HospitalInspections.org

Based on observation, review of medical record and incident/event documentation of a patient with suicidal ideation and self harm behaviors (Patient 4), review of medical record and incident/event documentation for 7 of 9 other patients who received hospital services (Patients 3, 7, 11, 13, 15, 16, and 17), review of grievance documentation for 2 of 7 patients selected from the grievance log (Patients 12 and 14), review of environmental risk assessment documentation, review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure the provision of safe and appropriate care to patients in the hospital that complied with the Conditions of Participation. Staff failed to:
* Prevent patient access to unsafe items;
* Provide appropriate and effective patient monitoring and supervision;
* Evaluate increased patient behaviors and other changes prior to discharge;
* Conduct clear, thorough and timely investigations of incidents/events including those with potential and actual harm related to access to unsafe items, patient death following discharge, repeated falls, transport of critically ill patients, anesthesia services, and skin alterations; and failed to develop timely follow up actions to ensure similar events did not recur:
* Ensure unsafe items, areas, and ligature risks in the physical environment that created the risk for self harm and/or harm to others were identified and/or mitigated; and
* Ensure written responses to patient complaints and grievances contained all of the required elements including the steps taken to investigate the grievance.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited under Tag A115, CFR 482.13 - CoP Patient's Rights.

2. Refer to the findings cited under Tag A263, CFR 482.21 - CoP Quality Assessment and Performance Improvement.

Based on observation, review of medical record and incident/event documentation of a patient with suicidal ideation and self harm behaviors (Patient 4), review of medical record and incident/event documentation for 7 of 9 other patients who received hospital services (Patients 3, 7, 11, 13, 15, 16, and 17), review of grievance documentation for 2 of 7 patients selected from the grievance log (Patients 12 and 14), review of environmental risk assessment documentation, review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients' rights were recognized, protected and promoted as follows:
* Hospital staff failed to ensure patients were provided care in a safe setting. A patient was not appropriately monitored and supervised in the ED, including in the ED "Red Pod," a secured area/unit for behavioral health patients, as he/she was repeatedly allowed access to unsafe items including scissors and/or suture forceps; and a pulse ox cord, telephone cord, and/or oxygen "hose," and used those to inflict self harm; and the hospital failed to conduct thorough investigations and follow up actions to ensure similar events did not recur. During an ED visit two months later, the same patient experienced an increase in self harm behaviors including hitting his/her head on a wall and subsequent abnormal vital signs and the hospital failed to evaluate the patient secondary to those behaviors and changes. The patient was then discharged from the "Red Pod" and within minutes jumped or fell from the hospital's parking structure and died; and the hospital failed to conduct a thorough investigation and follow up actions to ensure similar events did not recur.
* The hospital failed to conduct clear, thorough and timely investigations of incidents/events including those with potential and actual harm related to repeated falls, transport of critically ill patients, anesthesia services, and skin alterations; and failed to develop timely follow up actions to ensure similar events did not recur.
* The physical environment contained hazards such as unsafe items and ligature risks that had not been identified and/or mitigated and created risk for self harm.
* The hospital failed to ensure written responses to patient complaints and grievances contained all of the required elements including the steps taken to investigate the grievance.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A123, CFR 482.13(a)(2)(iii) - Patient's Rights: Standard: Notice of Grievance Decision. Those findings reflect the hospital's failure to provide written notice of follow-up investigation and resolution that contained the required elements.

2. Refer to the findings cited at Tag A144, CFR 482.13(c)(2) - Standard: Patient's Rights: Care in a Safe Setting. Those findings reflect the hospital's failure to ensure the patient's right to receive care in a safe setting; and failed to ensure patients were provided care in a safe physical environment that prevented access to unsafe items that created risk for self harm.

3. Refer to the findings cited at Tag A145, CFR 482.13(c)(3) - Standard: Patient's Rights: Free from Abuse/Harassment. Those findings reflect the hospital's failure to ensure investigations and follow up actions to potential abuse and neglect events were timely, clear, complete and/or accurate to prevent recurrence.

Based on review of grievance documentation for 2 of 7 patients selected from the grievance log (Patients 12 and 14) and review of policies and procedures, it was determined that the hospital failed to fully implement policies and procedures that ensured patients' rights were recognized, protected and promoted as follows:
* A written grievance notice that contained all of the required elements including the steps taken on behalf of the patient to investigate the grievance, was not provided to each patient/patient representative who filed a complaint/grievance with the hospital.

Findings include:

1. The hospital P&P titled "Patient Complaints and Grievances," dated as last revised "04/2018" reflected:
* "It is the policy of the Providence Health & Services - Acute Care Facilities to respond to and resolve complaints made by patients and their representatives in a manner consistent with the Providence Health & Services Mission and Core Values."
* "In the event a patient or patient's representative is dissatisfied with any aspect of their care, they will be afforded a process to express their concerns and for those concerns to be investigated and addressed."
* "Definitions...Grievance - a 'patient grievance' is a written or verbal complaint...by a patient, or the patient's legal representative...A written complaint is always considered a grievance..."
* "Grievance Management...When a currently admitted patient or that patient's designated representative's desire to file a grievance, the appropriate department leadership must be notified immediately and the appropriate leader(s) will visit the patient as soon as possible. The department leader(s) will notify the Customer Care Team or Quality Management so that the grievance can be documented...and so that support/guidance can be provided to the leader(s) in resolving the grievance and preparing a written response to the patient/patient's representative within 7 business days."
* "A template written response to the patient/patient's representative...has the following elements included to ensure compliance with CMS requirements...Steps taken to investigate the grievance...Results of the grievance process...Date of completion...Name of hospital contact person..."
* "...A written response to the patient or patient's representative applies to all grievances...Grievances that are complicated or require extensive investigation should be clearly documented. If a grievance is not resolved or if the investigation requires more time, a written interim response will be sent to the patient or patient's representative within 7 business days...from the date of receipt of the grievance to inform them that the hospital is still working to investigate and resolve the grievance...Every attempt will be made to resolve grievances, with final written response...within 14 business days from the date of receipt or identification of the grievance. For grievances extending beyond this 14 business day time frame, interim letters will be sent every 7 business days, until the grievance is resolved, to inform the patient or patient's representative that the hospital is still working to investigate and resolve the grievance."
* "Performance Improvement/Reporting...On a biannual basis, grievance activity will be reviewed to identify patterns and trends and reported at the hospital's Quality Council..."

2. The grievance documentation was reviewed with multiple hospital staff including the DQM and SCC on 09/03/2019 at 1355.

a. Patient 12: Grievance documentation for the patient was reviewed and reflected the grievance was submitted in writing from the patient and the "Received date" was 04/16/2019. The grievance was hand written and included a complaint related to Tylenol medication administration, "a nurse," and other complaints that were not legible.

Grievance documentation in the "Follow Up Notes" dated 09/05/2019 at 1332, 5 months after the grievance was received reflected "When I approached the patient on 4/19/19 to discuss these grievances [he/she] indicated to me that I could disregard them and did not wish to discuss them further. The patient did mention to me that [he/she] had an argument with a nurse and per the patient the nurse apologized immediately..."

A written notice provided to the patient dated 04/19/2019 was reviewed and reflected "I am responding to your complaints submitted on 4/16/19 and 4/18/19, regarding concerns about aspects of care and services provided to you during your admission to...Providence St. Vincent Medical Center. After meeting with you today, on April 19th, 2019, we discussed the written grievances you submitted on these dates. You told me at that time that you want me to rip up all of these grievances and don't want any further action taken. You told me that you had an argument with a nurse, and that the nurse has since apologized."

There was no documentation that reflected further investigation of the grievances had been conducted. There was no documentation in the written notice that reflected the steps taken to investigate the grievances. There was no documentation of any further written notices submitted to the patient.

b. Patient 14: Grievance documentation for the patient was reviewed and reflected the grievance was submitted in writing from the patient and the "Received date" was 05/11/2019. The grievance was described as "Patient upset with MD."

A written notice provided to the patient dated 05/14/2019 was reviewed. There was no documentation in the written notice that reflected the steps taken to investigate the grievance. There was no documentation of a written interim response sent to the patient to inform the patient that the hospital was still working to investigate and resolve the grievance. There was no documentation of any further written notices submitted to the patient.

