HospitalInspections.org

Based on review of hospital documents, policies, and staff interviews, it was determined that the hospital failed to require policies/procedures/systems/processes were identified and established that directed the staff to take action for notifying blood transfusion recipients that blood or blood components received increased the recipient's risk of contracting an infectious bloodborne pathogen/virus. This deficient practice posed the risk to patient health and safety if the hospital transfused contaminated blood and failed to notify/inform the recipient to seek testing and appropriate care.

Findings include:

The hospital's Master Blood Services Agreement with Blood Systems Inc. (signed by the hospital and the vendor on 07/29/16) requires: "...If (the vendor) becomes aware that blood or a blood component is potentially infectious, included with HIV (human immunodeficiency virus) or HCV (hepatitis C virus)...notification will be provided (to the hospital)...Upon such receipt of such notice...(the hospital) shall notify the recipient of the blood or blood component...or...recipient's physician...."

The hospital policy titled Blood Products Lookback (last revised 05/2009) requires: "...The hospital makes reasonable effort to identify and locate patients who may have been exposed to HIV, HTLV I/II or HCV...through the transfusion of blood products...identify the recipient of the blood product...provide the Blood Bank Medical Director with the information needed to notify the appropriate physician...arrange to have the recipient's blood specimen collected and forwarded to the testing facility...maintain copies of documentation of transfusion, records of notification, and specimen submission...records of the source and disposition of all units of blood and blood products are maintained for at least 10 years from the date of disposition...."

Laboratory Director #22, Blood Bank Technician #23, and Blood Bank Lead Technician #38 all indicated during interviews conducted on 05/15/17 and 05/17/17, that they were unfamiliar with the requirements for "look back".

The hospital's policy/practice failed to include the elements required in 482.27(b), regarding patient notification, physician notification, and required timeframes.