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Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.13, PATIENT RIGHTS, was out of compliance.

A-0122 At a minimum: the grievance process must specify time frames for review of the grievance and the provision of a response. Based on interviews and document review, the facility failed to ensure grievances were responded to within the specified time frame in four out of ten grievances reviewed (Patients E, F, G and H).

A-0143 The patient has the right to personal privacy. Based on observations, interviews and document reviews, the facility failed to have a process in place to ensure the personal privacy of six patients who, by observation and record review, received care while placed in hall beds located in the emergency department's corridors (Patients #22, #23, #24, #27, #25, and #28).

A-0144 The patient has the right to receive care in a safe setting. Based on interviews and document reviews, the facility failed to follow processes to ensure patient safety. The facility failed to ensure a patient's physician was notified by staff, prior to the patient leaving the emergency department (ED) without being evaluated, in one of one medical records reviewed for a missing patient (Patient #11). Additionally, the facility failed to ensure leadership, who were assigned patient safety events, followed policy. Specifically, leadership failed to investigate one of three ED patient safety events reviewed for restraints (Patient #16). The facility failed to ensure follow up and an action plan was implemented in one of one "missing patient" safety events reviewed (Patient #11).

A-0175 The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed independent practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. Based on interviews and document review, the facility failed to ensure patients placed in restraints and seclusion were monitored and assessed according to the facility's standards in one of one inpatient behavioral health patient's medical record reviewed for restraint/seclusion (Patient #29).

A-0213 [Death Reporting Requirements: Hospitals must report deaths associated with the use of seclusion or restraint.]
(1) With the exception of deaths described under paragraph (g) (2) of this section, the hospital must report the following information to CMS by telephone, facsimile, or electronically, as determined by CMS, no later than the close of business on the next business day following knowledge of the patient's death: (i) Each death that occurs while a patient is in restraint or seclusion. (ii) Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion. (iii) Each death known to the hospital that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death, regardless of the type(s) of restraint used on the patient during this time."Reasonable to assume" in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation....(3) The staff must document in the patient's medical record the date and time the death was: (i) Reported to CMS for deaths described in paragraph (g)(1) of this section; or ....
Based on interviews and document reviews, the facility failed to adhere to death reporting requirements for the Centers for Medicare and Medicaid Services (CMS). The death of a patients who expired within 24 hours after being restrained by roll belts, four side rails and mitts, were not reported to CMS in six of six patients required to be reported according to the regulation (Patients A, B, C, D, I, and J).

Based on interviews and document review, the facility failed to ensure grievances were responded to within the specified time frame in four out of ten grievances reviewed (Patients E, F, G and H).

Findings include:

Facility policy:

The Patient Complaint and Grievance policy read, all grievances in a formal investigation and the patient is notified within three days that the investigation has been initiated on their behalf.

1. The facility failed to ensure acknowledgement of grievances submitted by patients were completed within its specified time frames.

a. Review of the following four grievances revealed no evidence acknowledgement letters were sent to the family members within the required three days to notify them an investigation was initiated on their behalf. This conflicted with facility policy.

Patient E's grievance showed the patient's family member contacted the facility on 12/20/18 regarding an issue with a care provider.

Patient F's grievance revealed a family member filed a grievance on 12/20/18 for concerns with a care provider and the patient's treatment plan. An acknowledgement letter was not mailed until 1/2/19, which was 13 days after the grievance was initiated.

Review of Patient H's grievance, filed by a family member on 12/26/18, showed the facility was notified about concerns with a care provider.

Patient G's grievance, dated 1/14/19, showed the patient's family member contacted the facility with concerns about the patient's discharge plan.

All four grievances were either assigned to Patient Representative #10 or Patient Representative #23, for follow up.

b. On 2/19/19 at 2:44 p.m., an interview was conducted with Patient Representative #10, who stated she had worked at the facility for two years. She said she received on the job training from her previous manager.

Patient Representative #10 stated an acknowledgement letter was to let the person who filed the grievance know an internal review process was started. She said the letter should be mailed within three days. However, Patient Representative #10 said she was trained to mail three day acknowledgement letters for grievances only related to billing. She reported acknowledgement letters would not be mailed for concerns not related to billing.

Based on observations, interviews and document reviews, the facility failed to have a process in place to ensure the personal privacy of six patients who, by observation and record review, received care while placed in hall beds located in the emergency department's corridors (Patients #22, #23, #24, #27, #25, and #28).

Findings include:

Reference:

The Patient Rights and Responsibilities read, the patient had the right to personal privacy including the right to be interviewed and examined in surroundings designed to assure reasonable audio and visual privacy.

1. The Emergency Department (ED) staff provided care to patients in hall beds, located within the department corridors, without ensuring a uniform process was in place to protect patients' personal privacy and sensitive patient-staff confidentiality.

a. On 2/12/19 at 4:13 p.m., a tour of the ED was conducted with ED Nurse Manager (Manager #3). The ED had 25 beds which included two dedicated trauma rooms. Review of the public patient tracker located behind the nursing station showed additional rooms; H1, H2, H3, H4 and H5. Patient names were located on the tracker next to H1, H2 and H4 (Patients #22, #23 and #24). Four patients were in the waiting room.

Inspection of the ED confirmed hall beds (H1, H2 and H4) were in use. A laminated sign which read "Hall 1" was located on the wall across from ED Room #1. A laminated sign which read "Hall 2" was posted on the wall between ED rooms #1 and #2. Another two laminated signs were observed posted in the corridors; "Hall 3" sign was located on the wall between the security officer's cove and ED room #1; "Hall 4" sign was posted on the wall between ED rooms #17 and #18.

