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Based on interview, record review and policy review, the facility failed to:
- Initiate a timely review of, and implement timely, effective measures and monitoring to prevent potential reoccurrence of a Sentinel Event (SE, a serious safety event affecting patients, staff or visitors) related to tracheostomy (trach, surgical procedure to create an opening in the windpipe, to insert a plastic tube to help a patient breath) care, which caused serious injury to one discharged patient. This had the potential to lead to serious injury or death of any patient in the hospital with a trach. (A0286)
- Monitor trach care for one current patient according to policy. This had the potential to lead to negative outcomes, serious injury or death of any patient in the hospital with a trach. (A0286)
- Collect and analyze quality data related to blood or blood product transfusions, a high volume, high risk area. This had the potential to affect all patients receiving blood transfusions in the hospital by failing to ensure that standards of care were met during blood administration. (A0273)
- Ensure that the Governing Body (Corporate Board of Directors) annually approved the hospital's Quality Assurance Performance Improvement program, known as the Performance Improvement and Patient Safety (PIPS) plan. This had to potential to affect the health outcomes and quality of care for all patients. (A0308)

The severity and cumulative effect of these systemic practices resulted in the facility being out of compliance with 42 CFR 482.21 Condition of Participation: Quality Assessment and Performance Improvement, and resulted in the facility's failure to ensure quality health care and safety.

Based on interview and record review, the facility failed to collect and analyze quality data related to blood or blood product transfusions, a high volume, high risk area. This had the potential to affect all patients receiving blood transfusions in the hospital by failing to ensure that standards of care were met during blood administration. The facility transfuses approximately 400 units of blood products per month. The facility census was 300.

Findings included:

1. Record review of the facility's "Performance Improvement and Patient Safety Plan 2016," showed the hospital's Quality Control (the ongoing monitoring of outcomes and processes to assure that expected levels of performance are maintained), monitored key patient care and organizational processes and functions, particularly those which impact patient safety and are high volume, high risk, high cost or problem-prone, and included "Blood and Blood Component Use (transfusion)".

2. Record review on 05/19/16, of the facility's "Transfusion" scorecard (documents monthly audit and analysis of 10 blood transfusions per month, including expected goals and whether those goals were reached) showed no audit or analysis of blood transfusions since 01/2016.

During an interview on 05/18/16 at 9:10 AM, Staff JJ, Regional Coordinator of Patient Safety and Quality, and Staff KK, Regional Director of Patient Safety and Quality, stated that the facility had not collected or analyzed quality data related to blood transfusions since 01/2016. Both stated that the facility was expected to monitor blood transfusions because blood transfusions were a high volume, high risk area. Staff KK stated that she was responsible for collecting and analyzing the data.

Based on interview, record review and policy review, the facility failed to initiate a timely review of, and implement timely, effective measures and monitoring to prevent potential reoccurrence of a Sentinel Event (SE, a serious safety event affecting patients, staff or visitors) related to tracheostomy (trach, surgical procedure to create an opening in the windpipe, to insert a plastic tube to help a patient breathe) care, which caused serious injury to one discharged patient (#68) of three discharged patient SE's reviewed. The facility also failed to monitor trach care, according to policy, for one of one current patient (#28) reviewed with a trach. This had the potential to lead to serious injury or death of any patient in the hospital with a trach. The facility census was 300. There were three current patients with trachs in the facility and 20 patients with trachs in the facility in the past six months.

Findings included:

1. Record review of the facility's policy titled, "Event Reporting," dated 10/01/14, showed that all staff and managers were responsible for ensuring "Events" of any type that they witness, become aware of or are involved in are reported through the online event reporting system in a timely manner.

Record review of the facility's policy titled, "Sentinel and Serious Event," dated 09/15/15, showed that:
- A SE was a patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, permanent harm or severe temporary harm.
- A SE required a Root Cause Analysis (RCA, method of problem solving used to analyze sentinel and serious events) completed within 30 business days of the occurrence date and documents findings to include opportunities for improvement, actions and measures of success.
- A Serious Safety Event (SSE) was a breach or deviation from the standard of care (preventable) which resulted in moderate to severe harm or death.
- The SSE process included completing and documenting a preliminary patient safety investigation within seven business days.

Record review of the facility's policy titled, "Administering Oxygen via a Continuous Aerosol," dated 01/2014, showed that:
- Continuous aerosol provided an increase in humidity (moisture) to the inspired air (air breathed in), to achieve mobilization of bronchial secretions (phlegm produced in the lungs) for easier removal and humidification of the respiratory tract.
- A heater was required with the use of continuous aerosol for patients with tracheosotmies.
- Aerosols are checked every four hours at which time excess water is drained from the tubing and bag, the water is changed if necessary, and equipment is checked to make sure it is functioning properly.

