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Based on record review and staff interview, it has been determined that the hospital failed to ensure patients are free from hazards during the provision of radiologic services.

Findings are as follows:

1. The hospital failed to follow safety standards related to the administration of contrast dye which was injected in error into an External Ventricular Drain (EVD), a device used in neurosurgery to treat hydrocephalus and relieve elevated intracranial pressure, of a two-month-old premature infant, (Refer to A-0535).


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Based on record review and interviews, it has been determined that the hospital failed to follow safety standards related to the administration of contrast dye which was injected in error into an External Ventricular Drain (EVD), a device used in neurosurgery to treat hydrocephalus and relieve elevated intracranial pressure, of a two-month-old infant.

Findings are as follows:

The hospital reported to the Rhode Island Department of Health an incident which occurred on 6/9/2023, for a patient whom an MRI (Magnetic Resonance Imaging) with contrast was ordered, and the contrast was administered via the patient's External Ventricular Drain in error.

According to a "Medication Safety Alert" published by the Institute of Safe Medication Practices on 7/29/2021 titled, "Safety committees need to proactively address the risk of accidental cerebral injection of IV [intravenous] drugs," the following safe practices for EVDs were recommended:

" ...Affix bright warning labels. To distinguish EVD tubing from other medical tubing (including IV lines), affix a prominent and colorful label near the distal end of the EVD tubing set-up to communicate that it is a ventricular drain ...

...Provide a verbal handoff report ...For example, the trained professional accompanying a patient to the radiology suite for an invasive procedure or contrast-enhanced MRI should speak directly with the technologist or radiology practitioner(s) conducting the study, point out the EVD and the need to avoid all tubing connections and injections into any EVD access port, and identify which specific IV line and port to use if an IV injection is or might be required ...

...Perform a "time out" with all procedural staff in the room to identify the patient, the procedure being done, the access port for IV injections, and other IV lines or drains also attached to the patient...

...Trace the lines. All these cases highlight the importance of confirming the route of administration by tracing all access lines and injection ports to their origin (insertion site into the patient) prior to administration ...

...use a syringe to aspirate blood prior to injection to verify intravascular placement of a line being used for IV administration ..."

Record review revealed that Patient ID #2, a two month old premature infant who has a ventriculoperitoneal shunt (a device implanted in the head to drain excess cerebrospinal fluid) for obstructive hydrocephalus, presented to the hospital in June of 2023 for constipation and irritability.

According to nursing "Triage Notes" dated 6/8/2023, Patient ID #2 was "slightly pale" upon assessment and a slight bulging was identified at the shunt site.

Review of a note completed by Neurosurgery on 6/9/2023 at 12:52 PM revealed that a shunt removal was recommended in an "urgent fashion" since an infection was confirmed.

Patient ID #2 subsequently went to the Operating Room for a ventriculoperitoneal shunt removal on 6/9/2023 and an external ventricular drain was placed. The note states that the ventricular drain "tunneled out of the scalp" and was connected to a cerebrospinal fluid collection chamber (drainage bag).

Further review of this note revealed documentation of an active peripheral intravenous line (a small, short plastic catheter that is placed through the skin into a vein) on Patient ID #2's left hand.

After the above-mentioned procedures were performed on 6/9/2023, the Neurosurgery note states that Patient ID #2 remained intubated (a breathing tube into the trachea for mechanical ventilation) for an MRI of the brain to be obtained and the patient was subsequently transferred to the Pediatric Intensive Care Unit in stable condition.

Record review of the findings identified on Patient ID #2's brain MRI completed on 6/9/2023 states that Gadolinium contrast (an intravenous drug used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging) was injected into the patient's external vetricular drain in error resulting in the contrast entering the ventricles of the patient's brain.

Record review of a "Significant Event" note dated 6/9/2023 completed by Pediatric Critical Care states in part that during the MRI, Patient ID #2 had been accidentally administered contrast into the ventricular drain instead of the peripheral intravenous line. This resulted in a repeat dose of contrast having to be administered intravenously to obtain a second MRI. The note further indicates that after the error, the patient's ventricular drain had to be adjusted in order to drain the contrast dye and fluid out of the patients brain faster. Additionally, the note identified that this error placed Patient ID #2 at risk for seizures and medication was started to prevent seizure activity.

Review of a Pediatric Neurology Note dated 6/10/2023 at 7:51 AM states in part that two doses of 0.72 milliliters were administered to Patient ID #2, one of which was administered in error into the patient's ventricles. The note further indicates that in addition to seizure medication, which the patient was scheduled to receive twice daily thereafter, a continuous electroencephalogram (a test that measures electrical activity in the brain using small, metal discs attached to the scalp) was also ordered to "monitor for possible seizures."

