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Based on interview and record review, the facility's Governing Body failed to assume full legal responsibility for implementing, and monitoring policies governing the facility's ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) services. The facility's Governing Body failed to provide oversight for quality health care in a safe environment. The facility did not meet the condition for coverage in governing body and management by failing to:

1. Ensure the medical staff was accountable to the governing body for the quality of care provided to patients. This deficient practice resulted in no on-call physician (ready to give medical care after hours, typically in an emergency or urgent situation) who has knowledge of ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) was available on 4/2/24 when Patient 1 was decannulated (accidental cannula complete exiting the patient's body). wWhile on ECMO, Medical staff failinged to follow the facility's Policy and Procedure (P&P) to ensure ECMO services provide by the facility were implemented in a safe manner to avoid potential for patient receiving ECMO bled to death due to inadvertent decannulations (Refer to A049)

2. Ensure surgical services provide qualified physician (group) who instituted CARDIOHELP (an extracorporeal cardiopulmonary support system for the purpose of blood oxygenation and carbon dioxide removal with mechanical circulatory assistance) assured the cannula (medical tube insert into the body) entry site is visible for assessment by nursing staff in accordance with the facility's policy and procedure (P&P). And ensured the primary physician regarding patient management/direction throughout the ECMO period in accordance with the facility's policy and procedure (P&P). These deficient practices resulted in nursing staff inability to assess site where the cannula enters the body for securement of the cannula, such as intact sutures. Medical staff failing to follow the facility's Policy and Procedure (P&P) to ensure ECMO services provided by the facility were implemented in a safe manner to avoid potential for patient receiving ECMO to bleed to death due to unintentional decannulations. (Refer to A-063)

3. Ensure staff adhere to disclosure process to inform the POA (A power of attorney, a legal authorization designated person to make decisions about another person's medical care) of the unintentional decannulation of patient 1 while on ECMO treatment on 4/2/24, in accordance with the facility's policy and procedure which causes Patient 1 to bled to death. This deficient practice resulted in Patient 1's POA was not informed that on 4/2/24, Patient 1 bleed out and died due to unintentional decannulation while on ECMO treatment. (Refer to A-131)

4. Ensure that QAPI (Quality Assessment & Performance Improvement) Committee implemented an effective plan of correction that ensured staff adherence to the facility's policy and procedure (P&P) titled "CARDIOHELP System Setup, Operation, and Patient Management" after the incident of Patient 1's unintentional decannulation on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility involving cannulation procedures (insertion of a tube to a big blood vessels). (Refer to A-263, A-283, and A-286)

The cumulative effect of these systemic practices resulted in the facility's inability to ensure the governing body had oversight and accountability for all the facility's activities and total operations.

Based on interview and record review, the facility's Governing Body failed to ensure the medical staff was accountable to the governing body for the quality of care provided to patients.
This deficient practice resulted in no on-call physician (ready to give medical care after hours, typically in an emergency or urgent situation) who has knowledge of ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) was available on 4/2/24 when one of 30 sampled patients (Patient 1) was decannulated (accidental cannula complete exiting the patient's body). while on ECMO, Medical staff failing to follow the facility's Policy and Procedure (P&P) to ensure ECMO services provided by the facility were implemented in a safe manner to avoid potential for patient receiving ECMO to bleed to death due to inadvertent decannulations.
Findings:
During a review of Patient 1's "Emergency Department Encounter Note (ED Note, a summary of a patient's interval status during an emergency department encounter, including narrative and free text data)," dated 3/26/24, the "ED Note" indicated, Patient 1 "Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection."

During a review of Patient 1's "Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note," dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was "found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient's body) of the patient's VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m."
On 4/17/24 at 9:42 AM, during an interview with Registered Nurse (RN) 1, RN 1 stated, "When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician (ready to give medical care after hours, typically in an emergency or urgent situation), but we were not able to reach him."

On 4/18/24 at 10 AM, during an interview with the Director of the Intensive Care Unit (DICU), the DICU stated, "It is difficult to tell who is covering (physician on-call to response to emergency) that day; the nurses will communicate with the physician. There is no set schedule for on-call physicians."

During an interview on 4/18/24 at 12:00 PM with the Director of Risk and Regulatory (DIRR), the DIRR confirmed that the facility has one cardiac thoracic (surgeon that specialty is relating to, involving, or specializing in the heart and chest), surgeon, (Surgeon 1), who has knowledge and oversight of all ECMO cases in the facility. Confirmed with DIRR, the facility didn't have another physician who has the capability to troubleshoot problems with the ECMO.

During an interview with Senior Manager of Human Resource (HR, in charged with finding, screening, recruiting, and training job applicants, as well as administering benefits), (SMHR) on 4/18/24 at 12:26 AM, the SMHR confirmed that surgeon 1 is the only cardiac thoracic surgeon in the facility. Surgeon 1 performed all procedures related to general thoracic, heart lung machine, thoracic aorta (the largest elastic artery in the human body), pacemaker (an artificial device for stimulating the heart muscle and regulating its contractions), pericardium (a fibrous sac that encloses the heart and great vessels), and mediastinum (a space in the chest that holds they our heart and other important structures).

During an interview on 4/19/24 at 5:20 p.m. with the Director of Risk and Regulatory (DRR), the DRR stated the ECMO program was not brought up with the government body; the last time ECMO was brought up for review and discussion with the government body was when the program started in 2016.

During a concurrent interview and record review on 4/19/24 at 4:00 p.m. the Executive Director of Administrator (EDA), the document titled "Request for Addition of New Procedure: Upon Motion Made, Carried and Seconded," undated was reviewed. EDA stated, "The proposal requested was by the Department of Surgery and Department of Medicine to the government body on 2016 to add ECMO treatment to the facility's services." The proposal document indicated, there will be 8 physicians (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, and MD 8) participants that have received certification on ECMO competency.

During a concurrent interview and record review on 4/19/24 at 4:28 p.m. with the Executive Director of Administration (EDA), the "Quality Assurance and Improvement Committee" meeting minutes dated February 2024 were reviewed. The EDA stated that the Quality Assurance and Safety Committee (a committee whose functions are concerned with the arrangements for the purpose of monitoring and improving the quality of the facility) meets monthly with several task forces that report to the Quality Assurance and Improvement Committee (QAPI, team in the facility that seek to prevent, detect, and correct problems in the quality of services provided to individuals and populations) every fourth Wednesday of the month. EDA stated the last report was on March 27, 2024, and the next report is scheduled for April 24, 2024. The facility QAPI reviews policies, programs, and plans for improvement and new projects; however, EDA stated, "Nothing was reviewed regarding the ECMO program. The facility has not identified the need to do process improvement on ECMO because it was not brought up by nursing." EDA confirmed there have been no QAPI-related projects for ECMO since 2016.

