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Based on facility document review, policy review, medical record review, observation and interview, the facility failed to ensure care was provided in a safe setting for 1 of 1 (Patient #2) sampled patients who received burns after cardioversion.

The findings included:

Patient #2 was transferred from Hospital #1 on 11/19/2022 for a vascular surgery consultation and gangrene of the left foot following a transmetatarsal amputation.
Patient #2 received second degree burns on 11/24/2022 after being cardioverted when the defibrillator pads sparked, catching the patient on fire. Patient #2 received burns to his face, chest, head and face. Patient #2 was transferred to a sister-facility burn center where he died 58 minutes after arriving at the burn center.

Refer to A 144

Based on document review, medical record review, observation and interview the hospital failed to ensure patients received care in a safe setting when 1 of 1 (Patient #2) patients caught on fire and sustained second degree burns to the face, head, chest and hand while being cardioverted for atrial fibrillation. The potential for this to occur in the future placed all patients at risk to not receive care in a safe setting.

The findings included:

1. Medical record review for Patient #2 revealed an admission date of 11/19/2022 with chief complaint of Peripheral Artery Disease. The patient had a past medical history of Peripheral Artery Disease, Hypertension, Hyperlipidemia, Stroke with Right-sided weakness and is legally blind. Patient #2 presented to Hospital #1's Emergency Department (ED) with a left foot infection, dry gangrene, started on IV vancomycin, Rocephin and podiatry consult. Patient #2 underwent a left transmetatarsal amputation on 11/17/2022. A lower extremity arterial Doppler showed extensive peripheral artery disease. The patient was started on Plavix and aspirin and transferred to Hospital #2 with vascular surgery consultation. Patient #2 also had a Stage 3 pressure injury of the right hip and an unstageable pressure ulcer to the left hip.

Review of a hospitalist progress note dated 11/24/2022 at 8:26 AM revealed the patient's vital signs were stable and continue medications for hypertension: hydralazine, Metoprolol, Lisinopril.

Review of the telemetry monitor technician note dated 11/14/2022 at 3:50 PM revealed the patient's heart rate was 155 and the patient was in atrial fibrillation (Afib). A comment documented the patient had converted from normal sinus rhythm to atrial fibrillation.

Review of a nurses note revealed, "... 1600 [4:00 PM] tele [telemetry] tech [technician] called RN to notify that patient had converted to Afib w [with] RVR [rapid ventricular response] in the 140's-160's. RN went to room to obtain vitals [vital signs]. Patient responsive but complaining of gas pain and pressure in chest. unable to obtain blood pressure. O2 saturations in mid 80. Rapid response RN called and MD notified. Rapid RN at bedside. After pushing Amiodarone and a fluid bolus, MD ordered bedside cardioversion. Patient heart rate still Afib in 130's-140's. Patient sedated and connected to defibrillator with anterior and posterior chest pads. Patient cleared and one shock administered. Spart traveled up wire from defibrillator to pads. Patient then caught fire. Fire extinguished by bedside RN and MD. Transferred to ICU for intubation and pressors..."

Review of the Bronchoscopy report dated 11/24/2022 at 5:25 PM revealed, "...Patient was intubated, sedated and critically in the ICU [Intensive Care Unit] Diagnostic exam was performed. Airway appeared paler than normal. Frothy/bubbly copious secretions were present. There was no obstruction or mass. No complications were observed. Patient tolerated procedure well....Findings...no complications..."

Review of the Critical Care Consultation on 11/24/2022 at 5:28 PM revealed, "...Patient went into Afib with RVR 11/24 [2022] with hypotension. Patient placed on pads and cardioverted with 200 J [Joules]. Pads sparked fire (patient on 100% oxygen by non-rebreather) MD [Medical Doctor]/NP [Nurse Practitioner]/RN [Registered Nurse] at bedside used hands to put out fire and ripped NR [non-rebreather] off. CODE [urgent life saving measures are indicated] called. On arrival patient minimally responsive. Not following any commands. Burns on right hand, chest, face and top of head. Intubated. Bronchoscopy performed thin secretions/bubbles/pale no char or discoloring in airway. Patient on levophed [used to treat life-threatening low blood pressure]...Vasopressin [is used in emergency settings to raise blood pressure in adults who are in shock]...On fentanyl [very potent pain medication] and propofol [used to sedate a patient who is under critical care and needs a mechanical ventilator]...Physical Exam...Skin: burn right hand, chest, nose, face, scalp, back...Problem List/Plan Fire during synchronized cardioversion 11/24...Bronchoscopy with pale airways, clear bubbly secretions, no char...Patient was having severe chest pain per wife prior to Afib, hypotension, AMS [Altered Mental Status]...Converted with Amiodarone to sinus brady [bradycardia]...acute hypoxic respiratory failure...Hypertension...Currently in shock...Pancreatic Mass...Septic shock present on arrival to ICU [Intensive Care Unit].

Review of Physician's Clinical Note on 11/24/22 at 7:01 PM revealed, "...Physician #5 queried whether there was any utility for left heart catheterization after the patient's EKG [Electrocardiography] shows sinus bradycardia with PACs [Premature atrial contractions]...ST [the interval between ventricular depolarization and repolarization] depression in the inferior and lateral leads. Collateral data provided by the patient's wife states...prior to tonight events he complained "This pain is killing me. Get someone in here now." Unable to assess for chest pain now. Ultimately would recommend medical management at this time. He does not have ST elevations or active chest pain requiring emergent or urgent left heart catheterization. Data suggest that emergent catheterization is necessary only for ST-elevation MI [Myocardial Infarction], with an early invasive strategy within the 1st 36 hours of an event being appropriate strategy for management of non ST elevation MI. I am inclined to believe the patient likely has severe multivessel disease given his peripheral arterial disease and is globally ischemic in the setting of tonight's event...We agreed that if the patient's primary need at this time is Burn Care, then he should be transferred to a burn capable facility where Cardiology can also see him..."

Review of the Discharge Summary on 11/24/2022 at 7:37 PM revealed, "...HPI [History Present Illness]...64 year old with PAD [Peripheral Arterial Disease], HTN [Hypertension], HLD [Hypersensitivity Lung Disease], CVA [Cerebral Vascular Accident] with right side weakness in 2015 and legally blind presented gangrene admitted to hospital 11/19/22 after having a left transmetatarsal amputation 11/17/2022. Patient transferred to [Named Hospital] #2 for vascular surgery secondary to extensive peripheral artery disease. Patient underwent balloon lithotripsy cfa [common femoral artery], iliac, arteries, distal aorta, left aortoiliac stent and external and common iliac stents on 11/20. Cultures with proteus/providencia ID [identity document] treating with cefepime...Hospital Course...Patient had chest pain, AMS [Alert Mental Status] went into Afib with RVR 11/24 with hypotension. Patient placed on pads and cardioverted with 200 J [Joules]...Pads sparked fire (patient on 100% NR [Non-rebreather mask]). MD [Medical Doctor]/NP [Nurse Practitioner]/RN [Registered Nurse] at bedside used hands to put out fire and ripped NR off. CODE called. On arrival patient minimally responsive. Not following commands. Burns on right hand, chest, face and top of head. Intubated. Bronchoscopy performed thin/secretions/bubbles pale no char or discoloring in airway. Left brachial art line placed. Shock with levo [Levophed], vaso [Vasopressin], epi [Epinephrine]... Concern for ACS [Acute Coronary Syndrome] as etiology of decompensation. Consulted CICU [Cardiac Intensive Care Unit] ASA [Aspirin], plavix, statin [class of medicine used to lower cholesterol]. Serial troponin. Bedside ECHO [Echocardiogram] with WMA [in 2-dimensional]. Amiodarone gtt [drops] as HR [heart rate] tolerates. Will need formal ECHO [Echocardiogram] at [Named Hospital] #3 and cards [Cardiologist] consult. Patient has terrible vascular disease...Transferring to care to Burn center..."