Based on observation, review of medical record and incident/event documentation of a patient with suicidal ideation and self harm behaviors (Patient 4), review of medical record and incident/event documentation for 7 of 9 other patients who received hospital services (Patients 3, 7, 11, 13, 15, 16, and 17), review of environmental risk assessment documentation, review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients' rights were recognized, protected and promoted as follows:
* Hospital staff failed to ensure patients were provided care in a safe setting. A patient was not appropriately monitored and supervised in the ED, including in the ED "Red Pod," a secured area/unit for behavioral health patients, as he/she was repeatedly allowed access to unsafe items including scissors and/or suture forceps; and a pulse ox cord, telephone cord, and/or oxygen "hose," and used those to inflict self harm; and the hospital failed to conduct thorough investigations and follow up actions to ensure similar events did not recur. During an ED visit two months later, the same patient experienced an increase in self harm behaviors including hitting his/her head on a wall and subsequent abnormal vital signs and the hospital failed to evaluate the patient secondary to those behaviors and changes. The patient was then discharged from the "Red Pod" and within minutes jumped or fell from the hospital's parking structure and died; and the hospital failed to conduct a thorough investigation and follow up actions to ensure similar events did not recur.
* The hospital failed to conduct clear, thorough and timely investigations of incidents/events including those with potential and actual harm related to repeated falls, transport of critically ill patients, anesthesia services, and skin alterations; and failed to develop timely follow up actions to ensure similar events did not recur.
* The physical environment contained hazards such as unsafe items and ligature risks that had not been identified and/or mitigated and created risk for self harm.

Findings include:

1. a. The P&P titled "Regional Nursing Minimum documentation Reference," dated last revised "01/2017" was reviewed and reflected:
* For "Emergency Department" the P&P reflected the following minimum documentation:
- "VS 4hr (sic) and more frequently as pt condition dictates."
- The "Discharge Document" section reflected "At discharge assessment specific to presenting complaint and any other issues during visit, vitals reassessed if abnormal or intervention occurred, mobility of pt at discharge, AVS documented (sic) understanding of discharge instructions."

b. The P&P titled "ED Practice Guideline: Behavioral Health Patient," dated last revised "01/2015" reflected:
* "Staff member bringing the behavioral health patient to an ED room must stay with the patient, in constant observation, until a handover to another staff has occurred and care is transferred to that staff member..."
* "Receiving RN...completes and documents the following...Removal of all patient belongings...Removal of other items in the patient care area that can have the potential to cause injury/harm to patient or staff...Placement of patients into safe scrubs."
* "Primary RN...Confirm removal of patient belongings and other items that may be used to induce harm...Confirm that the patient is in safe scrubs...Assess safety risk...Determine environmental needs and place patient in appropriate location and safe environment...Determine observation needs..."
* "Reassess the patient's safety needs and response to intervention...Complete a nursing note, with vital signs every 8 hours (and more frequently as appropriate)..."
* "Disposition: The patient's immediate safety needs and the appropriate setting for treatment should be considered in disposition planning..."

c. The P&P titled ""ED Practice Guideline: Suicide Screening and Care of Behavioral Health Patients," dated last revised "07/2019" was reviewed and reflected:
* "Based on the patient assessment and nursing judgment, the patient's immediate safety needs should be addressed, including appropriate setting for treatment and consideration of observations needs..."
* "General Considerations...Prior to patient's arrival in the treatment room, the room must be assessed and mitigated for safety. This includes removing ligature risks, sharp objects and other potential dangerous objects from the area when possible...Preparation of the room should be charted once performed...The patient must remain in constant observation until a handover to another caregiver has occurred...The level of observation may be changed by the Treatment Team when appropriate."
* "Upon arrival of all behavioral health patients to their room, the receiving RN completes...and documents...Removal of all patient belongings...Removal of other items in the patient care area that can have the potential to cause injury/harm to patient or staff..."
* "Primary RN...Confirm removal of patient belongings and other items that may be used to induce harm...Determine observation needs of patient."

d. The P&P titled "ED Practice Guideline: Discharge Plan of Care & Education," dated as implemented "10/2008" and last revised "05/2019" was reviewed and reflected:
* "...This practice guideline describes essential components of assessment and intervention. Divergence...is acceptable based on provider judgement, and should be reflected in documentation."
* The "RN Discharge Process" reflected "Complete the discharge process, including but not limited to the following...Review the medical record for completeness of nursing care/reassessments and any noted areas of concern...complete and document discharge nursing assessment, including patient's condition and identification of education and training needs...specific to their care and treatment...Prepare discharge teaching plan, incorporating readiness to learn and learning needs assessment...Complete discharge teaching addressing ongoing care needs, which may include...General safety concerns...Coordinate discharge, including involvement of interdisciplinary team as needed...Assess patient...understanding and ability to follow discharge plan and readdress if needed...Obtain patient's signature acknowledging that they understand their discharge instructions and give the patient...a copy of written discharge instruction...Repeat discharge assessment (including vital signs) as appropriate for condition."

e. The P&P titled "Use of 1:1 Constant Observation for Inpatient Non-Behavioral Health Units," dated last revised "02/2017" was provided and reflected:
* "Constant observation allows for effective monitoring of the patient's behavior and mental state, while providing an opportunity to enable a rapid response by staff to any change by the patient, or within the environment that creates unsafe conditions..."
* "Constant Observation: One designated staff member assigned to one patient to provide active, undivided attention, and direct visualization at all times."
* "...Upon admission and throughout hospitalization, the safety of patients will be assessed...The use of constant shall be considered if either...The patient cannot be left unsupervised because of a suicide risk that is acute or imminent...Or...There is an injury potential to self and/or others..."
* "All patients at risk for suicide must have constant observation for safety until the Psych Services/Attending MD/Clinical Liaison (CL) service has completed a formal assessment to determine if constant observation is required."
* "...The RN will assess in collaboration with the interdisciplinary team potential causes for the behaviors and initiate appropriate nursing interventions to manage the safety needs of the patient."
* "The RN assigns and supervises appropriate care to the constant observer...It will be the responsibility of the RN to ensure all assigned patients are monitored as required based upon ongoing assessment and level of observation required."
* "Staff assigned responsibility for conducting routine or special patient observations are to...Verify identify of each patient assigned...Routinely observe environment for potential risk factors impacting safety...Maintain visual observation of patient at all times...Notify patient's RN or Charge nurse immediately of any changes in patient's condition or environment that could potentially decrease or elevate the level of observation...Document observations hourly in the medical record...Immediately inform patient's RN or Charge RN/House Supervisor if unable to complete observations as assigned."

2. a. Review of the medical record and incident/event documentation for Patient 4 revealed that he/she was suicidal and experienced self harm behaviors and the hospital failed to ensure the RN and other hospital staff appropriately monitored and maintained the patient in a safe physical environment in accordance with hospital P&Ps as he/she was allowed access to a telephone cord, pulse ox cord, and/or oxygen "hose" and scissors and/or suture forceps, and used those items to inflict self harm as follows:

