Guideline text:
(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)

## §482.27(b) Standard: - Potentially Infectious Blood and Blood Components

(1)Potentially human immunodeficiency virus (HIV) infectious blood and blood components.  Potentially HIV infectious blood and blood components are prior collections from a donor -

- (i) Who tested negative at the time of donation but tests reactive for evidence of HIV infection on a later donation;
- (ii) Who tests positive on the supplemental (additional, more specific) test or other follow-up testing required by FDA; and
- (iii) For whom the timing of seroconversion cannot be precisely estimated.
- (2) Potentially hepatitis C virus (HCV) infectious blood and blood components. Potentially HCV infectious blood and blood components are the blood and blood components identified in 21 CFR 610.47.
- (3) Services furnished by an outside blood collecting establishment.  If a hospital regularly uses the services of an outside blood collecting establishment, it must have an agreement with the blood collecting establishment that governs the procurement, transfer, and availability of blood and blood components.  The agreement must require that the blood collecting establishment notify the hospital --
- (i) Within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection;
- (ii) Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA;
- (iii) Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor,

whenever records are available, as set forth at 21 CFR 610.48(b)(3).

(4) Quarantine of blood and blood components pending completion of testing.  If the blood collecting establishment (either internal or under an agreement) notifies the hospital of the reactive HIV or HCV screening test results, the hospital must determine the disposition of the blood or blood component and quarantine all blood and blood components from previous donations in inventory. (i) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is negative, absent other informative test results, the hospital may release the blood and blood components from quarantine. (ii) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is positive, the hospital must (A)  Dispose of the blood and blood components; and (B) Notify the transfusion recipients as set forth in paragraph (b)(6) of this section. (iii) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is indeterminate, the hospital must destroy or label prior collections of blood or blood components held in quarantine as set forth at 21 CFR 610.46(b)(2), 610.47(b)(2), and 610.48(c)(2). (5) Recordkeeping by the hospital.  The hospital must maintain -(i) Records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition in a manner that permits prompt retrieval; and (ii) A fully funded plan to transfer these records to another hospital or other entity if such hospital ceases operation for any reason. (6) Patient notification. If the hospital has administered potentially HIV or HCV infectious blood or blood components (either directly through its own blood collecting establishment or under an agreement) or released such blood or blood components to another entity or appropriate individual, the hospital must take the following actions: (i) Make reasonable attempts to notify the patient, or to notify the attending physician who ordered the blood or blood component and ask the physician to notify the patient, or other individual as permitted under paragraph (b)(10) of this section,  that potentially HIV or HCV infectious blood or blood components were transfused to the patient and that there may be a need for HIV or HCV testing and counseling. (ii) If the physician is unavailable or declines to make the notification, make reasonable attempts to give this notification to the patient, legal guardian or relative. (iii) Document in the patient's medical record the notification or attempts to give the required notification. (7) Time frame for notification.  For donors tested on or after February 20, 2008. For notifications resulting from donors tested on or after February 20, 2008 as set forth at 21 CFR 610.46 and 21 CFR 610.47 the notification effort begins when the blood collecting establishment notifies the hospital that it received potentially HIV or HCV infectious blood and blood components.  The hospital must make reasonable attempts to give notification over a period of 12 weeks unless--

- (i) The patient is located and notified; or
- (ii) The hospital is unable to locate the patient and documents in the patient's medical record the extenuating circumstances beyond the hospital's control that caused the notification timeframe to exceed 12 weeks.
- (8) Content of notification. The notification must include the following information:
- (i) A basic explanation of the need for HIV or HCV testing and counseling.
- (ii) Enough oral or written information so that an informed decision can be made about whether to obtain HIV or HCV testing and counseling.
- (iii) A list of programs or places where the person can obtain HIV or HCV testing and counseling, including any requirements or restrictions the program may impose.

(9) Policies and procedures. The hospital must establish policies and procedures for notification and documentation that conform to Federal, State, and local laws, including requirements for the confidentiality of medical records and other patient information.

(10) Notification to legal representative or relative. If the patient has been adjudged incompetent by a State court, the physician or hospital must notify a legal representative designated in accordance with State law. If the patient is competent, but State law permits a legal representative or relative to receive the information on the patient's behalf, the physician or hospital must notify the patient or his or her legal representative or relative. For possible HIV infectious transfusion recipients that are deceased, the physician or hospital must inform the deceased patient's legal representative or relative.  If the patient is a minor, the parents or legal guardian must be notified.

## Interpretive Guidelines §482.27(b)

This regulation requires the hospital to have a system in place to take appropriate action when notified that blood or blood components it received are at increased risk of transmitting HIV or HCV.

Structured rule (JSON):
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