HospitalInspections.org

Based on interviews and records reviewed the Hospital failed for two (Patient #3 and Patient #9) patients of 10 sampled patients to follow their Hospital Policies and Procedures and ensure immediate corrective actions took place, timely implementation of preventative actions took place and disclosing adverse events to patients/family took place.

See A-0283

Based on interviews and records reviewed the Hospital failed for two (Patient #3 and Patient #9) patients of 10 sampled patients to follow their Hospital Policies and Procedures and ensure immediate corrective actions took place, timely implementation of preventative actions took place and disclosing adverse events to patients/family took place after; Patient #3's Computed Tomography Scan (CT scan) results were not read for two days, leading to emergency surgery and extended hospitalization for septic shock and for Patient #9 who received the wrong dose of fentanyl, who received 2000 mcg (micrograms) instead of 125 mcg.

Findings include:

1. For Patient #3, the Hospital failed to identify and implement corrective actions after an abdominal CT scan was not read and accidentally finalized by the physician to have normal findings, however, two days later, on 7/17/20, it was discovered that fluid and free air were obvious upon review of the films taken on 7/15/20.

Review of the Hospital's Quality Assessment and Performance Improvement Plan, date March 2020, indicated that the Hospital will promote teamwork and group responsibility and accountability in identifying, implementing and improving care and services.

It was reported by the Hospital that on 7/15/20 Patient #3 arrived in the emergency department following a motor bike collision resulting in Level 1 Trauma Activation. The Hospital further reported Patient #3 had multiple evident fractures to his/her face and forearms on arrival to the Emergency Department. The Hospital reported that on 7/17/20 Patient #3 became hypotensive/tachycardic with a rigid abdomen. Patient #3 had a positive bedside ultrasound for blood around the abdominal organs. The patient was transferred to the Intensive Care Unit (ICU) and then take to the operating room (OR) for a proximal jejunal transection, repair of a partial serosal tear and repair of a full thickness injury. The Patient was then brought back to the OR on 7/19/20 for re-exploration of the abdomen, washout, resection of about 45 cm of jejunim with primary hand sewn anastomosis and inflamed bowel. Patient #3 was taken back to the OR on 7/21/20 for final closure. It was reported that the findings of this investigation determined that this event was a result of human error and not systemic issues.

However, review of the Trauma History and Physical dated 7/15/20, indicated that there were bilateral wrist fractures, with arterial bleeding (upper abdominal firm to palpation. Abdominal system review indicated that there was mild tenderness to palpation bilaterally over abdomen. The focused assessment with sonography in trauma (FAST) showed some fluid in the abdomen.

Review of the CT results dated 7/15/20 indicated that there is no evidence of acute traumatic injury to the chest, abdomen or pelvis.

Review of the Plastic and Reconstructive Surgery consult dated 7/16/20 at 1:06 A.M. indicated that Patient #3 reports abdominal pain.

Review of the Orthopedic Surgery Consult to History and Physical Note dated 7/16/20 at 7:07 A.M. indicated that Patient #3 complained of some pain in his/her upper abdomen.

Review of the significant event note dated 7/16/20 at 6:08 P.M., indicated that Patient #3 was unable to void using urinal in bed. Bladder scan performed. Patient with good oral intake and continues with intravenous fluids.

Review of the significant event note dated 7/17/20 at 11:10 A.M., indicated that Patient #3 was unable to urinate. The bladder scan result was questionable, thus specimen obtained with intermittent urinary catheter.

Review of the Rapid Response Event Record dated 7/17/20 at 2:52 P.M., indicated that a rapid response was called for hypotension with systolic blood pressure in the 80's and tachycardia with heart rate in the 150's range. Patient assessed to have a firm, tender abdomen and there was concern for possible intra-abdominal bleeding. Stat labs ordered, CT scan of the abdomen and Patient #3 to be transferred to the ICU.

During an interview with Risk Manager #2 on 11/17/20 at 12:30 P.M., Risk Manager #2 said that during review of the case, it was identified that the original CT Scan on 7/15/20 of the abdomen was never read by the radiologist. Risk Manager #2 said that this CT scan was linked with multiple other scans for review when all results were final. Unfortunately, the Radiologist "signed" the results instead of saving them to read when all results were available. Signing the reports, instead of saving the reports to read later led to the inappropriate findings that the CT Scan of Patient #3's abdomen was "normal", although the CT scan was never read at all by the radiologist on 7/15/20. When the original CT scan films were reviewed on 7/17/20, it was discovered that the fluid and free air were obvious upon review on 7/15/20. Risk Manager #2 said that it was determined that the Hospital could possibly look into updating the software to prevent the radiologist from signing an unread report by doing a hard stop or updating the software to notify that the record hasn't been read before they do the final signature.

During an interview with Physician #1 on 11/17/20 at 1:00 P.M., Physician #1 said that this has happened in the past and will happen again if you hit the sign button without reading the results. The software utilized by the hospital defaults to "Normal" when signed if the physician doesn't write any specific findings. Physician #1 said that if there was a "pop-up" that alerted the Physician that no changes have been made to the findings when signing the document.