Patient #22 was in "Hall 2" bed.

Patient #23 was in "Hall 3" bed.

Patient #24 was in "Hall 4" bed.

All three patients in the hall beds were visible to other patients and visitors to the ED.

Continued tour of the ED revealed five empty rooms which were not occupied by patients: ED rooms #5, #12, #21 and Trauma rooms #1 and #2.

Manager #3 stated hall beds were used occasionally for overflow or if the patient "needed to have eyes on them." He said patients placed in the hall beds would be non-critical patients. Manager #3 stated conversations between patients and providers generally happened in the hallway.

At 4:39 p.m., an ED technician (Tech #13) was observed having a conversation with Patient #23. Tech #13 stated to Patient #23 she was "going to place a splint on" the patient's arm, until the patient could see an orthopedic provider. At 4:40 p.m., Physician Assistant (PA #14) spoke to the patient about her care. Both conversations took place in the open corridor. PA #14 stated he did not want to cast the patient's arm because her arm would swell a little bit. PA #14 then talked to the patient about pain control to include the use of ice, ibuprofen and Vicodin (a pain reliever).

Tech #13 proceeded to splint Patient #23's right arm while in Hall #3 bed.

b. Review of Patient #22's and Patient #24's medical records, dated 2/12/19, was conducted. The following patient care was provided while the patients were in the ED halls.

According to Patient #22's, ED course/Re-evaluation documented by Physician #24, the physician discussed with the patient the results of the patient's X-ray and the follow-up care required after her discharge from the ED. Physician #24 also documented in Patient #22's ED record, she conducted a physical exam of the patient's right ankle and foot.

According to Patient #24's ED Provider Report, PA #14 documented a physical exam of the patient's lower extremities was conducted. PA #14 documented the patient had ecchymosis (bruising) and swelling to his left ankle. Prior to departure, the patient was placed in a splint.

c. On 2/15/19 at 4:00 p.m., Registered Nurse (RN) #15, who was the nurse responsible for Patients #22, #23 and #24's care on 2/12/19, was interviewed. He stated he worked three days a week and hall beds were used maybe 50% of the time in a two week period. RN #15 stated an increased number of patients usually occurred around the first couple of weeks when the local college students would return for class and also during ski season when the ED would get a lot of patients from the local ski mountain.

RN #15 said there was no way to protect patient's privacy. He stated the patient could request a private room if needed.

d. Three patient safety events and their corresponding medical records were reviewed for use of hall beds in the ED. The following were examples of patient care provided while Patients #27, #25 and #28 were in hall beds, without any evidence in the medical records which showed how the patient's privacy was maintained.

Patient #27's safety event report, dated 1/24/19, showed the patient was brought into the ED by the local police department. The patient was placed in Hall #1 bed due to the ED fullness and the lack of notification from the police department prior to the patient's arrival. Review of Patient #27's ED audit trail showed the patient arrived to the ED at 6:38 p.m. and was then placed in hall bed #1. According to the audit trail, Patient #27 was in the hall bed from 6:38 p.m. until 7:24 p.m. Patient #27 was in the hall bed for a total of 46 minutes before she was placed in ED room #19.

Review of Patient #27's medical record showed the following care was provided while the patient was in the ED hallway. At 6:47 p.m., ED RN #25 documented a triage assessment was conducted. RN #25 documented the patient's vital signs were assessed, including blood pressure, heart rate and temperature. The RN behavioral health assessment revealed the patient answered questions about suicidal thoughts, alcohol use, and methamphetamine use and prescribed medications taken for anxiety, depression or other psychiatric disorders.

Patient #25's safety event report, dated 1/7/19, revealed the patient was brought into the ED by the local police department at 7:40 p.m. According to the ED audit trail for Patient #25, the patient remained in the hall bed for his entire stay. The patient was discharged at 8:58 p.m., one hour and 18 minutes later.

Review of the patient's medical record revealed the following care was conducted while the patient was in the ED hallway. According to the ED Provider Report, the patient's physician asked the patient about his drinking patterns, urinary symptoms, bowel movements and if the patient had any suicidal or homicidal thoughts. The ED physician documented the patient's lungs were clear to auscultation (the act of listening to sounds), the patient was assessed for murmurs (sound of blood flowing through the heart), his abdomen was soft with diffused tenderness to palpation and the patient's bowel sounds were present.

Review of Patient #28's safety event report, dated 3/8/18, showed at 7:45 p.m., the patient was brought to the ED by the local police department. According to the brief description on the report, the patient was very loud and uncooperative. Later the patient was placed on an M1 hold (an involuntary mental health hold) and then moved to ED room #19. According to the ED audit trail for Patient #28, the patient was placed in room #19 at 8:05 p.m., 20 minutes after arrival.

Review of the patient's medical record showed the initial RN assessment was conducted at 19:52 (7:52 p.m.). According to RN #26's General Complaint Assessment, the nurse documented the patient's abdomen was soft.

e. On 2/19/19 at 1:18 p.m., an interview was conducted with the Assistant Vice President for Nursing (VP #9) who was responsible for oversight of the ED. She stated the facility had not identified any issue with the use of hall beds. VP #9 stated the use of hall beds was to make the patient stay faster and to get the patients in and out. VP#9 stated the facility never looked at the use of a hall beds from a safety or privacy stand point.

