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 ELIZABETH'S MEDICAL CENTER 736 CAMBRIDGE STREET BRIGHTON, MA 02135 Dec. 1, 2020
VIOLATION: PATIENT RIGHTS Tag No: A0115
The Hospital failed to ensure for two (Patient # and Patient #2) patients of 10 sampled patients that the Hospital provided care in a safe setting.

See A-0144
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and Record Reviews, the Hospital failed, for 2 (Patient #1 and Patient #2) patients of 10 patients sampled, to provide care in a safe setting to prevent an attempted suicide and self-harm. Patient #1 was able to obtain and ingest foreign objects four times while under 1:1 observation throughout his/her admission and Patient #2 was able to obtain and use a razor to cut his/her wrist while on a 1:1 observation in the Emergency department and obtain and ingest a battery and a tack while on 1:1 observation when admitted on the medical unit.

Findings include:

Review of the Hospital's policy Suicide Risk Assessment and Management, last revised 12/10/19, indicated that the Registered Nurse is responsible for assessing/safeguarding the environment of a high-risk suicidal patient. Search patient and patient belongings and secure belongings and other items that could be used by the patient to harm him/herself or others. Examples include, but are not limited to ...Sharp objects, razors ....

The policy indicated that an initial room sweep be performed immediately after admission to examine the room systematically for any safety risks.

The policy further indicated that there should be ongoing monitoring of the environment to maintain safety.

Review of the Hospital's policy Patient Observation for Prevention of Harm (Non-Behavioral Health Units), last revised 2/26/19, indicated that patient observation is utilized for patients who are assessed and determined to be at risk for safety and/or harm to self and others. When patient observation is necessary, standardized processes and documentation are implemented. A clinical indication for 1:1 observation is patient at high risk for suicide.

The policy indicated that the 1:1 constant observer remains in the room or at the door facing into the room in direct line of sight with the sole responsibility to ensure patient safety of the patient.

Review of the Hospital's policy, Patient Search for contraband, last revised 7/23/19, indicated that indications to initiate a search for contraband of a patient, patient room and/or patient belongings include bur are not limited to:

1. When a nurse and/or physician assess a patient to be a danger to self or others;
2. When a nurse and/or physician has initiated an enhanced behavioral health patient observation including but not limited to homicidal or suicidal watch.

1. For Patient #1, the Facility failed to maintain patient safety when Patient #1 was able to obtain and ingest foreign objects four times while under 1:1 observation throughout his/her admission.

It was reported that Patient #1 was admitted on [DATE] for retrieval of foreign bodies that he/she ingested while at his/her group home. Patient #1 was transferred after being treated at an outside hospital with complaints of severe throat pain after ingesting a toothbrush fragment and a plastic utensil. Given his/her history of repeated foreign body ingestions, the patient was started on a 1:1 observation for safety. The patient underwent an upper endoscopy and retrieval of the foreign bodies.

Record review revealed that on 7/19/20, Patient #1 reported to the 1:1 observer that he/she was able to obtain and swallow an intravenous catheter tip. The patient then went to the operating room for esophagogastroduodenoscopy (EGD) for retrieval of the foreign body IV catheter tip.

Record review revealed that on 7/25/20, Patient #1 reported to the 1:1 observer that he/she ingested his/her room mates popsicle stick that was left on a food tray. Patient #1 underwent a repeat EGD on 7/25/20 and the foreign body was removed.

Record review revealed that on 7/28/20, while the 1:1 observer was present, the patient was able to eat the strings of his/her face mask and then later in the day while the 1:1 observer was present, Patient #1 was able to grab and ingest a hand of a clock that was in his/her room. The patient was taken back to the operating room where an EGD was performed to remove the clock hand safely.

Record review revealed that on 7/31/20, while the 1:1 observer was present, the patient broke his/her toothbrush and put a piece of it in his/her mouth and ingested it. Patient #1 had a final EGD and the foreign body was removed.

Review of the Hospital's internal investigation indicated that on the first three occasions which Patient #1 ingested foreign objects, the room sweep performed was not effective to maintain safety and the communication between staff members should have been more explicit at hand off.

During an interview with the Chief Nursing Officer (CNO) on 11/30/20 at 9:50 A.M., the CNO said that Patient #1 was a large patient, over 300 pounds, and could be intimidating to the 1:1 observer assigned to the patient.