The medical record reflected the patient presented to the ED on 01/13/2019 at 1108 with a chief complaint of "Withdrawal (Alcohol)."
* Physician notes dated 01/13/2019 at 1119 reflected "[Patient] presents here with a history of alcohol abuse, bipolar disorder, depression and hypertension who presents with alcohol withdrawal syndrome...states [he/she's] been off [his/her] medications for over a week...[family] brought [him/her] in...denies any active suicidal ideations but has had history of bipolar disorder and suicide attempts in the past...The patient will be moved to the red pod at this time for continued management of both [his/her] mental health issues including depression and suicidal thoughts along with alcohol withdrawal syndrome...the patient will be held here for continued observation..."
* MSW notes dated 01/13/2019 at 1615 reflected "SW met with Pt...patient's [family] reports that [he/she] is concerned with the patient discharging as [he/she]...has a history of 2 significant suicide attempts in the last year while going through detox..."
* RN notes dated 01/13/2019 at 1754 reflected the patient was moved from room ED13 to ED54.
* The RN notes dated 01/13/2019 at 1832 reflected:
- "Current Safety Status...Self Injurious Behavior: Yes..."
- "Suicidal Thinking Any Attempts this shift: Yes Intent: Continuous thoughts..."
* Physician notes dated 01/14/2019 at 1409 reflected "[Patient]...hospitalized through the emergency department with worsening depression, suicidal ideation, and alcohol withdrawal...[He/she] says the depression began first and then [he/she] relapsed on alcohol. [He/she] began to feel depressed and hopeless, as though [he/she] had no reason to live. [He/she] started having suicidal thoughts with a plan to jump off a tall building to end [his/her] life...[He/she] does not feel safe to leave the hospital...Plan...The patient is currently here on a voluntary basis. [He/she] is asking for hospitalization. [He/she] has been cooperative with treatment. Should this change abruptly and should [he/she] demand discharge I recommend placing the patient on a notice of mental illness...Patient is currently under one-to-one observations by nursing staff...I do think that [he/she] is at risk of suicide attempt, and I support continued one-to-one observations while in the emergency department or on the medical floor...Once [he/she] is medically clear I support referral for inpatient psychiatric stabilization..."
* RN notes dated 01/14/2019 at 2351 reflected the patient was moved from room ED54 to ED29.
* RN notes dated 01/15/2019 at 0347 reflected "As this RN walked past pt room, bed was empty. Walked into room to find patient hiding in corner of room with pulse ox cord wrapped around [his/her] neck. Code gray called. Staff and security to room..."
* RN notes dated 01/15/2019 at 0348 reflected the patient was moved from room ED29 to room ED31..."
* RN notes dated 01/15/2019 at 0355 reflected "At approximately 0349 this RN was in another pt's room, and heard a staff member call out for assistance to room ED29. When this RN entered ED room 29 the pt was sitting in a chair in the far corner of the room, tucked behind the outcropping of the wall, and had the pulse ox cord wrapped loosely around [his/her] neck. This RN immediately removed the cord from the pt's neck...
* Physician notes dated 01/15/2019 at 0403 reflected "Paged by nurse after code gray called. Pt found in corner of room with pulse ox cord wrapped around [his/her] neck...Pt allowed cord to be removed...However, concern for pt trying to harm [him/herself]. Now with 1:1 sitter."
* Physician notes dated 01/15/2019 at 0404 reflected "I was called to evaluate the patient after the patient having been found with a telephone cord around [his/her] neck....there is a faint red mark noted on the left lateral side...placed on one-to-one..."
* RN notes dated 01/15/2019 at 0428 reflected the patient was moved from room ED31 to room ED51.
* RN notes dated 01/15/2019 at 0941 reflected "...On q 15min checks."
* RN notes dated 01/15/2019 at 1021 reflected "[Patient] went to use the restroom...MHT checked [his/her] bed, [he/she] noticed a small hole on the mattress with a suture forceps inside it. Pt claims 'I took it from my other room.' [He/she] also showed this RN the superficial cut in [his/her] left wrist. Pt allowed RN with...MHT as standby, to perform a safety check. No other contrabands found at this time. On q15min checks."
* Physician notes dated 01/15/2019 at 1138 reflected "Was suicidal prior to drinking binge. Also here in hospital placed O2 hose around [his/her] neck and also had hemostats poking wrist..."
* MSW notes dated 01/15/2019 at 1500 reflected "...Pt continued to endorse SI. Decision made...to admit pt...for further stabilization...Current Self Harm Behavior: Pt injured [him/herself] during the course of ED with a pair of scissors [he/she] 'stole'...Violence or aggression history (include behavior in ED, on the Unit and access to weapons)...earlier in [his/her] visit [he/she] was presenting with more challenging behaviors such as grabbing the scissors...met with patient who continued to report SI...Decision made to pursue admission..."

The record contained a document titled "ED Behavioral Health Observation Form." The "guidelines" on the form reflected that the responsibilities for 1:1 constant observation included "Visual Observation At All Times...Never Leave The Patient Alone...Even When Using Restroom Or Shower...If Patient Leaves Area For Test/Procedure, Sitter Must Escort Patient At All Times...Document...every 15 minutes...Clearly indicate time that 1:1 is discontinued." The top of the form had a space for indicating either "Constant Observation (1:1)" or "Close Observation (q15")."

The "ED Behavioral Health Observation Form" dated 01/14/2019 for 0000 through 2345 did not reflect one-to-one observation was carried out as the check boxes at the top of the form reflected:
"Close Observation (q15")" was checked; and
"Constant Observation (1:1)" was not checked.
The form was initialed every 15 minutes from 0000 through 2345.

The "ED Behavioral Health Observation Form" dated 01/15/2019 for 0000 through 2345 did not reflect one-to-one observation was carried out as the check boxes at the top of the form reflected:
"Close Observation (q15")" was checked; and
"Constant Observation (1:1)" was not checked.
The form was initialed every 15 minutes for 0000 through 1830 and was not initialed at all for 1830 through 2345.

The physician notes dated 01/14/2019 at 1409 reflected the patient was suicidal, at risk for a suicide attempt and the physician supported "continued 1:1 observations," and on 01/15/2019 at 0404 the patient was "placed on one-to-one." However, the record lacked documentation that reflected 1:1 observations were carried out and there was no documentation that reflected the patient was assessed and determined 1:1 observations were not needed.

In addition, although the record reflected the patient was suicidal and he/she moved rooms 4 times while in the ED, there was no documentation that the patient's rooms were checked for unsafe items and unsafe items removed prior to when he/she accessed a telephone cord, pulse ox cord, and/or oxygen "hose;" and suture forceps and/or scissors that he/she used to inflict self harm.

b. An incident Event Reviewer form and investigation for Patient 4 reflected that on 01/15/2019 "At approximately 0349 this RN was in another pt's room, and heard a staff member call out for assistance to room ED29. When this RN entered ED room 29 the pt was sitting in a chair in the far corner of the room, tucked behind the outcropping of the wall, and had the pulse ox cord wrapped loosely around [his/her] neck. This RN immediately removed the cord from around the pt's neck, and did not observe any signs of trauma or injury. Pt...walked under [his/her] own power to ED 31 as directed by this RN..."
* The event was categorized "Self Harm/Self Inflicted Injury."
* The "Deviation?" section reflected "Was there a deviation from generally accepted performance standards (GAPS)? Unknown"
* The "Follow Up Notes" dated 01/18/2019 at 1402 reflected "Education to charge team regarding escalation of situations where there is no staff to perform 1:1 constant for patients. The escalation before new process ended at house supervisor. The process has charges (sic) escalating to manager on call and filing datix report."
* The "Actions Taken" reflected "code grey called. Pt moved to ED room 31, and sheets removed from bed, pt observed 1 to 1 by security officer. Pt then moved to Red Pod [room] 51."

The documentation lacked a clear, complete and thorough investigation and follow up actions, and did not align with the medical record as follows:
* There was no documentation in the investigation that reflected if the patient was at risk for self-harm or suicide prior to the event.
* There was no documentation in the investigation that reflected whether the patient should have been on 1:1 observation, or otherwise monitored at the time of the event, and if that was carried out.
* The physician notes dated 01/14/2019 at 1409 reflected the patient was suicidal, at risk for a suicide attempt and the physician supported "continued 1:1 observations" while in the ED; and on 01/15/2019 at 0404 "placed on one-to-one." There was no documentation in the investigation that reflected if there were physician orders for 1:1 observation at the time of the event, and if those were carried out.
* There was no documentation that reflected when the patient was last observed by staff prior to the event.
* It was unclear if the patient sustained an injury as the medical record reflected "there is a faint red mark noted" whereas the investigation reflected "RN...did not observe any signs of trauma or injury."
* It was unclear if the patient was found with a telephone cord, pulse ox cord, and/or an oxygen "hose" around [his/her] neck during the same or separate times as all three of those were documented in the medical record.
* The investigation reflected "...deviation from generally accepted performance standards (GAPS)? Unknown." There was no documentation in the investigation that reflected if P&Ps related to removal of personal belongings and items from the room that may be used to inflict self harm, patient observations or other P&Ps were applicable, and if they were carried out or not carried out.
* The documentation was unclear related to when 1:1 by security was started after the event and how long it continued.
* There was no documentation that reflected if the follow up action of education to the charge nurse team was carried out or not carried out.
* There was no documentation that reflected if abuse and neglect were ruled out.
* There was no definitive outcome and no further follow up or corrective actions identified for Patient 4 and any other patients who may experience similar events to prevent recurrence.

