HospitalInspections.org

Based on hospital policy reviews and staff interviews, the hospital staff failed to measure, analyze, and track the effectiveness and safety of services, and quality of care for high pressure alarm settings on mechanical ventilators to ensure patient safety.

The findings include:

Review of the hospital's "Performance Improvement Plan", dated 2015, revealed, "Purpose: ...Identify the important processes and outcomes related to patient care...Goals and Objectives: (Name of Hospital) will: ...1. Establish a systematic interdisciplinary mechanism to measure and assess the hospital's ability to do the right thing and to do it well...2. Identify known, suspected or potential opportunities to improve patient care processes...as well as opportunities for further improvement in currently acceptable performance...3. Establish ongoing measures that enable the hospital to improve patient care processes...4. Use appropriate statistical techniques to measure performance and display data...6. Monitor the performance of processes that involve risks...8. Collect data to monitor performance in areas targeted for further study. 9. Intensively analyze undesirable patterns or trends in performance...Scope and Organization: ...B. Patient Focused Functions ...5. Data are collected on an ongoing basis to determine the appropriateness of care: Ventilator weaning and management...C. Organization Functions and Essential Structural Components: 1. Organizational leaders shall ensure an ongoing systematic process for monitoring, measuring, assessing, and improving functions that support delivery of care...".

Review of the hospital's "Mechanical Ventilation Management Policy", dated 11/14/2014, revealed, "Purpose The ventilator is considered a life supporting intervention. Its proper function necessitates accurate and timely assessments of both the ventilator and patient. Procedure... 4. Alarm parameters are maintained at all times and are set for: ...Airway Pressure (Upper & Lower Limits) A. High-pressure alarm ideally is set 15 cm (centimeters) H2O (water) pressure above peak inspiratory pressure (PIP). (The pressure alarm can be set higher due to the patient's disease state, patient assessment and documentation must correspond with the changes.)..."

Interview on 03/03/2015 at 0900 with Administrative Staff revealed an unannounced on-site visit was conducted by the NC Respiratory Therapy Board in June and November 2014 in response to a complaint related to ventilator alarm settings. Interview revealed it was standard of practice in the facility for high alarm settings to be set at 60. Interview revealed, "we've always had a policy related to ventilator alarms. Our policy stated the high alarm should not be more than 10 to 15 above PIP (peak inspiratory pressure)". Interview further revealed, "we were accused of having high alarms set above 60. We checked them (ventilators) and none were ever above 60". Interview revealed 4 of the hospital's respiratory therapists were issued consent orders from the licensing board for not meeting standards of practice. Interview further revealed, "we changed our policy in November (2014) to set high alarms no more than 15 over PIP. We have since lowered it to no more than 10".

Interview on 03/04/2014 with the Respiratory Therapy Director revealed no formal data collection and analysis of the change in high alarm settings on ventilators has been conducted by the facility. Interview further revealed, "we haven't had negative outcomes related to the high alarm settings on the vents". Interview further revealed no data analysis related to high alarm settings on ventilators was available.

Based on review of hospital policy and procedures, medical record reviews, and staff interviews, the Respiratory Therapy staff failed to maintain safe ventilator alarm settings for 5 of 13 patients on ventilators (Patient # 1, 4, 5, 7, and 8).

The findings include:

Review of the hospital's "Mechanical Ventilation Management Policy", dated 11/14/2014, revealed, "Purpose The ventilator is considered a life supporting intervention. Its proper function necessitates accurate and timely assessments of both the ventilator and patient. Procedure... 4. Alarm parameters are maintained at all times and are set for: ...Airway Pressure (Upper & Lower Limits) A. High-pressure alarm ideally is set 15 cm (centimeters) H2O (water) pressure above peak inspiratory pressure (PIP). (The pressure alarm can be set higher due to the patient's disease state, patient assessment and documentation must correspond with the changes.)..."

1. Open medical record review on 03/03/2015 of Patient #1 revealed a 76 year old female, admitted on 02/24/2015 with a diagnosis of respiratory failure. Record review revealed Patient #1 was ventilator dependent. Review of the Mechanical Ventilator Log flow sheet revealed on 02/25/2015 at 1450, Patient #1's Peak Inspiratory Pressure (PIP) was documented as 30 cm H2O, with the high pressure alarm limit set at 50 cm H2O (5 cm H2O above the standard); 02/26/2015 at 1600, Patient #1's PIP was documented as 25 cm H2O, with the high pressure alarm limit set at 50 cm H2O (10 cm H2O above the standard); 02/28/2015 at 2045, Patient #1's PIP was documented as 24 cm H2O, with the high pressure alarm limits set at 45 cm H2O (6 cm H2O above the standard); 03/03/2015 at 0550 Patient #1's PIP was documented as 20 cm H2O, with the high alarm limit set at 40 cm H2O (5 cm H2O above the standard). Record review revealed no documentation by the respiratory therapist of the reason the high pressure alarm limit was above the standard of 15 cm H2O above the patient's PIP.

Interview on 03/03/2015 at 1300 with the Respiratory Therapy Director revealed Patient #1's high pressure alarm limit should have been adjusted to reflect Patient #1's PIP. Interview revealed the Respiratory Therapy staff did not follow the facility's Mechanical Ventilation Management policy for setting high pressure alarm limits.

