Administering Files, Records, and Grants

Administering Files / Records

Assignment Guide

Overview

Medical Administrative Specialists will often work with files and records. In this scenario, you will apply the skills and competencies you learn in your coursework to help organize files and update information.

Assignment #1– Administering Files / Records (100 points)

For the past several months, you have been working with Teeanna Brisco, Ph.D. and Ndia Jones, M.D. to gather research and information for a grant. You are now ready to assemble the information into one document, and review the document for polishing.

In the attached, zipped folder, you will see all of the files you have collected over several months. Some will be used in the grant application document, some will not. Your job is to use the information, to assemble the grant application into one document.

Drs. Brisco and Jones have given you an outline for the contents of the grant application document, below. Start a new Word document. Insert the files, in order, and with correct formatting and layout. Then, review the entire document spelling, grammar, formatting or layout mistakes and fix any errors.

Like a real-world project, the Doctors have given you enough information to complete the work without creating a time-consuming step-by-step guide. You must use your skills, knowledge and best judgement to complete the work.

Also replicating a real-world project, these Doctors have very busy schedules and cannot answer every question that pops-up. You will have only one opportunity to asks questions, if needed, before submitting. If you have questions, you must:

1. Send all questions in one email message to the instructor

2. Use the subject line: Internship Administering Files Project

3. Within the body, write your question(s) so that the recipient knows exactly what information you need. You will receive only one response, so be clear. You will not get a second chance to submit questions.

Don’t worry, you got this! Use your professional judgement to produce a final document that is ready for submission to the World Health Organization.

Dr. Brisco and Dr. Jones’ Grant Application. Assembly the information, into one MS Word document, in this order:

1 Introduction

2 International Biological Reference Preparations

3 Glossary

4 General considerations

4.1 Range of products made from human blood and plasma

4.2 Composition of human plasma

4.3 Pathogens present in blood and plasma

5 Measures to exclude infectious donations

5.1 Appropriate selection of blood/plasma donors

5.2 Screening of blood/plasma donations for infectious markers

5.3 Epidemiological surveillance of donor population

5.4 Strict adherence to Good Manufacturing Practices

5.5 Post-donation events

6 Production of plasma for fractionation

6.1 Methods used to obtain plasma for fractionation

6.2 Characteristics of plasma for fractionation

6.3 Premises and devices for collection of plasma for fractionation

6.4 Blood/plasma collection process

6.5 Separation of plasma

6.6 Freezing of plasma

6.7 Storage of plasma

6.8 Compliance with plasma fractionator requirements

6.9 Release of plasma for fractionation

6.10 Packaging of plasma

6.11 Transportation of plasma

6.12 Recall system

7 Quality assurance system and Good Manufacturing Practices

7.1 Organization and personnel

7.2 Documentation system

7.3 Premises and equipment

7.4 Materials

7.5 Validation program

7.6 Quality monitoring data

7.7 Virology safety testing

7.8 Electronic information system

7.9 Storage and transport

7.10 Change control system

7.11 Quality assurance auditing

7.12 Defect reporting system

7.13 Quality agreement between blood establishment and fractionator

7.14 Blood/plasma establishment audit and inspection

8 Regulatory control of plasma for fractionation

8.1 Role of national regulatory authority

8.2 Establishment license and inspections

8.3 Impact of Good Manufacturing Practices

8.4 Inspections

9 Authors

10 References

Appendix 1

Plasma products and clinical applications

Appendix 2

Donor selection

Appendix 3

Donor immunization and plasmapheresis for specific immunoglobulins

Appendix 4

Contract plasma fractionation program

Appendix 5

Technical points to consider in establishing plasma specifications criteria and obligations between blood establishment and plasma fractionator

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