CMS SOM App. W, Tag C-0890

The facility provides, either directly or under arrangements, the following--

(1) Services for the procurement, safekeeping, and transfusion of blood, including

the availability of blood products needed for emergencies on a 24-hours a day basis.

Interpretive Guidelines §485.618(c)(1)

This requirement can be met at a CAH by providing blood or blood products on an

emergency basis at the CAH, either directly or through arrangement, if that is what the

patient's condition requires. There is no requirement in the regulation for a CAH to store

blood on site, although it may choose to do so. In some cases, it may be more practical to

transport a patient to the source of the blood supply than to bring blood to the patient at

the CAH. A facility that has the capability of providing blood services on site would be

in compliance even if, in virtually all cases, the patients were actually taken to the blood

rather than vice versa.

A CAH that performs CLIA tests on blood on-site must have a CLIA certificate and is

subject to survey under CLIA. A CAH that is only storing blood for transfusion and

refers all related testing out to another laboratory, is not performing testing as defined by

CLIA. However, under this regulation, the CAH must ensure that blood is appropriately

stored to prevent deterioration, including documenting refrigerator temperatures. The

provision of blood services between the CAH and the testing laboratory should be

reflected in the written agreement or arrangement between the two. Also, if the CAH is

collecting blood, it must register with the Food and Drug Administration.

“Availability” in this context, means that the blood and blood products must be

accessible to CAH staff in time to effectively treat emergency patients at the CAH. In

order to comply with this requirement, a CAH must demonstrate that it has the capability

(i.e., an effective system is in place regardless of whether, in actual practice, it has been

utilized) of making blood products available to its emergency patients 24 hours a day.

If a CAH performs type and compatibility testing it must have the necessary equipment,

(i.e., serofuge and heat block), as well as typing and cross matching reagents, some of

which have a 30-day expiration date. Another way for a CAH to meet this requirement

would be to properly store 4 units of O negative packed red blood cells (the universal

donor type) for availability at all times for emergencies only. CAHs that choose to store

O negative packed red blood cells for emergency release of uncross matched blood will

require a release form to be signed by a doctor, prior to transfusion, acknowledging that

the blood has not been cross matched for the patient. Facilities that elect to store units of

O negative packed red blood cells should be able to demonstrate that they have an

arrangement (e.g., with the Red Cross or other similar product provider) for the provision

of fresh units of O negative packed red blood cells.