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Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Governing Body as evidenced by:

The facility ' s governing body failed to ensure their contract for extracorporeal services (services occurring outside the patient ' s body with use of specialty staff, equipment and/or devices, including setting up the heart-lung machine) were provided in a safe and effective manner.

This deficient practice resulted in one of 40 sampled patients (Patient 1) having a drop in brain oxygen saturation (an indicator of whether the brain is receiving enough oxygen from blood to meet its needs, measured in percentage) because of improper tubing connection to oxygen, during coronary artery bypass graft surgery (CABG - a surgical procedure to improve blood flow to the heart by rerouting blood around narrowed or blocked blood vessels from other parts of the body; aka bypass surgery).Refer to A-084.



The cumulative effect of these deficient practices resulted in the facility ' s inability to provide quality health care in a safe environment.

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



1. The facility failed to ensure one of 40 sampled patients (Patient 1) received safe care when the heart-lung bypass machine (a machine that temporarily takes over the function of the heart and lungs, putting oxygen in the blood and pumping that blood throughout the body, during surgeries where the heart is being operated on) was misconfigured (tubings incorrectly attached)) during coronary artery bypass graft surgery (CABG - a serious and intensive surgery where healthy blood vessels from another part of the body are used to reroute blood to the heart to improve blood flow and oxygen supply).



This deficient practice resulted in Patient 1 ' s brain oxygen saturation levels (an indicator of whether the brain is receiving enough oxygen to meet its needs, measured in percentage) becoming low for approximately (about) four minutes and sustaining (suffer) left-sided hemiplegia (paralyzed on the left side of the body). (Refer to A-0144)



2. The facility failed to ensure that one of 40 sampled patients (Patient 31), was free from restraints (a manual method physical or mechanical device, material or equipment that immobilizes or reduces the ability of patent to move his or her arms, legs, body, or head freely).

This deficient practice resulted in inappropriate and unnecessary use of restraints and had the potential for Patient 31 to suffer from physical harm (injury or damage to a person ' s body or health). (refer to A-0161).



The cumulative effect of these deficient practices resulted in the facility ' s inability to provide quality health care in a safe environment.

Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Medical Staff as evidenced by:



Based on observation, interview, and record review, the facility failed to ensure the medical staff provided adequate oversight of the contracted company responsible for furnishing extracorporeal (services occurring outside the patient ' s body with use of specialty staff, equipment and/or devices, including setting up the heart-lung machine) services when the heart-lung bypass machine (a machine that temporarily takes over the function of the heart and lungs, putting oxygen in the blood and pumping that blood throughout the body, during surgeries where the heart is being operated on) was misconfigured during coronary artery bypass graft surgery (CABG - a serious and intensive surgery where healthy blood vessels from another part of the body are used to reroute blood to the heart to improve blood flow and oxygen supply) for one of 40 sampled patients (Patient 1).



This deficient practice resulted in Patient 1 ' s brain oxygen saturation levels (an indicator of whether the brain is receiving enough oxygen to meet its needs, measured in percentage) becoming low for approximately (about) four minutes and sustaining (suffer) left-sided hemiplegia (paralyzed on the left side of the body).

(Refer to A-0347)



The cumulative effect of these deficient practices resulted in the facility ' s inability to provide quality health care in a safe environment.

Based on interview and record review, the facility ' s governing body failed to ensure their contracted services for extracorporeal services (services occurring outside the patient ' s body with use of specialty staff, equipment and/or devices, including heart-lung machine, were provided in a safe and effective manner.

This deficient practice resulted in one of 40 sampled patients (Patient 1) having a drop in brain oxygen saturation (an indicator of whether the brain is receiving enough oxygen from blood to meet its needs, measured in percentage) because of improper tubing connection to oxygen, during coronary artery bypass graft surgery (CABG – a surgical procedure to improve blood flow to the heart by rerouting blood around narrowed or blocked blood vessels from other parts of the body; aka bypass surgery).

On 5/1/2025, at 11:45 a.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) situation in the presence of the Vice President, Quality (VPQ), Vice President, Nursing (VPN), Chief Nursing Officer (CNO), and Accreditation Manager (AM).



The facility failed to ensure the governing body (group of individuals with the authority to make decisions and control an organization) provided oversight for the contracted service responsible for furnishing extracorporeal services (any medical procedure that takes place outside of the body) when Patient 1 ' s heart-lung bypass machine (a machine that temporarily takes over the function of the heart and lungs, pumping blood throughout the body, during surgeries where the heart is being operated on) was misconfigured during coronary artery bypass surgery (CABG - a serious and intensive surgery where healthy blood vessels from another part of the body are used to reroute blood to the heart to improve blood flow and oxygen supply). This deficient practice resulted in Patient 1 ' s brain oxygenation levels becoming low for approximately four minutes and sustaining left-sided hemiplegia (paralyzed on the left side of the body).



On 5/2/2025, at 8:59 p.m., the IJ was removed in the presence of the Chief Executive Officer (CEO)/Board Member, the CNO, the Vice President, Legal/Risk (VPLR), the Executive Director of Patient Safety (EDPS), the Chief Medical Officer (CMO), the Assistant General Counsel (AGC), and the AM.



The elements of the IJ Removal Plan (interventions to correct the deficient practice) were verified and confirmed by the survey team while onsite through observation, interview and record review.



The IJ Removal Plan indicated:

The medical director of the Cardiac Surgery Program at the facility has programmatic (schedule) responsibility to provide oversight with quality assurance and to review the appropriateness of services rendered under the program. Through the Cardiovascular Performance Improvement Committee, the Medical Chair

Establishes parameters (limit) for perfusionists (highly trained medical professionals that operate the heart-lung bypass machine during surgeries that require it) for onboarding including certifications, number of orientation cases, and

Signs-off on perfusionist competencies (Certification, annual testing, individual perfusionist reviews

Reviews quality metrics related to cases with perfusionists including morbidity and mortality, blood use, surgical complications, comparisons to like-kind facilities for quality metrics benchmarks.

Operating Room Operations Assistant, under the supervision of the Executive Director of the Operating Room, verifies that perfusionists hold valid certifications from recognized bodies, such as the American Board of Cardiovascular Perfusion (ABCP), and ensures that they meet the educational and experience requirements including, but not limited to: bachelor degree, perfusionist certification, additional certifications.. When a new perfusionist is going to be assigned to the facility, the Operating Room Assistant sends a packet to the Specialty Care Credentialing Team requesting various documents including educational, experience and credentialing documents so that hospital can verify the competencies. In addition, the perfusionist must agree to abide by hospital ' s policies including our policies on Fraud, Abuse and Improper Practices and Patient Safety in the Operating Room (OR). The perfusionist cannot be onboarded (process for new employee to get to know their new job) or receive a badge without hospital receiving all the required documentation including valid ID, contact information, copy of diploma, job description, license of expertise, basic life saving card, health test (Tuberculosis- (TB) –serious illness that affect the lungs), Covid Vaccine, Flu Shot), liability insurance, company credentials, confidentiality agreement, fraud, abuse, and improper practices sheet, conflict of interest, standards of behavior, patient safety in the OR, Torrance Safety exam. Once the documents are received, a personnel file is created for the perfusionist and updated as needed with annual competencies, taken from American Board of Cardio-Vascular Perfusion, etc. Perfusionists are a specialized healthcare professional and responsible for the lung-heart bypass machine, which is the accepted standard by their governing body (American Society of Extracorporeal Technology). No one else in the hospital can work the machine.