VP #9 stated the facility was not tracking the utilization of hall bed usage. VP #9 said the facility did not think hall beds were overused prior to the survey. She said some days there were no hall beds used, then other days the ED was full and hall beds were in use.

f. On 2/19/19 at 3:06 p.m., an interview was conducted with Manager #3. He stated hall beds were a part of the ED department's normal usage for the overflow of patients.

g. On 2/18/19 at 9:01 a.m., ED Charge RN (Registered Nurse) #16 was interviewed. He stated the ED department would use hall beds dependent on how busy the unit was. He said if the ED was full, the hall beds would be used for patients who were non-critical. He said the hall beds were used sort of like a fast track; where the PA could see the patient real quickly.

RN #16 stated the hall beds would be used when the department was really busy to decompress the waiting room. He said the days hall beds were used would vary. He said usage usually occurred in the afternoon during peak hours and were used on a weekly basis.

When asked how he ensured patient privacy, he stated since the patient was not in a private room, staff would have to be quiet with conversations. He said although the RN would not listen to the patient's heart and lungs, he said the provider would. RN #16 stated the patient would have his or her vital signs taken in the hall.

h. On 2/13/19 at 10:53 a.m., RN #17 was interviewed. She stated she had worked in the ED for three years. RN #17 stated she had seen hall beds used when the ED was busy. She said the last time she had seen hall beds used was the week prior to the survey.

RN #17 said patients who were placed in hall beds were mostly orthopedic patients who were ambulatory and non-critical. RN #17 stated hall beds were generally used at peak times, which would vary. She said the ED was located in a college town, so peak times could occur during spring break and also when it was cold outside.

i. On 2/13/19 at 11:28 a.m., Trauma Technician (Tech #18) was interviewed. She stated she had worked in the ED for 10 years and was currently working one day a week. Tech #18 stated hall beds were only used if the ED was completely out of beds and only if absolutely necessary, sometimes when it was snowing outside.

Tech #18 stated there were no call lights for patients who were placed in hall beds. She said the patient could wave a staff member down or call out if they needed something. Tech #18 said if a patient was in Hall 4, staff may not have their eyes on the patient. Tech #18 confirmed conversations between nurses or providers and patients did occur in the hall.

Based on interviews and document reviews, the facility failed to follow processes to ensure patient safety. The facility failed to ensure a patient's physician was notified by staff, prior to the patient leaving the emergency department (ED) without being evaluated, in one of one medical records reviewed for a missing patient (Patient #11). Additionally, the facility failed to ensure leadership, who were assigned patient safety events, followed policy. Specifically, leadership failed to investigate one of three ED patient safety events reviewed for restraints (Patient #16). The facility failed to ensure follow up and an action plan was implemented in one of one "missing patient" safety events reviewed (Patient #11).

Findings include:

Facility policies:

The Safety-Events Management policy read, safety events are an early warning system which contributes to improved quality and patient safety. Safety events are assigned to appropriate individuals within the organization based on the location of the safety event and category of the safety event report. The assigned individuals are responsible for reviewing and investigating the safety event and documenting all follow-up within the facility's internal reporting system. Risk Management and/or designee will monitor completeness of all follow-up and investigations.

The 2018 Patient Safety/Quality Plan read, the safety event reporting system is managed by the Risk Management Department and regular reports are provided to the Chief Medical Officers, the Director of Risk and Compliance, the Risk Manager, the Director of Quality, the Coordinator of Clinical Quality, employees and various improvement teams throughout the organization. Initial follow-up is completed and documented by the department manager.

1. The facility failed to ensure a physician was notified about a patient who wanted to leave the ED prior to being evaluated for suicidal ideation.

a. Review of Patient #11's medical record revealed on 12/14/18, the patient presented to the ED with suicidal and homicidal ideation. At 6:13 p.m., Registered Nurse (RN) #27 documented a behavioral health assessment. According to the suicide screening, Patient #11 answered yes, to having thoughts of killing himself without an active plan. RN #27 documented the patient's behavior was labile, cooperative, calm and erratic. The note further read, Patient #11 was having controlled auditory hallucinations with flight of ideas. Patient #11 was placed in a safe room in the psychiatric zone (a room with no ligature risks). Security observations were ordered at 6:30 p.m.

Review of the ED physician note, electronically signed 12/14/18 at 8:38 p.m., revealed Physician #1 documented the patient presented to the ED with reported suicidal and homicidal ideation. Physician #1 wrote, when he was initially informed about the patient, he was told the patient was on an M1 psychiatric hold (an involuntary mental health hold). However, Physician #1 then documented the patient apparently was not formally on an M1 hold and was allowed to leave the ED by security. Physician #1 documented he was not asked by staff if it was okay for the patient to leave the department.

According to the Discharge Data, Patient #11 left the ED at 8:20 p.m., without being seen by a physician.

b. On 2/18/19 at 1:22 p.m., RN #27 was interviewed. RN #27 stated she discussed with the ED physician in the hallway about the patient and why the patient presented to the ED. She reported the patient was not having suicidal ideation (SI) but then said the patient was "wishy washy." RN #27 stated the patient did not have a suicide plan. She said the patient was not placed on elopement precautions because he was not on an M1 hold. RN #27 stated if the physician saw the patient and determined the patient needed to be placed on an M1 hold, then she would change the precautions.

RN #27 stated she did not remember who the security guard was that night. RN #27 stated the patient was still sleeping in the room when she left the hospital at 7:10 p.m. or 7:15 p.m.

RN #27 stated she presented the case to Physician #1 to make the decision about the M1 hold. When asked where she documented the conversation with the physician, RN #27 stated she thought she wrote it in the notes. RN #27 stated she would present to the physician why the patient came in and how the patient answered the suicide screening questions. She said it was a brief conversation.