Record review of the facility's policy titled, "Tracheostomy Management Adult Patients," dated 03/2015, showed that tracheostomy care was performed every eight hours and as needed.

2. Record review of an event report (ER) dated 02/26/16 (entered as an event nine business days after the actual event occurred), showed:
- On 02/15/16 at approximately 10:00 PM (actual event occurred at 8:50 PM), Patient #68 coded (pulseless and not breathing), the code team (medical professionals administer life supporting measures to restore pulse and breathing) responded, the patient's pulse was restored (breathing was supported by a life support machine called a ventilator) and the patient was transferred to the Intensive Care Unit (ICU).
- The patient's family expressed concerns that the patient was not receiving proper respiratory care while on seven South (patient care unit), and felt it caused the patient to code.
- The manager's review of the event indicated that the patient coded due to the patient's trach being blocked with thick secretions.
- The event was caused by a deviation of the policy related to high humidity (administering oxygen via a continuous aerosol).
- The error was caused when Respiratory Therapy (RT) did not place the patient on heated humidity (aerosol) per policy and standards.
- Staff were unaware of the policy and reported that there were no heaters available, as three of them were broken and not usable.
- RT staff involved in the event were coached (educated on the errors made to prevent reoccurrence).
- There were no SE contributing factors (per the RT manager).

3. Record review of discharged Patient #68's medical record showed:
- Nurses notes for 02/14/16 until the patient coded on 02/15/16 at 8:50 PM, showed that the patient was not suctioned for greater than 24 hours prior to the event.
- There was no evidence that the patient received heat, with his continuous aerosol, through his trach.
- Nurses notes on 02/15/16 at 8:50 PM, documented that the patient was ventilated (forcing air into a patients lungs) by hand (indicates that hospital staff were administering life saving measures), and the patient was later placed on a ventilator (a machine that forces air into the lungs at a preset rate to simulate breathing when the patient cannot breathe on his/her own).
- The discharge summary indicated that the patient died on 04/27/16.

4. Record reviews of emails from Staff PP, Patient Safety and Quality, to and between other Patient Safety and Quality staff and management, showed an email dated 04/22/16 documented that the event was not yet determined to be a SE (67 days after the event occurred) and an email dated 05/06/16, documented that the RCA was not yet completed.

5. During an interview on 05/18/16 at 11:09 AM, Staff UU, RT Manager stated the following related to Patient #68's ER:
- She was not informed that the ER was not managed properly (not entered or investigated in a timely manner, not recognized to have SE contributing factors);
- She didn't realize that RT heaters were broken;
- The RCA action plan that was submitted wasn't approved until 05/06/16;
- Patients on trachs could be placed anywhere in the hospital, on any floor.

The facility failed to enter Patient #68's event into the event report system in a timely manner, failed to investigate the event in a timely manner, failed to determine the event was a SE in a timely manner, and the RCA was not completed in a timely manner, according to policy.

6. Record review of an undated "Sentinel Event RCA Form," indicated that the event which involved Patient #68 was a determined SE and showed:
- Root Cause/Contributing factors for the SE included that the patient was not placed on high humidity, RT missed assessment of the patient every four hours due to high demand of respiratory patients, respiratory therapy heaters were unusable because they were broken, Registered Nurses (RN) had not completed trach care per policy and there was a low volume of trach patients on seven South (prevented familiarity with trach care).
- Action Plans included review of the Continuous Aerosol policy with all RT staff and to highlight the need to add heater to aerosol system, required four hour monitoring of the patient to include proper functioning of aerosol and assessment of the patient's suctioning needs, complete order for additional aerosol heaters, review care of tracheostomy care policies with all RNs on seven South, and nurse collaboration with RT for real time education when patients with trachs were admitted to seven South.
- Success would be measured by audits of trach patients - five per month of RT documented trach care and 10 (per month) of nurse documented trach care (seven South only).
Record review of education rosters showed that trach care re-education was limited to only the nursing staff on seven South.

7. Record review of facility audits on 05/19/16 (three months after Patient #68's event), showed that none of the RT audits had been completed, and only five nurse audits, which were limited to trach patients on seven South, had been completed.

Even after the facility recognized Patient #68's event was a SE, they failed to re-educate all nursing staff through out the facility who provided care to patients with trachs, and failed to ensure appropriate monitoring audits were initiated and completed in a timely manner to include all nursing areas caring for patients with trachs.