During a surveyor interview on 6/16/2023 at 11:17 AM with Employee C, Intensivist (critical care physician) he revealed that prior to the administration of contrast dye a "time out" procedure was conducted to review Patient ID #2's status and all active lines were reviewed. When asked if Employee D, MRI Technologist, was present during the "time out" procedure, Employee C stated that Employee D was present. When asked if a nurse was present in the room with Employee D, Employee C stated that no nurse was present during the administration of contrast and Employee D was by himself when he administered the contrast dye.

During a surveyor interview on 6/19/2023 at approximately 11:50 AM with Employee D, MRI Technologist, he revealed that upon starting his shift he was assigned to replace one of the inital technologist who had already started this case therefore, he did not participate in the "time out" procedure. He also stated the procedure was already in process, the infant was already "on the table", and imaging had begun. Employee D then revealed that Employee C, Intensivist, told him that Patient ID #2 had "one line." Employee D revealed that at that time, he was not aware that Patient ID #2 had an external ventricular drain. Employee D indicated that after he "double checked" the contrast dye dose he was to administer, he proceeded to inject it into the stopcock (an external valve attached to tubing). When asked by the surveyor if he aspirated the line, Employee D stated that the lines for infants are small and only a small amount of dye was to be administered that he did not aspirate. Employee D revealed that while the Radiologist checked the images obtained after the contrast dye was injected, the Radiologist informed Employee C that it appeared as if Patient ID #2 had contrast dye in the ventricles. Employee D revealed that Employee C indicated the MRI needed to be repeated and the contrast dye had to be readministered. Employee D indicated he "unwrapped" Patient ID #2 who had been swaddled and saw the EVD collection chamber under the swaddle after unwrapping the infant. During the interview, Employee D acknowledged that he was unaware of the presence of the ventricular drain and did not express that he had traced the line connected to the stopcock to its origin.

During a surveyor interview on 6/16/2023 at 10:18 AM with the Director of Diagnostic Imaging, she indicated that MRI Technologists are taught to follow the line before administering contrast dye into any patient.

During a surveyor interview on 6/19/2023 at approximately 10:50 AM with the MRI Manager, she was unable to provide evidence that a thorough handoff was conducted with Employee D to identify the location of the EVD in the patient's scalp and the intravenous line on the left hand where the contrast dye should have been injected.

During a surveyor interview on 6/19/2023 at approximately 11:00 AM with the Risk Manager, she was unable to provide a policy related to the administration of Gadolinium contrast dye.

During a surveyor interview on 6/19/2023 at 10:21 AM with Employee E, MRI Technologist, and at 10:32 AM with Employee F, MRI Technologist, both indicated that it is their usual practice to confirm all present lines with a physician or a registered nurse to ensure contrast dye is injected into the appropriate line. Both Employees stated that when they provide care to infants who are swaddled, they ensure the infant is "unswaddled" and a visual inspection is conducted per the department's policy. Employee F stated that she also "unswaddles" infants to check all available lines and stated that she usually flushes the intravenous line with saline prior to the administration of contrast dye.



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Based on record review and staff interview it has been determined that the hospital failed to ensure an effective transition of a patient from the hospital to a skilled nursing facility for post-discharge care, regarding the inaccurate medication list provided to the skilled nursing facility on the continuity of care form, which resulted in a significant medication error for 1 of 5 patients reviewed who were prescribed insulin upon discharge to a skilled nursing facility (Patient ID #1).

Findings are as follows:

1. The hospital failed to prescribe the accurate insulin regimen upon transfer back to the skilled nursing facility, (Refer to A-0813).



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Based on record review and staff interview it has been determined that the hospital failed to discharge and transfer a patient along with all necessary medical information pertaining to the patient's current course of illness and treatment regarding changes to the insulin regimen for 1 of 5 patients reviewed who were prescribed insulin upon discharge to a skilled nursing facility, (Patient ID #1).

Findings are as follows:

A community reported complaint was submitted to the Rhode Island Department of Health on 6/14/2023 alleging that a patient was discharged back to a skilled nursing facility from the hospital with a higher dose of insulin without any rationale. The patient received three doses of the hospital prescribed insulin at the skilled nursing facility and subsequently expired at the facility a day and a half after being discharged from the hospital.

Record review revealed that Patient ID #1 was transferred from a skilled nursing facility in October of 2022 to the hospital's emergency room with a swollen left lower leg. Patient ID # 1's past medical history includes, but is not limited to, atrial fibrillation, diabetes, and left hip abscess.