c. Another incident Event Reviewer form and investigation for Patient 4 reflected that on 01/15/2019 at 1015, "[Patient 4] went to use the bathroom. When the MHT went to check [his/her] room, [he/she] noticed a small hole on [his/her] mattress with a suture forcep inside. Pt claims [he/she] found it from [his/her] previous room. [Patient 4] showed RN a small superficial cut on [his/her] left wrist."
* The event was categorized "Self Harm/Self Inflicted Injury."
* The "Contributing Factors" reflected only "Behavioral Health/Mental Illness."
* The "Deviation?" section reflected "...deviation from generally accepted performance standards (GAPS)? Yes...Did it reach the patient? Yes"
* The "Follow up Notes" reflected "Patient admitted to finding the tool while [he/she] was boarding as medical mental health patient. Education and safety story being shared with all staff regarding the importance of cleaning rooms, and searching patients."
* The "Actions Taken" reflected "Room searched (sic) was performed. Pt skin checked (sic) done."
* The documentation reflected both "Minimal Harm...may have contributed to or resulted in temporary harm to the patient and required intervention" and "No Detectable Harm."

The documentation lacked a thorough and complete investigation and follow up actions, and did not align with the medical record as follows:
* Although the medical record reflected the patient was "at risk of suicide attempts" and was experiencing "earlier in [his/her] visit...behaviors such as grabbing the scissors" there was no documentation in the investigation that reflected if the patient was or was not at risk for self harm or suicide.
* The investigation and medical record reflected the patient claimed he/she found suture forceps in a "previous room." However, the medical record also reflected the patient experienced behaviors such as "grabbing scissors" and he/she injured him/herself with a pair of scissors he/she "stole." There was no further investigation regarding if the patient "found" suture forceps, "stole" scissors, or both of those including but not limited to where the patient was allowed access to suture forceps and/or scissors, how the patient was allowed access to suture forceps and/or scissors, and when the patient was allowed access to suture forceps and/or scissors. The record reflected the patient was in at least 4 rooms at the time of this event and that was not considered in the investigation with respect to how the patient was allowed to gain access to these items and inflict self harm.
* The investigation reflected: "...deviation from generally accepted performance standards (GAPS)? Yes," and "Did it reach the patient? Yes," but did not identify what specific performance standards were deviated from.
* There was no documentation in the investigation that reflected if P&Ps related to removal of personal belongings and items from the room that may be used to inflict self harm, patient observations or other P&Ps were applicable, and if they were carried out or not carried out.
* There was no documentation in the investigation that reflected if interventions had been planned prior to the event, such as monitoring and observations, to address the patient's risk of self harm, and if those were carried out.
* There was no documentation in the investigation that reflected if physician orders for observations were in place, if any, at the time of the event, and if those were carried out.
* There was no documentation that reflected when the patient was last observed by staff prior to the event.
* The investigation was unclear regarding if the patient sustained an injury as it reflected both "Minimal Harm...may have contributed to or resulted in temporary harm to the patient and required intervention" and "No Detectable Harm," and the medical record reflected the patient sustained a "cut in [his/her] left wrist." The investigation was unclear if the patient required treatment for the left wrist cut and if so the extent of the treatment.
* The follow up actions reflected only "Education and safety story being shared with all staff regarding the importance of cleaning rooms, and searching patients." However, there was no other information in the investigation about "cleaning rooms" and "searching patients," including how these follow up actions were relevant to the event. There was also no documentation that reflected when or if the follow up actions were carried out, and what specific staff were or would be included.
* There was no documentation that reflected if abuse and neglect were ruled out.
* There was no definitive outcome and no further follow up or corrective actions identified for Patient 4 and any other patients who may experience similar events to prevent recurrence.

d. During an interview with the EDM on 09/03/2019 at 1530, the EDM stated he/she didn't know where Patient 4 got scissors or suture forceps. The EDM stated those items are normally kept in a supply room or with staff.

e. Review of the hospital's incident/event log for January 2019 through August 2019 reflected no evidence of an incident report, investigation or follow up actions related to Patient 4 grabbing scissors, stealing scissors, or otherwise accessing scissors on or around 01/15/2019.

3. a. Review of the medical record and incident/event documentation for a second ED encounter for Patient 4 revealed that he/she was suicidal and the hospital failed to ensure the RN and other hospital staff appropriately evaluated the patient after he/she experienced increased self-harm behaviors, hit his/her head on a wall, abnormal BP, increased heart rate and other potential changes. The patient was not evaluated secondary to these changes, was discharged, and within minutes fell or jumped from the hospital's multi-level parking structure and died as follows:

The medical record reflected the patient presented to the ED by ambulance on 03/18/2019 at 1928 with a chief complaint of "Suicidal."

* RN triage notes dated 03/18/2019 at 1942 reflected "...Per EMS, pt called lifeworks today reporting intent to harm [him/herself]...Upon arrival of police, pt asked police officer to shoot [him/her]. After officers refused, pt ceased communicating..."

* RN notes dated 03/18/2019 at 1946 on the "ED Suicide Risk Screen" reflected "Current Ideation within the last 6 months: Yes" and "Current Plan: (Walk into traffic)"

* LCSW notes dated 03/18/2019 at 2010 reflected:
- "...Pt continues to refuse verbal communication upon arrival to the ED, but does answer some yes/no questions by nodding or grunting...Pt reports SI and denies a plan at this time but indicates that [he/she] would try to kill [him/herself] if [he/she] left the hospital...Pt was recently admitted to [PSVMC] from 1/15/19 - 1/21/19 for depression and SI in the context of ETOH relapse and withdrawal. While in the ED, [he/she] put a pulse oximeter cord loosely around [his/her] neck...[he/she] also managed to superficially cut [his/her] wrist with suture forceps..."
- The C-SSRS reflected:
"Suicidal Ideation: yes, no stated plan"
"Current Self Harm Behavior: no"
"Suicide attempts or self-injury history: Records indicate hx of 2 attempts by overdose in the past couple years. Suicide Risk Level: chronically elevated"
- The notes following the C-SSRS reflected:
"...Pt has hx of self-harming multiple times in the ED, including during [his/her] most recent visit in January 2019..."

* Physician notes dated 03/18/2019 at 2244 reflected "...[patient] is boarding in the emergency department while awaiting a final psychiatric disposition...Recommendation/Plan for Next Shift: There are no available beds in the inpatient psychiatric unit, and therefore the patient will remain boarded in the emergency department..."

* The RN "Behavioral Health Assessment" dated 03/19/2019 at 0615 reflected:
- "Current Safety Status"
"Thoughts of Suicide: Yes"
- "Suicidal Thinking"
"...Intent: Intermittent thoughts"
"Willing to come to staff if Urges Strong? Yes"
"Plan: UTA, poverty of speech, denies plan in hospital"
"Agrees to Safety Plan in Hospital: Yes"
"Agrees to Safety Plan Outside Hospital: No"

* RN notes dated 03/19/2019 at 0615 reflected BP 118/82, pulse rate 77, and "MEWS Total Score: 1."

