Presbyterian St. Luke's Medical Center

Based on the manner and degree of standard level deficiency referenced to the Condition, it was determined the Condition of Participation º482.21 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PROGRAM was out of compliance.

A-0286 -(a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities .....

(2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.

Based on interviews and document review, the facility's quality committee failed to implement process changes and actions identified during analysis of internal safety reports to reduce the risk of future patient harm, affecting 2 of 11 patients (Patient #2 and #3) whose records were reviewed.

Based on interviews and document review, the facility's quality committee failed to implement process changes and actions identified during analysis of internal safety reports to reduce the risk of future patient harm, affecting 2 of 11 patients (Patient #2 and #3) whose records were reviewed. (Cross-reference A0395)

Findings include:

Facility policies:

The Quality Management, Risk Management, and Patient Safety Plan read, formal incident reviews are held related to events which result from some sort of process breakdown or breach in policy. These reviews result in action planning and are tracked for completion and ongoing effectiveness. Action planning that occurs as a result of the reviews is shared as needed to prevent further occurrence.

The Serious Event Analysis (SEA) policy read, a SEA was a process for identifying the basic or causal factor (s) underlying variation in performance. The SEA is utilized to determine root cause of events and find actionable solutions to prevent future harm. The product of the SEA is an action plan that identifies the strategies the organization intends to implement to reduce the risk of similar events occurring in the future.

1. Record review revealed the quality committee failed to ensure action plans were implemented after contributing factors to serious patient safety events were identified.

a. Review of Patient #2's internal safety report, entered on 10/14/19 at 4:42 p.m., revealed the patient had an anesthesia complication after a procedure. The documented details of the safety report revealed nursing staff were instructed not to call for assistance and not to use emergency patient care equipment after the equipment was retrieved by the operating room (OR) nurse.

According to the details documented in the report entered by Registered Nurse (RN) #11 at 11:48 a.m., the patient, who had been extubated, was not coming out of anesthesia while in the OR. At 11:49 a.m., Anesthesiologist #8 placed a laryngeal mask airway/LMA (a medical device that keeps a patient's airway open during anesthesia or unconsciousness) and RN #11 notified the charge nurse (RN #14), but not other staff, because Anesthesiologist #8 told her not to notify them as it would bring too much activity to the room.

The safety report further read Anesthesiologist #8 administered epinephrine (a drug which increases a person's heart rate and which helps improve blood flow) to the patient when his heart rate was 29. RN #11 wrote she got the code cart and brought it into the room but the anesthesiologist instructed her not to open the code cart or the defibrillator pads (pads applied directly to the chest wall to deliver a shock during cardiopulmonary resuscitation /CPR).

At 11:55 a.m., RN #11 notified the charge nurse the patient's heart rate was 21. At 11:58 a.m., Anesthesiologist #9 and the charge nurse arrived in the OR. RN #11 wrote the patient was in asystole (no pulse). RN #11 documented Anesthesiologist #9 and the charge RN checked a pulse, which they could not locate, and at 12:03 p.m., a code blue was called and chest compressions were started.

At 12:04 p.m., Anesthesiologist #8 asked for another pulse check (1 minute after compressions started) and there were no pulse. RN #11 wrote she moved to start compressions but was told not to start compressions while Anesthesiologist #8 began moving the EKG leads. Compressions were resumed one minute later at 12:05 p.m.

According to the patient's discharge summary, it was unclear how long he was hypoxic (absence of oxygen) or pulseless in the OR after he was extubated (removal of breathing tube), post procedure. The preliminary cause of death was anoxic (without oxygen) brain injury leading to acute respiratory failure.

On 10/24/19 and 10/28/19, the quality committee held meetings to analyze Patient #2's safety event. The documented root causes of the event were:

Physician behavior: a delay in calling the code was noted by staff who were concerned about the patient. Additionally, an opportunity was identified for education on medication usage.

Policy/Procedure, including education; timeout discussion to OR team regarding deep extubation and to know what to expect.

The risk reduction strategies created for the identified causes were to have the physician's behavior evaluated and implement changes to the timeout process for patients who were going to have deep extubation.

However, the facility was unable to provide evidence the action plans created during the review of the event were implemented prior to surveyors entering the facility, which was over two months after Patient #2's code in the OR.

On 12/26/19 at 4:31 p.m., the vice president of surgical services (VP #5) was interviewed. She stated there was some concern with intimidation during Patient #2's event, but she thought the intimidation was a onetime occurrence. She believed Anesthesiologist #8 sought quiet in the OR because he needed to reflect and she did not believe there was a culture of intimidation throughout. However, OR nursing staff were interviewed on 12/18/19 and 12/19/19 and stated a culture of intimidation did exist.

VP #5 stated she attended both Patient #2's event reviews. She said there was supposed to be staff training on deep extubation and the timeout process was going to be changed. VP #5 stated the education was not rolled out because the OR director was leaving. However, VP #5 said the lack of follow through fell on her and the ball had been dropped.

On 12/26/19 at 3:32 p.m., Chief Medical Officer (CMO #1) and Coordinator #20 were interviewed. CMO #1, who had oversight of the facility's quality program, stated he realized there needed to be more flexibility in event review meetings and the committee needed to figure out a process where the reviews could happen more rapidly. CMO #1 said there was opportunity for the quality committee to be more efficient coordinating safety event reviews.

b. Review of Patient #3's internal safety report, entered on 10/29/19, revealed on 10/18/19 at 9:50 a.m., the patient was found lying on her stomach and blue. The description of the event read a code blue was called. Cardiopulmonary resuscitation was initiated and the patient was intubated. The patient was placed on a cooling protocol and transferred to the intensive care unit (ICU). According to the report, later in the day Patient #3 experienced a second cardiopulmonary arrest and subsequently expired.

The corrective action listed was to re-educate and enforce policy. The target date for completion was 12/9/19. There was no other follow up documented in the report.

Review of Patient #3's serious event analysis dated 11/11/19 showed the quality committee identified the required pulse oximetry was not in place at the time the patient was on a patient-controlled analgesia (PCA); vital signs were missed the morning of the event; the patient expired and there was concern the patient's purse found in the room had bottles of medications, including Norco 5/325 and Ultram (both narcotic pain medications which slows respirations) that were not searched or reconciled during the patient's admission.

The documented risk reduction strategies were to standardize and revise the process for searching patient belongings to ensure all patients were searched in the emergency department prior to transferring to the patient care unit, including the ICU, conduct individual and global re-education on the importance of placing patients on appropriate monitoring per policy when patients were put on PCA pumps, as well as individual and global re-education on importance of completing vital signs per policy.

Review of follow up documentation provided showed the night nurse, who provided Patient #3's care, and ICU nurses were educated on the monitoring requirements for PCA patients. However, the facility was unable to provide evidence the day nurse caring for the patient and who found her lying on her stomach and blue, was educated, as well as evidence of global re-education of other nursing staff caring for patients who required monitoring. Further, the quality committee did not revise or standardize the process to search belongings as described in the risk reduction strategies.

