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GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS 

JUNE 1997

(APRIL 2001 - Editorial Revisions)

NOTE: This document is reference material for Investigators and other FDA personnel. The document does not bind FDA, and does not confer any rights, privileges, benefits, or immunities for or on any person(s). An alternative approach may be used if such an approach satisfies the requirements of the applicable statues, regulations, or both.

TABLE OF CONTENTS  

SECTION 1
Introduction Pg. 1
General Information Pg. 2
Operations Pg. 2
Standard Operating Procedures Pg. 2
Errors, Accidents and Fatalities Pg. 3
Adverse Reaction Pg. 3
Lookback Pg. 4
Plasmapheresis Facilities Pg. 4
Equipment Pg. 4
Medical Device Reporting Pg. 6
Medical Supervision Pg. 7

SECTION 2
Donor Identification Pg. 7
Informed Consent Pg. 7
Initial Medical Examination Pg. 8
Immunization Pg. 9
Donor Suitability Pg. 10
Infrequent Donations Pg. 12
Blood Collection Pg. 12
Donor Record Files Pg. 14
Plasma Separation and Pooling (Manual Only) Pg. 15
Reinfusion of Red Blood Cells (Manual Collection) Pg. 16

SECTION 3
HBsAg, Anti-HCV and Anti-HIV Testing Pg. 16
Handling of HBsAg, Anti-HCV and Anti-HIV Repeatedly Reactive Units Pg. 17
Serum Protein Quantitation Pg. 19
Serologic Test for Syphilis Pg. 19
Storage Pg. 19
Distribution Record Pg. 20
Disposal of Infectious Waste Pg. 20
Computerized Records Pg. 20
Disease State Donors Pg. 21
"High Risk" Donors pg. 21
Source Leukocytes Pg. 22
Therapeutic Exchange Plasma Pg. 22