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

1. The Governing Body failed to ensure the Nursing Services in the Pediatric Subacute Unit (provide specialized level of care to medically fragile patients for children) followed the user's manual instructions for the use of an enclosed bed (Posey Bed 8070) for five of five patients (Patients 1, 3, 4, 5, and 6). Patients 1, 3, 4, 5, and 6 (all the patients weighed less than 46 pounds [a unit of measurement]) were placed in Posey Beds 8070 (an enclosed hospital beds with a canopy and a mattress, considered a restraint [a device that limits a person's movement] by the manufacturer). The Posey Bed 8070's user's manual indicated the bed should not be used for patients who weigh less than 46 pounds or are shorter than 46 inches due to risk of serious injury or death. The manual also indicated that the head of the bed should not be raised due to risk of entrapment.

This deficient practice resulted in Patient 1, who weighed 26 pounds (under 46 pounds), was found in the enclosure bed (Posey Bed) unresponsive with the tracheostomy tube (trach tube - inserted by creating an opening into the trachea from outside the neck to help an individual breath) and gastrostomy tube (a G-tube inserted through the belly that brings nutrition directly to the stomach) dislodged. Patient 1 never regained consciousness and was declared dead. In addition, there was a potential for risk of death and entrapment (an event in which a person is caught, trapped or entangled in a confined space) for Patients 3, 4, 5, and 6 (all weighed under 46 pounds) who were placed in the Posey Bed 8070 with the head of the bed elevated for G-tube feeding. (Refer to A - 0063)

2. The Governing Body failed to ensure the contracted service who provided the Posey Bed 8070 (an enclosed hospital beds with a canopy and a mattress, considered a restraint [a device that limits a person's movement] by the manufacturer) for the Pediatric Subacute Unit (provide specialized level of care to medically fragile patients for children) provided staff with in-service training for safe use of the bed and included the user's manual in beds' pouch to ensure the facility staff was able to refer to the manual regarding the indications for use and the dangers associated with the use of the bed.

This deficient practice resulted in the Posey beds not being used as directed by the bed's manufacturer and may have led to the death of Patient 1, who was found in the enclosure bed (Posey Bed) unresponsive with the tracheostomy tube (trach tube - inserted by creating an opening into the trachea from outside the neck to help an individual breath) and gastrostomy tube (a G-tube inserted through the belly that brings nutrition directly to the stomach) dislodged. In addition, there was a potential for risk of death and entrapment (an event in which a person is caught, trapped or entangled in a confined space) for Patients 3, 4, 5, and 6 who were placed in the Posey Bed 8070. (Refer to A -0083)

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

Based on observation, interview, and record review, the facility's Governing Body failed to ensure the Nursing Services in the Pediatric Subacute Unit (provide specialized level of care to medically fragile patients for children) followed the user's manual instructions for the use of an enclosed bed (Posey Bed 8070) for five of five patients (Patients 1, 3, 4, 5, and 6). Patients 1, 3, 4, 5, and 6 (all the patients weighed less than 46 pounds [a unit of measurement]) were placed in Posey Beds 8070 (an enclosed hospital beds with a canopy and a mattress, considered a restraint [a device that limits a person's movement] by the manufacturer). The Posey Bed 8070's user's manual indicated the bed should not be used for patients who weigh less than 46 pounds or are shorter than 46 inches due to risk of serious injury or death. The manual also indicated that the head of the bed should not be raised due to risk of entrapment.

This deficient practice resulted in Patient 1, who weighed 26 pounds (under 46 pounds), was found in the enclosure bed (Posey Bed) unresponsive with the tracheostomy tube (trach tube - inserted by creating an opening into the trachea from outside the neck to help an individual breath) and gastrostomy tube (a G-tube inserted through the belly that brings nutrition directly to the stomach) dislodged. Patient 1 never regained consciousness and was declared dead. In addition, there was a potential for risk of death and entrapment (an event in which a person is caught, trapped or entangled in a confined space) for Patients 3, 4, 5, and 6 (all weighed under 46 pounds) who were placed in the Posey Bed 8070 with the head of the bed elevated for G-tube feeding.

Findings:

1. During a review of Patient 1's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)" dated 2/27/2023, the "H&P" indicated Patient 1's past medical history included twenty-six (26)-week preemies (an infant that is born prior to 37 weeks); ASD (Autism spectrum disorder, which is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave); PDA ligation (Patent ductus arteriosus surgery is done to close a blood vessel called the heart that is normally close after birth, in PDA, it stays open); tracheostomy (procedure to help air and oxygen reach the lungs by creating an opening into the windpipe), and GJ tube (a gastrojejunal tube, a soft feeding catheter, is placed through an existing hole in the stomach into the small bowel) dependence. The H&P indicated under the physical examination, "General: Awake, alert, and smiling," and "Musculoskeletal: Normal range of motion (the range of movement around a joint that is considered normal)." The H&P indicated the plan for respiratory care, "Patient continues to be tracheostomy tube dependent..."

During a concurrent interview and record review with License Vocational Nurse (LVN) 2, Patient 1's "Order Summary Report," was reviewed. The order summary indicated on 6/12/2023 "Routine, Patient (Patient 1) may use Posey bed enclosure." In addition, the order summary indicated on the top of the page, "Active Orders as of: 2/1/2024." LVN 2 stated the order was placed on 6/12/2023 and the order was active as of 2/1/2024.

During a review of Patient 1's code blue sheet titled "Code Blue Record," dated 1/31/2024 at 11:53 p.m., Patient 1's code blue record indicated Patient 1's weight was 12 kilogram (26.4 pounds).

During a review of Patient 1's "Emergency Note (ED, Provider Note is a critical document summarizing a patient's emergency encountered, including medical history, course of treatment, and follow-up plans)" dated 2/1/2024, the note indicated, "3-year-old male called as code white (initiated when emergency assistance is needed to care for an infant or child requiring resuscitation) in subacute. Per RT (respiratory therapist), he was found unresponsive and pulseless (non-palpable beat due to heart stop pumping blood to the body), with the trach falling out at 11:50 p.m. Unknown downtime ...On the pulse check, he remained pulseless, and in asystole (heart's electrical system fails entirely, which causes the heart to stop pumping) ...Time of death: 0015 (12:15 a.m.)."

During an interview with License Vocational Nurse (LVN) 1 on 2/21/2024 at 10:51 a.m., LVN 1 stated on 1/31/2024 she was giving medication to a patient in the same room as Patient 1, when she noticed Patient 1 was lying face down in the enclosure bed (Posey Bed 8070). LVN 1 stated Patient 1's pulse oximetry machine (a device used to measure the oxygen level in the blood) was not reading Patient 1's pulse oximetry and was showing a flat line.

During an interview on 2/21/24 at 9:30, a.m., with charge nurse (CN) 1, CN 1 stated on 1/31/2024 the primary nurse (LVN 1) came up to her at the nurse station and told her, "can you check on my patient (Patient 1), something is wrong." CN 1 stated she went to Patient 1's room, unzipped the enclosure bed (Posey Bed 8070) and found Patient 1 in middle of the Posey bed unresponsive.

In the same interview, CN 1 stated CPR (cardiopulmonary resuscitation, an emergency procedure consisting of chest compressions and assisted breathing) was performed to Patient 1, Patient 1 was not resuscitated and was pronounced death on 2/1/2024 at 12:14 a.m.

During an interview on 2/20/24 at 10:40 a.m., with the DIR, the DIR stated, "Patients who are active or patients who grew out of the crib and are between the crib and the adult beds, will be placed in the Posey bed."
During an interview on 2/20/24 at 3:30 PM with the DIR, the DIR stated, "I don't know that there is a weight indication for the Posey bed." The DIR also stated that she did not know that the Posey Bed was considered a restraint.

2. During an observation on 2/20/24 at 10:30 a.m., with the Director of Pediatric Subacute (DIR) in the Pediatric Subacute Unit Patients 3, 4, 5, and 6 were observed placed in Posey beds. Patients 3, 4, 5, and 6 were observed to have tube feeding infusions via G-tube.

During an interview on 2/20/24 at 10:40 a.m., with the DIR, the DIR stated, "Patients who are active or patients who grew out of the crib and are between the crib and the adult beds, will be placed in the Posey bed."

During an interview on 2/21/24 at 9:20 a.m., with the Charge nurse (CN) 1, CN 1 stated when a patient, who was placed in the Posey bed, has a G-tube, the patient will have tube feeding infused with the head of the bed raised to 30 degrees. The nurse will leave the room and let it (feeding) run. The alarm will beep, and the nurse will return to disconnect the patient.

During a review of Patient 3's "History and Physical (H&P)," dated 6/5/2023, the "H&P" indicated, Patient 3 was admitted to the facility since 2020. The H&P further indicated Patient 3's problem list included chromosome 15 q23.6 duplication (a duplicate in genetics, causing developmental disorder), chronic lung disease of prematurity (a long-term respiratory problem faced by babies born earlier than 37 weeks). The H&P indicated Patient 3 "had a complex history in the early years of her life ...She has been maintained on the ventilator (a machine used to support or replace the breathing) with a history of pulmonary hypertension (high blood pressure that affects the lungs) and high vent settings (requiring more mechanical aid for breathing) in the past." The H&P's physical examination indicated Patient 1 is "delayed (condition of children whose intellectual function and adaptive behavior are significantly below the expected average for their age) but appears to be aware of her surroundings."
During a concurrent interview and record review on 2/21/2024 at 9:45 a.m., with the DIR, the document titled "Posey Bed," undated, was reviewed. The document indicated Patient 3's weight was 38.36 pounds. The DIR confirmed that Patient 3's weight was under the recommended weight (more than 46 pounds and less than 300 pounds) instructed on the Posey Bed 8070's user manuals. The DIR stated she was not aware of the weight limits in using the Posey Bed 8070.

3. During a review of Patient 4's "History and Physical (H&P)," dated 12/28/2023, the "H&P" indicated Patient 4's medical history included seizure disorder (a sudden, uncontrolled burst of electrical activity in the brain), bronchomalacia (a congenital problem that arises from diminished cartilage support of the smaller airways below the windpipe), and hydrocephalus (a condition in which fluid accumulates in the brain).

During a concurrent observation and interview on 2/20/2024 at 11:00 a.m., with the DIR and charge nurse (CN) 2, Patient 4 was observed inside the Posey Bed 8070. CN2 stated Patient 4 is put in the Posey Bed because "he is also one of our active patients."

During a concurrent interview and record review on 2/21/2024 at 9:45 a.m., with the DIR, the document titled "Posey Bed," undated, was reviewed. The document indicated Patient 4's weight was 35.3 pounds. The DIR confirmed that Patient 4's weight was under the recommended weight (more than 46 pounds and less than 300 pounds) instructed on the Posey Bed 8070's user manuals. The DIR stated she was not aware of the weight limits in using the Posey Bed 8070.

4. During a review of Patient 5's "History and Physical (H&P)," dated /5/2023, the H&P indicated Patient 5's medical history included developmental delay (occurs when the child fails to attain developmental milestones as compared to peers), growth failure (When a child's growth rate falls below what's appropriate for their age), tube dependent (unintended result of long-term enteral feeding), seizures (a sudden, uncontrolled burst of electrical activity in the brain), and requiring BiPAP (Bilevel positive airway pressure is a machine that helps with breathing) during sleep. The H&P further indicated Patient 5 received three bolus feedings (method used to send formula through feeding tube through a syringe) and overnight feeding (type of cyclic feeding in which tube feeds is administered overnight via a feeding pump) for ten hours.

During a concurrent interview and record review on 2/21/2024 at 9:45 a.m., with the DIR, the document titled "Posey Bed," undated, was reviewed. The document indicated Patient 5's weight was 38.13 pounds. The DIR confirmed that Patient 5's weight was under the recommended weight (more than 46 pounds and less than 300 pounds) instructed on the Posey Bed 8070's user manuals. The DIR stated she was not aware of the weight limits in using the Posey Bed 8070.

5. During a review of Patient 6's "History and Physical (H&P)," dated 5/5/2023, the H&P indicated Patient 6's medical history included DiGeorge syndrome (a condition present from birth that can cause a range of lifelong problems, including heart defects and learning difficulties), seizure disorder (a sudden, uncontrolled burst of electrical activity in the brain), gastrostomy tube (a tube inserted through the wall of the abdomen directly into the stomach to allow tube feedings), and tracheostomy tube dependent (reliance on a medical device to aid in breathing through the tube created in the windpipe).

During a concurrent interview and record review on 2/21/2024 at 9:45 a.m., with the DIR, the document titled "Posey Bed," undated, was reviewed. The document indicated Patient 6's weight was 29.90 pounds. The DIR confirmed that Patient 6's weight was under the recommended weight (more than 46 pounds and less than 300 pounds) instructed on the Posey Bed 8070's user manuals. The DIR stated she was not aware of the weight limits in using the Posey Bed 8070.