Based on interview and record review, the facility's Governing Body failed to ensure surgical services provide qualified physician (group) who instituted CARDIOHELP (an extracorporeal cardiopulmonary support system for the purpose of blood oxygenation and carbon dioxide removal with mechanical circulatory assistance) will:
1. Assure the cannula (medical tube insert into the body) entry site is visible for assessment by nursing staff in accordance with the facility's policy and procedure (P&P).
2. Assure the primary physician regarding patient management/direction throughout the ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) period in accordance with the facility's policy and procedure (P&P).

These deficient practices resulted in nursing staff unable to assess site where the cannula enters the body for securement of the cannula, such as intact sutures. Also resulted in no on-call physician (ready to give medical care after hours, typically in an emergency or urgent situation) who has knowledge of ECMO was available on 4/2/24 when one of 30 sampled patients (Patient 1) was unintentionally decannulated (accidental cannula complete exiting the patient's body) while on ECMO, Medical staff failing to follow the facility's Policy and Procedure (P&P) to ensure ECMO services provide by the facility were implemented in a safe manner to avoid potential for patient receiving ECMO to bleed to death due to unintentional decannulations.

Findings:

1. During a review of Patient 1's "Emergency Department Encounter Note (ED Note, a summary of a patient's interval status during an emergency department encounter, including narrative and free text data)," dated 3/26/24, the "ED Note" indicated, Patient 1 "Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection."

During a review of Patient 1's "Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note," dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was "found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient's body) of the patient's VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m."

During a concurrent interview and record review on 4/16/24 at 2:36 p.m. with the Director of the Intensive Care Unit (DICU), Patient 1's Flowsheet (documents of the patient assessment regarding the patient's condition) titled, "Timeline," dated from 4/1/24 through 4/2/24 was reviewed. The Timeline indicated, "puncture side left groin, base of the wound unable to assessed," was documented by nursing throughout the time that Patient 1 was on ECMO treatment (from 3/26/24 through 4/2/24). The DICU stated, "the site (cannula entry site on the patient left groin) was not visible due to the gauze covering it (cannula entry site on the patient left groin)." DICU also stated, "Patients who come to ICU unit after operation to insert cannula, often have the site cover by gauze dressing when transfer into ICU (Intensive Care Unit, a unit in a hospital providing around- the -clock care for critically ill or injured patients) The RN does not touch the dressing or change the dressing, the surgeon will change the dressing." DICU confirmed, nursing staff have reached out to the surgeon (Surgeon 1) to change the dressing, but the dressing was not change since Patient 1 had the canula inserted on 3/26/24. Nursing staff did not escalate through the chain of command (the communication of problems/concerns to a higher level of authority such as from Department Chair to Chief of Staff and so on).

On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, "When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him."

During a review of Patient 1's "Operative Report (a report written in a patient's medical record to document the details of a surgery)," documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had "pump failure (a condition that develops when the heart doesn't pump enough blood for the body's needs) and thus underwent a procedure for "placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren't functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works)."

On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, "It is unclear how Patient 1 was decannulated." EDMD not able to visualize at first due to large dressing over site. After calling time of death, EDMD stated, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of Patient 1. EDMD stated he sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything came out. No suture seen for the cannula that came off, just the Ioban (iodine [chemical element that prevent infection]-impregnated incision drape) holding it down. EDMD stated he spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated.

During an interview on 4/17/24 at 12:15 p.m. with the Cardiac thoracic and vascular Surgeon (Surgeon 1), Surgeon 1 stated "Dressing change, there are no set formula of changing (changing the dressing) about a week or 10 days, nurses can do it." Surgeon 1 stated, "I have seen it (the patient's dressing) every day."

During a review of the facility's policy and procedure (P&P) titled, "Comprehensive Vascular Access Management" regional clinical standard," dated September 2019, the P&P indicated, for peripheral saline lock (device allows easy access to the peripheral vein for intermittent IV fluids or medications), short-term non-tunneled central venous access device (short term, venous access device [VAD], medical access line allow medication administration for 2-3 weeks), long-term tunneled central VAD (long-term, VAD, medical access line allow medication administration more than 3 weeks), peripheral inserted central venous catheter (PICC, a long, thin tube that's inserted through a vein in your arm to administered medication), and for Port-a-cath (a combination of a portal and a catheter device used to draw blood and give treatments), all medical access devices mention should have a transparent dressing.

During a review of the facility's policy and procedure (P&P) titled, "CARDIOHELP System Setup, Operation, and Patient Management," dated August 2020, the P&P indicated, "Cannula insertion sites should be frequently assessed to rule out excessive bleeding, hematoma formation, cannula kinking or cannula rotation or dislodgement. Verify the cannula remains securely fastened in place. Use dressings that allow the site to be visually assessed ... The CARDIOHELP System may be initiated, inserted, and maintained by those physicians who are privileged in ECMO. The qualified physician (group) who instituted CARDIOHELP will be the primary physician regarding patient management/direction throughout the ECMO period.

2. On 4/18/24 at 10 AM, during an interview with the Director of the Intensive Care Unit (DICU), the DCCU stated, "It is difficult to tell who is covering (physician on-call to response to emergency) that day; the nurses will communicate with the physician. There is no set schedule for on-call physicians."

During an interview on 4/18/24 at 12:00 PM with the Director of Risk and Regulatory (DIRR), the DIRR confirmed that the facility has one cardiac thoracic surgeon (a doctor who performs surgery on the organs in the chest, such as the heart, lungs and part of the alimentary canal that connects the throat to the stomach, (Surgeon 1), who has knowledge and oversight of all ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) cases in the facility. As confirmed with DIRR, the facility does not have another physician who has the capability to troubleshoot problems with the ECMO.

