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Based on observation, interview, and record review, the hospital failed to ensure a lidocaine order (a medication used to treat irregular heartbeats) was administered in accordance with the Physician Orders, facility policies and accepted standards of practice when Patient 100 was administered an accidental bolus (a rapid method of administering a concentrated) dose of Lidocaine.

This failure resulted in Patient 100 suffering symptoms of Lidocaine overdose and toxicity including low blood pressure, disorientation, muscle twitching, and seizures (sudden burst of electrical activity in the brain, causing changes in behavior or movements), respiratory failure (when the lungs can't get enough oxygen into the blood). Patient 100 required medical intervention including the administration of intravenous (IV through a peripheral vein in the arm) norepinephrine [a medication for the management of severe low blood pressure] to regain stable condition in addition to being placed on ECMO (Extracorporeal Membrane Oxygenation, a life-support therapy that provides temporary heart and lung support for patients whose own organs are unable to perform adequately) and died on 7/16/25.

Findings:

During a concurrent interview and record review on 7/17/25 at 2:50 p.m. with RN 3, Patient 100's "Medical Record" dated 7/9/25 was reviewed. Patient 100 was admitted to the facility from the same level of care facility at another facility for irregular heartbeats on 7/9/25 at 1:03 a.m. to the Intensive Care Unit (ICU, a specialized unit providing high -level monitoring and treatment for patients).

A review of Patient 100's Physician Orders dated 7/9/25 indicated an order for lidocaine as follow:

Lidocaine 2,000 mg (milligram, unit of measure) in D5W IV Drip 250 ml (Intravenous bag containing sugar and water, [milliliters, unit of measure])
Ordered Dose: 2 mg/min (milligram per minute)
Admin (administration) Dose: 2,000 mcg/min (microgram/minute)
Scheduled start date/time: 7/9/25 1:30 a.m.

A review of Patient 100's Medication Administration Report (MAR) showed that lidocaine was administered to Patient 100 with a rate of 15 ml/hr (milliliter per hour, unit of measure) from 1:34 a.m. to 5:47 a.m. using pump A and again administered from 5:47 a.m. to 5:56 a.m. using pump B.

During an interview on 7/17/25 at 11 a.m. with Registered Nurse 1 (RN), RN 1 stated that there was an incident involving Patient 100 receiving an accidental bolus dose (approximately 180 ml) of lidocaine instead of the prescribed dose on 7/9/25. RN 1 stated pump B was placed in standby mode when the Nurse Practitioner (NP) requested to discontinue Patient 100's lidocaine continuous infusion of 15 ml per hour; however, when the tube was disconnected by RN 1's colleague, RN 1 observed the medication was dripping out of the tube and the lidocaine bag previously containing about 180 ml of lidocaine was observed to be empty. RN 1 acknowledged that the medication error had occurred, and it contributed to patient 100 suffering from tonic clonic seizures, a type of seizure characterized by a loss of consciousness and involuntary muscle contractions.

During an interview on 7/23/25 at 1:00pm, with RN 2, RN 2 stated Patient 100 had an emergency event on 7/9/25 at around 6:00 a.m. and after the event, RN 2 had assisted RN 1 in administering medication to help support Patient 100's blood pressure. RN 2 stated the Lidocaine tube was being disconnected from entry into Patient 100's vein and noticed fluid was dripping but the pump was still in standby mode, meaning there should not have been any fluid coming from the tube. RN 2 stated the tube labeled, "Lidocaine" toward Patient 100 was followed up to the IV bag where it was observed to be empty. RN 2 acknowledged, it was identified that Patient 100 had the accidental bolus dose of Lidocaine.

During a concurrent record review and interview on 7/17/25 at 2:58 p.m., with RN 3 and Registered Pharmacist 1 (RPh1), Patient 100's, "Medical Record, Order for Lidococaine" dated 7/9/25, indicated, the lidocaine order was placed at 1:12 a.m. and approximately 67 ml out of the full Lidocaine of 250 ml bag (dispensed from the pharmacy) was administered to Patient 100, leaving approximately 180 ml left in the bag when the administration was stopped at 5:56 a.m.