RN #27 stated she was unaware the patient wanted to leave during her shift.

There was no evidence in Patient #11's medical record which showed if a night shift RN assessed Patient #11 prior to him leaving the ED or if the nurse was notified by security regarding the patient's request to leave. There also was no documentation in patient's medical record about a conversation between the patient's nurse and physician.

c. On 2/19/19 at 9:01 a.m., Physician #1 was interviewed. Physician #1 stated he did remember Patient #11 who left without being seen on 12/14/18. He said Patient #11 was placed in the psychiatric zone and he talked with the nurse who was assigned to the patient to see if he needed to see the patient urgently. Physician #1 said it was questioned whether the patient made the SI statement for secondary gain regarding his lack of housing. Physician #1 stated at the time, he was under the impression the patient was on a 72 hour M1 hold, so he ordered the routine psychiatric labs.

Physician #1 said when he went back to evaluate the patient, he found out the patient was not on a 72 hour hold. He reported the patient left the department. Physician #1 stated if a patient wanted to leave the ED, a physician should be notified. He said he was under the impression the patient was on a M1 hold but he was not. He said the patient was allowed to walk out.

Physician #1 said it was important for the physician to be notified when a patient was going to leave without being seen so the physician could evaluate the patient and ensure both the physician and nurse had the same assessment of the patient. He said this process was important to ensure the patient was safe, was not suicidal and could contract for safety. He said physician notification was also important to make sure the patient did not meet the criteria for a mental health hold.

Physician #1 stated neither security nor nursing staff notified him the patient left.

d. On 2/19/19 at 9:54 a.m., an interview was conducted with the ED Nurse Manager (Manager #3). Manager #3 said he was in the ED on 12/14/18 and the charge nurse notified him about Patient #11 leaving the ED without being seen.

Manager #3 stated the police were notified right away. He said the physician had a concern about Patient #11's safety and his elopement. He said the police were called to help the facility.

Manager #3 stated the normal process when the patient wanted to leave the ED was to notify the physician. He said sometimes patients walked out if they were not on a hold or elopement precautions. He said if the patient stated he wanted to leave, the physician should be notified right away and staff should go through the AMA (against medical advice) process if the patient was willing.

Manager #3 stated the AMA process was done so the physician could answer the patient's questions and concerns. He said the process also allowed the provider to ask why the patient was leaving and attempt to address the situation.

Manager #3 stated he did talk with the security officer who was on that night. He reported the security officer said the patient was watched but was not on any hold precautions. Manager #3 stated security usually gave nursing staff a heads up if a patient wanted to leave but it did not happen. Manager #3 said the patient's nurse was in another area of the ED taking care of another acute patient.

Manager #3 said Physician #1 was concerned for the patient's safety when the patient left. Manager #3 said when the patient's nurse consulted the physician, she deemed the patient not a suicide risk. He then said the physician started the work up and did not place the patient on a hold. However, as noted above, there was no documentation in the medical record about the conversation between the patient's nurse and physician.

Manager #3 said normally there was a good interaction between the ED physician and ED nurse. He said this was not the case regarding Patient #11's ED admission.

2. Facility leadership failed to investigate a patient safety event involving a patient who had a cardiopulmonary arrest during restraint application.

a. Review of Patient #16's safety event, dated 3/6/18, revealed the patient was brought into the ED by local police department at 11:50 a.m. According to the note, the patient was handcuffed and escorted by three police officers into the ED. Patient #16 was uncooperative, loud and aggressive. Three facility security officers met the police officers at the ambulance entrance and the patient was placed in ED room #19. While attempting to remove the patient's handcuffs, the patient rapidly escalated and required restraints. According to the note, the patient's nurse, the three security officers and three police officers were required to place Patient #16 into four point hard restraints at approximately 12:00 p.m. While attempting to place the patient in restraints, a police officer noticed the patient was not breathing. The patient's nurse was unable to find a pulse and CPR (cardiopulmonary resuscitation) was initiated. Resuscitation was successful.

The severity of the safety event was documented as severe; event reached the person and caused severe harm, and required intervention to sustain life. Contributing factors documented were human factors (patient, family, & visitor) and non-cooperation. Security Officer (Officer #2) submitted the event into the facility's internal reporting system.

Review of Patient #16's safety event follow up, documented in a separate spreadsheet, showed the patient's safety event follow-up was assigned to two employees; Security Manager (Manager #4) and Director of Safety, Security and Emergency Management (Director #5). There was no documentation on the spreadsheet which indicated how both Manager #4 and Director #5 investigated Patient #16's safety event and determined if the event could or could not have been prevented. This was contrary to facility policy.

b. On 2/13/19 at 2:26 p.m., an interview was conducted with Manager #4, who stated she was responsible for security and safety issues in the facility.

Patient #16's safety event was provided to Manager #4 for review. Manager #4 stated she did not remember the event because it was a long time ago. She stated any time security did hands on with patients, she would be assigned the event for review.

When asked how Patient #16's event was investigated, she stated her standard was to read the event, talk to the security officers and see if there was any additional information. Manager #4 stated she would see if the standard protocol was followed.

Manager #4 stated Patient #16 was in police custody and the patient was restrained for his behavior. She stated if there was any additional information, it would have been in her response to the patient safety event. Manager #4 was shown the follow up summary on the spreadsheet provided by the facility; it was a narrative of the event details. She stated she could not remember if she filled out the response because it was so long ago.

c. On 2/14/18 at 8:19 a.m., the compliance and risk officer (Compliance Officer #8) was interviewed about Patient #16's safety event. She stated a formalized follow up was not done for the event. She stated the safety event was reviewed by leadership in the department. She said upon initial review, leadership found all the processes were met. She said no process or policies seemed to be questioned. Compliance Officer #8 stated that the patient did not have any injury from his arrest or restraints, so an official follow up was not deemed necessary.