During an interview with Senior Manager of HR (SMHR) on 4/18/24 at 12:26 AM, SMHR confirmed that surgeon 1 is the only cardiac thoracic surgeon in the facility. Surgeon 1 performed all procedures related to Surgeon 1 related to general thoracic, heart lung machine, thoracic aorta (the largest elastic artery in the human body), pacemaker (an artificial device for stimulating the heart muscle and regulating its contractions), pericardium (a fibrous sac that encloses the heart and great vessels), and mediastinum (a space in the chest that holds the heart and other important structures).

During a concurrent interview and record review on 4/19/24 at 4:00 p.m. the Executive Director of Administrator (EDA), the document titled "Request for Addition of New Procedure: Upon Motion Made, Carried and Seconded," undated was reviewed. EDA stated, "The proposal requested was by the Department of Surgery and Department of Medicine to the government body on 2016 to add ECMO treatment to the facility's services." The proposal document indicated, there will be 8 physicians (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, and MD 8) participants that have received certification on ECMO competency.

During a review of the facility's policy and procedure (P&P) titled, "CARDIOHELP System Setup, Operation, and Patient Management," dated August 2020, the P&P indicated, "Cannula insertion sites should be frequently assessed to rule out excessive bleeding, hematoma formation, cannula kinking or cannula rotation or dislodgement. Verify the cannula remains securely fastened in place. Use dressings that allow the site to be visually assessed ... The CARDIOHELP System may be initiated, inserted, and maintained by those physicians who are privileged in ECMO. The qualified physician (group) who instituted CARDIOHELP will be the primary physician regarding patient management/direction throughout the ECMO period.

During a review of the facility's policy and procedure (P&P) titled, "Comprehensive Vascular Access Management" regional clinical standard," dated September 2019, the P&P indicated, for peripheral saline lock (device allows easy access to the peripheral vein for intermittent IV fluids or medications), short-term non-tunneled central venous access device (short term, venous access device [VAD], medical access line allow medication administration for 2-3 weeks), long-term tunneled central VAD (long-term, VAD, medical access line allow medication administration more than 3 weeks), peripheral inserted central venous catheter (PICC, a long, thin tube that's inserted through a vein in your arm to administered medication), and for Port-a-cath (a combination of a portal and a catheter device used to draw blood and give treatments), all medical access devices mention should have a transparent dressing.

Based on interview and record review, the facility failed to ensure the Condition of Participation for Patient Rights was met as evidenced by:

A. The facility's failure to ensure one of thirty (30) sampled patients (Patient 1's), ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient''s own organs are too sick or weak to work on their own) cannula ( a tube inserted into a vein) insertion sites is assessed and have available on-call physician to provide care in emergency situation for patient receiving ECMO treatment. This deficient practice resulted in Patient 1's decannulation (inadvertent removal of a cannula) while on ECMO treatment. (Refer to A -0144)

2. The facility's failure to ensure one of thirty (30) sampled patients (Patient 1's), POA (A power of attorney, a legal authorization designated person to make decisions about another person's medical care) was informed in accordance to the facility's policy and procedure, of the unintentional decannulation of Patient 1 while on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) treatment on 4/2/24, which causes Patient 1 to bleed out and result in death. This deficient practice resulted in Patient 1's POA was not informed that on 4/2/24, Patient 1 bleed out and died due to unintentional decannulation while on ECMO treatment. This can lead to breakdown of trust between the facility and the POA; causing POA severe emotional trauma, and stress and a sense of mistrust from the lack of transparency. (Refer to A -0131)

Findings:

During a review of Patient 1's "Emergency Department Encounter Note (ED Note, a summary of a patient's interval status during an emergency department encounter, including narrative and free text data),"dated 3/26/24, the "ED Note" indicated, Patient 1 "Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection."

During a review of Patient 1's "Operative Report (a report written in a patient's medical record to document the details of a surgery)," documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had "pump failure (a condition that develops when the heart doesn't pump enough blood for the body's needs) and thus underwent a procedure for "placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren't functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works)."

During a review of Patient 1's "Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note,"" dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was "found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient's body) of the Patient 1's VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m."

On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, "When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him."

On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, "It is unclear how Patient 1 was decannulated." EDMD not able to visualize at first due to large dressing over site, after calling time of death, EDMD stated, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. EDMD stated he sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything came out. No suture seen for the cannula that came off, just the Ioban (iodine [chemical element that prevent infection]-impregnated incision drape) holding it down. EDMD stated he spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated.

During a concurrent interview and record review on 4/17/24 at 2:50 p.m. with the Director, Risk and Regulatory (DIRR), Patient 1''s electronic medical record (EMR, an electronic version of a patient's medical history, that is maintained over time), under titled "Physician notes" was reviewed. DIRR confirmed that no disclosure of Patient 1's unintentional decannulation (removal of a medical tube) was documented on physicians' notes. DIRR stated that during her interview with RN 3, RN 3 reported that she informed Patient 1's wife that Patient 1 had bled out. The DIRR confirmed there was no documentation within Patient 1's medical record that indicates the disclosure to Patient 1's POA of the unintentional decannulation that led to his death on 4/2/24.

During a review of the facility's policy and procedure (P&P) titled, "Responding TO/Disclosure of Adverse Events,"" dated August 2021, the P&P indicated, "Prompt, compassionate, and honest communication with the patient and family following an incident is essential. Because of the emotional effects of these events on both the patients and caregivers, this communication process can be difficult for everyone. If handled poorly, injury to both patient and caregivers can be compounded, damaging the patient-caregiver relationship. Open communication and authentic apologies help to dissipate patients' feelings of anger and mistrust ...Ideally, the initial communication should be from a person with whom the patient has a trusting relationship. Usually, the physician who is responsible for the patient's care is the most appropriate person. Documentation: All communications with the patient and family are also documented supports the best interests of both the patient and caregivers and advances good patient care"

Based on interview and record review, the facility failed to ensure one of thirty (30) sampled patients (Patient 1's), POA (A power of attorney, a legal authorization designated person to make decisions about another person's medical care) was informed in accordance to the facility's policy and procedure, of the unintentional decannulation (removal of a medical tubing from the patient' body) of Patient 1 while on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) treatment on 4/2/24, which causes Patient 1 to bleed to death.

This deficient practice resulted in Patient 1's POA was not informed that on 4/2/24, Patient 1 bled out and died due to unintentional decannulation while on ECMO treatment. This can lead to breakdown of trust between the facility and the POA, causing POA severe emotional trauma, and stress and a sense of mistrust from the lack of transparency.

