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Based on records reviewed and interviews, the Hospital failed to ensure for one (Patient #1) patient out of ten sampled patients, that the safe preparation and administration of the life-saving blood pressure medication (Norepinephrine) was in accordance with accepted standards of care.

Findings included:

1.) The Hospital failed to have policies, procedures, guidelines, or education to ensure consistent nursing practice and competency regarding Intravenous Infusion Pumps that promoted safe medication preparation and administration of Norepinephrine to Patient #1 in accordance with accepted standards of practice required for safe medication administration.

The document titled, Building a Smart Infusion System Drug Library, https://www.ismp.org/sites/default/files/attachments/2017-11/Building-Smart-Infusion-System-Drug-Library.pdf, indicated detailed guidance for programming the computerized Intravenous Infusion Pumps regarding Volume To Be Infused (VTBI, the programmed volume of a medication that an Intravenous Infusion Pump would deliver). The Institute of Safe Medicine Practice (ISMP) document, Building a Smart Infusion System Drug Library, indicated the VTBI should not exceed the labeled total volume on the intravenous (IV) container (bag). The ISMP document indicated at completion of the programmed infusion (of the medication), the Intravenous Infusion Pump would infuse at the Keep Vein Open (KVO) rate configured (pre-programmed) for the medication or at the current (medication) infusion rate if it was lower than the configured KVO rate. The KVO rate was not intended as a therapeutic (treatment) dose. The ISMP document indicated that the Hospital's configured drug library software (Intravenous Infusion Pump Reference Tool) may provide configurable KVO options specific to each medication.

The Surveyor interviewed the Surgical Intensive Care Unit (SICU) Nurse Manager at 11:00 A.M. on 10/28/19. The SICU Nurse Manager said this was a VTBI issue. The SICU Nurse Manager said Registered Nurse #1 (the night nurse) programmed the VTBI greater that the estimated volume of medication in the intravenous medication bag when the VTBI alarmed that the VTBI was complete. The SICU Nurse Manager said RN #2 (the following nurse on the day shift) did not evaluate with the off-going night nurse (RN #1) during change of shift bed-side report a visualization of the intravenous medication bag. The SICU Nurse Manager said Patient #1's intravenous medication bag ran dry (the intravenous medication bag of Norepinephrine had completed and was empty), and Patient #1 had a cardiac arrest as RN #2 changed the intravenous medication bag. The SICU Nurse Manager said Patient #1 was without the medication, Norepinephrine, for approximately 90 seconds. The SICU Nurse Manager said that patients received Norepinephrine on six different units in the Hospital that included the Operating Room, the Recovery Room, the Emergency Department and three Intensive Care Units. The SICU Nurse Manager said she did not know what other nursing educators taught nursing staff working in the six units where patients received Norepinephrine.

The Surveyor interviewed Nurse Educator #1 at 1:00 P.M. on 10/28/19. Nurse Educator #1 said that she could not ensure that all nurse educators were teaching the same nursing procedures regarding VTBI. Nurse Educator #1 said the nurses estimate the volume left in the bag. Nurse Educator #1 said she taught nurses to prime the intravenous tubing with 25 milliliters from the intravenous medication bag. Nurse Educator #1 said that she taught nurses to program the Intravenous Infusion Pump VTBI at 200 milliliters for a 250 milliliter bag of medication.

The Surveyor interviewed the Attending Physician at 1:00 P.M. on 10/28/19. The Attending Physician said that Patient #1 would have a cardiac arrest related to not receiving the medication, Norepinephrine, due Patient #1's completely severed spinal cord.

The Surveyor interviewed the Clinical Engineer (Hospital resource for Intravenous Infusion Pumps) at 2:00 P.M. on 10/28/19. The Clinical Engineer provided two examples of infusion rates after VTBI was reached. The Clinical Engineer said if the infusion rate was greater than 20 milliliters per hour/hr for a medication and VTBI was completed, the infusion rate would decrease to 20 milliliters per hour. The Clinical Engineer said if the infusion rate was less than 20 milliliters per hour, then the infusion rate would remain at the same rate. For example, if the infusion rate was set for 5 milliliters per hour, and the VTBI was completed, then the infusion rate would continue at 5 milliliters per hour.

Regarding two patients (Patient #3 & #5) and Norepinephrine rates greater than 20 milliliters per hour:

The Surveyor interviewed the Pharmacist at 2:25 P.M. on 10/28/19. The Pharmacist said that the Hospital followed the ISMP as a standard of care and was unaware of constant infusion medications that were administered at a rate greater than 20 milliliters per hour.

