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Based on interview and record review, the hospital failed to ensure two of 31 patients (Patients 12 and 24) were informed of their health status when:

1. Patient 12 did not receive the results of a colonoscopy (a procedure that uses a colonoscope [flexible tube with a light and camera on one end] to examine the inside of the colon [large intestine]) from 2018 that showed lymphoma (type of blood cancer);

2. Patient 24 did not receive information on her PET/CT (a combined picture from a positron emission tomography [PET] scan and a computed tomography [CT] scan) results with recommendations for further evaluation.

These failures resulted in the patients not being informed of their abnormal procedure results timely and had the potential to result in delayed treatment.

Findings:

1. Review of Patient 12's medical record indicated the patient was scheduled for a colonoscopy with biopsy (procedure that involves removing tissue or cells from the body for examination) on 12/12/18.

Review of Patient 12's Pathology Specimen Review, dated 12/12/18 indicated eight specimens were collected during the colonoscopy and examined. The Review further indicated, " ... findings support a diagnosis of mantle cell lymphoma [cancer of white blood cells]" and was signed by the gastroenterologist (GI) physician (GIP).

There was no documentation in Patient 12's medical record that indicated the patient was informed of his colonoscopy/biopsy results and diagnosis of mantle cell lymphoma.

Review of Patient 12's Surgical General results, dated 10/2/24 indicated he had a colonoscopy with biopsy and esophagogastroduodenoscopy, (EGD, procedure that uses an endoscope [flexible tube with a light and camera on one end] to examine the upper digestive tract [esophagus, stomach, or small intestine]) with biopsy on 10/2/24. The results further indicated a diagnosis of residual/recurrent mantle cell lymphoma.

Review of Patient 12's Progress Notes, dated 10/10/24 indicated, "Called patient with Spanish interpreter to discuss recent EGD/Colonoscopy biopsy results showing mantle cell lymphoma of the colon as well as adenocarcinoma [a type of cancer that starts in the glands lining the inside of organs] (likely invasive) of the colon. I disclosed that pathology results from his colonoscopy in 2018 also showed mantle cell lymphoma. The patient reports he was never informed of the pathology results from 2018 and was surprised to hear about this result. I explained to the patient that [the hospital] is looking into what occurred in 2018 to understand why he was not informed about the biopsy results. The patient needs to be evaluated by a medical oncologist for his mantle cell lymphoma and a colorectal surgeon for his colon adenocarcinoma. I will place expedited referrals to these two specialties today."

During an interview on 11/6/24 at 3 p.m., the Executive Director of Quality & Safety (EDQS) stated there was a technology issue that affected how the results were sent to the provider. The EDQS stated the doctor was devastated that the results were missed.

During an interview on 11/12/24 at 2:56 p.m., the Laboratory Quality Director (LQD) and Director of Surgical Pathology (DSP) stated the ordering provider was the GIP. The LQD and DSP stated once reports are finalized, they are available for providers and the GIP should have informed Patient 12 of his 2018 colonoscopy results.


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2. Review of the hospital's grievance records indicated Patient 24 reported that she was not informed about her PET/CT) findings which was performed on 12/20/23.

Review of Patient 24's medical record indicated she had an outpatient visit to the facility's heart failure clinic on 12/20/23 for routine follow-up.

Review of Patient 24's Study Result for PET/CT Heart Sarcoidosis (a rare autoimmune disease that causes inflammation and scarring in the heart), dated 12/20/23, indicated two impressions. The result indicated, "Intense radiotracer uptake (displays when cells in a specific area of the body absorb more of a radiotracer than the surrounding tissues) in the uterus (a hollow muscular organ located in the female pelvis) unlikely to be physiologic (normal fuctioning) given age, recommend further evaluation with pelvic ultrasound (an imaging test) and gynecologic exam (a physical exam of the reproductive organs)."

Review of Patient 24's Heart Failure Clinic Patient Follow Up, dated 12/20/23, indicated, "PET done earlier today for evaluation of cardiac sarcoid - results pending though initial images do not appear overly positive."

During an interview and record review on 11/13/24 at 10:16 a.m. with Quality Specialist (QS) D, she confirmed there was no documentation indicating Patient 24 was informed about the PET/CT finding of intense radiotracer uptake in the uterus or recommended for the further evaluation with pelvic ultrasound and gynecologic exam.

During a review of the hospital's policy and procedure (P&P) titled, "Patient Rights and Responsibilities Policy," approved 11/2024, the P&P indicated, "Patients have the right to: ... 5. Receive information about the health status, the course of treatment, prospects for recovery, and outcomes of care (including unanticipated outcomes) in a manner that the patient can understand and in their preferred language."