Findings:

During a review of Patient 1's "Emergency Department Encounter Note (ED Note, a summary of a patient's interval status during an emergency department encounter, including narrative and free text data),"dated 3/26/24, the "ED Note" indicated, Patient 1 "Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection."

During a review of Patient 1's "Operative Report (a report written in a patient's medical record to document the details of a surgery)," documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had "pump failure (a condition that develops when the heart doesn't pump enough blood for the body's needs) and thus underwent a procedure for "placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren't functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works)."

During a review of Patient 1's "Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note,"" dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was "found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient's body) of the Patient 1's VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m."

On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, "When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him."

On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, "It is unclear how Patient 1 was decannulated." EDMD not able to visualize at first due to large dressing over site, after calling time of death, EDMD stated, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. EDMD stated he sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything came out. No suture seen for the cannula that came off, just the Ioban (iodine [chemical element that prevent infection]-impregnated incision drape) holding it down. EDMD stated he spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated.

During a concurrent interview and record review on 4/17/24 at 2:50 p.m. with the Director, Risk and Regulatory (DIRR), Patient 1''s electronic medical record (EMR, an electronic version of a patient's medical history, that is maintained over time), under titled "Physician notes" was reviewed. DIRR confirmed that no disclosure of Patient 1's unintentional decannulation (removal of a medical tube) was documented on physicians' notes. DIRR stated that during her interview with RN 3, RN 3 reported that she informed Patient 1's wife that Patient 1 had bled out. The DIRR confirmed there was no documentation within Patient 1's medical record that indicates the disclosure to Patient 1's POA of the unintentional decannulation that led to his death on 4/2/24.

During a review of the facility's policy and procedure (P&P) titled, "Responding TO/Disclosure of Adverse Events,"" dated August 2021, the P&P indicated, "Prompt, compassionate, and honest communication with the patient and family following an incident is essential. Because of the emotional effects of these events on both the patients and caregivers, this communication process can be difficult for everyone. If handled poorly, injury to both patient and caregivers can be compounded, damaging the patient-caregiver relationship. Open communication and authentic apologies help to dissipate patients' feelings of anger and mistrust ...Ideally, the initial communication should be from a person with whom the patient has a trusting relationship. Usually, the physician who is responsible for the patient's care is the most appropriate person. Documentation: All communications with the patient and family are also documented supports the best interests of both the patient and caregivers and advances good patient care"

Based on interview and record review, the facility failed to ensure one of thirty (30) sampled patients (Patient 1's), ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) cannula (a tube inserted into a vein) insertion sites were assessed for securement and any signs of infection (such as redness, swelling, or pus drainage) and have an available on-call physician to provide care in emergency situation for patient receiving ECMO treatment. This deficient practice resulted in Patient 1's decannulation (inadvertent removal of a cannula) while on ECMO treatment causing excessive bleeding and death of Patient 1.

On 4/18/2024 at 5:22 p.m., the survey team called an immediate jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Director of Risk and Regulatory (DRR), the Chief Executive Officer (CEO), the Executive Director Risk & Patient Safety, the Director of Risk and Regulatory, and the Accreditation Program Manager. The facility failed to establish a safe process to monitor and provide an emergency response for Patient 1, who had an unintentional decannulation (accidental cannula complete exiting the patient's body) while receiving ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) treatment and bled to death. An on-call physician (a physician who is ready to give medical care after hours, typically in an emergency or urgent situation), who has knowledge of ECMO, was unavailable.

On 4/19/2023, at 7:22 p.m., while the survey team was onsite at the facility, the IJ was removed in the presence of the Chief Nursing Officer (CNO), the Manager of Accreditation Program (MAP), the Director of Risk and Regulatory (DRR), and the Nurse Manager (NM) after the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practice). The elements of the IJ Removal Plan were verified and confirmed by the survey team through observations, interviews, and record review. The IJ Removal Plan indicated that on April 11, 2024, the facility suspended their ECMO (Extracorporeal Membrane Oxygenation) program indefinitely; by April 19, 2024, the ECMO program was terminated. The facility provides emails sent on 4/19/24 to all facility's leaders indicating the ECMO program has been terminated. The team reviewed with the DRR an on-call schedule for cardiac thoracic (relating to, involving, or specializing in the heart and chest), and vascular surgery (open surgeries and minimally invasive procedures that treat a range of blood vessel problems) that has been established. On April 18, 2024, the facility placed the following safety stand-down plan into place: The survey team reviewed with the DRR the "Culture of Safety sign-in sheet" and attestation for the following: Surveillance of surgical site (area of the body where medical lines or tubing is inserted) and dressings of medical devices such as central lines (a thin, flexible tube that is inserted into a vein), hemodialysis catheters (medical tubing used for exchanging blood to and from a machine and a patient), PICC (peripheral inserted central catheter, a thin tube that's inserted through a vein), port-a-cath (a device used to draw blood and give treatments, including intravenous fluids, and blood transfusions), arterial lines (a thin, flexible tube that is placed into an artery), IABP (intra-aortic balloon pump, a device that helps the heart pump more blood), Impella (Percutaneous Ventricular Assist Device, heart pump used to help maintain blood flow), and CRRT (Continuous renal replacement therapy, a type of blood purification therapy). Charge Nurses review with the primary nurses the following: MD (Doctor of Medicine) orders; if there are no orders, request an order from the MD; escalate any concerns; and document MD notification in EMR (electronic medical record, a digital version of the paper charts in clinician offices, clinics, and hospitals). Laminated copies of the 2024 Chain of Command flowchart for all nursing units.

Findings:

During a review of Patient 1's "Emergency Department Encounter Note (ED Note, a summary of a patient's interval status during an emergency department encounter, including narrative and free text data)," dated 3/26/24, the "ED Note" indicated, Patient 1 "Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection."

During a review of Patient 1's "Operative Report (a report written in a patient's medical record to document the details of a surgery)," documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had "pump failure (a condition that develops when the heart doesn't pump enough blood for the body's needs) and thus underwent a procedure for "placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren't functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works)."

During a review of Patient 1's "Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note," dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was "found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient's body) of the patient's VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m."

During a review of Patient 1's "Operative Report (a report written in a patient's medical record to document the details of a surgery)," documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had "pump failure (a condition that develops when the heart doesn't pump enough blood for the body's needs) and thus underwent a procedure for "placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren't functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works)."

On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, "When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him."

