HospitalInspections.org

Based on the nature of the standard level deficiency, it was determined §482.13 Condition of Participation: Patient's Rights was out of compliance.

A-0144- The patient has the right to receive care in a safe setting. Based on interviews and document review, the facility failed to ensure a process was in place to provide a safe environment of care for patients who required continuous pulse oximetry monitoring (a measurement of the saturation of oxygen carried in red blood cells). Specifically, the facility failed to implement process changes and actions to reduce the risk of future patient harm after a patient experienced a delay in care when staff identified the patient's continuous pulse oximetry probe was off for approximately 41 minutes in 1 of 3 records reviewed in which the patient had continuous pulse oximetry monitoring ordered (Patient #1).

Based on interviews and document review, the facility failed to ensure a process was in place to provide a safe environment of care for patients who required continuous pulse oximetry monitoring (a measurement of the saturation of oxygen carried in red blood cells). Specifically, the facility failed to implement process changes and actions to reduce the risk of future patient harm after a patient experienced a delay in care when staff identified the patient's continuous pulse oximetry probe was off for approximately 41 minutes in 1 of 3 records reviewed in which the patient had continuous pulse oximetry monitoring ordered (Patient #1).

Facility policy:

The Clinical Alarms policy read, level of alarm response for other equipment/clinical alerts requires assessment/attention as soon as possible, including, but not limited to, call light, pulse oximetry, dysrhythmia/telemetry (yellow alarms). Life sustaining equipment/crisis alarms require immediate assessment/attention, including, but not limited to lethal dysrhythmia/telemetry (red alarms). Clinical staff receive department-specific education on clinical alarm systems which includes alarm purpose, operation, response, management of false and nuisance alarms and soft or customized alarm settings. Definitions: Clinical Alarm: A patient generated or activated audible and/or visual notification that a patient's immediate physiological or health status is, or could be, life threatening. Equipment with clinical alarm systems include, but are not limited to pulse oximeters.

The Telemetry Monitoring policy read, telemetry monitoring may be used for continuous pulse oximetry. These patients are located in areas which have telemetry capability. The Registered Nurse (RN) in conjunction with the Telemetry Technician (tele tech) will identify changes in rhythm, rate, and/or pulse oximetry for rapid assessment and intervention regarding dysrhythmia and oxygenation issues. Communication of telemetry monitoring alarms and response to alarms will occur based on classification of red and yellow alarms outlined in Clinical Alarms policy. Red Alarms / Level I would include pulse oximetry less than 85%. Red Alarm Response requires immediate assessment of the patient. The tele tech will call the appropriate RN. If unable to reach RN, the tele tech will escalate the call to the Charge RN. The RN will remain on the phone until in the patient's room. Based on the RN assessment, the RN will activate the appropriate resources.

References:

The Telemetry Notification Algorithm read, for crisis alarms which include pulse oximeter probe off, the telemetry tech was instructed to call the primary RN for notification and to document the call. If there was no answer, the tele tech should call the charge nurse and document the notification. If there was no answer from the charge nurse, the tele tech continues to call the unit until an RN is reached.

1. The facility had an incident when a pulse oximeter was off a patient and staff did not respond, the facility failed to identify failures and implement process changes needed to prevent reoccurrence.

a. Patient #1's medical record was reviewed. On review, Patient #1 had a delay in care for approximately 41 minutes from the time staff was notified his continuous pulse oximetry was off until he was found unresponsive with no pulse or respirations.

According to Provider Notes on 4/16/20 at 10:33 a.m., Patient #1 had a COVID-19 positive test on 4/16/20 with pneumonia (an infection in the lungs which causes inflammation which makes breathing difficult), hypoxia (a condition in which the body is deprived of adequate oxygen supply at the tissue level) and a new oxygen requirement.

On 4/22/20 at 7:34 p.m., Telemetry Technician (Tech #2) called the COVID Medical Unit (CMU) and notified Registered Nurse (RN) #1 Patient #1's continuous pulse oximeter was off. At 8:02 p.m. Tech #2 called the CMU unit again and notified RN #4, who was the charge RN, Patient #1's continuous pulse oximeter remained off.

On 4/22/20 at 11:25 p.m., a Significant Event was entered by RN #3 which read, RN #3 entered Patient #1's room at 8:15 p.m. and found him unresponsive with no pulse or respirations.

