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Clinical Alarms Incident Investigation Protocol
Clinical Alarms Incident Investigation Protocol

Clinical Staff
BME Technicians
Respiratory Staff
Clinical Engineers
QA & Safety Manager

CLINICAL STAFF RESPONSIBILITIES
  1. Preserve monitor settings. DO NOT DISCHARGE the patient or change any parameter levels or volumes. NOTE: If the monitor is discharged, all full disclosure will be lost and Biomed will be unable to complete a formal incident investigation.
  2. If a patient death is involved: Place monitor into alarm pause or standby mode. Preserve the situation and label all equipment “do not use” until an incident investigation is initiated by Biomedical Engineering.
  3. Note the Biomedical Engineering barcode numbers of each device involved.
  4. Call 4-1333 between 8am-4pm, during off hours call the Biomedical Engineering on call pager 24800.
    1. Report to the operator “Incident with monitor/alarm.”
    2. Inform Biomedical Engineering representative if patient needs to be discharged.
  5. Print full disclosure from a minute before the event to a minute after the event. Include multiple leads, SpO2 waveform, and invasive blood pressure on the print outs. 4 print outs are needed (see “Procedure to Print Full Disclosure” instructions below):
    1. Full disclosure report: All ECG leads
    2. Full disclosure report: Monitor displayed waveforms
    3. Full strip print out of actual event: All ECG Leads (8 seconds per page. 1 page before the event, the event, 1 page after the event)
    4. Full strip print out of actual event: Monitor displayed waveforms
  6. Complete Safety Report. Include device control number in report.
Procedure to Print Full Disclosure Reports - GE Systems

REPORTS: Two reports are needed. The first with all ECG signals, the second with the waveforms displayed on the monitor.

For CIC version 5.0 and above
NOTE: The central station software version # is located on the top right hand corner of the central station screen.

  1. Click in the patient window on any central station.
  2. Click on the following tabs in this order: Patient Data, FD Strip, View All ECG, FD Page.
  3. Click on PRINT REPORT button which is the Printer icon on the right side.
  4. A window should pop up with various options.
    1. Select the START and END time. Specify 2 minutes before and 2 minutes after the event. Verify the correct date.
    2. Choose 15 seconds in the time pull down menu.
    3. Click on Refresh Preview.
    4. Click on the PRINT button.
  5. Verify report printed at the laser printer
  6. Click CANCEL in the Full Disclosure Report window.
  7. Click on the Main Menu tab and then the MONITOR tab.
  8. Click on the Patient Data tab and then the FD Page tab.
  9. Repeat steps 3-7 for the second report.
FULL STRIPS: Two full strips are needed. The first with all ECG signals, the second with the waveforms displayed on the monitor.
  1. Click in the patient window on any central station.
  2. Click on the Patient Data tab and then the FD Strip tab.
  3. Scroll to the time of the event or waveform in question.
  4. Click on the VIEW ALL ECG button.
  5. Click on the PRINT button at the middle right of the screen.
    1. Print 1 minute before and 1 minute after the event in 8 second intervals.
  6. Click the MONITOR button.
  7. Repeat steps 5-6.
For CIC between version 4.0 and 5.0
NOTE: The central station software version # is located on the top right hand corner of the central station screen.
  1. Click in the patient window on any central station.
  2. Click on the FULL DISCLOSURE tab on the right of the screen.
  3. Click on the VIEW ALL ECG button.
  4. Click on PRINT REPORT button.
  5. A window should pop up with various options.
    1. Select the START and END time. Specify 2 minutes before and 2 minutes after the event. Verify the correct date.
    2. Choose 15 seconds in the time pull down menu.
    3. Click on the PRINT button.
  6. Verify report printed at the laser printer
  7. Click CANCEL on the print window
  8. Click on the MONITOR button
  9. Repeat steps 4-7 for the second report.

FULL STRIPS: Two full strips are needed. The first with all ECG signals, the second with the waveforms displayed on the monitor.

  1. Click in the patient window on any central station.
  2. Click on the FULL DISCLOSURE tab on the right of the screen.
  3. Scroll to the time of the event or waveform in question.
  4. Click on the VIEW ALL ECG button.
  5. Click on the PRINT button at the bottom of the screen.
    1. Print 1 minute before and 1 minute after the event in 8 second intervals.
  6. Click the MONITOR button.
  7. Repeat steps 5-6.