Compliance Officer #8 stated the facility did not have any further documentation to provide.

d. On 2/18/19 at 3:56 p.m., Security Officer #2 was interviewed and stated he remembered Patient #16's safety event. He stated every safety event which took place with security would have an internal review done. He said Patient #16's safety event was reviewed with his supervisor. He said both reviewed the safety event to see if anything went wrong and decided there were no failures in the process.

Security Officer #2 said he was not interviewed by leadership. He also said he did not have any documentation of the conversation with his supervisor and the other officer who was present at the time Patient #16's safety event occurred.

e. On 2/19/19 at 9:38 a.m., an interview was conducted the second leader who was assigned to Patient 16's safety event, Director #5. Director #5 stated when it comes to security, "the buck stopped with him." He said he relied on Manager #4 to help with functioning of the security department.

A review of Patient #16's safety event was done. He stated Patient #16's safety event was almost a year ago and his first hand remembrance was very limited. He said he would review the safety event to ensure an order was in place for restraints. Director #5 stated if handcuffs were used or if there were hands placed on the patient, he also would review the event to see if policy was followed.

When asked how he reviewed Patient #16's safety event, Director #5 read from the patient safety event then said the patient went from handcuffs to hard restraints. He said the patient's nurse was there. He said the handcuffs were not inappropriate because they were placed by law enforcement. He said that would be the extent of his review. He said there was nothing in the narrative for Patient #16's event that concerned him. He said he did not have to investigate the event further. He said the narrative was factual.

f. On 2/19/19 at 3:49 p.m., an interview was conducted with Compliance Officer #8, Quality Director #7 and Clinical Risk Manager (Manager #20).

A review of Patient #16's event was conducted. Quality Director #7 said Director #5 assessed the process and found no deviation from the standard. She said Director #5 completed the follow up for the safety event. However, Director #7 then stated the facility had no documentation for Director #5's review.

Compliance Officer #8 stated Director #5 did comment on the safety event, but did not go into detail of the analysis or how the event occurred. After she reviewed the safety event, she stated she was unable to determine by the document if the process was followed.

Compliance Officer #8 said for safety events, the quality department relied on the department or manager of the individuals involved for follow-up. Compliance officer #8 said the quality department relied on the manager and their expertise for the review of the event and to report back if an issue was identified.

3. Facility leadership failed to follow up and implement actions to prevent reoccurrence of a patient safety event.

a. Review of Patient #11's safety event, dated 12/14/18, revealed the patient presented to the ED for suicidal ideation (SI) at 6:13 p.m. According to the brief description, the patient had suicidal thoughts with no active plan. Patient #11 was not placed on suicide precautions or under security observation; however, the patient was placed in one of the ED's safe rooms (a room without ligature risks). The note indicated the ED provider was not contacted about a M1 hold or mentally incapacitated hold (MIH). Security was not made aware the patient needed to be stopped or held against his will. At 8:00 p.m., two hours after the patient arrived, the ED provider (Physician #1) went to examine the patient and found out the patient had left the department. The note indicated the patient's registered nurse (RN) was made aware after the patient had left the ED.

There were no contributing factors documented on the safety event report sheet. ED Nurse Manager (Manager #3) submitted the safety event into the facility's internal reporting system.

Review of Patient #11's safety event follow-up, which was documented on a separate spreadsheet, showed the patient's safety event follow-up was assigned to Security Manager (Manager) #4 and Manager #3. Neither the patient safety event report nor the follow-up spreadsheet indicated an action plan to prevent reoccurrence of the safety event.

b. On 2/19/19 at 9:01 a.m., Physician #1 was interviewed. Physician #1 stated he remembered Patient #11 who left without being seen on 12/14/18. He said he remembered his shift as being fairly busy. He said Patient #11 was placed in the psychiatric zone and he talked with the nurse who was assigned to the patient to see if he needed to see the patient urgently. Physician #1 stated at the time, he was under the impression the patient was on a 72 hour hold, so he ordered the routine psychiatric labs.

Physician #1 said when he went back to evaluate the patient, he found out the patient was not on a 72 hour M1 hold. He stated the patient left the department. Physician #1 said he requested a patient safety event to be filed. Physician #1 stated if a patient wanted to leave the ED, a physician should be notified.

Physician #1 said it was important for the physician to be notified if a patient wanted to leave the hospital without being seen so the physician could evaluate the patient and ensure both the physician and nurse had the same assessment of the patient. He said this process was important to ensure the patient was safe, was not suicidal and could contract for safety. He said physician notification was also important to make sure the patient did not meet the criteria for a mental health hold.

c. On 2/19/19 at 9:54 a.m., an interview was conducted with the ED Nurse Manager (Manager #3) who stated he reviewed Patient #11's safety event. He said he was in the ED that night and the charge nurse notified him about Patient #11 leaving the ED without being seen. He said the safety event was entered because Physician #1 was concerned he was not notified when the patient walked out of the ED. Manager #3 stated the physician had a concern about Patient #11's safety.

Manager #3 stated he talked with the security officer who was on that night. He reported the security officer said the patient was watched but was not on precautions. Manager #3 stated security usually gave nursing staff a heads up if a patient wanted to leave but it did not happen. Manager #3 said he spoke with the nurse assigned to the patient and the patient's nurse was in another area of the ED taking care of another acute patient when Patient #11 left the ED.