During an interview on 2/22/2024 at 3:58 p.m., with the Clinical Manager for the Subacute Unit (MSAU), the MSAU stated that Posey beds have been used in Pediatric Subacute Unit for the past 10 years. The MSAU stated the Posey beds did not come with instructions for use or a user's manual.
In the same interview, the MSAU stated she had worked in the Pediatric Subacute Unit for over 15 years and does not remember the last time there was an in-service for the use of the Posey bed. The MSAU stated she did not have any training on the use of the Posey bed and was not aware that the Posey bed was considered a restraint as indicated in by the manufacturer. Furthermore, the MSAU verified, after reviewing the Posey Bed 8070 user manuals, that the bed was considered a restraint, and the bed should not be used for patients who weighed less than 46 pounds due to risk for entrapment, choking, and death. The MSAU stated Patients 1, 3, 4, 5, and 6's weight did not meet the criteria for the use of the Posey Beds.

During a review of the Posey Bed user manual titled, "Posey Bed 8070," dated 2017, the user manual indicated the following:
-This can result in serious injury or death from suffocation, compression, or lack of proper blood flow ...The Bed is a hospital bed, canopy and mattress system designed to help provide a safe controlled environment for patients at extreme risk of injury from a fall or an unassisted bed exit.
-Because the bed is a restraint, its use must be prescribed by a licensed doctor.
- Improper use of the Posey Bed 8070 may lead to serious injury or death.
-The head of the bed should not be raised due to risk of entrapment.
-The bed must be used in accordance with: 1. All state regulations. 2. Federal Center for Medicare & Medicaid Services (CMS, a federal agency dedicated to improving health outcomes) Regulations.
-The Posey Bed is not intended for use with: Patients who weighs less than 46 pounds or are shorter than 46 inches - these patients are at risk for serious injury or death, and the Posey Bed has not been tested for use by such patients.

During a review of the facility's Governing Body's Board Meeting minutes titled, "Boardroom Minutes," dated 2/7/2023, 3/7/2023, 4/4/2023, 5/2/2023, 6/6/2023, 7/11/2023, 8/1/2023, 10/3/2023, 11/7/2023, and 12/5/2023, the meeting minutes did not reflect documentation regarding the Governing Body's oversight to ensure the use of Posey Beds in the Pediatric Subacute Unit was in accordance with the user's manual.

Based on observation, interview, and record review, the facility's Governing Body failed to ensure the contracted service who provided the Posey Bed 8070 (an enclosed hospital beds with a canopy and a mattress, considered a restraint [a device that limits a person's movement] by the manufacturer) for the Pediatric Subacute Unit (provide specialized level of care to medically fragile patients for children) provided staff with in-service training for safe use of the bed and included the user's manual in beds' pouch to ensure the facility staff was able to refer to the manual regarding the indications for use and the dangers associated with the use of the bed.

This deficient practice resulted in the Posey beds not being used as directed by the bed's manufacturer and may have led to the death of Patient 1, who was found in the enclosure bed (Posey Bed) unresponsive with the tracheostomy tube (trach tube - inserted by creating an opening into the trachea from outside the neck to help an individual breath) and gastrostomy tube (a G-tube inserted through the belly that brings nutrition directly to the stomach) dislodged. In addition, there was a potential for risk of death and entrapment (an event in which a person is caught, trapped or entangled in a confined space) for Patients 3, 4, 5, and 6 who were placed in the Posey Bed 8070.

Findings:

1. During a review of Patient 1's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)" dated 2/27/2023, the "H&P" indicated Patient 1's past medical history included twenty-six (26)-week preemies (an infant that is born prior to 37 weeks); ASD (Autism spectrum disorder, which is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave); PDA ligation (Patent ductus arteriosus surgery is done to close a blood vessel called the heart that is normally close after birth, in PDA, it stays open); tracheostomy (procedure to help air and oxygen reach the lungs by creating an opening into the windpipe), and GJ tube (a gastrojejunal tube, a soft feeding catheter, is placed through an existing hole in the stomach into the small bowel) dependence.

The H&P indicated under the physical examination, "General: Awake, alert, and smiling," and "Musculoskeletal: Normal range of motion (the range of movement around a joint that is considered normal)." The H&P indicated the plan for respiratory care, "Patient continues to be tracheostomy tube dependent..."

During a concurrent interview and record review with License Vocational Nurse (LVN) 2, Patient 1's "Order Summary Report," was reviewed. The order summary indicated on 6/12/2023 "Routine, Patient (Patient 1) may use Posey bed enclosure." In addition, the order summary indicated on the top of the page, "Active Orders As Of: 2/1/2024." LVN 2 stated the order was placed on 6/12/2023 and the order was active as of 2/1/2024.

During a review of Patient 1's code blue sheet titled "Code Blue Record," dated 1/31/2024 at 11:53 p.m., Patient 1's code blue record indicated Patient 1's weight was 12 kilogram (26.4 pounds).

During a review of Patient 1's "Emergency Note (ED, Provider Note is a critical document summarizing a patient's emergency encountered, including medical history, course of treatment, and follow-up plans)" dated 2/1/2024, the note indicated, "3-year-old male called as code white (initiated when emergency assistance is needed to care for an infant or child requiring resuscitation) in subacute. Per RT (respiratory therapist), he was found unresponsive and pulseless (non-palpable beat due to heart stop pumping blood to the body), with the trach falling out at 2350 (11:50 p.m.). Unknown downtime ...On the pulse check, he remained pulseless, and in asystole (heart's electrical system fails entirely, which causes the heart to stop pumping) ...Time of death: 0015 (12:15 a.m.)."

During an interview on 2/21/24 at 9:30, a.m., with charge nurse (CN) 1, CN 1 stated on 1/31/2024 the primary nurse (LVN 1) came up to her at the nurse station and told her, "can you check on my patient (Patient 1), something is wrong." CN 1 stated she went to Patient 1's room, unzipped the enclosure bed (Posey Bed 8070) and found Patient 1 in middle of the Posey bed unresponsive.

During an interview on 2/20/24 at 10:40 a.m., with the DIR, the DIR stated, "Patients who are active or patients who grew out of the crib and are between the crib and the adult beds, will be placed in the Posey bed."

During an interview on 2/20/24 at 3:30 PM with the DIR, the DIR stated, "I don't know that there is a weight indication for the Posey bed." The DIR also stated that she did not know that the Posey Bed was considered a restraint.

2. During an observation on 2/20/24 at 10:30 a.m., with the Director of Pediatric Subacute (DIR) in the Pediatric Subacute Unit Patients 3, 4, 5, and 6 were observed placed in Posey beds. Patients 3, 4, 5, and 6 were observed to have tube feeding infusions via G-tube.

During an interview on 2/20/24 at 10:40 a.m., with the DIR, the DIR stated, "Patients who are active or patients who grew out of the crib and are between the crib and the adult beds, will be placed in the Posey bed." The DIR stated The Posey bed had a pouch that indicated, "To avoid injury or death, read and follow User and Assembly Manual instructions and store all manuals in the pocket below." The DIR stated 4 of the 4 Posey beds did not have the manual in the pouch that is attached to the bed.

During an interview on 2/22/2024 at 2:34 p.m., with the Director of Respiratory Department (DRD), the DRD stated that respiratory therapists (RTs) in the hospital rotated to all the units, including the Pediatric Subacute Unit to provide respiratory treatments, such as suction and breathing treatment, for all patients including patients who were placed in Posey beds. The DRD stated RTs would need to open the zipper to the Posey beds in order to access the patients inside. The DRD stated he (DRD) was not aware of any training provided to the RTs on how to safely use the Posey Beds.

During an interview on 2/22/2024 at 4:30 p.m., with the Assistant Chief Nursing Officer (ACNO), the ACNO stated she did not know that the Posey beds in the Subacute Unit were considered restraints by the manufacturer.

During an interview on 2/22/2024 at 4:57 p.m., with the Director of the Pediatric Subacute Unit (DIR), the DIR stated that the Posey beds in the Pediatric Subacute Unit did not come with an instruction manual. The DIR stated that the BioMed Department (department that install, maintain, or provide technical support for medical equipment) should check the equipment (Posey bed) to ensure the instruction manuals came with the bed.

In the same interview, The DIR stated the contracted service, who provides the Posey beds, exchanges the beds every year. The DIR stated the Posey bed had been in used at the Pediatric Subacute Unit for approximately 10 years now. The DIR stated an in-service for the Posey bed was provided around 5 to 10 years ago, and no in-service was done recently.
Furthermore, the DIR verified that the facility's new staff, who work in the Pediatric Subacute Unit, did not receive an in-service for the use of the Posey bed. The DIR stated she was not aware that the Posey Bed was considered a restraint, and she was not aware of the dangers associated with the use of the Posey bed.

During an interview on 2/22/2024 at 3:30 p.m. with the Staff for the BioMed Department (SBM), the SBM stated the BioMed Department (department that install, maintain, or provide technical support for medical equipment) checked the medical equipment in the hospital to ensure the equipment was functioning properly and safe for use. In addition, the SBM stated the Posey beds were being exchanged every year by the contracted service. The SBM stated the Posey beds did not come with a user manual, the user manual was not provided by the contracted service. The SBM stated the contracted service usually provides an in-service the first-time equipment was used in the facility to ensure the staff know how to use the equipment.

During an interview on 2/22/2024 at 3:58 p.m., with the Clinical Manager for the Subacute Unit (MSAU), stated she had worked in the Pediatric Subacute Unit for over 15 years and does not remember the last time there was an in-service for the use of the Posey bed. The MSAU stated she did not have any training on the use of the Posey bed and was not aware that the Posey bed was considered a restraint as indicated in by the manufacturer.
In addition, the MSAU verified, after reviewing the Posey Bed 8070 user manuals, that the bed was considered a restraint, and the bed should not be used for patients who weighed less than 46 pounds due to risk for entrapment, choking, and death. The MSAU stated Patients 1, 3, 4, 5, and 6's weight did not meet the criteria for the use of the Posey Beds.

During an interview on 2/22/2024 at 4:27 p.m., with the Chief Nursing Officer / Chief Operating Officer (CNO/COO), the CNO/COO stated that the Governing Body was not aware that the Posey beds in the Subacute Unit were considered restraints per the manufacturer or that the staff needed training on the use of the beds. The CNO/COO verified that the Governing Body had not discussed the use of the Posey beds provided by the contracted service and that the Governing Board Meeting minutes did not include any documentation regarding the contracted service who provided the Posey beds.

During a concurrent interview and record review on 2/23/2024, at 11:38 a.m., with the Director of Human Resources (DHR) and the Human Resources Generalist (HRG), the employee files of the staff who worked in the Pediatric Subacute Unit were reviewed. The DHR and HRG stated the following staff, who worked in the Pediatric Subacute Unit, did not have evidence of training for the Posey Bed 8070:

- Licensed Vocational Nurses (LVNs) 1, 2, 3, 4;
- Respiratory Therapists (RTs) 1 and 2; and,
- Certified Nurse Assistant (CNA) 1.

During a review of the Posey Bed user manual titled, "Posey Bed 8070," dated 2017, the user manual indicated the following:
- This User's manual is intended as a guide for those using the Posey Bed 8070 (Bed) in the care of patients, and who have successfully completed training.
- Proper training in the use of the Posey Bed 8070 is important and is provided by your authorized Posey Bed dealer or Posey Products, LLC sales representative.
- In addition, to this manual, you should also review: The Assembly Instructions and The In-Service Training Manual ...Entrapment - an event in which a patient is caught, trapped or entangled in a confined space. This can result in serious injury or death from suffocation, compression, or lack of proper blood flow.
-The Bed is a hospital bed, canopy and mattress system designed to help provide a safe controlled environment for patients at extreme risk of injury from a fall or an unassisted bed exit.
- Because the bed is a restraint (devices that limit a person's movement), its use must be prescribed by a licensed doctor.
- Anyone interacting with the bed must complete the Posey Bed 8070 In-Service Training Program which includes the ability to use this manual.
- Improper use of the Posey Bed 8070 may lead to serious injury or death.
- The bed must be used in accordance with: 1. All state regulations. 2. Federal Center for Medicare & Medicaid Services (CMS, a federal agency dedicated to improving health outcomes) Regulations.
-The Posey Bed is not intended for use with: Patients who weighs less than 46 pounds or are shorter than 46 inches - these patients are at risk for serious injury or death, and the Posey Bed has not been tested for use by such patients.

During a review of a service agreement titled, "Contract Approval Form," dated 1/15/2020, between the facility (Customer) and the contracted service who supplied the Posey beds to the facility, the service agreement indicated that the contracted service "will perform the following services: Deliver equipment in ready condition in accordance with the manufacturer's specifications...Customer must use the equipment for the purpose for which it was intended.

During a review of the facility's Governing Body's Board Meeting minutes titled, "Boardroom Minutes," dated 2/7/2023, 3/7/2023, 4/4/2023, 5/2/2023, 6/6/2023, 7/11/2023, 8/1/2023, 10/3/2023, 11/7/2023, and 12/5/2023, the meeting minutes did not reflect documentation regarding the Governing Body's oversight over the contracted service that provided the Posey Beds to the Pediatric Subacute Unit, nor that the contracted service provided in-service training or user manuals to ensure the staff was aware of safe use of the Posey beds and its indication.