A Perfusion Management Plan is created for surgeries by the Cardiac Surgeon. The Plan is discussed during the initial time out and updated during the surgery. The Plan includes patient information (name, medical record number (MRN), sex, age, history), orders that are patient specific orders, type of procedure, risk factors, medications, labs, anti-coagulation, Mean Arterial Pressure (average blood pressure in the body), and safety checklist. Procedural medical care and directions are led by the Cardiac Surgeon, and contributed to by the anesthesiologist (medical doctor who provide pain relief) the perfusionist and others team members in the room. At the end of the surgery, the Plan is signed by the Cardiac Surgeon, the Anesthesiologist and the Perfusionist.

Immediately following this incident, nursing leadership contacted Specialty Care leadership and requested that the two perfusionists involved should not return to hospital; this request was agreed to by Specialty Care leadership and they have not been back. A third perfusionist had already submitted their resignation to and did not return.

The Director, Lundquist Lurie Cardiovascular Institute did a visual inspection and review of the operating room and equipment and noticed that two of the tubes looked identical and the alarm on the machine was faint. Director worked with Specialty Care to have adjust alarms, which was confirmed. Took additional findings to Vice President of Nursing for mitigation (see next bullet point)

Vice President of Nursing met with Executive Director Lundquist Lurie Cardiovascular Institute and the Chief Nursing Officer to review the walkthrough done of the operating room and equipment by the Director Lundquist Lurie Cardiovascular Institute. They also discussed mitigation (reduction of a harmful effects) actions including

Safety checklist in each physician-initiated timeout, which started with next case.

Research into equipment engineered to prevent tubing set-up errors.

Limiting perfusionists to a small, vetted group (implemented 4/30/2025)

Following the Root Cause Analysis (problem solving approve), the Chief Nursing Officer approved to purchase a different type of oxygenator supply, which has preconnected tubing to prevent improper hookup. Since the item is a change in existing supply, no additional budget or board approval was required, as per the board delegated authority to the Chief Nursing Officer. This will eliminate any human factor risks related to this error. The new oxygenator was implemented on May 1, 2025. Additional competencies were given to the identified nine perfusionists. Three have already completed the competencies. The additional six will not work on a case until completed. Must be completed by May 31, 2025. Competencies will be reviewed by OR Manager and signed off by Medical Director of Cardiac Surgery.



Findings:

A review of Patient 1 ' s face sheet (a document that summarizes a patient ' s personal and demographic information), dated 3/14/2025, indicated patient was admitted to the facility with chest pain.

On 4/29/2025, at 9:34 a.m., during a concurrent interview with the medical director of emergency department (DED) and record review of Patient 1 ' s cardiac catheterization (a minimally invasive procedure used to diagnose and treat heart conditions) note, dated 3/15/2025, DED stated patient had severe left coronary artery disease (heavy blockage throughout the heart).

Concurrently, during review of Patient 1 ' s Cardiac Surgery note, dated 3/18/2025, DED stated Physician 1 discussed, with the patient and his family, the plan for bypass surgery on 3/19/2025, after reviewing the diagnostic (process of identifying a disease or condition) and laboratory tests.

On 4/29/2025, at 11:40 a.m., during concurrent interview with executive director of perioperative (around the time of the surgery) services (DOP), DOP stated that the facility relies (depend) on the contractor for extracorporeal services to have a system in place for standards of care, competencies, and policies and procedures for the perfusionist (a person who operate a heart-lung machine during open heart surgery) to set up the bypass machine.

On 4/29/2025, at 12:13 p.m., during concurrent interview with operating room manager (ORM) and record review of Patient 1 ' s Nursing Notes, dated 3/19/25, ORM stated the circulating nurse cannot verify the setup of the heart-lung machine by the perfusionists because the circulating nurse does not know how to set up the bypass machine because it is not within the circulating nurse ' s scope of practice (duties) and the circulating nurse cannot verify that the setup of the bypass machine was done correctly. ORM stated it was the perfusionist ' s job to ensure that the bypass machine was set up correctly.

Concurrently, ORM stated there were two perfusionists (Perfusionist 1 and Perfusionist 2) in the operating room (OR) with the circulating nurse. ORM stated perfusionist setup the bypass machine, prior to the patient entering the OR. ORM stated Perfusionist 1 was being oriented by Perfusionist 2.

On 4/30/2025, at 11:32 a.m., during concurrent interview with perfusionist director of operations (PDO) and record review of Patient 1 ' s perfusionist records, dated 3/19/2025, PDO stated there were two perfusionists in the OR with Patient 1. Perfusionist 2 proctored (supervised performance) Perfusionist 1. PDO stated Perfusionist 1 had 15 years of experience, was new to this facility, and had to be proctored for bypass surgeries ten times before being able to work alone at this facility, per facility contract. PDO stated Perfusionist 1 was the primary perfusionist and this was the 8th proctored case for Perfusionist 1.

PDO stated the perfusionist were responsible for setting up the bypass machine for the surgery. PDO stated that there were three perfusionists involved with the bypass machine set up: Perfusionist 3 set up the bypass machine the night before the surgery; Perfusionist 1 was the primary perfusionist and documented that the set up was done correctly with a checklist; Perfusionist 2 was proctoring Perfusionist 1 and supposed to ensure that the bypass machine was set up correctly, prior to beginning the bypass surgery.

Concurrently, PDO stated that the bypass machine for Patient 1 was not set up correctly because the gas line was incorrectly connected to the gas outlet, instead of the gas inlet. And, as a result, Patient 1 was not getting oxygen to the heart for four minutes.

On 4/30/2025, during interview with Patient 1 ' s cardio-thoracic (heart and chest) surgeon (Physician) 1 regarding Patient 1 ' s surgery on 3/19/2025, Physician 1 stated there were two perfusionists in the OR. Physician 1 stated he knew Perfusionist 2 for many years, but did not know Perfusionist 1. Physician 1 stated during Patient 1 ' s surgery, he was alerted that something might be wrong during the surgery, when the anesthesiologist (medical doctor specializing in pain management) (Physician) 2 informed him that Patient 1 ' s oximetry (oxygen in the blood) was low. Physician 1 stated he noticed that Patient 1 ' s arterial blood (blood that has oxygen, that goes throughout the body) was very dark and should have been bright red.