During an interview with Physician #2 on 11/17/20 at 1:30 P.M., Physician #2 said that there was documented abdominal pain and the history and physical identified a +FAST; when you put those together the clinical decision can be determined without having imaging. Physician #2 said that on 7/17/20, the surgeon read the abdominal CT scan from 7/15/20 and saw that it was misread and/or not read.

During an interview with Physician #1 on 11/18/20 at 9:15 A.M., Physician #1 said that that the software could possibly be updated to include a "time out".

During an interview with Risk Manager #2 on 11/19/20 at 10:00 A.M., she said that no immediate corrective actions took place as a result of this investigation.

The Hospital failed to identify any corrective measures to prevent the Radiologists from being able to sign the reports without reading them, leaving other patient's vulnerable to a like occurrence resulting in increased level of care needs, multiple surgeries and prolonged hospitalization.

2. For Patient #3, the Hospital failed to properly communicate findings of unanticipated outcomes to a patient according to their policy and procedure.

Review of the Hospital's Communication of Unanticipated Outcomes/Apology and Disclosure policy dated 1/18/2019 indicated that documentation in the patient's medical record should include a summary of the event, discussion with the patient/family/authorized representative, their understanding of the information received and the plan of care for monitoring and treating the patient.
It was reported by the Hospital that on 7/15/20 Patient #3 arrived in the emergency department following a motor bike collision resulting in Level 1 Trauma Activation. The Hospital further reported Patient #3 had multiple evident fractures to his/her face and forearms on arrival to the Emergency Department. The Hospital reported that on 7/17/20 Patient #3 became hypotensive/tachycardic with a rigid abdomen. Patient #3 had a positive bedside ultrasound for blood around the abdominal organs. The patient was transferred to the Intensive Care Unit (ICU) and then take to the operating room (OR) for a proximal jejunal transection, repair of a partial serosal tear and repair of a full thickness injury. The Patient was then brought back to the OR on 7/19/20 for re-exploration of the abdomen, washout, resection of about 45 cm of jejunim with primary hand sewn anastomosis and inflamed bowel. Patient #3 was taken back to the OR on 7/21/20 for final closure. It was reported that the findings of this investigation determined that this event was a result of human error and not systemic issues.

However, review of the Trauma History and Physical dated 7/15/20, indicated that there were bilateral wrist fractures, with arterial bleeding (upper abdominal firm to palpation. Abdominal system review indicated that there was mild tenderness to palpation bilaterally over abdomen. The focused assessment with sonography in trauma (FAST) showed some fluid in the abdomen.
In an interview with Risk Manager #2 on 11/17/20 at 12:30 P.M., Risk Manager #2 said that during review of the case, it was identified that the original CT Scan on 7/15/20 of the abdomen was never read by the radiologist. Risk Manager #2 said that this CT scan was linked with multiple other scans for review when all results were final. Unfortunately, the Radiologist "signed" the results instead of saving them to read when all results were available. Signing the reports, instead of saving the reports to read later led to the inappropriate findings that the CT Scan of Patient #3's abdomen was "normal", although the CT scan was never read at all by the radiologist on 7/15/20. When the original CT scan films were reviewed on 7/17/20, it was discovered that the fluid and free air were obvious upon review on 7/15/20.

During an interview with Physician #1 on 11/17/20 at 1:00 P.M., Physician #1 said that the images were not read for a few days which lead to Patient #3 having multiple surgeries.

During an interview with the Associate Vice-President of Quality Compliance and Regulation on 11/18/20 at 10:30 A.M., she said that there was no formal disclosure to Patient #3 regarding the fact that his/her CT scans weren't read timely. Just a conversation with the patient.

The Hospital failed to provide documentation in Patient #3's medical record that included a summary of the event, discussion with the patient/family/authorized representative, their understanding of the information received and the plan of care for monitoring and treating the patient.

3. For Patient #9, the Hospital failed to implement timely preventive actions for staff across all departments potentially impacted, to prevent the potential for future medication pump errors following an intravenous (IV) Fentanyl overdose (an opioid used to treat patients in extreme pain)

Fentanyl is a High-alert medication or a drug that bears a heightened risk of causing significant patient harm when it's used in error.

Review of the Hospital's policy Management of High Risk/High Alert Medications, dated 1/16/2020 indicates the following :

* Independent verification with double signature documented on the high alert medication MAR (medication administration record).
* Smart pump settings, including but not limited to, selected concentration and infusion rate.
(The Hospital does not currently have a policy for the transfer of high alert medications to a new pump such as the MRI Iradimed pump used for Patient #9).

On 8/24/2020, Patient #9 was in the Critical Care Unit (CCU) with a diagnosis of encephalopathy (brain disease or damage due to an infection) with respiratory failure and on mechanical ventilation (a breathing machine). The Patient was receiving Fentanyl, 125 micrograms (or 0.125 milligrams and @ 6.25 ml/hour) per hour via a "Smart" pump. Smart pumps are used in the intensive care units and contain a "drug library" (a list of drugs stored in the smart pump's memory, being a key tool to prevent medication errors. Each drug can have set parameters such as concentration, infusion rate and maximum and minimum dosages.)