On 4/22/20 at 8:34 p.m. a Death Pronouncement note was documented which read, Patient #1's time of death was 8:23 p.m.

b. Interviews revealed the facility did not identify failures and implement process changes needed to prevent reoccurrence.

i. On 5/14/20 at 2:10 p.m., an interview with the CMU float pool Nurse Manager (Manager #7) was conducted. She stated she considered a continuous pulse oximeter off a patient to be a red alarm. Manager #7 reviewed the Telemetry Monitoring policy and stated even though she did not see a specific line regarding continuous pulse oximetry off, she stated a pulse oximetry reading of less than 85% was a red alarm and was the same as a continuous pulse oximetry being off. Manager #7 reviewed the Clinical Alarms policy and stated under the other equipment alert there was a section which lists pulse oximetry. She stated her interpretation was an alarm related to a continuous pulse oximeter would require attention or assessment as soon as possible according to the Clinical Alarms policy. Even though the policies reviewed had conflicting information, Manager #7 stated when the tele tech called with a red alarm, staff should respond immediately.

Manager #7 stated she reviewed Patient #1's medical record for her review. She stated she did not have a discussion with either RN #3 who found Patient #1 unresponsive or Tech #2 who called the unit two times prior to Patient #1 being found unresponsive. Manager #7 stated she expected RN #3 to assess the patient when she received the first notification Patient #1's continuous pulse oximeter was off. Manager #7 stated if the RN assigned to the patient was not available, then whomever received the call was responsible for assessing the patient.

The CMU was a COVID-19 positive unit and staffed with float pool staff and staff which had been reassigned from other hospital units. Manager #7 stated she sent an email to float staff on 5/7/20 to review the Telemetry Monitoring policy and Clinical Alarms policy and emphasized the nurse's response. She stated it was not new education, but a review of the current policy in use. She stated RN #3 did not receive the 5/7/20 education about the priority or urgency of a patient's pulse oximeter being off.

ii. On 5/18/20 at 9:01 a.m., an interview with RN #4 was conducted who was the charge nurse on the unit when Patient #1 expired. RN #4 stated patient care monitoring on the unit included continuous pulse oximetry because he had COVID-19 which was a respiratory disease and patients' oxygen needs could increase rapidly.

RN #4 stated on 4/22/20, she received the second call from the Tech #2 at 8:02 p.m. with the notification Patient #1's continuous pulse oximeter was off and RN #3 was beside her. RN #4 stated she told RN #3 Patient #1's continuous pulse oximeter was off. RN #4 stated RN #3 responded and stated, the patient was not on oxygen and she would go into his room after she had prepared his scheduled medications due at 8:00 p.m. RN #4 stated she thought RN #3 was going into Patient #1's room shortly to correct it. However, RN #4 stated she did not follow up to ensure RN #3 had corrected Patient #1's pulse oximeter in a short amount of time because it was the beginning of the shift and call lights were sounding.

RN #4 stated she received an email to review the Telemetry Monitoring policy the week of 5/11/20. She stated prior to the review of the policy, she was not aware a pulse oximeter off was considered a red alarm. She stated in the future she would ensure a continuous pulse oximeter was corrected immediately and would ensure staff stayed on the phone with the tele tech until the issue was resolved.

iii. On 5/18/20 at 9:32 a.m., RN #3 was interviewed. RN #3 stated she normally worked on the surgical unit and was sometimes reassigned to the CMU. She stated she was instructed to cluster care on the CMU to conserve personal protective equipment (PPE). Clustering care meant preparing medications, assessing the patient, taking vital signs and assisting the patient with toileting at the same time.

RN #3 stated a patient positive with COVID-19 had their pulse oximetry monitored continuously because respiratory compromise was a symptom of the disease. She stated a decrease in pulse oximeter reading could be the first sign a patient was deteriorating. RN #3 stated the risk of not monitoring a patient's pulse oximeter was the inability to identify when a patient was deteriorating.
RN #3 then contradicted herself and stated, the priority of a patient off pulse oximetry depended on the patient's condition. She stated if a patient was on oxygen and more critical, she would be more concerned if the pulse oximeter was off. If the patient was stable and not on oxygen with no current problems, she would wait until she did her assessment to resolve the patient's pulse oximeter being off.

