The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST CHARLES HOSPITAL 200 BELLE TERRE ROAD PORT JEFFERSON, NY 11777 April 15, 2016
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0206
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Based on document review and interview in eleven (11) of eleven (11) Personnel Files reviewed, the facility failed to ensure that staff who participate in non-violent crisis intervention, and/or place patients in restraints, had the required training in the use of First Aid Techniques.

This places restrained patients at risk for potential harm.

Findings:

The Personnel File for Staff H (Security Officer) hired on 04/16/15 lacked evidence that the staff member received training in First Aid Techniques.

The Personnel File for Staff J (Security Officer) hired on 12/08/15 lacked evidence that the staff member received training in First Aid Techniques.

The Personnel File for Staff E (Security Officer) hired on 12/10/15 lacked evidence that the staff member received training in First Aid Techniques.

Similar findings were noted in the Personnel Files of Staff Members A, B, C, D, F, G, I and K.

During interview with Staff M (Director of Nursing Education) on 04/13/16 at 2:45PM the staff member confirmed this finding.
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VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
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Based on Medical Record review, document review and interview in two (2) of four (4) Medical Records reviewed, the facility failed to ensure the use of the restraint was documented in the patient's plan of care.

This places patients at risk for poor coordination of care.

Findings:

Patient #3's Medical Record identified that on 03/31/16 at 5:52AM the patient was placed in "four (4) point restraints". The use of the restraint was not documented in the patient's plan of care.

During interview with Staff Q (Registered Nurse) on 04/15/16 at 10:15AM, when asked should the care plan be updated to include the restraints, stated "I forgot".

During an interview with Staff N (Performance Improvement) on 04/14/16 at 9:50AM the staff member confirmed this finding.

Patient #4's Medical Record identified that on 03/11/16 at 2:32AM the patient was placed in "four (4) point restraints". The use of the restraint was not documented in the patient's plan of care.

During an interview with Staff N on 04/14/16 at 1:30PM the staff member confirmed this finding.

The facility's Policy and Procedure titled "Restraint" last revised 05/14, directed Nursing Staff to document "interventions in the Nursing Plan of Care".
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VIOLATION: PATIENT RIGHTS Tag No: A0115
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Based on record review and staff interview, the facility failed to ensure the patients' right to be protected from harm. This was evident by the facility's failure to: 1) develop a Policy and Procedure to protect Pediatric Patients housed on a mixed Adult / Pediatric Unit, 2) investigate allegations of abuse, and 3) ensure staff who participate in non-violent crisis intervention and/or place patients in restraints are trained in First Aid.

These failures place all patients at risk for potential harm.

Findings:

1) See Tag A 144.
2) See Tag A 145
3) See Tag A 206.
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VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
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Based on document review, observation and interview, the facility failed to develop and implement a Policy and Procedure to ensure the safety of Pediatric Patients housed on an Adult / Pediatric Unit.

This failure places all Pediatric Patients at potential safety risk.

Findings:

During observation of the 22 (twenty-two) Bed Unit located on the 3rd Floor between 9:45AM and 11:00AM on 04/16/16, it was revealed that the Unit housed Acute Pediatrics (8 {eight} beds), Adolescent Detox (Alcohol and Drug Detoxification) (4 {four} beds), and Pediatric / Adult Rehabilitation (10 {ten} beds).

The Unit is an "L" Shaped Unit with two (2) hallways and a Nursing Station at the center of the Unit.

Observation from the Nursing Station identified that neither hallway is visible from the Nursing Station. With the exception of one (1) patient room, all of the remaining twenty-one (21) rooms are obstructed from view of the Nursing Station by walls.

Per interview with Staff U, Unit Nurse Manager, at 10:15AM on 04/16/16, while Pediatric Patients are only placed in rooms with other Pediatric Patients, Adult Patients can be placed in any room adjacent to or across from the Pediatric Patient's rooms.

During the interview, Staff U stated that the Unit has an Alarm System to ensure all Pediatric Patients cannot be removed from the Unit, but there is no system or protocol to prevent Adult or Adolescent Patients from entering a Pediatric Patient's room.

Per Staff U, there are no Policies or Procedures to protect the Pediatric Patients on the Unit from the other populations housed on the Unit. This was confirmed in the presence of Staff S (Vice President of Performance Improvement for the Facility Corporation).
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VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT Tag No: A0145
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Based on document review and interview, the facility failed to ensure that patients were protected from abuse by failing to thoroughly investigate an allegation of abuse.