Medical Record review of Patient #3's Flow-Sheet, dated at 9:30 A.M. on 10/27/19, indicated a rate of Norepinephrine at 56.3 milliliters per hour (inconsistent with the interview of Pharmacist #1). The Flow-Sheet indicated that if the VTBI alarmed, completed, and the Intravenous Infusion Pump decreased its rate of medication administration to 20 milliliters per hour and Patient #3 would receive less that the prescribed dosage of Norepinephrine therefore potentially increasing the risk of Patient #3 to experience an adverse event.

Medical Record review of Patient #5's Flow-Sheet, dated at 5:06 A.M. on 10/10/19, indicated a rate of Norepinephrine at 37.5 milliliters per hour (inconsistent with the interview of the Pharmacist). The Flow-Sheet indicated that if the VTBI alarmed, completed, and the Intravenous Infusion Pump decreased its rate of medication administration to 20 milliliters per hour, Patient #5 would receive less that the prescribed dosage of Norepinephrine therefore potentially increasing the risk of Patient #5 to experience an adverse event.

The Surveyor interviewed Nurse #4 at 10:25 A.M. on 10/29/2019. Nurse #4 said that when a VTBI was completed, the Intravenous Infusion Pump begins to beep, making her aware that the manually entered VTBI was completed. Nurse #4 said this prompts her to obtain a new IV bag. Although Nurse #4 acknowledged that there was still drug volume in the IV bag (as is the intent is to ensure the given patient does not run out of medication), Nurse #4 said she was unaware how the pump operated (relative to infusion rate) during the time period between when a programmed VTBI was reached and to when the actual remaining volume was totally infused (signifying an empty bag, air in the line and thus the pump completely stopped).

The Surveyor interviewed Nurse #5 at 11:45 A.M. on 10/29/19. Nurse #5 said that when VTBI was completed, the Intravenous Infusion Pump begins to beep, making her aware that the manually entered VTBI was completed. Nurse #5 said this prompts her to go obtain a new IV bag. During the time period between the VTBI was completed and to when the actual remaining volume was totally infused, Nurse #5 said that the pump continued to infuse at the given rate specified.

The policy titled, Medication Administration, dated 01/2018, indicated that the purpose of this policy was "to ensure that all medication(s) were administered accurately and safely". The Medication Administration policy indicated no guidance for continuous medication infusion VTBI in accordance with ISMP guidelines (https://www.ismp.org/sites/default/files/attachments/2017-11/Building-Smart-Infusion-System-Drug-Library.pdf)

The Hospital provided no policies, procedures, guidelines, or education to ensure consistent nursing practice regarding VTBI.


2.) The Hospital failed to comply with requirements under the Quality Assessment and Performance Improvement (QAPI) Condition of Participation that used a comprehensive systems approach to all components of the medication process. The Hospital failed to conduct a thorough investigation, identify a thorough and complete plan for effective and corrective actions after Patient #1's adverse patient event.

Findings included:

The Institute of Safe Medicine Practice (ISMP) document, Building a Smart Infusion System Drug Library, indicated the KVO rate was not intended as a therapeutic dose. The ISMP document indicated that the Hospital's configured drug library software (Intravenous Infusion Pump Reference Tool) may provide configurable KVO options specific to each drug.

The document titled, Intravenous Infusion Pump Reference Tool, dated 5/2019, indicated intravenous drug therapy concentrations. The Intravenous Infusion Pump Reference Tool indicated high and low limit parameters for the life-saving blood pressure medication, Norepinephrine. The Intravenous Infusion Pump Reference Tool did not indicate a VTBI reference for Norepinephrine.

Pharmacist #1 said that the Intravenous Infusion Pumps were not pre-programmed for VTBI by Pharmacy.

The SICU Nurse Manager said that patient's received Norepinephrine on six different units in the Hospital, that included the Operating Room, the Recovery Room, the Emergency Department and three Intensive Care Units. The SICU Nurse Manager said that the Hospital did not document audits on paper and that the Hospital did not conduct audits after Patient #1's adverse event specific to nursing practices of VTBI.

Nurse Educator #1 said that VTBI was not a part of the action plan and the Hospital thought the event was an isolated event (that is: pertaining to the nursing practice of RN's #1 & #2).

The Surveyor interviewed the Chief Nursing Officer at 3:16 P.M. on 10/28/19. The Chief Nursing Officer said that nursing practice regarding VTBI was not brought to a nursing council (nursing review committee) for review regarding Patient #1's adverse event.

The Hospital provided no documentation of QAPI activities that investigated the capabilities of the Hospital's Intravenous Infusion Pumps to configure KVO options specific to Norepinephrine and the Hospital provided no documentation of QAPI activities that evaluated nursing practice and knowledge regarding VTBI in the six units where Patient's received Norepinephrine in order to develop an effective and preventative corrective action plan.