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

1. The facility failed to provide a safe environment for two of the thirty (30) sampled patients (Patient 1 and Patient 2) to ensure:

a. that there was no delay in calling a code White (initiated when emergency assistance is needed to care for an infant or child requiring resuscitation) in accordance with the facility policy and procedure regarding code White.

b. that the correct pediatric life-saving medications and supplies were brought into Patient 1's room instead of the adult crash cart (which did not contain the pediatric medication and supplies), and ensure staff has knowledge of the location of emergency supplies.

c. Patient 1's pulse oximetry (device to measure the oxygen level of the blood) alarm was functioning on 1/31/2023 when the alarm did not go off. And ensure that all other pulse oximetry alarms in the unit do not have the same issue of not alarming when there is no reading of the patient's oxygen saturation in accordance with the facility's policy and procedure regarding pulse oxymetry use.

d. that the facility select the appropriate bed or crib based upon the Patient 1's needs and review the manufacture recommendation prior to placing Patient 1 in the Posey Bed 8070 (a restraint, tent-like enclosure hospital bed, in which someone on the outside of the bed must unzip one of the tent flaps before the individual can get out of the bed) in accordance with the facility's policy and procedure.

These deficient practices resulted in insufficient monitoring of a pediatric patient and a delay in life-saving measures for Patient 1, which may have resulted in Patient 1's death. (Refer to A-0144)

2. The facility failed to ensure Patient 2, a pediatric patient who was unable to verbalize needs and unable to move extremities, did not suffer from burns from being laid on top of a humidifier tubing for an unknown length of time. This deficient practice resulted in Patient 2 suffering injuries caused from a heated ventilator tubing, which has caused burns to Patient 2's back and right forearm and has the potential for patients in the units that are unable to verbalize their needs and unable to move their extremities to suffer from burns and for a length of time before staff becomes aware. (Refer to A-0144)

3. the facility failed to follow the user manual instructions for the use of an enclosure bed, such as weight restriction and the head of the bed should not be raised, the Posey Bed 8070 (an enclosed hospital beds with a canopy and a mattress, considered a restraint [a device that limits a person's movement] by the manufacturer), to place pediatric patients and did not follow the facility policy and procedure for restraint safety for five (5) of thirty (30) sampled patients (Patient 1, Patient 3, Patient 4, Patient 5, and Patient 6). This deficient practice resulted in Patient 1, a 3-year-old pediatric patient who weighed 26 pounds, under 46 pounds, being found in the enclosure bed (Posey Bed) with the trach and G-tube out and was unresponsive. Patient 1 never regained consciousness and was declared dead. And the potential for risk of death and entrapment for 4 of the 4 patients observed (on 2/20/24 at 10:45 AM) placed in the Posey Bed 8070. (Refer to A - 0154)

4. the facility failed to ensure order for restraint were renewed for five of thirty (30) sampled patients (Patient 1, Patient 3, Patient 4, Patient 5, and Patient 6), in accordance with the facility's policy and procedure. This deficient practice compromises patients' (Patient 1, Patient 3, Patient 4, Patient 5, and Patient 6) comfort and safety and does not ensure that an assessment is completed to evaluate the continued use of restraints, the effectiveness of the restraints, and if alternative interventions is warranted. (Refer to A - 0173)

5. The facility failed to ensure seven of seven staff (Licensed Vocational Nurses 1, 2, 3, 4, Respiratory Therapist 1, 2, and Certified Nurse Assistant 1) who worked in the Pediatric Subacute Unit were competent and trained in the proper use of the Posey Beds 8070 (an enclosed hospital beds with a canopy and a mattress, considered a restraint [a device that limits a person's movement] by the manufacturer), in accordance with the Posey Beds user's manual and the facility's policy and procedures, affecting four of 16 patients (Patients 3, 4, 5, and 6) in the Pediatric Subacute Unit.

This deficient practice resulted in untrained staff not knowing that the Posey bed was a restraint, the weight requirements to place patients in the Posey bed, and the dangers associated with the use of the bed (Posey) and had the potential to result in injury, such entrapment (an event in which a patient is caught, trapped or entangled in a confined space), strangulation or death for Patient 3, 4, 5, and 6 in the Pediatric Subacute Unit. (Refer to A - 0194)

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

Based on observation, interview, and record review, the facility failed to provide a safe environment for six of the thirty (30) sampled patients (Patients 1, 2, 3, 4, 5, and 6), as evidenced by:

1. When Patient 1, a pediatric patient (with an age less than 15 years old and/or weight of less than 36 kilos (unit of measurement (79.2 pounds), was found unresponsive on 1/31/2024 by LVN 1, the facility failed to:

1.a. Ensure there was no delay in calling a code White (initiated when emergency assistance is needed to care for an infant or child requiring resuscitation) in accordance with the facility's policy and procedure (P&P).

1.b. Ensure that the correct crash cart (a set of trays/drawers on wheels used in the hospitals for transportation and dispensing of emergency medication/equipment at site for life support protocols), containing pediatric life-saving medications and supplies, were brought into Patient 1's room instead of the adult crash cart (which did not contain the pediatric medication and supplies) and the staff in Pediatric Subacute Unit has knowledge of the location of the emergency supplies.

1.c. Ensure Patient 1's pulse oximetry (device to measure the oxygen level of the blood) alarm was functioning on 1/31/2023, when the alarm did not go off and to ensure that all other pulse oximetry alarms in the unit do not have the same issue of not alarming when there is no reading of the patient's oxygen saturation in accordance with the facility's P&P.

These deficient practices resulted in Patient 1 to not be monitored and a delay in providing life-saving measures to Patient 1 may have resulted in the patient's death.

2. When the nursing services failed to ensure the user's manual instructions for the use of an enclosed bed (Posey Bed 8070) were followed for Patients 1, 3, 4, 5, and 6. Patients 1, 3, 4, 5, and 6 (all the patients weighed less than 46 pounds [a unit of measurement]) were placed in Posey Beds 8070 (an enclosed hospital beds with a canopy and a mattress, considered a restraint [a device that limits a person's movement] by the manufacturer). The Posey Bed 8070's user's manual indicated the bed should not be used for patients who weigh less than 46 pounds or are shorter than 46 inches due to risk of serious injury or death. The manual also indicated that the head of the bed should not be raised due to risk of entrapment.

This deficient practice resulted in Patient 1, who weighed 26 pounds (under 46 pounds), was found in the enclosure bed (Posey Bed) unresponsive with the tracheostomy tube (trach tube - inserted by creating an opening into the trachea from outside the neck to help an individual breath) and gastrostomy tube (a G-tube inserted through the belly that brings nutrition directly to the stomach) dislodged. Patient 1 never regained consciousness and was declared dead.
In addition, there was a potential for risk of death and entrapment (an event in which a person is caught, trapped or entangled in a confined space) for Patients 3, 4, 5, and 6 (all weighed under 46 pounds) who were placed in the Posey Bed 8070 with the head of the bed elevated for G-tube feeding.

3. When Patient 2, who was unable to verbalize needs and unable to move extremities, was laid on top of a humidifier tubing for an unknown length of time.

This deficient practice resulted in Patient 2 suffered from burn injury on the back and right forearm caused by a heated ventilator tubing. In addition, this deficient practice has the potential for other patients in the units that are unable to verbalize their needs and unable to move their extremities to suffer from burns caused by the heated ventilator tubing.

On 2/21/2024 at 4:20 p.m., the survey team called an immediate jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Assistance Chief Nursing and the Director of Pediatric Subacute Unit. The facility failed to establish a safe process to monitor two patients; Patient 1 and Patient 2, and provide an emergency response for Patient 1, a pediatric patient who was found on 1/31/2024, unresponsive with a trach (a tube that is connected to an opening into the windpipe from outside the neck to help air and oxygen reach the lungs) out of placed. During an interview on 2/21/24 at 9:30 a.m., with charge nurse (CN)1, CN 1 stated the wrong crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) was brought to Patient 1's room. The adult crash cart (which did not contain the correct pediatric life-saving meds and supplies) was brought into the patient 1's room instead of the pediatric crash cart. The backboard (a board use to insert under the torso of a patient that is to receive cardiopulmonary resuscitation in order to provide a firm surface during chest compression), was brought in without the crash cart. CN 1 stated, she was not able to locate the Broselow tape (a tool for determining the correct dosage of medications and equipment sizes such as suction catheters). During an interview with License Vocational Nurse (LVN) 1 on 2/21/2024 at 10:51 a.m., LVN 1 stated that on 1/31/2024, the pulse oximetry (device to measure the oxygen level of the blood) alarm did not go off when Patient 1 was found unresponsive. During an interview on 2/22/24 at 3:30 p.m. with the Senior Biomedical (SBM), the SBM stated the facility did not check all other pulse oximetry machines on the unit to ensure the alarm was working. Patient 2 who was unable to verbalize needs and unable to move extremities sustained a burn injury to the upper back and right forearm from lying on a ventilator humidifier tube for unknown period of time, and the facility did not identify the degree of burn injury. During an interview on 2/20/24 at 10:38 a.m., with CN 2, CN 2 stated staff were expected to do hourly rounding but there was no system or documentation in place to track if staff adhere to this practice.

On 2/23/2024 at 7:10 p.m., the IJ was removed in the presence of the Chief Nursing Officer, Chief Operating Officer, Assistance Chief Nursing, and the Director of Pediatric Subacute after the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practice). The elements of the IJ Removal Plan were verified and confirmed through observations, interviews, and record review. The IJ Removal Plan indicated that pediatric subacute staff must attend at least one (1) in-person training on code white response roles and responsibilities and a review of crash cart supplies within the drawer, including the location of Broselow tape and the Ez-IO device (a device can be used when vascular access is difficult to obtain in emergent, urgent or medically necessary cases). Label Crash Cart to locate Broselow Tape. Hourly and frequent checks by nursing and clinical staff are to be completed per shift for every pediatric subacute patient contact or interaction, or as needed, to verify device connections, including tubing, are in place and secured. Pediatric subacute patients on a ventilator have tubing clipped to a skyhook. There is visualization of tubing from the device for each patient. Medical devices and equipment at the bedside are properly functioning, patient positioning is correct, and device settings are accurate per the doctor's orders. Implement safety device equipment check logs per patient every shift, every patient in the Pediatric Subacute Unit contact/interaction, or as needed. The Biomedical staff have checked all pulse oximeters in the Pediatric Subacute Unit and ensured these are functional and safe to use on the units on 2/21/2024. In the Pediatric Subacute Unit, signage is posted outside the room and above the patient's bed who meets the criteria for adult crash cart use.

Findings:

1.a. During a review of Patient 1's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)" dated 2/27/2023, the "H&P" indicated Patient 1's past medical history included twenty-six (26)-week preemies (an infant that is born prior to 37 weeks); ASD (Autism spectrum disorder, which is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave); PDA ligation (Patent ductus arteriosus surgery is done to close a blood vessel called the heart that is normally close after birth, in PDA, it stays open); tracheostomy (procedure to help air and oxygen reach the lungs by creating an opening into the windpipe), and GJ tube (a gastrojejunal tube, a soft feeding catheter, is placed through an existing hole in the stomach into the small bowel) dependence. The H&P indicated under the physical examination, "General: Awake, alert, and smiling," and "Musculoskeletal: Normal range of motion (the range of movement around a joint that is considered normal)." The H&P indicated the plan for respiratory care, "Patient continues to be tracheostomy tube dependent..."

A review of Patient 1's "Nursing Note" dated 1/31/24, documented by LVN 3, indicated, "I heard Charge Nurse (CN 1) call for a code white. I went into the room and turned on the patient's headlight. When I turned on the light, I saw the patient was unresponsive. CN 1 verbalized that the patient was decannulated (a removal of the tube called a trach that is connected to an opening into the windpipe from outside the neck to help air and oxygen reach the lungs) while she was trying to reinsert the patient's (Patient 1) trach."

During a review of Patient 1's "Code Blue Record (recording of the emergency response and describing treatments and the critical status of a patient)" dated 1/31/2024, the "Code Blue Record" indicated that Patient 1's time of arrest (the abrupt loss of heart function) was at 11:53 p.m. The record also indicated "three epis (epinephrine was given, a medication that is the principal blood pressure-raising medication), asystole (when the heart's electrical system fails entirely, which causes the heart to stop pumping.) throughout, time of death 12:14 a.m. on 2/1/2024."