8. Record review of current Patient #28's medical record showed:
- A physician's order dated 04/18/16 for trach care once a day with warm water and soap (policy stated every eight hours).
- There was no documented trach care on the patient's flowsheets between 05/13/16 at 10:37 AM and 05/13/16 at 10:45 PM (approximately 12 hours), 05/14/16 at 7:56 AM and 0/14/16 at 11:43 PM (approximately 16 hours), 05/14/16 at 11:43 PM and 05/15/16 at 3:54 PM (approximately 16 hours), 05/15/16 at 10:39 PM and 05/16/16 at 11:26 PM (approximately 24 hours), 05/16/16 at 11:26 PM and 05/17/16 at 12:07 PM (approximately 11 hours), 05/17/16 at 8:46 PM and 05/18/16 at 5:42 PM (approximately 21 hours), 05/18/16 at 5:42 PM and 05/19/16 at 10:29 AM (approximately 16 hours).
- There was no documentation on the patient's flowsheet to show if staff suctioned the patient (option to choose yes or no was left blank) between 05/13/16 at 10:37 AM and 05/14/16 at 7:42 AM (approximately 21 hours), 05/14/16 at 7:56 AM and 05/16/16 at 4:44 AM (approximately 45 hours), 05/16/16 at 8:14 AM and 05/16/16 at 11:26 PM (approximately 15 hours); 05/17/16 at 9:22 AM and 05/17/16 at 8:46 PM (approximately 11 hours).
- Documentation of the oxygen therapy used on 05/15/16 at 4:37 AM did not indicate that the patient was receiving heat to his humidified oxygen through his trach.

9. Record review of facility audits on 05/19/16 showed that Patient #28's trach care was not audited by nursing or RT.

Because the facility failed to put timely measures in place to track and monitor all patients
with trachs, and because the facility failed to implement preventive actions that included feedback and learning throughout the facility, Patient #28's trach care was not completed according to policy, and the lack of trach care, trach suctioning and humidified oxygen went unrecognized by the facility.

Based on interview and record review, the facility failed to ensure that the Governing Body (Corporate Board of Directors) annually approved the hospital's Quality Assurance Performance Improvement (QAPI) program, known as the Performance Improvement and Patient Safety (PIPS) plan. This had to potential to affect the health outcomes and quality of care for all patients. The facility census was 300.

Findings included:

1. Record review of the PIPS plan for 2016 showed that annually, the hospital determined the number and scope of distinct quality and patient safety improvement priorities and projects proportional to the scope and complexity of the hospital's services and operations, and submitted it to the Board of Directors for approval. The Board of Directors was responsible and accountable for ensuring an ongoing program for quality improvement and patient safety, including the improvement in reliability of care delivery.

2. During an interview on 05/24/16 at 1:35 PM, Staff RR, Assistant Chief Nursing Officer, stated that the Board of Directors assumed full legal authority and responsibility for operations of the hospital.

During an interview on 05/18/16 at 3:40 PM, Staff KK, Regional Director of Patient Safety and Quality, stated that the Board of Directors had not approved the 2016 PIPS plan, and did not approve the 2015 PIPS plan, because it had been overlooked.

Based on interview, record review and policy review, the facility failed to initiate a timely review of, and implement timely, effective measures and monitoring to prevent potential reoccurrence of a Sentinel Event (SE, a serious safety event affecting patients, staff or visitors) related to tracheostomy (trach, surgical procedure to create an opening in the windpipe, to insert a plastic tube to help a patient breathe) care, which caused serious injury to one discharged patient (#68) of three discharged patient SE's reviewed. The facility also failed to monitor trach care, according to policy, for one of one current patient (#28) reviewed with a trach. This had the potential to lead to serious injury or death of any patient in the hospital with a trach. The facility census was 300. There were three current patients with trachs in the facility and 20 patients with trachs in the facility in the past six months.

Findings included:

1. Record review of the facility's policy titled, "Event Reporting," dated 10/01/14, showed that all staff and managers were responsible for ensuring "Events" of any type that they witness, become aware of or are involved in are reported through the online event reporting system in a timely manner.

Record review of the facility's policy titled, "Sentinel and Serious Event," dated 09/15/15, showed that:
- A SE was a patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, permanent harm or severe temporary harm.
- A SE required a Root Cause Analysis (RCA, method of problem solving used to analyze sentinel and serious events) completed within 30 business days of the occurrence date and documents findings to include opportunities for improvement, actions and measures of success.
- A Serious Safety Event (SSE) was a breach or deviation from the standard of care (preventable) which resulted in moderate to severe harm or death.
- The SSE process included completing and documenting a preliminary patient safety investigation within seven business days.

