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Based on staff interviews, review of facility documents, and review of three of three medical records (MR) (MR1, MR4 and MR5), it was determined that the facility failed to ensure that the quality assurance and performance improvement (QAPI) program analyzes the cause of medication errors and implements preventive actions, in accordance with the facility's QAPI Plan.

Findings include:

Facility policy titled, "Hoboken University Medical Center Quality Assurance and Performance Improvement Plan (HUMC QAPI)," 2024-2025, stated, "...D. The Patient Safety Committee is a multidisciplinary forum to identify, review and analyze patient safety concerns. The Committee will provide a mechanism for a systemic approach to effective clinical error reduction, minimize injury, and reduce the potential for unsafe practice .... VIII. Data Collection/Reporting ... There is ongoing collection and evaluation of information related to key patient care priorities to identify opportunities of improvement and identify problems that have an impact on patient care, patient safety, and organization performance. Activities and results of all improvement initiatives will be communicated on a periodic scheduled basis to the Quality Assurance & Performance Improvement Committee as dictated ..."

On 02/20/25 at 11:30 AM, P1's medical record was reviewed in the presence of Staff (S) 1, Chief Nursing Officer, and S4, Risk Management Director.

Patient (P)1 presented to the ED (Emergency Department) on 01/11/25 with a chief complaint of "High Fever." P1 was triaged at 8:55 AM by S6, ED Nurse. The "Nursing Assessment/Treatments," dated 01/11/25 at 8:55 AM, stated, " ...Vital Signs Height 30 in [inches] Weight 19.8 kg [Kilograms] weight obtained by Baby Scale ..."

P1's order detail dated 01/11/25 at 09:19 [9:19 AM] stated, "... Order Ibuprofen Susp [Suspension] ...200 mg [milligrams] po [by mouth] STAT [immediately]...Last Administration 01/11/25 09:28 [9:28 AM] 200 mg...Dose Calculations Selected Dosing Set Ibuprofen 10 mg/kg ... Calculated dosing weight 19.8 kg ...Calculated Dose 198 mg ...Round to Nearest Dose 200 mg ..."

Review of P1's medication administration documentation dated 01/11/25 at 9:28 AM, indicated that P1 was administered one dose of 200 mg of Ibuprofen (a pain/fever medication). This dose was based on the weight of 19.8 kg documented during the triage.

The "ED Additional Note" dated 01/11/25 at 13:44 [1:44 PM] and signed by S7, Physician Assistant, stated, "Patient's [Parent] has called back, child's weight was incorrectly entered as 19.8 kg, patient is 9.07 kilograms. Instructed to change cefdinir (an antibiotic) dose to 2.5 ml (milliliters), ibuprofen dose to 4.5 ml, Tylenol dose to 4 ml. All questions answered. Reiterated return precautions. (Parent) verbalized understanding ..."

The "PHA (pharmacy) order" dated 01/11/25 at 9:19 AM, stated, "...Warnings Type: Single Dose Range: Ibuprofen (100 mg/5 ml) .... Daily Dose Dosing Range is 4 mg/kg/day- 10 mg/kg/day. Ordered dose of 10.1 mg/kg/day is above daily dose range ..." P1's correct weight is 9.07 kg and maximum dosage for Ibuprofen should have been no more than 90.7 mg per dose.

On 02/21/25 at 10:15 AM, S4 stated that Risk Management reviews and monitors all medication errors reported via Verge (internal incident reporting system) and reports the data to the Clinical Safety Committee (Formerly known as Patient Safety Committee). Review of the Clinical Safety Committee meeting minutes dated November 6, 2024, indicated that six events of improper medication dose were reported during the meeting. Two out of six events of improper medication dose were related to an inaccurate weight measurement documented in the medical records for P4 and P5.