Review of the Emergency Provider Report on 11/24/2022 at 8:36 PM from [Named Hospital] #3 revealed, "...Patient presents for evaluation for respiratory failure after a burn...During a letter "cardioversion caused his non-rebreather to night [ignite]causing significant burns to his face and chest and neck and necessitating endotracheal intubation for airway protection. Patient arrives intubated and sedated. He is on multiple pressors and IV fluids...MDM [Medical Decision Making] notes on 11/24/2022 revealed, "...Patient has respiratory failure from burns at the previous facility. He was intubated for airway protection. He remains hypotensive despite pressors. These have been titrated. His PEEP [positive end-expiratory pressure] was increased because of his persistent hypoxia...Patient has significant critical illness with multiple organ systems involved..." Patient's condition deteriorated to the point where he required CPR [Cardiopulmonary Resuscitation] and we did obtain return of spontaneous circulation. However his condition continued to worsen and despite maximum pressors and CPR the patient became bradycardic again. No palpable pulse and patient's wife who at this point recognizes electrical activity. Case was discussed with the patient's wife who at this point recognizes the futility of the medical care and suggest that no further medical intervention be done and CPR not be done. I believe this is in the patient's best interest as his condition is still critical and now that he has fixed and dilated pupils with no cardiac activity I do not feel that there is any medical intervention that would be able to result in a meaningful neurological outcome. Trauma surgeon and hospitalist in agreement. Patient's wife is at the bedside and bedside ultrasound that shows asystole along with fixed and dilated pupils and no spontaneous respirations. Patient pronounced at 9:15 PM..."

Review of the SBAR on [situation, background, assessment and recommendation] on 11/25/2022 revealed the following:
S [situation]
1. "...64 M [Male] was transferred to [Named Hospital] #1 from [Named Hospital] #2 on 11/19/22 for vascular surgery consultation and left foot gangrene following a transmetatarsal amputation.
2. Patient #2 was admitted to [room number] and plans were made for percutaneous revascularization of his left lower extremity. Procedure was completed on 11/20/22 without incident.
3. On 11/24/22 at approximately 4:15 PM, staff called a rapid response for patient decompensation and telemetry room notification of new patient AFIB with RVR. Last cuff pressure was approximately 80 mmHG systolic but unable to get a blood pressure at time of event. Patient oxygen saturation was 90% on a non-rebreather (NRB) mask.
4. Patient given Amiodarone without successful rhythm conversion. Patient decompensation worsening. Decision made for cardioversion.
5. Upon discharge of 200 J for cardioversion, the anterior pad arced, lighting the patient's facial hair, upper chest, and NR mask on fire.
6. The physician pulled the mask off of his head and along with another nurse, put the flames out with their hands. The patient had suffered superficial burns to his upper chest, right hand, lower face, and top of his head.
7. Patient #2 was transferred to the CCU [cardiac care unit] for further management.
8. Patient #2 was intubated to protect his airway. An echocardiogram and bronchoscopy were completed. As a precaution, the clinical team, in collaboration with [Named Hospital] #3 physicians, decided to transfer the patient to [Named Hospital] #3. There was concern regarding potential thermal injury complications to the patient's airway.
9. Patient #2 was transferred to [Named Hospital} on 11/24/22 at 7:45 PM.

B [background] as follows:
1. 64 M [male] with past medical history of peripheral artery disease, hypertension, hyperlipidemia, stroke with right-sided weakness in 2015, and is legally blind.
2. Patient is bed-bound and lives with his wife at home with good social support.

A [Assessment] as follows:
1. Debrief occurred:
(a) Clinical team responded quickly to the patient's decompensating status and to the fire
All established clinical processes followed correctly
(b) Before cardioversions, staff double-checked the pads to ensure good patient contact.
Anterior/Posterior pad placement for cardioversion
(c) Staff report that defibrillator created a loud electrical pop upon cardioversion
(d) Several staff witnessed a "spark' travel down the cords from the defibrillator to the pads right before the fire.
(e) In review of the print-out from the defibrillator, it was set at 200 J but delivered 299 J.
(f) Patient was lying on his back during incident but sustained burns to his back.

R [recommendations] as follows:
1. Sequester defibrillator pads, and NRB mask - Completed and chain of custody in place.
2. Meet with Biomed to Review PM's [preventive maintenance] on defibrillator and process for PM's - Scheduled for 11/29/2022
3. Engage manufacturer ([Named Company] #2) - to be completed following the Biomed meeting
4. Complete MedWatch/UIRS [unusual incident reporting system] reports - in progress
5. Review FDA [Food and Drug Administration] reports for issues with specific defibrillator and/or pads used - in progress
6. Tracers on all defibrillators in use - in progress
7. Review of occurrence reports for similar internally reported incidents - in progress
8. Preparing a report for the Board of Directors - Pending
9. Facilities Engineering to inspect room to ensure safety prior to patient use again - in progress.

Review of the Incident Report on 11/29/22 at 2:23 PM revealed, "...Fire/Life Safety incident Date/Time/Name of staff became aware of the incident...on 11/24/2022 at 5:44 PM Nurse #2...Date/Time administrator was notified of the incident and by whom 11/25/2022 at 10:21 AM Nurse #10...alleged victim...Patient #2 with a date of birth 5/19/1958...Please insert as much accurate information as possible...Physician was called to Patient #2's room due to a new onset atrial fibrillation. The patient was wearing a non-rebreather mask with oxygen saturation of 90%. On cardioverting the patient, the defibrillator pads arched causing a fire which reached the patient's face and upper chest. The non-rebreathing mask was immediately removed from the patient and flames were extinguished...What was reported and to whom or which agency/entity Fire causing harm to patient (no person or agency listed that the fire was reported to)...Date and time when the alleged incident occurred... 11/24/2022 at 5:44 PM. Where the alleged incident occurred [patient room number]...Provide details of any physician harm, pain or mental anguish to the alleged victim...The patient suffered what appears to be second degree burns to the upper chest and lower face. The patient was transferred to the CCU for further management. The patient was intubated for airway protection. Bronchoscopy was performed which showed thin secretions, no charring or discoloring in the airway. The patient was transferred to a burn center at another facility...Provide all steps taken immediately to ensure resident(s) are protected...Facility is doing audits of all the defibrillators to assure that staff completing daily checks. Biomedical Services evaluating the defibrillators preventive maintenance history...Witness(es) RN #1...Risk Manager [submitted report] 11/29/2022 at 2:23 PM..."

Observations on 1/4/2022 beginning at 2:15 PM in the Vice President of Quality and Risk Management (VPQRM) reception area adjacent to the VPQRM's office revealed, a defibrillator, defibrillator pad, and non-rebreather mask in a plastic bag. There was a dark black charring on the anterior defibrillator pad, the posterior defibrillator pad did not have any charring just looked like it had been applied to a patient. The oxygen tubing and non-rebreather mask also had a dark black charring.