Physician 1 asked the perfusionists (Perfusionist 1 and Perfusionist 2) what was going on. Physician 1 noticed the two perfusionists were scrambling to troubleshoot the problem. Physician 1 stated he observed Perfusionist 2 rearrange the tubing on the oximeter for the bypass machine, which fixed the problem, and the patient ' s arterial blood became bright red, again. Physician 1 stated the perfusionists did not check to make sure the oxygen line was connected correctly because the lines were reversed – oxygen line should have been connected to the inlet (narrow opening) but instead was connected to the outlet (exit) – and Patient 1 did not get oxygen to the heart for four minutes.

On 5/1/2025, at 12:38 p.m., during interview with chief cardiothoracic (heart and chest) surgeon (CCS), CCS stated he recommended the perfusionists have ten proctored (supervised) cases at this facility, before being on their own, to learn the surgeon ' s preferences and style of doing bypass surgery.

Concurrently, CCS stated he does not know how to set up the bypass machine – not part of their practice - and he leaves it up to the perfusionists, who are contracted with the hospital, to set up and run the machine. CCS stated during bypass surgery, his back is turned to the perfusionist, and he cannot see what is going on. CCS stated he is in constant communication with the perfusionist during the entire bypass surgery. CCS stated, for example, he would give a verbal order to the perfusionist and the perfusionist must repeat back what was ordered by him.

On 5/1/2025, at 4:32 p.m., during interview with the chief medical officer (CMO), CMO stated the medical executive committee (MEC) reviewed the services contracted for the facility, on 11/30/2023, which is done every two years. CMO stated then the board of trustees (group of individuals responsible for managing organization) read, reviewed, and approved the contracts in December 2023. CMO stated the governing body (a group that manages and control activities of organization) delegates (turn over) patient care to the medical staff and the hospital administration manages the care and ensures that quality of care is provided to the patients, including the care provided by the contracted services. CMO stated together, the medical staff and hospital administration exercise the oversight of the care provided by the contracted services. The CMO stated that the facility does not have its own policies and procedures and standards of practice for the contracted services for extracorporeal services to follow. The CMO stated that the MEC was not aware of the facility ' s requirement for 10 proctored cases for the newly hire perfusionists, new to the facility.

A review of the facility ' s medical executive committee (MEC) report to the board of trustees, dated 11/29/2023, indicated a list of clinical contracts, which included the following:

The contract for extracorporeal services is effective 3/1/2015.

Term - 5/21/2017.

Oversight by executive director of perioperative services



A review of the facility ' s contract for Extracorporeal services, dated 2/20/2009, indicated the following:

Services will provide appropriate staffing by individuals employed by the company who will communicate with the physician in charge of the procedure.

Contracted staff will administer medications, as supervised by and directed by the physician in charge.

Contracted staff will have a process to monitor and report clinical and non-clinical variances (difference), in connection with the services provided under the agreement, including participation in the hospital ' s quality improvement process.

There will be a joint quality improvement or peer review of privileges, and sharing of information and documentation related to variances.

The contracted company will provide capital equipment, as determined by the company, for the contracted company ' s use in performing the services.

The contracted company will maintain the equipment.

Contracted staff have the right to enter the facility where the equipment is located to inspect and/or remove the equipment.

Facility will provide contracted staff with basic orientation to the facility ' s policies and procedures, including documentation of care and/or services, procedures for medication ordering system, and reporting of industrial hazards.

The facility will provide contracted staff with medical supplies, including medications.

Facility agrees and acknowledges that is shall have full medical responsibility for its patients, in general, and specifically, during the provision of services and agrees to supervise its patients, accordingly.



A review of facility ' s twelve amendment to contract for Extracorporeal services, dated 7/1/2023, indicated monthly retainer for perfusion professional services included services performed for the first 300 open heart on or off bypass or open-heart standby procedures performed each year.

A review of American Society of Extra-Corporeal Technology – Standards and Guidelines for Perfusion Practice,(standard of practice approved for facility use) dated 2023, indicated the following 19 standards, which included qualifications/competency, communication, perfusion record, checklist, safety devices, and monitoring:

Qualification/competency standard indicated board certification by the American Board of Cardiovascular Perfusion or one who demonstrated equivalent qualifications and competency to conduct cardiopulmonary bypass procedures.

Communication standard indicated protocol-driven communication (closed loop) is utilized to acknowledge verbal commands, verify the content, and reduce ambiguity, with deviations from the intended treatment plan communicated to the supervising physician and documented.

Perfusion record standard indicated written and/or electronic records for cardiopulmonary bypass procedure shall be included in the patient ' s medical records, including patient ' s pre-operative risk factors, information regarding the procedure/personnel/equipment, patient ' s physiological parameters, signature of perfusionist, and commentary with supervising physician verbal orders pertinent to the procedure and blood flow.

Checklist standard indicated a checklist in a read-verify manner where critical steps that should have been performed are confirmed by two people, including the primary perfusionist responsible for operating the heart lung machine during surgery.

Safety devices standard indicated a method for retrograde(backward) flow avoidance (escape) used during bypass surgery or procedures, including low speed visual and audible alarms to allow an appropriate reaction time and a safe operational volume.

Monitoring standard indicated monitoring of blood gases, oxygen fraction, arterial oxygen saturation continually during cardiopulmonary bypass procedures.

Based on observation, interview, and record review, the facility failed to ensure one of 40 sampled patients (Patient 1) received safe care when the heart-lung bypass machine (a machine that temporarily takes over the function of the heart and lungs, putting oxygen in the blood and pumping that blood throughout the body, during surgeries where the heart is being operated on) was misconfigured (incorrectly) during coronary artery bypass graft surgery (CABG - a serious and intensive surgery where healthy blood vessels from another part of the body are used to reroute blood to the heart to improve blood flow and oxygen supply).



This deficient practice resulted in Patient 1 ' s brain oxygen saturation levels (an indicator of whether the brain is receiving enough oxygen from blood to meet its needs, measured in percentage) becoming low for approximately(about) four minutes and sustaining (suffer) left-sided hemiplegia (paralyzed on the left side of the body).



On 4/30/2025, at 4:04 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) situation in the presence of the Vice President, Quality (VPQ), Vice President, Nursing (VPN), Chief Nursing Officer (CNO), and Accreditation Manager (AM).



The facility failed to ensure one of 40 sampled patients (Patient 1) received safe care when the heart-lung bypass machine (a machine that temporarily takes over the function of the heart and lungs, pumping blood throughout the body, during surgeries where the heart is being operated on) was misconfigured(tubings incorrectly attached) during coronary artery bypass surgery (CABG - a serious and intensive surgery where healthy blood vessels from another part of the body are used to reroute blood to the heart to improve blood flow and oxygen supply). This deficient practice resulted in Patient 1 ' s brain oxygenation (adding oxygen to the body) levels becoming low for approximately (about) four minutes and sustaining (suffer) left-sided hemiplegia (paralyzed on the left side of the body).