Based on interview and record review, the hospital failed to obtain an order for the use of restraints (any manual method or device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely) for one of three patients (Patient 21) when Patient 21 was placed in bilateral (both sides) wrist restraints without a physician order. This failure had the potential to result in an inappropriate and prolonged use of restraints.

Findings:

Review of Patient 21's medical record indicated she was admitted to the facility on 11/05/24 for stereo intracranial EEG lead placement (a procedure where electrodes are surgically inserted into the skull to monitor brain activity).

Review of Patient 21's restraints flowsheet, dated 11/06/24 to 11/12/24, indicated the patient had soft restraints on the right wrist and left wrist, starting on 11/06/24 at 7:49 a.m.

Review of Patient 21's physician's orders, dated 11/07/24 to 11/12/24, indicated the patient had an order for restraints for both wrists. There was no order for restraints for both wrists on 11/06/24.

During an interview and record review on 11/12/24 at 10 a.m. with Nursing Quality Management Coordinator (NQMC) A, he confirmed there was no order for bilateral wrist restraints on 11/06/24.

During a review of the hospital's policy and procedure (P&P) titled "Restraint and Seclusion," approved 2/2024, the P&P indicated, "All assessments, care provided, and orders will be documented in the patient's EHR. In an emergency, trained RN can initiate the application of restraints and obtain an order from a LIP/APP as soon as patient has been safely restrained. LIP/APP orders for non-violent restraints must specify the following: type of restraints used; description of condition requiring restraints; criteria for release; order duration."

Based on interview and document review, the hospital failed to develop an effective, ongoing, hospital wide, data driven quality assessment and performance improvement (QAPI) program as evidenced by:

1. Failure to identify the hospital's MRI hazard checklist was complete in accordance with American College of Radiology (ACR) in order to prevent patient safety events (Refer to A-283);

2. Failure to review and revise the hospital's MRI Safety policy as required (Refer to A-283).

These cumulative failures resulted in the hospital's inability to provide quality health care as required by the QAPI Program Condition of Participation and provide care to their patients in a safe environment. Patient 18 had an esophageal temperature probe (a device used to measure core body temperature) and underwent a magnetic resonance imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) scan, and it resulted in Patient 18 sustaining burn injuries to the lips, mouth, and tongue.

Based on interview and record review, the hospital failed to fully implement its Quality Assessment and Performance Improvement (QAPI) program when the program did not identify the hospital's magnetic resonance imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) screening process was inadequate and did not meet standards of practice. The QAPI program also did not identify the hospital's MRI Safety policy required to be reviewed and revised.

These deficient practices resulted in burns to Patient 18's lips, mouth, and tongue and had the potential to jeopardize the health and safety of patients.

Findings:

Review of Patient 18's Vascular Surgery Progress Note, dated 4/25/24 indicated the patient was admitted to the hospital on 4/6/24 with diagnoses including ruptured abdominal aortic aneurysm (AAA, enlargement of the aorta, the main blood vessel that delivers blood to the body). The note indicated Patient 18 underwent a procedure to repair the aneurysm, was intubated (a medical procedure that involves inserting an endotracheal tube [ETT] into a person's airway to help them breathe), sedated (in a state of calmness, relaxation, or sleepiness caused by certain drugs) and required continuous renal replacement therapy (CRRT, a type of dialysis that removes wastes, toxins, and excess fluid from the body).

Review of Patient 18's Flowsheets, from 4/6/24 to 5/28/24 indicated on 4/22/24 at 10 a.m., Patient 18 had a temperature of 38.4 degrees Celsius (measurement of temperature) and the temperature source (how the temperature was taken) was "esophageal." Patient 18's Flowsheets also indicated on 4/25/24 the patient temperature source was "esophageal" at 2 a.m., 3 a.m., 4 a.m., 5 a.m., and 6 a.m.

Review of Patient 18's Comprehensive Critical Care Notes, dated 4/25/24 indicated on 4/24/24 the patient had an MRI of the brain and it was recommended that Patient 18 have an MRI of the spine.

Review of Patient 18's Screening Form Questions, dated 4/25/24 indicated Patient 18 had an appointment scheduled on 4/25/24 at 3 p.m. for MR Thoracic and Lumbar Spine (middle and lower section of the backbone). The form also indicated the answer to the question, "Does your patient have a temperature sensitive Foley?" was "No." The form did not include a question regarding an esophageal temperature probe.