Patient #9 required a transfer to the magnetic resonance imaging (MRI) suite for new onset seizures. Due to the use of strong magnetic fields, the MRI scanner requires a specialized pump (an Iradimed pump), which is compatible with the MRI scanner. Currently, the Iradimed pumps do not have a drug library and therefore, do not allow for concentration and infusion rate parameters.
On 11/19/20 at 8:50 A.M., the survey team interviewed the Regional Director for the MRI contracted services and the Senior Vice President of Clinical Services. The Director said that only Stat nurses know how to operate the MRI pumps and the Memorial campus (where the IV overdose happened on 8/24/20) does not have a staffed MRI nurse familiar with the MRI pump.
Review of the Patient Safety Committee meeting minutes from 11/12/20) indicates that "this leads to 2 different standards of care".

During an interview on 11/19/20 at 10:30 A.M., the Stat Nurse said that "Stat" nurses are part of the rapid response team for hospital emergencies and are familiar with the Iradimed pumps because they assist with the transport of critical care patients to the MRI scanners. He/she said that the MRI location does not have a staffed MRI Nurse. He/she also said that a lot of the ICU nurses are not comfortable using the MRI Iradimed pumps because they don't use them all the time and the pumps are very "temperamental". He/she said that on the night of 8/24/20, the CCU Nurse was not familiar with the Iradimed pump and called for assistance.

The CCU Nurse and the "Stat" Nurse transferred the Fentanyl and tubing from the Smart pump to the "Iradimed pump. The two nurses did not independently verify the medication concentration and infusion rate prior to the transfer. The Iradimed pump was incorrectly programmed to infuse at 125 ml/hour, instead of the ordered rate of 6.25 ml/hour and dose delivery of 125 mcg/hour. The patient received 2000 mcg. instead of 125 mcg. while in the MRI scanner (an entire bag infused over approximately 30-40 minutes while in the scanner). The Stat Nurse said that the pump started beeping just as the patient was ready to exit the scanner and that's when both nurses realized that the entire bag of Fentanyl had incorrectly infused. The Nurse also said that the Stat nurse does not usually remain with the primary nurse (usually from one of the ICUs or emergency department) and that he/she has had to assist the nurses "dozens" of times since the event on 8/24/20.

Review of the Hospital investigation , dated 11/12/20 indicates the following:
*Lack of knowledge of MRI pump by ICU staff (in-servicing not completed as of survey date 11/19/20).
*No drug library in MRI pump (on-going discussion in progress as of 11/19/20).
*No dual verification when transferring a high-risk medication to a new pump (no revision to policy as of 11/19/20 for pump transfer of high alert medications).
*Discussion of how 2 campuses should have same staffing systems for MRI nurse availability (no further updates from contracted service or Hospital as of 11/19/20).

Review of the "MRI pump training" sign in sheets (initiated on 10/23/20 or 60 days following the 8/24/20 event and still ongoing), indicates the following:
*Critical Care (Stat nurses): 8/13 nurses completed training
*Surgical ICU nurses: 15/31 nurses completed training
*Cardiac Care nurses: 39/52 nurses completed training
*Per Diem nurse: ¾ nurses completed training
*Travelers: ½ nurses completed training

During an interview with the Associate Vice President of Regulatory and Quality Reporting on 11/19/20 at 11:20 A.M., The Associate Vice President of Regulatory and Quality Reporting said that following the event of 8/24/20, the ICU Nurse Manager had "spoken to the individuals involved" followed by daily "huddles" with staff (a template provided with no date or staff listed), an ICU staff meeting (9/24/20, 20 days following the investigation was completed on 9/4/20), and MRI pump in-servicing is "on-going". The MRI pump training in-servicing was initiated on 10/23/20 and according to the in-service sheets indicated that the CCU nurse involved in the 8/24/20 event had not been in-serviced as of 11/19/20.

Following surveyor inquiry, she also said that another department that may send patients on high-alert medications to the MRI scanner with nurses (not trained to use MRI pump) would be maternity however, these staff members were not considered or included in the corrective action in-servicing.

Based on observations and interviews the Hospital failed to fully address a leak in the critical zone of the Operating Room.

The Surveyor toured the Operating Room (OR) suite at 8:30 A.M. on 11/19/2020 and interviewed the Director of Perioperative Services. At the entrance of OR Room #17. the Surveyor observed a water diverter in the ceiling with a tube into a large open trash barrel below. The water diverter was surrounded by brown discolored ceiling tiles. The Director said the OR was under the Maternity Unit's showers that had leaked in the past. Any leak that renders an area damp can support the growth of mold.

The Surveyor interviewed the Building Maintenance Director at 10:15 A.M. on 11/18/2020. The Building Maintenance Director said the leak had been addressed and the apparatus outside of OR #17 should have been removed and replacement tiles installed.