RN #3 stated she was the primary nurse assigned to Patient #1 on 4/22/20. She stated she was told in the shift change report, Patient #1 was stable with no issues reported and was planned to discharge once he received two negative COVID-19 test results. RN #3 stated she was notified by the charge RN Patient #1's pulse oximeter was off. RN #3 stated she had planned to go to Patient #1's room and assess him once she prepared his medication. She stated when she went into his room at 8:15 p.m., she found him unresponsive.

RN #3 stated after the event on 4/22/20 she had been re-educated via email on 5/16/20. She stated she did not receive the email education on 5/7/20 or 5/13/20. She stated the new education was regarding an updated policy on telemetry monitoring and the different alarms such as red alarms and yellow alarms and how to respond to them. She stated a yellow alarm meant to respond as soon as possible and a red alarm meant to respond immediately. RN #3 stated the continuous pulse oximeter being off was not part of the education recently provided to her. She stated continuous pulse oximeter off was not a red or yellow alarm and she would continue to assess the patient when she got to it. She stated she signed an attestation indicating she understood the policy and her expectations.

iv. On 5/18/20 at 10:30 a.m., an interview with Tech #2 was conducted. Tech #2 stated her role was to watch telemetry monitors for multiple hospitals within the health system from an offsite central monitoring location called the Virtual Health Center (VHC). Tech #2 stated a continuous pulse oximeter off was a high priority. She stated if the patient was only on a continuous pulse oximeter, then it was the only way to monitor the patient.

Tech #2 stated she followed the Telemetry Notification Algorithm for notification to staff when a continuous pulse oximeter was off a patient. Tech #2 stated she would call the RN assigned to the patient if the pulse oximeter was off a patient for two minutes. Even though the algorithm for continuous pulse oximeter off a patient did not have a timeframe for notification, if the pulse oximeter remained off after four to five minutes, she would re-notify staff by calling the charge RN. If the pulse oximeter remained off, Tech #2 would escalate again after four to five minutes and call the RN, charge RN or unit phone. Tech #2 stated she would repeat the cycle according to the algorithm. She stated the process had not changed since working for the facility.

Tech #2 stated a pulse oximeter reading less than 85% was considered a red alarm. She stated her response for a red alarm was to call the patient's RN and notify them of the alarm, silence the alarm and document the notification. If the alarm continued, she would call the RN again and document the notification. Tech #2 stated she was not required to stay on the phone with the RN after notification until the issue was resolved. She stated a continuous pulse oximeter off a patient was not a red or yellow alarm. Tech #2 stated she did know there were policies for guidance, but she used the algorithm for notification guidance.

On 4/22/20 at 7:34 p.m., Tech #2 called the CMU and notified RN #1 Patient #1's pulse oximeter was off. At 8:02 p.m. Tech #2 called the CMU unit again and notified RN #4 Patient #1's continuous pulse oximeter remained off. Tech #2 stated she should have called back multiple times in the 28 minutes time frame. Tech #2 stated she did not follow the algorithm because she did not follow up sooner. She stated she should have notified staff sooner within a couple of minutes. Tech #2 stated per the Telemetry Notification Algorithm, she was not supposed to call the red phone (a phone the charge nurse carries for emergency communication) for a pulse oximeter off a patient, but could have since the event on 4/22/20 occurred at shift change. She stated calling the red phone was a notification and she did not need to stay on the phone until the issue was resolved or until the RN went into the patient room. This was in contrast to Manager #7 and RN #4's interview which stated a continuous pulse oximeter off was a red alarm which required staff to resolve the issue immediately while on the phone with the tele tech.

Tech #2 stated no one had spoken with her regarding Patient #1 and she stated she had not received any education updates related to a patient off continuous pulse oximeter after 4/22/20.

v. On 5/18/20 at 11:16 a.m., an interview with VHC Nursing Director (Director #9) was interviewed. Director #9 stated once the tele tech notified staff a patient was off their continuous pulse oximetry, there was not a timeframe for the pulse oximeter reading to be corrected. She stated if the tele tech called the unit and the primary RN did not answer their phone, the tele tech would escalate the call to the charge RN. She stated tele techs would continue to follow the cycle on the algorithm until the patient was placed back on the pulse oximeter. Director #9 stated the suggested time frame for follow up notification was 10 to 15 minutes, but it was not required. This timeframe was in contrast to Tech #2's interview which stated, she should have renotified staff within four to five minutes.