Interview in the Conference Room on 12/5/2022 at 9:16 AM with the VPQRM Department stated Patient #2 died about 58 minutes after he got to [named Hospital #3] and the burns were not the cause of death. The Medical Examiner has accepted the case.

In a e-mail correspondence on 12/7/22 at 10:16 AM an e-mail was sent to the VPQRM. The VPQRM was asked What action was taken immediately to stop this (Patient #4 catching on fire during a Cardioversion) from happening again to another patient. VPQRM stated, "...Patient was removed from harms way, transferred to critical care, and then to a burn unit at a sister facility...Patient was removed from harms way, transferred to critical care, then to a burn unit at a sister facility...The defibrillator and other relevant devices and cables were sequestered...Disclosure to wife who was in the room when the incident occurred...Notification of leadership..." The VPQRM was asked what has been put into place since that time to make sure this type of accident does not happen again. The VPQRM stated, "...We are still completing the RCA [Root Cause Analysis] and analysis of this incident. That said, All [Named Company] #2 defibrillators that are in use have been inspected utilizing a tracer methodology. This review/tracer includes checking the history on the device, and well completion of the daily and weekly checks...Review with Biomed/Engineering to assure the PM's [Preventative Maintenance] were completed according to the FU [Instructions For Use] for the device...Patient safety Alert created by the CA [Healthcare] Patient safety Organization. This is intended for and being distributed to all members of the patient care teams, including pharmacy, nursing, providers, infection prevention, and all staff involved in patient safety and risk management...Brands of defibrillators reduced from 2 brands to 1...R code [a machine-readable code] with informational video in place on defibrillators demonstrating use of the device...Algorithm for ABCS [Advanced Cardiovascular Life Support measures - airway, breathing, circulation] protocol available on each crash cart...FDA, Med Watch report was completed...Search of MAUDE [Manufacturer and User Facility Device Experience] database for like events with this device, and other devices in use at the time of the incident...report was completed to notify the State..." The
1. The VPQRM was asked what was the expiration date on the [Named Brand] of defibrillator pads. The VPQRM stated, "...3 [three] pairs of pads involved - two dated 9/30/25 and one 8/25/25.

In an interview in the conference room on 12/13/2022 at 10:35 AM the Bio Med #1 was asked who is responsible for the daily inspections. Bio Med #1 stated, "...the charge nurse..." Bio Med #1 stated that the defibrillator had received the daily and annual checks that were required by our equipment maintenance policy's and the manufacture's recommendations.

In an interview in the conference room on 12/13/2022 beginning at 10:35 AM the Director of Patient Safety stated, "...The facility is doing audits of all the defibrillators to assure that staff are completing daily checks...and Biomedical Services evaluated the defibrillators preventive maintenance history..."

In a e-mail correspondence on 12/20/2022 at 3:03 PM, the VPQRM was asked has the [Named Company] #2 manufacturer been onsite and determined the cause of the defibrillator fire yet. The VPQRM stated, "...(a)[Named Company] #2 has been onsite since the event to complete the rollout and education on the [Named Company] #2 defibrillators. They have not examined the defibrillator as it has been sequestered until an independent expert could be obtained to complete the examination and interrogation of the device. In speaking with them, they would not determine the source of the fire, but would examine just their piece of equipment which would be the defibrillator itself.
(b)legal counsel has been retained by the wife of the patient, and we have received notice from the Plaintiff ' s counsel that the device should remain sequestered until an agreed upon expert could be retained to examine and interrogate the device
(c) Our facility has a contract with [Named Company] #1 for Biomed services. The engineer from [Named Company] #1 that leads Biomed onsite here at [Named Hospital] #2 visually inspected the device, the electrical cord on the device, and the cable that leads to the defibrillator pads on 11/29/2022, and did not find visually any issues with the device, electrical plug, or the cable leading to the defibrillator pads.
(d) MedWatch report on the [Named Company] #2 defibrillator was completed on 11/30/2022 to alert the FDA of the incident. When these alerts are completed the manufacturer is notified that a report has been filed.
(e) A search of the MAUDE database for 2022 reports on [Named Company] #2 R series devices was conducted to review for any similar reports to the FDA or manufacturer on 11/29/2022. There was 1 report of arcing in that database in 2022.
The VPQRM was asked has the [Named Brand] #1 by [Named Company] #3 been onsite and determined the cause of the defib fire yet. The VPQRM stated, "...(a) [Named Brand] #1 has not been on site to determine the cause of the fire.
(b) The pads have not been examined by an independent expert as they have been sequestered until an independent expert could be obtained to complete the examination.
(c) Legal counsel has been retained by the wife of the patient, and we have received notice from the Plaintiff ' s counsel that the device should remain sequestered until an agreed upon expert could be retained to examine and interrogate the device
(d) Our facility has a contract with [Named Company] #1 for Biomed services. The engineer from [Named Company] #1 that leads Biomed onsite here at [Named Hospital] #1 visually inspected the defibrillator pads on 11/29/2022 and did not find visually any issues with the pads. It was identified that on one side of the anterior defibrillator pad the pad was slightly "melted" which could indicate that this is where the arc/spark occurred.
(e) MedWatch report on the [Named Brand] #1 defibrillator pads was completed on 12/8/2022.
(f) A search of the MAUDE database for 2022 reports on [Named Brand #1 defibrillator pads was conducted to review for any similar reports to the FDA or manufacturer on 11/29/2022. There was 1 report of arcing in 2022.
The VPQRM was asked if the [Named Company] #2 defibrillator was the defibrillator used in the accident: Brand R series and was approximately 2 years old; and how many of these models defibrillators are in the hospital and why did the hospital not take this brand out of circulation after the fire. The VPQRM stated, "...(a)In response to the number of [Named Brand] #2 series R devices in use in the hospital at the time of the incident, there were 75 in use. Since that time, we have continued with the transition to all [Named Company] #2 R series devices, and completed the removal of [Named Company] #4 defibrillator devices. At the time of the incident, there were 75 [Named Company] #2 R series devices in use in the facility. Today, there are 109 with completion of the rollout. Note: All PM's [Preventative Maintenance] have been completed on the new devices prior to placing them in service on the units.
(b) On 11/28/2022, the Quality team began conducting tracers on each of the [Named Company] #2 defibrillator devices. There were 70/75 (93.33%) tracers of the units in use on 11/24/2022 (date of incident). The tracers included serial number, review of the crash cart checklist for completion, assuring that the defib pads were in date and unopened, daily and weekly checks had been completed, defibrillator operational at the time of the tracer...Note: All PM's have been completed on the new devices prior to placing them in service on the units...
(c) In response to "why did the hospital not take this brand out of circulation after the fire", the involved devices were sequestered immediately. To have removed all of the [Named Company] #2 R series devices from the facility would have resulted in there being only 48 [Named Company]#4 defibrillators in the facility. This would have resulted in a less than adequate supply of these devices (defibrillators and defibrillator pads) in all areas throughout the facility where crash carts are necessary. Our response to assure patient safety was to review with Biomed the annual PM's on all [Named Company] #2 devices which was completed by 12/1/2022, and to have the Quality team conduct tracers to check functionality of the devices throughout the facility..."
The VPQRM was asked what was the reason you decided to change to all [Named Company] defibrillators; which defibrillators were changed out just the [Named Company] #4 brand defibrillators. The VPQRM stated, "...(a) The decision to change to one type of defibrillator was a patient safety initiative. This change out resulted in product and process standardization across the facility. The goal of this standardization is to ensure uniformity to certain processes and practices. The focus in this initiative was to make uniform the product, the technology, the process, and the operational use of the equipment during cardioversion/defibrillation whether emergent or scheduled.
(b) In response to "which defibrillators were changed out just the [Named Company] #4 brand", all of the [Named Company] #4 brand defibrillators were removed and replaced with [Named Company] #2 defibrillators. There were no [Named Company] #2 defibrillators replaced during this conversion..."
The VPQRM was asked how did the staff pat the fire out; did any of the staff receive any type of injuries. The VPQRM stated, "...(a) The nurse and the physician that were at bedside during the cardioversion procedure, immediately removed the high flow oxygen source that was being administered to the patient via non-rebreather mask. They then proceeded to "pat" with their hands the small amount of fire that had ignited in the hair on the patient ' s chest, face, and top of his head which resulted from the removal of the O2 non-rebreather mask as it was pulled off of the patient..."
(b) In response to "staff receive any types of injuries" question, both the nurse and the provider did have minor burns to their hands. They were both released to return to work and did so for their scheduled shifts following this incident..."
The VPQRM was asked does the facility have a copy of the autopsy report and death certificate and if not. The VPQRM stated, "...We do not have a copy of an autopsy or medical examiners (ME) report for this patient. The patient was at another facility at the time of death..."