On 5/2/2025, at 8:59 p.m., the IJ was removed in the presence of the Chief Executive Officer (CEO)/Board Member, the CNO, the Vice President, Legal/Risk (VPLR), the Executive Director of Patient Safety (EDPS), the Chief Medical Officer (CMO), the Assistant General Counsel (AGC), and the Accreditation Manager (AM). The elements of the IJ Removal Plan (interventions to correct the deficient practice) were verified and confirmed by the survey team while onsite through observation, interview and record review.



The IJ Removal Plan indicated:

The Operating Room Manager, in conference with the Chief Nursing Officer, informed the contracted services leadership to not return the perfusionists (highly trained medical professionals that operate the heart-lung bypass machine during surgeries that require it) involved in the event.

The facility initiated the pre-bypass checklist, during the physician-initiated time-out and read by the Operating Room Registered Nurse (OR RN), prior to the start of the procedure. The checklist is in the contracted services electronic medical record, then printed and scanned into the facility ' s electronic medical record. The surgeon specifically calls out the checklist and requires the perfusionist to answer that the check was complete. The physician will continue the current practice of reviewing the printed record, including the checklist, and signs the profusion record. This is scanned into the electronic medical record.

After the Root Cause Analysis, the team committed to ordering the oxygenator designed to prevent improper setup. This was approved by the Chief Nursing Officer. Since the item is a change in existing supply, no additional budget or board approval was required, as per the board delegated authority to the Chief Nursing Officer. The design of the new oxygenator (the part of the heart-lung bypass machine that puts oxygen in the blood) prevents human factors from causing future errors in setting up tubing and would have prevented this error. Supplies were delivered May 1, 2025, and were used in the first procedure on May 2, 2025.

The contracted service created a new pump set-up checklist and ensured competency for the new oxygenator. This was reviewed and approved by the Chief Nursing Officer and the Executive Director of Operating Room Services. Competencies are completed for four of the nine perfusionists. The additional perfusionists will complete before their next case at hospital, before May 31, 2025.

The Register nurse (RN) circulator is responsible to validate in room with the perfusionist that the pre-bypass checklist is complete and perfusionist will verbally attest(confirm) to accuracy (being correct).

The number of accepted perfusionists has been limited to eight individuals assigned to the facility. The Chief Nursing Officer verbally communicated to the contracted services on May 1, 2025. The Chief Nursing Officer followed up with an email to the cardiovascular surgeons with the plan and list or perfusionists on May 2, 2025, verified with email read-receipt.





Findings:



During a review of Patient 1 ' s "Emergency Department Provider Note," dated 3/14/2025, at 11:04 a.m., the "Provider Note" indicated that Patient 1 presented to the emergency department for chest pain.



During a review of Patient 1 ' s "History & Physical" (H&P - a formal and complete assessment of the patient and the problem), dated 3/14/2025, at 2:26 p.m., the H&P indicated Patient 1 was admitted to the facility for NSTEMI (non-ST-elevation myocardial infarction - a type of heart attack where the heart muscle experiences a temporary or partial blockage of blood supply, resulting in damage to the heart tissue).



During a review of Patient 1 ' s "Progress Note," dated 3/17/2025, at 9:19 a.m., the "Progress Note" indicated Patient 1 was scheduled to have CABG surgery (a serious and intensive surgery where healthy blood vessels from another part of the body are used to reroute blood to the heart to improve blood flow and oxygen supply) on 3/19/2025.



During a review of Patient 1 ' s "Operating Room (OR) Nursing Record," dated 3/19/2025, the "Record" indicated that Patient 1 entered the OR for their CABG surgery at 8:00 a.m. and left the OR at 4:25 p.m.



During an interview with the Operating Room Manager (ORM), on 4/29/2025, at 11:23 a.m., the ORM stated the facility contracts out its perfusionist (highly trained medical professionals that operate the heart-lung bypass machine during surgeries that require it, such as CABG) services. The ORM confirmed there were two contracted perfusionists present at Patient 1 ' s CABG surgery, Perfusionist 1 and Perfusionist 2.



During an interview with the ORM, on 4/29/2023 at 11:23 a.m., the ORM stated that Patient 1 ' s surgery was going well until it was time to "go on bypass" (reroute the patient ' s blood through the heart-lung bypass machine, to allow the surgeon to work on the heart while it is not beating) at approximately 12:20 p.m. The OR Manager confirmed Perfusionist 1 was the one operating the heart-lung bypass machine, "because Perfusionist 2 was observing Perfusionist 1."



During a concurrent interview and record review, on 4/30/2025, at 4:45 p.m., with Physician 2, Patient 1 ' s "Anesthesia (medicine use to prevent pain) Record" was reviewed. Physician 2 stated that prior to going on bypass, Patient 1 ' s baseline brain oxygenation saturation levels were in the 50s, but when they went on bypass, Physician 2 "noticed a downward trend in the brain oxygenation saturation levels." Between approximately 12:20 p.m. and 12:30 p.m., the "Record" indicated that Patient 1 ' s brain oxygenation saturation was 47%, then 42%, then 29%. Physician 2 stated he informed Physician 1 and Perfusionist 1, who Physician 2 confirmed was the primary perfusionist for this case, about the low brain oxygenation saturation levels. Physician 2 then noticed that the blood coming out of the bypass pump ' s oxygenator was dark (meaning it was not carrying any oxygen) and stated it "looked like venous blood (deoxygenated blood (reduce oxygen) that is returning to the heart, typically through the veins)." Physician 2 stated Perfusionist 2 then "grabbed the green tubing and pulled it off and stuck it to the back of the oxygenator" (the part of the heart-lung bypass machine that puts oxygen in the blood); "As soon as that happened, within 5 seconds, the [brain oxygen saturation levels] came up." Physician 2 estimated that these events occurred over a three-minute period.



During an interview with the Director of Operations (DO) for the contracted perfusionist service, on 5/1/2025, at 11:39 a.m., the DO stated the following:

1. Perfusionist 1 was new to the facility, but not to the contracted service. Perfusionist 1 had 15 years of experience as a perfusionist. Perfusionist 1 was being proctored (person who guides less experience) by Perfusionist 2 in order to become familiar with the facility, and the surgeon ' s preferences during open heart cases. This was Perfusionist 1 ' s eighth case at the facility, with the goal of 10 proctored cases prior to Perfusionist 1 being able to work independently.

2. The heart-lung bypass machine was set up by Perfusionist 3 after an open-heart case (a surgery where the heart is directly being operated on, such as CABG) the day before (3/18/2025). Perfusionist 3 connected the gas line connector to the gas outlet instead of the gas inlet.

3. There is a checklist that perfusionists must complete prior to the patient going on bypass, but not a checklist for perfusionists setting up the bypass machine after a procedure is completed.