Review of P4's Verge report dated 05/05/24 at 2:00 PM, stated, " ... Factual description of the event: Patient received at 0830 [8:30 AM], patient's weight was rechecked. Correct weight was 39.46 kg. Wrong dose of solumedrol was given in ER. ... Document any additional monitoring, treatment or intervention that have been taken as a result of this event: Comments: Not answered .... Manager Action Education ... " The staff educated regarding this event was not indicated. On 2/21/25, the staff re-education regarding this event was requested. The facility failed to provide this documentation upon request.

Review of P5 's Verge report dated 05/20/24 at 5:14 AM, stated, " ... Factual description of the event: I was doing the triage for the patient and was copying the weight from what was placed by the ER tech and have written the BMI which was 18.7 instead of the weight. Putting the weight at 18.7 instead of 10.87 as previously put by the ER tech. Weight was then changed now to 18.7. Initial dose of medication was based on the 10.8 kg weight which was 150 mg and an additional 120 mg was given. Weight was then confirmed by (parent), weight was changed to 10.7 kg as it was originally ...Document any additional monitoring, treatment or intervention that have been taken as a result of this event... ED Tech approached and educated on being careful in entering patients weights which is needed for proper dosing ..." On 02/21/25 at 2:30 PM, S4 stated as part of the corrective action, the ED technician, involved in the error with P5, was re-educated on entering patient weights accurately.

On 02/21/25 at 2:45 PM, S4 stated that because the severity level of above reported events was a category D, meaning it reached the patient and required monitoring and intervention to confirm no patient harm, and category C, meaning it reached the patient but did not cause harm, respectively, the facility was not required to implement a systemic change.

Based on staff interviews, review of facility documents, and review of one of three medical records (MR 1) that contained a medication administration error, it was determined that the facility failed to ensure the implementation of policies and procedures that address internal reporting of medication administration errors.

Findings include:

Facility policy titled, "Event Reporting," last reviewed 05/24, stated, "...Staff should report events that occur on the hospital premises which are not consistent with routine operations or care for patient...2. Examples of events are...b. Medication administration Variances (wrong patient, wrong dose, wrong time, wrong route, wrong drug, dose omitted, extra dose...C. Event Report Completion... Enter an event report in the On-line Event Reporting System...Complete the report as soon as possible after the event and notify your supervisor...."

Review of MR1 was conducted in the presence of Staff (S) 1, Chief Nursing Officer and S4, Risk Management Director.

Patient (P)1 presented to the ED (Emergency Department) on 01/11/25 with a chief complaint of "High Fever." P1 was triaged at 8:55 AM by S6, ED Nurse. The "Nursing Assessment/Treatments," dated 01/11/25 at 8:55 AM, stated, "...Vital Signs Height 30 in [inches] Weight 19.8 kg [Kilograms] weight obtained by Baby Scale ..."

P1's order detail dated 01/11/25 at 09:19 [9:19 AM] stated, "... Order Ibuprofen Susp [Suspension]...200 mg [milligrams] po [by mouth] STAT [immediately]...Last Administration 01/11/25 09:28 [9:28 AM] 200 mg...Dose Calculations Selected Dosing Set Ibuprofen 10 mg/kg... Calculated dosing weight 19.8 kg...Calculated Dose 198 mg...Round to Nearest Dose 200 mg..."

Review of P1's medication administration documentation dated 01/11/25 at 9:28 AM, indicated that P1 was administered one dose of 200 mg of Ibuprofen (a pain/fever medication). This dose was based on the weight of 19.8 kg documented during the triage.

The "ED Additional Note," dated 01/11/25 at 13:44 [1:44 PM] and signed by S7, Physician Assistant, stated, "Patient's [Parent] has called back, child's weight was incorrectly entered as 19.8 kg, patient is 9.07 kilograms. Instructed to change cefdinir (an antibiotic) dose to 2.5 ml (milliliters), ibuprofen dose to 4.5 ml, Tylenol dose to 4 ml. All questions answered. Reiterated return precautions. (Parent) verbalized understanding ..."