Director #9 stated a continuous pulse oximeter probe off did not require tele techs to call the red phone or wait on the phone for the RN to resolve. This was in contrast to Manager #7 and RN #4's interview which stated a continuous pulse oximeter off was a red alarm which required staff to resolve the issue immediately while on the phone with the tele tech.

Director #9 stated she expected tele techs to provide real time notification to the front line staff and in turn expected front line staff to follow up on the notification within 10 to 15 minutes. Director #9 stated a continuous pulse oximeter off was a serious alarm and she expected action from the front line staff.

Director #9 stated tele techs had the Telemetry Monitoring policy for guidance which was reviewed in orientation. She stated the Telemetry Notification Algorithm was not part of the policy, but what tele techs used for day to day guidance.

Director #9 stated she reviewed Patient #1's significant event from 4/22/20. She stated her review was Tech #2 made contact with front line staff each time she called and front line staff should have assessed the patient. Director #9 stated she determined Tech #2's care was appropriate because she made contact each time she called. Director #9 stated the follow up notification time of 10 to 15 minutes was a suggestion not a requirement. She stated Tech #2 followed the Telemetry Monitoring policy, because a continuous pulse oximeter off of a patient was not written in the policy as a red alarm. This was in contrast to Manager #7's interview which stated a continuous pulse oximeter off was a red alarm. She stated ideally Tech #2 would have made contact more often, but according to the policy and algorithm she acted appropriately. Director #9 stated Tech #2 followed the intent of the policy.
Director #9 stated after her review of the 4/22/20 significant event for Patient #1, she did not consider reviewing or updating the algorithm.

Director #9 stated there was an education gap. She stated continuous pulse oximeter off was not in the Telemetry Monitoring policy as a red alarm, nor did it generate a red alarm on the monitor. She stated since it did not generate a red alarm and was not mentioned in the policy and the notifications were not going to the red phone.

vi. On 5/14/20 at 3:01 p.m., an interview was conducted with Risk Coordinator (Coordinator #10). Coordinator #10 stated she reviewed the nursing response for Patient #1's significant event on 4/22/20 and did not feel there was a gap in response based on the policy. She stated a patient off continuous pulse oximetry was not identified in the policy. Coordinator #10 stated a continuous pulse oximeter off, did not fall under red or yellow alarm responses.

She stated pulse oximetry less than 85% was a red alarm which would mean the tele tech would stay on the phone while the RN assessed the patient. She stated pulse oximetry less than 85% were not the same as continuous pulse oximeter off.

This was in contrast to Manager #7 who stated she considered a pulse oximeter off a patient to be a red alarm.

Coordinator #10 stated her review revealed the nurses did not respond to Patient #1 when they received the notification he was off his continuous pulse oximeter, but their response time was clinical judgment.

This was in contrast to The Clinical Alarms policy which read, clinical alerts which included pulse oximetry required attention or assessment as soon as possible.

Coordinator #10 stated there was no policy or algorithm review since the occurrence, nor was a review planned. She stated education went out on 5/7/20 in the facility safety huddle as well as an email to float pool staff, but since RN #3 primarily worked on the surgical floor; she had not received the education. Coordinator #10 stated no education had been sent to the telemetry monitoring unit. Coordinator #10 stated after a discussion with leadership on 5/13/20 it was decided an additional email education would go out to all nurses who worked with telemetry.

Coordinator #10 stated the biggest contributing factor identified for the event on 4/22/20 was due to COVID-19, nurses were instructed to cluster care to conserve PPE. She stated after the event the facility needed to go back and instruct nurses to cluster their care, but to respond urgently and immediately to alarms. Coordinator #10 then stated after the discussion with the surveyor, she felt the policies and algorithm needed to be reviewed.

c. Document review revealed conflicting guidance for staff to follow regarding when a continuous pulse oximeter was off.

i. The Clinical Alarms policy read, clinical alerts required assessment or attention as soon as possible which included pulse oximetry as the same response as yellow alerts for telemetry.

ii. The Telemetry Monitoring policy read, communication of telemetry monitoring alarms and response to alarms will occur based on classification of red and yellow alarms outlined in Clinical Alarms policy. Red Alarms would include pulse oximetry less than 85%. Red Alarm Response required immediate assessment of the patient. The tele tech would call the appropriate RN. If unable to reach RN, the tele tech will escalate the call to the Charge RN. The RN would remain on the phone until in the patient's room.

iii. The Telemetry Notification Algorithm read, for crisis alarms which include pulse oximeter probe off, the telemetry tech was instructed to call the primary RN for notification and to document the call. If there was no answer, the tele tech should call the charge nurse and document the notification. If there was no answer from the charge nurse, the tele tech continued to call the unit until an RN was reached.