During an observation on 7/16/25 at 2:20 p.m., the empty lidocaine IV bag was still attached to pump B, in the surveyors' conference room, with the following information on the label:

Lidocaine in D5W IV Drip 2000mg/250ml
Dose: 2000 mcg/min
On the bottom of the label, it was printed:
INIT [initial] with one set of RN's initials

During an interview on 7/23/25 at 2:56 pm. with MD 1, MD 1 stated as a consultant for Patient 100 they do not write orders for medications in the medical record. MD 1 stated he spoke with NP and recommened to stop the Lidocaine transfusion since Patient 100 was indicated to be experiencing level of consciousness changes which could be associated with an unwanted symptom of someone who was not tolerating a Lidocaine continuous transfusion. MD 1 stated Patient 100 had tolerated Lidocaine infusions before, but had not experienced these symptoms and it was not uncommon to experience these symptoms if a patient was not tolerating a Lidocaine transfusion.

During an interview on 7/23/25 at 3:26 p.m. with ICU Manager, (ICU-M), ICU-M stated that lidocaine IV bag used for lidocaine administration on 7/9/25 was observed to be empty and was unable to explain how Patient 100 had received the accidental bolus dose since the three nurses in the room (Patient 100's room) observed the pump to be in standby mode. ICU-M stated, the nurse practitioner who made rounds on 7/9/25 had entered the provider held order for Lidocaine on 7/9/25 at 5:57 a.m.

The Nurse Practitioner was unavailable to be interviewed by the Department.
The Attending Physician was unavailable to be interviewed by the Department.

According to the Institute for Safe Medication Practices (ISMP), a nonprofit organization in the United States devoted to the prevention of medication errors), an Acute Care ISMP Medication safety Alert published in 2018, stated, high-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. The ISMP publication included a list of high alert/ high risk medications to determine which medications require special safeguards to reduce the risk of errors. The list included lidocaine IV.

During a review of the facility's policy and procedure (P&P) titled, "Medication Administration and Safe Practices", dated 6/20/25, the P&P indicated, "b. The medication must be removed from IV pumps and IV poles once the medication has been discontinued ...RN-#2 (person double checking med) performs an independent verification away from RN #1 by confirming 5 Rights + & appropriateness against the Prescriber order & order & any necessary reference double signature/high risk med section".

During a review of the facility's P&P titled, "High Alert Medications", dated 6/20/25, the P&P indicated, lidocaine was not part of the high alert/risk meds.

During an interview on 7/17/25 at 5:12 p.m. with the Director of Pharmacy (DOP), the DOP stated, ISMP was a reputable resource, and it did include lidocaine as a high Alert/high risk medication, but both the medication administration and high alert medication policies, did not include lidocaine as a high-risk medication.

According to the manufacturer's product labeling, Lidocaine Hydrochloride and 5% Dextrose Injection serves as a cardiac antiarrhythmic agent(medication used to prevent or correct irregular heart rhythms) intended for intravenous use. There is no specific antidote for overdose of lidocaine. The risk of overdose can be minimized by close monitoring during treatment

According to an online publication on low blood pressure by the Mayo Clinic, Mayo Foundation for Medical Education and Research (a nonprofit American academic medical center focused on integrated health care, education, and research), severely low blood pressure can reduce the body's oxygen levels, which can lead to heart and brain damage, and a sudden fall in blood pressure can be dangerous. A change of just 20 mmHg - a drop from 110 mmHg systolic to 90 mmHg systolic can cause dizziness and fainting, and significant drops in blood pressure can be life-threatening.