The "PHA (pharmacy) order" dated 01/11/25 at 9:19 AM, stated, "...Warnings Type: Single Dose Range: Ibuprofen (100 mg/5 ml).... Daily Dose Dosing Range is 4 mg/kg/day- 10 mg/kg/day. Ordered dose of 10.1 mg/kg/day is above daily dose range..." P1's correct weight is 9.07 kg and maximum dosage for Ibuprofen should have been no more than 90.7 mg per dose.

On 02/20/25 at 2:00 PM, S4 stated that all adverse drug events should be reported to Risk management via Verge, the online event reporting system. S4 confirmed that the facility was not aware of the event with P1, and a Verge report was not completed for this medication error event.

During an interview on 02/21/25 at 10:25 AM, S6 confirmed that they were responsible for documenting P1's weight in the medical record. S6 stated that he/she measured the patient weights in kilograms (kg) as the computer system requires weights to be documented in kg only. S6 stated that he/she has no knowledge as to how P1's weight was measured incorrectly. S6 stated that sometimes when the ED is busy, an ER (Emergency Room) technician records patient vital signs, including weight and height, on a piece of paper. The nurses would then enter that information into the electronic medical record during the triage/assessment process.

On 02/21/25 at 12:45 PM, during an interview, S7 stated that after P1's discharge, P1's parent called the ED from the outside retail pharmacy, where he/she was filling P1's prescriptions that were prescribed at discharge. S7 stated that the outpatient retail pharmacist had some concerns about the high dose of antibiotics prescribed to P1. During that conversation, S7 realized that the wrong weight was entered during the triage process and a medication error occurred. S7 further stated that he/she informed the nurse on duty about this event to correct the weight in P1's medical record and he/she thought that the nurse would report this event via Verge reporting system, however it was not done.

On 02/21/25 at 1:00 PM, S4 confirmed the above findings and stated that a Verge report should have been completed.

Based on a review of three of three medical records (MR) (MR1, MR4, and MR5) and staff interviews, it was determined that the facility failed to ensure that the documentation in medical records is accurate in accordance with facility policy.

Findings include:

Facility policy titled, "Scope of Service, Unit Description," last reviewed 04/24, states, " ...All assessments, interventions, diagnostic testing and results, patients' responses and outcomes are documented in the ED medical record ...Department goals include: 1. To provide a rapid, skilled and accurate triage assessment for every patient entering the department seeking care."

Medical records (MR) review was conducted in the presence of Staff (S)1, Chief Nursing Officer and S4, Risk Management Director, and revealed the following:

Patient (P)1 presented to the ED (Emergency Department) on 01/11/25 with a chief complaint of "High Fever." P1 was triaged at 8:55 AM by S6, ED Nurse. The "Nursing Assessment/Treatments," dated 01/11/25 at 8:55 AM, stated, "...Vital Signs Height 30 in [inches] Weight 19.8 kg [Kilograms] weight obtained by Baby Scale ..."

P1's order detail dated 01/11/25 at 09:19 [9:19 AM] stated, "... Order Ibuprofen Susp [Suspension]...200 mg [milligrams] po [by mouth] STAT [immediately]...Last Administration 01/11/25 09:28 [9:28 AM] 200 mg...Dose Calculations Selected Dosing Set Ibuprofen 10 mg/kg... Calculated dosing weight 19.8 kg...Calculated Dose 198 mg...Round to Nearest Dose 200 mg..."

Review of P1's medication administration documentation dated 01/11/25 at 9:28 AM, indicated that P1 was administered one dose of 200 mg of Ibuprofen (a pain/fever medication). This dose was based on the weight of 19.8 kg documented during the triage.

The "ED Additional Note," dated 01/11/25 at 13:44 [1:44 PM] and signed by S7, Physician Assistant, stated, "Patient's [Parent] has called back, child's weight was incorrectly entered as 19.8 kg, patient is 9.07 kilograms. Instructed to change cefdinir (an antibiotic) dose to 2.5 ml (milliliters), ibuprofen dose to 4.5 ml, Tylenol dose to 4 ml. All questions answered. Reiterated return precautions. (Parent) verbalized understanding ..."