4. It was Perfusionist 1 ' s responsibility to verify that the lines were connected correctly.



A concurrent interview and record review of a blank copy of the contracted service ' s "Perfusion Record" on 5/1/2025 with the DO. The "Perfusion Record" indicated that the following items needed to be completed by the perfusionist prior to going on bypass:

1. Gas lines connections secure (the tubing that carries oxygen to the machine)

2. Gas exhaust unobstructed and scavenge set up (the part of the machine that allows leftover gases to be removed from the machine)

The DO stated that the error in Perfusionist 1 ' s verification was with the second item. The DO further stated the connections were both secured, "but the problem is they were reversed, so the gas supply line was put on the gas exhaust and the gas scavenge line was put on the gas inlet." This led to "some of the gas going out into the atmosphere instead of all of it going through the oxygenator."



During an interview with Physician 1, on 5/1/2025, at 2:35 p.m., Physician 1 stated when they went on bypass, Physician 2 informed the OR team that Patient 1 ' s brain oxygenation saturation levels were down and that the arterial blood (the oxygenated blood pumped from the heart to be carried to the rest of the body) leaving the bypass machine was very dark. Physician 1 stated that if deoxygenated blood goes to the brain, cerebral anoxia (when the brain is deprived of oxygen which can lead to brain damage) can occur. Physician 1 further stated that after Patient 1 was transferred out of the OR and into the Intensive Care Unit (ICU), Patient 1 was "not moving the left side [of their body] at all." Physician 1 stated that this should never have happened.



During a review of Patient 1 ' s "Perfusion Record", indicated that the following items were marked as complete prior to Patient 1 going on bypass:

1. Gas lines connections secure

2. Gas exhaust unobstructed and scavenge set up

Physician 1 stated that this checklist was marked as complete, however, "they obviously did not do it."



During a review of Patient 1 ' s "Operative Report," dated 3/19/2025, at 7:36 p.m., indicated that during the CABG surgery, "it was noted that the cerebral oximetry [the amount of oxygen in the blood in the brain] readings were quite low indicating poor oxygenation to the brain and then noted that the arterial inflow from the heart-lung machine [the blood that is being pumped from the bypass machine into the patient ' s arteries, usually meant to carry oxygenated blood to the body] to the aortic cannula [a tube placed into the aorta, the main artery of the body] was very dark indicating deoxygenated blood being delivered to the patient. The perfusionist then noted that the heart-lung machine had been set up improperly and they went about reconnecting tubing on the heart-lung machine such that the blood could be oxygenated. After this was done the blood became red again indicating oxygenated blood which flowed to the arterial cannula and then the cerebral oximetry values rose to normal levels. The cerebral oximetry had been very low for approximately 4 minutes according to anesthesia." The "Report" further indicated, "Complications: Hypoxia [lack of oxygen] from cardiopulmonary bypass set up by perfusionist."





During a review of Patient 1 ' s" Interdisciplinary Summary, indicated the following:

1. On 3/19/25, at 4:30 p.m., Registered Nurse (RN) 1 documented Patient 1 arrived in the ICU from the OR.

2. On 3/19/25, at 5:07 p.m., RN 1 documented Medical Doctor (MD) 1 was at Patient 1 ' s bedside; Patient 1 was not moving their left arm or left leg but moving their right sided extremities (arm and leg).

3. On 3/19/25, at 5:25 p.m., RN 1 documented that a Code Stroke (a hospital-wide call for help when a patient has symptoms of a stroke) was called.



During a review of Patient 1 ' s "Teleneurology Consultation Note," dated 3/19/25, at 9:23 p.m., indicated, "Prior to surgery, patient was at baseline (starting point). Prior to hospitalization, he was very functional and independent with ADLs [activities of daily living - fundamental tasks individuals perform to care for themselves to ensure basic needs are met, such as personal hygiene, dressing, eating, toileting, and mobility] per daughter. Intra-op [during the surgery], patient reportedly had prolonged hypoxia. After CABG, he remained intubated (breathing tube) but off sedation (state of calm) and was spontaneously moving [right] side but not left."



During a review of Patient 1 ' s "Post-Anesthesia Evaluation," dated 3/20/2025, at 12:07 p.m., the "Evaluation" indicated, "[Patient] stable ... but complicated by potential hypoxic injury due to pump malfunction. EEG and CT head [electroencephalogram and computed tomography of the head, two diagnostic procedures used to diagnose whether or not the patient had a stroke] have ruled out stroke but continues to have LUE [left upper extremity] neuro (nerve) deficits."



During a review of the "American Society of ExtraCorporeal Technology Standards and Guidelines for Perfusion Practice," revised 2023, the "Standards" indicated, "Standard 5.1: The Perfusionist shall use a checklist for each cardiopulmonary bypass procedure."



During a review of the facility ' s contract with the company that furnishes extracorporeal services, titled "Agreement for Extracorporeal Services," effective 5/5/2023, indicated, "Hospital agrees and acknowledges that it shall have full medical responsibility for its patients in general, and specifically, during the provision of the Services and agrees to supervise its patients accordingly."

ased on observation, interview and record review, the facility failed to ensure that one of 40 sampled patients (Patient 31), was free from restraints (a manual method physical or mechanical device, material or equipment that immobilizes or reduces the ability for the patient to move freely). When Patient 31 ' s four side rails of the bed were raised, without a physician ' s order and in accordance with the facility ' s policy and procedures regarding the use of restrains.

This deficient practice resulted in Patient 31 ' s rights violated with inappropriate (incorrect) and unnecessary use of restraints and had the potential for Patient 31 to suffer physical harm (any injury, damage, or pain to a person ' s body).

Findings:

During a record review of Patient 31 ' s history and physical dated 4/25/2025 at 00:20 a.m. with diagnosis for failure to thrive (inadequate physical growth in infants and children, often indicating undernutrition).



On 4/28/2025, at 3:00 p. m., Patient 31 was observed in bed with four side rails in the up position.

During an interview on 4/28/2025 at 3:02p.m. with Registered Nurse (RN) 4,

RN 4 stated that Patient 31 did not have an active restraint order, in the medical chart and the one or two side rails up should have been lowered, instead of all four side rails being up, at the same time. RN 4 stated that Patient 31 ' s four side rails were up for no reason and without an order written by the physician.



During a record review of the facility ' s Policy, Restraints Clinical Practice, dated 03/26/24, indicated, "All patients have the right to be free from restraints, of any form. The use of restraints will not be imposed as a means of corporal punishment, coercion, discipline, convenience, or retaliation by staff. Furthermore, "Physical Restraints are any unusual method, physical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, bod, or heat freely." An example of physical restraints includes the use of four side rails up, to prevent a patient from voluntarily getting out of bed.

