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575 SOUTH DUPONT HIGHWAY

NEW CASTLE, DE 19720

PATIENT RIGHTS

Tag No.: A0115

Based on observation, medical record review, policy and document review and staff interview, it was determined that the hospital failed to obtain the patients consent prior to treatment with psychotropic medications (ref to A117); and failed to ensure patients received care in a safe setting (refer to A 144). The cumulative effect of these deficient practices resulted in the hospital's inability to protect patient rights and provide services in a safe setting.

PATIENT RIGHTS: NOTICE OF RIGHTS

Tag No.: A0117

Based on medical record review, policy review and staff interview, it was determined that for 1 of 10 patients (Patient #2) in the medical record review sample, the facility failed to inform the patient, or patient's representative, of the patient's rights in advance of furnishing patient care. Findings included:

The policy entitled "Right to Informed Consent" stated, "...The patient or if patient is a minor...the legal guardian... has the right to be reasonably informed and participate in...healthcare, treatment ans services...The patient...is not subjected to any procedure without...consent..."

Medical record review revealed no evidence to support that Patient #2 or the legal guardian was informed of their rights in advance of furnishing care.

This finding was confirmed on 6/9/21 at 3:10 PM by Nursing Supervisor A.

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on medical record review, policy and document review and staff interview, it was determined that for 3 of 10 patients (Patient #'s 1, 4 and 5) in the sample, the hospital failed monitor patients as ordered by the physician. Findings included:

The hospital policy entitled "Routine Observation of Inpatients" stated, "...staff...documents routine safety rounds on patients in accordance with the level of observation ordered by the practitioner...RN (registered nurse) may increase the level of observation if the patient's condition changes...practitioner will be contacted soon as possible for notification of the change in condition and to obtain and order for the observation level...Documentation of the observation is to be completed once the patient has been observed. It is not permissable to complete in advance and to back fill time frames that were not completed in a timely manner...Remain vigilant for specific risks for patients on Special Precautions...and potential ways the patient can elope from the facility..."

The hospital policy entitled "Nursing Accountability" stated, "Registered Nurse (RN)...responsible for...primary responsibility for the overall safety...of individual patients...careful execution of all applicable physician or treatment orders for patients on the program..."

Patient #1 (Admission 2/5/21)
A. Medical record revealed:
1. "Physician Orders"
a. Admission orders dated 2/5/21 6:15 AM, included orders for staff to observe the patient every 5 minutes and daily vital signs.
b. The frequency and level of observation order was revised by the physician, as follows:
- 2/5/21 at 4:30 PM: observation frequency to every 15 minutes
- 2/14/21 at 3:04 PM: observation every 5 minutes
- 3/3/21 at 8:25 PM: observation 5 minutes while asleep and 1:1 observation while awake
- 3/5/21 at 7:00 PM: discontinued 1:1 observation; observation every 5 minutes while awake and every 15 minutes while asleep
- 3/31/21 at 3:16 PM begin 1:1 observation
- 4/6/21 at 1:10 PM: discontinue 1:1 observation; observation every 5 minutes
- 4/7/21 at 12:05 PM: observation every 15 minutes

2. "Patient Observation Record" documentation revealed:
a. Observations were not conducted on Patient #1 every 5 minutes during the following timeframe:
- 2/5/21 7:00 AM to 8:15 AM (10 observations not performed)
- 2/16/21 10:00 AM to 10:15 AM (2 observations not performed)
- 2/16/21 11:15 PM to 11:45 PM (4 observations not performed)
- 2/17/21 7:00 AM to 8:45 AM (14 observations not performed)
- 2/17/21 11:00PM to 11:15 PM (2 observations not performed)
- 2/19/21 10:00 PM to 11:15 PM (10 observations not performed)
- 2/24/21 7:20 PM to 7:30 PM (1 observation not performed)
- 2/26/21 7:00 AM to 7:45 AM (6 observations not performed)
- 3/1/21 10:15 PM to 11:30 PM (10 observations not performed)
- 3/12/21 1:30 PM to 2:00 PM (4 observations not performed)
- 3/16/21 9:30 AM to 10:15 AM (6 observations not performed)
- 3/17/21 8:00 PM to 8:45 PM (6 observations not performed)
- 3/26/21 8:00 AM to 3:15 PM (58 observations not performed)
- 3/29/21 10:00 AM - 10:15 AM (2 observations not performed)