Record review of the facility's policy titled, "Administering Oxygen via a Continuous Aerosol," dated 01/2014, showed that:
- Continuous aerosol provided an increase in humidity (moisture) to the inspired air (air breathed in), to achieve mobilization of bronchial secretions (phlegm produced in the lungs) for easier removal and humidification of the respiratory tract.
- A heater was required with the use of continuous aerosol for patients with tracheosotmies.
- Aerosols are checked every four hours at which time excess water is drained from the tubing and bag, the water is changed if necessary, and equipment is checked to make sure it is functioning properly.

Record review of the facility's policy titled, "Tracheostomy Management Adult Patients," dated 03/2015, showed that tracheostomy care was performed every eight hours and as needed.

2. Record review of an event report (ER) dated 02/26/16 (entered as an event nine business days after the actual event occurred), showed:
- On 02/15/16 at approximately 10:00 PM (actual event occurred at 8:50 PM), Patient #68 coded (pulseless and not breathing), the code team (medical professionals administer life supporting measures to restore pulse and breathing) responded, the patient's pulse was restored (breathing was supported by a life support machine called a ventilator) and the patient was transferred to the Intensive Care Unit (ICU).
- The patient's family expressed concerns that the patient was not receiving proper respiratory care while on seven South (patient care unit), and felt it caused the patient to code.
- The manager's review of the event indicated that the patient coded due to the patient's trach being blocked with thick secretions.
- The event was caused by a deviation of the policy related to high humidity (administering oxygen via a continuous aerosol).
- The error was caused when Respiratory Therapy (RT) did not place the patient on heated humidity (aerosol) per policy and standards.
- Staff were unaware of the policy and reported that there were no heaters available, as three of them were broken and not usable.
- RT staff involved in the event were coached (educated on the errors made to prevent reoccurrence).
- There were no SE contributing factors (per the RT manager).

3. Record review of discharged Patient #68's medical record showed:
- Nurses notes for 02/14/16 until the patient coded on 02/15/16 at 8:50 PM, showed that the patient was not suctioned for greater than 24 hours prior to the event.
- There was no evidence that the patient received heat, with his continuous aerosol, through his trach.
- Nurses notes on 02/15/16 at 8:50 PM, documented that the patient was ventilated (forcing air into a patients lungs) by hand (indicates that hospital staff were administering life saving measures), and the patient was later placed on a ventilator (a machine that forces air into the lungs at a preset rate to simulate breathing when the patient cannot breathe on his/her own).
- The discharge summary indicated that the patient died on 04/27/16.

4. Record reviews of emails from Staff PP, Patient Safety and Quality, to and between other Patient Safety and Quality staff and management, showed an email dated 04/22/16 documented that the event was not yet determined to be a SE (67 days after the event occurred) and an email dated 05/06/16, documented that the RCA was not yet completed.

5. During an interview on 05/18/16 at 11:09 AM, Staff UU, RT Manager stated the following related to Patient #68's ER:
- She was not informed that the ER was not managed properly (not entered or investigated in a timely manner, not recognized to have SE contributing factors);
- She didn't realize that RT heaters were broken;
- The RCA action plan that was submitted wasn't approved until 05/06/16;
- Patients on trachs could be placed anywhere in the hospital, on any floor.

The facility failed to enter Patient #68's event into the event report system in a timely manner, failed to investigate the event in a timely manner, failed to determine the event was a SE in a timely manner, and the RCA was not completed in a timely manner, according to policy.

6. Record review of an undated "Sentinel Event RCA Form," indicated that the event which involved Patient #68 was a determined SE and showed:
- Root Cause/Contributing factors for the SE included that the patient was not placed on high humidity, RT missed assessment of the patient every four hours due to high demand of respiratory patients, respiratory therapy heaters were unusable because they were broken, Registered Nurses (RN) had not completed trach care per policy and there was a low volume of trach patients on seven South (prevented familiarity with trach care).
- Action Plans included review of the Continuous Aerosol policy with all RT staff and to highlight the need to add heater to aerosol system, required four hour monitoring of the patient to include proper functioning of aerosol and assessment of the patient's suctioning needs, complete order for additional aerosol heaters, review care of tracheostomy care policies with all RNs on seven South, and nurse collaboration with RT for real time education when patients with trachs were admitted to seven South.
- Success would be measured by audits of trach patients - five per month of RT documented trach care and 10 (per month) of nurse documented trach care (seven South only).
Record review of education rosters showed that trach care re-education was limited to only the nursing staff on seven South.

7. Record review of facility audits on 05/19/16 (three months after Patient #68's event), showed that none of the RT audits had been completed, and only five nurse audits, which were limited to trach patients on seven South, had been completed.

Even after the facility recognized Patient #68's event was a SE, they failed to re-educate all nursing staff through out the facility who provided care to patients with trachs, and failed to ensure appropriate monitoring audits were initiated and completed in a timely manner to include all nu