During a review of Patient 1's "ED Note (Emergency Department Provider Note is a critical document summarizing a patient's emergency clinical status and treatment) dated 2/1/2024 at 12:35 a.m., the "ED Note" indicated, "3 year old male called as code white in subacute. Per RT (respiratory therapist), he (Patient 1) was found unresponsive, pulseless (nonpalpable beat as the heart is not pumping blood to the body), with trach (tube in the windpipe that provides an alternative airway for breathing) fallen out at 2350 (11:50 p.m.). Unknown downtime... On my arrival, CPR (Cardiopulmonary Resuscitation - is an emergency lifesaving procedure performed when the heart stops beating) already in progress with patient pale, unresponsive, pulseless, apneic (involuntarily and temporarily stops breathing). On pulse check, he remained pulseless and in asystole on monitor...He (Patient 1) was given Epi (epinephrine, a medication that is the principal blood pressure-raising medication) x (three) 3, but remained pulseless and in asystole (heart's electrical system fails entirely, which causes the heart to stop pumping) Time of death at 0015 (12:15 a.m.)."

During an interview on 2/21/24 at 9:30 a.m., with charge nurse (CN) 1, CN 1 stated on 1/31/2024 the primary nurse (LVN 1) came up to her at the nurse station saying, "can you check on my patient (Patient 1), something is wrong." CN 1 stated she went to Patient 1's room and unzipped the enclosure bed (Posey Bed 8070). CN 1 stated Patient 1 was in middle of the Posey bed, unresponsive. CN 1 stated, "He (Patient 1) never regain consciousness, and died."

During an interview on 2/20/2024 at 2:20 p.m. with the Director of Pediatric Subacute Unit (DIR), the DIR confirmed that the LVN 1 (first responder) did not call a code or start CPR. The charge nurse came in the room and requested another nurse to call a code. DIR also stated that it is expected that the person who finds the patient unresponsive should immediately call a code.

During an interview on 2/20/24 at 3:20 p.m. with the Director of Pediatric Subacute (DIR), the DIR stated, "There is a phone in each patient's room to call a code, but a code was not called from the patient's room."

During a review of the facility's policy and procedure (P&P) titled, "Code Blue and Code White," dated 7/5/2022, the P&P indicated the following:

All employees will adhere to the following standards for cardiopulmonary arrests in accordance to the standards established by American Heart Association (AHA), Advanced Cardiac Life Support (ACLS), Pediatric Advanced Life Support (PALS) or Neonatal Resuscitation Program (NRP). Code Blue/White procedures will be initiated when a witnessed or unwitnessed respiratory and/or cardiac arrest occurs within a patient care area ...

1. Call extension 5555, and inform the operator to overhead page Code Blue and specify the location ...
2. Basic Life Support will be initiated by Basic Life Support (BLS) trained employees until the Code Blue Team arrives.
3. Unit staff will bring the unit's crash cart into the patient's care area.
4. The video laryngoscope will be brought to the location by the nursing supervisor their delegate, or the ED Physician. (See Video Laryngoscope Policy)
5. Code Blue Team consists of an Emergency Department (ED) physician, an ED Registered Nurse, an ACLS certified Intensive Care Unit (ICU)
Code White (resuscitation of a neonate/pediatric patient):
1. Call extension 5555, and inform the operator to overhead page Code White and specify the location.
a. Specify type - neonatal (i.e. postpartum, nursery L&D, lobby) or Code White Pediatric Subacute.

1.b. During a review of Patient 1's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)" dated 2/27/2023, the "H&P" indicated Patient 1's past medical history included twenty-six (26)-week preemies (an infant that is born prior to 37 weeks); ASD (Autism spectrum disorder, which is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave); PDA ligation (Patent ductus arteriosus surgery is done to close a blood vessel called the heart that is normally close after birth, in PDA, it stays open); tracheostomy (procedure to help air and oxygen reach the lungs by creating an opening into the windpipe), and GJ tube (a gastrojejunal tube, a soft feeding catheter, is placed through an existing hole in the stomach into the small bowel) dependence.

The H&P indicated under the physical examination, "General: Awake, alert, and smiling," and "Musculoskeletal: Normal range of motion (the range of movement around a joint that is considered normal)." The H&P indicated the plan for respiratory care, "Patient continues to be tracheostomy tube dependent..."

During an interview on 2/21/24 at 9:30 a.m. with the charge nurse (CN) 1, CN 1 stated she requested for the backboard (a board use to insert under the torso of a patient that is to receive cardiopulmonary resuscitation in order to provide a firm surface during chest compression), but the backboard was brought in without the crash cart (a cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel during efforts to resuscitate a patient experiencing cardiac arrest). The adult crash cart, which did not contain the correct pediatric life-saving meds and supplies, was brought into the patient's room instead of the pediatric crash cart at 11:53 p.m., on 1/31/24, when the code team arrived. The pediatric crash cart was stationed beside the adult crash when not in use. When CN 1 realized it was the adult crash cart brought in, the CN 1 requested for the pediatric crash cart. In addition, CN 1 stated she was not able to retrieve the Broselow tape (a tool for determining the correct dosage of medications and equipment sizes such as suction catheters) from the crash cart as she did not know where it was kept. Thus, Pharmacy handed the Broselow tape to CN 1. When the code team asked about the IO's (Intraosseous, access refers to the placement of a specialized hollow needle through the bone to administered emergency medications) supplies, CN1 assumed the IO's supplies should be by the IVs' supplies, but it was not there.

During an interview on 2/21/2024 at 10:51 a.m., with LVN 1, LVN 1 stated on 1/31/2024, the day that Patient 1 was found unresponsive, when code white (initiated when emergency assistance is needed to care for an infant or child requiring resuscitation) was called for Patient 1, the staff were not able to locate the Broselow tape, and LVN 1 confirmed that staff was also looking for other emergency supplies. In the same interview, LVN 1 stated she had worked in the facility as an LVN for two years, and she did not received a mock code (practice runs where teams are activated and members go through a simulated cardiac arrest under the supervision of instructors) training in the facility, thus she is not familiar with the contents inside the crash cart on the unit.

During an interview on 2/22/2024 at 4:29 p.m. with the DIR and the Assistance Chief Nursing Officer (ACNO), the DIR stated, hand on code white training had started on 2/9/2024 for all staff in the (pediatric subacute) unit. Mock code includes going over roles and responsibilities during a code and review of crash cart supplies within the drawer including location of Broselow tape and IO device.

During an interview on 2/23/2024 at 5:55 p.m. with the ACNO, the ACNO stated that staff will determine whether to bring the adult crash cart or the pediatric crash cart to the bedside or the location of the emergency by the overhead announcement of the code. ACNO stated, "For example, code white indicates pediatric emergency resuscitation, and code blue means adult emergency resuscitation. The staff differentiates between adult and pediatric crash carts based on the color of the crash cart."

During a review of the facility's policy and procedure (P&P) titled, "Code Blue and Code White," dated 7/5/2022, the P&P indicated, "All employees will adhere to the following standards for cardiopulmonary arrests in accordance with the standards established by American Heart Association (AHA), Advanced Cardiac Life Support (ACLS), Pediatric Advanced Life Support (PALS) or Neonatal Resuscitation Program (NRP). Code Blue/White procedures will be initiated when a witnessed or unwitnessed respiratory and/or cardiac arrest occurs within a patient care area ...Call extension 5555 and inform the operator to overhead page Code Blue and specify the location ...Basic Life Support will be initiated by Basic Life Support (BLS) trained employees until the Code Blue Team arrives. Unit staff will bring the unit's crash cart into the patient's care area."

1.c. During a review of Patient 1's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)" dated 2/27/2023, the "H&P" indicated Patient 1's past medical history included twenty-six (26)-week preemies (an infant that is born prior to 37 weeks); ASD (Autism spectrum disorder, which is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave); PDA ligation (Patent ductus arteriosus surgery is done to close a blood vessel called the heart that is normally close after birth, in PDA, it stays open); tracheostomy (procedure to help air and oxygen reach the lungs by creating an opening into the windpipe), and GJ tube (a gastrojejunal tube, a soft feeding catheter, is placed through an existing hole in the stomach into the small bowel) dependence. The H&P indicated under the physical examination, "General: Awake, alert, and smiling," and "Musculoskeletal: Normal range of motion (the range of movement around a joint that is considered normal)." The H&P indicated the plan for respiratory care, "Patient continues to be tracheostomy tube dependent..."

During an interview with License Vocational Nurse (LVN) 1 on 2/21/2024 at 10:51 a.m., LVN 1 stated that on 1/31/2024, when she was giving medication to a patient in the same room as Patient 1, she noticed Patient 1 was lying face down in the enclosure bed (Posey Bed 8070), and his pulse oximetry machine (a device used to measure the oxygen level in the blood) was not reading and was showing a flat line. LVN 1 stated, "The pulse oximetry machine should make an alarm sound, but it did not; she did not hear an alarm."

During an interview on 2/21/24 at 9:30. am. with charge nurse (CN) 1, CN 1 stated on 1/31/2024 the primary nurse (LVN 1) came up to her at the nurse station saying, "can you check on my patient (Patient 1), something is wrong." CN 1 stated she went to Patient 1's room, unzipped enclosure bed (Posey Bed 8070) and found Patient 1 unresponsive. CN 1 stated, "He (Patient 1) never regain consciousness, and died."

During an interview on 2/20/24, at 3:15 p.m., the Director of the Pediatric Subacute Unit (DIR), the DIR stated, "We do not know why the alarm for the pulse oximeter machine did not set off." The biomedical staff (personnel responsible for maintaining, installing, testing, calibrating, and repairing biomedical equipment; training users; and maintaining safe operations), checked the pulse oximetry machine that was used for Patient 1, but the DIR confirmed that the biomedical staff did not check the other pulse oximeter machines for other patients on the unit to ensure the pulse oximeters were properly working for all patients using them.

During an interview on 2/22/24 at 3:30 p.m. with the Biomedical Senior (SBM), the SBM stated that he was called on 2/1/2024 to check the pulse oximetry machine that was used for Patient 1 on 1/31/2023. After checking the pulse oximetry machine that was used for Patient 1, he walked around and noticed some machines were working by hearing alarms, but stated, "I did not go around and test all the machines on the unit." The SBM further stated they are utilizing a machine that is a tester to check the function of the alarm annually. Starting today (2/22/2024), they will use the tester machine to check the pulse oximetry alarm in the pediatric subacute unit daily.

During a review of the facility's policy and procedure (P&P) titled, "Clinical Alarm System Management," dated 10/3/2023, the P&P indicated, "The objective: To describe a policy that promotes the monitoring of patients through the use of and response to clinical alarms. For purposes of this policy, the facility's hospital staff shall include hospital employees and independent contractors of the hospital. Medical staff shall include the active and courtesy members of the hospital's medical staff. To implement realistic strategies to address "Alarm Fatigue" and vulnerabilities. Periodically review an inventory of alarm equipped medical devices used in high-risk areas and for high-risk clinical conditions and identify the default settings and the limits.

1. The Bio-Medical Department shall be responsible for performing regular preventative maintenance testing on all alarms on patient physiological monitoring and patient care equipment.
a. Alarms include: all patient physiologic monitoring and patient care equipment alarms (i.e., cardiac monitor alarms, apnea alarms, cell¿salvaging devices, elopement alarms, infusion pump alarms, ventilator alarms, pulse oximeters and emergency assistance alarms.
2. The Bio-Medical Department in conjunction with Unit
Directors/Managers/Supervisors shall ensure that all alarms are set to activate at appropriate settings for each patient and are sufficiently audible with respect to distances and competing noise within the unit.
3. The above general provision shall apply regardless of whether facility owns, borrows, rents or leases the equipment for long term or short-term use ...
4. All facility staff and members of the Medical Staff who use medical equipment shall check alarm settings prior to device use to ensure they are appropriate and that audible alarms will be clearly discernable relative to ambient and competing noise."

2. During a concurrent observation and interview on 2/20/2024 at 10:45 a.m., with the DIR and charge nurse (CN) 2 the following were observed:
- In, Patient room 160 there were Posey bed in bed 2 and Posey bed in bed 4; and,
- In Patient room 164 there were Posey bed in bed 3 and Posey bed in bed 4.
All the Posey bed observed did not have an instruction manual in the pouch that is attached to the bed. The label on the bed pouch indicated, "To avoid injury or death, read and follow User and Assembly Manual instructions and store all manuals in the pocket below."
In the same interview, the DIR stated the Posey bed was rented from a company and never came with a manual in the pouch.

2.a. During a review of Patient 1's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)" dated 2/27/2023, the "H&P" indicated Patient 1's past medical history included twenty-six (26)-week preemies (an infant that is born prior to 37 weeks); ASD (Autism spectrum disorder, which is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave); PDA ligation (Patent ductus arteriosus surgery is done to close a blood vessel called the heart that is normally close after birth, in PDA, it stays open); tracheostomy (procedure to help air and oxygen reach the lungs by creating an opening into the windpipe), and GJ tube (a gastrojejunal tube, a soft feeding catheter, is placed through an existing hole in the stomach into the small bowel) dependence. The H&P indicated under the physical examination, "General: Awake, alert, and smiling," and "Musculoskeletal: Normal range of motion (the range of movement around a joint that is considered normal)." The H&P indicated the plan for respiratory care, "Patient continues to be tracheostomy tube dependent..."

