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PATIENT RIGHTS

Tag No.: A0115

The Condition of Participation of Patient's Rights was not met.

Findings included:

The Hospital failed to ensure for one (Patient #10) patient of 15 sampled patients that the Hospital provided care in a safe setting.

Refer to TAG: A-0144

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on interviews and record reviews, the Hospital failed, for one (Patient #10) patient of 15 patients sampled, to provide care in a safe setting to prevent an attempted suicide, by ingesting his/her own antipsychotic and sedative medications, while being observed and treated in the Emergency Department for suicidal ideation.

Findings included:

It was reported that Patient #10 arrived into triage at the Emergency Department on 6/20/20 at 10:15 A.M. with a chief complaint of depression. On 6/30/20 at 10:37 A.M. Patient #10 was assessed as being suicidal with the intention of self-harm. On 6/30/20 at 10:38 A.M., Nurse #1 documented a request for psychiatric consult in Patient #10's medical record for suicidal intent.

Record review indicated that on 6/30/20 at 10:45 A.M. Patient #10 was transferred from the Emergency Department waiting room (triage area) to the evaluation section of the Emergency Department with security standby outside the evaluation room for safety.

Record review indicated that on 6/30/20 at 11:16 A.M. the physician ordered a section 12a (allowing a patient to be brought against his or her will for evaluation), on unit safety orders to secure patient belongings, as per protocol, search clothing and search belongings. At 11:17 A.M. the Emergency Department consult to Acute Psychiatric Services was placed and On-Unit Safety Orders were placed which included constant observation, restrict patient to unit and snap pajamas.

Record review indicated that on 6/30/20 at 11:32 A.M. Patient #10 was changed into APS (Acute Psychiatric Services) pajamas and belongings were gathered. Patient #10's phone case was checked by security and safety was maintained.

Record review indicated that on 6/30/20 at 11:34 A.M. Patient #10 was transferred to the CDU (Clinical Decision Unit) with safety orders in place. At 11:45 A.M. the patient was observed to arrive to the CDU with APS attire and was positive for Suicidal Ideation.

Record review indicated that on 6/30/20 at 12:40 P.M. the APS provider tried to wake Patient #10 up for consult and Patient #10 did not respond. Patent #10 was assessed and found to have a hypotensive blood pressure reading of 61/34, was responsive to sternal rub and moved to acute unit for closer monitoring.

Record review indicated that on 6/30/20 at 12:53 P.M. Patient #10 had a peripheral IV inserted and received sodium chloride (NS) 0.9% syringe flush 3 milliliters; sodium chloride 0.9% bolus 1,000 milliliters.

Record review indicated that on 6/30/20 at 12:55 P.M. Patient #10's bra and underwear were removed and the patient was changed into a gown with provider agreement for gown instead of the APS pajamas.

Record review indicated that on 6/30/20 at 2:19 P.M., Patient #10 told the APS provider that he/she took 900 MG of Seroquel (an antipsychotic medication) and 12 Milligrams of Klonopin (a sedative medication) just prior to security search.

Record review indicated that on 6/30/20 at 2:32 P.M., Patient #10 told Registered Nurse #2 that he/she took Seroquel and Klonopin while in the evaluation section of the Emergency Department while under observation of the security guards who were standing by outside of Patient #10's evaluation room.

In an interview on 11/4/20 at 10:00 A.M. the Emergency Department Nurse Practice Specialist said that once the section 12a is in place, then the nurse will change the patient into APS safe pajamas and do a belongings search.

In an interview on 11/5/20 at 10:15 A.M. Registered Nurse #2 said that there is no search of the patient prior to the Section 12a order. Security stands outside of the room with direct observation of the patient.

In an interview on 11/5/20 at 10:45 A.M. the Patient Safety Staff Specialist said that due to the COVID pandemic, security will stand outside of the evaluation room and provide observation of the patient to attempt to make sure the patients are not doing anything to harm themselves and to stay safe.

The Hospital failed to identify the potential for Patient #10 to have access to his/her own antipsychotic and sedative medications which resulted in the subsequent over-dose and increased level of medical care needed to be provided to the patient while in the Emergency Department for depression and suicidal ideation. The patient had access to these medications from 10:15 A.M. until his/her belongings were searched at 11:32 A.M. while in the Emergency Department.

