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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 252.100- Source Plasma - Regulatory Action Based on Overbleeding

 

BACKGROUND:

The *Center for Biologics Evaluation and Research (CBER)* has re-evaluated the health hazard criteria associated with overbleeding plasmapheresis donors, based on current scientific evaluations.

A substantial degree of deviation from the requirements [21 CFR 640.65(b)(4), (5) and (6)] is significant. Critical factors that are to be considered in determining overbleeding by volume are: 1) the volume (normally converted from weight) of whole blood collected at one time or within a specified period of time (2 days and/or 7 days); and 2) the volume of plasma obtained from whole blood collections. The precision of blood weight and volume determinations may be affected by factors such as biologic variability of the donors, human errors in blood collection, variability in bag weights, accuracy of the scales, and the amount of anticoagulant.

POLICY:

1. Whole Blood Volumes

Overbleeding is considered significant when: a) the volume of whole blood removed routinely exceeds the maximum allowable limits in 21 CFR 640.65(b)(4), (5) and (6); or b) there is no indication that overbleeding is recognized and corrected.

2. Plasma Volumes

Overbleeding is considered significant when the volume of units of Source Plasma routinely exceeds the maximum allowable limit of 770 mls (790 gms) for donors weighing less than 175 pounds and 925 mls (949 gms) for those weighing 175 pounds or more. (Plasma collected in heparin solution will have a lower yield).

NOTE: Documentation must establish a pattern of conduct over a period of time which illustrates a normal or customary (routine) practice of overbleeding.

REGULATORY ACTION GUIDANCE:

Overbleeding, as described above, coupled with significant deficiencies in determining donor suitability, described below, warrants considering recommendation for suspension of activities under U.S. license.

A. Personnel unfamiliar with or improperly determining hematocrit, blood pressure, temperature, or total protein (T.P.).

B. Refractometer for determining T.P. not adequately cleaned between determinations or malfunctioning and correct readings cannot be obtained.

C. Donors plasmapheresed whose plasma protein composition was outside the normal range established by the testing laboratory.

*Material between asterisks is new or revised*

[] Indicates material has been deleted

Issued: 8/1/78 as 7134.16
Revised: 10/10/78, 10/1/80, 7/1/82, 3/95