During an interview with Observer #1 on 12/1/20 at 7:45 A.M., she said that during report, she was told that Patient #1 swallowed items and that while she was observing Patient #1, she did not see her grab the popsicle stick and ingest it.

2. For Patient #2, the Hospital failed to maintain patient safety and provide care in a safe setting when Patient #2 was able to hide a razor blade on his/her body and use it to cut his/her wrists while on a 1:1 observation while in the emergency department and when
Patient #2 was able to obtain and ingest a AA battery and a tack while on 1:1 observation on a medical unit.

It was reported that Patient #2 was sent to the Hospital from another hospital after presenting with suicidal ideation and ingesting 5 metal nails. Patient #2 had a history of other foreign body ingestions. She was accepted for transfer to the Hospital by surgery for evaluation.

Review of the Emergency Department Vital Signs/Progress Note dated 7/2/20 at 2:25 P.M. indicated that Patient #2 was tearful, reports abdominal pain and suicidal ideation. Patient was on a 1:1 observation.

Review of the Emergency Department Vital Signs/Progress Note dated 7/2/20 at 2:45 P.M. indicated that the Nurse was called into the room by the 1:1 observer. Patient #2 was screaming that he/she had "cut him/herself" on right lateral wrist with a razor blade. The Patient reported to the nurse that he/she had the razor tucked under his/her breast.

Record review indicated that when the Registered Nurse attempted to perform a Columbia Suicide Assessment on 7/2/20 at 3:17 P.M., the patient was sleeping and couldn't complete the assessment.

Record review indicated that a Columbia Suicide Assessment was performed on Patient #2 on 7/2/20 at 4:03 P.M. Indicating patient as high risk for suicide with an attempted suicide overnight. Patient was placed on a 1:1 observation due to high risk for suicide.

Record review indicated that on 7/13/20 Patient #2 was yelling and agitated and threw a clock against the wall. A code gray (standardized hospital code that alerts all staff to a potentially or actively combative person) was called. Attempts to verbally de-escalate the patient were unsuccessful. On exam she was tense, hypervigilant and irritable. During the code gray she claimed that she swallowed a AA battery and a tack.

Record review revealed that on 7/13/20 an order for an X-Ray KUB (kidney, ureter and bladder) was ordered and performed. The KUB revealed that there was a new radiopaque foreign body projected over the left upper quadrant of the abdomen consistent with a AA battery. A metallic nail is projected over the hepatic flexure of the colon.

Review of the Psychiatric Progress Note dated 7/14/20 at 9:48 P.M. indicated that Patient #2 said he/she swallowed the battery to prove that the 1:1 observation isn't working.

During an interview on 12/1/20 at 8:30 A.M., the Chief Nursing Officer said that Patient #2 came to the Hospital from an outside hospital. Patient #2 was already in a hospital gown and didn't come with any personal belongings. The CNO said it is not the practice of the Hospital to search under a patient's breast for hidden objects.

During an interview on 12/1/20 at 8:45 A.M., the Emergency Department Nurse Manager said that the nurses ask patient's if they have any sharps or weapons on them. If the patient's say no, they take their word at face value.

During an interview on 12/1/20 at 11:00 A.M., Risk Manager #2 said that the patient had a thorough physical assessment performed on her and that the nurses don't go into crevices for assessments.

During an interview on 12/1/20 at 12:30 P.M the Director of Quality and Risk said that the Quality and Risk Department did not know that Patient #2 swallowed the battery while on 1:1 observation until the surveyor informed them.

The Hospital failed to identify the potential for Patient #1 and Patient #2 to have access to sharp and/or foreign objects which resulted in the subsequent ingestion for Patient #1 and Patient #2 and the laceration of Patient #2's right wrist with a hidden razor blade requiring increased level of medical care needed to be provided to the patients while in the Hospital for suicidal ideation.
VIOLATION: QAPI Tag No: A0263
The Hospital failed for two (Patient #1 and Patient #2) patients of 10 sampled patients to follow their Hospital Policies and Procedures and ensure an investigation and implementation of preventative actions after Patient #1 ingested foreign objects 4 times while being treated at the hospital and when Patient #2 was able to hide and use a razor blade to lacerate his/her right wrist, resulting in requiring sutures and also able to obtain and ingest a foreign object. All events took place while Patient #1 and Patient #2 were on 1:1 supervision due to high risk for suicidal ideation and recent attempts.

