop a professional telephone personality that reflects well both on staff and the blood center.
• Provide practice and guidance on how to handle difficult customers and/or dissatisfied callers.

Customer Service Training on Prestorage Leukoreduction

This workshop is for blood center customers interested in learning about the importance of the customer service role. Specifically, it focuses on developing skills to promote value-added services and products to the hospital customer without the "sales pitch."

Program objectives:

• Provide knowledge and tools to help the blood center establish an effective dialogue between customer service and hospital blood bank.
• Develop skills to identify the appropriate blood component to meet patient needs.
• Help customers understand the clinical benefits and logistical preferences for the pre-storage advantage, by emphasis on quality blood components through process validation and performance consistency.

Inventory Management / Consultation Services

The consultative services are designed to assist the blood center staff on quality / regulatory issues and to help the blood center acquire a level of understanding of the clinical benefits and logistical preferences for the pre-storage advantage. An emphasis on quality blood components through process validation and performance consistency, product training, inventory management, cost analysis, production capacity, and time study is utilized.

Pall works with our customers to develop co-marketing programs for prestorage leukocyte reduced blood components.

Consider the opportunities:

• While leukocyte reduced blood components have been a special product for hematology/oncology patients, the clinical evidence and the economics strongly support the routine use of leukocyte reduction for surgical transfusion. Pall will work with regional blood center customers to develop a strategic marketing plan and support material targeting the surgery department with direct mail, clinical updates for surgeons and hospital calls.
  
  
• Hospitals are considering all their options for cutting costs including scrutiny of their red cell and platelet use. Pall’s Random Donor Platelet Alternative showcases prestorage leukocyte reduced random donor platelets as a new, lower cost, quality component that blood centers can offer their hospital customers. This brings a compelling new option to add to the other services and products a blood center can offer.