The algorithm did not specify if the patient off pulse oximetry was classified as a yellow or red alarm or a timeframe in which to continue to notify staff.

d. Prior to the survey exit, the facility provided evidence an email education went out to all units whose staff monitored pulse oximetry. The email stated all notifications from telemetry staff informing the presence of red alarms or a patient is off their telemetry pads and/or pulse oximeter required an immediate response, assessment and documentation from the RN. The email additionally read, staff should review the Telemetry Monitoring policy and specifically review what qualified as a red alarm. The facility provided attestations from each unit monitoring pulse oximeters which identified which staff had received the education prior to the survey exit. The facility also provided an updated Telemetry Algorithm which added continuous pulse oximeters off to the column which required red phone notification and telemetry staff staying on the phone with unit staff until they were in the patient's room. The facility provided attestations of which telemetry monitoring staff had received the education regarding the updated algorithm.

Based on document review and interviews, the facility failed to ensure an order was obtained within one hour for a patient in violent restraints in 1 of 1 restraint records reviewed (Patient #3).

Findings:

Facility Policy:

The Restraint policy read, for safe and appropriate use of restraint for non-violent/non-self-destructive behavior or for violent/self destructive behavior. A restraint was defined as any manual method, material or equipment used to immobilize or prevent the patient's free movement. As defined in the policy, violent behavior was the intentional use of physical force against oneself of another person which results in or was likely to result in injury. A non-violent behavior was defined as an action performed by the patient which compromises medical treatment. An example would be the purposeful movement towards lines. The staff initiate restraints based on the provider order. In regards to violent/self destructive restraints, if restraints were initiated for emergently, the provider must be notified within one hour and an order must be initiated within one hour.

1. The facility failed to ensure an order was obtained within one hour of the violent restraints being placed on the patient.

Due to the failure, the patient was placed in violent restraints without an active order for three hours.

a. Patient #3's medical record was reviewed.

i. According to Registered Nurse (RN #22)'s documentation on the Non-Violent Flowsheet, the patient was placed in restraints on 3/30/20 at 4:00 a.m. RN #22 documented Patient #3's behavior as agitated, restless and verbally abusive.

ii. A Significant Event note written by Provider #21 on 3/30/20 at 4:23 a.m. revealed the patient was physically aggressive and staff were not able to deescalate the patient.

iii. On review of Patient #3's orders, an order for violent restraints was obtained at 7:13 a.m. by RN #22 three hours after Patient #3 had been placed in restraints. This was not in accordance with facility policy which read a violent restraint order must be placed within one hour of the initiation of the restraints.

b. On 5/19/2020 at 8:46 a.m., an interview was conducted with RN #18. RN #18 was a progressive care unit (PCU) nurse who cared for Patient #3 in the intensive care unit (ICU) during the violent restraint episode from 7:00 a.m. until 12:00 p.m. on 3/30/20.

RN #18 stated violent restraints were used if there was a threat to harm the staff member or a threat for self-harm. RN #18 stated she used the restraint policy for guidance. RN #18 stated the RN needed a physician order for restraints. If restraints were applied emergently, an order would need to be obtained right after restraints were applied. RN #18 explained an initial order was needed because the provider needed to be aware of the situation and ensure the restraint was appropriate for the patient and their behaviors. RN #18 stated it was not appropriate to restrain a patient without an order from the physician because it was not in the best interest of the patient if the provider was unaware. She further explained, a patient placed in restraints caused the patient to be at risk for pressure injuries, which was an additional reason the physician's order was needed.

Patient #3's medical record was reviewed with RN #18. RN #18 stated the patient was placed in restraints initially at 4:00 a.m., and the first order for the restraints was at 7:13 a.m., 3 hours after the initiation of the violent restraints. RN #18 stated the order should have been obtained at 4:00 a.m.

c. On 5/19/20 at 9:37 a.m., an interview was conducted with Patient Safety Specialist (Specialist #19). Specialist #19 stated one of her roles was to create Best Practice Advisories (BPAs) as reminders sent through the electronic medical record (EMR) to ensure orders and documentation on restraints was correct.