See A-0286
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and records reviewed the Hospital failed for two (Patient #1 and Patient #2) patients of 10 sampled patients to follow their Hospital Policies and Procedures and ensure an investigation and implementation of preventative actions after Patient #1 ingested foreign objects 4 times while being treated at the hospital and when Patient #2 was able to hide and use a razor blade to lacerate his/her right wrist, resulting in requiring sutures and also able to obtain and ingest a foreign object. All events took place while Patient #1 and Patient #2 were on 1:1 supervision due to high risk for suicidal ideation and recent attempts.

Findings include:

Review of the Hospital's Quality and Safety Plan, effective for calendar year 2020 - 2021, indicated that the Hospital shall have "Patient Safety Strategies". The Hospital will identify opportunities for improvement and prioritize for system redesign.
Staff members are encouraged to report all recognized safety risks, error and harm in accordance with the requirements and processes outline in the Hospital's policies.

Review of adverse events and systems and process failures that meet certain criteria will be accomplishment in part through the mechanism of a systemic approach of individual or pattern problem identification, followed by the institution of appropriate measures to improve patient care, safety and patient satisfaction and reduce the likelihood of recurrence. The Quality and Patient Safety team tracks recommendations until all are implemented by the team identified as responsible for the action plan.

Review of the Hospital's policy Suicide Risk Assessment and Management, last revised 12/10/19, indicated that the Registered Nurse is responsible for assessing/safeguarding the environment of a high-risk suicidal patient. Search patient and patient belongings and secure belongings and other items that could be used by the patient to harm him/herself or others. Examples include, but are not limited to ...Sharp objects, razors ....

The policy indicated that an initial room sweep be performed immediately after admission to examine the room systematically for any safety risks.

The policy further indicated that there should be ongoing monitoring of the environment to maintain safety.

Review of the Hospital's policy, Patient Observation for Prevention of Harm (Non-Behavioral Health Units), last revised 2/26/19, indicated that patient observation is utilized for patients who are assessed and determined to be at risk for safety and/or harm to self and others. When patient observation is necessary, standardized processes and documentation are implemented. A clinical indication for 1:1 observation is patient at high risk for suicide.

The policy indicated that the 1:1 constant observer remains in the room or at the door facing into the room in direct line of sight with the sole responsibility to ensure patient safety of the patient.

Review of the Hospital's policy, Patient Search for contraband, last revised 7/23/19, indicated that indications to initiate a search for contraband of a patient, patient room and/or patient belongings include bur are not limited to:

1. When a nurse and/or physician assess a patient to be a danger to self or others;
2. When a nurse and/or physician has initiated an enhanced behavioral health patient observation including but not limited to homicidal or suicidal watch.

1. For Patient #1, the Facility failed to follow their own policies for implementation of corrective actions when Patient #1 was able to obtain and ingest foreign objects four times while under 1:1 observation throughout his/her admission.

It was reported that Patient #1 was admitted on [DATE] for retrieval of foreign bodies that he/she ingested while at his/her group home. Patient #1 was transferred after being treated at an outside hospital with complaints of severe throat pain after ingesting a toothbrush fragment and a plastic utensil. Given his/her history of repeated foreign body ingestions, the patient was started on a 1:1 observation for safety. The patient underwent an upper endoscopy and retrieval of the foreign bodies.

Record review revealed that on 7/19/20, Patient #1 reported to the 1:1 observer that he/she was able to obtain and swallow an intravenous catheter tip. The patient then went to the operating room for esophagogastroduodenoscopy (EGD) for retrieval of the foreign body IV catheter tip.

Record review revealed that on 7/25/20, Patient #1 reported to the 1:1 observer that he/she ingested his/her roommate's popsicle stick that was left on a food tray. Patient #1 underwent a repeat EGD on 7/25/20 and the foreign body was removed.

Record review revealed that on 7/28/20, while the 1:1 observer was present, the patient was able to eat the strings of his/her face mask and then later in the day while the 1:1 observer was present, Patient #1 was able to grab and ingest a hand of a clock that was in his/her room. The patient was taken back to the operating room where an EGD was performed to remove the clock hand safely.

Record review revealed that on 7/31/20, while the 1:1 observer was present, the patient broke his/her toothbrush and put a piece of it in his/her mouth and ingested it. Patient #1 had a final EGD and the foreign body was removed.

Review of the Hospital's internal investigation indicated that on the first three occasions which Patient #1 ingested foreign objects, the room sweep performed was not effective to maintain safety and the communication between staff members should have been more explicit at hand off.