In an interview in the First Conference Room on 1/4/2023 beginning at 1:18 PM Nurse #1 was asked what was your role in the cardioversion was for Patient #2. RN #1 stated, "...I was a extra hand if they needed one... The decision was made to cardiovert at bedside and Versed was given to sedated him...Once they made the decision to shock him .. the protocol to shock was used...you know all clear and etc [similar items are used]...once the doctor push the button there was a very loud pop...in the previous cardioversion's that I have been a part of I never heard the cardioversion ...I mean I could have turn my back to it and I would it I would have never known the cardioversion happen it was like dynamite...it start at leads ...spark at the top of the leads and it travel straight to the patient like dynamite in a cartoon once it hit the patient where the pads were on the front of the patient it set the patient's chest hair's on fire and his arm. It happen so fast we were all in shock ...Physician #3 and the Nurse #3 started patting the fire out with their hands...it caught the Non-rebreather mask on fire as well he (Patient #2) did not really react ...Nurse #3 ripped the facemask off and stomped it on the ground and also turned the oxygen off...the sheet and blanket was pulled off on the ground...the sheet and blanket were on fire and we were trying to put that out as well. Nurse Practitioner #1 had yelled out to call the fire department at that time we didn't know what else would catch on fire, so I exited the room to get the secretary to call the fire department. They called a code blue, and he never lost a pulse the reason a code blue was called was to get more staff...Rapid Response was already there and had been working with him for about 30 minutes before we decided to cardiovert him..." Nurse #1 was asked who checks off the defibrillator check list on the day and night shift. Nurse #1 stated the charge nurse. Nurse #1 was asked is there anything you look for and check other that the checklist. Nurse #1 stated, "...To be honest with you the two times I did it the day shift nurse helped me with it..."

In an interview in the First Conference Room on 1/4/2023 beginning at 1:38 PM with Nurse #2 was asked what was your role in the cardioversion was for Patient #2. Nurse #2 stated, "... at the beginning I was just bystander and then I started to record..." Nurse #2 what do you remember about the cardioversion for Patient #2. Nurse #2 stated, "...I remember we had to switch the pads out. Nurse #2 was asked why the pads were switched out. Nurse #2 stated, "...The pads were put on anterior and lateral. Nurse #2 was asked who made the decision to change the pads out. Nurse #2 stated, "...The ICC Physician #3 and the Nurse Practitioner #1. Nurse #2 was asked what position the pads were changed to. Nurse #2 stated, "...anterior and posterior...then the defibrillator was charged and the shock was delivered...Patient #2 did come off the bed like a person does when they are cardioverted...then I heard the pop and then the spark started coming from the wire, it travel up the wire...it looked like a sparks coming from a sparkler on the 4th of July...then the spark became a flame...I was looking at one who was charging that day and I saw Nurse #3 jerked the non-rebreather off the wall and turned the oxygen off at the same time...I turned around and looked for a blanket and I saw the bedside nurse (Nurse #3) going toward the patient trying to put the fire out...they were putting the fire out with their hands...the Code Blue button was pushed so we could get extra hands...they (medical personnel) begin to get ready for a bed down stairs and physician #6 came in and was looking at the airway both Physician #3 and #6 were assessing the patient..." Nurse #2 was asked do you do the emergency crash cart check list checks. Nurse 2 stated, "Yes." Nurse #2 was asked to tell me what is included in your defibrillator checks. Nurse #2 stated, "...I just look at the items on the check list." Nurse #2 was asked is there anything else you look at. Nurse #2 stated, "...Just what I mentioned."

In an telephone interview on 1/5/2023 at 1:00 PM Physician #3 was asked about the cardioversion for Patient #2. Physician #3 stated, " ...Patient was in a rapid atrial Fibrillation and was hypoxia as well as having an oxygen mask...had a systolic blood pressure of 60 or 70 when 120 is normal and we tried to give him some Amiodarone and it did not work and Patient #2 was getting light headed and passed out. The pads were already on and they were switched out to have better success so there was a pad on the front and one on his back...gave Versed and Fentanyl...Pushed the button to cardiovert and starting at the bottom of the front pad wire was a spark...then the oxygen mask caught on fire and the Nurse #3 grabbed the mask off his face and me and Nurse #3 started patting on the flames it burned my right hand more of the fingers between the middle finger, ring and pinky finger inside of the fingers and all over the ring finger and the back base of the pinky finger in the back...I received second degree burns and the burns were about there for a month now they are gone now. We called for assistance...during this whole time with all this attention being paid to him, Patient #2 was asleep and he (Patient #2) did not code during this time ...My partner came and intubated Patient #2 and moved him to CCU [Cardiac Care Unit]. Physician #3 was asked about the defibrillator being set at 200 J [Joules] for the cardioversion and it delivered 299 J would that have been to much for Patient #2. Physician #3 stated, "...I don't know that it would have been too much...I have seen doctors use two defibrillators at the same time and I have seen patients be cardioverted with 700 J..."

Based on policy review, medical record review, observation and interview the hospital failed to provide nursing services which provided oversight and supervision to ensure care was provided to meet patient's needs by providing accurate assessments to identify alterations in the patient's skin, assess and manage the patient's pain, accurately assess patient's pulses in the extremities, answer call lights timely and provide a clean and sanitary environment for 2 of 4 (Patient #1 and #3) sampled patients reviewed.

The findings included:

1. Patient #1 was admitted on 10/17/2022 with a diagnosis of Leg Edema and Renal Insufficiency. During the course of the hospital stay, Patient #1 was incontinent. There was no documentation Patient #2 had a pressure injury upon admission but four days later, documentation revealed Patient #1 had a pressure ulcer. The documentation of the patient's pressure injury was not consistent during the hospital stay.