During a concurrent interview and record review with License Vocational Nurse (LVN) 2, Patient 1's "Order Summary Report," was reviewed. The order summary indicated on 6/12/2023 "Routine, Patient (Patient 1) may use Posey bed enclosure." In addition, the order summary indicated on the top of the page, "Active Orders As Of: 2/1/2024." LVN 2 stated the order was placed on 6/12/2023 and the order was active as of 2/1/2024.

During a review of Patient 1's code blue sheet titled "Code Blue Record," dated 1/31/2024 at 11:53 p.m., Patient 1's code blue record indicated Patient 1's weight was 12 kilogram (26.4 pounds).

During a review of Patient 1's "Emergency Note (ED, Provider Note is a critical document summarizing a patient's emergency encountered, including medical history, course of treatment, and follow-up plans)" dated 2/1/2024, the note indicated, "3-year-old male called as code white (initiated when emergency assistance is needed to care for an infant or child requiring resuscitation) in subacute. Per RT (respiratory therapist), he was found unresponsive and pulseless (non-palpable beat due to heart stop pumping blood to the body), with the trach falling out at 2350. Unknown downtime ...On the pulse check, he remained pulseless, and in asystole (heart's electrical system fails entirely, which causes the heart to stop pumping) ...Time of death: 0015."

During an interview on 2/21/24 at 9:30, a.m., with charge nurse (CN) 1, CN 1 stated on 1/31/2024 the primary nurse (LVN 1) came up to her at the nurse station and told her, "can you check on my patient (Patient 1), something is wrong." CN 1 stated she went to Patient 1's room, unzipped the enclosure bed (Posey Bed 8070) and found Patient 1 in middle of the Posey bed unresponsive.

During an interview on 2/20/24 at 10:40 a.m., with the DIR, the DIR stated, "Patients who are active or patients who grew out of the crib and are between the crib and the adult beds, will be placed in the Posey bed."

During an interview on 2/20/24 at 3:30 PM with the DIR, the DIR stated, "I don't know that there is a weight indication for the Posey bed." The DIR also stated that she did not know that the Posey Bed was considered a restraint

2.b. During an observation on 2/20/24 at 10:30 a.m., with the Director of Pediatric Subacute (DIR) in the Pediatric Subacute Unit Patients 3, 4, 5, and 6 were observed placed in Posey beds. Patients 3, 4, 5, and 6 were observed to have tube feeding infusions via G-tube.

During an interview on 2/20/24 at 10:40 a.m., with the DIR, the DIR stated, "Patients who are active or patients who grew out of the crib and are between the crib and the adult beds, will be placed in the Posey bed."

During a concurrent interview and record review on 2/21/2024 at 9:45 a.m., with the DIR, the document titled "Posey Bed," undated, was reviewed. The document indicated the following weights:
-For Patient 3, the recorded weight was 38.36 pounds;
-For Patient 4, the recorded weight was 35.3 pounds;
-For Patient 5, the recorded weight was 38.13 pounds; and,
-For Patient 6, the recorded weight was 29.9 pounds.
The DIR confirmed that Patients 3, 4, 5, and 6's weight were under the recommended weight (more than 46 pounds and less than 300 pounds) instructed on the Posey Bed 8070's user manuals. The DIR stated she was not aware of the weight limits in using the Posey Bed 8070.

During an interview on 2/22/2024 at 4:30 p.m., with the Assistant Chief Nursing Officer (ACNO), the ACNO stated she did not know that the Posey beds in the Subacute Unit were considered restraints by the manufacturer.

During an interview on 2/22/2024 at 4:57 p.m., with the Director of the Pediatric Subacute Unit (DIR), the DIR stated that the Posey beds in the Pediatric Subacute Unit did not come with an instruction manual. The DIR stated that the BioMed Department (department that install, maintain, or provide technical support for medical equipment) should check the equipment (Posey bed) to ensure the instruction manuals came with the bed. In the same interview, The DIR stated the contracted service, who provides the Posey beds, exchanges the beds every year. The DIR stated the Posey bed had been in used at the Pediatric Subacute Unit for approximately 10 years now. The DIR stated an in-service for the Posey bed was provided around 5 to 10 years ago, and no in-service was done recently. Furthermore, the DIR verified that the facility's new staff, who work in the Pediatric Subacute Unit, did not receive an in-service for the use of the Posey bed. The DIR stated she was not aware that the Posey Bed was considered a restraint, and she was not aware of the dangers associated with the use of the Posey bed.

During an interview on 2/22/2024 at 3:30 p.m. with the Staff for the BioMed Department (SBM), the SBM stated the BioMed Department (department that install, maintain, or provide technical support for medical equipment) checked the medical equipment in the hospital to ensure the equipment was functioning properly and safe for use. In addition, the SBM stated the Posey beds were being exchanged every year by the contracted service. The SBM stated the Posey beds did not come with a user manual, the user manual was not provided by the contracted service. The SBM stated the contracted service usually provides an in-service the first-time equipment was used in the facility to ensure the staff know how to use the equipment.

During an interview on 2/22/2024 at 3:58 p.m., with the Clinical Manager for the Subacute Unit (MSAU), stated she had worked in the Pediatric Subacute Unit for over 15 years and does not remember the last time there was an in-service for the use of the Posey bed. The MSAU stated she did not have any training on the use of the Posey bed and was not aware that the Posey bed was considered a restraint as indicated in by the manufacturer.
In addition, the MSAU verified, after reviewing the Posey Bed 8070 user manuals, that the bed was considered a restraint, and the bed should not be used for patients who weighed less than 46 pounds due to risk for entrapment, choking, and death. The MSAU stated Patients 1, 3, 4, 5, and 6's weight did not meet the criteria for the use of the Posey Beds.

During a review of the Posey Bed user manual titled, "Posey Bed 8070," dated 2017, the user manual indicated the following:
- This User's manual is intended as a guide for those using the Posey Bed 8070 (Bed) in the care of patients, and who have successfully completed training.
- Proper training in the use of the Posey Bed 8070 is important and is provided by your authori

Based on observation, interview, and record review, the facility failed to ensure the user manual instructions for the use of an enclosure bed (Posey Bed 8070, a restraint, tent-like enclosure hospital bed in which someone on the outside of the bed must unzip one of the tent flaps before the individual can get out of the bed) was followed for five of 30 sampled patients (Patients 1, 3, 4, 5, and 6) when the patients were placed in Posey bed 8070.

This deficient practice resulted in an inappropriate, unnecessary, and prolonged use of restraints (any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely) which may have resulted in Patient 1's death. In addition, this deficient practice had the potential for risk of death and entrapment for Patients 3, 4, 5, and 6.

On 2/21/2024 at 4:22 p.m., the survey team called a 2nd Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Assistance Chief Nursing and the Director Pediatric Subacute Unit. The facility failed to follow the user manual instructions for the use of an enclosure bed, the "Posey Bed 8070 (an enclosed hospital beds with a canopy and a mattress, considered a restraint [a device that limits a person's movement] by the manufacturer) to place pediatric patients (Patient 1, Patient 3, Patient 4, Patient 5, and Patient 6) and did not follow state and federal regulations for restraint safety. During an interview with LVN 1 on 2/21/2024 at 10:51 a.m., LVN1 stated that on 1/31/2024 she noticed Patient 1 was lying face down in the enclosure bed (Posey Bed 8070), and his pulse oximetry machine (a device to measure the oxygen level of the blood) was not reading and showing a line. The patient's tracheostomy tube (trach tube - inserted by creating an opening into the trachea from outside the neck to help an individual breath) was out of place, and his gastrostomy tube (a G-tube inserted through the belly that brings nutrition directly to the stomach) was not attached to the abdominal (stomach). During a review of Patient 1's "Emergency Note (ED, Provider Note is a critical document summarizing a patient's emergency encountered)" dated 2/1/2024, the note indicated, "A 3-year-old male called a code white (initiated when emergency assistance is needed to care for an infant or child requiring resuscitation) in subacute. Per RT (respiratory therapist), he was found unresponsive and pulseless (non-palpable beat due to heart stop pumping blood to the body), with the trach falling out at 2350. Unknown downtime ... he remained pulseless and in asystole (flatline, when there is no electrical activity in the heart) ...Time of death: 0015." During a concurrent interview and observation on 2/20/23 at 10:40 a.m., observed Patients 3, Patient 4, Patient 5, and Patient 6, were placed in an enclosure bed (Posey 8070 bed). The Director of Pediatric Subacute (DIR) stated, "Patients who are active or patients who grew out of the crib and are between the crib and the adult beds will be placed in the Posey bed." During observation on 2/21/2024 at 9:00 a.m., four patients were observed in the Posey bed, which was in a room where staff did not have direct visual contact with the patients. During a concurrent interview and record review on 2/21/2024 at 9:45 a.m., with the DIR, the Posey bed 8070's user manual (provided by the facility biomed manager) was reviewed. The Posey Bed 8070's user manual indicated, "Because the bed is a restraint, its use must be prescribed by a licensed doctor (pg.4). Contraindications, when bed should not be used: for patients who weigh less than 46 pounds or are shorter than 46 inches. These patients are at risk of serious injury or death, and the Posey Bed has not been tested for use by such patients" (pg.6). The manual also indicated that the head of the bed should not be raised due to risk of entrapment (pg.9). A record review on 2/20/24 of 4 sampled patients who were in Posey beds indicated the following: Patient 1 weighs 26 pounds (a unit of measuring mass), less than 46 pounds. Patient 3 weighs 38.38 pounds, less than 46 pounds. Patient 4 weighs 35.3 pounds, less than 46 pounds. Patient 5 weighs 38.13 pounds, less than 46 pounds. Patient 6 weighs 29.90 pounds, less than 46 pounds. During an interview on 2/20/24 at 3:30 PM with the DIR, the DIR stated, "I don't know that there is a weight indication for the Posey bed." The DIR also stated that she did not know that the Posey Bed was considered a restraint.

On 2/23/2024 at 7:10 p.m., the 2nd IJ was removed in the presence of the Chief Nursing Officer, Chief Operating Officer, Assistance Chief Nursing, and the Director Pediatric Subacute after the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practice). The elements of the IJ Removal Plan were verified and confirmed through observations, interviews, and record review. The IJ Removal Plan indicated Posey beds have been removed from the Pediatric Subacute Unit as of 2/23/2024. RN Charge Nurse or designee will ensure compliance with restraint policy at all times. The facility will address the proper monitoring of Pediatric Subacute patients with restraints or restrictive devices per policy and procedures by conducting a retraining or in-service on restraints and devices. This training will be provided as a mandatory training to Pediatric Subacute clinical staff (registered nurse, license vocational nurse, and certified nursing assistant) on direct patient care areas. In addition, with the existing performance improvement plan regarding restraints, a new measure will be added to expand and ensure compliance to policy and safe practice. Monitoring of compliance will be performed and reported as part of the performance improvement plan of action. Pediatric Subacute nursing staff completes hourly rounding log. Pediatric Subacute clinical manager or designee will conduct random chart audits to ensure compliance to practice. Pediatric Subacute patients with feeding tubes will be frequently assessed: pre-feeding, during and post-feeding or until feeding is completed. For cribs, where the head of the bed cannot be elevated or adjusted, patients are transferred out of the crib and moved to a chair with safety harness in place. Visual supervision of patient during feeds is maintained at all times. care for patients being fed while in a crib. In addition, the facility will reinforce proper patient positioning of the bed while being fed, orally or with feeding tubes.

Findings:

1. During a review of Patient 1's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)" dated 2/27/2023, the "H&P" indicated Patient 1's past medical history included twenty-six (26)-week preemies (an infant that is born prior to 37 weeks); ASD (Autism spectrum disorder, which is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave); PDA ligation (Patent ductus arteriosus surgery is done to close a blood vessel called the heart that is normally close after birth, in PDA, it stays open); tracheostomy (procedure to help air and oxygen reach the lungs by creating an opening into the windpipe), and GJ tube (a gastrojejunal tube, a soft feeding catheter, is placed through an existing hole in the stomach into the small bowel) dependence.
The H&P indicated under the physical examination, "General: Awake, alert, and smiling," and "Musculoskeletal: Normal range of motion (the range of movement around a joint that is considered normal)." The H&P indicated the plan for respiratory care, "Patient continues to be tracheostomy tube dependent..."

During a concurrent interview and record review with License Vocational Nurse (LVN) 2, Patient 1's "Order Summary Report," was reviewed. The order summary indicated on 6/12/2023 "Routine, Patient (Patient 1) may use Posey bed enclosure." In addition, the order summary indicated on the top of the page, "Active Orders As Of: 2/1/2024." LVN 2 stated the order was placed on 6/12/2023 and the order was active as of 2/1/2024. LVN 2 confirmed it has been over 24 hours since the order for the Posey bed was renewed.