* RN notes dated 03/19/2019 at 1000 reflected "BARS: 2-Asleep but responds normally to verbal or physical contact"

* Physician "Psychiatry - Initial Evaluation" notes dated "Date of Service: 3/19/2019" and "Time patient seen: 1100" electronically signed by the physician on 03/19/2019 at 1746 reflected:
- "Psychiatric Exam...Speech: No speech, other than grunts for emphasis when writing. Pt does respond readily to questions by writing on paper and by shaking/nodding head to yes/no questions, with fluent written responses...vague chronic SI without intent or plan...Insight/Judgement: limited"
- "...given lack of clear acute risk factors, hospitalization may be relatively contraindicated. As we discuss this together, pt notes [he/she] would prefer to discharge, notes [he/she] will take the bus and followup (sic) with lifeworks...declines to discuss further treatment options. I discuss with pt the option of calling friend/family for more support though pt declines this, insists on discharge...does not appear to be at imminent risk of lethality...pt now insisting on discharge...pt expresses [his/her] understanding and intention to followup (sic) with lifeworks...Unfortunately, shortly after discharge from ED, pt died after falling from parking structure."
* "Suicide risk estimation: at the time of discharge, no acutely increased risk; pt mildly irritable though clearly future oriented, focused on returning to Lifeworks and finding shelter. Pt with chronic vague SI without intent or plan. Pt with cluster B traits with chronic SI, lability, self harm, as well as etoh abuse, and [his/her] risk is likely elevated by such static risk factors which are unable to be modified by inpatient treatment."

* LCSW "ED Behavioral Health Re-Assessment" notes dated 03/19/2019 at 1153 reflected:
- "...Pt reports not feeling safe and wants to stay here...[psychiatrist] shared w the patient that given [his/her] hx and dx, admission is not indicated...attempted to plan OP follow-up...pt became frustrated and wrote more aggressively and began to shake. Eventually when we left the room the pt began to moan and groan and hit [his/her] head on the wall. Pre-code grey was called. Pts behaviors appeared to be volitional and based on [his/her] dissatisfaction with [his/her] d/c plan. Pt declined bus pass and shelter vouchers...saying [he/she] only wants to stay in the hospital. Pt declined Lines for Life referral as well...Current Safety Risk Assessment: Pt does endorse SI, when asked about a plan, the pt says [he/she] has no plan..."

* RN "Vital Signs" documentation dated 03/19/2019 at 1215 reflected the patient's BP was "148/108 (Abnormal) !" and his/her heart rate had increased to 137.

* RN documentation dated 03/19/2019 at 1215 reflected the patient's MEWS total score had changed and was "4 (Abnormal) !"

* The RN "Behavioral Health Assessment" at 1218 reflected:
- "Current Safety Status"
"Self Injurious Behavior: No"
"Thoughts of Suicide: Yes (no plan)"
- "Suicidal Thinking"
"Any Attempts this shift?: No"
"Intent: Intermittent thoughts"
"Willing to Come to Staff if Urges Strong?: Yes (writes notes)"
"Agrees to Safety Plan in Hospital: Yes"
"Agrees to Safety Plan Outside Hospital: No"
- "Mental Status Exam"
"Appearance: Hospital scrubs"
"Eye Contact: Avoids"
"Speech: (remains mute)"
"Cooperation: No participation in program (refuses to talk)"
"Attention Span: Brief"
"Mood/Affect: Withdrawn"
"Orientation: WDL"
"Thought Process: Ruminative"
"Thought Content: Victim thinking"
"Insight/Judgment: Lacks insight; Impaired judgment"
"Behavior: Quiet; Withdrawn"
"Motor Activity: WDL"
"Interaction with Peers: Withdrawn"
"Interaction with Staff: Other...writes notes, refuses to talk to staff)"
- "Self Inflicted Injury"
"Any New Self Inflicted Lesions: No"
"Medical Complaints: No"

* RN documentation at 1225 reflected "...Pt refused to talk, would only write on paper. Angry to discharge because [he/she] wanted to stay. When told [he/she] would discharge, began to yell and moan. [He/she] discharged with bus ticket."

* Physician notes electronically signed by the physician on 03/19/2019 at 1349 reflected:
- "...discussed the patient with [psychiatrist] after [his/her] evaluation and it was fel

Based on observation, review of medical record and incident/event documentation of a patient with suicidal ideation and self harm behaviors (Patient 4), review of medical record and incident/event documentation for 7 of 9 other patients who received hospital services (Patients 3, 7, 11, 13, 15, 16, and 17), review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients' rights were recognized, protected and promoted and all components of an effective abuse and neglect prevention program were evident, including clear and complete investigations of abuse or neglect, as defined by CMS, to ensure those incidents did not recur:
* Hospital staff failed to ensure patients were provided care in a safe setting. A patient was not appropriately monitored and supervised in the ED, including in the ED "Red Pod," a secured area/unit for behavioral health patients, as he/she was repeatedly allowed access to unsafe items including scissors and/or suture forceps; and a pulse ox cord, telephone cord, and/or oxygen "hose," and used those to inflict self harm; and the hospital failed to conduct thorough investigations and follow up actions to ensure similar events did not recur. During an ED visit two months later, the same patient experienced an increase in self harm behaviors including hitting his/her head on a wall and subsequent abnormal vital signs and the hospital failed to reevaluate the patient secondary to those changes. The patient was then discharged from the "Red Pod" and within minutes jumped or fell from the hospital's parking structure and died; and the hospital failed to conduct a thorough investigation and follow up actions to ensure similar events did not recur.
* The hospital failed to conduct clear, thorough and timely investigations of incidents/events including those with potential and actual harm related to repeated falls, transport of critically ill patients, anesthesia services, and skin alterations; and failed to develop timely follow up actions to ensure similar events did not recur.

The CMS Interpretive Guideline for this requirement at CFR 482.13(c)(3) reflects "Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Further, the CMS Interpretive Guideline reflects that components necessary for effective abuse protection include, but are not limited to:
o Prevent.
o Identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.
o Protect. The hospital must protect patients from abuse during investigation of any allegations of abuse or neglect or harassment.
o Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment.
o Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law.

Findings included:

1. a. The P&P titled "Unusual Occurrence Reporting," dated last revised "09/2018" was reviewed and reflected:
* "It is the policy...to ensure patient and staff safety by the identification of unusual events, near misses, and problem prone processes."
* "An unusual occurrence is any event, which is not consistent with routine operation of the hospital or routine care/service of a particular patient/visitor/staff member. An unusual occurrence can also be defined as an event, or a process which places patients and/or others in an unplanned risk situation for harm or possible harm."
* "Datix Event Record...tool for any employee, physician, or volunteer to report an unusual occurrence. Reports will be completed and submitted through the PH&S Intranet."
* "Each hospital has a Quality Council...with responsibility for the review and coordination of quality assessment and improvement activities...This committee assesses the aggregate data, prioritizes identified opportunities for improvement, facilitates problem resolution, develops and/or assures responses to risk management concerns and monitors to determine the effectiveness of action taken...In addition, the Hospital Administrator appoints a Safety Committee whose primary responsibility is the environment of care. The Safety Committee and the sub-committee can review Datix Event Record findings for unsafe conditions and practices. The work of these groups and other groups...are coordinated and integrated to provide an overall Patient Safety Program."
* "When an unusual occurrence is discovered, the individual involved in the event and/or the individual discovering the event will complete the Datix Event Record as soon as possible so that details will not be forgotten. It is expected that anytime an event of serious consequences occurs, the person who becomes aware of the event will notify their supervisor/manager immediately to provide assistance and take actions, if appropriate. The supervisor/manager should contact Quality Management as soon as possible. Action will be taken as appropriate to reduce any immediate danger to patients, visitors, or staff."
* "...the facts of the event should be documented in the medical record if it has an impact on patient care."
* "The Datix Event Record will be reviewed by the unit manager or department head (or designee) who is responsible to investigate the situation, take actions as indicated, follow-up with applicable staff, and document their findings on the Datix Event Record. This individual also reviews the Datix Event Record for completeness and accuracy, and submits the completed record within 14 days."

