CMS SOM App. A, Tag A-0592

(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.