During a review of Patient 1's "Emergency Note (ED, Provider Note is a critical document summarizing a patient's emergency encountered, including medical history, course of treatment, and follow-up plans)" dated 2/1/2024, the note indicated, "3-year-old male called as code white (initiated when emergency assistance is needed to care for an infant or child requiring resuscitation) in subacute. Per RT (respiratory therapist), he was found unresponsive and pulseless (non-palpable beat due to heart stop pumping blood to the body), with the trach falling out at 2350. Unknown downtime ...On the pulse check, he remained pulseless, and in asystole (heart's electrical system fails entirely, which causes the heart to stop pumping) ...Time of death: 0015."

During a record review of Patient 1's code blue sheet titled "Code Blue Record," dated 1/31/2024 at 11:53 p.m., Patient 1's code blue record indicated Patient 1's weighs 12 kilogram (26.4 pounds), less 46 pounds.

During an interview on 2/21/24 at 9:30, a.m., with charge nurse (CN) 1, CN 1 stated on 1/31/2024 the primary nurse (LVN 1) came up to her at the nurse station and told her, "can you check on my patient (Patient 1), something is wrong." CN 1 stated she went to Patient 1's room, unzipped the enclosure bed (Posey Bed 8070) and found Patient 1 in middle of the Posey bed unresponsive.

2. During an observation on 2/20/24 at 10:30 a.m., with the Director of Pediatric Subacute (DIR) in the Pediatric Subacute Unit Patients 3, 4, 5, and 6 were observed placed in Posey beds.

During an interview on 2/20/24 at 10:40 a.m., with the DIR, the DIR stated, "Patients who are active or patients who grew out of the crib and are between the crib and the adult beds, will be placed in the Posey bed."
2.a. During a concurrent observation and interview on 2/20/2024 at 11:00 a.m., with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2. Patient 3 was observed inside the Posey Bed 8070. CN 2 stated Patient 3 is put in the Posey Bed because "the patient (Patient 3) is active."

During a review of Patient 3's "History and Physical (H&P)," dated 6/5/2023, the "H&P" indicated, Patient 1 was admitted to the facility since 2020. The H&P further indicated Patient 1's problem list included chromosome 15 q23.6 duplication (a duplicate in genetics, causing developmental disorder), chronic lung disease of prematurity (a long-term respiratory problem faced by babies born earlier than 37 weeks). The H&P indicated Patient 1 "had a complex history in the early years of her life ...She has been maintained on the ventilator (a machine used to support or replace the breathing) with a history of pulmonary hypertension (high blood pressure that affects the lungs) and high vent settings (requiring more mechanical aid for breathing) in the past." The H&P's physical examination indicated Patient 1 is "delayed (condition of children whose intellectual function and adaptive behavior are significantly below the expected average for their age) but appears to be aware of her surroundings."

During a concurrent interview and record review on 2/23/2024 at 11:55 a.m. with LVN 2, Patient 3's "Order Summary Report," dated 1/26/2024, was reviewed. The order summary report indicated, "Treatment, May use large bed with bed enclosure," date order was on 10/29/2021. On top of the order summary page indicated, "Active Orders As Of: 2/1/2024." LVN 2 confirmed it has been over 24 hours since the order for the Posey bed was renewed.

2.b. During a concurrent observation and interview on 2/20/2024 at 11:00 a.m. with the DIR and the CN 2. Patient 4 was observed inside the Posey Bed 8070. CN2 stated Patient 4 is put in the Posey Bed because "he is also one of our active patient."
During a review of Patient 4's "History and Physical (H&P)," dated 12/28/2023, the "H&P" indicated Patient 4's medical history included seizure disorder (a sudden, uncontrolled burst of electrical activity in the brain), bronchomalacia (a congenital problem that arises from diminished cartilage support of the smaller airways below the windpipe), and hydrocephalus (a condition in which fluid accumulates in the brain).

During a concurrent interview and record review on 2/23/2024 at 11:55 a.m. with Licensed Vocational Nurse (LVN) 2, Patient 4's "Orders Summary Report," dated 1/26/2024 was reviewed. The order summary indicated, "Routine, Posey bed enclosure for patient safety and in lowest position for safety. Bed Enclosure intact for safety when not in direct contact," date of order, 12/29/2023. "Active Orders As Of: 2/1/2024." LVN 2 confirmed it has been over 24 hours since the order for the Posey bed was renewed.

2.c. During a review of Patient 5's "History and Physical (H&P)," dated /5/2023, the H&P indicated Patient 5's medical history included developmental delay (occurs when the child fails to attain developmental milestones as compared to peers), growth failure (When a child's growth rate falls below what's appropriate for their age), tube dependent (unintended result of long-term enteral feeding), seizures (a sudden, uncontrolled burst of electrical activity in the brain), and requiring BiPAP (Bilevel positive airway pressure is a machine that helps with breathing) during sleep. The H&P further indicated Patient 5 received three bolus feedings (method used to send formula through feeding tube through a syringe) and overnight feeding (type of cyclic feeding in which tube feeds is administered overnight via a feeding pump) for ten hours.

During a concurrent observation and interview on 2/20/2024 at 11:00 a.m. with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2. Patient 5 was observed inside the Posey Bed 8070.

During a concurrent interview and record review on 2/24/2024 at 11:55 a.m. with LVN 2, Patient 5 's "Order Summary Report," dated 1/26/2024, was reviewed. The order summary report indicated, "Routine, Bed with bed enclosure as order. Lock and secure, bed enclosure when not under direct supervision," date order was on 1/27/2023. LVN 2 stated the order was placed on 6/12/2023; the order is continuously active as (LVN 2 pointed to the date at the top of the page) of 2/1/2024." LVN 2 confirmed it has been over 24 hours since the order for the Posey bed was renewed.

2.d. During a review of Patient 6's "History and Physical (H&P)," dated 5/5/2023, the H&P indicated Patient 6's medical history included DiGeorge syndrome (a condition present from birth that can cause a range of lifelong problems, including heart defects and learning difficulties), seizure disorder (a sudden, uncontrolled burst of electrical activity in the brain), gastrostomy tube (a tube inserted through the wall of the abdomen directly into the stomach to allow tube feedings), and tracheostomy tube dependent (reliance on a medical device to aid in breathing through the tube created in the windpipe).

During a concurrent observation and interview on 2/20/2024 at 11:14 a.m., with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2. Patient 6 room was observed to have a Posey Bed 8070. CN 2 stated, "He (Patient 6) is in school. He is very active and possibly get out of bed" CN 2 stated the reason for Patient 6's use of Posey bed 8070 was for the patient's high risk for fall.

During a concurrent interview and record review on 2/24/2024 at 11:55 a.m. with LVN 2, Patient 6 's "Order Summary Report," dated 1/26/2024, was reviewed. The order summary report indicated, "Routine, Bed with bed enclosure Lock and secure when not in direct contact with patient," date order was on 1/27/2023. the order is continuously active as (LVN 2 pointed to the date at the top of the page) of 2/1/2024." LVN 2 confirmed it has been over 24 hours since the order for the Posey bed was renewed.

During an interview on 2/22/2024 at 4:30 p.m., with the Assistant Chief Nursing Officer (ACNO), the ACNO stated she did not know that the Posey beds in the Subacute Unit were considered restraints by the manufacturer.

During a concurrent interview and record review on 2/21/2024 at 9:45 a.m., with the DIR, the Posey bed 8070's user manual (provided by the facility biomed manager) was reviewed. The DIR confirmed the Posey Bed 8070's user manual indicated, "Because the bed is a restraint, its use must be prescribed by a licensed doctor..." The DIR stated she did not know that the Posey Bed was considered a restraint.

During a review of the facility's policy and procedure (P&P) titled, "Restraint/Seclusion, Use of," dated 10/5/2021, the P&P indicated, "The purpose of this document is to define restraint and delineate the appropriate use of restraints for patient safety and protection. This policy reflects systematic process of restraint reduction and care planning prior to using restraints. The hospital believes that patients have the right to be free from restraints, of any form, that are not medically necessary or are used as a means of coercion, discipline, convenience, or retaliation by staff. This is accomplished through limited use of restraints whenever possible and by encouraging alternatives. Seclusion or Timeouts are not used at this hospital ...Application: Restraint devices are applied/removed in accordance with manufacturer's instructions and used in a manner consistent with their intended purpose ..."

Based on observation, interview, and record review, the facility failed to ensure order for restraint were renewed for five of thirty (30) sampled patients (Patient 1, Patient 3, Patient 4, Patient 5, and Patient 6), in accordance with the facility's policy and procedure.

This deficient practice compromises patients' (Patient 1, Patient 3, Patient 4, Patient 5, and Patient 6) comfort and safety and does not ensure that an assessment is completed to evaluate the continued use of restraints, the effectiveness of the restraints, and if alternative interventions is warranted.

Findings:

During a review of Patient 1's "History and Physical (H&P)," dated 2/27/2023, the "H&P" indicated that Patient 1's past medical history includes twenty-six (26)-week preemies (an infant that is born prior to 37 weeks), ASD (Autism spectrum disorder, which is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave), and PDA ligation (Patent ductus arteriosus surgery is done to close a blood vessel called the heart that is normally close after birth, but in PDA, it stays open), tracheostomy (procedure to help air and oxygen reach the lungs by creating an opening into the windpipe), and GJ tube (gastrojejunal tube, a soft feeding catheter, is placed through an existing hole in the stomach into the small bowel) dependence.
Under physical examination, the H&P indicated, "General: Awake, alert, and smiling. Well perfused (a clinical finding in which there is sufficient blood flow to the core and extremities). And under Musculoskeletal: Normal range of motion (the range of movement around a joint that is considered normal). the plan for respiratory, "Patient continues to be tracheostomy tube dependent..."

During an interview on 2/21/24 at 9:30. am. with charge nurse (CN) 1, CN 1 stated on 1/31/2024 the primary nurse (LVN 1) came up to her at the nurse station saying, "can you check on my patient (Patient 1), something is wrong." CN1 stated she went to patient 1's room and unzipped enclosure bed (Posey Bed 8070) and found Patient 1 in middle of the Posey bed unresponsive. CN 1 stated, "The patient's (Patient 1) trach has fallen out. CN 1 also stated Patient 1s' G-tube (gastronomy tube, a tube inserted through the belly that brings nutrition directly to the stomach) was not connected to Patient1's stomach and the facility was not able to find the G-tube. CN 1 stated Patient 1 never regain consciousness and died.

During a concurrent interview and record review with License Vocational Nurse (LVN) 2, Patient 1's "Order Summary Report," dated 1/26/2024, was reviewed. The order summary indicated, "Routine, Patient may use Posey bed enclosure," order date was 6/12/2023. The order summary also indicated on the top of the page, "Active Orders As Of: 2/1/2024." LVN 2 stated the order was placed on 6/12/2023, the order is continuously active as (LVN2 pointed to the date at the top of the page) of 2/1/2024. LVN2 further confirmed that the order was not renew within 24 hours.

During an interview on 2/21/2024 at 9:15 a.m. with the Director of the Pediatric Subacute Unit (DIR), the DIR stated, "Because we did not think it (the Posey Bed 8070) was a restraint, the order for the bed is renewed every 30 days."

During a review of Patient 3's "History and Physical (H&P)," dated 6/5/2023, the "H&P" indicated, Patient 1 is a 5 years old patient of the facility since 2020. The H&P further indicates that Patient 3 problem listed includes chromosome 15 q23.6 duplication (a duplicate in genetics, causing developmental disorder), chronic lung disease of prematurity (a long-term respiratory problem faced by babies born earlier than 37 weeks). The H&P indicates Patient 1 "had a complex history in the early years of her life ...She has been maintained on the ventilator (a machine used to support or replace the breathing) with a history of pulmonary hypertension (high blood pressure that affects the lungs) and high vent settings (requiring more mechanical aid for breathing) in the past." H&P's physical examination indicates Patient 1 is "delayed (condition of children whose intellectual function and adaptive behavior are significantly below the expected average for their age) but appears to be aware of her surroundings."

During a concurrent interview and record review on 2/21/2024 at 9:45 a.m. with the DIR, the Posey bed 8070's user manual (provided by the facility biomed manager) was reviewed. The Posey Bed 8070's user manual indicated, "Because the bed is a restraint, its use must be prescribed by a licensed doctor (pg.4). Improper use of the Posey Bed 8070 may lead to serious injury or death. Patient monitoring should be determined by hospital protocol, a doctor, and the patient care plan. As with any less restrictive restraint system, it is important to understand when the Posey Bed 8070 is needed, when it should not be used, and the dangers related to entrapment, suffocation, choking, and falls. The DIR stated, "We did not know that the bed is a restraint."

During a concurrent observation and interview on 2/20/2024 at 11:00 a.m. with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2. Observed Patient 3 inside the Posey Bed 8070. CN 2 stated Patient 3 is put in the Posey Bed because "the patient (Patient 3) is active."

During a concurrent interview and record review on 2/24/2024 at 11:55 a.m. with LVN 2, Patient 3's "Order Summary Report," dated 1/26/2024, was reviewed. The order summary report indicated, "Treatment, May use large bed with bed enclosure," date order was on 10/29/2021. On top of the order summary page indicated, "Active Orders As Of: 2/1/2024." LVN 2 confirmed it has been over 24 hours since the order for the Posey bed was renew.