Review of Patient 18's Study Result MR Thoracic and Lumbar Spine indicated the patient's exam ended on 4/25/24 at 5:25 p.m.

Review of Patient 18's Flowsheets, dated 4/25/25 indicated the patient had wounds to the left lateral (to the side) lip and mouth, first assessed on 4/25/24 at 7:25 p.m. The Flowsheets also described the mouth wound as tongue white blistering and surrounding skin was edematous (swollen with fluid).

Review of Patient 18's Comprehensive Critical Care Note, dated 4/26/24 indicated, "... esophageal temp probe found melted in mouth with wire exposed, some burns noted along lips ..."

Review of Patient 18's Otolaryngology - Head and Neck Surgery Consult History and Physical, dated 4/26/24 indicated, "Yesterday, patient was taken to radiology to undergo an MRI T and L spine. Unfortunately, an esophageal temperature probe was kept in place for the duration of the scan (approximately 90 minutes). Once the patient was received, primary team noticed the probe fused to his upper left lip, ETT and tongue. ENT consulted for evaluation of oral and OP burns and management." The consult also indicated the pertinent findings of a flexible fiber laryngoscopy were the following: temp probe adhered to ETT; Burns involving the left upper lip; burn with fibrinous tissue involving 40% of central tongue, 30% of soft and hard palate, right base of tongue.

Review of Patient 18's Plastic and Reconstructive Surgery History and Physical/Consult Note, dated 4/26/24 indicated, "Plastic surgery was consulted to evaluate the lip burn ... Will require surgical reconstruction pending clinical stability."

During an interview on 11/7/24 at 11:30 a.m., the MRI Manager (MRIM) stated when a patient has an order for an MRI, a screening form is generated for a nurse to complete. She stated once the form is completed, the MR technologist (tech) would review the answers and ask questions as needed. She stated when the patient was taken to the department, the MR tech does a visual check on the patient before the MRI procedure. The MR tech also waves a mental detecting wand over the patient to identify any unknown metal before the procedure. The MRIM stated Patient 18 was on a ventilator and the nursing team took the patient to get an MRI. She stated after Patient 18's MRI, the MRIM was alerted that there was a concern with a burn. The MRIM stated a nurse did an assessment and saw that Patient 18 still had an esophageal temperature probe in place. The MRIM stated they reviewed the screening form the hospital used and identified that the form only asked if the patient had a foley catheter (a tube inserted in the urinary tract into the bladder to drain urine) temperature probe. She stated the form did not ask about other temperature probes, like an esophageal probe. The MRIM stated in an ideal world, the esophageal temp probe should have been identified by the MR tech during the visual check. She stated the MR tech did not realize there was an esophageal temp probe in place because it was white and looked like it was part of Patient 18's ET tube/respiratory equipment. She stated the MRI generated heat because of the metal in the esophageal probe, which caused the plastic on the probe to melt, and resulted in Patient 18's burns in his mouth.

During an interview on 11/8/24 at 8:55 a.m., the MR tech (MRT) involved in Patient 18's 4/25/24 MRI stated the responsibility of the MR tech to confirm verbally with the nurse that the patient did not have any devices that could not go in the MR scanner. The MRT stated he did a visual check on Patient 18 and did not identify the esophageal probe because of the respiratory bundle surrounding the patient's mouth. The MRT stated that the hospital's MRI screening form did not have a question asking whether the patient has an esophageal probe.

During an interview on 11/13/24 at 1:02 p.m., the MRIM stated the hospital's MR policy was not changed.

During a telephone interview on 11/14/24 at 3:25 p.m. the Executive Director Quality & Safety (EDQS) stated the hospital uses The American College of Radiology as their reference. She stated the hospital policy was adapted from ACR, but it might not be 100 percent what is published.

Review of the hospital's policy, "Magnetic Resonance Imaging (MRI) Safety", last approved 7/2019 indicated, "Practices outline here are aligned with the 2017 American College of Radiology (ACR) Practice Parameters for Performing and Interpreting MRI and the 2013 ACR Guidance Document on MRI Safe Practices." The policy also indicated, "All patients entering Zone 4 [MRI scanner magnet room] will be thoroughly screened for non-MRI conditional apparatuses prior to entry ... it is the responsibility of the MRI technologist to review the screening form with the patient and visually check for any metal objects." The policy further indicated, "This policy will be reviewed and/or revised every three years or as required by change of law or practice." The hospital's policy should have been updated in 2022.

Review of "Appendix A; MRI Screening Procedure for Incapacitated Inpatients," of the hospital's "MRI Safety" policy, indicated, "The MR safety screening form is the final safety checkpoint for patients undergoing a MRI exam ... The screening for will then be filled out with the nurse who will go through the questions ..."