Based on observation, interview, and record review, the facility failed to ensure the medical staff provided adequate oversight of the contracted company responsible for furnishing extracorporeal (services occurring outside the patient ' s body with use of specialty staff, equipment and/or devices, including setting up the heart-lung machine) services when the heart-lung bypass machine (a machine that temporarily takes over the function of the heart and lungs, putting oxygen in the blood and pumping that blood throughout the body, during surgeries where the heart is being operated on) was misconfigured during coronary artery bypass graft surgery (CABG - a serious and intensive surgery where healthy blood vessels from another part of the body are used to reroute blood to the heart to improve blood flow and oxygen supply) for one of 40 sampled patients (Patient 1).



This deficient practice resulted in Patient 1 ' s brain oxygen saturation levels (an indicator of whether the brain is receiving enough oxygen to meet its needs, measured in percentage) becoming low for approximately (about) four minutes and sustaining (suffer) left-sided hemiplegia (paralyzed on the left side of the body).



On 5/2/2025, at 3:38 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) situation in the presence of the Vice President, Nursing (VPN), Chief Nursing Officer (CNO), the Vice President, Legal/Risk (VPLR), the Executive Director of Patient Safety (EDPS), the Chief Medical Officer (CMO), the Chief Operating Officer (COO), and Accreditation Manager (AM).



The facility failed to ensure the medical staff provided adequate oversight of the contracted company responsible for furnishing extracorporeal services (any medical procedure that takes place outside of the body) when the heart-lung bypass machine (a machine that temporarily takes over the function of the heart and lungs, putting oxygen in the blood and pumping that blood throughout the body, during surgeries where the heart is being operated on) was misconfigured during coronary artery bypass graft surgery (CABG - a serious and intensive surgery where healthy blood vessels from another part of the body are used to reroute blood to the heart to improve blood flow and oxygen supply) for one of 40 sampled patients (Patient 1). This deficient practice resulted in Patient 1 ' s brain oxygenation levels becoming low for approximately four minutes and sustaining left-sided hemiplegia (paralyzed on the left side of the body).



On 5/2/2025, at 8:59 p.m., the IJ was removed in the presence of the Chief Executive Officer (CEO)/Board Member, the CNO, the Vice President, Legal/Risk (VPLR), the Executive Director of Patient Safety (EDPS), the Chief Medical Officer (CMO), the Assistant General Counsel (AGC), and the AM. The elements of the IJ Removal Plan (interventions to correct the deficient practice) were verified and confirmed by the survey team while onsite through observation, interview and record review.

The IJ Removal Plan indicated:

Immediately after the event, the facility Operating Room Manager, in conference with the Chief Nursing Officer, informed the contracted service leadership to remove from service the three perfusionists involved in the event. The three perfusionists have been designated as "Do Not Return."

Immediately after the event, and before the next procedure, the facility initiated:

The pre-bypass checklist, during the physician-initiated time-out and read by the operating room RN, prior to the start of the procedure. The checklist is in the contracted services ' electronic medical record, then printed and scanned into the facility ' s electronic medical record.

The following items are included in the checklist:

Pre-Bypass Safety

Pre-Bypass Assisted Venous Return

Pre-Bypass Sterility

Pre-Bypass Gas Supply (includes checking that the gas lines and connections are secure, gas exhaust unobstructed and scavenge set up. The source and appropriate gas connections must be confirmed.)

Pre-Bypass Patient Information

Pre-Bypass Equipment

Pre-Bypass Autotransfusion System

Pre-Bypass Circuit Components

The pre-bypass checklist is signed and dated by the perfusionist.

The surgeon specifically calls out the checklist and requires the perfusionist to answer that the checklist has been completed.

Current practice, the physician reviews the Perfusion Management Plan. The Plan is created for surgeries by the Cardiac Surgeon. The new practice is for the plan to be discussed during the initial time out and updated during the surgery. This was discussed with the Cardio-Thoracic physicians and Operation Room leadership. The Plan includes patient information (name, MRN, sex, age, history), orders that are patient specific orders, type of procedure, risk factors, medications, labs, anti-coagulation, Mean Arterial Pressure and the pre-bypass checklist. In addition, the Plan describes medical care, orders and directions led by the Cardiac Surgeon, and contributed to by the anesthesiologist, the perfusionist and others team members in the room. The physician will continue the current practice of reviewing the printed record, including the checklist, and signs the profusion record. This is scanned into the electronic medical record.

After the Root Cause Analysis, the team committed to ordering a different oxygenator designed to prevent improper setup. This was approved by the Chief Nursing Officer. Since the item is a change in existing supply, no additional budget or board approval was required, as per the board delegated authority to the Chief Nursing Officer. The design of the new oxygenator (the part of the heart-lung bypass machine that puts oxygen in the blood) prevents human factors from causing future errors in setting up tubing and would have prevented this error. The new oxygenator was ordered on April 25, 2025, and delivered on April 28, 2025. Supplies were installed on May 1, 2025, and were used in the first procedure on May 2, 2025.

This was reviewed and approved by the Chief Nursing Officer and the Executive Director of Operating Room Services. Competencies for the new pump include verifying proper set up and preparation to reinforce the necessity of using pre-procedure checklists and reviewing the oxygenators focusing on the inlet and out connections of each. It specifically calls out what to look for when the inlet and the outlet of the oxygenator are incorrectly connected. The competency instructs the perfusionist to notify the surgeon immediately if they notice something different in the "proper color" of blood. This competency has been completed by four of the nine perfusionists. The additional perfusionists will complete the competency before their next case at the facility, before May 31, 2025.

The contracted service has also created a new pump setup checklist for the new oxygenator. The new pump set up checklist includes the following:

All connections sterile and secure by tiebands.

Tubing direction traced and correct.

All safety and temp probes connected.

Cardioplegia is connected and ratio checked.

Gas, scavenger, water and power lines are connected and correct direction.

Have available: VAVD Hemoconcentrator (use to remove excessive waste from the body), CDI, Level cage, 5 clamps and three fluids.

All equipment is wiped down and check integrity.

The perfusionist must sign and date the new pump setup checklist.

The RN circulator is responsible for validating in the room with the perfusionist that the pre-bypass checklist is complete and the perfusionist will verbally attest to accuracy. This will be documented in the Electronic Medical Record.

The number of accepted perfusionists has been limited to eight individuals assigned to the facility. The Chief Nursing Officer verbally communicated to the contracted services on May 1, 2025. The Chief Nursing Officer followed up with an email to the Cardio-Vascular surgeons with the plan and list or perfusionists on May 2, 2025, verified with email read-receipt.

The Root Cause Analysis regarding this incident was conducted on 4/22/2025 and an Action Plan is in the process of being completed. Once the Action Plan is completed, it will be introduced and approved by the Medical Staff Performance Improvement Committee and subsequently by the Medical Executive Committee. The Medical Executive Committee meets on the second Tuesday of each month and the Root Cause Analysis will be presented at the meeting following the completion of the Action Plan.