2. Patient #3 was admitted on 11/25/2022 with an diagnosis of Abdominal Pain. During the course of the hospital stay the pain assessment was not complete each time it was documented, reassessment was not consistently performed timely or the pain assessment and the medication administration record (MAR) did not consistently document the same medication as administered at a particular time.
A gastroesophageal consultation note documented the patient had been born with congenial malformation of the extremities. Observation of the patient revealed only little nubs for arms.
The shift assessment documented Patient #3 had upper extremities that were equal and strong, had capillary refill of the nailbeds less than three seconds and peripheral pulses were strong and equal with nailbeds pink in both the left and right arm.
A call light call report documented Patient #3's call light was not answered timely and observations revealed the patient's bathroom was not clean and sanitary.

Refer to A 395

Based on medical record review, policy review, and interview, the hospital failed to ensure nursing services provided adequate oversight and supervision to ensure patient's needs were met when skin assessments to prevent the development of pressure injuries were not performed for 1 of 4 (Patient #1) sampled patients. The hospital's nursing service failed to ensure nursing services managed and assessed patient's pain and reassessed pain levels after the administration of pain medication; nursing services failed to document an assessment for vascular capillary refill and peripheral pulses and failed to ensure a clean and sanitary environment and answered call lights timely for 1 of 4 (Patient #3) sampled patients.

The findings included:

1. Review of the facility's "Pain Assessment and Reassessment, Management and Documentation" policy with a last revision date of "03/2022" revealed, "...Pain Management orientation includes, but is not limited to, controlling, assessing and managing pain...Reassessment of pain after the administration of pain medication is dependent on several patient factors (age and disease process) and medication factors (drug, dose, route, absorption, onset, peak...)...Unless otherwise directed by departmental policy and/or licensed practitioner order, the goal to assess the effectiveness of pain medication within one hour of administration...Pain assessment (includes the following) Frequency, Pain descriptors and indicators, Patient teaching, documentation..."

Review of the facilities "Assessment/Reassessment/Plan of Care" policy with a revision date of "7/2019" revealed, "...The assessment process is structured with three components: Assessment, re-assessment and plan of care. The goal of the assessment, re-assessment and care planning process is to provide the patient with the most appropriate individualized care and treatment...Plan of Care...The patient assessment process is collaborative to facilitate, identify and prioritize the patient's needs for care and treatment...The following variable influence and direct the process of patient assessment and re-assessment for all disciplines...In addition, health care providers assess pertinent medical...elements in their respected discipline specific to the patient assessment...Functional...screen...Education needs...Body System assessment..."

Review of the facility's "Pressure Injury Prevention" with a revision date of "10/2022" revealed, "...All patients will be evaluated for skin breakdown through completion of a risk assessment process. This will occur upon admission; minimum of once per shift...Based on the level of skin risk, nursing interventions will be initiated and will be captured on the patient's plan of care...Regardless of risk, standard of care pressure injury prevention elements should be implemented on all patients...Particular focus should be given to bony prominence's, including the sacrum, heels, hips...Assess for signs of maceration, paying attention to skin fold/creases...Assess vascular/perfusion status...Interventions and an individualized plan of care will be implemented and documented as appropriate...The nurse should notify the provider/practitioner of any new or existing wound...Preventative measures should be applied based on individualized risk factors...Protect skin with barrier products...Minimize skin contact with urine/feces...Provide/assist the patient with repositioning & [and] turning as needed to offload pressure on dependent area (e.g.[for example] sacrum)...Consider use of a prophylactic dressing as an interface layer between device and skin...Evaluate nutritional risk factors, collaborate and discuss concerns with interdisciplinary team an consult clinical nutritional screening...Consider the use of a specialty support surface for at risk individuals...Prevalence of hospital acquired pressure injuries should be tracked, monitored, and reviewed regularly with an interdisciplinary team..."

Review of the facility's "Specialty Beds" policy with an revision date of "03/2022" revealed, "...To provide guidelines for selection of support surfaces which includes, but not limited to Medical-Surgical mattresses, low-air loss, air fluidized, bariatric, and waffle overlay...The criteria for utilization of a pressure redistribution surface include, but not limited to...Identified as vulnerable population for developing pressure necrosis or skin breakdown...The patient population that meet the above criteria and identified as high risk for skin breakdown or have an existing skin breakdown will be evaluated for appropriate support surface...Wound Ostomy Continence Nurse (s)...or nursing leadership which includes, but not limited to the charge nurse of the unit to evaluate the need for rental support surface...Primary nurse will accomplish a skin assessment and notify the provider for a waffle overlay mattress...When a patient...is at high risk for skin breakdown...Has a documented Stage 1 or 2 pressure injury...Primary nurse will obtain an order from the provider for a Wound Consult...The Wound Team will assess, treat patient as necessary, and document the requirement for specialty products in [Named System] #1..."

2. Medical Record Review revealed that Patient #1 was admitted on 10/17/2022 with diagnoses of Leg Edema and Renal Insufficiency. The medical record documentated Patient #1 had no abnormalities of the skin upon admission.

Review of the Emergency Patient Record on 10/18/2022 revealed the following skin findings: no legions, rash, wounds, bruises, petechiae or abrasions. Patient #1 had an estimated height of 5 feet and 1 inch and a stated/reported weight of 113.636 kg [kilograms] (250 pounds).

Review of the admission assessment on 10/18/2022 revealed, "...Skin Risk... Incontinent...Yes... Existing pressure injury: No; Pressure injury risk...Yes..."

Review of the shift assessment from 10/18/22 through 10/21/22 revealed that the right buttock pressure ulcer was found on the night shift [7:00 PM-7:00 AM] on 10/21/22 at 6:30 AM assessment. The assessment documented the pressure injury had been present on admission. The shift assessment on 10/21/22 at 8:15 AM (one hour and 45 minutes later) revealed, "...Skin alteration/Procedure site: None...Skin Risk...Existing pressure injury... No..." Documented under activity 10/21/22 at 12:35 PM revealed, "...Discharge Needs - Home Health...I certify face to face encounter occurred on 10/21/22...Skilled Nursing Treatment: 3 times per week for 4 weeks or daily...Wound Care: Dressing Changes..." On the shift assessment on 10/21/22 at 8:03 PM revealed, "...Skin Alteration...Present injury present on admission...Yes..."
There was no documentation of a physician order to treat pressure injury.

Review of the daily skin alterations on 10/21/2022 at 6:30 AM revealed, "...Skin Alterations...Presents/Exists...Press [Pressure] Injur [injury] immobility related to Buttock right...Pressure Injury present of admission: Yes...Skin alteration details: Smooth/red/moist...Altered level/stage- Stage 2 - Pressure Injury...Date of last dressing change; 10/21/2022 at 6:30 AM ... Dressing/reinforcement type: Mepilex..." There was no documentation of a physician's order for treatment of a pressure injury.

Review of daily skin alterations assessment revealed documentation Patient #1 had a Pressure Injury on the following day/date:
Admission;
10/21/2022 at 6:30 AM;
10/24/22;
10/27/22 at 7:50 PM; and
10/28/22.

Review of daily skin risk assessment revealed documentation Patient #1 did not have an existing pressure injury on the following day/date: 10/18/22;
10/19/22;
10/20/22;
10/21/22 at 8:15 AM;
10/22/22;
10/23/22;
10/24/22 at 8:33 AM;
10/25/22 at 8:08;
10/26/22; and
10/27/22.