Review of the ACR Guidance Document on MR Safe Practices: 2013 contained Appendix 2, which included a "Hazard Checklist for MRI Personnel." The checklist indicated an area to check yes or no to the following: Endotracheal tube, Swan-Ganz catheter (a tube placed inside the heart to monitor heart function and blood flow), Extra ventricular device (a system that drains fluid from the brain), Arterial line transducer (a device used to measure blood pressures), Foley catheter with temperature sensor and/or metal clamp, Rectal probe (device inserted in the rectum to take temperature or examine the rectum), Esophageal Probe (device inserted in the esophagus to take temperature), Tracheotomy tube (tube inserted in the trachea to help with breathing), and Guidewires (a thin wire used to help place catheters in the body).

According to the American College of Radiology (ACR) website, "MR Safety continues to evolve and in response, the ACR's Committee on MR safety created the ACR Manual on MR Safety with updates and critical new information which replaces all earlier versions of the ACR Guidance Document on MR Safe Practices." The website contained links to access documents, including the ACR Manual on MR Safety 2024 and Safety Screening Form for MR Procedures.

Review of the "ACR Manual on MR Safety 2024" indicated, "This 2024 edition of the ACR Manual on MR Safety replaces all earlier versions."

Review of ACR's Safety Screening for Magnetic Resonance (MR) Procedures indicated the Hazard Checklist for Level 2 MR Personnel included yes/no check boxes for the following: pulse oximetry device, EKG pads/leads, Endotracheal tube, Swan-Ganz catheter, Extra ventricular device, Arterial line transducer, Foley catheter with temperature sensor and/or metal clamp, Rectal probe, Esophageal Probe, Tracheotomy tube, Guidewires, Halo vest, and other. The screening procedures also indicated, "If any Level 2 MR Personnel checklist items are answered yes, this should be brought to the attention to the covering MR Physician."

Review of the hospital's "Quality Assessment and Performace Improvement Plan 2024," approved 2/2024 indicated, "Along with Management Guidance Team, Quality Councils, and Improvement Programs, [the hospital] seeks input from executive leadership, departments, and services from all areas involved with quality performace measurement and improvement to determine if there are gaps or opportunities for improvement."

Based on interview and record review, the hospital failed to comply with the Condition of Participation for Nursing Services as evidenced by:

1. Failure to implement hospital policy and procedure when nursing staff did not change the patient's condom catheter (a urine collection device that fits over the penis and is held in place with adhesive) (Refer to A-398).

2. Failure to identify and communicate the presence of an esophageal temperature probe (a device used to measure core body temperature) prior to a magnetic resonance imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) (Refer to A-398).

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment. Patient 2 developed a condom catheter-related pressure injury (pressure-related damage to the skin and/or underlying tissue). Patient 18 suffered burn injuries to the lips, mouth, and tongue during the MRI.

Based on interview and record review, the hospital failed to implement its policies and procedures for two of 10 patients when:

1. Nursing staff did not change Patient 2's condom catheter (a urine collection device that fits over the penis and is held in place with adhesive); and

2. Nursing staff failed to identify and communicate the presence of Patient 18's esophageal temperature probe (a device used to measure core body temperature) prior to a magnetic resonance imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body).

These failures resulted in injuries for both patients. Patient 2 developed a condom catheter-related pressure injury (pressure-related damage to the skin and/or underlying tissue). Patient 18 suffered burn injuries to the lips, mouth, and tongue during the MRI.

Findings:

1. Review of Patient 2's History & Physical, dated 9/14/24, indicated Patient 2 was admitted with diagnoses including Huntington's disease (a disease that causes nerve cells in the brain to decay over time) and perirectal abscess (a collection pus in the rectal area).

Review of Patient 2's skin assessment, dated 9/15/24, indicated Patient 2 did not have any wounds or other skin issues at the time of this assessment.

Review of Patient 2's External Urinary Catheter assessment indicated the hospital placed a condom catheter on Patient 2 on 9/15/24 at 7:30 p.m. The assessment further indicated the condom catheter was removed on 9/20/24 at 9:00 a.m. There was no documentation in the medical record that indicated the hospital changed Patient 2's condom catheter from the time it was placed to the time it was removed.

Review of Patient 2's Progress Notes, dated 9/20/24, indicated Patient 2's condom catheter was accidentally pulled off when he turned in bed. The Progress Notes further indicated a wound was found on Patient 2's penis.