As of May 2, 2025, the Medical Director of Cardiac Surgery will sign off on the competencies of the perfusionists and will also sign off on the successful completion of the proctoring which includes a minimum of 10 cases.

As of May 2, 2025, the Medical Director of Cardiac Surgery will review quality metrics related to perfusion services at the monthly Cardiac Surgery Committee of the Medical Staff, indefinitely.

The Medical Laboratory Director reviews and signs off on the contracted service ' s Autotransfusion (process of using own blood and clean waste and return to body) Service Practice Guidelines annually, indefinitely, as oversight of the contracted service ' s perfusion services.





Findings:



During a review of Patient 1 ' s "Emergency Department Provider Note," dated 3/14/2025, at 11:04 a.m., indicated that Patient 1 presented to the emergency department for chest pain.



During a review of Patient 1 ' s "History & Physical" (H&P - a formal and complete assessment of the patient and the problem), dated 3/14/2025, at 2:26 p.m., the H&P indicated Patient 1 was admitted to the facility for NSTEMI (non-ST-elevation myocardial infarction - a type of heart attack where the heart muscle experiences a temporary or partial blockage of blood supply, resulting in damage to the heart tissue).



During a review of Patient 1 ' s "Progress Note," dated 3/17/2025, at 9:19 a.m., indicated Patient 1 was scheduled to have CABG (a serious and intensive surgery where healthy blood vessels from another part of the body are used to reroute blood to the heart to improve blood flow and oxygen supply) surgery on 3/19/2025.



During a review of Patient 1 ' s "Operating Room (OR) Nursing Record," dated 3/19/2025, the "Record" indicated that Patient 1 entered the OR for their CABG surgery at 8:00 a.m. and left the OR at 4:25 p.m.



During an interview with the Operating Room Manager (ORM), on 4/29/2025, at 11:23 a.m., the ORM stated the facility contracts out its perfusionist (highly trained medical professionals that operate the heart-lung bypass machine during surgeries that require it, such as CABG) services. The ORM confirmed there were two contracted perfusionists present at Patient 1 ' s CABG surgery, Perfusionist 1 and Perfusionist 2.



During the same interview, the ORM stated that Patient 1 ' s surgery was going well until it was time to "go on bypass" (reroute the patient ' s blood through the heart-lung bypass machine, to allow the surgeon to work on the heart while it is not beating) at approximately 12:20 p.m. The OR Manager confirmed Perfusionist 1 was the one operating the heart-lung bypass machine, "because Perfusionist 2 was observing Perfusionist 1".



During a concurrent interview and record review, on 4/30/2025, at 4:45 p.m., with Physician 2, Patient 1 ' s "Anesthesia (medication use to lower pain during surgery) Record" was reviewed. Physician 2 stated that prior to going on bypass, Patient 1 ' s baseline (beginning) brain oxygenation saturation levels (an indicator of whether the brain is receiving enough oxygen to meet its needs, measured in percentage) were in the 50s, but when they went on bypass, Physician 2 "noticed a downward trend in the brain oxygenation saturation levels." Between approximately 12:20 p.m. and 12:30 p.m., the "Record" indicated that Patient 1 ' s brain oxygenation saturation was 47%, then 42%, then 29%. Physician 2 stated he informed Physician 1 and Perfusionist 1, who Physician 2 confirmed was the primary perfusionist for this case, about the low brain oxygenation saturation levels.



Physician 2 then noticed that the blood coming out of the bypass pump ' s oxygenator (the part of the heart-lung bypass machine that puts oxygen in the blood )was dark (meaning it was not carrying any oxygen) and stated it "looked like venous blood (deoxygenated (reduce oxygen) blood that is returning to the heart." Physician 2 stated Perfusionist 2 then "grabbed the green tubing and pulled it off and stuck it to the back of the oxygenator" (the part of the heart-lung bypass machine that puts oxygen in the blood); "As soon as that happened, within 5 seconds, the brain oxygen saturation levels came up." Physician 2 estimated that these events occurred over a three-minute period.



During an interview with the Director of Operations (DO) for the contracted perfusionist service, on 5/1/2025, at 11:39 a.m., the DO stated the following:

1. Perfusionist 1 was new to the facility, but not to the contracted service. Perfusionist 1 had 15 years of experience as a perfusionist. Perfusionist 1 was being proctored(supervised) by Perfusionist 2 in order to become familiar with the facility and the surgeon ' s preferences during open heart cases. This was Perfusionist 1 ' s eighth case at the facility, with the goal of 10 proctored cases prior to Perfusionist 1 being able to work independently.

2. The heart-lung bypass machine was set up by Perfusionist 3 after an open-heart case (a surgery where the heart is directly being operated on, such as CABG) the day before (3/18/2025). Perfusionist 3 connected the gas line connector to the gas outlet(exit) instead of the gas inlet(entrance).

3. There is a checklist that perfusionists must complete prior to the patient going on bypass, but not a checklist for perfusionists setting up the bypass machine after a procedure is completed.

4. It was Perfusionist 1 ' s responsibility to verify (confirm) that the lines were connected correctly.



During concurrent interview and record review with the Director of Operations (DO) on 5/1/2025 at 11:40a.m., a blank copy of the contracted service ' s "Perfusion Record" documentation was reviewed with the DO. The "Record" indicated that the following items needed to be completed by the perfusionist prior to going on bypass:

1. Gas lines connections secure (the tubing that carries oxygen to the machine)

2. Gas exhaust unobstructed and scavenge set up (the part of the machine that allows leftover gases to be removed from the machine)

The DO stated that the error in Perfusionist 1 ' s verification (confirming) was with the second item. The DO further stated the connections were both secure, "but the problem is they were reversed (opposite), so the gas supply line was put on the gas exhaust (waste) and the gas scavenge (search) line was put on the gas inlet (entrance)." This led to "some of the gas going out into the atmosphere instead of all of it going through the oxygenator."



During an interview with Physician 1, on 5/1/2025, at 2:35 p.m., Physician 1 stated when they went on bypass, Physician 2 informed the Operating Room (OR) team that Patient 1 ' s brain oxygenation saturation levels were down and that the arterial blood (the oxygenated blood pumped from the heart to be carried to the rest of the body) leaving the bypass machine was very dark. Physician 1 stated that if deoxygenated blood goes to the brain, cerebral anoxia (when the brain is deprived of oxygen which can lead to brain damage) can occur. Physician 1 further stated that after Patient 1 was transferred out of the OR and into the Intensive Care Unit (ICU-unit in the hospital providing advance medical care), Patient 1 was "not moving the left side of their body at all." Physician 1 stated that this should never have happened.



During review of Patient 1 ' s "Perfusion (process of delivering oxygen to tissue and organs by blood) Record", indicated that the following items were marked as complete prior to Patient 1 going on bypass:

1. Gas lines connections secure

2. Gas exhaust unobstructed and scavenge set up

Physician 1 stated that this checklist was marked as complete, however, "they (Perfusionist 1 and Perfusionist 2) obviously did not do it."