This failure places all patients at risk for potential abuse.

Findings:

Per interview with Staff R, Chief Nursing Officer, in the afternoon of 04/13/16, the facility received a complaint from Patient #1's family member on 02/22/16, alleging a male staff member inappropriately touched her.

Review of Patient #1's Medical Record revealed that the patient was admitted to the ICU (Intensive Care Unit) on 02/08/16 with a diagnosis of Cellulitis. The patient was also being treated for detoxification of a controlled substance. The patient was transferred to a Medical-Surgical Floor on 02/14/16, and discharged from the facility on 02/15/16.

The facility's Complaint Log for January 2016 - April 2016 provided no evidence of a complaint or investigation for the allegation.

Per interview with Staff R in the afternoon on 04/13/16, allegations against employees are given to Human Resources for investigation.

Per interview with Staff T (Vice President of Human Resources) in the afternoon of 04/13/16, there is no "written investigation", but the staff member provided email documentation of the communication regarding the investigation for review.

The email communication by Staff T was sent to Administrative Staff R and Staff W, Chief Administrative Officer. No evidence of a response by either Administrative Staff regarding the allegation was provided by the facility.

Review of Staff T's emails identified that only the accused staff member and the receiving Medical-Surgical Nurse was interviewed on 02/22/16, regarding the alleged abuse. No interview was conducted with any of the ICU Staff Members, where the alleged abuse occurred and the investigation was completed by Staff T on 02/23/16.

During interview with Staff T, the staff member responded that she did not review the patient's record because she does not have access to patient Medical Records.

Staff T also stated that she does not keep track of allegations against staff, and only keeps a Log of staff actions that require disciplinary action.

Per interview with Staff R, the facility lacks a Policy or Procedure for investigation of abuse or neglect allegations or maintaining the safety of patients alleging the abuse.

Staff R also stated there is no tracking or trending of abuse allegations or reporting to the Quality Assurance / Performance Improvement Committee.
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VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
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Based on Medical Record review, document review and interview in two (2) of four (4) Medical Records reviewed, the facility did not ensure that staff immediately obtained an Order for the emergency application of restraint.

This places patients at risk for potential harm.

Findings:

Patient #5's Medical Record identified that on 03/01/16 at 10:23PM the patient was described as combative and abusive. The One to One (1:1) Observation Sheet documented by Staff P (Security Officer) on 03/02/16 at 1:00AM noted "restraints removed".

The Risk Management Work Sheet dated 03/02/16 documented that on 03/01/16 at 10:02PM the patient was threatening staff and "placed in four (4) point restraints".

Electronic email between Staff N (Performance Improvement) and the Emergency Department staff on 03/02/16 at 8:13 AM documented "in the Notes I do not see any mention of four (4) point restraint and I don't see an Order or a Provider Note".

During an interview with Staff P on 04/15/16 at 12:05 PM the staff member stated "if I wrote it down he was in restraints and I removed them under the direction of the Nurse. The black bag restraints-four (4) point restraints".

The patient was restrained for approximately two and one-half (2) hours without an Order for four (4) point restraints required by Policy.

Although the patient was on one to one (1:1) observation between 03/01/16 10:30PM and 03/02/16 7:45AM, approximately nine (9) hours, there was no documented Order for the one to one (1:1) observation as required by Policy.

Patient #6's Medical Record identified that on 01/18/16 at 5:28PM when the patient was "swinging at the staff members with his fists" he was placed in four (4) point restraints.

At 01/18/16 at 11:57PM, approximately six and one-half (6) hours after the patient was placed in violent restraints, the Physician incorrectly ordered "all side rails" instead of four (4) point restraints. An Order for the emergency application of four (4) point restraints was not immediately obtained at the time of restraint.

On 01/19/16 at 3:00AM when the patient was described as cooperative, the restraints were removed. An Order for the emergency application of four (4) point restraints was never obtained during the nine and one-half (9) hours the patient was restrained.

During an interview with Staff N (Performance Improvement) on 04/14/16 at 2:30PM the staff member confirmed this finding.