The "PHA (pharmacy) order" dated 01/11/25 at 9:19 AM, stated, "...Warnings Type: Single Dose Range: Ibuprofen (100 mg/5 ml).... Daily Dose Dosing Range is 4 mg/kg/day- 10 mg/kg/day. Ordered dose of 10.1 mg/kg/day is above daily dose range..." P1's correct weight is 9.07 kg and maximum dosage for Ibuprofen should have been no more than 90.7 mg per dose.

P4 presented to the ED on 05/05/24 with a chief complaint of "Shortness of Breath." P4 was triaged at 4:50 AM by S20, ED Nurse. The "Nursing Assessment/Treatments," dated 05/05/24 at 4:40 AM, stated, "... Weight 89 kg weight obtained by Standing Scale ..." A second "Nursing Assessment/Treatments," dated 05/05/24 at 5:01 AM, stated, "Vital Signs Weight 89 kg Weight Obtained by Standing Scale ..."

Review of P4's Verge Report [an electronic incident reporting system] on 05/05/24 at 2:00 PM, stated, "...Factual description of the event: Patient received at 0830 [8:30 AM], patient's weight was rechecked. Correct weight was 39.46 kg. Wrong dose of solumedrol was given in ER (Emergency room)."

P5 presented to the ED on 05/20/24 with a chief complaint of "Fever." P5 was triaged at 4:09 AM by S19, ED Nurse. The "Nursing Assessment/Treatments," dated 05/20/24 at 4:19 AM, stated, "... Vital Signs 18.7 kg (Kilograms) Weight Obtained by Baby Scale ..."

The "ED Physician Documentation," dated 05/20/24 at 0443 [4:43 AM] stated, "...Medical Decision Making ...weight was incorrectly entered: patient given slightly more Tylenol than recommended dosage ..."

On 02/21/25 at 2:00 PM, S1 and S4 confirmed the above findings. S1 stated that the ED nurses were responsible for ensuring patient vital signs, including patient weights, were documented accurately in the medical records.

Based on medical record review, review of facility documents, and staff interviews, it was determined the facility failed to ensure that adverse drug events are reported to and reviewed at the Pharmacy and Therapeutic (P&T) Committee.

Findings include:

Facility policy titled, "Pharmacy: Adverse Drug Reactions," last reviewed 04/24, stated, "...5. The Pharmacy Department will report ADR (Adverse drug reactions) data to Pharmacy and Therapeutics Committee on a regular basis for review and recommendations...10. The pharmacist-in-charge shall be responsible for maintaining a system by which all reported adverse drug reactions are recorded and reviewed by the Pharmacy and Therapeutics Committee..."

On 02/20/25 at 1:30 PM, the facility's Pharmacy and Therapeutics Committee (P&T) meeting minutes for year 2024 were reviewed and the following was identified:

The P&T Committee meeting minutes dated 03/14/24, stated, "...Adverse Drug Events... Unable to report..."

The P&T Committee meeting minutes dated 04/25/24, stated, "...Adverse Drug Reactions...NO AVAILABLE REPORTING ..."

The P&T Committee meeting minutes dated 06/20/24 and 08/29/24 indicated that no adverse drug events data was reported.

The P&T Committee meeting minutes dated 10/30/24 at 10:00 AM, stated, "...Medication Incident Policy Update- Title Change to Medication Safety Committee. Policy to remain the same, only changes made to the title to include the words medication safety as required by Joint commission. Medication Safety Committee is an interdisciplinary team including Pharmacy, Nursing, Risk Management and the Medical Staff working in cooperation to identify, classify reports in VERGE and minimize the occurrence of medication incidents. Committee meets quarterly to discuss and resolve any medication related incidents such as delays, adverse events, errors in administration etc., and consider implementation plans..." The meeting minutes lacked documentation that medication incidents were reviewed during this meeting.

On 02/21/25 at 11:50 AM, Staff (S) 5, the Director of Pharmacy, provided a Pharmacy Dashboard for the year 2024 that indicated that the facility was tracking adverse drug reactions and medication errors, however, the P&T meeting minutes lacked documentation that the adverse drug reactions and medication errors data was reviewed. Upon interview, S5 stated that she/he was assigned to this role recently and was not sure why data from adverse drug events was not reported to the P&T committee.