b. Observations were not conducted on Patient #1 every 15 minutes during the following timeframe:
- 2/7/21 9:45 AM to 10:15 AM (1 observation not performed)
- 3/13/21 1:45 AM to 3:00 AM (4 observations not performed)

Patient #3 (Admission 3/1/21)
A. Review of facility's incident investigation report revealed:
- patient alleges on 3/5/21 patient # 4 inappapropriately touched her

B. Video surveillance on 3/5/21 revealed:
- 8:40 PM patient #3 sitting in Unit A group room
- 8:51 PM patient #4 enters the group room and sits next to patient #3
- 8:56 PM patient #4 touches patient #3's buttock area
- 8:57 PM patient #4 exits group room
- 9:00 PM patient #3 remains in group room

C. Medical record revealed:
1. "Patient Observation Record" documentation revealed:
a. on 3/5/21 at 9:00 PM patient #3 was documented as in room, calm and sitting/lying

2. Accurate patient observation was not completed.

Interview on 6/10/21 between 10:22 AM and 10:45 AM with Director of Risk Management A and CEO A confirmed this finding.


Patient #4 (Admission 3/3/21)
A. Review of facility's incident investigation report revealed:
- patient accused by patient #3 on 3/5/21 of inappapropriate touching

B. Video surveillance on 3/5/21 revealed:
- 8:40 PM patient #3 sitting in Unit A group room
- 8:51 PM patient #4 enters the group room and sits next to patient #3
- 8:56 PM patient #4 touches patient #3's buttock area
- 8:57 PM patient #4 exits group room
- 9:00 PM patient #3 remains in group room

C. Medical record revealed:
1. "Physician Orders" dated 3/5/21
- Transfer to unit B for sexually acting out

2. "Psychiatry Progress Note" dated 3/6/21
- physician discussed allegations of sexually inappropriate behavior with patient
- due to sexually inappropriate behavior patient agreed to behavioral therapy going forward.

3. No evidence patient was moved to unit B

This finding was confirmed on 6/9/21 at 3:55 PM by Nursing Supervisor A.

Patient #5 (Admission 3/23/21)
A. Medical record revealed:
1. "Physician Orders"
a. Admission orders dated 3/23/21 8:40 PM, included orders for staff to observe the patient every 5 minutes.

2. "Patient Observation Record" documentation revealed:
a. Observations were not conducted every 5 minutes during the following timeframes:
- 3/23/21 9:00 PM to 11:30 PM (20 observations not performed)

3. No evidence of observations conducted as ordered on 4/2/21 and 4/3/21

These findings were confirmed on 6/10/21 at 9:48 AM by Nursing Supervisor A.

B. Review of facility's incident investigation report revealed:
- on 4/4/21 patient #10 and patient #5 attacked BHA #3 and stole badge
- both patients eloped from the facility
- witness statements state patient #10 was not supposed to be on the unit and was supposed to be in the annex as ordered by the physician.
- witness statements expressed concerns of patient #5 and patient #10 together on same unit.

C. Medical record revealed:
1. "Patient Observation Record" dated 4/3/21 revealed:
- between 4:15 PM and 8:00 PM patient #5 was in annex

C.Interview with CEO A on 6/9/21 between 9:52 AM and 10:00 AM revealed:
-annex is an offset unit withing Unit C (Adolescent units) considered the "quiet room"
- physician order required to place patient in annex

1.No evidence of physician order for patient #5 to be placed in annex.
2. Patient placed in annex despite safety concerns by staff

These findings were confirmed on 6/10/21 at 10:22 AM by CEO A and Director of Risk Management A.