Review of personnel records for the four 1:1 observers assigned to Patient #1 during the ingestion of foreign objects indicated that none of them have received any training or re-education after the events took place in regards to room sweeps or 1:1 observation.

During an interview on 11/30/20 at 9:50 A.M. with the Chief Nursing Officer and the Director of Quality and Risk were not able to provide any formal updates or information to share with the Surveyor in regards to implementation of corrective action after Patient #1 was found to have ingested foreign objects four times while admitted to the hospital from 7/18/20 - 8/3/20.

During and interview with observer #1 on 12/1/20 at 7:45 A.M. the observer said that she has not received any education or updated information regarding 1:1 observation and room sweeps as a result of Patient #1 swallowing foreign objects while admitted in the hospital.

2. For Patient #2, the Hospital failed to maintain patient safety and provide care in a safe setting when Patient #2 was able to hide a razor blade on his/her body and use it to cut his/her wrists while on a 1:1 observation while in the emergency department and when Patient #2 was able to obtain and ingest a AA battery and a tack while on 1:1 observation on a medical unit.

It was reported that Patient #2 was sent to the Hospital from another hospital after presenting with suicidal ideation and ingesting 5 metal nails. Patient #2 had a history of other foreign body ingestions. She was accepted for transfer to the Hospital by surgery for evaluation.

Review of the Emergency Department Vital Signs/Progress Note dated 7/2/20 at 2:25 P.M. indicated that Patient #2 was tearful, reports abdominal pain and suicidal ideation. Patient was on a 1:1 observation.

Review of the Emergency Department Vital Signs/Progress Note dated 7/2/20 at 2:45 P.M. indicated that the Nurse was called into the room by the 1:1 observer. Patient #2 was screaming that he/she had "cut him/herself" on right lateral wrist with a razor blade. The Patient reported to the nurse that he/she had the razor tucked under his/her breast.

Record review indicated that when the Registered Nurse attempted to perform a Columbia Suicide Assessment on 7/2/20 at 3:17 P.M., the patient was sleeping and couldn't complete the assessment.

Record review indicated that a Columbia Suicide Assessment was performed on Patient #2 on 7/2/20 at 4:03 P.M. Indicating patient as high risk for suicide with an attempted suicide overnight. Patient was placed on a 1:1 observation due to high risk for suicide.

Record review indicated that on 7/13/20 Patient #2 was yelling and agitated and threw a clock against the wall. A code gray (standardized hospital code that alerts all staff to a potentially or actively combative person) was called. Attempts to verbally de-escalate the patient were unsuccessful. On exam she was tense, hypervigilant and irritable. During the code gray she claimed that she swallowed a double A battery and a tack.

Record review revealed that on 7/13/20 an order for an X-Ray KUB (kidney, ureter and bladder) was ordered and performed. The KUB revealed that there was a new radiopaque foreign body projected over the left upper quadrant of the abdomen consistent with a AA battery. A metallic nail is projected over the hepatic flexure of the colon.

Review of the Psychiatric Progress Note dated 7/14/20 at 9:48 P.M. indicated that Patient #2 said he/she swallowed the battery to prove that the 1:1 observation isn't working.

During an interview on 12/1/20 at 8:30 A.M., the Chief Nursing Officer said that Patient #2 came to the Hospital from an outside hospital. Patient #2 was already in a hospital gown and didn't come with any personal belongings. The CNO said it is not the practice of the Hospital to search under a patient's breast for hidden objects.

During an interview on 12/1/20 at 8:45 A.M., the Emergency Department Nurse Manager said that the nurses ask patient's if they have any sharps or weapons on them. If the patient's say no, they take their word at face value.

During an interview on 12/1/20 at 11:00 A.M., Risk Manager #2 said that the Hospital provides annual training fairs which includes observation and room sweeps, but isn't sure when the education takes place. There was no evidence that any staff members were re-educated on safety sweeps and observation requirements after the incidents took place.

During an interview on 12/1/20 at 12:30 P.M the Director of Quality and Risk said that the Quality and Risk Department did not know that Patient #2 swallowed the battery while on 1:1 observation until the surveyor informed them. The nurses and doctors involved did not report the ingestion through the RL solutions system as expected, so the Quality and Risk Department weren't able to complete an investigation.

The Hospital failed to follow their own policies and procedures for investigating incidents and implementing systemic corrective action to prevent a like occurrence from happening in the future.