On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, "It is unclear how Patient 1 was decannulated. EDMD not able to visualize at first due to large dressing over site, after calling time of death, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. Sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything come out. Sent photo but Surgeon, but he did not respond after. No suture seen for the cannula that came off, just the Ioban holding it down. Spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated, did not mention about the suture.

On 4/17/23, at 9:00 a.m., during an interview with RN2 (Registered Nurse 2), RN2 stated that she and RN1 was assigned to care for Patient 1. On 4/2/23 around 4:30 a.m., patient's 1 ECMO machine started alarming and when RN3 (the charge nurse) assess the cannulas entry site by pulling back the dressing on the left femoral, there was a "hissing" and "pop" sound, then there was blood everywhere. Patient bled to death, there was not much time, time of death was called at 4:45 a.m., RN 2 stated, "time of death was called about 10-15 minutes from when the alarm went off." RN 2 also confirmed that the ECMO Circuit Checklist is done every hour. RN 2 confirmed for Patient 1, nurses cannot assess ECMO cannula entry site because there is a gauze dressing over the cannula entry site and Ioban on top of the cannulas' entry site. RN stated, "nurses cannot change dressing, that is of concern because nurse is not able to assess the surgical site with the gauze covering the cannulas' entry site."

On 4/17/24, at 9:40 am., during an interview with RN1 (Registered Nurse 1), RN1 stated that after Patient 1 passed, it was found out that 1 of 2 ECMO cannula was out. Normally a cannula should be sutured to patient skin, the cannula that came out has no indication that it was sutured in. Surgeon should also do the initial dressing change; its last dressing change was on 3/26/24. Ideally a surgical dressing site is change within 24-48 hours. There should have been a follow up or escalation to chain of command to change or inspect patient 1 ECMO surgical site. Dressing has not been changed since 3/26/24, it was not escalated or brought up to leadership.

On 4/18/24 at 10:00 a.m., during an interview with the Director of Intensive Care Unit (DICU), the DCCU stated, "It is difficult to tell who is covering that day, the nurses will communicate with the physician. There is no set schedule of on call physician."

On 4/18/24 at 12:00 p.m., during an interview with the Director of Risk and Regulatory (DIRR), the DRR confirmed that the facility has only one cardiac thoracic surgeon, (Surgeon 1), who has knowledge and oversight of all ECMO cases in the facility. As confirmed with DIRR, the facility does not have another physician who has the capability to troubleshoot problems with the ECMO.
During a review of Patient 1's "Active LDA (assessment documentation of patient line, drains and airway," dated 4/2/24 at 4:00 a.m., the "flowsheet" indicated, Patient 1 surgical incision on the left groin was noted "unable to assess", and its dressing was last changed on 3/26/2024.

During a concurrent interview and record review on 4/19/24 at 4:00 p.m. the Executive Director of Administrator (EDA), the document titled "Request for Addition of New Procedure: Upon Motion Made, Carried and Seconded," was reviewed. The proposal requested was by the Department of Surgery and Department of Medicine to the government body on 2016 to add ECMO treatment to the facility's services. The proposal document indicated the following physician participants to have received a certificate of training: Surgeon 1, MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, and MD 7.

Based on interview and record review, the facility failed to meet the condition of participation of QAPI (Quality Assessment & Performance Improvement) as evidenced by:

1. The QAPI (Quality Assessment & Performance Improvement) Committee failed to ensure staff's adherence to the facility's policy and procedure (P&P) titled "CARDIOHELP System Setup, Operation, and Patient Management" after the incident of one of 30 sampled patients (Patient 1's) unintentional decannulation (accidental cannula complete exiting the patient's body) on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility involving cannulation (insertion of a tube to a major blood vessel). (Refer to A-283, A-144 and A-395)

2. The QAPI (Quality Assessment & Performance Improvement) Committee failed to ensure one of 30 sampled patients (Patient 1's) POA (A power of attorney, a legal authorization designated person to make decisions about another person's medical care) was informed in accordance to the facility's policy and procedure, of the unintentional decannulation (removal of a medical tubing from the patient' body) while on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) treatment on 4/2/24, which causes Patient 1 to bleed to death. This deficient practice resulted in Patient 1's POA was not informed that on 4/2/24, Patient 1 bleed out and died due to unintentional decannulation while on ECMO treatment. (Refer to A-286 and A-131)

3. E The QAPI (Quality Assessment & Performance Improvement) Committee failed to ensure the implementation of an effective preventative measures to prevent the potential reoccurrence of accidental disconnection of medically inserted lines, drains, tubing, and cannulas (tubes that are inserted into a body cavity, duct, or vessel for medical purposes) after an incident of unintentional decannulation of one of 30 sampled patients (Patient 1) that occurred on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility. (Refer to A-286, A-144 and A-395.)

The cumulative effect of these systemic practices resulted in the facility's inability to ensure the condition of participation for quality assurance and performance improvement was met.

Based on interview and record review, the QAPI (Quality Assessment & Performance Improvement) Committee failed to ensure staff adherence to the facility's policy and procedure (P&P) titled "CARDIOHELP System Setup, Operation, and Patient Management" after the incident of one of 30 sampled patients (Patient 1's) unintentional decannulation (accidental cannula complete exiting the patient's body) on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility involving cannulation (insertion of a tube to a major blood vessel).

Findings:

During a concurrent interview and record review on 4/19/24 at 4:28 p.m. with the Executive Director of Administrator (EDA), the facility's QAPI meeting minutes from 2/22/23 through 2/28/24 was reviewed. There was no discussion regarding review of policy, programs improvement, data collection for the ECMO program. The EDA stated, "There is a Harm Committee, which is under the QAPI. Harm Prevention Committee, (team that prevents, preventable harm to patient and reduction of risk of unnecessary harm associated with health care), meets at the end of the month, monthly." The ECMO program have not been brought up in their (Harm Prevention Committee's) meetings because there was no event at that time. EDA stated, "Quality tracks patient safety indicator. Other program like L&D are being monitor but ECMO program was not part of the monitoring by QAPI committee."

During a review of the facility's policy and procedure (P&P) titled, "CARDIOHELP System Setup, Operation, and Patient Management," dated August 2020, the P&P indicated, "Cannula insertion sites should be frequently assessed to rule out excessive bleeding, hematoma formation, cannula kinking or cannula rotation or dislodgement. Verify the cannula remains securely fastened in place. Use dressings that allow the site to be visually assessed ... The CARDIOHELP System may be initiated, inserted, and maintained by those physicians who are privileged in ECMO. The qualified physicians (group) whom instituted CARDIOHELP will be the primary physician regarding patient management/direction throughout the ECMO period."