Manager #3 stated there was a discussion with Risk Management at a huddle about Patient #11's safety event. He said the team talked about conducting a RCA (root cause analysis) for the event. He said the purpose of the RCA was to gather information about the event, identify gaps and discuss those gaps to make better processes. He said the huddle was done a day after Patient #11's safety event occurred. He said it was two months ago. He said no specific actions were put into place for the safety event and processes had not been changed. He said the department was waiting for the RCA to be done and it was on his "to-do list." He said he did talk with staff involved in the event. However, Manager #3 could not provide evidence of the conversations.

d. On 2/19/19 at 3:49 p.m., an interview was conducted with Compliance Officer #8, Quality Director #7 and Clinical Risk Manager (Manager #20).

Compliance Officer #8 said for safety events, the quality department relied on the department or manager of the individuals involved for follow-up. After review of Patient #11's safety event, Compliance Officer #8 stated there was a communication gap with staff. She stated the event was on the radar for an RCA to be done. When asked if there was any education or process in place to prevent reoccurrence, Director #7 stated she was unsure. Compliance Officer #8 stated each manager handled things differently. She said the managers would move forward with how they saw fit.

Based on interviews and document review, the facility failed to ensure patients placed in restraints and seclusion were monitored and assessed according to the facility's standards in one of one inpatient behavioral health patient's medical record reviewed for restraint/seclusion (Patient #29).

Findings include:

Facility policy:

The Restraints and Seclusion: Violent Patient policy read, assessment/monitoring documentation for the restrained patient includes:

Ongoing monitoring through one to one care or the use of both video and audio equipment that is in close proximity to the patient, as well as face to face checks at least every 15 minutes.

Specific to Behavioral Health Unit: there is continuous face to face monitoring for restrained patients and for patients who are simultaneously restrained and secluded.

Hourly face-to-face assessment documentation by an RN assessing level of distress and agitation, mental status, cognitive functioning, patient understanding of the need for restraint, physical assessment, and the need for the continuation of the seclusion.

A physical safety assessment documented every two hours, including: nutrition/hydration, repositioning and range of motion to restrained limb, skin integrity and circulation, hygiene/elimination, comfort/privacy, and proper application of the restraint.

1. The facility failed to ensure staff monitored and assessed Patient #29 while in seclusion to ensure the patient's emotional and physical needs were met.

a. Review of Patient #29's medical record revealed on 2/8/19 at 7:15 a.m., an order was entered for a manual hold because the patient was verbally threatening, physically intimidating, shoving staff and needed emergent meds for a safe transfer to seclusion. At 7:25 a.m., the patient was ordered to be placed in seclusion.

Patient #29's seclusion order was renewed at 11:42 a.m. and at 3:42 a.m.

Review of the nursing documentation revealed from 8:30 a.m. until 3:00 p.m. there was no evidence an hourly RN (registered nurse) assessment was conducted. Additionally, there was no evidence a physical safety assessment was conducted every two hours. This conflicted with facility policy.

From 8:30 a.m. until 3:00 p.m., a RN did not assess the patient's level of distress and agitation, mental status, cognitive functioning, patient understanding of the need for restraint, physical assessment and the need for the continuation of the seclusion. The only documentation was done by a mental health technician, which indicated the patient was sleeping during the 6 ½ hour time frame. Additionally, during the same time period, there was no evidence in the medical record which indicated the patient was offered hygiene care and assessed for nutrition and hydration needs.

b. On 2/19/19 at 11:38 a.m., an interview was conducted with RN #6 who was Patient #29's day nurse on 2/8/19. She said seclusion was used when a patient was reaching a point of being a danger to themselves or others. She said seclusion was a serious thing and was used when other interventions failed.

RN #6 stated if the patient was in seclusion over one hour, then 15 minutes checks needed to be done to make sure the patient was breathing, was comfortable and if the patient needed anything. RN #6 stated a RN needed to assess the patient face to face every two hours for safety, comfort, range of motion if needed, food and water. She said this was also done with every 15 minute check.

RN #6 stated she remembered Patient #29. When the documentation was reviewed from 8:00 a.m. until 4:00 p.m., she said there should have been several two hour assessments documented between that period of time.

She confirmed documentation was missing. She said the patient was sleeping a lot of the day.

c. On 2/19/19 at 3:31 p.m., the inpatient behavioral health unit manager (Manager #12) was interviewed. She stated the day shift was missing documentation for every 2 hour checks in Patient #29's medical record. She stated the checks missed were at 10:00 a.m., 12:00 p.m. and 2:00 p.m. Manager #12 said a RN does have to go see the patient every two hours to ensure the patient was offered fluids and food and to check circulation if the patient was in physical restraints.

Based on interviews and document reviews, the facility failed to adhere to death reporting requirements for the Centers for Medicare and Medicaid Services (CMS). The death of a patients who expired within 24 hours after being restrained by roll belts, four side rails and mitts, were not reported to CMS in six of six patients required to be reported according to the regulation (Patients A, B, C, D, I, J).

Findings include:

Facility policy:

The Restraints: Non-Violent Patient policy read, staff will file a Patient Safety Event and the facility reports the following to CMS:

Each death that occurs while a patient is in a restraint and/or seclusion, excluding 2-point soft wrist restraints and the patient was not in seclusion at the time of death.

Each death that occurs within 24 hours after the patient was removed from restraint or seclusion, excluding 2-point soft wrist restraints and the patient was not in seclusion at the time of death.