BMET RESPONSIBILITIES

Please note:
  • If an incident occurs off hours technicians must come onsite for the investigation in the event of a patient adverse event (death or clinical intervention) or at the clinician’s request. The CE on-call should be made aware of the incident in this case.
  • For a call NOT involving a patient adverse event BMETs should:
    • Verify the patient does not need to be discharged before the next morning
    • Confirm clinicians have printed out the necessary strips
    • Follow-up with the incident the next morning
    • After completing the steps below, pass the investigation to the next assigned CE found in: L:\DBEMAIN\Clinical Alarm Issues\Incident Investigations\Clinical Alarms Assignment Tracking 2 JCB.xls
  1. Use the Incident Investigation Tool/Form to record information.
    1. Open a folder in L:\DBEMAIN\Clinical Alarm Issues\Incident Investigations for the investigation. Name the folder “Unit Name Month, Date, Year”
    2. Save the investigation tool and all log files to this folder
  2. Touch base with the resource nurse, patient’s nurse and any other staff involved in the incident. Remind them to NOT DISCHARGE the patient.
    1. Ask and document the following:
      1. When does the patient need to be discharged?
      2. What were you expecting?
      3. What actually happened/what did clinicians observe?
      4. What time did the event occur?
      5. Which room and bed?
      6. Name of the staff involved in the incident
      7. Who is the floor contact for investigation and follow-up?
  1. Inform CE
    1. Page the CE on-call OFF HOURS and brief them about the incident for a patient death or if the clinician requests an immediate investigation.
    2. Refer to the Incident spreadsheet to determine which CE should facilitate the incident.
  2. For incidents involving patient adverse event- swap the monitor involved with a loaner monitor. DO NOT DISCHARGE PATIENT.
  3. Verify full disclosure information was printed-if it was not printed PLEASE print the required information. Full disclosure should include multiple leads, SpO2 waveform, and invasive blood pressure if applicable.
    NOTE: For multiple episodes of the same clinical alarm issue for the same patient, print all the necessary strips on the first noted event. Print a single strip of the subsequent events.
  4. Print all defaults
    1.  Hand-write any patient specific defaults at the central station and bedside monitor.
      2. NOTE: any unit defaults changed for an individual patient can be viewed on the central station:
      1. Click in the patient window
      2. Click on alarm control (V.4) or patient data then alarm control (V.5)
      3. Any defaults in BLUE are the defaults that have been changed for the patient.
      4. Hand-write the defaults in blue and their parameter/alarm level.
  5. Hand-write alarm volumes at the central and bedside.
  6. Print the alarm directory in the alarm histories tab.
  7. Hand-write the control numbers, serial numbers, and software versions of all systems involved.
  8. Retrieve the log files (CIC and Telemetry servers) for the day of the incident from the central stations. Retrieve the day before, day of, and day after for a patient death incident.
  9. Open a work order in AMM and document time spent on incident in the timesheet. Select INCIDENT in the reason field. Assign the WO to the CE assigned to facilitate.
  10. Update the CE on-call if needed.
  11. Report incident to the QA & Safety Manager and all non-OR CE’s: send an email with AMM WO#.  If the event is off hours report to the QA & Safety Manager the next business day.
RESPIRATORY THERAPIST RESPONSIBILITIES

The Charge Respiratory Therapist is the first in house responder to Biomedical Engineering assistance calls during off hours.
  1. Determine location of Clinical Alarm Incident (floor, room number, bed).
  2. Remind clinicians to NOT DISCHARGE the patient. 
  3. Ask clinicians to follow the protocol outlined above and print all strips and reports.
  4. Immediately contact the BMET on-call.
  5. Document in RC events.

CLINICAL ENGINEER RESPONSIBILITIES

Please note: If the BMET is unreachable for any reason, the CE must come onsite for a patient adverse event (death or clinical intervention) or follow-up on the incident. 
  1. Assess event criticality and respond on-site if appropriate.
  2. Verify all information was attained.
    1. Full Disclosure
    2. System info on investigation tool: serial numbers, software versions
    3. Log files
    4. Answers to questions and contact information
    5. Enter safety report number on all documents
  3. Evaluate log files.
  4. Initiate and track investigation with device manufacturer. Per HIPAA regulations, black out all patient data from waveforms when sending strips to manufacturer.
  5. Document all findings in the work order initiated by the BMET involved.
  6. Communicate all findings with QA& Safety Manager and Unit Leadership involved.
  7. Manage investigation documents (L:\DBEMAIN\Clinical Alarm Issues\Incident Investigations):
    1. Clinical alarm events.xls
    2. Clinical alarms assignment tracking.xls
    3. Folder opened by the BMET involved in the investigation.
      1. L:\DBEMAIN\Clinical Alarm Issues\Incident Investigations Folder name: “Unit Name Month, Date, Year”
  8. Close work order when official vendor report is received and documented.

QA & SAFETY MANAGER RESPONSIBILITIES
  1. Verify all information was attained
    1. Full Disclosure
    2. System info: serial numbers, software versions
    3. Log files
    4. Answers to questions and contact information
    5. Safety  Report
  2. Track manufacturer investigation with CE.
  3. Ensure all details are being properly documented.
  4. Ensure Unit leadership is kept abreast of progress and findings.
  5. Identify any patterns in incident occurrences.
    1. Initiate investigation with FDA and ECRI if patterns are identified
    2. Communicate with product/hazard recall groups
  6. Follow up and complete the safety report.



Added to site: February, 2010
Source: Biomedical Engineering
Send comments regarding the website to: ehall@mgb.org





This page was last updated on 8/27/2014