Based on the interview and record review, the QAPI (Quality Assessment and Performance Improvement) failed to:
1. Ensure one of 30 sampled patients (Patient 1's) POA (A power of attorney, a legal authorization designated person to make decisions about another person's medical care) was informed in accordance to the facility's policy and procedure, of the unintentional decannulation (removal of a medical tubing from the patient' body) while on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) treatment on 4/2/24, which causes Patient 1 to bleed to death. This deficient practice resulted in Patient 1's POA was not informed that on 4/2/24, Patient 1 bleed out and died due to unintentional decannulation while on ECMO treatment.

2. Ensure the implementation of an effective preventative measures to prevent the potential reoccurrence of accidental disconnection of medically inserted lines, drains, tubing, and cannulas (tubes that are inserted into a body cavity, duct, or vessel for medical purposes) after an incident of unintentional decannulation of one of 30 sampled patients (Patient 1) that occurred on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility.

Findings:
1. During a concurrent interview and record review on 4/17/24 at 2:50 p.m. with the Director, Risk and Regulatory (DIRR), Patient 1's electronic medical record (EMR, an electronic version of a patient's medical history, that is maintained over time), under titled "Physician notes" was reviewed. DIRR confirmed that no disclosure of Patient 1's unintentional decannulation (removal of a medical tube) was documented on physicians' notes. DIRR stated that during her interview with RN 3, RN 3 reported that she informed Patient 1's wife that Patient 1 had bled out. DIRR confirmed there was no documentation within Patient 1's medical record that indicates the disclosure to Patient 1's POA of the unintentional decannulation that led to his death on 4/2/24.

2. During a concurrent interview and record review on 4/19/24 at 4:28 p.m. with the Executive Director of Administrator (EDA), the facility's QAPI meeting minutes from 2/22/23 through 2/28/24 was reviewed. There was no discussion regarding review of policy, programs improvement, data collection for the ECMO program. The EDA stated, "There is a Harm Committee, which is under the QAPI. Harm Prevention Committee, (team that prevents, preventable harm to patient and reduction of risk of unnecessary harm associated with health care), meets at the end of the month, monthly." The ECMO program have not been brought up in their (Harm Prevention Committee's) meetings because there was no event at that time. EDA stated, "Quality tracks patient safety indicator. Other program like L&D are being monitor but ECMO program was not part of the monitoring by QAPI committee."

Based on interview, and record review, the facility failed to ensure the Condition of Participation for Nursing Services was met as evidenced by:

1. The facility failed to ensure one of thirty (30) sampled patients (Patient 1), who was on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) and on CRRT (Continuous Renal Replacement, type of blood purification therapy used with patients who are experiencing acute kidney injury) was reposition with at minimum three staff in accordance with the facility ECMO, "New User Class," guidance to assure one RN has responsibility to assure cannulas does not get pulled out during repositioning of the patient. This deficient practice places Patient 1, who was on ECMO and on CRRT, at increased risk for inadvertent decannulation (accidental cannula complete exiting the patient's body). (Refer to A-0392)

2. The facility failed to ensure one of thirty (30) sampled patients (Patient 1) was assessed and monitored for changes such as cannula site bleeding, positioning of cannulas, clots, color of blood, connector site for any cracks, and ensuring tubing is secure in accordance with the facility's policy and procedure, while on ECMO. This deficient practice places patients on ECMO treatment at risk for unintentional disconnection or dislodge of cannula (medical tube inserted into the body) and led to Patient 1's inadvertent decannulation on 4/2/24 that resulted in his death. (Refer to A-0395)

3. The facility failed to ensure four (4) of the four (4) sampled registered nurses (RN 1, RN 2, RN 3, and RN 4) completed an annual ECMO user competency in accordance with the proposal requested by the Department of Surgery and Department of Medicine to the government body in 2016 to add ECMO treatment to the facility's services. This deficient practice places Patient 1 and patients treated with ECMO at risk for error in care, compromised patients' safety, and reduced quality of treatment due to lack of updated knowledge and skills. It could lead to adverse events, delays in critical decision-making, and overall jeopardized the patients' wellbeing. (Refer to A-0397)

The cumulative effect of these systemic practices resulted in the facility's inability to ensure the condition of participation for nursing service was met.

Based on interview and record review, the facility failed to ensure one of thirty (30) sampled patients (Patient 1), who was on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) and on CRRT (Continuous Renal Replacement, type of blood purification therapy used with patients who are experiencing acute kidney injury) was reposition with at minimum three staff in accordance with the facility ECMO, "New User Class," guidance to assure one RN has responsibility to assure cannulas (medical tube inserted into the body) does not get pulled out during repositioning of the patient.

This deficient practice places Patient 1, who was on ECMO and on CRRT, at increased risk for inadvertent decannulation (accidental cannula complete exiting the patient's body).

Findings:

During a review of Patient 1's "Emergency Department Encounter Note (ED Note, a summary of a patient's interval status during an emergency department encounter, including narrative and free text data)," dated 3/26/24, the "ED Note" indicated, Patient 1 "Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection."

During a review of Patient 1's "Operative Report (a report written in a patient's medical record to document the details of a surgery)," documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had "pump failure (a condition that develops when the heart doesn't pump enough blood for the body's needs) and thus underwent a procedure for "placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren't functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works)."

During a review of Patient 1's "Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note," dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was "found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient's body) of the patient's VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m."

During an interview on 4/17/24 at 9:03 a.m. with Registered Nurse (RN) 2, RN 2 stated, Patient 1 was repositioning at 4:00 a.m. by herself and RN 1. RN 2 stated she was on one side of the bed and RN 1 was on one side of the bed. During repositioning of the patient both nurses have their hands on the air tape. Confirmed with RN 1 there were two nurses during the repositioning of Patient 1 at 4:00 a.m.

On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, "When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him."

On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, "It is unclear how Patient 1 was decannulated. EDMD not able to visualize at first due to large dressing over site, after calling time of death, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. Sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything come out. Sent photo but Surgeon, but he did not respond after. No suture seen for the cannula that came off, just the ioban holding it down. Spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated, did not mention about the suture.

