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3015 N BALLAS RD

TOWN AND COUNTRY, MO 63131

ORDERS FOR DRUGS AND BIOLOGICALS

Tag No.: A0409

Based on observation, interview, and record review, the facility failed to follow its policy with regard to administration of five blood products for three (#4, #5, and #19) of four patient medical records reviewed having received blood products while in the facility. The facility census was 239.

Findings included:

1. Record review of the facility's policy titled, "Blood Administration," dated 12/17/10, showed the following direction:
- Obtain baseline vital signs (temperature, pulse, respirations, and blood pressure) no more than 30 minutes prior to initiation of a transfusion.
- Record patient's vital signs:
- Within 5-15 minutes of initiation of the transfusion;
- Periodically throughout transfusion as warranted by clinical observation of patient;
- Within 30 minutes of completion of the transfusion.
- Initiate infusion of blood products within 30 minutes of receiving.

Record review of the facility's "Blood Component Transfusion Record" form showed boxes for documentation of vital signs three times during each transfusion - Pre-transfusion, 15 minutes Interim, and Post-transfusion. The form did not require documentation of the time the vital signs were obtained.

2. Record review of Patient #4's Electronic Medical Record (EMR) and "Blood Component Transfusion Record" forms showed the following:
- Unit #17LJ02942 was initiated on 04/04/12 at 6:00 PM.
- "Interim" vital signs were documented on the "Blood Component Transfusion Record," however the time the vital signs were obtained was not documented. Therefore, it was impossible to determine whether the vital signs were taken within 15 minutes after the transfusion was initiated. Review of the EMR failed to show documentation of this set of vital signs.
- Unit #17KG15291 was initiated on 04/08/12 at 4:04 PM and was completed at 6:34 PM.
- Review of the EMR showed that vital signs documented as "post-transfusion" on the "Blood Component Transfusion Record" were obtained at 5:42 PM.
- No vital signs were documented between 6:34 PM and 7:04 PM.

3. Record review of Patient #5's EMR and "Blood Component Transfusion Record" forms showed the following:
- Unit 11KV58167 was initiated on 04/04/12 at 11:30 AM.
- "Interim" vital signs were documented on the "Blood Component Transfusion Record," however the time the vital signs were obtained was not documented. Therefore, it was impossible to determine whether the vital signs were taken within 15 minutes after the transfusion was initiated. Review of the EMR failed to show documentation of this set of vital signs.
- Unit 17GL32007 was released from the Laboratory on 04/04/12 at 3:19 PM.
- Review of the "Blood Component Transfusion Record" form showed that the blood transfusion was initiated at 3:30 PM, however review of the EMR showed that the transfusion was initiated at 4:08 PM. There was no documentation explaining the delay in initiating the transfusion.
- Review of the EMR showed that vital signs documented as "pre-transfusion" on the "Blood Component Transfusion Record" were obtained at 2:56 PM. There was no evidence that "pre-transfusion" vital signs were obtained a second time (as required by policy) when the transfusion was delayed.
- Documentation on the "Blood Component Transfusion Record" showed that the transfusion was completed at 7:15 PM. Review of the EMR showed that "post-transfusion" vital signs were not obtained within 30 minutes as required by policy. Vital signs documented as "post-transfusion" on the "Blood Component Transfusion Record" were obtained at 8:09 PM.

4. Record review of Patient #19's electronic medical record and "Blood Component Transfusion Record" form showed the following:
- Unit 11LQ02268 was initiated on 04/10/12 at 9:24 AM.
- Review of the "Blood Component Transfusion Record" form showed "pre-transfusion" vital signs, however the time the vital signs were obtained was not documented. Therefore, it was impossible to determine whether the vital signs were taken within 30 minutes prior to the initiation of the transfusion. Review of the EMR failed to show documentation of this set of vital signs.
- Review of the EMR showed that "Interim" vital signs were not obtained within 15 minutes of transfusion initiation, as required by policy. The vital signs documented as "Interim" on the "Blood Component Transfusion Record" were obtained at 10:00 AM.
- The "Blood Component Transfusion Record" showed the transfusion was completed at 12:40 PM. Review of the EMR showed that "post-transfusion" vital signs were not obtained within 30 minutes as required by policy. Vital signs documented as "post-transfusion" on the "Blood Component Transfusion Record" were obtained at 2:00 PM.

5. During an interview on 04/10/12 at 10:20 AM, Staff BB, Educator, stated nurses were trained to record vital signs taken during transfusion on the "Blood Component Transfusion Record," and were taught to enter this information into the patient's EMR after the completion of the transfusion.

During an interview on 04/10/12 10:24 AM, Staff AA, Registered Nurse (RN) made the following statements:
- Because the time vital signs were obtained was not documented on the form, the nurse would estimate the "Interim" vital sign timeframe based on the time the blood transfusion was initiated.
- If routine vital signs were taken during the time the blood was infusing, those vital signs could be used as one of the required sets of vital signs (as appropriate), or they could be used as additional evidence of monitoring during transfusion.
- To her knowledge, no one reviewed the "Blood Component Transfusion Record" forms to determine whether the blood was hung in a timely manner, whether vital signs were taken as required by policy, or whether blood was transfused within required timeframes.

During an interview on 04/10/22 at 10:26 AM, Staff X, Inpatient Business Manager, stated the time the blood was issued from the Blood Bank was not recorded on the form, but that information was documented and kept in the Blood Bank.

During an interview on 04/11/22 at 11:00 AM, Staff AA stated that the "Blood Component Transfusion Record" had been revised to add boxes for date and time of vital signs to be entered, and acknowledged:
- that errors occurred when nurses were required to transfer information from a form into the EMR;
- that staff were not following the facility policy in regard to initiating transfusions in a timely manner; and
- that vital signs were not being taken and/or recorded in a manner that was consistent with the facility policy.