QAPI

Tag No.: A0263

The Condition of Participation of Quality Assessment & Performance Improvement Program was not met.

Findings included:

The Hospital failed for one (1) patient (Patient #9) in a sample of fifteen (15) sampled patients, to ensure implementation of physician communication improvements regarding specific individualized patient needs, after Patient #9s unplanned tracheostomy de-cannulation (tracheostomy tube removed) event.

Refer to TAG: A-0283.

The Hospital failed for one (Patient #10) patient of 15 sampled patients to follow their Hospital Policies and Procedures and ensure an investigation and implementation of preventative actions after Patient #10 ingested antipsychotic and sedative medications in an attempted suicide while in the Emergency Department.

Refer to TAG: A-0286.

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

1.) Based on records reviewed and interviews the Hospital failed for one (1) patient (Patient #9) in a sample of fifteen (15) sampled patients, to ensure implementation of physician communication improvements regarding specific individualized patient needs, after Patient #9's unplanned tracheostomy de-cannulation (tracheostomy tube removed) event.

Findings included:

The Medical Staff Bylaws, dated 4/17/2020, indicated duties of the Quality and Patient Safety Committee included oversight of the programs of the Hospital which were designed to assure the effective assessment of patient care in all departments of the Hospital and quality assurance.

The Hospital policy titled Tracheostomy Care, dated 8/20/2018, indicated the Hospital cared for patients with tracheostomies [a surgically created (stoma) in the windpipe (trachea) that provides an airway for breathing through a specialized tube] in all Clinical Areas of the Hospital. The Tracheostomy Care Policy indicated instructions in the event of a de-cannulation for patients with a laryngectomy (surgical removal of the vocal cords) or upper airway obstruction; attach a pediatric mask to a manual resuscitator (breathing bag) and administer oxygen; place the pediatric mask over the stoma and manually ventilate (breath) the patient; and locate the spare cuffed tracheostomy tube in preparation for re-insertion (by qualified staff).

The History and Physical, dated 6/23/2020, indicated Patient #9 presentation to the Emergency Department with complaints of worsening hypoxia (decreased oxygen) and dyspnea (shortness of breath), became very hypoxic during a CT (Computerized Tomography) scan requiring intubation (a breathing tube) and was admitted to the Hospital. Two days later Patient #9 underwent a tracheostomy and a hypopharyngeal (bottom part of the throat) mass biopsy. Patient #9 was transferred to a General Medical Unit approximately one week later. In the late evening on the day of transfer, monitoring alarms sounded and staff found Patient #9 with the tracheostomy tube pulled out, unresponsive and without a heartbeat. Cardio-pulmonary efforts revived Patient #9 and the Hospital transferred Patient #9 to an Intensive Care Unit.

The Brief Medicine Transfer Note, dated at 4:31 on 6/23/2020 (transfer from the ICU to the General Medical Unit), indicated Patient #9 underwent s successful tracheostomy and did well from a respiratory perspective. The Brief Medicine Transfer Note indicated no documentation regarding a biopsy or a plan for specific individualized needs regarding anticipatory guidance in the event of a tracheostomy de-cannulation; in accordance with the Tracheostomy Care policy for patients with a laryngectomy or upper airway obstruction.

The Hospital Report, dated 6/23/2020, indicated the Physician handoffs (after the tracheostomy procedure to the Intensive Care Unit (ICU) and handoff form ICU to the General Medical Unit) did not include specifics of the tracheostomy (special individualized needs and information to care for Patient #9's vulnerable airway). The Hospital Report indicated that the Physician to Physician and Respiratory Therapist to Respiratory Therapist handoff lacked focus on Patient #9's upper airway obstruction.