The facility's Policy and Procedure titled "Restraint" last revised 05/14, directed Nursing Staff to document "when emergency restraints are applied the Physician / MLP (Mid-Level Practitioner) is immediately summoned".

The facility's Policy and Procedure titled "Patient Observation: 1:1 / 1:2" last revised 02/13, stated the following: "a Physician / MLP Order is required for patient Observation 1:1".
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VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0171
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Based on Medical Record review, document review and interview in two (2) of two (2) Medical Records reviewed, the facility failed to ensure that Violent Restraint Orders were renewed timely.

This places patients at risk for potential harm.

Findings:

Patient #3's Medical Record documented that on 03/31/16 at 5:52AM the patient in was placed in "four (4) point restraints". On 03/31/16 at 12:00 Noon the bilateral ankle restraints were removed. The Violent Restraint Order was not renewed at 9:52AM, every four (4) hours as required by Regulation and facility Policy.

During an interview with Staff N (Performance Improvement) on 04/14/16 at 9:50AM the staff member confirmed this finding.

Patient #6's Medical Record identified that on 01/18/16 at 5:28PM the patient was placed in four (4) point restraints. On 01/19/16 at 3:00AM the restraints were removed. The Violent Restraint Order was not renewed every four (4) hours, as required by Regulation and facility Policy, during the nine and one-half (9) hours the patient was restrained.

During an interview with Staff N (Performance Improvement) on 04/14/16 at 2:30PM the staff member confirmed this finding.

The facility's Policy and Procedure titled "Restraint" last revised 05/14, described the following: Violent Restraint Orders will be renewed every four (4) hours for adults 18 (eighteen) years and older.
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VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
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Based on Medical Record review, document review and interview in four (4) of four (4) Medical Records reviewed, the facility did not ensure that patients in violent restraints were monitored and assessed as required by facility Policy.

This places patients in violent restraints at risk for potential harm.

Findings:

The facility' Policy and Procedure titled "Restraint" last revised 05/14, stated the following: "The RN documents circulation, and psychological status every 15 (fifteen) minutes for violent restraints and the RN documents range of motion, release, fluids, food / meal and elimination every two (2) hours at a minimum, more often if clinically indicated."

Patient #5's Medical Record identified that on 03/02/16 at 10:23PM the patient was placed on one to one (1:1) observation and in four (4) point restraints. On 03/03/16 at 1:00AM the restraints were removed.

Between 03/02/16 10:23PM and 03/03/16 1:00AM, approximately two and one-half (2) hours there was no documented evidence the patient's circulation and psychological status was monitored every fifteen (15) minutes and that the RNs addressed range of motion, release of restraints, fluids, food / meal and elimination every two (2) hours at minimum as per facility Policy.

Patient #6's Medical Record identified that on 01/18/16 at 5:28PM the patient was placed on one to one (1:1) observation and in four (4) point restraints. On 01/19/16 at 3:00AM the restraints were removed.

Between 01/18/16 5:40PM and 10:25PM, for approximately five (5) hours, the RN's assessment of the patient's circulation and psychological status was monitored every half () hour instead of every fifteen (15) minutes as required by Policy.

There was no documented evidence for the same time period that the RNs addressed range of motion, release of restraints, fluids, food / meal and elimination every two (2) hours at minimum.

Between 01/18/16 10:25PM and 01/19/16 3:00AM, approximately four and one-half (4) hours, there was no documented evidence that the patient's circulation and psychological status was monitored every fifteen (15) minutes and that the RNs addressed range of motion, release of restraints, fluids, food / meal and elimination every two (2) hours at minimum as per facility Policy.

During an interview with Staff N (Performance Improvement) on 04/15/16 at 2:30PM the staff member confirmed this finding.

Patient #3's Medical Record identified that on 03/31/16 at 5:52AM the patient in was placed in "four (4) point restraints". On 03/31/16 at 12:00 Noon the bilateral ankle restraints were removed. There was no documented evidence at 6:45AM, 8:45AM and 10:45AM, every two (2) hours, that the restraint was released and range of motion was performed as per facility policy.

During interview with Staff N (Performance Improvement) on 04/14/16 at 9:50AM the staff member confirmed this finding.
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VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0176
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Based on Medical Record review, document review and interview, the facility failed to ensure that a Physician's Assistant had a working knowledge of the Restraint Policy.