During a review of Patient 1 ' s "Operative Report," dated 3/19/2025, at 7:36 p.m., indicated that during the CABG surgery, "it was noted that the cerebral oximetry (the amount of oxygen in the blood in the brain] readings were quite low indicating poor oxygenation to the brain and then noted that the arterial inflow from the heart-lung machine (the blood that is being pumped from the bypass machine into the patient ' s arteries, usually meant to carry oxygenated blood to the body) to the aortic cannula (a tube placed into the aorta, the main artery of the body) was very dark indicating deoxygenated blood being delivered to the patient. The perfusionist then noted that the heart-lung machine had been set up improperly and they went about reconnecting tubing on the heart-lung machine such that the blood could be oxygenated. After this was done the blood became red again indicating oxygenated blood which flowed to the arterial cannula and then the cerebral oximetry values rose to normal levels. The cerebral oximetry had been very low for approximately four minutes according to anesthesia." The Operative Report further indicated, "Complications (difficulty): Hypoxia (lack of oxygen) from cardiopulmonary (heart and lung) bypass set up by perfusionist."



During a review of Patient 1 ' s" Interdisciplinary Summary," indicated the following:

1. On 3/19/25, at 4:30 p.m., Registered Nurse (RN) 1 documented Patient 1 arrived in the ICU from the OR.

2. On 3/19/25, at 5:07 p.m., RN 1 documented MD 1 was at Patient 1 ' s bedside; Patient 1 was not moving their left arm or left leg but moving their right sided extremities (arm and leg).

3. On 3/19/25, at 5:25 p.m., RN 1 documented that a Code Stroke (a hospital-wide call for help when a patient has symptoms of a stroke) was called.



During an interview with the Chief of Cardiovascular Surgery (CCS), on 5/1/2025, at 12:37 p.m., the CCS stated he was the one who required the contracted service to send an additional perfusionist to proctor (supervise) staff that are new to the facility for 10 cases. The CCS stated he is responsible for the entire room and that it is important that the operating room team, including the perfusionist, is consistent and knowledgeable about the procedure and how each team member communicates. Setting up and operating the bypass machine is not part of any surgeon ' s training across the country, and they have to trust the perfusionist.



Additionally, the CCS stated the surgeons must "sign off" on the perfusionist being proctored for each of the ten cases, but during review of Perfusionist 1 and Perfusionist 2 ' s personnel files, there was no documentation or evaluation completed by the surgeons present for sign off.



During an interview with the Senior Vice President/Chief Medical Officer (CMO), on 5/1/2025, at 4:32 p.m., the CMO that the medical staff is responsible for ensuring the quality of care provided to patients which includes the provision of contracted services. The CCS has oversight of the cardiovascular surgery program, and the perfusionists are an integral(necessary) part of the program. The CMO also stated they rely on the provider of the contracted services to demonstrate the qualification and competencies of the perfusionists. The CMO stated the Medical Executive Committee (MEC) reviews the contract, and the CCS "is the one that ' s in the position to ensure they are meeting competencies." The MEC last approved the contract in November 2023.



Concurrently, the CMO stated the facility does not have their own requirements for the perfusionists, who are contracted by the facility, nor any standards of care, nor any guidelines for the perfusionists to follow. The CMO stated the facility relies solely on the contracted services for perfusionists on policies and procedures, standards of practice, and guidelines for perfusionist practice. The CMO also stated that that as long as he has been in the facility ' s administration, the facility has relied only on contracted perfusionists.



During a review of the facility ' s contract with the company that furnishes extracorporeal services, titled "Agreement for Extracorporeal Services," effective 5/5/2023, the contract indicated, "Hospital agrees and acknowledges that it shall have full medical responsibility for its patients in general, and specifically, during the provision of the Services and agrees to supervise its patients accordingly."

Based on observation, interview and record review, the facility failed to ensure that two of 40 sampled patients ' (Patient 33 and Patient 34), intravenous (IV) tubings, which are used to infusing fluids, were properly labeled (adhesive stickers used to identify and manage, and provide essential information to healthcare professionals with the information when the tubing needs to be replaced), in accordance with the facility ' s nursing policy and procedures.

These deficient practices resulted in improperly labeled IV tubings for Patient 33 and Patient 34, which had a potential for hospital acquired infections.

Findings:

1. On 4/28/2025, at 2:30 p.m., during a concurrent observation and interview with Registered Nurse (RN) 2, it was observed Patient34 IV tubing had no label on it., RN 2 stated that the IV tubings should be labeled with the day of the week, that the IV tubing was hung, because IV tubings are changed every 72 hours. RN 2 stated Patient 32 ' s IV tubing had no label attached to the IV tubing, to indicate the date for the IV tubing to be changed. RN 2 stated that once a new IV tubing is hung and connected to the patient, a new label is attached to the IV tubing to indicate the day of the week, to change the tubing.

During a review of Patient 34 ' s History and Physical (H&P – a comprehensive assessment performed by a healthcare provider to gather information about a patient ' s medical history and conduct a physical exam), dated 04/25/2025, the H&P indicated that patient ' s chief complaint was back pain after a trip and fall, three days ago. Patient 34 had a past medical history of atrial fibrillation (which is a condition where the heart's upper chambers (atria) beat chaotically and irregularly), diabetes mellitus (a metabolic disorder where blood sugar levels are abnormally high), & hypertension (a chronic condition where the force of blood against the walls of the arteries is consistently too high).

During a record review of the facility ' s Nursing Policy - Peripheral IV (intravenous) Insertion, Maintenance, Discontinuation, and tubing administration set, dated 08/01/2022, indicated that IV tubing should be labeled with RN initials and the date and time, of the tubing change, and affixed to the patient ' s IV tubing.



2. On 4/28/2025, at 2:45p.m., during a concurrent observation and interview with Registered Nurse (RN) 3, it was observed Patient 33 ' s IV tubing did not have a label on it. RN3 stated Patient 33 ' s IV tubing had no label affixed on the IV tubing. RN 3 stated that affixing the labels to the tubing is important for the nurses to do in order to know because it indicates the day to change the IV tubing.

During a review of Patient 33 ' s H&P, dated 04/25/2025, the H&P indicated that Patient 33 ' s chief complaint was slurred speech and left sided weakness. Patient 33 had a past medical history of asthma (a chronic respiratory condition characterized by recurrent episodes of wheezing, shortness of breath, chest tightness, and coughing) and hypertension (a chronic condition where the force of blood against the walls of the arteries is consistently too high).

During a record review of the facility ' s Nursing Policy - Peripheral IV (intravenous) Insertion, Maintenance, Discontinuation, and tubing administration set, dated 08/01/2022, indicated that IV tubing should be labeled with RN initials and the date and time, of the tubing change, and affixed to the patient ' s IV tubing.