The hospital safely provides blood and blood components.

(1)

For hospitals that use Joint Commission accreditation for deemed status purposes: The hospital develops and implements written policies and procedures, including documentation and notification procedures, addressing potentially infectious blood and blood components, consistent with Centers for Medicare & Medicaid Services requirements at 42 CFR 482.27. Note 1: The procedures for notification and documentation conform to federal, state, and local laws, including requirements for the confidentiality of medical records and other patient information. Note 2: See the Glossary for definitions of potentially infectious blood and blood component.

(2)

For hospitals that use Joint Commission accreditation for deemed status purposes: If the hospital receives notification of blood that is reactive to the human immunodeficiency virus (HIV) or hepatitis C virus (HCV) screening test, the hospital determines the disposition of the blood or blood components and quarantines all previously donated blood and blood components in inventory.

(3)

For hospitals that use Joint Commission accreditation for deemed status purposes: If the hospital receives notification that the result of the supplemental (additional, more specific) test for potentially infectious blood or blood components or other follow-up testing required by the US Food and Drug Administration is negative and there are no other informative test results, the hospital may release the blood and blood components from quarantine.

(4)

For hospitals that use Joint Commission accreditation for deemed status purposes: If the hospital receives notification that the result of the supplemental (additional, more specific) test for potentially infectious blood or blood components or other follow-up testing required by the US Food and Drug Administration is positive, the hospital does the following: - Disposes of the blood and blood components - Notifies the transfusion recipients as set forth in 42 CFR 482.27(b)(6)

(5)

For hospitals that use Joint Commission accreditation for deemed status purposes: If the hospital receives notification that the result of the supplemental (additional, more specific) test for potentially infectious blood or blood components or other follow-up testing required by the US Food and Drug Administration (FDA) is indeterminate, the hospital destroys or labels prior collections of blood or blood components held in quarantine, consistent with FDA requirements 21 CFR 610.46(b)(2) and 610.47(b)(2).

(6)

For hospitals that use Joint Commission accreditation for deemed status purposes: When potentially human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infectious blood or blood components are administered (either directly through the hospital’s own blood collecting establishment or under an agreement) or released to another entity or individual, the hospital takes the following actions: - Makes reasonable attempts to notify the patient, the attending physician or other licensed practitioner, or the physician or other licensed practitioner who ordered the blood or blood component and ask the practitioner to notify the patient, or other individuals as permitted under 42 CFR 482.27, 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 - Attempts to notify to the patient, legal guardian, or relative if the practitioner is unavailable or declines to make the notification - Documents in the patient’s medical record the notification or attempts to give the required notification

(7)

If the hospital receives notification that it received potentially human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infectious blood and blood components, the hospital makes reasonable attempts to give notification over a period of 12 weeks unless one of the following occurs: - The patient is located and notified. - 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 time frame to exceed 12 weeks. Note: For notifications resulting from donors tested on or after February 20, 2008, as set forth at 21 CFR 610.46 and 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.

(8)

When notifying patients who have received potentially human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infectious blood or blood components, the notification includes the following: - Oral or written information explaining the need for HIV or HCV testing and counseling, so that the patient can make an informed decision about whether to obtain HIV or HCV testing and counseling - 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)

If a patient has received an infectious blood or blood component, the hospital notifies the specified individual(s) under the following circumstances: - A legal representative designated in accordance with state law if the patient has been adjudged incompetent by a state court - The patient or their legal representative or relative if the patient is competent but state law permits a legal representative or relative to receive the information on the patient's behalf - The patient's legal representative or relative if the beneficiary of the potentially human immunodeficiency virus infectious transfusion is deceased - The parents or legal guardian if the patient is a minor

(10)

The hospital complies with US Food and Drug Administration regulations pertaining to blood safety issues in the following areas: - Appropriate testing and quarantining of infectious blood and blood components - Notification and counseling of potential recipients of infectious blood and blood components Note: This applies to lookback activities only related to new blood safety issues that are identified after August 24, 2007.