Review of Patient 2's Wound Ostomy Continence Nurse (WOCN) Note, dated 9/20/24 indicated, "Wound care consult for wound to penile area. Per primary RN [registered nurse] noted wound on removal of condom catheter. Patient denies having wound to area prior. Patient reports having catheter in place for 4 days." The WOCN Note further indicated the wound on Patient 2's penis was a stage 3 pressure injury (full-thickness loss of skin).

Review of Patient 2's Neurology Discharge Note, dated 9/20/24, indicated he had a pressure-related wound on the penis. The note further indicated this was a condom catheter-related wound that needed wound care twice a day.

During an interview and concurrent record review with quality specialist B (QS B) on 11/6/24 at 10:04 a.m., QS B acknowledged that the hospital's policy indicated condom catheters must be changed every two days. QS B reviewed Patient 2's medical record and confirmed it appeared as though Patient 2 had the same condom catheter from the time it was placed to the time it was removed. QS B stated he would conduct further review of Patient 2's medical record and try to find documentation that the condom catheter was changed.

During an interview with interim assistant patient care manager C (IAPCM C) on 11/6/24 at 12:53 p.m., IAPCM C confirmed she was a wound specialist. IAPCM C explained it was important to change condom catheters every two days so the underlying skin can be assessed. IAPCM C confirmed that not changing a condom catheter could contribute to the development of a pressure injury.

During a follow-up interview with QS B on 11/7/24 at 2:24 p.m., QS B confirmed there was no documentation that indicated Patient 2's condom catheter was changed from the time it was placed to the time it was removed.

The hospital's policy and procedure titled "External Urinary Collection Devices," dated 5/2019, was reviewed. The section related to condom catheters indicated, "Change catheter when site is soiled, and condom catheter needs to be removed for adequate cleansing, if leaking is present or every two days."


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Review of Patient 18's Vascular Surgery Progress Note, dated 4/25/24 indicated the patient was admitted to the hospital on 4/6/24 with diagnoses including ruptured abdominal aortic aneurysm (AAA, enlargement of the aorta, the main blood vessel that delivers blood to the body). The note indicated Patient 18 underwent a procedure to repair the aneurysm, was intubated (a medical procedure that involves inserting an endotracheal tube [ETT] into a person's airway to help them breathe), sedated (in a state of calmness, relaxation, or sleepiness caused by certain drugs) and required continuous renal replacement therapy (CRRT, a type of dialysis that removes wastes, toxins, and excess fluid from the body).

Review of Patient 18's Flowsheets, from 4/6/24 to 5/28/24 indicated on 4/22/24 at 10 a.m., Patient 18 had a temperature of 38.4 degrees Celsius (measurement of temperature) and the temperature source (how the temperature was taken) was "esophageal." Patient 18's Flowsheets also indicated on 4/25/24 the patient temperature source was "esophageal" at 2 a.m., 3 a.m., 4 a.m., 5 a.m., and 6 a.m. It also indicated on 4/25/24 at 7 a.m. there was no temperature source documented.

Review of Patient 18's Comprehensive Critical Care Notes, dated 4/25/24 indicated on 4/24/24 the patient had an MRI of the brain and it was recommended that Patient 18 have an MRI of the spine.

Review of Patient 18's Screening Form Questions, dated 4/25/24 indicated Patient 18 had an appointment scheduled on 4/25/24 at 3 p.m. for MR Thoracic and Lumbar Spine (middle and lower section of the backbone). The Form also indicated the answer to the question, "Does your patient have a temperature sensitive Foley?" was "No."

Review of Patient 18's Study Result MR Thoracic and Lumbar Spine indicated the patient's exam ended on 4/25/24 at 5:25 p.m.

Review of Patient 18's Flowsheets, dated 4/25/25 indicated the patient had wounds to the left lateral (to the side) lip and mouth, first assessed on 4/25/24 at 7:25 p.m. The Flowsheets also described the mouth wound as tongue white blistering and surrounding skin was edematous (swollen with fluid).

Review of Patient 18's Comprehensive Critical Care Note, dated 4/26/24 indicated, "... esophageal temp probe found melted in mouth with wire exposed, some burns noted along lips ..."

Review of Patient 18's Otolaryngology - Head and Neck Surgery Consult History and Physical, dated 4/26/24 indicated, "Yesterday, patient was taken to radiology to undergo an MRI T and L spine. Unfortunately, an esophageal temperature probe was kept in place for the duration of the scan (approximately 90 minutes). Once the patient was received, primary team noticed the probe fused to his upper left lip, ETT and tongue. ENT consulted for evaluation of oral and OP burns and management." The consult also indicated the pertinent findings of a flexible fiber laryngoscopy were the following: temp probe adhered to ETT; Burns involving the left upper lip; burn with fibrinous tissue involving 40% of central tongue, 30% of soft and hard palate [roof of the mouth], right base of tongue."