Review of the records for two other patients who were admitted to the hospital after Patient #3's safety event (Patients #9 and #10), showed nursing staff continued to fail to monitor the patients in a manner consistent with facility policy and standard of practice. Cross Reference A0395

2. Interviews confirmed the facility's failure to implement action plans to ensure the patient safety events did not recur.

On 12/26/19 at 1:05 p.m., an interview was conducted with Director Risk Management and Safety (Director #4). Director #4 stated she was responsible for reviewing safety reports for any patient events.

Director #4 said the process of the safety event review and implementation of action plans was to ensure the facility was doing what they should be doing for patient safety and to ensure the patient safety event did not happen again.

She stated the purpose of a safety event review was to get the perspective of staff involved and evaluate if there was anything that could have been done differently. She said the purpose of action plans was to fix the process issues identified. She stated once action plans were created, she followed up with the leaders responsible for the action items before the division meetings. She said she was not usually involved in action plans, but acted more as a facilitator.

When asked about the lack of evidence to show the action plans for Patient #2 and #3's safety events had been implemented, Director #4 stated this was due to leadership changes and the lack of division meetings. She said the changes in the timeout process in Patient #2's action plan were to be reviewed in December, but the OR director was leaving and the division meeting was cancelled. She stated the reason why Patient #3's action plan was not implemented was the facility did not have a director of security for a couple of months and the process change fell through the cracks. She said there were definitely opportunities to improve.

On 12/26/19 at 2:02 p.m., the Vice President of Quality Management (VP #3) was interviewed. VP #3 stated the committee prioritized safety events depending on how worried the committee was that the event could happen again quickly or in the immediate future. She stated the committee tried to schedule the review of events as quickly as possible.

A review of Patient #3's actions was conducted. When asked about Patient #3's event, she stated she could not say why, after the review, all action items were not implemented. She said she had specifically discuss the general roll out with the ICU director. She said she did not think anyone recognized whether the event was an isolated event but said the committee had not thought there was a universal problem. VP #3 said the quality team probably should have dug deeper. VP #3 stated the change in the process to search patient belongings should have been prioritized but there was a change in security leadership.

A review of Patient #2's action plans was conducted. VP #3 stated when she reviewed the report, the event sounded unbelievable and outrageous. She stated the quality department knew immediately they wanted to conduct a review of the provider's actions and that was referred to the responsible department. VP #3 stated cardiopulmonary arrests in the operating room were not common. She said she was unsure why the VP of Surgery had not completed the education about patients awakening from deep sedation.

VP #3 stated the Time Out policy was a corporate policy and there was a section on the timeout sheet created which needed to be reviewed by corporate, but that had not happened yet. She said the director of the OR had left in November, and she did not know if the VP of Surgical Services and the Director discussed what was going to be done and by whom.

Review of additional patient safety reports that also lacked follow up was conducted. VP #3 stated she would have to ask the nurse leaders about the lack of follow up. VP #3 said the incident reporting system was very cumbersome and frustrating. She stated the follow up should be done within two weeks, but sometimes people were on vacation. She then stated the reports must be signed off to corporate within 60 days.

Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation º482.23, NURSING SERVICES, was out of compliance.

A-0395 A registered nurse must supervise and evaluate the nursing care for each patient.

Based on interviews and document review, nursing staff failed to evaluate and monitor four of 11 patients whose records were reviewed (Patient #3, #9, #10 and #2) in accordance with standards of practice and facility policy. Specifically, staff failed to monitor Patients #3, #9 and #10 as required and Patient #3 subsequently died . In addition, staff failed to follow basic life support protocol to check for a pulse when Patient #2 experienced a change of condition post-operatively.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document review, nursing staff failed to evaluate and monitor four of 11 patients whose records were reviewed (Patient #3, #9, #10 and #2) in accordance with standards of practice and facility policy. Specifically:

Staff failed to monitor Patients #3, #9 and #10 as required. Patient #3 subsequently died . In addition, staff failed to follow the basic life support protocol to check for a pulse when Patient #2 experienced a change of condition post-operatively.

Findings include:

A. Monitoring of patients on the medical-surgical unit

The Patient Controlled Analgesia (PCA) policy read: Oxygen saturation (SaO2 a measurement of the percentage of how much hemoglobin is saturated with oxygen) and end-tidal carbon dioxide (etCO2) will be monitored continuously for all patients on a PCA pump. This may be overridden by provider order or direction, or patient discharge. SaO2 will be monitored for the entire duration of PCA utilization. End-tidal carbon dioxide will be monitored for at least the first 12 hours of PCA utilization and may be discontinued thereafter unless the PCA remains at a basal rate. After the initial assessment, the heart rate, blood pressure, temperature, respirations, SaO2, etCO2, and pain and sedation scales should be reassessed at the following intervals: Every 30 minutes x 2, then every 1 hour x 2, then every 2 hours x 4, then every 4 hours for the duration of the PCA administration.

With any increase in rate or change in medications: A full set of vital signs shall be assessed and documented prior to change and then every 30 minutes x 2. If the patient remains stable, revert back to previous monitoring.

The Standards of Practice and Scope of Services-Acute Care Medical/Surgical Units read, vital signs should be measured every 4 hours or as ordered by the physician. Vital signs include heart rate, respirations, blood pressure, and temperature and pulse oximetry.

1. Nursing staff did not monitor Patient #3 who was on PCA, according to facility policy and unit standards.

a. Review of Patient #3's medical record revealed the patient admitted on [DATE] with a chief complaint of epigastric abdominal pain, nausea and vomiting.

Review of Patient #3's physician orders showed on 10/17/19 at 7:39 p.m., the patient's physician ordered a hydromorphone PCA (opioid medication used to treat moderate to severe pain) with an incremental dose at 0.5 milligrams (mg) every 15 minutes, and a basal rate from 11:00 p.m. until 6:00 a.m. Vital signs frequency was ordered in accordance with the Patient Controlled Analgesia (PCA) policy. Continuous pulse oximetry (monitors the oxygen saturation of a patient's blood)

On 10/17/19 at 8:09 p.m., Registered Nurse (RN) #13 documented the hydromorphone PCA was started.

Review of the clinical notes showed RN #13 documented vital signs at 8:14 p.m., 11:30 p.m., 4:01 a.m. However, according to PCA policy, additional vital signs should have been obtained to assess the patient's status at approximately 8:45 p.m., 9:15 p.m., 10:15 p.m., and 1:30 a.m. Moreover, the medical record showed no evidence RN #13 placed the patient on end-tidal CO2 monitoring (measures the concentration of carbon dioxide (CO2) at the end of an exhaled breath, which is expressed as a percentage of CO2 or mmHg) and continuous pulse oximetry as required by PCA policy and physician order.