Specialist #19 explained violent restraints were to be ordered within an hour of the patient placed in the restraints. Specialist #19 further explained the type of restraint ordered, either violent or non-violent, was dependent upon the patient's behavior, not the type of restraint used.

Patient #3's medical record was reviewed with Specialist #19.

Specialist #19 reviewed the Significant Event note written by Provider #21 on 3/30/20 at 4:33 a.m. Provider #21's note read, the patient was determined to be physically aggressive and staff were not able to deescalate the patient. Specialist #19 stated Patient #3 was physically aggressive which would be an indicator for violent restraints. Additionally, she stated staff would not attempt de-escalation for a nonviolent person. Therefore, Specialist #19 stated the provider intended for Patient #3 to be in violent restraints and a violent restraint order should have been placed at the time Provider #21 wrote the Significant Event note.

Based on document review and interviews, the facility failed to ensure monitoring and documentation was completed for a patient in violent restraints. Specifically, the facility failed to monitor the patient in violent restraints every fifteen minutes and complete documentation in 1 of 1 restraint records reviewed (Patient #3).

Findings:

Facility Policy:

The Restraint policy read, the purpose of the policy was to describe the process for safe and appropriate use of restraint for non-violent/non-self-destructive behavior or for violent/self-destructive behavior. A restraint was defined as any manual method, material or equipment used to immobilize or prevent the patient's free movement. As defined in the policy, violent behavior was the intentional use of physical force against oneself or another person which results in or was likely to result in injury. The staff were to initiate restraints based on the provider order. Staff were to monitor the patient every 15 minutes for proper positioning of the patient, the patient's circulation, the patient's airway was not obstructed, and any additional physical needs the patient needed addressed. A patient in violent restraints was to be monitored every 15 minutes and the documentation was to be completed every 15 minutes as well.

1. The facility failed to ensure a patient in violent restraints was monitored and documentation was completed every 15 minutes according to facility policy.

a. A review of Patient #3's medical record revealed a lack of monitoring and documentation for restraints.

i. Registered Nurse (RN) #22 documentation on the Non-Violent Flowsheet, the patient was placed in restraints on 3/30/20 at 4:00 a.m. RN #22 documented Patient #3's behavior as agitated, restless and verbally abusive.

ii. A Significant Event note written by Provider #21 on 3/30/20 at 4:23 a.m. revealed the patient was physically aggressive and staff were not able to deescalate the patient.

iii. At 5:00 a.m., RN #22 documented on the Critical Care (CC) Assessment Flowsheet, Patient #3's behavior was aggressive and violent.

iv. An Order for violent restraints was obtained at 7:13 a.m. by RN #22 who was the nurse who initiated the restraints at 4:00 a.m.

v. The care team Flowsheet documentation was reviewed. Patient #3 was in restraints a total of eight hours; from 4:00 a.m. to 12:00 p.m. Both RN #22 and RN #18 documented the violent restraint episode in the Non-Violent Flowsheet for the eight hour time period.

Review of the documentation completed by both RNs revealed the monitoring and documentation completed was for non-violent restraints. The documentation was completed every two hours instead of every 15 minutes. This was not in accordance with the Restraint Policy, which read a patient in violent restraints was to be monitored every 15 minutes and the documentation was to be completed every 15 minutes.

b. Interviews with staff revealed a lack of monitoring and documentation for restraints for Patient #3.

i. On 5/19/2020 at 8:46 a.m., an interview was conducted with RN #18. RN #18 was a progressive care unit (PCU) nurse who cared for Patient #3 in the intensive care unit (ICU) during the violent restraint episode from 7:00 a.m. until 12:00 p.m. on 3/30/20. RN #18 stated violent restraints were used if there was a threat to harm the staff member or a threat for self-harm. RN #18 stated she used the restraint policy for guidance. RN #18 stated the RN needed a physician order for restraints. RN#18 stated she thought violent restraints were locked leather restraints and non-violent restraints were soft restraints. RN #18 stated she did not consider Patient #3 to be in violent restraints despite the order for violent restraints.

This was in contrast to the Restraint policy which read, violent behavior was the intentional use of physical force against oneself or another person which results in or was likely to result in injury and staff were to initiate restraints based on the provider order. The policy further required staff to assess the patient for proper positioning, circulation, a non-obstructed airway and other physical needs that the patient had and documented on the Flowsheet every 15 minutes.