Review of Patient 18's Plastic and Reconstructive Surgery History and Physical/Consult Note, dated 4/26/24 indicated, "Plastic surgery was consulted to evaluate the lip burn ... Will require surgical reconstruction pending clinical stability."

During an interview on 11/7/24 at 11:30 a.m., the MRI Manager (MRIM) stated when a patient has an order for an MRI, a screening form is generated for a nurse to complete. She stated once the form is completed, the MR technologist (tech) would review the answers and ask questions as needed. She stated when the patient is taken to the department, the MR tech does a visual check on the patient before the MRI procedure. The MR tech also waves a mental detecting wand over the patient to identify any unknown metal before the procedure. The MRIM stated Patient 18 was on a ventilator and the nursing team took the patient to get an MRI. She stated after Patient 18's MRI, the MRIM was alerted that there was a concern with a burn. The MRIM stated a nurse did an assessment and saw that Patient 18 still had an esophageal temperature probe in place. The MRIM stated they reviewed the screening form the hospital used and identified that the form only asked if the patient had a foley catheter (a tube inserted in the urinary tract into the bladder to drain urine) temperature probe. She stated the form did not ask about other temperature probes, like an esophageal probe. The MRIM stated in an ideal world, the esophageal temp probe should have been identified by the MR tech during the visual check. She stated the MR tech did not realize there was an esophageal temp probe in place because it was white and looked like it was part of Patient 18's ET tube/respiratory equipment. She stated the MRI generated heat because of the metal in the esophageal probe, which caused the plastic on the probe to melt, and resulted in Patient 18's burns in his mouth.

During an interview on 11/8/24 at 8:55 a.m., the MR tech (MRT) involved in Patient 18's 4/25/24 MRI stated the responsibility of the MR tech to confirm verbally with the nurse that the patient did not have any devices that could not go in the MR scanner. The MRT stated he confirmed with Patient 18's nurse that the patient did not have any devices that could not go in the MR scanner.

During an interview on 11/8/24 at 10 a.m., Registered Nurse E (RN E) stated he was Patient 18's primary nurse on 4/25/24. RN E stated he was not aware Patient 18 had an esophageal temperature probe. He stated he only found out about Patient 18's esophageal probe after the MRI on 4/25/24.

During an interview on 11/12/24 at 9:53 a.m., Quality Specialist B (QS B) stated RN E could not remember whether Patient 18's esophageal temp probe was communicated to him by the previous nurse.

During an interview on 11/13/24 at 10:45 a.m., the Executive Director Quality & Safety (EDQS) stated Patient 18's flowsheet contained documentation of of an esophgeal probe and it is the nurse's responsibility to know and check for what items the patient has.

Review of an email sent on 11/14/24 at 10:41 a.m., QS B indicated that there were no care plans prior to 4/25/24 specifically addressing esophageal probes.

Review of the hospital's policy, "Magnetic Resonance Imaging (MRI) Safety," last approved 7/2019 indicated, "Practices outline here are aligned with the 2017 American College of Radiology (ACR) Practice Parameters for Performing and Interpreting MRI and the 2013 ACR Guidance Document on MRI Safe Practices." The policy also indicated, "All patients entering Zone 4 [MRI scanner magnet room] will be thoroughly screened for non-MRI conditional apparatuses prior to entry ... "

Review of "Appendix A; MRI Screening Procedure for Incapacitated Inpatients," of the hospital's "MRI Safety" policy, indicated, "The MR safety screening form is the final safety checkpoint for patients undergoing a MRI exam ... The screening for will then be filled out with the nurse who will go through the questions ..."

Review of the hospital's policy, "Standards of Practice for Acute and Critical Care Nursing," approved 11/2021 indicated, "Through Assessment, the nurse collects data pertinent to the patient's condition or health status ... Documents relevant data in EHR [electronic health record] in a clear, timely manner ... The nurse caring for the patient develops a plan of care that prescribes strategies and alternatives to attain desired outcomes ... establishes priorities and continuity of care within the plan, including transfer of information and handoffs at shift change ... documents plan in the Care Plan system within the EHR and provides handoff of the plan in a clear, timely manner."

Review of the "Appendix A: Critical Care Standard Work" from the policy, "Standards of Practice for Acute and Critical Care Nursing" indicated record temperature (and more frequently as needed) and document lines and tubes every four hours.