On 10/18/19 at 7:30 a.m., RN #12 and RN #13 documented a PCA handoff. There was no evidence either nurse identified Patient #3 was not on the required and ordered monitoring.

Review of the 8:00 a.m. shift assessment by RN #12 revealed the patient had a small amount of yellow emesis. There were no documented vital signs found at the time the nurse assessed the patient. The last set of vital signs were obtained at 4:01 a.m., which was four hours prior to the day RN's assessment.

Based on the medical record above, RN #12 did not follow either the PCA policy or the Standards of Practice and Scope of Services-Acute Care Medical/Surgical Units; both policies state, at a minimum, patient vital signs should be obtained every 4 hours.

RN #12 documented a nurse note at 4:19 p.m. It read at 8:30 a.m., the patient called her to report she had vomited. RN #12 documented at 9:00 a.m., the patient was resting comfortably. RN #12 then documented at 9:50 a.m., she checked on the patient and found Patient #3 lying on her stomach and blue. A code blue (a medical emergency requiring immediate resuscitation) was called and compressions were started immediately.

A second RN (RN #15) documented a nurse note at 6:34 p.m. It read at 9:50 a.m., Patient #3 was found with her skin dusky throughout and face, around her mouth. The patient's nose was cyanotic. RN #15 documented the patient was unresponsive to deep and painful stimulation, without a pulse and the patient was flaccid. Cardiopulmonary resuscitation (CPR) was started. The note further read, later in the day, Patient #3 coded a second time and expired at 1:35 p.m.

b. Review of two physician notes showed Patient #3 had a prolonged period of hypoxemia prior to her cardiac arrest and the patient was unresponsive for an unknown period of time.

The Critical Care Consult note, documented on 10/18/19 at 12:43 p.m., revealed the duration of the patient's hypoxia was unclear and the CT (computed tomography) scan of the brain (x-ray images taken from different angles which allow physicians to see inside the body) showed diffuse anoxic (without oxygen) brain injury. Physician #16 documented the CT results implied Patient #3 had a prolonged period of hypoxemia aside from the duration of her cardiac arrest.

The Clinical note, documented on 10/18/19 at 11:46 a.m. by Physician #17, read the patient's prognosis was poor given she was unresponsive for an unknown period of time between nursing assessment.

c. On 12/19/19 at 8:40 a.m., Registered Nurse (RN) #12 was interviewed. Her interview confirmed she failed to follow both PCA policy and the Standards of Practice and Scope of Services-Acute Care Medical/Surgical Units on 10/18/19 in caring for Patient #3 on 10/18/19.

RN #12 stated she worked on various floors, including, medical/surgical, orthopedic/spine, oncology, BMT (bone marrow transplant) and telemetry. She said she remembered providing care to Patient #3 on 10/18/19. RN #12 said she met the patient during hand off when Patient #3 was awake, alert and independent.

RN #12 stated patients were monitored to make sure their vital signs were stable, blood pressure was not too low or too high, pulse was within normal limits and oxygen levels were looking okay; all of which would ultimately tell us how the patient is doing.

When questioned about her assessment of the patient at 8:00 a.m. on 10/18/19 when she did not obtain vital signs, RN #12 said there was nothing alarming during the patient's assessment; Patient #3 was nauseated so she was going to let her calm down before she obtained vital signs.

When asked if 6 hours was too long to wait for vital signs, RN #12 said not every patient was on an every 4-hour schedule. RN #12 said she had three other patients and one of them was an elderly patient who needed assistance. RN #12 stated she was not worried about Patient #3; if she had been worried or the patient sedated, she would have obtained vital signs. She stated, (Patient #3) seemed totally fine to me.

-However, contrary to RN #12's statements, standards of practice for the medical surgical unit required vital signs every four hours.

RN #12 confirmed patients on a PCA were to be monitored closely, but said Patient #3 was not on continuous pulse oximetry. She said the patient was a medical/surgical overflow patient in the intensive care unit (ICU) and therefore, pulse oximetry was every 4 hours with vital signs. She said continuous pulse oximetry was only for patients with a basal rate. She said this was facility policy across the board.

-However, contrary to RN #12's statements, PCA policy (see above) required patients on a PCA pump to receive pulse oximetry monitoring at all times for either a demand rate and/or basal rate. In addition, the patient had orders for continuous pulse oximetry.

When asked if there were any process changes since the events on 10/18/19 with Patient #3, RN #12 stated she was not sure. RN #12 stated she was invited to a meeting to review the event but she did not attend. She stated she had not received any education after the event.

d. On 12/19/19 at 11:02 a.m., Interim Staffing Office Manager (Manager #18) who was a RN was interviewed. She stated lack of monitoring contributed to the events involving Patient #3 on 10/18/19.

Manager #18, who said she had oversight of 60 employees, including nursing supervisors, critical care float nurses and medical-surgical float nurses, reviewed Patient #3's record. She stated monitoring would have made a difference in Patient #3's event.

She stated if the patient's oxygenation decreased and her end tidal CO2 went up, the monitor would have alarmed and someone would have gone into the room and checked on the patient. Manager #18 said if the monitor alarmed, staff could have done something if the alarm was accurate; she stated staff could have placed oxygen on the patient if she was not on oxygen, adjusted the PCA rates or turned the machine off, aroused the patient if needed to get her to breath and given reversal drugs. Manager #18 stated a lot could have been done to prevent what happened.

Manager #18 said when she spoke with RN #12 the day of the event, RN #12 was not aware Patient #3 was not on the required monitoring. Manager #18 stated she did not have a follow up conversation with RN #12 after the facility identified the patient was not on a continuous pulse oximetry. Manager #18 stated after the review of the event held on 11/11/19, she was told to have a coaching conversation with RN #12 but confirmed she had not.

2. Review of Patient #9 and #10's records revealed additional non-compliance with PCA policy and the Standards of Practice and Scope of Services-Acute Care Medical/Surgical Units following the above events with Patient #3.

a. Patient #9

Nursing staff did not monitor Patient #9 according to PCA policy

Patient #9's medical record revealed on 11/22/19 at 1:31 p.m., the patient's nurse scanned hydromorphone cartridge for the patient's PCA pump. Review of PACU (post-anesthesia care unit) notes documented by nursing staff showed from 1:04 p.m. until 3:20 p.m., the patient was in the recovery room when the hydromorphone PCA was started.

There was no evidence Patient #9 was placed on an etCO2 monitor while she was in the PACU.

At 3:21 p.m., nursing staff documented a handoff/chain of custody controlled substance. The documentation revealed the patient was on the hydromorphone PCA for two hours prior to handoff.

Review of nursing documentation, including controlled substance documentation and vital signs documentation, showed no evidence Patient #9 was placed on etCO2 monitoring at any time while she was on the medical/surgical floor.