During a review of Patient 1's "View Doc Flowsheet (documentation that identifies the actual flow of events in a process)," dated 4/2/24 at 4:00 a.m., the "flowsheet" indicated, Patient 1 was reposition on 4/2/24 at 4:00 a.m. from the right side to the left side (by two nurses as indicated in interview above on 4/17/24 at 9:03 a.m. with Registered Nurse (RN) 2).

During an interview on 4/17/24 at 3:12 p.m. with Registered Nurse (RN) 4, who is the destinated super user (someone who knows a lot about the program) of ECMO (RN) 4, RN 4 stated, the process of repositioning a patient who is on ECMO and CRRT, "We use a four-man team; three staff and one RN who is destinated to be responsible to monitor and protect the of the ECMO's lines and cannulas." RN 4 further confirmed that to prevent dislodging, kinking or decannulation of the ECMO's cannulas, a minimum of three RNs is required to reposition a patient receiving ECMO treatment.
During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of the Intensive Care Unit (DICU), the facility's Power Points (a presentation program developed to creates a slide show of important topic) for ECMO education materials that is taught to RNs by the DICU titled, "Extra Corporeal Membrane Oxygenation (ECMO): Cardio Help New User Class," undated was reviewed. The power points indicated, "Basic ICU Care: Minimum 3 people, Primary RN responsible for cannula." The DICU stated, "During repositioning of a patient receiving ECMO a minimum of three people is required when repositioning of the patient. One RN has to primary hold and monitor the ECMO canula."

Based on interview and record review, the facility failed to ensure one of thirty (30) sampled patients (Patient 1) was assessed and monitored for changes such as cannula site bleeding, positioning of cannulas, clots, color of blood, connector site for any cracks, and ensuring tubing is secure in accordance with the facility's policy and procedure, while on ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own).

This deficient practice places patients on ECMO treatment at risk for unintentional disconnection or dislodge of cannula (medical tube inserted into the body) and led to Patient 1's inadvertent decannulation on 4/2/24 that resulted in his death.

Findings:
During a review of Patient 1's "Emergency Department Encounter Note (ED Note, a summary of a patient's interval status during an emergency department encounter, including narrative and free text data)," dated 3/26/24, the "ED Note" indicated, Patient 1 "Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with sever crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection."

During a review of Patient 1's "Operative Report (a report written in a patient's medical record to document the details of a surgery)," documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had "pump failure (a condition that develops when the heart doesn't pump enough blood for the body's needs) and thus underwent a procedure for "placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren't functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works)."

During a review of Patient 1's "Emergency Code Blue (page over head in the hospital for staff to be summon to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note," dated 4/2/24, the note indicated Patient 1 was "found to be in extremis and severe distress. There has been an inadvertent decannulation of the patient's VA (venous [carries dark red, oxygen-poor blood in the veins-arterial [carries red blood that has been oxygenated in lungs]) ECMO circuit ...Time of death was called at 4:45 a.m."

During an interview on 4/17/24 at 9:00 a.m. with Registered Nurse (RN) 2, RN 2 stated she and another nurse, Registered Nurse (RN) 1, were assigned to care for patient 1 on 4/2/23. RN 2 stated around 4:30 AM, the patient ECMO machine started alarming, and when RN 3 assessed the cannulas entry site by pulling back the dressing on the left femoral (top portion of the long bone in the upper part of the leg), there was a "hissing" and "popping" sound, and then there was blood everywhere. RN 2 further stated, "The patient bled to death; there was not much time; the time of death was called at 4:45 AM. The time of death was called about 10-15 minutes from when the alarm went off." RN 2 also confirmed that the process during the care of a patient on ECMO, is RN to assess and monitor for items on the "Hourly Cardio Help Circuit Checklist," every hour.

On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, "When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him."
During an interview on 4/17/24 at 10:49 a.m. with the Nurse Educator of ICU (NEDICU), the NEDICU stated, "Hourly Cardio Help Circuit Checklist" is part of the safety process, nurses are require completing the check list during the care of a patient on ECMO treatment.

On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, "It is unclear how Patient 1 was decannulated. EDMD not able to visualize at first due to large dressing over site, after calling time of death, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. Sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything came out. Sent photo but Surgeon, but he did not respond after. No suture seen for the cannula that came off, just the Ioban holding it down. Spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated, did not mention about the suture.

During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), the facility's ECMO safety checklist titled, "Hourly Cardiohelp Circuit Checklist," dated from 3/26/24 (date initiated ECMO treatment for Patient 1) through 4/2/24 (date of unintentional decannulation of Patient 1) was reviewed. The check list indicated "Use one sheet per Shift (initials = checked and done)." The following items require checking every hour:
Venous cannula (medical tube inserted in the vein): Bleeding, position, clots, color of blood
Arterial cannula (medical tube inserted in the artery): Bleeding, position, clots, color of blood
Puncture site: Bleeding, position
Pressures: Document all elements in ECLS Flowsheet in EPIC
Stopcocks (an operated valve regulating the flow of a liquid or gas through a pipe): Off to circuit & capped & Tight connection to Luer lock (a screw connection that creates a leak-free seal)
Connector: Any cracks? Tubing is secure, clots.
Centrifugal Pump (a pump that uses an impeller to move water or other fluids): air, clots, blood flow
Oxygenator: clots, leaks
De-Airing Port (Yellow): CAP ON-Do Not Burp
Heater: Water Bathe temp, patient temp, water level, watercolor & remain ON. Adjust temperature per MD order!
Gas Flow Meter: Tubing connections to flowmeter and oxygenator, Gas source connections to wall outlets, sweep setting, oxygen setting.
Dates of entries on the "Hourly Cardio Help Circuit Checklist," by RNs are as follow:
Night shift, 3/26/24 at 7:00 p.m. through 3/27/24 at 6:00 a.m., was completed with the RN's initials.
Day shift, 3/27/24 at 7:00 a.m. through 3/27/24 at 6:00 p.m. Not completed, No hourly initial by the RN
Night shift, 3/27/24 at 7:00 p.m. through 3/28/24 at 6:00 a.m. Not completed, No hourly initial by the RN
Day shift, 3/28/24 at 7:00 a.m. through 3/28/24 at 6:00 p.m., was completed with the RN's initials.
Night shift, 3/28/24 at 7:00 p.m. through 3/29/24 at 6:00 a.m. Not completed, No hourly initial by the RN
Day shift, 3/29/24 at 7:00 a.m. through 3/29/24 at 6:00 p.m., was completed with the RN's initials.
Night shift, 3/29/24 at 7:00 p.m. through 3/30/24 at 6:00 a.m., was completed with the RN's initials.
Day shift. 3/30/24 at 7:00 a.m. through 3/30/24 at 6:00 p.m. was completed with the RN's initials.
Night shift: 3/30/24 at 7:00 p.m. through 3/31/24 at 6:00 a.m. Not completed, No hourly initial by the RN
Day shift: 3/31/24 at 7:00 a.m. through 3/31/24 at 6:00 p.m. Not completed, No hourly initial by the RN
Night shift: 3/31/24 at 7:00 p.m. through 4/1/24 at 6:00 a.m. Not completed, No hourly initial by the RN
Day shift 4/1/24 at 7:00 a.m. through 4/1/24 at 6:00 p.m. was completed with the RN's initials.
Night shift, 4/1/24, at 7:00 p.m., through 4/2/24 (date that Patient 1 had inadvertent decannulation at 4:30 a.m.) at 6:00 a.m. Not completed, no hourly initial by the RN

