REGULATORY REQUIREMENTS

GENERAL INFORMATION

Blood establishments are regulated by FDA (Food and Drug Administration) and CBER (Center for Biologics Evaluation and Research), and must also follow federal regulations defined by CLIA (Clinical Laboratory Improvement Amendments), OSHA (Occupational Safety and Health Administration), and NRC (Nuclear Regulatory Commission). They must also adhere to any additional state regulations relating to collection or testing of blood components.

Current good manufacturing practices (cGMPs) for blood establishments, defined in the Code of Federal Regulations (CFR), apply not only to blood centers and hospital based blood banks, but to hospital transfusion services that may not be registered or licensed by FDA.

LOOKBACK & HOSPITAL NOTIFICATION

Lookback is a process to identify prior donations from donors with positive screening tests and inform the patients who received these products (recipients).

When a blood donor tests repeatedly reactive (RR) in screening tests for an infectious disease such as HIV, hepatitis B or C, HTLV or West Nile virus, the possibility exists that the donor may have had an undetectable infection at the time of a previous donation. This is due to the window period or time between donor infection and the appearance of detectable markers of disease.

Lookback and notification is required by the US Food and Drug Administration. Refer to the following links for the regulatory requirements for:

• HIV
• HCV
• Hepatitis B and HTLV I/II

Lookback is performed in four main steps:

1. Retrieval and consignee notification of in-date blood components

Blood centers must perform retrieval and quarantine of in-date blood components—whether the components are still at the blood center or have been sent to a consignee—within 72 hours of positive screening test results for:

• HIV 1/2
• HCV
• Individual NAT for HIV, HCV or WNV

within 7 days of positive screening test results for:

• HBsAg
• HBc
• HTLV I/II

2. Consignee notification of positive screening test for HIV for all components

• Notification must be made by blood centers to consignees of prior donations within the target group of donations from donors testing screening test positive for HIV within 72 hours of the positive screening test.
• This notification is for retrieval and destruction purposes only, not for recipient notification. If the confirmatory testing is completed within the 72 hour timeframe, the blood center may convey both pieces of information in the same notification.

3. Consignee notification of confirmatory/supplemental testing for HIV and supplemental testing positive HCV

• Consignee notification of the confirmatory/supplemental testing for HIV-1 and HIV-2 is made by blood centers within 30 calendar days after the donor’s positive screening test.
• Consignee notification of supplemental testing positive for HCV is made by blood centers within 45 calendar days of the positive screening test. (Consignees are NOT notified if supplemental testing is negative or indeterminate).

4. Recipient notification, if necessary

Recipient notification is necessary if the confirmatory test for HIV 1/2 is positive or if the supplemental test for HCV is positive.

HIV:

• If the confirmatory testing is positive and the unit was transfused, the transfusion service notifies the recipient’s attending physician (physician of record) and asks him or her to inform the recipient of the need for HIV testing and counseling. If the physician is unavailable or declines to notify the recipient, it is the transfusion service’s responsibility to notify the recipient and inform the recipient of the need for HIV testing and counseling.
• The recipient notification process requires a minimum of 3 attempts to notify the recipient and must be completed within a maximum of 8 weeks of receipt of the confirmatory testing notification. The attempts to notify the recipient should be documented.
• The notification should include basic explanations to the recipient and a referral for counseling.
• If the recipient is deceased, notification must be made to the deceased recipient’s legal representative or relative.
• If the confirmatory testing is negative or indeterminate, recipient notification is not required.

HCV:

• If the recipient is deceased, the consignee may discontinue the notification process.
• The transfusion service notifies the recipient’s attending physician (physician of record) and asks him or her to inform the recipient of the need for HCV testing and counseling. If the physician is unavailable or declines to notify the recipient, it is the transfusion service’s responsibility to notify the recipient and inform the recipient of the need for HCV testing and counseling.
• The recipient notification process requires a minimum of 3 attempts to notify the recipient and must be completed within a maximum of 12 weeks of receipt of the confirmatory testing notification. The attempts to notify the recipient should be documented.
• The notification should include basic explanations to the recipient and a referral for counseling.

POST DONATION INFORMATION

There are times when, upon a subsequent donation attempt, the donor gives information that is potentially deferring. In this instance, the blood center may need to contact the hospital/consignee for in-date components from prior donations. The hospital notification is typically made by telephone, but may come as a fax or notification letter. The correspondence will identify the action to be taken along with a brief description as to why this process has been initiated for the component(s). The most common causes of post donation notification are:

• Donor received a tattoo less than 1 year prior to the affected donation and did not reveal this information at the time of donation.
• Donor traveled to malaria risk area and did not reveal this information at the time of donation.
• Donor recently diagnosed with a deferring condition not known at the time of the prior donation.
• Donor gives an unacceptable response to a health history or high risk question on current donation attempt.
• Eligibility requirements change causing previous donors to now be deferred. Most common is the vCJD deferrals for military personnel and their dependents stationed in Europe from 1980-1996.

The hospital/consignee should have policies in place that identify how to handle this type of notification.

QUALITY ASSURANCE NOTIFICATION

United Blood Services is a leader in quality management and process improvement. The manufacturing processes are continuously audited and improved in order to provide safe, high quality products to the customers we serve.

There are rare occasions when the blood center may initiate a voluntary market withdrawal for components when deviations are identified through quality assessment. If at any time, through review of current records or processes or through quality assurance audits from either internal or external inspectors, the integrity of the component(s) cannot be verified, the hospital/consignee will be notified. This notification may be by telephone, fax or letter and will contain information about the withdrawal as well as instructions on what to do with the component(s).

The hospital/consignee should have policies in place that identify how to handle this type of notification.

HOSPITAL REPORTING OF FATALITIES

In rare instances, death in patients can occur as a result of complications in blood collection or transfusion. According to 21 CFR 606.170(b), the Center for Biologics Evaluation and Research (CBER) must be notified as soon as possible. This notification can be made by telephone, facsimile, e-mail or express mail followed by a written report within 7 days of the fatality. If the fatality occurred during a transfusion, it is the hospital’s responsibility to notify the appropriate agency. In some instances, a joint report between the blood center and the transfusion facility may be indicated.

For information on reporting Transfusion Adverse Reactions to United Blood Services, click to download Report of Transfusion Adverse Reaction form (BS 962).

For detailed information on how to report fatalities to CBER along with contact information, click here.

BSI BLOOD CENTERS/TESTING FACILITIES

BSL: Blood Systems Laboratories
BCP: Blood Center of the Pacific

Click here to download a PDF of this table.