PATIENT SAFETY

Tag No.: A0286

Based on review of quality assessment and performance improvement (QAPI) documentation, policy review and staff interview, it was determined that the hospital's QAPI program failed to ensure sustained improvement was achieved for the corrective action plan initiated as part of the investigation for Patient's # 3 and #7. Findings included:

The facility policy entitled "Quality and Safety Plan" stated, "...is to outline an effective system for ensuring ...quality and safety of services across all settings ...includes ...provision for quality assurances and improvement with overarching principles of ...best practice ...consistent safety ...staff training ...teams are supported in performing continuous improvement activities and projects ...Quality Council (or process improvement Committee) is the steering committee for the facility process improvement program ...ensure implementation of process improvement activities through , training and, education ...improvement activates ...with methods such as ...Root Cause Analysis (RCA) ..."

The facility policy entitled "Incident Reporting-Risk Management Program" stated, "...enables the facility to .... Increase safety ...improve the quality of health care provided in the facility through risk control intervention ...monitoring the effectiveness ...corrective action plan ...Facility Risk Manager will collect data for statistical analysis and trending ...Facility Risk manager must review and sign all Incident Reports. Recommendations and/ or outcomes should be noted on the Incident Report ... incidents include ...the action taken to mitigate damages ...prevent further loss..."

A. Review of the facility's root cause analysis and incident investigation report for Patient #3 and Patient # 7 revealed the following corrective action as of result of the investigation:

1. Patient # 3
A. Incident investigation report revealed:
-Orders were received to transfer Patient #4 to Unit B for sexually acting out, continuum of care and for the safety of Patient #3.

B. Review of the incident investigation report documents and medical record revealed:
- no evidence that patient #4 was transfer from Unit A (Inpatient Adult Psychiatric ) to Unit B( Inpatient Adult Co-Occurring ) as part of the corrective action plan stated in the incident investigation report of Patient #3.
- no evidence that sustained improvement was achieved for the corrective action plan initiated as part of the investigation for Patient's # 3.

During an interview on 6/10/21 between 10:11 AM and 10:36 AM, Director of Risk Management A and CEO A confirmed this finding.

2. Patient # 7
A. Incident investigation report revealed:
-"*Q15 Minute Observation Training-educating staff to visually ensure a patient's chest rises and falls during any observation checks"
- "*Code Blue Training - educating clinical staff on ensuring the right equipment is available and the correct procedures are being followed"

B. Root cause analysis and corrective action revealed:
- "Missing physician signature on admission order, high dose detoxification order, medication consent for psychotropic medication and valium detox protocol "
- "No AED presents"
- "Vital Signs were not documented at the time of the incident"
- "Re-education will be provided to all nursing staff by the Director of Nursing. Education will include staff appropriately documenting vital signs completed daily for each patient. The DON will reiterate the importance for staff to follow the facilities vital sign policy"
- " Re-education will be provided to all physician and/ or nurses practitioners by the medical Director. Education will include staff applicably signing documents in the patients' medical records. This includes but is limited to the admission order, high dose detoxification order, medication consent for psychotropic medication and valium detox protocol"

C. Reviewed of the education and training documents revealed:
- Training and re-education on "Temperature & Vital Sign Assessment" was provided to staff on 02/15/2021.
- no evidence that staff re-education and training was provided on all the other areas to improve as identified in the root causes analysis and incident investigation report of Patient # 7.

During an interview on 6/10/21 between 10:11 AM and 10:36 AM, Director of Risk Management A and CEO A confirmed this finding.

MEDICAL STAFF

Tag No.: A0338

Based on review of medical records, policies, bylaws and other hospital documentation and staff interview, it was determined that the medical staff failed to ensure that the physician adhered to facility policies and procedures in the care and treatment of patients as required by medical staff bylaws. The cumulative effect of these deficient practices resulted in the hospital's failure to provide services in a safe setting.