In an interview, at 10:00 A.M. on 11/12/2020, the Executive Director Quality, Safety & Practice said the Hospital was still rolling out the nursing re-education (regarding special individualized needs and information to care for patients with vulnerable airways). The Executive Director Quality, Safety & Practice said the Hospital did not have a designated unit to care for patients with a tracheostomy. The Executive Director Quality, Safety & Practice said that it was possible that a high-risk tracheostomy patient (patients with vulnerable airways) could be assigned to a (General Medical Surgical) Unit that did not have the staff re-education. The Executive Director Quality, Safety & Practice said the Hospital had an increased number of patients with the COVID-19 virus that required tracheostomies. The Chief Compliance Officer said the Hospital needed clear communication from hospital-B (that performed Patient #9's tracheostomy and throat mass biopsy).

The Hospital provided no documentation to indicate re-educational opportunities to improve Physician handoff communication regarding special individualized needs and information to care for patients with vulnerable airways. The Hospital provided no specific strategy to match the location of patients with tracheostomy vulnerable airways to General Medical Surgical Units with staff re-educated to care for these patients; anticipating with the forecasted, increase in COVID-19 cases for the Winter of 2020-2021.

2.) The Hospital failed to ensure it had its own agreement (contract) for Travel Staff, as its own entity (a Hospital separate and distinct of Partners Healthcare System, Inc.).

The document titled Managed Service Provider Agreement, dated 4/26/14, indicated a contact between AMN Healthcare, Inc. and Partners Healthcare System, Inc. for temporary staffing services. The Managed Service Provider Agreement indicated a signature representing Partners HealthCare System, Inc. The Managed Service Provider Agreement indicated no signature to represent the Hospital and therefor no indication of the Governing Body's responsibility for services furnished by the Managed Service Provider Agreement, through the Hospital's Quality Assessment & Performance Improvement Program.

The Hospital provided no documentation to indicate the Hospital assessed services provided by The Managed Service Provider, identified quality and performance problems, implemented appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of corrective or improvement activities, that permit the Hospital to comply with applicable conditions of participation.

PATIENT SAFETY

Tag No.: A0286

Based on interviews and records reviewed the Hospital failed for one (Patient #10) patient of 15 sampled patients to follow their Hospital Policies and Procedures and ensure implementation of preventative actions after Patient #10 ingested antipsychotic and sedative medications in an attempted suicide while being observed and treated in the Emergency Department for Depression and Suicidal Ideation.

Findings included:

The Hospital's policy Patients at Risk for Suicide: Care Of approved 3/25/20, indicated that in the Emergency Care Setting, suicide precautions should be implemented to ensure the safety of at risk patients. The precautions should include environmental and safety monitoring. Refer to Appendix 3 - Care of the Patient on Suicide Precautions (emergency care). Appendix 3 indicated that:

-Once suicide risk has been determined, any staff member may contact Police and Security for assistance.
-Patient is observed at all times. Suicide precautions should be implemented to ensure the safety of at-risk patients. These precautions should include environmental and safety monitoring.
- Place patient in safe pajamas (no ties). If patient declines changing, Police and Security will search patient. Belongings should be separated and secured. Remove dangerous objects.
- Emergency clinician initiates Acute Psychiatry Service (APS) consult and writes a Section 12a and safety orders.

The Hospital's RCA2 Timeline and Checklist indicated that the goals of the debriefing of event, hazard, system vulnerability that occurs is to ensure the immediate safety concerns are addressed and to immediately identify an action to prevent this from happening until other interventions are identified. The RCA2 Timeline and Checklist further indicated that multiple meetings will be needed to develop causal statements and identify solutions and corrective actions.

It was reported that Patient #10 arrived into triage at the Emergency Department on 6/20/20 at 10:15 A.M. with a chief complaint of depression. On 6/30/20 at 10:37 A.M. Patient #10 was assessed as being suicidal with the intention of self-harm. On 6/30/20 at 10:38 A.M., Nurse #1 documented a request for psychiatric consult in Patient #10's medical record for suicidal intent.

Record review indicated that on 6/30/20 at 10:45 A.M. Patient #10 was transferred from the Emergency Department waiting room (triage area) to the evaluation section of the Emergency Department with security standby outside the evaluation room for safety.

Record review indicated that on 6/30/20 at 11:16 A.M. the physician ordered a Section 12a (allowing a patient to be brought against his or her will for evaluation), on unit safety orders to secure patient belongings, as per protocol, search clothing and search belongings. At 11:17 A.M. the Emergency Department consult to APS was placed and On-Unit Safety Orders were placed which included constant observation, restrict patient to unit and snap pajamas.