A review of Patient 100's clinical record showed that the Patient 100 had a lidocaine blood level of 24 mcg/mL (microgram per milliliter, unit of measure) on 7/9/25.
According to another online publication by the Mayo Clinic, for cardiac therapy, optimal therapeutic response is seen when lidocaine serum concentrations are between 1.5 and 5.0 mcg/mL. Toxicity occurs when the serum concentration of lidocaine is greater than 6.0 mcg/mL and is usually associated with symptoms of central nervous system excitation, confusion, dizziness, and blurred or double vision. This can be accompanied by bradycardia (a slow heart rate) and hypotension (low blood pressure) leading to cardiovascular collapse (a life-threatening and critical medical emergency that requires immediate intervention).

According to another Acute Care ISMP Medication safety Alert published in 2023, ISMP has advocated for the use of smart infusion pump technology with drug libraries and dose error-reduction systems (DERS) when administering intravenous (IV) infusions. The ISMP Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps included:
- Close the roller clamp: While the device's anti-free-flow protection mechanism is intended to eliminate free-flow events, it should not be solely relied upon. If the door latch has been compromised, the anti-free-flow protection may not engage when the door is opened. The antifree-flow protection is a secondary protection mechanism; the roller clamp is the primary method of preventing flow. During times when the practitioner does not intend to administer an infusion to a patient, ensure the roller clamp is closed to prevent an inadvertent bolus dose from being delivered to a patient. Only unclamp the roller clamp when starting or restarting the infusion.
-Monitor infusions for unintended flow. Periodically check throughout the infusion that the remaining infusion volume approximately corresponds to the expected delivery time. Check that there is no flow in the drip chamber whenever the pump is off, paused, or not programmed to be infusing. For critical medications, consider more frequent monitoring.

During a review of the facility's P&P titled, "Medication Administration", dated 6/20/25 the P&P indicated, "All medications require an order from authorized prescriber containing the following elements: 1. Medication/agent 2. Dose 3. Frequency 4. Route of Administration."

During a review of the facility's P&P titled, "Large Volume Pump (LVP) for Infusions with Interoperability", dated 9/2024, the P&P indicated, "Demonstrate Discontinuing Fluid Administration ...close all clamps."

Based on observation, interview, and record review, the facility failed to ensure a high risk/high alert medication (medication that carries a high risk of causing significant patient harm if used incorrectly), lidocaine (a medication used to treat irregular heartbeats was not identified as a high risk/high alert medication.

This failure had the potential to cause significant medication errors related to lidocaine overdose and toxicity including low blood pressure, seizures, or death.

Finding:

During an observation and inspection of a previously used lidocaine IV bag still attached to an infusion pump on 7/16/25 at 2:30 p.m.in the conference room, showed that the IV (intravenous [infusing into a vein])bag was labeled with the following in the center of the label:

Lidocaine in D5W IV Drip 2000mg/250ml
Dose: 2000 mcg/min
On the bottom of the label, it was printed:
INIT [initial] with one set of RN's initials

According to the Institute for Safe Medication Practices (ISMP), a nonprofit organization in the United States devoted to the prevention of medication errors), an Acute Care ISMP Medication safety Alert published in 2018, stated, high-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. The ISMP publication included a list of high alert/ high risk medications to determine which medications require special safeguards to reduce the risk of errors. The list included lidocaine IV.

During an interview on 7/17/25 at 5:12 p.m. with the Director of Pharmacy (DOP), the DOP stated, ISMP was a reputable resource and it did include lidocaine as a high Alert/high risk medication, but both the medication administration and high alert medication policies, did not include lidocaine as a high-risk medication. The DOP acknowledged both facility polices needed to be updated to follow the standards of practice.

During a review of the facility's policy and procedure (P&P) titled, "Medication Administration", dated 6/20/25, the P&P indicated, " [ double signature/high risk med section]

During a review of the facility's P&P titled, "High Alert Medications", dated 6/20/25, the P&P indicated, lidocaine was not part of the high alert/risk meds.