b. The P&P titled "Fall Prevention Practice Guideline," dated last revised "04/2017" was reviewed and reflected:
* "A patient fall is a sudden, unintentional descent, with or without injury to the patient, that results in the patient coming to rest on the floor, on or against some other surface (e.g. a counter), that results in the patient coming to rest on the floor, on another person, or on an object...When a patient rolls off a low bed onto a mat or is found on a surface where you would not expect to find a patient, this is considered a fall..."
* "After a Fall...Complete a post fall assessment...Assess the patient for injury. Leave patient on the floor until this is done...Assess for neck and spine injury...To rule out head injury, assess...Current level of consciousness...Pupil responses (PERRLA)...Subtle cognitive changes...Check for vital signs...Assess the skin for pallor, trauma, circulation, bleeding, and sensation...Assess...for sensation and movement of all extremities...Assess for pain, points of tenderness and changes in range of motion...Observe leg rotations and assess for hip pain, shortening of the extremity...Reassess patient for injuries in 24 hours following the fall..."
* "Debrief the fall...Conduct a fall debrief with all involved caregivers prior to the end of the current shift...Follow the Debrief Checklist...including...What happened...When the fall occurred including calendar, date, time of fall...Where the fall occurred...use of equipment...What may have contributed...If observed or not...If assisted or not...Findings from assessment...If possible, use patient's words to obtain an overall description of contributed (sic) to the fall, as well as caregiver's."
* "Communicate the patient fall, the results of the debrief and document in electronic medical record (EMR) Notes...Notify attending LIP of fall, patient status, and risk for injury...Notify patient's family/contact immediately after the fall occurs unless the patient outwardly refuses to have them notified...In EMR Notes, document the findings of the patient fall debrief...In EMR also signify occurrence of 'Significant Event'...Review and up-date plan of care..."

c. The P&P titled "Regional Nursing Minimum Documentation Reference," dated last revised "01/2017" was reviewed and reflected the minimum documentation for "Pressure Ulcer Risk Assessment (Braden or Braden Q Scale)" was every 24 hours.

2. Regarding Patient 3: An Event Reviewer form and investigation for the patient reflected that on 01/05/2019 "Pt had a fall at approximately 2000. Alarm heard - RN [name] and RN [name] rushed to the room. Pt was sitting on the floor with back placed on lower edge of bed. Pt on a low boy bed...3 side rails were up at the time of the incident...Pt seemed slightly more confused from baseline...CNA reported [he/she] had just assisted pt prior to fall. VSS. No new injury noted. Did complain of R hip pain but stated no more than usual...received 10mg of Oxycodone at 1734 pm...Frequent rounds made..."
* The "Fall Debrief Form" dated 01/05/2019 at 2000 reflected:
- "Witnessed...No"
- "Anticoagulation Therapy: Yes"
- "Hit Head...No"
- "Change in LOC: Yes...seems more confused."
* The "Follow Up Notes" dated 02/25/2019 at 1135, more than a month after the event reflected "Discussed with RN the plan with the patient, opportunities for improvement. Patient had just been rounded on, the CNA had just left to get [him/her] some water when [he/she] got out of bed 'to shut the door'...Reviewed the need and opportunity that we have now to use RVM.
* The "Follow Up Notes" dated 09/05/2019 at 0952, 8 months after the event reflected "This patient had all the safety measures in place to reduce the risk associated with a fall while in the hospital. After the event however, real time debrief identified that the staff could use a second strip alarm on the upper body to allow for even earlier alert system..."

The documentation reflected interventions and actions taken that included "Increased frequent rounding, decreased narcotics and "Strip along placed." However, the documentation lacked clear, thorough and timely investigation and follow up actions as follows:
* The documentation lacked information to reflect if the 3 side rails up were a potential restraint and were appropriate for the patient who was confused and if the side rails contributed to the fall.
* The documentation lacked an evaluation of the cause of the increased confusion.
* There was no documentation that reflected how it was determined that the patient, who was on anticoagulation therapy, did not hit his/her head as the documentation reflected the fall was not witnessed.
* The follow up actions reflected "Increased frequent rounding" but there was no documentation that reflected how frequently the increased rounding was increased to.

3. Regarding Patient 4: Refer to the findings identified under Tag A144, CFR 482.13(c)(2) - Standard: Patient Rights: Care In A Safe Setting. Those findings reflect the hospital's failure to conduct clear, complete and thorough investigations and follow up actions of Patient 4's repeated access to unsafe items that resulted in self harm; failure to conduct an investigation and follow up actions of the patient's increased self harm behaviors that included hitting his/her head on a wall; and failure to conduct a clear, complete and thorough investigation and follow up actions after the patient was discharged from the hospital and within minutes jumped or fell from the hospital's parking structure and died.

4. Regarding Patient 7: An Event Review form and investigation for the patient reflected that on 03/03/2019 at 0815 "[RN]...left in the morning without giving oncoming Day shift RN...report on patient in [room number]. Waited until 0815 and was unable to locate RN. No written report left either."
* The "Contributing Factors" reflected "Care Plan Not Followed...Too high patient to RN ratio/Too high acuity patient assignment"
* The "Follow Up Notes" dated 03/05/2019 at 0637 reflected "Reviewed protocol with RN, RN thought [he/she] had given report. Understands policy and will make sure to give report on all patients in the future."
* The "Follow Up Notes" dated 09/05/2019 at 1247, 6 months after the event reflected "...reviewed other options for obtaining patient report...Reviewed protocol and expectations for future...deemed a one-time human error event..."

The investigation was not timely, clear or complete. For example:
* The investigation reflected "Reviewed protocol...understands policy" but did not include if a protocol and/or policy was or was not followed and if it contributed to the event.
The investigation reflected that the care plan was not followed but did not include what goals, interventions or other components of the care plan were or were not followed.
The investigation and follow up actions were not completed within 14 days in accordance with hospital P&Ps, as notes related to those continued 6 months after the event.

5. a. Regarding Patient 11: An Event Reviewer form dated 05/09/2019 and investigation documents provided with the Event Reviewer form reflected that on 04/13/2019 the patient was induced with anesthesia in preparation for a surgical procedure, the ventilator was turned off but not turned back on, the patient coded, and later died.

The Event Reviewer form and investigation lacked documentation that they were initiated and completed timely in accordance with hospital P&Ps. For example:

The investigation documents reflected numerous hospital staff were involved in or were aware of the event at the time it occurred including a surgeon, at least 2 anesthesiologists, a circulator RN, a CN, and an OR tech. However, the Event Reviewer form reflected it was not initiated by any of those individuals "as soon as possible" in accordance with the hospital's P&P as the "Reported Date" was not until 05/09/2019 at 0646, 26 days after the event occurred on 04/13/2019.

* An undated "Notification of Event Timeline" reflected:
- "4/15/2019...PSVMC not informed of event."
- "5/2/2019...Informed of event by member of the medical staff who thought we were already investigating...Review of all datix events for the month revealed no event reporting that would fit this event..."
- "5/3/19...I requested a formal investigation to begin..."

* An event action plan provided reflected:
- "Event date 4/13/2019..."
- "Safety Commission Report Submission 7/17/2019..."
- "Ministry Practice Session...8/12/2019..."
- "Quality Council Initial Review 8/22/2019..."

None of the documentation clearly reflected when the investigation was initiated or when it was completed. During an interview on 09/03/2019 at 0935 with hospital staff that included the DQM, it was stated that the investigation for the event was completed and the "conclusion" included that there were distractions in the OR and staff focused on equipment versus the patient.

The investigation documentation lacked evidence of a timely and clear follow up actions to ensure the event did not recur. For example:

* The Event Reviewer form "Follow Up Notes" dated 05/09/2019 at 1528 reflected "QM and anesthesia department along with Main OR nursing leadership is investigating this event." The "Actions Taken" reflected "Undergoing Investigation."

* The "Notification of Event Timeline" reflected "4/23/19 [staff] Last day working...On leave." This was 10 days after the event occurred and there were no further follow up actions to ensure the event did not recur to other patients during the course of the investigation.

* The "Key Issues/Recommendations" on an event timeline provided included:
- "Patient loads increasing/not enough staff"
- "Recommendations: - Forget about everything else, except the patient - Somehow the vent could help remind the anesth?.." It was unclear if these key issues and recommendations were intended to be carried out or not carried out.

* The event action plan provided reflected:
- "Initial interventions post occurrence to prevent same or similar events (prior to completion of RCA):" followed by a blank space.
- "Local Actions...Add a secondary monitor(s) to anesthesia machine cardiac monitors...Trial for three months...Re-evaluate secondary monitors at the end of the trial period for further use." The implementation of the trial monitor was "July 2019." This follow up action was not initiated until 3 months after the event. There was no further follow up actions to ensure the event did not recur to other patients during the investigation.