Review of the Order's Audit Trail of Events for Evaluate, Treatment, Education Wound Care, Dressing Changes on 10/27/2022 "...Comments: right buttock: clean w [with]/peri wipes. Apply Cavilon spray. Cover w [with] foam. Rn [Registered Nurse] to change daily and prn [as needed] if soiled. Lateral offload w [with]/pillow and alt [alternate] sides..."

Review of the Wound Care Progress Notes on 10/27/2022 at 3:17 PM revealed, "...Chief Complaint Initial consultation for integumentary [skin] complaint...HPI [History Present Illness] The following HPI elements were documented for the patient's wound:
Location: right buttock
Duration: acute
Context: "wounds"
Associated Signs and Symptoms: none...
Medical History of: Chronic Back Pain, GERD [Gastroesophageal Reflux Disease], CKD [Chronic Kidney Disease], Lymphedema, CHF [Congested Heart Failure], HTN [Hypertension]...
Complaints and Systems...
Patient complains of: Cardiovascular (Central/Peripheral) Lower extremity (leg) swelling Musculoskeletal: Decreased Activity: All other symptoms relevant to the chief complaint were reviewed today and were negative: Yes...
Physical Exam...Afebrile, patient is warm and well perfused. Morbidly obese...
Integumentary (Hair, Skin) right buttock: two areas of new epithelium pt [patient] reports were wounds. approx. [approximately] .8x [times]5cm [centimeters] each. stable new epithelium over surfaces...
Plan Assessment & [and] Plan...Medical History and Testing Reviewed Today
I have reviewed medical records: from current and prior visits to formulate plan of care...
Lab results reviewed today: glu [Blood Glucose] 128...
Orders Treatment plan: treatment orders (s) entered for bedside nurse to perform...
Standard of Care Skin breakdown Prevention Indicated: Yes...
With recommendation to: - follow facility skin care/pressure prevention policy: consult wound team if new breakdown occurs,-
assess skin each shift and notify wound team if new integument problems arise...
Wound Assessment & [and] Plan...
Assessment: initial visit - plan of care developed to promote healing and reduce risk of infection...
Plan of Care: Newly healed. Res [Recommendations] for Cavil and foam for protection. Pt agreeable and order in cope [computerized provider order entry]. Will f/U [follow-up] RN [as needed]
Relevant history was obtained and patient goals and plan of care were discussed with patient-nursing...
Wound Care Team will continue to follow and will return: in 1 (one) week.
Please continue the above treatment plan if discharge occurs..." There was no documentation of a physician's order for treatment of a pressure injury or pressure ulcer.

Review of the daily skin alterations on 10/28/22 revealed, "...
Press [Pressure] Injur [Injury] immobility related Buttock right- Pressure injury present on admission: Yes
Wound/skin alteration comment: Wound Care Nurse consulted Per Dr [doctor]..."

Review of the Hospitalist Discharge Summary on 10/29/2022 at 8:31 AM revealed, "...Morbid obesity with a BMI [Body Mass Index] 47 [large amount of body fat in relation to the height of the patient] ... A 61 year old female with history of lymphedema, hypertension, congestive heart failure presented to the ED [Emergency Department] for evaluation of lower extremity to pain on both sides. She reports a longstanding history of bilateral lower extremity swelling and pain but has been severe over the last 3 days point that she cannot walk. She is not sure if he [she] has fever. She reports taking antibiotics almost every month for infection', including recently prescribed Bactrim and clindamycin. She reports intermittent nausea and vomiting and not able to tolerate p.o. [by mouth] ...Skin: Chronic skin changes or both lower extremities consistent with lymphedema..." There was no documentation of a physician's order for pressure injury or pressure ulcer.

Review of the orders sent to Home Health #1 on 10/29/2022 revealed, "...Other Conditions...Evaluate, Treatment, Education Wound Care, Dressing Changes..."

Review of a letter dated 11/17/2022 [Named Hospital] #2 was replying back to the Quality of Care Department to [Named Insurance] #1 which handles Medicaid and Medicare revealed, "...I am in receipt of your letter dated November 17, 2022 I cognize [recognize] that [Named Insurance] #1 member (Patient #1) alleges she did not receive appropriate care during her 10/17/22 - 10/29/22 dates of service..." [Named Insurance] #1 invites responses to the following questions:
(a) Do your records indicate any skin breakdown while at your facility Yes. If so, what were circumstances surrounding the member acquiring the pressure ulcer. Morbid obesity, chronic acquired lymphedema, localized edema, reduced mobility
(b) What nursing care interventions were taken to prevent pressure ulcers. Protected her skin with barrier products, minimized her skin contact with urine/feces, promoted early/frequent activity Occupational Therapy, repositioned frequently, Nutritional consult, prophylactic dressings, specialty beds, and provided her education..."

In review of the hospital's answers above to the insurance company in the letter, review of medical record and interviews, the surveyor's investigation revealed the following answers to the interventions the hospital were taken to prevent pressure ulcers for Patient #1:
(a) Barrier Products used: There was no documentation barrier cream was applied or used for Patient #1 during the hospital stay.
(b) Minimized skin contact with urine/feces: Patient #1 was incontinent and used an external catheter. A physician order documented Patient #1 was to have Lasix 80 mg [milligrams] twice a day. The documentation revealed Patient #1 received perineal care once each shift. An orthopedic note dated 10/20/22 at 4:46 PM revealed the following documentation: "...Pt [patient] sup [supine] in bed wanting to get OOB [out of bed] and clean up d [due]/t [to] being soiled in bed. Bed linens saturated w [with] urine. External catheter in Place..."
(c) Promoted early/frequent activity Occupational Therapy: A physician's order was written on 10/19/2022 at 7:00 AM for Occupational Therapy.
Review of occupational therapy visits for Patient #1 are following:
10/22/2022 at 3:47 PM - 4:37 PM
10/24/22 missed visit due to RN care and scheduled upper endoscopy 3. 10/25/22 from 1:03 PM - 1:28 PM
10/28/22 from 1:25 PM - 1:54 PM.
(d) Repositioned frequently - Review of documentation on the daily musculoskeletal assessments for repositioning revealed there was no documentation positioning aides were used for Patient #1 on the following days: 10/18/2022, 10/19/2022, 10/20/2022, 10/21/2022, 10/22/2022, 10/23/2022, 10/24/2022, 10/25/2022, 10/26/2022, 10/28/2022, and 10/29/2022.
(e) Nutritional consult - In an e-mail correspondence on 12/14/22 the Quality Coordinator #1 stated, "...After reviewing the orders, a nutritional consult was not present..."
(f) Prophylactic dressings - review of the daily skin alterations on 10/21/2022 at 6:30 AM revealed, "... Date of last dressing change;10/21/2022 at 6:30 AM Dressing/reinforcement type"
(g) Specialty beds - There was no documentation a specialty bed was ordered for Patient #1.
In an interview in the conference room on 1/3/2023 the Quality Coordinator #1 was asked to review Patient #1 chart to see if there was a specialty bed ordered for Patient #1. Quality Coordinator stated, "...In reviewing Patient #1 chart I need no see a specialty bed ordered..."
(h) Provided her (Patient #1) education - There was no documentation of interventions listed under education.

In an interview in the Conference Room on 12/12/2022 beginning at 9:30 AM Quality Coordinator #1 stated, "...I have reviewed the Admission Assessment and I do not see any documentation of a pressure injury.