Each death known to the hospital that occurs within one week after the restraint and/or seclusion episode where it is reasonable to assume that the placement in seclusion or the use of the restraint contributed directly to a patient's death.

The hospital reports each death noted above to CMS by faxing form CMS-10455 no later than the close of business the next business day following knowledge of the patient's death. Date and time of reports to the CMS are documented in the patient's medical record.

The policy also read, restraint documentation included the following type of restraints:
1, 2, 3, or 4 point
Freedom Splints
4 side rails up for patient safety
Mitts
Roll belt

1. The Regulatory Readiness Manager (Manager #19) did not contact CMS, to report patient deaths within restraints, as required by CMS.

a. Review of the CMS Death Log, from 1/1/18 through 1/17/19, revealed six patients restrained by mitts, roll belt and side rails, prior to the patients' deaths. There was no evidence on the log which indicated the facility reported the deaths to CMS, according to the regulation requirements.

b. Review of Patient A's medical record revealed the patient death information was entered into the Restraint Death Log on 2/13/18 by Manager #19. According to the CMS Death Log, Patient A was in the following restraints: four side rails, mitts and a roll belt.

Review of the Non Violent Restraint Flowsheet showed on 2/10/18 at 1900 (7:00 p.m.), the patient's restraints were discontinued, three hours prior to the patient's death. Review of the patient's death certificate showed Patient A expired at 10:03 p.m.

c. Review of Patient B's medical record revealed the patient's death information was entered into the Restraint Death Log on 2/13/18 by Manager #19. According to the CMS Death Log, Patient B was in a roll belt.

Review of the Restraint Termination documentation showed the patient's restraint was terminated on 2/12/18 at 7:20 a.m. According to the Clinical Notes, the patient's nurse documented Patient B's time of death was at 1:00 p.m., the same day.

d. Review of Patient C's medical record revealed the patient's death information was entered into the Restraint Death Log on 3/16/18 by Manager #19. According to the CMS Death Log, Patient C was in mitts and a roll belt.

Review of the Restraint Termination documentation showed the last restraint documentation was on 3/14/18 at 6:00 p.m. On 3/19/18 at 7:05 a.m., the intensive care unit Nurse Manager (Manager #21) documented a late entry in the Clinical Notes, five days after the patient expired, the patient's time of death was 3/14/18 at 8:01 p.m.

e. Review of Patient D's medical record revealed the patient's death information was added to the Restraint Death Log on 6/19/18. According to the Death Record documentation, the patient expired on 6/13/18 at 8:20 a.m. The patient's nurse documented the patient was in restraints within 24 hours prior to the patient's death. Review of the Death Log, showed the patient was in a roll belt restraint.

Two additional patients (Patients I and J) were documented on the Restraint Death Log as being in restraints other than two point soft restraints, which should have been reported to CMS.

f. On 2/14/19 at 2:55 p.m., Manager #19 was interviewed. She was asked to review the Death in Restraint Reporting Log. She stated none of the deaths had been reported to CMS. Manager #19 stated she was under the impression only patient deaths in violent restraints needed to be reported to CMS unless the restraint caused the death.

g. On 2/14/19, at 3:39 p.m., the Compliance and Risk Officer (Compliance Officer #8) was interviewed. She confirmed the organization had not reported the deaths in restraints as required by CMS. She stated Manager #19 read the regulations wrong. She stated the regulations seemed confusing and there was a misinterpretation of the regulations.

h. On 2/19/19 at 3:49 p.m., an interview was conducted with Compliance Officer #8, Quality Director #7, Clinical Risk Manager (Manager #20) and Manager #19. Manager #19 stated since she took over her position in 2013, there had not been a death in restraint reported to CMS. She said there had not been any deaths in restraints except the few in 2018. Manager #19 stated she was unsure when the last time a death was reported. Manager #19 stated she misinterpreted the regulation. She thought only death in violent restraints needed to be reported to CMS. She said this was how she was trained.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.41 PHYSICAL ENVIRONMENT, was out of compliance.

A-0725 The extent and complexity of facilities must be determined by the services offered. Based on observations, interviews and document review, the facility failed to ensure the emergency department (ED) was utilized to accommodate the extent and volume of patients who presented to and were treated in the ED. Furthermore, the facility failed to ensure the safety of hall bed patients by providing a call mechanism at 4 of 4 hall beds observed (Hall 1, Hall 2, Hall 3 and Hall 4).

Based on observations, interviews and document review, the facility failed to ensure the emergency department (ED) was utilized to accommodate the extent and volume of patients who presented to and were treated in the ED. Furthermore, the facility failed to ensure the safety of hall bed patients by providing a call mechanism at 4 of 4 hall beds observed (Hall 1, Hall 2, Hall 3 and Hall 4).

Findings include:

1. The facility failed to ensure the emergency department (ED) was appropriately utilized to accommodate the volume of patients who presented to and were treated in the emergency department by routinely utilizing hall beds. Additionally, there was no call mechanisms in place for the patients to call for assistance.

a. On 2/12/19 at 4:13 p.m., a tour of the ED was conducted with ED Nurse Manager (Manager #3). The ED had 25 beds which included two dedicated trauma rooms. Review of the public patient tracker located behind the nursing station showed additional rooms; H1, H2, H3, H4 and H5. Patient names were located on the tracker, next to H1, H2 and H4 (Patients #22, #23 and #24). Four patients were in the waiting room.