During a review of Patient 4's "History and Physical (H&P)," dated 12/28/2023, the "H&P" indicated, Patient 4, "Is a 3 years old with complex medical history including seizure disorder (a sudden, uncontrolled burst of electrical activity in the brain. It can cause changes in behavior and movements), bronchomalacia (a congenital problem that arises from diminished cartilage support of the smaller airways below the windpipe), and hydrocephalus (a condition in which fluid accumulates in the brain).

During a concurrent observation and interview on 2/20/2024 at 11:00 a.m. with the DIR and the CN 2. Observed Patient 4 inside the Posey Bed 8070. CN2 stated Patient 4 is put in the Posey Bed because "he is also one of our active patient."

During a concurrent interview and record review on 2/23/2024 at 11:55 a.m. with Licensed Vocational Nurse (LVN) 2, Patient 4's "Orders Summary Report," dated 1/26/2024 was reviewed. The order summary indicated, "Routine, Posey bed enclosure for patient safety and in lowest position for safety. Bed Enclosure intact for safety when not in direct contact," date of order, 12/29/2023. "Active Orders As Of: 2/1/2024." LVN 2 confirmed it has been over 24 hours since the order for the Posey bed was renew.

During a review of Patient 5's "History and Physical (H&P)," dated /5/2023, the "H&P" indicated, Patient 5 is a 6 years old patient. H&P further indicates Patient 5 medical history includes developmental delay (occurs when the child fails to attain developmental milestones as compared to peers), growth failure (When a child's growth rate falls below what's appropriate for their age), tube dependent (unintended result of long-term enteral feeding), seizures (a sudden, uncontrolled burst of electrical activity in the brain. It can cause changes in behavior and movements), and requiring BiPAP (Bilevel positive airway pressure is a machine that helps with breathing) during sleep ... He has reportedly been tolerating feeds with Pediasure Peptide (a tube feeding formula providing completed nutritional needs) relatively well. He gets three bolus (method used to send formula through feeding tube through a syringe), and overnight feeds (type of cyclic feeding in which tube feeds is administered overnight via a feeding pump) for ten hours.

During a concurrent observation and interview on 2/20/2024 at 11:00 a.m. with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2. Observed Patient 5 inside the Posey Bed 8070.

During a concurrent interview and record review on 2/24/2024 at 11:55 a.m. with LVN 2, Patient 5 's "Order Summary Report," dated 1/26/2024, was reviewed. The order summary report indicated, "Routine, Bed with bed enclosure as order. Lock and secure, bed enclosure when not under direct supervision," date order was on 1/27/2023. LVN 2 stated the order was placed on 6/12/2023; the order is continuously active as (LVN 2 pointed to the date at the top of the page) of 2/1/2024." LVN 2 confirmed it has been over 24 hours since the order for the Posey bed was renew.

During a review of Patient 6's "History and Physical (H&P)," dated 5/5/2023, the "H&P" indicated that Patient 6 is a 3 year old with a medical history that includes DiGeorge syndrome (a condition present from birth that can cause a range of lifelong problems, including heart defects and learning difficulties) and seizure disorder (a sudden, uncontrolled burst of electrical activity in the brain). It can cause changes in behavior and movements), Gastrostomy tube (a tube inserted through the wall of the abdomen directly into the stomach to allow tube feedings), and tracheostomy tube dependent (reliance on a medical device to aid in breathing through the tube created in the windpipe).

During a concurrent observation and interview on 2/20/2024 at 11:14 a.m. with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2. Observed Patient 6's bed is a Posey Bed 8070. CN 2 stated, "He (Patient 6) is in school. He is very active and possibly get out of bed, so he is high risk for fall is reason for the use of bed enclosures."

During a concurrent interview and record review on 2/24/2024 at 11:55 a.m. with LVN 2, Patient 6 's "Order Summary Report," dated 1/26/2024, was reviewed. The order summary report indicated, "Routine, Bed with bed enclosure Lock and secure when not in direct contact with patient," date order was on 1/27/2023. the order is continuously active as (LVN 2 pointed to the date at the top of the page) of 2/1/2024." LVN 2 confirmed it has been over 24 hours since the order for the Posey bed was renew.

During a concurrent interview and record review on 2/21/2024 at 9:45 a.m. with the DIR, the Posey bed 8070's user manual (provided by the facility biomed manager) was reviewed. The Posey Bed 8070's user manual indicated, "Because the bed is a restraint, its use must be prescribed by a licensed doctor. Improper use of the Posey Bed 8070 may lead to serious injury or death. Patient monitoring should be determined by hospital protocol, a doctor, and the patient care plan. As with any less restrictive restraint system, it is important to understand when the Posey Bed 8070 is needed, when it should not be used, and the dangers related to entrapment, suffocation, choking, and falls. The DIR stated, "We did not know that the bed was a restraint. (p. 4)"

During a review of the facility's policy and procedure (P&P) titled, "Restraint/Seclusion, Use of," dated 10/5/2021, the P&P indicated, "The purpose of this document is to define restraint and delineate the appropriate use of restraints for patient safety and protection. This policy reflects systematic process of restraint reduction and care planning prior to using restraints. The hospital believes that patients have the right to be free from restraints, of any form, that are not medically necessary or are used as a means of coercion, discipline, convenience, or retaliation by staff. This is accomplished through limited use of restraints whenever possible and by encouraging alternatives. Seclusion or Timeouts are not used at this hospital ... Ordering/Initiating Restraints - General Requirements & Authority: At a minimum, physicians who order restraints, have a working knowledge of hospital policy regarding use of restraint. Orders for the use of restraints are never written as a standing order. PRN (as needed) orders are NOT permitted ... Non-Violent Restraints: Requirements ...Renewal orders for restraint are obtained daily. Another 1-hour face-to¿face patient evaluation is not required when the original order is renewed. If the original order expires, a physician or LIP must see and assess the patient before issuing a new order."

Based on observation, interview, and record review, the facility failed to ensure seven of seven staff (Licensed Vocational Nurses 1, 2, 3, 4, Respiratory Therapist 1, 2, and Certified Nurse Assistant 1) who worked in the Pediatric Subacute Unit were competent and trained in the proper use of the Posey Beds 8070 (an enclosed hospital beds with a canopy and a mattress, considered a restraint [a device that limits a person's movement] by the manufacturer), in accordance with the Posey Beds user's manual and the facility's policy and procedures, affecting four of 16 patients (Patients 3, 4, 5, and 6) in the Pediatric Subacute Unit.

This deficient practice resulted in untrained staff not knowing that the Posey bed was a restraint, the weight requirements to place patients in the Posey bed, and the dangers associated with the use of the bed (Posey) and had the potential to result in injury, such entrapment (an event in which a patient is caught, trapped or entangled in a confined space), strangulation or death for Patient 3, 4, 5, and 6 in the Pediatric Subacute Unit.

Findings:

During an observation on 2/20/24 at 10:40 a.m., in the Pediatric Subacute Unit Patient 3, Patient 4, Patient 5, and Patient 6, were placed in an enclosure beds (Posey bed 8070). The director (DIR) stated, "Patients who are active or patients who grew out of the crib and are between the crib and the adult beds, will be placed in the Posey beds.

During an interview on 2/22/2024 at 4:57 p.m., with the Director (DIR) of the Subacute Unit, the DIR stated that the Subacute Unit has been using the Posey beds for approximately 10 years and stated that an in-service was provided around 5 to 10 years ago, but not recently. The DIR verified the facility hired new staff after the first in-service around 5 - 10 years ago and stated the staff who work in the Pediatric Subacute Unit did not receive an in-service for the use of the Posey Bed. The DIR stated she (DIR) was not aware that the Posey Bed was considered a restraint or dangers associated with the use of the bed.

During record review on 2/20/2024 of Patients 3, 4, 5, and 6's weight, who were in Posey beds, the review indicated the following:
Patient 3 in room 160-2, weighs 17:40 kg (38.38 pounds) - less than 46 pounds.
Patient 4 in room 160-4, weighs 16.20 kg. (35.3 pounds) - less than 46 pounds
Patient 5 in room 164-3, weighs 17/30 kg. (38.13 pounds) - less than 46 pounds
Patient 6 in room 164-4, weighs 13.60 kg. (29.90 pounds) - less than 46 pounds

During an interview and record review of the user's manual for the Posey Bed 8070 on 2/22/2024 at 3:58 p.m., with the Clinical Manager for the Subacute Unit (MSAU), the MSAU stated that Posey beds have been used in Pediatric Subacute Unit for the past 10 years. The MSAU stated she (MSAU) has worked in the Pediatric Subacute Unit for over 15 years and does not remember the last time there was an in-service for the use of the Posey bed. The MSAU stated she (MSAU) has not had any training on the use of the Posey bed and used the bed for safety reasons and was not aware that the Posey bed was considered a restraint by the manufacturer. The MSAU reviewed the user manual for the Posey Bed and verified the Posey bed was a restraint and patients who were placed in a Posey bed were at risk for entrapment, choking, death, and the bed should not be used for patients who weigh less than 46 pounds. The MSAU stated that none of the patients in the Pediatric Subacute Unit met the weight requirements to be placed in the Posey beds. The MSAU also verified that staff who handled the beds must have in-service training, according to the Posey bed's user manual.

During a concurrent interview and record review of personnel files for staff who worked in the Pediatric Subacute Unit, on 2/23/2024 at 11:38 a.m., with the Director of Human Resources (DHR) and the Human Resources Generalist (HRG), the DHR and HRG stated that Licensed Vocational Nurses (LVNs) 1, 2, 3, 4 worked in the Subacute Unit and none of them had evidence of training for the Posey Bed 8070. In addition, the DHR and HRG stated Respiratory Therapists (RTs) 1 and 2 had no evidence of training for the use Posey Bed 8070. The DHR and HRG also verified that Certified Nurse Assistant (CNA) 1 also worked in the Subacute Unit and did not have evidence of training for the Posey Bed 8070.

During a review of the Posey Bed user manual titled, "Posey Bed 8070," dated 2017, the user manual indicated the following. This User's manual is intended as a guide for those using the Posey Bed 8070 (Bed) in the care of patients, and who have successfully completed training. Proper training in the use of the Posey Bed 8070 is important and is provided by your authorized Posey Bed dealer or Posey Products, LLC sales representative. In addition, to this manual, you should also review: The Assembly Instructions and The In-Service Training Manual ...Entrapment - an event in which a patient is caught, trapped or entangled in a confined space. This can result in serious injury or death from suffocation, compression, or lack of proper blood flow ...The Bed is a hospital bed, canopy and mattress system designed to help provide a safe controlled environment for patients at extreme risk of injury from a fall or an unassisted bed exit. Because the bed is a restraint (devices that limit a person's movement), its use must be prescribed by a licensed doctor. Anyone interacting with the bed must complete the Posey Bed 8070 In-Service Training Program which includes the ability to use this manual. Improper use of the Posey Bed 8070 may lead to serious injury, entrapment, or death ...The bed must be used in accordance with: 1. All state regulations. 2. Federal Center for Medicare & Medicaid Services (CMS, a federal agency dedicated to improving health outcomes) Regulations ...The Posey Bed is not intended for use with: Patients who weighs less than 46 pounds or are shorter than 46 inches - these patients are at risk for serious injury, entrapment, or death, and the Posey Bed has not been tested for use by such patients ...

During a review of the facility's policy and procedure (P&P) titled, "Restraint / Seclusion, Use Of, "dated 8/2021, the P&P indicated the following. Training and Competency of Staff: Staff involved with the application of restraints, providing care for patients in restraints, or with assessing and monitoring the condition of the restrained patient is trained and competent. Staff is trained and able to demonstrate competency in the application of restraints, monitoring, and providing care for patients in restraints prior to doing so. Training of staff occurs at the following times: Upon hire as port of the initial orientation process, before participating in the use of restraint, and annually, thereafter.

Based on observation, interview, and record review, the facility failed to ensure five of the thirty (30) sampled patients (Patient 3, Patient 18, Patient 19, Patient 20, and Patient 21) pulse oximetry (a device to measure the oxygen level of the blood) parameter (setting a limit that affects how low or high the oxygen level is to be maintained) was not set lower than the physician's order in accordance with the facility's policy and procedure.

This deficient practice may result in alarms not sounding off at the patients' prescribed lowest oxygen level tolerance, potentially delaying required intervention and compromising patient safety.

Findings:

1. During a review of Patient 3's "History and Physical (H&P)," dated 6/5/2023, the "H&P" indicated that Patient 1 has been a 5-year-old patient of the facility since 2020. The H&P further indicates that the Patient 1 problem listed includes chromosome 15 q23.6 duplication (a duplicate in genetics causing developmental disorder) and chronic lung disease of prematurity (a long-term respiratory problem faced by babies born earlier than 37 weeks). The H&P indicates Patient 1 "had a complex history in the early years of her life... She has been maintained on the ventilator (a machine used to support or replace breathing) with a history of pulmonary hypertension (high blood pressure that affects the lungs) and high vent settings (requiring more mechanical aid for breathing) in the past." H&P's physical examination indicates Patient 1 is "delayed (a condition of children whose intellectual function and adaptive behavior are significantly below the expected average for their age) but appears to be aware of her surroundings."