3. Medical record review revealed Patient #3 was admitted on 11/25/2022 with an diagnosis of Abdominal Pain. Patient #3 also has Type 2 Diabetes Mellitus, Hypertension, and Cogential Malformation of the Extremities. Patient #3 states that she rode in a car from [Named State] #1 to [Named State] #2 earlier today, and during her ride she developed acute onset abdominal pain in the bilateral lower quadrants, with the worse pain in the right lower quadrant. Patient #3 estimated this started about 10 hours ago.

(a) pain medication assessment and reassessment
Review of the medication order on 11/26/2022 at 2:30 AM revealed a physician's order for Morphine IV injection 4 mg [milligram] a one time dose.

Review of the medication order on 11/26/2022 at 3:46 AM revealed a physician's order for Dilaudid IV injection 0.6 mg [milligram] PRN [as needed] every 3 hours for a pain scale 7-10.

Review of the Medication Administration Sheet (MAR) on 11/26/2022 at 4:16 AM revealed that Morphine 4 mg injections was given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/26/22 at 8:11 AM revealed that Dilaudid 0.6 mg [milligrams] IV [intravenous] injections were given for a pain score of 10 or severe/worst pain possible. There was no documentation of a pain assessment prior to the administration of the medication. The pain reassessment was at 3:15 PM which was 7 hours and 4 minutes later.

Review of the MAR on 11/26/22 at 3:29 PM revealed that Dilaudid 0.6 mg [milligram] IV injections were given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/26/22 at 7:39 PM revealed Dilaudid 0.6 mg IV injections were given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/27/22 at [no correct time documented (41)] revealed that Dilaudid 0.6 mg [milligrams] IV injections were given or a pain score of 10 severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/27/22 at 4:03 AM revealed Dilaudid 0.6 mg IV injections were given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 11/27/22 at 8:30 AM revealed a pain score of 6 or moderate pain. Relieving factors documented opioid and non-opioid medications were given. There was no documentation on the patient's MAR any medication was administered for the pain score or 6.

Review of the MAR on 11/27/22 at 8:38 AM revealed Dilaudid 0.6 mg IV injections were given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 11/27/22 at 11:02 AM revealed a pain score of 6 or moderate pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the patient's MAR any medication was administered for the pain score or 6.

Review of the MAR on 11/27/22 at 1:26 PM revealed Dilaudid 0.6 mg IV injections were given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/27/2022 at 3:23 PM revealed Dilaudid 0.6 mg IV injection was given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/27/2022 at 6:09 PM revealed Dilaudid 0.6 mg IV injection was given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication. The pain reassessment was not completed in a timely manner. The pain reassessment was completed at 9:35 PM for a total of 3 hours and 26 minutes.

Review of the pain assessment on 11/27/22 at 8:00 PM revealed a pain score of 10 or severe/worst possible pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the patient's MAR any medication administered for this pain score of 10.

Review of the MAR on 11/27/2022 at 10:13 PM revealed Dilaudid 0.6 mg IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 11/28/22 at 12:00 AM revealed a pain score of 4 or moderate pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR medication administered for this pain score or 4.

Review of a nurse's note on 11/28/2022 at 12:00 PM revealed, " ...pt [patient] awkae [awake] upon entering ...Complains of a 10/10 pain and states diluadid [Dilaudid] did not help at all ...no acute needs or wants at this time ...will continue to monitor ..." Review MAR revealed the last pain medication for Dilaudid was given at 11/27/22 at 10:13 PM. There was no documentation of any other interventions to provide pain relief for the patient.

Review of the pain assessment on 11/28/2022 at 8:00 AM revealed a pain score of 6 or moderate pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR medication administered for this pain score of 6.

Review of the MAR on 11/28/2022 at 8:15 AM revealed Dilaudid 0.6 mg IV injection was given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 11/28/2022 at 10:53 AM revealed a pain score of 6 or moderate pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR any medication was administered for the pain score of 6.

Review of the MAR on 11/28/2022 at 11:37 AM revealed Dilaudid 0.6 mg IV injection was given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 11/28/2022 at 2:32 PM revealed a pain score of 6 or moderate pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR any medication was administered for the pain score of 6.

Review of the MAR on 11/28/2022 at 2:48 PM revealed Dilaudid 0.6 mg IV injection was given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the medication orders on 11/28/2022 at 5:50 PM revealed an physician's order for Morphine 2 mg [milligrams] IV [Intravenous] injections every 3 hours PRN [as needed] for a pain scale 7-10.

Review of the MAR on 11/28/2022 at 8:48 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 7 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/29/2022 at 1:36 AM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 7 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/29/2022 at 4:02 AM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 7 or severe pain. given. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 11/29/2022 at 8:00 AM revealed a pain score of 6 or moderate pain with relieving factors documented as opioid and non-opioid medication given. There was no documentation on the MAR any medication was administered for the pain score of 6.

Review of the MAR on 11/29/2022 at 9:09 AM revealed . Morphine 2 mg [milligram] IV injection was given for a pain score of 7 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 11/29/2022 at 11:35 AM revealed a pain score of 6 or moderate pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR any medication was administered for the pain score of 6.

Review of the MAR on 11/29/2022 at 12:54 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 8 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 11/29/2022 at 3:16 PM revealed a pain score of 6 or moderate pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR any medication was administered for the pain score of 6.

Review of the MAR on 11/29/2022 at 5:36 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 7 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 11/29/2022 at 8:02 PM revealed a pain score of 9 or severe pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR any medication was administrated for the pain score of 9.

Review of the MAR on 11/29/2022 at 10:58 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 9 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication. The pain reassessment was not completed in a timely manner. Pain reassessment score was completed at 1:23 AM which was 2 hours and 21 minutes.

Review of the pain assessment on 11/30/2022 at 1:45 AM revealed a pain score of 7 or severe pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR any medication was administrated for the pain score of 7.

Review of the MAR on 11/30/2022 at 2:04 AM revealed Morphine 2 mg [milligram]IV injection was given for a pain score of 9 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication. The pain reassessment was not completed in a timely manner. Pain assessment was completed at 5:28 AM which was 3 hours and 24 minutes.

Review of the MAR on 11/30/2022 at 6:10 AM revealed Morphine 2 mg[milligram] IV injection was given for a pain score of 10 or severe/worst possibly pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/30/2022 at 9:25 AM revealed Morphine 2 mg. [milligram] IV injection given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/30/2022 at 12:38 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 10 or severe/worst possible pain was given. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/30/2022 at 4:26 PM revealed Morphine 2 mg[milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 11/30/2022 at 8:46 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 7 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/1/2022 at 4:12 AM Morphine 2 mg [milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/1/2022 at 8:00 AM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/1/2022 at 1:00 PM revealed Morphine 2 mg [milligrams] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/1/2022 at 2:05 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 9 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/1/2022 at 7:16 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/1/2022 at 10:28 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 9 or severe pain. Morphine 2 mg [milligram] injection Morphine 2 mg [milligram] injection. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/2/2022 at 1:48 AM revealed Morphine 2 mg[milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/2/2022 at 5:39 AM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/2/2022 at 11:39 AM revealed Morphine 2 mg [milligrams] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/2/2022 at 2:56 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/2/2022 at 6:03 PM revealed Morphine 2 mg [milligram]IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/2/2022 at 10:13 PM revealed Morphine 2 mg[milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 12/3/2022 at 8:00 AM revealed a pain score of 7 or severe pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR any medication was administrated for the pain score of 7.