On 02/21/25 at 1:10 PM, S5 confirmed the above findings.

Based on staff interviews and facility document review, it was determined that the facility failed to ensure that medication errors are reported to and reviewed by the hospital's Quality Assurance Performance Improvement (QAPI) program.

Findings include:

The Hoboken Univeristy Medical Center [HUMC] QAPI Plan stated, ".... D. The Patient Safety Committee is a multidisciplinary forum to identify, review and analyze patient safety concerns. The Committee will provide a mechanism for a systemic approach to effective clinical error reduction, minimize injury, and reduce the potential for unsafe practice. ... F. The Pharmacy and Therapeutics [P&T] Committee will serve an advisory group to the Medical Board in all matters relating to the use of pharmaceuticals... The committee will also be responsible for the review of all adverse drug reactions and perform criteria -based drug usage evaluation on an on-going basis ...VIII. Data Collection/Reporting ... There is ongoing collection and evaluation of information related to key patient care priorities to identify opportunities of improvement and identify problems that have an impact on patient care, patient safety, and organization performance. Activities and results of all improvement initiatives will be communicated on a periodic scheduled basis to the QAPI committee ... "

The P&T Committee meeting minutes dated 10/30/24 at 10:00 AM, stated, "...Medication Incident Policy Update- Title Change to Medication Safety Committee. Policy to remain the same, only changes made to the title to include the words medication safety as required by Joint commission. Medication Safety Committee is an interdisciplinary team including Pharmacy, Nursing, Risk Management and the Medical Staff working in cooperation to identify, classify reports in VERGE and minimize the occurrence of medication incidents. Committee meets quarterly to discuss and resolve any medication related incidents such as delays, adverse events, errors in administration etc., and consider implementation plans..."

On 02/20/25 at 2:00 PM, the facility's Medication Safety Committee meeting minutes mentioned in the P&T Committee meeting minutes above, were requested. The facility failed to provide meeting minutes from the Medication Safety Committee.

Upon interview, Staff (S) 4, Risk Managment Director, stated that all medication errors should be reported to Risk Management via Verge, the online event reporting system.

On 02/21/25 at 10:15 AM, S4 stated that Risk Management reviews and monitors medication errors and reports the data to the Clinical Safety Committee (Formerly known as Patient Safety Committee). He/she was not aware of the Medication Safety Committee. The Clinical Safety Committee meeting minutes for the year 2024 was requested and reviewed.

The Clinical Safety Committee meeting minutes indicated that medication errors were reported to this committee, however the meeting minutes lacked documentation of corrective actions developed and implemented to ensure patient safety.

On 02/21/25 at 11:50 AM, S5, the Director of Pharmacy, provided a Pharmacy Dashboard for the year 2024 that indicated that the facility was tracking adverse drug reactions and medication errors. S5 provided the Pharmacy and Therapeutic (P&T) Committee meeting minutes for year 2024. The meeting minutes were reviewed and lacked evidence that the data collected from the monitoring of adverse drug events was reviewed at P&T committee. Upon interview, S5 stated that she/he was assigned to this role recently and was not sure why the data was not reviewed at the P&T committee meeting.

The HUMC QAPI meeting minutes for 2024, were reviewed and lacked evidence that adverse drug events were reported to the hospital QAPI committee. On 02/21/25 at 3:00 PM, during an interview, S9, the QAPI Director, stated that he/she was assigned to this role recently and was not aware of reporting requirements of adverse drug events to the hospital QAPI committee and stated, "this will be on his/her to do list for year 2025." S9 confirmed that adverse drug events were not reported to the hospital QAPI committee. It could not be determined what corrective actions were implemented to minimize medication errors and adverse drug events to improve patient safety.

On 02/21/25 at 3:55 PM, S1, Chief Nursing Officer and S4 confirmed the above findings.