Further, on 11/22/19 at 10:50 p.m., RN #19 documented she increased the patient's demand dose rate from 0.1 mg to 0.2 mg. According to PCA policy, at the time of the rate change, nursing staff should have obtained the patient's vital signs every 30 minutes x 2. There was no evidence nursing staff followed the policy. The next set of vital signs were not documented until 2:20 a.m., over two hours after the rate change.

Nursing staff from both the PACU and the medical/surgical floor did not follow the PCA policy. Patient #9's lack of monitoring occurred after the facility identified nursing staff's non-compliance as one of the root causes for Patient #'3's unexpected death.

b. Patient #10

Nursing staff did not evaluate a patient's vital signs every four hours according to unit standards.

Review of Patient #10's record revealed on 11/8/19, the patient was admitted to the 9th floor general medical surgical unit. According to the Standards of Practice and Scope of Services-Acute Care Medical/Surgical Units, vital signs should be measured every 4 hours or as ordered by the physician. Vital signs include heart rate, respirations, blood pressure, and temperature and pulse oximetry. However, on, 11/9/19, 11/10/19 and 11/11/19, nursing staff did follow policy and ensure the patient's vital signs were evaluated according to nursing standards of practice.

Specifically, on 11/9/19, nursing staff documented Patient #10's vital signs at 10:42 p.m. The next set of vital signs were not obtained until six hours later on 11/10/19 at 5:48 a.m. On the same day, the medical record showed no vital signs documentation from 5:48 a.m. until 2:16 p.m., which was an 8-hour gap. Further, from 2:16 p.m. until 11/11/19 at 6:30 a.m., a 16 hour timeframe, there was no evidence nursing staff obtained Patient #10's vital signs.

The Associate Chief Nursing Officer (Officer #6), interviewed on 12/26/19 at 11:45 a.m., confirmed nursing staff for Patient #10 did not obtain vital signs every 4 hours per the standards of practice for medical/surgical patients. He stated an 8-hour gap and a 16-hour gap was extremely concerning. Officer #6 said vital signs are done to track any potential changes in the patient's condition, including respiratory and cardiac changes and need to include temperature, pulse oximetry, respiratory rate and blood pressure.

Officer #6 stated the facility did not have a consistent process to validate vital signs were being done.

B. Monitoring of patients with change of condition post-operatively

The Code Blue-Adult Patients policy read a Code Blue is an event of cardiac or respiratory arrest (lack of pulse or breathing). BLS (Basic Life Support) were standards established by the American Heart Association. A Code Blue will be called to the operator (dial 5555) for patients who suffer cardiac or respiratory arrest.

According to the Basic Life Support (BLS) provider manual, the following steps should be taken to assess the patient: (1) Check responsiveness; (2) Activate the emergency response system; (3) Check for absent or abnormal breathing; (4) Check for pulse. If no pulse start CPR (cardiopulmonary resuscitation) and begin chest compressions.

1. Patient #2's change in condition:

Review of Patient #2's medical record revealed the patient admitted for outpatient sinus surgery on 10/14/19.

RN #11 documented a late entry from 10/14/19 at 1:00 p.m. in the medical record, that upon entering the operating room (OR) from lunch at 11:40 a.m., she noted the patient was extubated, on a stretcher for transfer to the post-operative area. Patient #2's oxygen saturation dropped, anesthesia re-intubated the patient with a laryngeal mask airway (medical device that keeps a patient's airway open during anesthesia or unconsciousness) and the patient's oxygen saturation went up to 80% (normal range 90% to 100%). RN #11 documented Patient #2's pulse then lowered to 31 (normal range 60 to 100) on the monitor and RN #11 notified the charge nurse of the patient's status change.

RN #11's note further read anesthesia administered epinephrine and she went to retrieve the crash cart. When the crash cart arrived, the patient's pulse was 29. RN #11 wrote she notified the charge nurse the patient's pulse was in the 20s. The charge nurse came to the patient's stretcher and another anesthesiologist came into room. Patient #2's pulse converted to asystole and a code blue was called.

2. The facility failed to ensure nursing staff followed the basic life support protocol - checking for a pulse - when Patient #2 experienced a change of condition.

Contrary to BLS protocol (see above), which directs that if a patient has absent or abnormal breathing a pulse should be checked to determine how to proceed and if CPR is required, there was no evidence in RN #11's note that indicated nursing staff physically evaluated Patient #2 to see if he had a palpable pulse at any time as his heart rate decreased below normal and he was re-intubated due to abnormal breathing.

Additionally, contrary to the facility's Code Blue policy, which states a code blue should be called to the operator (dial 5555) for patients who suffer cardiac or respiratory arrest, there was no evidence in RN #11's note that indicated the code blue for Patient #2 was called to the operator.

The charge nurse (RN #14) was interviewed on 12/18/19 at 4:29 p.m. She stated after a patient's procedure ended in the operating room (OR), nursing continues to monitor the patient for changes in status. She said sometimes the physical monitors are not accurate and it is important for nursing staff to continue to evaluate a patient's physical status.

She stated the process for a code blue was for the nurse in the room to call 5555; at that point, a charge nurse will request available staff to the OR. She stated other staff would show up to assist, including pharmacy, the intensive care unit charge nurse, and the house supervisor RN. She said if a nurse in the OR thought the patient was in a critical situation, she or he was encouraged to call a code blue if she or he thought the situation required it. She stated if a patient was pallor (unhealthy pale skin tone), nursing staff should check the patient's carotid pulse because the pulse tells staff about the patient's circulatory system (the heart was beating).

RN #14 stated Patient #2's event was an unfortunate situation. RN #14 said she was called by the patient's primary nurse (RN #11) and was told the patient's breathing tube was removed and his vital signs decreased, specifically, his blood pressure and oxygen saturation. RN #14 stated she was told the patient was going to be re-intubated. She said the same nurse then called her again, requesting help. RN #14 stated she grabbed Anesthesiologist #9 and went into the OR.

She said the anesthesiologist in the room (Anesthesiologist #8) was trying to read the monitor and trying to understand what was going on with the patient. RN #14 stated the patient did not have a great rhythm on the monitor, so she checked for a pulse, which the patient did not have. At that point, she said an overhead page was called for a code blue and compressions were started.

RN #14 stated the only thing she found unusual regarding the event were the timeframes. She stated once the code was initiated the process was like clockwork. She said she was concerned with the downtime after the laryngeal mask airway was placed and before Anesthesiologist #9 came in and took action based on the patient's skin color and pulse check. RN #14 stated anyone could have called the code, but the primary nurse (RN #11) felt intimidated by Anesthesiologist #8.

RN #14 stated the nurses in the OR were required to have BLS certification. RN #14 stated if she was the primary nurse in the OR that day, she would have called the code blue sooner.