Review of the MAR on 12/3/2022 at 9:21 AM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 7 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/3/2022 at 12:26 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/3/2022 at 4:08 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 7 or severe pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the MAR on 12/4/2022 at [no correct documented time (22)] revealed Morphine 2 mg [milligrams] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 12/4/2022 at 1:03 AM revealed a pain score of 10 or severe/worst possible pain with relieving factors documented as opioid and non-opioid medications given. There was no documentation on the MAR any medication was administrated for the pain score of 10.

Review of the MAR on 12/4/2022 at 4:59 PM revealed Morphine 2 mg [milligram] IV injection was given for a pain score of 10 or severe/worst possible pain. There was no documentation of a pain assessment prior to the administration of the medication.

Review of the pain assessment on 12/4/2022 at 5.44 AM revealed a pain score of 9 or severe pain with no pain location, radiation or description documented. The relieving factors were documented as opioid and non-opioid medications given. There was no documentation on the MAR any medication was administrated for the pain score of 9.

Review of the pain assessment on 12/4/2022 at 7:30 PM rev

Based on policy review, medical record review and interview the hospital failed to ensure the nursing staff developed and implemented individualized interventions for the plan of care for 2 of 4 (Patient #1 and #3) sampled patients reviewed.

The findings included:
1. Review of the facilities "Assessment/Reassessment/Plan of Care" policy with a last revision date of "7/2019" revealed, " ...The assessment process is structured with three components: Assessment, re-assessment and plan of care. The goal of the assessment, re-assessment and care planning process is to provide the patient with the most appropriate individualized care and treatment ...Plan of Care ...The patient assessment process is collaborative to facilitate, identify and prioritize the patient's needs for care and treatment...The following variable influence and direct the process of patient assessment and re-assessment for all disciplines...In addition, health care providers assess pertinent medical...elements in their respected discipline specific to the patient assessment...Functional...screen...Education needs...Body System assessment..."

Review of the facilities "Evidenced Based Clinical Documentation: Documenting Standard of Care" with a last approved date of "08/2020" ...Plan of Care is with each professional involved in the patient's care contributing to the plan by identifying problems, establishing goals, setting time frames, and prescribing interventions. Based on the comprehensive assessment and patient ...For each problem added to the Plan of Care, the electronic information system will suggest related interventions. The clinician will review and edit the suggested interventions to meet the patient's needs. The list of interventions...reflects four action types ...Assess/Monitor ...Collect and analyze data on the health status ...Perform/Care ...Perform a therapeutic action ...Manage/Refer ...Coordinate care process ...Teach/Instruct...The Plan of Care is reviewed daily and updated as needed based on changes in the patient condition and progress toward identified outcomes or goals. Progress is documented as Improved, Stabilized, or Deteriorated ..."

Review of the facility's "Pressure Injury Prevention" with a revised date of "10/2022" revealed, "...All patients will be evaluated for skin breakdown through completion of a risk assessment process. This will occur upon admission; minimum of once per shift...Based on the level of skin risk, nursing interventions will be initiated and will be captured on the patient's plan of care...Regardless of risk, standard of care pressure injury prevention elements should be implemented on all patients...Particular focus should be given to bony prominences, including the sacrum, heels, hips...Assess for signs of maceration, paying attention to skin fold/creases...Assess vascular/perfusion status...Interventions and an individualized plan of care will be implemented and documented as appropriate...The nurse should notify the provider/practitioner of any new or existing wound...Preventative measures should be applied based on individualized risk factors...Protect skin with barrier products...Minimize skin contact with urine/feces...Provide/assist the patient with repositioning & [and] turning as needed to offload pressure on dependent area (e.g.[for example] sacrum)...Consider use of a prophylactic dressing as an interface layer between device and skin...Evaluate nutritional risk factors, collaborate and discuss concerns with interdisciplinary team an consult clinical nutritional screening...Consider the use of a specialty support surface for at risk individuals...Prevalence of hospital acquired pressure injuries should be tracked, monitored, and reviewed regularly with an interdisciplinary team..."

2. Medical Record Review revealed that Patient #1 was admitted on 10/17/2022 with a diagnosis of Leg Edema and Renal Insufficiency.

Review of the Wound Care Progress Notes on 10/27/2022 at 3:17 PM revealed, "...Chief Complaint Initial consultation for integumentary complaint...HPI [History Present Illness] The following HPI elements were documented for the patient's wound: Location: right buttock Duration: acute Context: "wounds" Associated Signs and Symptoms: none...Medical History of: Chronic Back Pain, GERD [Gastroesophageal Reflux Disease], CKD [Chronic Kidney Disease], Lymphedema, CHF [Congested Heart Failure], HTN [Hypertension]...Complaints and Systems...Patient complains of: Cardiovascular (Central/Peripheral) Lower extremity (leg) swelling Musculoskeletal: Decreased Activity: All other symptoms relevant to the chief complaint were reviewed today and were negative: Yes...Physical Exam...Afebrile, patient is warm and well perfused. Morbidly obese...Integumentary (Hair, Skin) right buttock: two areas of new epithelium pt reports were wounds. approx. [approximately] .8x [times]5cm [centimeters] each. stable new epithelium over surfaces...Plan Assessment & [and] Plan...Medical History and Testing Reviewed Today I have reviewed medical records: from current and prior visits to formulate plan of care...Lab results reviewed today: glu [Blood Glucose] 128...Orders Treatment plan: treatment orders (s) entered for bedside nurse to perform...Standard of Care Skin breakdown Prevention Indicated: Yes...With recommendation to: - follow facility skin care/pressure prevention policy: consult wound team if new breakdown occurs,-assess skin each shift and notify wound team if new integumentary problems arise...Wound Assessment & [and] Plan...Assessment: initial visit - plan of care developed to promote healing and reduce risk of infection...Plan of Care: Newly healed. Recs [Recommendations] for Cavilon and foam for protection. Pt agreeable and order in cpoe [ ]. Will f [follow]/u [up] PRN [as needed] Relevant history was obtained and patient goals and plan of care were discussed with patient-nursing...Wound Care Team will continue to follow and will return: in 1 (one) week. Please continue the above treatment plan if discharge occurs..."

Review of the Plan of Care for Patient #1 on the shift assessment on 12/20/21 - 12/28/21 revealed the following care plans:
(a) Skin Integrity Alteration
(b) Fluid volume alteration
(c) Infection Alternation
(d) Tissure Perfusion Alteration
(e)Activity Alternation
There was no documentation of individualized interventions for Patient #3's care plans.

2. Medical record review revealed Patient #3 was admitted on 11/25/2022 with an diagnosis of Abdominal Pain. Patient #3 has congenital malformations and has no arms, no nailbeds for capillary refill for right or left hands and no pulses in her brachial or radial bilaterally.

Review of the Plan of Care for Patient #3 on the shift assessment on 11/26/2022 - 1/5/2022 revealed the following care plans with no interventions:
(a) Gastrointestinal Alteration
(b) Urinary Elimination Alteration
(c) Bowel Elimination Alteration
(d) Comfort Alternation
(e) Pain Problem
(f) Sensory Perceptual Alteration
(g) self Concept Alteration
(h) Health Maintenance Alteration
There was no documentation of individualized interventions for Patient #3's care plans.

Refer to A 395.