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Based on document review, medical record review, and interview, the hospital failed to ensure the administration of blood and blood products was conducted in accordance with facility policy and New York State regulations.

Refer to findings under Tag #A0409.

Based on document review, medical record review, and interview, the facility did not ensure the administration of blood and blood products was conducted in accordance with facility policy and New York State Title 10 Codes, Rules and Regulations Subpart 58-2, Blood Banks in 11 of 14 records reviewed. Failure to adhere to policy and regulation for the administration of blood and blood products increases the liklihood of an adverse event occurring.

Findings include:

Review of New York State Title 10 Codes, Rules and Regulations Subpart 58-2, Blood Banks revealed:

58-2.8(a) Current standard operating procedure manuals or other procedural guides specific to the facility shall be available at all times in the immediate work area of personnel engaged in the collection, processing, testing, storage, distribution and administration of blood, blood components or derivatives for autogenic or allogenic use, and for therapeutic, prophylactic or diagnostic purposes; and (d) The policies and procedures specified in the procedure manual shall be followed at all times.

58-2.18 Records to be kept when blood or blood component transfusions are performed: (c) date of the transfusion and quantity of material transfused; and (d) time of starting and time of completing the transfusion.

58-2.27(g) No reinfusion of a processed product shall be performed unless two individuals other than the patient have confirmed the identity of the recipient and the product to be reinfused as matching in name and in at least one additional identifier. This confirmation shall be documented in writing.


Review of facility policy #TX.052.3201 "Administration of Blood/Blood Products Protocol", last reviewed 11/30/11, revealed the following:

1. The physician must obtain the patient's consent for the administration of blood/blood products using the "Consent for Transfusion of Blood, Plasma, and other Blood Components" form.
8. Additionally, ensure that the code number on the blood armband matches the code number on the blood compatibility tag. The two RNs (registered nurses) or one RN and an IV Certified LPN (licensed practical nurse) must then sign the top of the blood/blood products record slip after verifying the elements in #7 and #8.
13. After blood transfusion is complete record the time, volume, lung sounds, and post transfusion vital signs in the blood/blood products documentation
14. REMEMBER-Documentation to include the following: ... d. The time the transfusion started.... Record this time on the blood/blood products record.

In addition, the policy indicates blood products are to be infused in 2-4 hours, but not to exceed 4 hours.


Medical record review on 11/10/15 for the following patients who received blood transfusions revealed:
- The record for Patient #5 showed the Consent for Non-Emergent Transfusion of Blood, Plasma and Other Components document was signed and dated by the physician on 2/2/15 at 4:40 PM, but it contained no documentation of patient consent for blood transfusion.
- The records for Patients #8-11 and 15 had no documentation of the "total volume infused value" on the Blood/Blood Product Transfusion form.
- The records for Patients #6-8, 10, 12 and 13 had no documentation of transfusion start time on the Blood/Blood Product Transfusion form.
- The records for Patients #8 and 14 had no documentation of a second licensed nurse signature on the Blood/Blood Product Transfusion Form.
- The records for Patients #9, 12 and 15 had no documentation of 30 minute post transfusion vital sign values on the Blood/Blood Product Transfusion Form.
- The record dated 1/12/15 at 5:15 PM for Patient #16 contained an order for blood transfusion to not exceed 4 hours total. The transfusion was completed in 5 hours 15 minutes.

These findings were verified with Staff F and J on 11/10/15 at 1:00 PM.