On review of Patient #3's medical record there was no documentation of the required assessment of Patient #3 to ensure proper positioning, circulation and non-obstructed airway and his other physical needs every 15 minutes.

c. On 5/19/20 at 9:37 a.m., an interview was conducted with Patient Safety Specialist (Specialist #19). Specialist #19 stated one of her roles was to create Best Practice Advisories (BPAs) as reminders sent through the electronic medical record (EMR) to ensure orders and documentation on restraints was correct. In the EMR, there was a specific place for violent restraints to be documented. Upon review of Patient #3's chart, Specialist #19 stated the care associated with the violent restraint episode was documented on the wrong flowsheet. She stated the RN's should have documented care for this episode on the Violent Flowsheet. Specialist #19 stated patients in violent restraints were to be monitored and documented every fifteen minutes to ensure patient safety.

Specialist #19 reviewed the Significant Event note written by Provider #21 on 3/30/20 at 4:33 a.m. Provider #21's note read, the patient was determined to be physically aggressive and staff were not able to deescalate the patient. Specialist #19 stated Patient #3 was physically aggressive which would be an indicator for violent restraints. Additionally, she stated staff would not attempt de-escalation for a nonviolent person. Therefore, Specialist #19 stated the provider intended for Patient #3 to be in violent restraints.

Based on the nature of the standard level deficiency, it was determined §482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

A-0749- The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, interviews and document reviews, the facility failed to ensure staff actively screening health care personnel for signs and symptoms of the novel Coronavirus (COVID-19), a highly infectious disease, prior to the start of their shift in accordance with Center for Disease Control (CDC) infection control guidelines.

Based on observations, interviews and document reviews, the facility failed to ensure staff actively screening health care personnel for signs and symptoms of the novel Coronavirus (COVID-19), a highly infectious disease, prior to the start of their shift in accordance with Center for Disease Control (CDC) infection control guidelines.

Findings include:

Facility policy:

The facility intranet page displayed guidance provided to staff regarding COVID-19. Per the intranet site, staff were to call the COVID hotline if they were experiencing a fever or symptoms of COVID-19.

References:

According to the CDC, symptoms of COVID-19 include but are not limited to cough, shortness of breath (SOB) or difficulty breathing, fever, chills, muscle aches, sore throat and the loss of taste and/or smell.

According to the CDC's Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Health Care Settings, updated May 18, 2020, a facility should actively screen anyone entering the health facility for fever or symptoms of COVID-19. All healthcare personnel should be screened at the beginning of their shift by actively checking their temperature for the absence of fever and documenting the absence of symptoms consistent with COVID-19.

According to the CDC's Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with Coronavirus Disease 2019 (COVID-19), updated April 15, 2020, healthcare facilities should consider foregoing contact tracing for exposures in a healthcare setting in favor of universal source control for healthcare personnel (HCP) and screening for fever and symptoms of COVID-19 before every shift.

According to the QSO 20-20 CMS Memo dated March 23, 2020, state surveyors are to use a streamlined review checklist to ensure providers are implementing actions to protect the health and safety of individuals during the COVID-19 pandemic.

According to COVID-19 Focused Infection Control Survey: Acute and Continuing Care (attached to the QSO 20-20 CMS Memo), facilities are expected to be in compliance with CMS guidance that is in effect at the time of the survey.

According to the Summary of the COVID-19 Focused Survey for Acute and Continuing Care Providers,(page 27 of the QSO 20-20 memo), surveyors should review the Focused Infection Control Survey tool in light of the established State Operations Manual Survey Protocol for more detailed information. Facilities can review the Focused Survey to determine CMS's expectations for an infection prevention and control program during the COVID-19 pandemic. Facilities should utilize the COVID-19 Focused Survey as a self-assessment tool. Priority areas for self- assessment include education, monitoring, and screening of staff.

According to the COVID-19 Focused Infection Control Survey: Acute and Continuing Care, (page 24 of the QSO memo), surveyors are to investigate if the facility is screening all staff at the beginning of their shift for fever and signs and symptoms of illness. Is the facility actively taking their temperature and documenting absence of illness. If the facility did not provide appropriate education, monitoring, and screening of staff, the appropriate IPC tag is to be cited for the provider/supplier type.