This places patients at risk for being placed in violent restraints without appropriate justification and potential harm.

Finding:

The facility's Policy and Procedure titled "Restraint" last revised 05/14, documented violent restraints may be applied to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient and others. "Staff members providing direct patient care, receive annual instruction in the use and application of restraints, properly assessing patients, and in the Laws, Regulations, Policies and Procedures governing the use of restraints."

Per interview with Staff O (Physician' Assistant) on 04/15/16 at 10:30AM regarding Patient #3 who was in four (4) point restraints, the staff member stated it was appropriate to order non-violent restraint for a patient in four (4) point restraints. He also stated "I have never been educated about restraints at St. Charles".

The Personnel File for Staff O (Physician's Assistant) revealed that there was no documented evidence that he received Restraint Education and Training as required by Regulation and facility Policy.

During interview with Staff L (Administrator) on 04/15/16 at 10:50AM the staff member stated that Staff O (Physician's Assistant) was hired on 09/03/13. He received the Restraint Policy when he started. He didn't sign anything stating that he received the Restraint Policy. He has not received an update (regarding the Restraint Policy) since orientation. Restraint Education is required annually.
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VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
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Based on document review and interview the facility did not ensure that the Performance Improvement Program identified, assessed and addressed problems concerning patient restraints.

This places patients at risk for potential harm while in restraints.

Findings:

The Risk Management Work Sheet documented on 03/01/16 at 22:02PM that Patient #5 was threatening staff and "placed in four (4) point restraints".

Electronic email between Staff N (Performance Improvement) and the Emergency Department staff on 03/02/16 at 8:13AM documented "in the Notes I do not see any mention of four (4) point restraints and I don't see an Order or a Provider Note".

During an interview with Staff N on 04/14/16 at 3:15PM the staff member stated "I did not receive a response" (regarding her above inquiry).

Patient #6's Medical Record identified that on 01/18/16 at 5:28PM the patient was placed on one to one (1:1) observation and in four (4) point restraints.

Between 01/18/16 5:40PM and 10:25PM, for approximately five (5) hours, the RN's assessment of the patient's circulation and psychological status was monitored every half () hour instead of every fifteen (15) minutes. The record also lacked documented evidence for the same time period that the RNs addressed range of motion, release of restraints, fluids, food / meal and elimination every two (2) hours at minimum.

The facility's Patient Safety Committee Minutes dated 02/05/16 and 03/04/16 revealed that Patient #5 and Patient #6 were documented as reviewed by the Committee. However the Committee did not identify that the Restraint Policy was not effectively implemented.

The investigative findings, corrective actions and patient impact / follow up sections were blank. As a result, the scope of the problem was not addressed and corrective actions were not considered or implemented to prevent a recurrence.

During an interview with Staff L (Administrator) on 04/15/16 at 2:30PM, the staff member confirmed the finding and stated that "each restrained patient's care is discussed during the Patient Safety Committee Meetings. It is not documented. We know we have problems with restraints. We identified information is missing. It's a difficult culture."

The facility's Policy and Procedure titled "Restraint" last revised 05/14, stated the following: "use of restraint is documented and monitored" by Performance Improvement.

The Patient Safety Committee Meeting Minutes lacked documented evidence that the Policy was followed.
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VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
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Based on document review and interview, the facility Administration failed to ensure that patients were protected from potential abuse. This was evident by the Administration's failure to ensure a complete investigation of an allegation of abuse, implementation of Policies and Procedures, and tracking and trending of all allegations of abuse or neglect.

These failure places all patients at risk for not identifying potential abuse patterns.

Findings:

Per interview with Staff R (Chief Nursing Officer) during an abuse allegation investigation on the afternoon of 04/13/16, the staff member stated that the Human Resource Department investigates any allegation regarding a staff member.

Per interview with Staff T (Vice President of Human Resources) on the afternoon of 04/13/16, the staff member does not complete a formal investigation report for allegations of abuse, or report her findings to the hospital Quality Assurance / Performance Improvement Program (QAPI).

This was confirmed with Staff R at the time of interview.

Review of Staff T's emails revealed that Staff R and Staff W, Chief Administrative Officer, were notified of the allegation of abuse on 04/22/16, however the facility provided no documented evidence that Nursing or facility Administration were involved in the investigation, or reported the investigation to QAPI or the Governing Body.