MEDICAL STAFF BYLAWS

Tag No.: A0353

Based on review of medical records, policies, bylaws and other hospital documentation and staff interview, it was determined that for 2 of 10 patients (Patient #'s 6 and 7) in the sample, the medical staff failed to ensure that the physician adhered to facility policies and procedures in the care and treatment of patients as required by medical staff bylaws. Findings include:

The hospital bylaws stated, "...Each practitioner agrees to adhere to the design of the Facility's treatment programs and agrees to practice in accordance with the program model. Each practitioner will adhere to all written Facility policies, procedures, protocols, and guidelines...In the event of a patient's death ...a summation statement shall be entered in the medical record in the form of a discharge summary. The summation statement shall include the circumstances leading to death ..."

The hospital policy entitled "Urine Testing For Drugs or Alcohol" stated, " ...the physician ...writes an order to obtain a urine drug screen ...If the patient's results are positive for drugs ...the physician and treatment team evaluate the situation, and plan the appropriate course of action for the remaining length of stay in the program ..."

I. Patient #6 (Admission 1/12/21)
A. Medical record review revealed:
1. "High Risk Notification Form" dated 1/12/21 at 9:29 PM documented that Patient #6 was having suicide ideation with thoughts of overdose.

2. Physician Orders
a. Admission orders dated 1/12/21 included:
- admitting diagnosis: Major Depressive Disorder recurrent severe
- a urine drug screen (UDS).

3. Results of UDS date reported 1/14/21 revealed:
- positive for benzodiazepines
- positive for opiates
- positive for fentanyl

B. Interview with Nursing Supervisor A on 6/3/21 between 2:03 PM and 2:17 PM revealed:
- facility unaware patient has died after being discharged from facility
- UDS is typically ordered for all patients
- the physician signs off on UDS results to note it has been reviewed

C. Interview with Medical Director A on 6/7/21 between 1:20 PM and 1:30 PM revealed:
- expectation is for practitioner to talk with patient about positive UDS results and ask patient about what drugs patient is using.
- practitioner is to document reviewal of UDS results in patient's record.
- patient is to be monitored for withdrawal symptoms.

D. No evidence of practitioner evaluation of positive UDS results and appropriate course of action.
This finding was confirmed on 6/7/21 at 1:30 PM by Medical Director A.

II. Patient #7 (Admission 1/22/21)
A. Medical record review revealed:
1. "Admission orders" dated 1/22/21 documented:
- admitting diagnosis opiate use disorder, ETOH (alcohol) use disorder
- level of observation every 15 minutes.

2. "Admission Psychiatric Evaluation" dated 1/23/21 documented"
- patient voluntary commitment for detox treatment from alcohol and opioid use.
- patient uses 2.5 - 3 bundles of heroin by snorting.
- patient drank 0.5 liter of vodka per day.
- denied any suicide or violent thoughts.

3. "Progress Notes" dated 1/24/21 at 8:50 AM documented:
- around 7:12 AM the nurse administering medications unable to arouse patient
- patient was observed laying on his back with no pulse detected.
- physician was notified.
- patient moved to floor and cardiopulmonary resuscitation (CPR) started.
- 911 called for emergency assistance
- paramedics arrived and took over CPR efforts
- patient remained unresponsive

B. Review of facility incident data analysis revealed:
- type of incident was an active patient death
- date of incident 1/24/21
- location of incident was in patient's room 46A on Unit B of the facility.

C. Interview with Medical Director A on 6/7/21 between 1:20 PM and 1:30 PM revealed:
- a discharge summary is required for all discharged patients even if patient dies.
- due to chart being reviewed for investigation purposes feels that is reason chart never got back to physician to dictate a discharge summary.
- feels that patient's record never made it back to physician due to the record being reviewed for investigation purposes.