Anesthesiologist #9, who was called to Patient #2's room on 10/14/19, was interviewed on 12/18/19 at 12:33 p.m. He stated when he arrived into the OR to help, there were discussions about how convincing the rhythm was on the monitor, specifically if the monitor reading was real. Anesthesiologist #9 stated he was concerned about the patient's skin color and with the patient's hypotension and bradycardia, he thought a pulse should be checked to ensure staff were not being fooled by the monitor readings.

Anesthesiologist #9 said it was not until he checked Patient #2's pulse that staff realized the monitor was not accurate. He stated the patient did not have a pulse and CPR was started.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document review, the facility failed to ensure an order was obtained from a physician, or other Licensed Independent Practitioner (LIP), for a patient prior to the patient being placed in physical restraints (Patient #10). The facility failed to obtain a renewal restraint order for a patient that remained in restraints after the initial restraint episode ended (Patient #11).

These failures created the potential for an unsafe patient care environment in which the responsible attending physicians or practitioners were not aware of patients' medical needs and current health status.

FINDINGS:

POLICY

According to the policy, Patient Restraints, an order for restraint must be obtained from an LIP/Physician who was responsible for the care of the patient prior to the application of restraint. The duration of an order for restraint with non-violent and non-self destructive behavior must not exceed 24 hours for the initial order. The order must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint and behavior-based criteria for release.

To continue restraint use beyond the initial order duration, the LIP/physician must see the patient, perform a clinical assessment and determine if continuation of restraint was necessary. If reassessment indicates an ongoing need for restraint, a new order must be written each calendar day by the LIP/Physician. Documentation requirements for restraint use include order for restraint and any renewal orders for restraint. The Chief Nursing Officer (CNO) provides leadership and organizational accountability for monitoring the safety, appropriateness, and necessity of restraint use.

1. The facility failed to obtain a restraint order for a patient prior to placing the patient in physical restraints.

a) On 01/10/16 Patient #10 was admitted for altered mental status and placed in restraints for his/her safety because s/he was disoriented and confused.

Review of the Clinical Documentation Record, 24 Hour Restraint Care Record for Patient Safety, and Rights and Dignity Check sheet each dated 01/10/16 at 7:00 a.m. revealed bilateral soft wrist restraints were placed on Patient #10 on 01/10/16 at 7:00 a.m. by Registered Nurse (RN) #11.

The facility obtained a Medical Doctor (MD) order at 11:25 a.m. on 01/11/16, more than 28 hours after the restraints were applied to Patient #10's bilateral upper extremities (BUE).

b) On 02/03/16 at 11:40 a.m., an interview was conducted with RN #14. S/he stated nursing staff needed a physician's order before restraints were applied. Further, s/he stated physicians were readily available to write a restraint order in emergency situations, and physicians went directly into the patient's room and assessed the patient before writing an order for restraints.

c) On 02/04/16 at 2:40 p.m., an interview was conducted with Clinical Nurse Coordinator (CNC) #1. S/he stated nursing staff needed to get a physician's order before placing a patient in restraints.

d) On 02/04/16 at 3:21 p.m., an interview was conducted with Director #2. The Director stated the expectation was for nursing staff to always get a physician's order before placing restraints on a patient, and in emergency situations, the physician should be notified as soon as possible to obtain a restraint order. S/he stated there were always physicians in the Intensive Care Unit (ICU), which made it easy to obtain a restraint order within minutes.

e) On 02/09/16 at 8:45 a.m., an interview was conducted with the Chief Nursing Officer (CNO #5). The CNO stated the physician had to complete a face-to-face assessment of the patient prior to writing a restraint order. Further, s/he stated in an emergency situation an order had to be received within minutes of applying the restraints, and all restrained patients should have a current restraint order in the medical record.

2. The facility failed to obtain a renewal restraint order for a patient that continued to be in restraints after the initial restraint episode ended.

a) Patient #11 was admitted on [DATE] with altered mental status.

Review of Patient #11's IDEV - Discharge Report, dated 01/28/16, revealed an initial order for a non-violent, BUE, soft restraint was received on 01/24/16 at 8:22 p.m. by MD #13. The order expiration time was 01/25/16 at 8:22 p.m., 24 hours later.

b) During an interview conducted with the CNO on 02/09/16 at 8:45 a.m., the CNO stated all restrained patients needed to have a current MD order in their medical record. S/he stated standing or as needed orders could not be used, and physicians had to do a face-to-face assessment of the patient. In the event of an emergency, restraints could be applied to a patient, but a MD order had to be obtained and placed in the patient's medical record within minutes of the patient being restrained.

c) Review of the Clinical Documentation Record, dated 01/25/16, showed Patient #11's condition changed, and the patient required additional restraints due to combative behavior. A new physician's restraint order was obtained, which expired four hours later.

Record review revealed restraints were applied to Patient #11's four extremities on 01/25/16 at 2:20 p.m., and the patient's response to the restraint was Combative. The Restraints Monitor also revealed a restraint notification to a physician was made. The order expiration time was 01/25/16 at 6:38 p.m., 4 hours later.

d) During an interview conducted on 02/04/16 at 2:40 p.m. with CNC #1, the CNC stated the expectation of nursing staff related to behavioral restraint orders was to keep the patient safe, apply restraints, and have a MD come see the patient immediately and provide a written order for the restraint. The CNC stated behavioral restraint orders were only valid for 4 hours. Further, s/he stated if the patient was ready to transition from 4 point restraints (a behavioral restraint order) to 2 point restraints (a non-violent, medical restraint order), a separate discussion would have needed to take place with the MD. A new physician's order for restraints would need to be obtained because patients could not be transitioned from a behavioral restraint order to a medical 24-hour restraint order without the MD writing a new order.

There was no documentation a new restraint order for Patient #11 was obtained as the CNC specified.

e) Review of Patient #11's Restraints Monitor, dated 01/25/16, revealed the patient was in soft wrist restraints to all extremities (4 point restraints) at 3:00 p.m., 4:00 p.m., and 5:00 p.m. At 6:00 p.m., a change occurred and Patient #11 was restrained using BUE soft restraints only.

No new restraint orders were located within the medical record for Patient #11, despite the patient being restrained from 6:00 p.m. on 01/25/16 until 01/26/16 at 4:00 a.m., which resulted in an additional 10 hours without a restraint order from a LIP or physician.

f) During an interview conducted on 02/04/16 at 3:21 p.m. with the Director, s/he stated the expectation of nursing staff was that MD orders were obtained and documented when restraints were used. Specifically, s/he stated behavioral restraint orders needed to be renewed every 4 hours.

The Director stated if a patient was ready to transition from behavioral restraints (4 point restraints) to medical restraints (2 point restraints), the expectation of nursing staff was to have a conversation with a MD.