Record review indicated that on 6/30/20 at 11:32 A.M. Patient #10 was changed into APS pajamas and belongings were gathered. Patient #10's phone case was checked by security and safety was maintained.

Record review indicated that on 6/30/20 at 11:34 A.M. Patient #10 was transferred to the CDU (Clinical Decision Unit) with safety orders in place. At 11:45 A.M. the patient was observed to arrive to the CDU with APS attire and was positive for Suicidal Ideation.

Record review indicated that on 6/30/20 at 12:40 P.M. the APS provider tried to wake Patient #10 up for consult and Patient #10 did not respond. Patent #10 was assessed and found to have a hypotensive blood pressure reading of 61/34, was responsive to sternal rub and moved to acute unit for closer monitoring.

Record review indicated that on 6/30/20 at 12:53 P.M. Patient #10 had a peripheral IV inserted and received sodium chloride (NS) 0.9% syringe flush 3 milliliters; sodium chloride 0.9% bolus 1,000 milliliters.

Record review indicated that on 6/30/20 at 12:55 P.M. Patient #10's bra and underwear were removed and the patient was changed into a gown with provider agreement for gown instead of the APS pajamas.

Record review indicated that on 6/30/20 at 2:19 P.M., Patient #10 told the APS provider that he/she took 900 MG of Seroquel (an antipsychotic medication) and 12 Milligrams of Klonopin (a sedative medication) just prior to security search.

Record review indicated that on 6/30/20 at 2:32 P.M., Patient #10 told Registered Nurse #2 that he/she took Seroquel and Klonopin while in the evaluation section of the Emergency Department while under observation of the security guards who were standing by outside of Patient #10's evaluation room.

In an interview on 11/4/20 at 10:00 A.M. the Emergency Department Nurse Practice Specialist said that once the Section 12a is in place, then the nurse will change the patient into APS safe pajamas and do a belongings search. The Emergency Department Nurse Practice Specialist said that no systemic immediate corrective measures were taken as a result of this event.

In an interview on 11/5/20 at 10:15 A.M. Registered Nurse #2 said that there is no search of the patient prior to the Section 12a order. Security stands outside of the room with direct observation of the patient.

In an interview on 11/5/20 at 11:00 A.M., Registered Nurse #3 said that once a patient reports they are suicidal, Police and Security is called for observation. Registered Nurse #3 said that patients remain in their street clothes and maintain their own belongings until a physician orders a Section 12a.

In an interview on 11/5/20 at 11:30 A.M., the Emergency Department Nurse Practice Specialist said that she was not aware of the policy Patients at Risk for Suicide: Care Of updated 3/25/20, Appendix 3 - Care of the Patient on Suicide Precautions (emergency care). She said that the Emergency Department has their own policy in their computer system that is not consistent with the Hospital's policy.

In an interview on 11/5/20 at 11:30 A.M. the Interim Emergency Department Nurse Director said that there have been no systemic preventative actions as a result of this event and this could be a good opportunity to update the policy.

In an interview on 11/5/20 at 1:00 P.M., Police and Security Officer #1 said that when she was observing Patient #10 from outside of the evaluation room, she recalls Patient #10 had his/her street clothes on when in the evaluation room and his/her belongings were in the evaluation room as well. Police and Security Officer #1 said that until today, 11/5/20, she was never informed of Patient #10's attempted suicide by ingesting his/her own antipsychotic and sedative medication while in the evaluation room and no corrective measures have been made as a result of this case.

In an interview on 11/5/20 at 2:25 P.M., the Chief Compliance Officer said that there is inconsistency between the hospital wide policy and the departmental policy and the staff need to understand the procedure.

The Hospital failed to follow their own Policy and Procedure by immediately placing the patient in safe pajamas and doing a search of his/her belongings as soon as the suicide risk was determined by the nursing staff on assessment at 10:38 A.M. The Patient remained his/her own clothing and was able to retain his/her own belongings until being changed and having belongings removed at 11:32 A.M. The Hospital further failed to identify corrective action to prevent a like occurrence from happening again, leaving patients at risk for self-harm while in the Emergency Department.