During a concurrent observation and interview on 2/20/2024 at 11:00 a.m. with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2, CN2 stated, "90% (percent)," is the oxygen parameter (setting a limit that affects how low or high oxygen level will be maintained) that was set on Patient 3's pulse oximetry (device to measure the oxygen level of the blood) machine. CN 2 confirmed that the pulse oximetry alarm will sound at the lowest parameter that is set on the pulse oximetry; for Patient 3, it was 90%.

During a concurrent interview and record review on 2/23/2024 at 2:29 p.m. with Licensed Vocational Nurse (LVN) 2, Patient 3's "Order Summary Report," dated 1/26/2024, was reviewed. The report indicated, "Keep O2 (oxygen) saturation greater than 92% on 2/20/2024." LVN2 stated she is unsure of the reason that the oxygen parameter was set at a lower level than the 92% parameter that was prescribed by the physician. LVN 2 further stated that all active orders are in the patient's physical charts.

During a review of the facility's policy and procedure (P&P) titled, "Clinical Alarm System Management," dated 10/3/2023, the P&P indicated, "To describe a policy that promotes the monitoring of patients through the use of and response to clinical alarms. For purposes of this policy, the facility staff shall include hospital employees and independent contractors of the hospital. Medical staff shall include the active and courtesy members of the hospital's medical staff. To implement realistic strategies to address "Alarm Fatigue" and vulnerabilities. Periodically review an inventory of alarm equipped medical devices used in high-risk areas and for high-risk clinical conditions and identify the default settings and the limits ... Pulse Oximetry: Default Settings for Pulse Oximetry should be set at 92% for all areas with the exception of the Perinatal areas which should be set at 90%. Unlike the telemetry central monitoring system, the Pulse Oximetry settings do not default automatically upon patient discharge. The RN must ensure that settings are appropriately set ...Nurses shall ensure that equipment and devices that enunciate locally at the bedside (i.e., infusion pump alarms) are carefully monitored with special attention given to patient care areas that are remote from a nurse's station, isolation rooms (including negative airflow rooms) and other situations that require patient room door to remain closed."

2. During a review of Patient 18's "History and Physical (H&P)," dated 2/1/2024, the "H&P" indicated that Patient 18 had "severe cerebral encephalomalacia (softening or loss of brain tissue) secondary to non-accidental trauma with subsequent quadriplegia (paralysis of all four limbs), cerebral palsy (a condition marked by impaired muscle coordination) and intellectual disability), chronic lung disease... Now the patient is on a full-time ventilator (a machine used to support or replace the breathing support) ..."

During a concurrent observation and interview on 2/20/2024 at 11:14 a.m. with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2, CN2 stated, "90% (percent)," which is the oxygen parameter that was set on Patient 18's pulse oximetry machine. Patient 19 has a tracheostomy tube and is connected to a ventilator. CN 2 confirmed that the pulse oximetry alarm will sound at the lowest parameter that is set on the pulse oximetry; for Patient 18, it was 90%.

During a concurrent interview and record review on 2/23/2024 at 2:28 p.m. with Licensed Vocational Nurse (LVN) 2, Patient 18's "Order Summary Report," dated 1/26/2024, was reviewed. The report indicated, "Keep O2 (oxygen) saturation greater than 94% on 1/11/2023." LVN2 stated, "The order is active as of 2/1/2024, as indicated at the top of the "Order Summary Report." LVN2 stated that she is unsure why staff did not follow the parameter as ordered; "the order can easily be obtained from the patient's physical charts."

During a review of the facility's policy and procedure (P&P) titled, "Clinical Alarm System Management," dated 10/3/2023, the P&P indicated, "To describe a policy that promotes the monitoring of patients through the use of and response to clinical alarms. For purposes of this policy, the facility staff shall include hospital employees and independent contractors of the hospital. Medical staff shall include the active and courtesy members of the hospital's medical staff. To implement realistic strategies to address "Alarm Fatigue" and vulnerabilities. Periodically review an inventory of alarm equipped medical devices used in high-risk areas and for high-risk clinical conditions and identify the default settings and the limits ... Pulse Oximetry: Default Settings for Pulse Oximetry should be set at 92% for all areas with the exception of the Perinatal areas which should be set at 90%. Unlike the telemetry central monitoring system, the Pulse Oximetry settings do not default automatically upon patient discharge. The RN must ensure that settings are appropriately set ...Nurses shall ensure that equipment and devices that enunciate locally at the bedside (i.e., infusion pump alarms) are carefully monitored with special attention given to patient care areas that are remote from a nurse's station, isolation rooms (including negative airflow rooms) and other situations that require patient room door to remain closed."

3. During a review of Patient 19's "History and Physical (H&P)," dated 10/13/2023, the "H&P" indicated that Patient 19 is "a 5-year-old with multiple congenital anomalies (comprise a wide range of abnormalities of body structure or function that are present at birth) who has been a long-term resident at our facility for the past year." H&P further indicates Patient 19 "remains encephalopathic (damage or disease that affects the brain) and with his known seizure disorder... He remains on NPO (nothing by mouth) and GT (gastrostomy tube) feeds due to his encephalopathic state."

During a concurrent observation and interview on 2/20/2024 at 11:15 a.m. with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2, CN2 stated, "90% (percent)," which is the oxygen parameter that was set on Patient 19's pulse oximetry machine. Patient 19 was connected to the pulse oximetry at the right toe. CN 2 confirmed that the pulse oximetry alarm will sound at the lowest parameter that is set on the pulse oximetry; for Patient 19, it was 90%.

During a concurrent interview and record review on 2/23/2024 at 2:21 p.m. with Licensed Vocational Nurse (LVN) 2, Patient 19's "Order Summary Report," dated 1/26/2024, was reviewed. The report indicated, "Keep O2 (oxygen) saturation greater than 92% on 9/21/2020." LVN2 stated, "The order is active as of 2/1/2024, as indicated at the top of the "Order Summary Report."

During a review of the facility's policy and procedure (P&P) titled, "Clinical Alarm System Management," dated 10/3/2023, the P&P indicated, "To describe a policy that promotes the monitoring of patients through the use of and response to clinical alarms. For purposes of this policy, the facility staff shall include hospital employees and independent contractors of the hospital. Medical staff shall include the active and courtesy members of the hospital's medical staff. To implement realistic strategies to address "Alarm Fatigue" and vulnerabilities. Periodically review an inventory of alarm equipped medical devices used in high-risk areas and for high-risk clinical conditions and identify the default settings and the limits ... Pulse Oximetry: Default Settings for Pulse Oximetry should be set at 92% for all areas with the exception of the Perinatal areas which should be set at 90%. Unlike the telemetry central monitoring system, the Pulse Oximetry settings do not default automatically upon patient discharge. The RN must ensure that settings are appropriately set ...Nurses shall ensure that equipment and devices that enunciate locally at the bedside (i.e., infusion pump alarms) are carefully monitored with special attention given to patient care areas that are remote from a nurse's station, isolation rooms (including negative airflow rooms) and other situations that require patient room door to remain closed."

4. During a review of Patient 20's "History and Physical (H&P)," dated 6/5/2023, the "H&P" indicated that Patient 20 is an 8-year-old patient who was in a pedestrian versus automobile accident in 2019. H&P indicates Patient 21's medical history includes traumatic brain injury (TBI, caused by a forceful bump, blow, or jolt to the head or body, or from an object that pierces the skull and enters the brain), tracheostomy dependent (long-term use of a tube inserted in the windpipe that provides an alternative airway for breathing), and gastrostomy tube dependent (long-term use of a tube inserted through the wall of the abdomen directly into the stomach to provide nutrition).

During a concurrent observation and interview on 2/20/2024 at 11:02 a.m. with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2, CN2 stated, "90% (percent)," which is the oxygen parameter that was set on Patient 20's pulse oximetry machine. CN 2 confirmed that the pulse oximetry alarm will sound at the lowest parameter that is set on the pulse oximetry; for Patient 20, it was 90%.

During a concurrent interview and record review on 2/23/2024 at 2:21 p.m. with Licensed Vocational Nurse (LVN) 2, Patient 20's "Order Summary Report," dated 1/26/2024, was reviewed. The report indicated, "Keep O2 (oxygen) saturation greater than 95% on 4/17/2023." LVN2 stated, "The order is active as of 2/1/2024, as indicated at the top of the "Order Summary Report." In addition, LVN 2 stated she is unsure of the reason that the oxygen parameter was set at a lower level than the 95% parameter that was prescribed by the physician.

During a review of the facility's policy and procedure (P&P) titled, "Clinical Alarm System Management," dated 10/3/2023, the P&P indicated, "To describe a policy that promotes the monitoring of patients through the use of and response to clinical alarms. For purposes of this policy, the facility staff shall include hospital employees and independent contractors of the hospital. Medical staff shall include the active and courtesy members of the hospital's medical staff. To implement realistic strategies to address "Alarm Fatigue" and vulnerabilities. Periodically review an inventory of alarm equipped medical devices used in high-risk areas and for high-risk clinical conditions and identify the default settings and the limits ... Pulse Oximetry: Default Settings for Pulse Oximetry should be set at 92% for all areas with the exception of the Perinatal areas which should be set at 90%. Unlike the telemetry central monitoring system, the Pulse Oximetry settings do not default automatically upon patient discharge. The RN must ensure that settings are appropriately set ...Nurses shall ensure that equipment and devices that enunciate locally at the bedside (i.e., infusion pump alarms) are carefully monitored with special attention given to patient care areas that are remote from a nurse's station, isolation rooms (including negative airflow rooms) and other situations that require patient room door to remain closed."

5. During a review of Patient 21's "History and Physical (H&P)," dated 10/13/2024, the "H&P" indicated, Patient 21 is a 16 years old patient, who suffered a near drowning event. The H&P further indicated "The patient remains deeply encephalopathic (type of brain damage that is caused when the brain doesn't get enough oxygen) without any changes or improvements. She is completely nonresponsive. She is 100% dependent on others for all of her activities of daily living. She continues with her seizure disorder (a sudden, uncontrolled burst of electrical activity in the brain. It can cause changes in behavior, movements)."

During a concurrent observation and interview on 2/20/2024 at 11:10 a.m. with the Director of the Pediatric Subacute Unit (DIR) and charge nurse (CN) 2, CN2 stated, "90% (percent)," which is the oxygen parameter that was set on Patient 21's pulse oximetry machine. CN 2 confirmed that the pulse oximetry alarm will sound at the lowest parameter that is set on the pulse oximetry; for Patient 21, it was 90%.

During a concurrent interview and record review on 2/23/2024 at 2:20 p.m. with Licensed Vocational Nurse (LVN) 2, Patient 21's "Order Summary Report," dated 1/26/2024, was reviewed. The report indicated, "Keep O2 (oxygen) saturation greater than 95% on 6/1/2016." LVN2 stated, "The order is active as of 2/1/2024, as indicated at the top of the "Order Summary Report." In addition, LVN 2 stated she is unsure of the reason that the oxygen parameter was set at a lower level than the 95% parameter that was prescribed by the physician. LVN 2 stated, "It is important that the oxygen parameter that is ordered by the physician be followed."

During a review of the facility's policy and procedure (P&P) titled, "Clinical Alarm System Management," dated 10/3/2023, the P&P indicated, "To describe a policy that promotes the monitoring of patients through the use of and response to clinical alarms. For purposes of this policy, the facility staff shall include hospital employees and independent contractors of the hospital. Medical staff shall include the active and courtesy members of the hospital's medical staff. To implement realistic strategies to address "Alarm Fatigue" and vulnerabilities. Periodically review an inventory of alarm equipped medical devices used in high-risk areas and for high-risk clinical conditions and identify the default settings and the limits ... Pulse Oximetry: Default Settings for Pulse Oximetry should be set at 92% for all areas with the exception of the Perinatal areas which should be set at 90%. Unlike the telemetry central monitoring system, the Pulse Oximetry settings do not default automatically upon patient discharge. The RN must ensure that settings are appropriately set ...Nurses shall ensure that equipment and devices that enunciate locally at the bedside (i.e., infusion pump alarms) are carefully monitored with special attention given to patient care areas that are remote from a nurse's station, isolation rooms (including negative airflow rooms) and other situations that require patient room door to remain closed."

During a review of the facility's policy and procedure (P&P) titled, "Physician's Orders And Telephone Orders," dated 8/3/2021, the P&P indicated, "Physician's orders shall be obtained prior to the initiation of any medication or treatment. All orders must be specific and complete, and no standing orders shall be used. All telephone orders must be verified by the licensed nurse, indicating that the order was read back to the physician/nurse practitioner giving the order. No verbal orders are to be received."