Further, the Director stated s/he would expect the RN to notify the MD that the patient had transitioned from behavioral to medical restraint use, and the expectation was both the MD notification and the new MD order should occur within minutes of the restraint being changed. The Director stated the ICU was fortunate that they always had access to a MD within the ICU setting to obtain such orders.

The facility failed to obtain a physician's order to transition Patient #11 from behavioral to medical restraints which resulted in the patient being restrained after the initial order expired.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation º482.23, NURSING SERVICES, was out of compliance.

A-0395: A registered nurse must supervise and evaluate the nursing care for each patient. The facility failed to ensure nursing staff reassessed the patient after a change in condition that warranted additional nursing assessments and prior to administering a medication. Additionally, the facility failed to ensure nursing staff obtained a physician's order for a patient prior to the patient being placed in physical restraints and failed to obtain a renewal restraint order for a patient that remained in restraints after the initial restraint episode ended (Patients #10 and #11). These failures resulted in the patient receiving a medication without a nursing assessment to ensure the medication was warranted when administered. Further these failures created the potential for an unsafe patient care environment in which the responsible attending physicians or practitioners were not aware of patients' medical needs and current health status.

A-0398: Non-employee licensed nurses who are working in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel which occur within the responsibility of the nursing services. The facility failed to ensure contracted personnel (Registered Nurses #8 and #9) adhered to the facility's policies. Specifically, the facility failed to ensure contracted nursing staff obtained a renewal restraint order for a patient that remained in restraints for 10 hours after the initial restraint episode ended. This failure resulted in patients not having a physician's order for restraints while being restrained and created the potential for negative outcomes.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document review, the facility failed to ensure nursing staff reassessed a patient after the patient experienced a change in condition that warranted additional nursing assessments and prior to administering a medication that was ordered before the change of condition in 1 of 1 records reviewed where a change in condition occurred without a reassessment (Patient #11)

Additionally, the facility failed to ensure nursing staff obtained a physician's order for a patient prior to the patient being placed in physical restraints and failed to obtain a renewal restraint order for a patient that remained in restraints after the initial restraint episode ended (Patients #10 and #11).

This failure resulted in a patient receiving a medication after experiencing a change in condition without a nursing assessment to ensure the medication was warranted when administered. Further these failures created the potential for an unsafe patient care environment in which the responsible attending physicians or practitioners were not aware of patients' medical needs and current health status.

FINDINGS:

POLICY

According to the policy, Adult Fall Prevention Guidelines, if a patient falls, the following is initiated: assess immediately for evidence of injury before moving the patient.

According to the policy, Patient Restraints, an order for restraint must be obtained from an LIP/Physician who was responsible for the care of the patient prior to the application of restraint. The duration of an order for restraint with non-violent and non-self destructive behavior must not exceed 24 hours for the initial order. The order must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint and behavior-based criteria for release.

To continue restraint use beyond the initial order duration, the LIP/physician must see the patient, perform a clinical assessment and determine if continuation of restraint was necessary. If reassessment indicates an ongoing need for restraint, a new order must be written each calendar day by the LIP/Physician. Documentation requirements for restraint use include order for restraint and any renewal orders for restraint. The Chief Nursing Officer (CNO) provides leadership and organizational accountability for monitoring the safety, appropriateness, and necessity of restraint use.

REFERENCE

According to the Lippincott Manual of Nursing Practice 10th Edition, (pp. 1210), subsequent assessment for patients with a head injury includes assessing level of consciousness. Change in mental status is the most sensitive indicator of a change in the patient's condition. Subsequent assessments for patient with a head injury also include vital sign collection. Patients who have sustained a head injury may have associated irregular heartbeat, noted by an irregular or rapid pulse.

According to the Mosby's 2013 Nursing Drug Reference 26th Edition, (pp. 605), Cardiovascular Side Effects for Haloperidol Lactate include: orthostatic hypotension, hypertension, heart rhythm changes, rapid heart rate and sudden death.

1. Patient #11's medical record lacked evidence the patient was reassessed after a change of condition that warranted additional nursing assessments and before administering a medication that was ordered prior to the change of condition.

a) Record review of Patient #11's Clinical Documentation Record, dated, 01/26/16 at 6:38 a.m. showed Registered Nurse #9 (RN) documented the patient woke up agitated, at approximately 4:00 a.m., tore his/her restraints off and jumped out of bed, which led to the patient removing his/her peripheral IV, monitoring equipment, and Foley catheter. S/he documented the patient left his/her room and stumbled into the Intensive Care Unit (ICU), the patient was agitated, not following commands, and non-verbal.

RN #9 documented a MD (Physician) was notified at 4:05 a.m. of Patient #11's agitation and a verbal order for Haldol 10 MG (an antipsychotic medication used in the treatment of schizophrenia, delirium, agitation, acute psychosis and hallucinations in alcohol withdrawal) was received to be given intramuscularly (IM) due to the loss of the patient's intravenous (IV) access.

RN #9 documented Patient #11 hit his/her head twice on a nursing station desk which left two lacerations to the patient's forehead. RN #9 noted Patient #11 was placed back in his/her bed about 4:10 a.m. and leather restraints were applied. S/he documented Patient #11 was breathing but lethargic and Haldol was given.

There was no documentation a nursing assessment was completed after the patient hit his/her head and experienced a change in condition and prior to the administration of Haldol.

b) Review of a Condensed Activity Report, dated 01/26/16, showed Security Officer (SO) #17 documented Patient #11 was placed in 4 point restraints (all four extremities were restrained), right arm up, left arm down, and both legs when s/he was returned to bed after the fall.

c) Review of a Medication Discharge Summary, revealed Haldol 10 mg IM was given on 01/26/16 at 4:12 a.m. The Medication Summary revealed the injection site was Patient #11's right thigh, and the most common medication side effects were reviewed with the patient, including decreased blood pressure.

However, given the facility documented the patient was lethargic and recently sustained a head injury it was not evident if Patient #11 understood what was reviewed with him/her regarding medication side effects.

d) On 02/03/16 at 11:40 a.m. an interview with RN #15 was conducted. S/he stated Haldol should not be given to a patient who was lethargic due to its additional sedative effect. RN #15 stated Haldol could compromise a patient's airway and the nurse should continue to monitor and reassess the patient after a baseline assessment and vital signs were collected.

e) During an interview, on 02/04/16 at 2:00 p.m., Charge RN #3 stated nursing assessments and vital signs should have been completed before administering Haldol to a patient. S/he stated his/her expectation was that Haldol would be held if a patient was too sedated, and s/he would expect nursing staff to hold Haldol if a patient was lethargic and reassess the patient at a later time.