1. The facility failed to ensure healthcare personnel were actively screened prior to their shift to include active temperature checks and documenting the absence of symptoms consistent with COVID-19 in order to prevent the spread of COVID-19.

a. Interviews conducted with front line staff members revealed CDC guidelines referenced above were not followed and staff members did not check their temperature and document the absence of COVID-19 symptoms prior to the start of their shift.

i. On 5/12/20 at 11:55 a.m., an interview was conducted with a Registered Nurse from the float pool staff who was currently assigned on the COVID Medical Unit (RN #14). RN #14 stated there was not a formal screening process for COVID-19 in place to be completed prior to the start of her shift. RN #14 stated staff were to not report to work if they had a cough or any other symptoms and were told to call the COVID hotline if they did.

ii. On 5/12/20 at 12:05 p.m., an interview was conducted with RN #15. RN #15 was a RN on the COVID Intensive Care Unit (ICU). RN #15 stated she did not take her temperature regularly and she was not required to check and document her temperature prior to her shift. RN #15 further stated, staff did not document absence of COVID-19 symptoms prior to the start of their shift. RN #15 stated if a staff member were to work with a fever or other symptoms such as a cough, there was a risk the infectious disease would spread to patients and other staff members.

iii. On 5/13/20 at 12:00 p.m., an interview was conducted with RN #16. RN #16 worked on the cardiovascular unit. RN #16 stated there was not a formal process in place for staff members to complete prior to the start of their shift. RN #16 further explained, staff were not asked if they had a fever or other symptoms prior to their shift symptoms and no one at the facility checked staff members' temperature prior to the start of the shift. RN #16 stated staff members were told not to come to work if symptoms such as a fever, cough or SOB were present. If symptoms were present, staff were directed to call the COVID-19 hotline.

iv. On 5/14/2020 at 1:03 p.m., an interview was conducted with RN #12, who was the charge nurse on the COVID Medical Unit. RN #12 stated there was not a process for staff to be screened to ensure the absence of fever and COVID-19 symptoms. RN #12 stated staff were educated to stay at home if sick. RN #12 was unsure who monitored compliance to ensure staff members were not at work while sick. RN #12 stated there was a high risk to staff members and patients if a staff member went to work sick. She stated the staff member could spread the disease, which would be dangerous for patients and other staff members.

b. Further interviews were conducted with various leadership staff members who had oversight over front line staff.

i. On 5/13/20 at 2:59 p.m., an interview was conducted with the Director of Employee Health (Director #17). Director #17 stated his role was to oversee employee health and work functions. Director #17 stated the current employee process was for staff to self-screen and self-monitor for signs and symptoms of COVID-19. Director #17 stated staff were educated on the signs and symptoms of COVID-19 and were told to contact the COVID hotline if the staff members were positive for any symptoms. Director #17 stated the signs and symptoms of COVID-19 were a new onset of a cough, upper respiratory symptoms, fever and shortness of breath. Director #17 further stated leadership was educated on the need to escalate concerns and if a leader or manager recognized an employee was sick while at work and the leader would remove the employee from work. Director #17 explained the department leadership had oversight to ensure staff members were not at work while sick. Director #17's statement was in contrast to the information received from Manager #7's interview who stated it was the staff member's responsibility to ensure they did not work sick and management did not monitor for compliance.

Director #17 stated staff did not check their temperatures and document the absence of symptoms prior to their shift. Director #17 explained staff checking their temperature and documenting the absence of symptoms prior to their shift was one mechanism to obtain a safe work environment. Director #17 stated it was important to follow CDC guidance in order to increase workplace safety.

ii. On 5/19/20 at 8:00 a.m., an interview was conducted with the Nurse Manager who was currently assigned as manager of the staff on the COVID medical unit (Manager #7). Manager #7 stated staff were provided guidance to call the sick line if they were sick and not to come to work. Manager #7 stated it was the staff's responsibility to ensure they did not report to work sick. She stated staff were not monitored for compliance by the managers. Manager #7 stated she did not ensure staff members were not at work while sick on a daily basis. Manager #7 stated staff were not required to document the absence of symptoms prior to the start of their shift. Manager #7 stated she did not specifically recall when education on the process was provided. Finally, Manager #7 stated if a staff member were to work while sick, there would be a higher risk for the spread of the illness.

c. The facility provided the CDC guidelines they used to create their process. Review of the guidelines sent revealed it was the CDC's Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Health Care Settings, which read, health care personnel should be screened by actively taking their temperature and documenting the absence of COVID-19 symptoms.