Inspection of the ED confirmed hall beds (H1, H2 and H4) were in use. A laminated sign which read "Hall 1" was located on the wall across from ED room #1. A laminated sign which read "Hall 2" was posted on the wall between ED rooms #1 and #2. Another two laminated signs were observed posted in the corridors; "Hall 3" sign was located on the wall between the security officer's cove and ED room #1; "Hall 4" sign was posted on the wall between ED rooms #17 and #18.

Patient #22 was in "Hall 2" bed.

Patient #23 was in "Hall 3" bed.

Patient #24 was in "Hall 4" bed.

All three patients in the hall were observed without a call light or any other mechanism to call for assistance.

Continued tour of the ED revealed five empty rooms which were not occupied by patients: ED rooms #5, #12, #21 and Trauma rooms #1 and #2.

Manager #3 stated hall beds were used occasionally for overflow or if the patient "needed to have eyes on them." He said patients placed in the hall beds would be non-critical patients.

When asked how the patient in Hall 4 bed could ask for help, he stated the patient could send family member to the nursing station. He said if the patient had no family with them, they would have to be evaluated to determine if it was safe to be in Hall bed #4.

c. On 2/15/19 at 4:00 p.m., Registered Nurse (RN) #15, who was the nurse responsible for Patients #22, #23 and #24's care on 2/12/19, was interviewed. He stated he worked three days a week and hall beds were used maybe 50% of the time in a two week period. RN #15 stated an increased number of patients usually occurred around the first couple of weeks when the local college students would return for class and also during ski season when the ED would get a lot of patients from the local ski mountain.

d. Three patient safety events and their corresponding medical records were reviewed for use of hall beds in the ED.

Patient #27's safety event report, dated 1/24/19, showed the patient was brought into the ED by the local police department. The patient was placed in Hall 1 bed due to the ED fullness and the lack of notification from the police department prior to the patient's arrival. Review of Patient #27's ED audit trail showed the patient arrived to the ED at 6:38 p.m. and was then placed in Hall 1 bed. According to the audit trail, Patient #27 was in the hall bed from 6:38 p.m. until 7:24 p.m. Patient #27 was in the hall bed for a total of 46 minutes, before she was placed in ED room #19.

Patient #25's safety event report, dated 1/7/19, revealed the patient was brought into the ED by the local police department at 7:40 p.m. According to the ED audit trail for Patient #25, the patient remained in the hall bed for his entire stay. The patient was discharged at 8:58 p.m., one hour and 18 minutes later.

Review of Patient #28's safety event report, dated 3/8/18, showed at 7:45 p.m., the patient was brought to the ED by the local police department. According to the brief description on the report, the patient was very loud and uncooperative. Later the patient was placed on an M1 hold (an involuntary mental health hold) and then moved to ED room #19. According to the ED audit trail for Patient #28, the patient was placed in room #19 at 8:05 p.m., 20 minutes after arrival.

e. On 2/19/19 at 1:18 p.m., an interview was conducted with the Assistant Vice President for Nursing (VP #9) who was responsible for oversight of the ED. She stated the facility had not identified any issue with the use of hall beds. VP #9 stated the use of hall beds was to make the patient stay shorter and to get the patients in and out. VP#9 stated the facility never looked at the use of a hall beds from a safety stand point. She then said it was unsafe if a patient was alone without access to a bell to call for assistance. She said staff must keep eyes on the patients. She said staff typically asked patients if they were okay to be placed in the hallway.

VP #9 stated the facility was not tracking the utilization of hall bed usage. VP #9 said the facility did not think hall beds were overused prior to the survey. She said some days there were no hall beds used, then other days the ED was full and hall beds were in use.

Review of Patients #22, #23 and #24's medical records showed no evidence staff ask the patients for their permission to be placed in a hall bed.

f. On 2/19/19 at 3:06 p.m., an interview was conducted with Manager #3. He stated hall beds were a part of the ED department's normal usage for the overflow of patients.

g. On 2/18/19 at 9:01 a.m., ED Charge RN (Registered Nurse) #16 was interviewed. He stated the ED department would use hall beds dependent on how busy the unit was. He said if the ED was full, the hall beds would be used for patients who were non-critical. He said the hall beds were used sort of like a fast track, where the PA could see the patient real quick.

RN #16 stated the hall beds would be used when the department was really busy to decompress the waiting room. He said the days hall beds were used would vary. He said usage usually occurred in the afternoon during peak hours and were used on a weekly basis.

h. On 2/13/19 at 10:53 a.m., RN #17 was interviewed. She stated she had worked in the ED for three years. RN #17 stated she had seen hall beds used when the ED was busy. She said the last time she had seen hall beds used was the week prior to the survey.

RN #17 said patients who were placed in hall beds were mostly orthopedic patients who were ambulatory and non-critical. RN #17 stated hall beds were generally used at peak times, which would vary. She said the ED was located in a college town, so peak times could occur during spring break and also when it was cold outside.

RN #17 stated patient in hall beds were placed in front of the nursing station where nurses would chart. She said the patients would be in the line of site. When asked about Hall #4 bed (which was not located in front of a nursing station), she stated the patient would be frequently checked on.

i. On 2/13/19 at 11:28 a.m., Trauma Technician (Tech #18) was interviewed. She stated she had worked in the ED for 10 years and was currently working one day a week. Tech #18 stated hall beds were only used if the ED was completely out of beds and only if absolutely necessary, sometimes when it was snowing outside.

Tech #18 stated there were no call lights for patients who were placed in hall beds. She said the patient could wave a staff member down or call out if they needed something. Tech #18 said if a patient was in Hall #4 bed, staff may not have their eyes on the patient.