Charge RN #3 acknowledged RN #21 administered Haldol for RN #9, who was the primary RN taking care of Patient #11 the morning of 01/26/16. S/he also stated a blood pressure and pulse were not collected prior to RN #21 administering Haldol to Patient #11, after s/he sustained a fall and change in condition, nor was the patient hooked up to cardiac monitoring equipment prior to the administration of Haldol.

f) On 02/04/16 at 2:40 p.m., an interview was conducted with the ICU Clinical Nurse Coordinator (CNC #1). S/he stated nurses were required to perform a patient assessment before administering Haldol and s/he expected nurses to assess if the patient was alert and oriented and could follow commands. The CNC stated a patient should be placed on a cardiac monitor before administering Haldol to assess for cardiac rhythm changes, and s/he expected nurses to not administer Haldol if a patient was lethargic. S/he stated nurses should not administer Haldol to a patient who had just sustained a head injury.

g) An interview with the Director of the Adult ICU (Director #2) was conducted on 02/04/16 at 3:21 p.m. S/he stated his/her expectation was for nursing staff to assess the patient's level of consciousness, agitation level, and cardiac monitoring prior to Haldol being administered.

h) An interview was conducted on 02/09/16 at 8:45 a.m. with the Chief Nursing Officer (CNO #5). S/he stated the expectation when administering Haldol IM was for nurses to collect, assess, and document vital signs. S/he stated Haldol IM would be held if the patient were not responsive, or if the patient's blood pressure or heart rate were low. The CNO stated s/he expected nursing staff to call the physician if there was a change in patient condition. The CNO stated RN #21 did not meet facility expectations for collecting vital signs, and did not meet facility expectations for a nursing reassessment before s/he administered Haldol IM to Patient #11.

There was no documentation the facility reassessed the patient after s/he experienced a fall and change in condition and prior to administering Haldol.

According to the Patient Notes, dated 01/26/16 at 6:36 a.m., RN #9 documented a code (an emergency situation in which a patient is in cardiopulmonary arrest) was called at approximately 4:11 a.m. on 01/26/16 and Patient #11 was declared deceased at 4:34 a.m.

2) Nursing staff failed to assess Patient #11 for injuries after s/he suffered a fall.

a) Record review of the Risk Management Report, dated 01/26/16, revealed RN #9 documented Patient #11 slipped in his/her blood, fell to the floor and sustained two lacerations to his/her forehead. RN# 9 documented the patient was lethargic; however, no further assessment was done including vital signs.

b) An interview with Charge RN #3 was conducted on 02/04/16 at 2:00 p.m. Charge RN #3 stated if a patient sustained a fall in the ICU, the expectation of nursing staff was to initially check the patient for any injuries prior to moving the patient, which included an assessment to check if the patient was alert and oriented, and if the patient had a change in condition.

c) On 02/04/16 at 2:40 p.m., an interview was conducted with CNC #1 . S/he stated if a patient fell in the ICU the expectation of nursing staff was to assess the patient before moving him/her back to the bed. The CNC stated the assessment should include vital signs, if the patient was alert and orientated, whether or not the patient could follow commands, and a visual assessment.

d) An interview with Director #2 was conducted on 02/04/16 at 3:21 p.m. The Director stated if a patient sustained a fall, the expectation of nursing staff would have been to collect and document the patient's vital signs in his/her medical record.

There was no documentation in the clinical record to show Patient #11 was assessed after his/her fall.

3. Nursing staff failed to obtain a restraint order for a patient prior to placing the patient in physical restraints.

a) On 01/10/16 Patient #10 was admitted for altered mental status and placed in restraints for his/her safety because s/he was disoriented and confused.

Review of the Clinical Documentation Record, 24 Hour Restraint Care Record for Patient Safety, and Rights and Dignity Check sheet each dated 01/10/16 at 7:00 a.m. revealed bilateral soft wrist restraints were placed on Patient #10 on 01/10/16 at 7:00 a.m. by Registered Nurse (RN) #11.

The facility obtained a Medical Doctor (MD) order for restraints at 11:25 a.m. on 01/11/16, more than 28 hours after the restraints were applied to Patient #10's bilateral upper extremities (BUE).

b) On 02/03/16 at 11:40 a.m., an interview was conducted with RN #14. S/he stated nursing staff needed a physician's order before restraints were applied. Further, s/he stated physicians were readily available to write a restraint order in emergency situations, and physicians went directly into the patient's room and assessed the patient before writing an order for restraints.

c) On 02/04/16 at 2:40 p.m., an interview was conducted with Clinical Nurse Coordinator (CNC) #1. S/he stated nursing staff needed to get a physician's order before placing a patient in restraints.

d) On 02/04/16 at 3:21 p.m., an interview was conducted with Director #2. The Director stated the expectation was for nursing staff to always get a physician's order before placing restraints on a patient, and in emergency situations, the physician should be notified as soon as possible to obtain a restraint order. S/he stated there were always physicians in the Intensive Care Unit (ICU), which made it easy to obtain a restraint order within minutes.

e) On 02/09/16 at 8:45 a.m., an interview was conducted with the Chief Nursing Officer (CNO #5). The CNO stated the physician had to complete a face-to-face assessment of the patient prior to writing a restraint order. Further, s/he stated in an emergency situation an order had to be received within minutes of applying the restraints, and all restrained patients should have a current restraint order in the medical record.

4. Nursing staff failed to obtain a renewal restraint order for a patient that continued to be in restraints after the initial restraint episode ended.

a) Patient #11 was admitted on [DATE] with altered mental status.

Review of Patient #11's IDEV - Discharge Report, dated 01/28/16, revealed an initial order for a non-violent, BUE, soft restraint was received on 01/24/16 at 8:22 p.m. by MD #13. The order expiration time was 01/25/16 at 8:22 p.m., 24 hours later.

b) During an interview conducted with the CNO on 02/09/16 at 8:45 a.m., the CNO stated all restrained patients needed to have a current MD order in their medical record. S/he stated standing or as needed orders could not be used, and physicians had to do a face-to-face assessment of the patient. In the event of an emergency, restraints could be applied to a patient, but a MD order had to be obtained and placed in the patient's medical record within minutes of the patient being restrained.

c) Review of the Clinical Documentation Record, dated 01/25/16, showed Patient #11's condition changed, and the patient required additional restraints due to combative behavior. A new physician's restraint order was obtained, which expired 4 hours later, on 01/25/16 at 6:38 p.m.

Record review revealed restraints were applied to Patient #11's four extremities on 01/25/16 at 2:20 p.m., and the patient's response to the restraint was Combative. The Restraints Monitor form also revealed a restraint notification to a physician was made. The order expiration time was 01/25/16 at 6:38 p.m., 4 hours later.

d) During an interview conducted on 02/04/16 at 2:40 p.m. with CNC #1, the CNC stated the expectation of nursing staff related to behavioral restraint orders was to keep the patient safe, apply restraints, and have a MD come see the patient immediately and provide a written order for the restraint. The CNC stated behavioral restraint orders were only valid for 4 hours.