2. Open medical record review on 03/03/2015 of Patient #4 revealed a 86 year old female, admitted on 12/04/2014 with a diagnosis of ventilator dependent respiratory failure. Review of the Mechanical Ventilator Log flow sheet revealed on 12/17/2014 at 2345, Patient #4's PIP was documented as 25 cm H2O, with the high pressure alarm limit set at 45 cm H2O (5 cm H2O above the standard); 02/20/2015 at 0404, Patient #4's PIP was documented as 24 cm H2O, with the high pressure alarm limit set at 45 cm H2O (6 cm H2O above the standard); 02/22/2015 at 0415, Patient #4's PIP was documented as 24 cm H2O, with the high pressure alarm limits set at 55 cm H2O (16 cm H2O above the standard); 02/24/2015 at 1950, Patient #4's PIP was documented as 28 cm H2O, with the high alarm limit set at 45 cm H2O (2 cm H2O above the standard); 02/28/2015 at 0455, Patient #4's PIP was documented as 22.3 cm H2O, with the high alarm limit set at 45 cm H2O (7.7 cm H2O above the standard); 03/02/2015 at 1255, Patient #4's PIP was documented at 23.1 cm H2O, with the high alarm limit set at 45 cm H2O (6.9 cm H2O above the standard). Record review revealed no documentation by the respiratory therapist of the reason the high pressure alarm limit was above the standard of 15 cm H2O above the patient's PIP.

Interview on 03/03/2015 at 1300 with the Respiratory Therapy Director revealed Patient #4's high pressure alarm limit should have been adjusted to reflect Patient #4's PIP. Interview revealed the Respiratory Therapy staff did not follow the facility's Mechanical Ventilation Management policy for setting high pressure alarm limits.

3. Open medical record review on 03/03/2015 of Patient #5 revealed a 74 year old male, admitted on 02/17/2015 with a diagnosis of respiratory failure. Open record review revealed Patient #5 was ventilator dependent. Review of the Mechanical Ventilator Log flow sheet revealed on 02/27/2015 at 2025, Patient #5's PIP was documented as 25 cm H2O, with the high pressure alarm limit setting not documented; 02/28/2015 at 2030, Patient #5's PIP was documented as 21 cm H2O, with the high pressure alarm limit set at 45 cm H2O (9 cm H2O above the standard); 03/01/2015 at 2130, Patient #5's PIP was documented as 22 cm H2O, with the high pressure alarm limits set at 45 cm H2O (8 cm H2O above the standard); 03/02/2015 at 0300, Patient #5's PIP was documented as 22 cm H2O, with the high alarm limit set at 45 cm H2O (8 cm H2O above the standard); 03/03/2015 at 0000, Patient #5's PIP was documented as 21 cm H2O, with the high alarm limit set at 45 cm H2O (9 cm H2O above the standard). Record review revealed no documentation by the respiratory therapist of the reason the high pressure alarm limit was not documented, or above the standard of 15 cm H2O above the patient's PIP.

Interview on 03/03/2015 at 1300 with the Respiratory Therapy Director revealed Patient #5's high pressure alarm limit should have been adjusted to reflect Patient #5's PIP. Interview revealed the Respiratory Therapy staff did not follow the facility's Mechanical Ventilation Management policy for setting high pressure alarm limits.


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4. Open medical record review on 03/03/2015 of Patient #7 revealed a 60 year-old male admitted on 02/16/2015 with Guillain-Barre syndrome with respiratory failure. Record review revealed #7 was mechanical ventilator dependent. Review of the Mechanical Ventilator Log flow sheet revealed on 02/17/2015 at 0210 the patient's Peak Inspiratory Pressure (PIP) was documented as 19 cm H2O, with the high pressure limit alarm set at 40 cm H2O (6 above the standard); 02/17/2015 at 0415, PIP at 14, with high pressure limit alarm set at 55 ( 26 above the standard); 02/20/2015 at 2000, PIP at 12, with high pressure limit alarm set at 45 (18 above the standard); 02/21/2015 at 0340, PIP at 12, with high pressure limit alarm set at 45 (18 above the standard); 02/21/2015 at 1140, PIP of 13, with high pressure limit alarm set at 45 (17 above the standard). Record review revealed no documentation by the respiratory therapist of the reason the high pressure alarm limit was above the standard of 15 above the patient's PIP.

Interview on 03/03/2015 at 1455 with the Respiratory Therapy Director revealed Patient #7's high pressure alarm limit should have been lowered to no more than 15 above the PIP when the patient's PIP lowered. Interview revealed the respiratory therapy staff did not follow the facility's mechanical ventilator policy for setting high pressure alarms.

5. Open medical record review on 03/03/2015 of Patient #8 revealed a 62 year-old female admitted on 02/27/2015 with ventilator dependent respiratory failure. Review of the Mechanical Ventilator Log flow sheet revealed on 03/03/2015 at 0416 the patient's Peak Inspiratory Pressure (PIP) was documented as 12 cm H2O, with high pressure limit alarm set at 30 cm H2O (3 above the standard); 03/03/2015 at 0724, PIP at 12, with high pressure limit alarm set at 30 (3 above the standard). Record review revealed no documentation by the respiratory therapist of the reason the high pressure alarm limit was above the standard of 15 above the patient's PIP.

Interview on 03/03/2015 at 1455 with the Respiratory Therapy Director revealed Patient #8's high pressure alarm limit should have been lowered to no more than 15 above the PIP when the patient's PIP lowered. Interview revealed the respiratory therapy staff did not follow the facility's mechanical ventilator policy for setting high pressure alarms.

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