Review of the patient's hospital record revealed documentation from the skilled nursing facility which included a medication administration record (MAR) dated October 2022 containing the following insulin administration orders:

Insulin NPH (Human) (Isophane/suspension 100 unit/milliliter (ml), inject 7 units subcutaneously at 5:00 PM
Insulin NPH (Human) (Isophane/suspension 100 unit/ml, inject 7 units subcutaneously at 8:00 AM

Review of the hospital's MAR revealed that while Patient ID #1 was in the hospital, the insulin regimen they were receiving was as follows:

Insulin Lispro (AdmeLOG, HumaLOG) Sliding Scale 0-10 Units subcutaneously three times a daily with meals and 0-6 units at bedtime

Review of the patient's hospital "Inpatient History and Physical Admission Note" dated 10/25/2022 under "Assessment and Plan" listed the following:

"Insulin-dependent diabetes hold home regimen (NPH 7 units twice daily) Sliding scale for now"

The patient was discharged from the hospital and returned to their previous skilled nursing facility on 11/6/2022.

Review of the Continuity of Care (COC) form that the skilled nursing facility received at the time of discharge revealed that Patient ID #1 was discharged with a different insulin regimen than he/she had been taking at the time of the admission and during his/her inpatient hospital stay. The COC contained the following information:

"Continue these medications which have NOT CHANGED ...

Insulin NPH-insulin regular 70/30 (Humulin 70/30 U-100 Insulin) 100 unit/ml (70/30) injection with the following details: INJECT 60 UNITS UNDER THE SKIN EVERY MORNING AND THEN INJECT 50 UNITS EVERY EVENING ...

Stop taking these medications ...

Insulin NPH (Humulin NPH, Novolin NPH) 100 units/ml with the following details Inject 7 Units under the skin every morning and Inject 7 units under the skin daily with dinner
Comments: Reason for stopping: No documentation entered ..."

Additional review of Patient ID #1's "Medication History Reconciliation" at the hospital revealed an "Order History" for "Insulin NPH- insulin regular 70/30 injection" dated 11/5/2022 at 9:48 AM. This insulin order was entered into the "Medication History Reconciliation" by Medical Resident, Employee A.

Further review of the "Order History" revealed that on 11/6/2022 at 12:00 PM, Medical Resident, Employee B, resumed the medication 70/30 insulin upon discharge.

Additional review of the "Order History" revealed that after resuming the 70/30 insulin, Employee B then discontinued the following insulin orders on 11/6/2022 at 2:38 PM:
-Insulin NPH (Humulin NPH, Novolin NPH) 100 units/ml with the following details Inject 7 Units under the skin every morning and Inject 7 units under the skin daily with dinner.

The patient's medical record failed to reveal evidence of any documentation that included a reason for the change in the patient's insulin regimen and the new addition of the 70/30 insulin.

During a surveyor interview with the Internal Medicine Resident, Employee A, on 6/15/2023 at 11:30 AM, he indicated to the surveyors that he reviewed the Patient ID #1's medical record but did not recall ordering the 70/30 insulin. Employee A then stated that he assumed the insulin regimen had been discussed during morning rounds and that he was only covering Patient ID #1 for one day, 11/5/2022. Employee A stated that it is not his practice to start a patient on 70/30 insulin and would only consider ordering it if the patient had previously been on the medication.
Employee A then stated that Patient ID #1 while in the hospital was switched to a sliding scale insulin. Employee A was then asked by this surveyor why the 70/30 Insulin order was entered into the patient's medication list, and he did not recall why it was put in. Employee A then acknowledged that after reviewing the Medication Reconciliation list, he was the one who entered the 70/30 insulin order and could not explain why.

During a surveyor interview on 6/16/2022 at 1:15 PM with Internal Medicine Resident Employee B, she acknowledged that she was the physician who completed Patient ID #1's discharge paperwork. Employee B stated that she does not remember why she discontinued Patient ID #1's NPH Insulin and continued the 70/30 Insulin upon discharge.

During the surveyor interview with Employee B, she stated that after reviewing Patient ID #1's medical record she acknowledged that upon admission in October of 2022, the patient was receiving 7 units of NPH Insulin in the morning and the evening, and she was unable to explain why the patient was discharged back to the skilled nursing facility on the 70/30 Insulin.

Both Employees A and B were unable to provide evidence of documentation in the hospital medical record of a discharge plan which included an insulin regimen for the patient upon return back to the skilled nursing facility. Additionally, they were unable to provide evidence of any documentation that included a reason for the change in the patient's insulin regimen and the new addition of the 70/30 insulin.






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