This finding was confirmed on 6/7/21 at 1:33 PM by Medical Director A.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on medical record review, policy review and staff interview, it was determined that the registered nurse (RN) failed to supervise and evaluate the nursing care for 4 of 10 patients in the sample (Patient #'s 1, 2, 3 and 4). Findings included:

The hospital policy entitled "Vital Signs and Pain Re-Assessment" stated, "...Physician...orders an appropriate frequency of vital signs monitoring...When the physician orders non-routine vital signs, the specific frequency of monitoring is noted both on the medication administration record...and the non-medication kardex...'Routine vital signs' Following admission, temperature, blood pressure, pulse and respirations are obtained from patients at least once a day in the morning and recorded on the vital sign sheet..."

The hospital policy entitled "Nursing Accountability" stated, "Registered Nurse (RN)...responsible for...primary responsibility for the overall safety...of individual patients...careful execution of all applicalbe physician or treatment orders for patients on the program..."

Patient #1 (Admission 2/5/21)
A. Medical record revealed:
1. Admission orders dated 2/5/21 6:15 AM, included an order for vital signs to be checked daily.
a. No documentation to support vital signs were checked, or that the patient refused, on the following days:
- 2/11/21, 2/19/21, 2/24/21, 3/10/21, 3/14/21, 3/26/21, 3/27/21, 4/1/21, 4/2/21, and 4/3/21

These findings were confirmed on 6/9/21 at 12:18 PM by Nursing Supervisor A.

Patient #2 (Admission 2/11/21)
A. Medical record revealed:
1. "Physician Orders" dated 2/12/21
- discontinue (d/c) every 5 minutes observations
- start every 15 minuts observations

2. "Patient Observation Record" documentation revealed:
a. on 2/15/21 between 10:15 AM and 9:00 PM observations were conducted every 5 minutes

3. No evidence of change of condition in record to warrant an increase in observations.
4. No evidence physician notified of change in patient status to increase observations.
5. No order by physician to change observation status from every 15 minutes to every 5 minutes.

These findings were confirmed on 6/9/21 at 3:22 PM by Nursing Supervisor A.

Patient #3 (Admission 3/1/21)
A. Medical record revealed:
1. No documentation to support vital signs were checked, or that the patient refused during the admission period 3/2/21 - 3/15/21 (13 days).

These findings were confirmed on 6/9/21 at 1:11 PM by Nursing Supervisor A.

Patient #4 (Admission 3/3/21)
A. Medical record revealed:
1. Admission orders dated 3/3/21 8:10 PM, included an order for vital signs to be checked routinely.

2. No documentation to support vital signs were checked, or that the patient refused during the admission period 3/4/21 - 3/9/21 (6 days).

These findings were confirmed on 6/9/21 at 3:32 PM by Nursing Supervisor A.

Patient #5 (Admission 3/23/21)
A. Medical record revealed:
1. Admission orders dated 3/23/21 8:40 PM, included an order for vital signs to be checked routinely.

2. No documentation to support vital signs were checked, or that the patient refused, on the following days: 3/25/21, 4/2/21 and 4/3/21.

These findings were confirmed on 6/10/21 at 9:41 AM by Nursing Supervisor A.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, policy and document review and staff interview, it was determined that the hospital failed to ensure COVID-19 infection control measures were adhered to in 1 of 3 patient units observed on 5/28/21 (Unit C). Findings include:

The hospital policy entitled "COVID Response Plan" stated, "...Prevention...best prevention methods being universal masking and proper social distancing...The patient and staff are to remain 6 feet (ft) at all times..."

A. During observation conducted in Unit C with Director of Risk Management A and Chief Executive Officer (CEO) A on 5/28/21 between 9:21 AM and 10:00 AM:
- Patient #'s 12 - 26 were seated in the activity room and were observed to be not socially distanced.
- The group was monitored by Behavioral Health Associate (BHA) #1 and BHA #2 who were also seated in the activity not socially distanced.
- Patients were not prompted to distance from one another.

These findings were observed and confirmed by CEO A on 5/28/21 at 10:05 AM.