Based on observation, interview, and record review, the hospital failed to comply with the Condition of Participation for Radiologic Services as evidenced by:

Failure to maintain compliance with facility policy and in accordance with American College of Radiology (ACR)'s safe Magnetic Resonance Imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) practices (refer to A535).

The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality health care in a safe environment. Patient 18 had an esophageal temperature probe (a device used to measure core body temperature) and underwent an MRI and it resulted in Patient 18 sustaining burn injuries to the lips, mouth, and tongue.

Based on interview and record review, the hospital failed to follow their Magnetic Resonance Imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) policy when the MR tech did not identify one of four patients (Patient 18) had a device that was unsafe to be used in an MR scanner. The hospital also failed to ensure the MRI Safety policy was in accordance with American College of Radiology (ACR)'s safe MRI practices, and review and revise their policy as required. These failures resulted in Patient 18 sustaining burn injuries to the lips, mouth, and tongue when he had an esophageal temperature probe (a device used to measure core body temperature) when undergoing an MRI.

Findings:

Review of Patient 18's Vascular Surgery Progress Note, dated 4/25/24 indicated the patient was admitted to the hospital on 4/6/24 with diagnoses including ruptured abdominal aortic aneurysm (AAA, enlargement of the aorta, the main blood vessel that delivers blood to the body). The note indicated Patient 18 underwent a procedure to repair the aneurysm, was intubated (a medical procedure that involves inserting an endotracheal tube [ETT] into a person's airway to help them breathe), sedated (in a state of calmness, relaxation, or sleepiness caused by certain drugs) and required continuous renal replacement therapy (CRRT, a type of dialysis that removes wastes, toxins, and excess fluid from the body).

Review of Patient 18's Flowsheets, from 4/6/24 to 5/28/24 indicated on 4/22/24 at 10 a.m., Patient 18 had a temperature of 38.4 degrees Celsius (measurement of temperature) and the temperature source (how the temperature was taken) was "esophageal." Patient 18's Flowsheets also indicated on 4/25/24 the patient temperature source was "esophageal" at 2 a.m., 3 a.m., 4 a.m., 5 a.m., and 6 a.m.

Review of Patient 18's Comprehensive Critical Care Notes, dated 4/25/24 indicated on 4/24/24 the patient had an MRI of the brain and it was recommended that Patient 18 have an MRI of the spine.

Review of Patient 18's Screening Form Questions, dated 4/25/24 indicated Patient 18 had an appointment scheduled on 4/25/24 at 3 p.m. for MR Thoracic and Lumbar Spine (middle and lower section of the backbone). The Form also indicated the answer to the question, "Does your patient have a temperature sensitive Foley?" was "No." The form did not include a question regarding an esophageal temperature probe.

Review of Patient 18's Study Result MR Thoracic and Lumbar Spine indicated the patient's exam ended on 4/25/24 at 5:25 p.m.

Review of Patient 18's Flowsheets, dated 4/25/25 indicated the patient had wounds to the left lateral (to the side) lip and mouth, first assessed on 4/25/24 at 7:25 p.m. The Flowsheets also described the mouth wound as tongue white blistering and surrounding skin was edematous (swollen with fluid).

Review of Patient 18's Comprehensive Critical Care Note, dated 4/26/24 indicated, "... esophageal temp probe found melted in mouth with wire exposed, some burns noted along lips ..."

Review of Patient 18's Otolaryngology - Head and Neck Surgery Consult History and Physical, dated 4/26/24 indicated, "Yesterday, patient was taken to radiology to undergo an MRI T and L spine. Unfortunately, an esophageal temperature probe was kept in place for the duration of the scan (approximately 90 minutes). Once the patient was received, primary team noticed the probe fused to his upper left lip, ETT and tongue. ENT consulted for evaluation of oral and OP burns and management." The consult also indicated the pertinent findings of a flexible fiber laryngoscopy were the following: temp probe adhered to ETT; Burns involving the left upper lip; burn with fibrinous tissue involving 40% of central tongue, 30% of soft and hard palate [roof of the mouth], right base of tongue.

Review of Patient 18's Plastic and Reconstructive Surgery History and Physical/Consult Note, dated 4/26/24 indicated, "Plastic surgery was consulted to evaluate the lip burn ... Will require surgical reconstruction pending clinical stability."