* An email dated 09/05/2019 at 1217 reflected "To clarify, the action is to add the monitors in ORs 14 and 20. We will trial in these ORs for 3 months (ending in October) and seek feedback from staff of their effectiveness. We will also monitor Datix for any events, near-misses and good catches coming from these ORs since installation of these display monitors."

b. During an interview with the PSS on 09/03/2019 at 1000, the PSS stated the hospital had 40 ORs. However, there was no documentation of further follow up actions to ensure the event did not recur to other patients during the investigation aside from one staff member who was placed on leave 10 days after the event occurred.

c. The P&P titled "Unusual Occurrence Reporting" dated last revised "09/2018" did not include a process that ensured a timely investigation and follow up actions for circumstances when an incident/event was referred to QA, hospital leadership or other departments to complete those tasks.

6. a. Regarding Patient 13: An Event Reviewer form and investigation for the patient reflected the event date and time was 05/04/2019 at 0030. The documentation reflected:
* The "Patient was in ED lobby waiting for a room when [he/she] suddenly had a seizure and fell off chair...hit forehead (right side) on the lobby floor resulting in laceration. A rapid response was called to the lobby...Patients fall was seen on review of lobby camera by security."
* The event was categorized as "Fall."
*The "Fall Debrief" reflected "...patient was 'training for an ultramarathon...[He/she] did not mention this during triage..."

The medical record for Patient 13 reflected:
* The patient arrived at the ED on 05/03/2019 at 2224. The RN triage notes at 2307 reflected "Patient reports vomiting x 2 hours and 'feeling off' x 5 hours. Dizziness Pale in triage."
* The RN notes dated 05/03/2019 at 2335 reflected "Large thump heard in lobby, pt found on the floor on back lying in [male/female's] arms, large amount of blood coming from above right eyebrow. Pt with generalized tonic clonic movement, unresponsive....Tonic/clonic movement lasted approximately 45 seconds..."
* The RN notes dated 05/03/2019 at 2346 reflected "Patient found down in triage, actively seizing...began to vomit..."

The investigation documentation was unclear and did not align with the medical records as follows:
* It was unclear how many seizures and/or falls the patient experienced as the RN notes reflected:
- On 05/03/2019 at 2335 "Large thump heard in lobby, pt found on the floor...large amount of blood coming from above right eyebrow...generalized tonic clonic movement;" and
- On 05/03/2019 at 2346 "Patient found down in triage, actively seizing."
However, the investigation reflected:
- On 05/04/2019 at 0030 the patient experienced seizure activity and fell off a chair in the ED lobby that resulted in a right side forehead laceration.
* The investigation did not include how long the patient was waiting in the lobby for a room and when or if the patient was last checked prior to the fall(s) and/or seizure(s).
* The investigation reflected the "Fall was seen on review of lobby camera by security" but did not include any further information about what was observed on the lobby camera, or if any other hospital individuals observed it.

b. Review of the hospital's incident/event log for January 2019 through August 2019 reflected one event report for Patient 13 on 05/04/2019. That event report was categorized as "Fall" and coincided with the Event Reviewer form for the event on 05/04/2019 at 0030. However, there were no event reports for the 2 falls and seizures documented in the medical record on 05/03/2019 at 2335 and 05/03/2019 at 2346.

7. Regarding Patient 15: An Event Reviewer form and investigation for the patient reflected that on 07/02/2019 at 0800 "Transport was ordered stat to transfer pt from [room number] to CICU [room number]. Transport didn't arrive for well over 15 minutes...Delay could have affected pt treatment."
* The "Extent of harm" reflected "Minimal Harm."
* The "Severity" reflected "Event may have contributed to or resulted in temporary harm to the patient and required intervention."
* The "Deviation?" section reflected "...deviation from generally accepted performance standards (GAPS)? Unknown."
* The "Follow Up Notes" dated 08/01/2019 at 1113, a month later reflected "action sent to unit manager for further information."
* The "Follow Up Notes" dated 08/13/2019 at 1034 reflected "Involved transporter was a newly hired employee we had provide (sic) additional training to avoid this delays (sic) in future."
* The "Actions Taken" dated 08/13/2019 at 1034 reflected "Additional training. Proper response time for critical transitions in care."

The medical record for Patient 15 reflected:
* Physician notes on 07/02/2019 at 0800 reflected "...On my evaluation this morning, patient appeared pale & diaphoretic...HR was initially 109 and steadily increasing to the 120's...Cardiothoracic surgery PA...arrived at the bedside...STAT Echo was obtained, which revealed a moderate pericardial effusion. Shared decision was made to transfer patient to CICU due to concern for tamponade and need for possible surgical intervention...RN was called to the bedside to assist with transfer."
* RN notes on 07/02/2019 at 0833 reflected "...Pt transported to CICU accompanied by Rapid response nurse and physician..."

The investigation documentation lacked a timely, thorough and complete investigation and follow up actions as follows:
* The investigation was unclear regarding the harm the patient experienced as it referenced both "minimal harm" and "temporary harm" but did not include details about what the "harm" was.
* The investigation reflected "...deviation from generally accepted performance standards (GAPS)? Unknown." There was no documentation in the investigation that reflected if applicable P&Ps including those related to stat patient transports were carried out.
* There was no documentation that reflected if the newly hired employee had completed the appropriate training prior to the event.
* The investigation was not timely as it was not completed within 14 days in accordance with hospital P&Ps.
* There were no further follow up or corrective actions identified for Patient 15 and any other patients who may experience similar events to prevent recurrence.

8. a. Regarding Patient 16: An Event Reviewer form and investigation for the patient reflected that on 08/10/2019 at 0900 "...RN assessed new skin tear near the wound vac. L lateral hip. Redness and partial skin loss..."
* The "Skin Integrity Event Contributing Factors" reflected "Select all applicable...Unable to Determine"
* The "Extent of harm" unclearly reflected "No Detectable Harm"
* The "Deviations?" section reflected "Was there a deviation from generally accepted performance standards (GAPS)?" This was followed by a blank space.
* The "Actions Taken" dated 08/27/2019 at 1134 reflected "Appropriate follow-up (sic) Pt turned more frequently. Is high priority. Frequent skin reassessment may have prevented this."

The medical record for the patient reflected:
* RN notes dated 08/09/2019 at 1215 reflected "...[patient] with TBI...with traumatic L intertrochanteric femur fracture d/t bicycle accident...[underwent] trochanteric nail [procedure] 7/20. On 8/6 [he/she] underwent I&D...wounds were closed...wound vac placed in the OR..."
* RN notes dated 08/10/2019 at 1639 reflected "New skin tear found on L lateral hip during bedbath (sic) this a.m. Dressing applied." The "Skin" flowsheet documentation for "Skin Tear" dated 08/10/2019 at 0900 reflected the following sections were blank "Periwound Area," "Periwound Comment," "Edges," "Wound Width (cm)," "Wound Length (cm)," and "Wound Depth (cm)."
* "Skin" flowsheet documentation dated 08/06/2019 a 0820 reflected a Braden skin assessment with Braden score "!15." The next Braden risk assessment was not documented until 08/10/2019 at 0900, 4 days later and that Braden score was "!16."
* There was no documentation that reflected the physician was informed of the new skin tear.

The investigation documentation lacked a thorough and complete investigation and follow up actions as follows:
* There was no documentation that reflected if the patient had a care plan related to skin care and management, and if interventions were appropriate and were or were not carried out.
* The documentation reflected "Frequent skin reassessment may have prevented this." There was no documentation that reflected if P&Ps related to skin assessments, skin care and management were or were not carried out.
* There was no documentation that reflected when the patient's skin was last checked.
* There was no documentation of interviews with hospital staff who cared for the patient who may have had information about how the skin tear occurred.
* There was no further documentation that described the new skin tear, including size, drainage, edges, periwound, and signs and symptoms of infection.
* There was no further investigation that reflected the cause, potential cause and/or contributing factors.
* There were no further follow up actions for Patient 16 or other patients who may experience similar events.

b. During interview and review of the medical record with numerous hospital staff including DQM and QMC on 09/03/2019 at 0945, the staff present confirmed there was no documentation in the medical record that reflected the size of the skin tear. The QMC confirmed there was no documentation in the medical record that the physician was notified of the new skin tear. The QMC stated "I can't find it."