The DICU stated the RN caring for the patient receiving ECMO should submit a completed report of the "Hourly Cardio Help Circuit Checklist" by the end of shift to the ICU's supervisor." DICU confirmed that there are several missed documentations for several days of the "Hourly Cardio Help Circuit Checklist" for Patient 1.
During a review of the facility's policy and procedure (P&P) titled, "In keeping with the mission and values of (name of the facility) adopts the "Comprehensive Vascular Access Management" regional clinical standard," dated September 2019, the P&P indicated, for peripheral saline lock (device allows easy access to the peripheral vein for intermittent IV fluids or medications), short-term non-tunneled central venous access device (short term, venous access device [VAD], medical access line allow medication administration for 2-3 weeks), long-term tunneled central VAD (long-term, VAD, medical access line allow medication administration more than 3 weeks), peripheral inserted central venous catheter (PICC, a long, thin tube that's inserted through a vein in your arm to administered medication), and for Port-a-cath (a combination of a portal and a catheter device used to draw blood and give treatments), all medical access devices mention should have a transparent dressing.

During a review of the facility's policy and procedure (P&P) titled, "Cardiohelp System Setup, Operation, and Patient Management," dated August 2020, the P&P indicated, "Use the "Hourly Cardiohelp Circuit Checklist" (Attachment A) to assess for changes such as signs of coagulation, cracks, system leaks, etc ...Trained ICU RNs and/or Perfusionists (A certified medical technician responsible for extracorporeal [situated outside the body] oxygenation of the blood) must continuously monitor the patient, the volume status, the circulation parameters and the system."

Based interview and record review, the facility failed to ensure four (4) of the four (4) sampled registered nurses (RN 1, RN 2, RN 3, and RN 4) completed an annual ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is used to do the work of the heart and lungs when a patient's own organs are too sick or weak to work on their own) user competency in accordance with the proposal requested by the Department of Surgery and Department of Medicine from the government body in 2016 to add ECMO treatment to the facility's services.

This deficient practice places Patient 1 and patients treated with ECMO at risk for error in care, compromised patients' safety, and reduced quality of treatment due to lack of updated knowledge and skills. It could lead to adverse events, delays in critical decision-making, and overall jeopardized the patients' wellbeing.

Findings:

a. For Registered Nurse 1: During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), RN 1's training on ECMO on sign-in logs and an excel spread sheet that indicates what date RNs completed training created by the DICU was reviewed. The spread sheet indicated the last training RN 1 received was on 10/9/2019 for attending a "Cardiohelp Refresher Course," over 4 years since RN1 was evaluated on ECMO competency. Also reviewed with the DICU the sign-in log titled, "Cardiohelp Refresher Fall 2019," dated 11/14/2019 indicated RN 1 was in attendant. DICU confirmed that RNs are not required to complete annual competency on ECMO .

b. For Registered Nurse 2: During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), RN 2's training on ECMO sign-in logs and an excel spread sheet that indicates what date RNs completed training created by the DICU was reviewed. DICU stated RN 2 was being trained by RN 1 on 4/2/24. DICU stated the required training for RNs to become ECMO user and care for patient on ECMO are to attend a "New User" training, attend a "Wet Lab (hand-on training, exercise)," and worked with a preceptor for 3 shifts caring for patient on ECMO . RN 2 completed the "New User," training on 1/26/22, and complete "ECMO Wet Lab," on 2/3/22. The spread sheet indicated the last training RN 2 received was on 1/26/22 for attending the "New User Lecture," over a year since RN 1 was evaluated on ECMO competency. DICU confirmed that RNs are not required to complete annual competency on ECMO.

c. For Registered Nurse 3: During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), RN 3's training on ECMO sign-in logs and an excel spread sheet that indicates what date RNs completed training created by the DICU was reviewed. The spread sheet indicated the last training RN 3 received was on 10/18/2019 for attending a "Cardiohelp Refresher Course," over 4 years since RN 1 was evaluated on ECMO competency. Also reviewed with the DICU the sign-in log titled, "Cardiohelp Refresher Fall 2019," dated 10/18/19 indicated RN 1 was in attendance. DICU confirmed that RNs are not required to complete an annual competency on ECMO.

d. For Registered Nurse 4: During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), RN 4's training on ECMO sign-in logs and an excel spread sheet that indicates what date RNs completed training created by the DICU was reviewed. The spread sheet indicated the last training RN 4 received was on 10/21/2019 for attending a "Cardiohelp Refresher Course," over 4 years since RN4 was evaluated on ECMO competency. Also reviewed with the DICU the sign-in log titled, "Cardiohelp Refresher Fall 2019," dated 10/21/2019 indicated RN4 was in attendant. DICU confirmed that RNs are not required to complete annual competency on ECMO.
During a concurrent interview and record review on 4/19/24 at 4:00 p.m. the Executive Director of Administrator (EDA), the document titled "Request for Addition of New Procedure: Upon Motion Made, Carried and Seconded," was reviewed. The proposal requested was by the Department of Surgery and Department of Medicine to the government body on 2016 to add ECMO treatment to the facility's services. The proposal document indicated, "Requirements to Maintain Clinical Competence: Annual Competencies and training for the ECMO team and operator of the unit."