During an interview on 11/7/24 at 11:30 a.m., the MRI Manager (MRIM) stated when a patient has an order for an MRI, a screening form is generated for a nurse to complete. She stated once the form is completed, the MR technologist (tech) would review the answers and ask questions as needed. She stated when the patient is taken to the department, the MR tech does a visual check on the patient before the MRI procedure. The MR tech also waves a mental detecting wand over the patient to identify any unknown metal before the procedure. The MRIM stated Patient 18 was on a ventilator and the nursing team took the patient to get an MRI. She stated after Patient 18's MRI, the MRIM was alerted that there was a concern with a burn. The MRIM stated a nurse did an assessment and saw that Patient 18 still had an esophageal temperature probe in place. The MRIM stated they reviewed the screening form the hospital used and identified that the form only asked if the patient had a foley catheter (a tube inserted in the urinary tract into the bladder to drain urine) temperature probe. She stated the form did not ask about other temperature probes, like an esophageal probe. The MRIM stated in an ideal world, the esophageal temp probe should have been identified by the MR tech during the visual check. She stated the MR tech did not realize there was an esophageal temp probe in place because it was white and looked like it was part of Patient 18's ET tube/respiratory equipment. She stated the MRI generated heat because of the metal in the esophageal probe, which caused the plastic on the probe to melt, and resulted in Patient 18's burns in his mouth.

During an interview on 11/8/24 at 8:55 a.m., the MR tech (MRT) involved in Patient 18's 4/25/24 MRI stated the responsibility of the MR tech to confirm verbally with the nurse that the patient did not have any devices that could not go in the MR scanner. The MRT stated he did a visual check on Patient 18 and did not identify the esophageal probe because of the respiratory bundle surrounding the patient's mouth. The MRT stated that the hospital's MRI screening form did not have a question asking whether the patient has an esophageal probe.

During an interview on 11/13/24 at 1:02 p.m., the MRIM stated the hospital's MR policy was not changed.

Review of the hospital's policy, "Magnetic Resonance Imaging (MRI) Safety", last approved 7/2019 indicated, "Practices outline here are aligned with the 2017 American College of Radiology (ACR) Practice Parameters for Performing and Interpreting MRI and the 2013 ACR Guidance Document on MRI Safe Practices." The policy also indicated, "All patients entering Zone 4 [MRI scanner magnet room] will be thoroughly screened for non-MRI conditional apparatuses prior to entry ... it is the responsibility of the MRI technologist to review the screening form with the patient and visually check for any metal objects." The policy further indicated, "This policy will be reviewed and/or revised every three years or as required by change of law or practice." The hospital's policy should have been updated in 2022.

Review of "Appendix A; MRI Screening Procedure for Incapacitated Inpatients," of the hospital's "MRI Safety" policy, indicated, "The MR safety screening form is the final safety checkpoint for patients undergoing a MRI exam ... The screening for will then be filled out with the nurse who will go through the questions ..."

Review of the ACR Guidance Document on MR Safe Practices: 2013 contained Appendix 2, which included a "Hazard Checklist for MRI Personnel." The checklist indicated an area to check yes or no to the following: Endotracheal tube, Swan-Ganz catheter (a tube placed inside the heart to monitor heart function and blood flow), Extra ventricular device (a system that drains fluid from the brain), Arterial line transducer (a device used to measure blood pressures), Foley catheter with temperature sensor and/or metal clamp, Rectal probe (device inserted in the rectum to take temperature or examine the rectum), Esophageal Probe (device inserted in the esophagus to take temperature), Tracheotomy tube (tube inserted in the trachea to help with breathing), and Guidewires (a thin wire used to help place catheters in the body).

According to the American College of Radiology (ACR) website, "MR Safety continues to evolve and in response, the ACR's Committee on MR safety created the ACR Manual on MR Safety with updates and critical new information which replaces all earlier versions of the ACR Guidance Document on MR Safe Practices." The website contained links to access documents, including the ACR Manual on MR Safety 2024 and Safety Screening Form for MR Procedures.

Review of the "ACR Manual on MR Safety 2024" indicated, "This 2024 edition of the ACR Manual on MR Safety replaces all earlier versions."

Review of ACR's Safety Screening for Magnetic Resonance (MR) Procedures indicated the Hazard Checklist for Level 2 MR Personnel included yes/no check boxes for the following: pulse oximetry device, EKG pads/leads, Endotracheal tube, Swan-Ganz catheter, Extra ventricular device, Arterial line transducer, Foley catheter with temperature sensor and/or metal clamp, Rectal probe, Esophageal Probe, Tracheotomy tube, Guidewires, Halo vest, and other. The screening procedures also indicated, "If any Level 2 MR Personnel checklist items are answered yes, this should be brought to the attention to the covering MR Physician."