9. a. Regarding Patient 17: An Event Reviewer form and investigation for the patient reflected that on 08/26/2019 at 1720 "[Patient] was found sitting on the left side floor of the foot of the bed, RVM alarm was activated. Per RVM personnel, [patient] had lowered [him/herself] to the floor after an employee left [him/her] sitting on the side of the bed. Pt's RN [name] followed up w/ the RN [name] who went to reposition pt before [he/she] fell. Per [name], [he/she] helped [patient] move to the center of the bed from the edge. When [name] left the pt's room, [he/she] was sitting in the middle of the bed. The bed alarm was on and was activated at the time of the fall when unit staff arrived to the room. Pt was confused and disoriented...No injuries were found, no c/o pain, pt appeared calm and easily reoriented...Pt requested to sit in the chair...transfer to chair...MD notified about the fall, recommended sitter, charge RN notified. RVM personnel to activate alarm if the pt started to move out of the chair." The Event Reviewer form reflected "Date closed...09/04/2019."

The investigation documentation lacked a thorough and complete investigation and follow up actions as follows:
* The "Deviation?" section reflected "...deviation from generally accepted performance standards (GAPS)?" followed by a blank space. There was no documentation in the investigation that reflected if applicable P&Ps including those related to patient falls, post fall assessments, and RVM were carried out.
* The "Actions Taken" reflected:
- "...sitter placed at bedside." There was no documentation that reflected when the sitter was placed at the bedside as the medical record below reflected the patient fell again on 08/26/2019 at 1805.

The medical record for the patient reflected:
* On 08/26/2019 at 1600 "pt found on the floor...Morse Fall Risk Level...High."
There was no documentation that reflected the RN assessed the patient after the fall.
There was no documentation of a "Post Falls Assessment" completed after the fall in accordance with hospital P&Ps.
There was no documentation that vital signs were taken after the fall.
There was no documentation that the RN notified the physician or other LIP regarding the fall. This was confirmed during a review of the medical record on 09/03/2019 at 1045 with numerous hospital staff including QMC and DQM.

* On 08/26/2019 at 1720 the record reflected the patient had another fall. The documentation reflected "pt found on the floor...Morse Fall Risk Level...High."
* On 08/26/2019 at 1720 the record reflected "[Patient] was found sitting on the left side floor of the foot of the bed, RVM alarm was activated. When [name] left the pt's room, [he/she] was sitting in the middle of the bed. The bed alarm was on and was activated at the time of the fall when unit staff arrived to the room. Pt was confused and disoriented...No injuries were found, no c/o pain, pt appeared calm and easily reoriented. MD notified about the fall, recommended sitter, charge RN notified. RVM personnel to activate alarm if the pt started to move out of the chair."
* RN documentation dated 08/26/2019 at 1720 reflected a "Post Falls Assessment" was completed and the "Post Fall Interventions" reflected "monitoring." There was no documentation that reflected how frequently the patient was to be monitored.
There was no documentation that vital signs were taken after the fall.

* RN notes dated 08/26/2019 at 1805 reflected the patient had another fall. The RN notes reflected "Pt was found on the floor by [his/her] chair. [Patient] wanted to go to the restroom, CNA left to find help as mobility aide and RN were heading to the room, the RVM alarm was activated, the pt was found sitting on the floor. Event occurred within about 5 minutes of CNA leaving the room...Per RVM personnel, pt lowered [him/herself] to the ground quickly, pt was disoriented...[Patient] verbalized [he/she] wanted to use the bathroom. Pt was assisted by RN and mobility aide to the BSC after which [he/she] was transferred to the bed. Chair alarm was on and activated at the time of the fall...MD notified, CN notified, sitter requested."
There was no documentation that reflected the RN assessed the patient after the fall.
There was no documentation of a "Post Falls Assessment" completed in accordance with hospital P&Ps.
There was no documentation that vital signs were taken until 08/26/2019 at 1900, an hour after the fall.

* RN notes dated 08/26/2019 at 2007 reflected "...Pt found on floor x 2 today, no signs of injuries..." Although the documentation reflected "no signs of injury" there was no documentation that reflected the patient was assessed for injuries after the falls recorded on 08/26/2019 at 1600 and 08/26/2019 at 1805.

b. The medical record unclearly reflected 2 or 3 falls occurred on 08/26/2019. However, review of the hospital's incident/event log for January 2019 through August 2019 reflected only one event report related to a fall for Patient 17 on 08/26/2019, and that event corresponded with the fall on 08/26/2019 at 1720. There was no documentation of an incident/event or investigation in the log for the falls that were documented in the medical record on 08/26/2019 at 1600 and 1805.

Based on observation, review of medical record and incident/event documentation of a patient with suicidal ideation and self harm behaviors (Patient 4), review of medical record and incident/event documentation for 7 of 9 other patients who received hospital services (Patients 3, 7, 11, 13, 15, 16, and 17), review of grievance documentation for 2 of 7 patients selected from the grievance log (Patients 12 and 14), review of environmental risk assessment documentation, review of policies and procedures, and review of other documentation, it was determined that the QAPI program was not effective to ensure the provision of safe and appropriate care to patients in the hospital that complied with the Conditions of Participation. Staff failed to:
* Prevent patient access to unsafe items;
* Provide appropriate and effective patient monitoring and supervision;
* Evaluate increased patient behaviors and other changes prior to discharge;
* Conduct clear, thorough and timely investigations of incidents/events including those with potential and actual harm related to access to unsafe items, patient death following discharge, repeated falls, transport of critically ill patients, anesthesia services, and skin alterations; and failed to develop timely follow up actions to ensure similar events did not recur:
* Ensure unsafe items, areas, and ligature risks in the physical environment that created the risk for self harm and/or harm to others were identified and/or mitigated; and
* Ensure written responses to patient complaints and grievances contained all of the required elements including the steps taken to investigate the grievance.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited under Tag A115, CFR 482.13 - CoP Patient's Rights.

Based on interview, incident/event documentation and medical records for 3 of 3 patients reviewed for provision of nursing services (Patients 4, 16 and 17), and review of policies and procedures, it was determined that the hospital failed to ensure the RN supervised and evaluated patients to ensure the provision of safe and appropriate care in accordance with hospital policies and procedures including:
* Supervision and observations to prevent patient access to unsafe items used to inflict self harm were not carried out and/or were ineffective;
* A patient was not assessed for injuries and ability to follow discharge instructions after increased self harm behaviors that included hitting his/her head on a wall.
* BARS assessments were not conducted following increased self harm behaviors;
* Abnormal vital signs and abnormal MEWS were not reassessed prior to discharge;
* Post fall assessments and vital signs were not completed or were not completed timely;
* Assessment of skin alterations were incomplete; and
* Braden risk assessments were not conducted.

Findings include:

1. Refer to the findings identified under Tag A144, CFR 482.13(c)(2) - Standard: Patient Rights: Care in a Safe Setting. Those findings reflect the hospital's failure to ensure the RN appropriately supervised and evaluated Patients 4, 16 and 17.

Based on observation, review of medical record and incident/event documentation of a patient with suicidal ideation (Patient 4), review of policies and procedures, review of physical environment risk documentation, and review of other documentation, it was determined that the hospital failed to fully develop and implement clearly written policies and procedures that ensured the physical environment was arranged and maintained for the safety of patients as follows:
* The physical environment contained hazards such as unsafe items and ligature risks that had not been identified and/or mitigated and created risk for self harm.
* Measures to prevent patients from accessing unsafe items in the physical environment were unclear and were not effective. A patient who was at risk for suicide and self harm repeatedly gained access to unsafe items including scissors and/or suture forceps and a pulse ox cord, telephone cord, and/or oxygen "hose," and used those to inflict self harm.

Findings include:

1. Refer to the findings cited under Tag A115, CFR 482.13 - CoP: Patient's Rights. Those findings reflect the hospital's failure to ensure the provision of care in a safe physical environment.