CMS SOM App. A, Tag A-0411

adverse drug reactions, and errors in administration of drugs.

Interpretive Guidelines §482.23(c)(5)

Adverse drug reactions and drug administration errors

There is a similar but more detailed and prescriptive requirement concerning internal hospital

reporting of adverse drug reactions, drug administration errors and incompatibilities under the

Pharmaceutical Services CoP at §482.25(b)(6). Therefore, it is not necessary for hospitals to

establish a different procedure in the case of adverse drug reactions and drug administration

errors for such events when nurses administer drugs or transfusions. Consult the guidance for

§482.25(b)(6) to see what must be reported, to whom, and in what timeframe. Failure to make

required reports concerning adverse drug reactions and errors in administration of drugs should

be cited under §482.23(c)(5) when the drug was administered by a nurse, as well as under

§482.25(b)(6).

Transfusion reactions

Transfusion reactions can occur during or after a blood transfusion. A patient’s immune system

recognizes the foreign blood product and attempts to destroy the transfused cells. Incompatible

blood products are typically the cause of transfusion reactions. Symptoms may include back

pain, bloody urine, hives, chills, fainting, dizziness, fever, flank pain, and skin flushing. More

serious complications may include acute kidney failure, anemia, respiratory distress, shock and

even death.

Transfusion reactions are serious and can be life-threatening. The hospital must have policies

and procedures in place for the internal reporting of transfusion reactions. The policies must

include procedures for reporting transfusion reactions immediately to the practitioner responsible

for the care of the patient. The transfusion reaction must also be reported to the hospital-wide

quality assessment performance improvement program as an adverse event, in accordance with

the QAPI CoP at 42 CFR 482.21(c)(2). The transfusion reaction must be documented in the

patient’s medical record, including the prompt notification of the responsible practitioner.

Survey Procedures §482.23(c)(5)

• For adverse drug events and medication administration errors, follow the survey

procedures for §482.25(b)(6). Deficiencies are to be cited under both §482.23(c)(5)and

§482.25(b)(6) when the drug or transfusion related to an adverse drug reaction,

transfusion reaction or medication administration error relates to a drug or transfusion

administered by a nurse.

• Request the hospital policy and procedure for internal reporting of transfusion reactions.

• Interview nursing staff responsible for administering blood transfusions to determine

whether they are familiar with and comply with the hospital’s policies.

• Ask to see if there are any transfusion-related incident reports. Is there evidence that the

transfusion reaction was reported immediately to the practitioner responsible for the

patient’s care? Was it reported to the hospital’s QAPI program?