Further, s/he stated if the patient was ready to transition from 4 point restraints (a behavioral restraint order) to 2 point restraints (a non-violent, medical restraint order), a separate discussion would have needed to take place with the MD. A new physician's order for restraints would need to be obtained because patients could not be transitioned from a behavioral restraint order to a medical 24-hour restraint order without the MD writing a new order.

There was no documentation a new restraint order for Patient #11 was obtained as the CNC specified.

e) Review of Patient #11's Restraints Monitor, dated 01/25/16, revealed the patient was in soft wrist restraints to all extremities at 3:00 p.m., 4:00 p.m., and 5:00 p.m. At 6:00 p.m., a change occurred and Patient #11 was restrained using BUE soft restraints only.

No new restraint orders were located within the medical record for Patient #11, despite the patient being restrained from 01/25/16 at 6:00 p.m. until 01/26/16 at 4:00 a.m., which resulted in an additional 10 hours without a restraint order from a LIP or physician.

f) During an interview conducted on 02/04/16 at 3:21 p.m. with the Director, s/he stated the expectation of nursing staff was that MD orders were obtained and documented when restraints were used. Specifically, s/he stated behavioral restraint orders needed to be renewed every 4 hours. The Director stated if a patient was ready to transition from behavioral restraints (4 point restraints) to medical restraints (2 point restraints), the expectation of nursing staff was to have a conversation with a MD.

Further, the Director stated s/he would expect the RN to notify the MD that the patient had transitioned from behavioral to medical restraint use, and the expectation was both the MD notification and the new MD order should occur within minutes of the type of restraint being changed. The Director stated the ICU was fortunate that they always had access to a MD within the ICU setting to obtain such orders.

The facility failed to obtain a physician's order to transition Patient #11 from behavioral to medical restraints which resulted in the patient being restrained after the initial order expired.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document reviews, the facility failed to ensure contracted personnel (Registered Nurses #8 and #9) adhered to the facility's policies. Specifically, the facility failed to ensure contracted nursing staff obtained a renewal restraint order for a patient that remained in restraints for 10 hours after the initial restraint episode ended.

This failure resulted in patients not having a physician's order for restraints while being restrained and created the potential for negative outcomes. Further, the failure created the potential for an unsafe patient care environment in which the responsible attending physicians were not aware of patients' medical needs and current restraint status.

FINDINGS:

POLICY

According to the policy, Patient Restraints, an order for restraint must be obtained from an LIP/Physician who was responsible for the care of the patient prior to the application of restraint. The duration of an order for restraint with non-violent and non-self destructive behavior must not exceed 24 hours for the initial order. The order must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint and behavior-based criteria for release.

To continue restraint use beyond the initial order duration, the LIP/physician must see the patient, perform a clinical assessment and determine if continuation of restraint was necessary. If reassessment indicates an ongoing need for restraint, a new order must be written each calendar day by the LIP/Physician. Documentation requirements for restraint use include order for restraint and any renewal orders for restraint.

The Chief Nursing Officer (CNO) provides leadership and organizational accountability for monitoring the safety, appropriateness, and necessity of restraint use.

1. The facility failed to ensure non-employee (contracted) nursing personnel adhered to facility policies and protocols by neglecting to obtain a renewal restraint order for a patient.

a) Patient #11 was admitted on [DATE] with altered mental status. Review of the Restraints Monitor Form, dated 01/25/16, revealed contracted personnel (Registered Nurses #8 and #9, RN) provided services for Patient #11 on 01/25/16.

Review of Patient #11's IDEV - Discharge Report, dated 01/28/16, revealed an initial order for a non-violent, BUE, soft restraint was received on 01/24/16 at 8:22 p.m. by MD #13 (Medical Doctor). The order expiration time was 01/25/16 at 8:22 p.m., 24 hours later.

b) During an interview conducted with the Chief Nursing Officer (CNO #5) on 02/09/16 at 8:45 a.m., the CNO stated all restrained patients needed to have a current physician's order in their medical record. S/he stated standing or as needed orders could not be used, and physicians had to do a face-to-face assessment of the patient. In the event of an emergency, restraints could be applied to a patient, but a MD order had to be obtained and placed in the patient's medical record within minutes of the patient being restrained.

c) Review of the Clinical Documentation Record, dated 01/25/16, showed Patient #11's condition changed, and the patient required additional restraints due to combative behavior. A new physician's restraint order was obtained, which expired 4 hours later.

Record review revealed restraints were applied to Patient #11's four extremities on 01/25/16 at 2:20 p.m., and the patient's response to the restraint was Combative. The Restraints Monitor also revealed a restraint notification to a physician was made. The order expiration time was 01/25/16 at 6:38 p.m., 4 hours later.

d) During an interview conducted on 02/04/16 at 2:40 p.m. with the Clinical Nurse Coordinator (CNC #1), the CNC stated the expectation of nursing staff related to behavioral restraint orders was to keep the patient safe, apply restraints, and have a MD come see the patient immediately and provide a written order for the restraint. The CNC stated behavioral restraint orders were only valid for 4 hours. Further, s/he stated if the patient was ready to transition from 4 point restraints (a behavioral restraint order) to 2 point restraints (a non-violent, medical restraint order), a separate discussion would have needed to take place with the MD. A new physician's order for restraints would need to be obtained because patients could not be transitioned from a behavioral restraint order to a medical 24-hour restraint order without the MD writing a new order.

There was no documentation a new restraint order for Patient #11 was obtained by RN #8 or RN #9 as the CNC specified.

e) Review of Patient #11's Restraints Monitor, dated 01/25/16, revealed the patient was in soft wrist restraints to all extremities at 3:00 p.m., 4:00 p.m., and 5:00 p.m. At 6:00 p.m., a change occurred and Patient #11 was restrained using BUE soft restraints only.

No new restraint orders were located within the medical record for Patient #11, despite the patient being restrained from 01/25/16 at 6:00 p.m. until 01/26/16 at 4:00 a.m., which resulted in an additional 10 hours without a restraint order from a LIP or physician.

f) During an interview conducted on 02/04/16 at 3:21 p.m. with the Director (Director #2), s/he stated the expectation of nursing staff was that MD orders were obtained and documented when restraints were used. Specifically, s/he stated behavioral restraint orders needed to be renewed every 4 hours.

The Director stated if a patient was ready to transition from behavioral restraints (4 point restraints) to medical restraints (2 point restraints), the expectation of nursing staff was to have a conversation with a MD.

Further, the Director stated s/he would expect the RN to notify the MD that the patient had transitioned from behavioral to medical restraint use, and the expectation was both the MD notification and the new MD order should occur within minutes of the type of restraint being changed. The Director stated the ICU was fortunate that they always had access to a MD within the ICU setting to obtain such orders.

The facility failed to ensure contracted staff obtained a physician's order to transition Patient #11 from behavioral to medical restraints which resulted in the patient being restrained after the initial order expired.