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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QAPI CONDITION, was out of compliance.

A-0286 PATIENT SAFETY (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. Based on interviews and record review, the facility failed to ensure patient events were reported, analyzed and preventative measures were implemented. Specifically, the facility failed to report an adverse patient event in order to investigate causative factors and implement preventative actions (Patient #20). Additionally, the facility failed to implement preventive measures after patient safety concerns were identified however continued to occur in 8 of 26 medical records reviewed. (Patient #1, #2, #3, #4, #12, #17, #19, and #25).

Based on interviews and record review, the facility failed to ensure patient events were reported, analyzed and preventative measures were implemented. Specifically, the facility failed to report an adverse patient event in order to investigate causative factors and implement preventative actions (Patient #20). Additionally, the facility failed to implement preventive measures after patient safety concerns were identified however continued to occur in 8 of 26 medical records reviewed. (Patient #1, #2, #3, #4, #12, #17, #19, and #25).

Findings include:

Facility policies:

The Incident Notification Communication policy read, the purpose was to establish a uniform procedure to outline communication expectations for potential events that occur at the facility. The policy defined an adverse event as a patient safety event that resulted in harm to a patient. Adverse events should prompt notification of organization leaders, investigation, and corrective actions. An adverse event may or may not result from an error.

The Incident Report Protocol and Patient Safety Events policy read, an incident report was a detailed notice in the information system of a patient safety incident. A patient safety incident was an event, incident, or condition that could have resulted or did result in harm to a patient. A patient safety incident could be, but was not necessarily, the result of a defective system or process design, a system breakdown, equipment failure, or human error. A Sentinel Event included an adverse event of a severe and urgent nature, which could result in an unexpected and undesirable patient outcome. Examples included any occurrence, which has resulted in an unanticipated death or major loss of function, not related to the natural course of the individual's condition; death caused by self-inflicted injurious behavior while in a health care setting; abduction of any individual receiving care, treatment, or services; sexual abuse/assault (including rape); and any elopement (that is, unauthorized departure) of an individual served from a staffed around the clock setting (including the ED) leading to the death, permanent harm or severe temporary harm of the individual served.

Patient Safety Incidents must be captured via the incident reporting system. It was the responsibility of all staff to report all patient safety incidents, accidents, or injuries involving
patients or visitors and to report such occurrences using the Incident Reporting system along with notifying their supervisor immediately. When a patient safety incident was discovered, the employee making the discovery was required to notify their immediate supervisor and enter the incident in the incident management system. Incident reports were to be filled out for any patient safety incident.

The Incident Report Management policy read, the Director of Quality and Risk Management will lead the investigation for all patient-related incidents. Supervisors/Managers must complete additional information within the incident reporting system, related to their review of patient-related incidents. The Director of Quality and Risk Management was responsible for closing out all incident reports within 72 hours of notice of the event.

The Risk Management Plan policy read, for further investigation: gather all pertinent facts about the incident including the scene, who was involved, description of the event, and any damages. Continues to communicate with the patient and family through the physician. Enter notification/incident form into the database for trend analysis. Determine, possibly through quality improvement analysis evaluation if changes in processes, in-service education, or other steps were necessary.

Risk Management/Quality Improvement completed the following: identified risk and adverse events through incident reporting, patient complaints, and other data resources; identified problems through continuous monitoring or critical indicators or the quality and appropriateness of patient care; assessed incidents, adverse events, and trends through the Quality Improvement Committee and risk management analysis; assessed performance improvement data through peer review; recommended and monitored corrective actions designed to reduce patient risks; monitored effectiveness or corrective actions.

The Integration of Risk Management and Education section read, accountability and corrective measures for incidents most often involved educational functions. Once the exposure to loss had been identified and priorities set or new policies developed, the Risk Manager may request that an effective educational program in which training and retraining will be implemented. The Risk Manager would coordinate, plan and implement educational programs to minimize the risk of harm to patients and others through the general orientation and/or handbooks (as available), risk management educational sessions as indicated and coordinate an annual presentation, Hospital wide by the Risk Manager, insurance carrier and/or legal counsel.

The Elopement policy read, the purpose was to provide adequate documentation in the patient's medical record of the elopement. In the patient's medical record document time, who was notified, efforts made to ensure that the patient was safe, areas searched, and the patient's behavior and mental status in the progress notes.

The Facility Risk Assessment policy read, the assessment would evaluate the risk from a variety of functions including the structure of the environment and performance of everyday tasks. Risks were also identified from internal sources, such as ongoing monitoring of the environment, results of root cause analyses, results of annual proactive risk assessments of high-risk processes, and credible external sources (i.e. Sentinel Event Alerts). The Facility would conduct a risk assessment of the physical environment to evaluate hazards and identify features in the physical environment that could be used to attempt suicide and/or cause harm to patients, staff, and visitors.

The facility will use the assessment to take necessary action to minimize the risk(s) and develop protective measures associated with various tasks performed in each area within the Hospital and off-site Facilities. The Facility will conduct a full risk assessment annually or whenever there was a change in the environment and will review the progress of the assessment and action plans related to the assessment at least quarterly at the facility safety committee. The Risk Assessment Team Members will identify the appropriate risk elements in the environment and the activities conducted in the area that could have an impact on patient care. The team will also address any risks reported by staff members in the risk assessment as they were received. The assessment for safety and security-related risk can be completed on the Risk Assessment form. The assessment will be conducted in all areas of the Facility, including the areas conducted in environmental tours. The Risk Assessment Team Members complete the form by identifying the risks related to each area. The team members will evaluate the risk to determine if current mitigation strategies were in place that sufficiently mitigate the risk. Risks that require additional mitigation will require immediate clinical and physical mitigation until a long-term strategy is put in place. The Safety Officer, Risk Assessment Team, and/or EOC Committee will determine if additional changes in process, training, policy, and/or procedure or PPE/Safety equipment will be required to eliminate or minimize the impact of the risk.

1. The facility failed to ensure an adverse patient event was reported and investigated.

a. A review of Patient #20's record and the EMTALA log for 3/7/24 and 3/10/24 revealed the patient overdosed on medication while in the intake area.

i. On 3/7/24 at 3:30 p.m., Patient #20 arrived at the facility.

ii. The safety assessment form was completed by the patient at 3:34 p.m. The form read the patient was seeking services due to alcohol and drug use. Patient #20 indicated on the form they did not have thoughts to harm themselves and felt safe.

iii. The close observation form read at 3:30 p.m. the patient was located in "other" and the patient displayed calm behavior. There was no additional documentation of 15-minute checks performed after 3:30 p.m. There were two sticky notes placed on the form with vital signs written down.

Vital signs at 3:50 p.m. read, blood pressure 142/88; heart rate 139 beats per minute (BPM), and a blood alcohol level (BAL) of .069.

iv. At 3:41 p.m. the patient's eligibility insurance was reviewed by the facility.

v. At 5:36 p.m., the patient's urine drug screen revealed they were positive for barbituates, meth, amphetamine, and benzodiazepines.

Vital signs at 6:07 p.m., written on the second sticky note, read the patient's blood pressure was 99/54; heart rate was 125 bpm; and respirations of 11.

vi. The EMTALA form read the form was completed at 6:35 p.m. The patient was sent to another hospital due to the need for medical clearance. The patient was incapacitated, unresponsive, and had decreased vital signs. The patient reported ingesting 600 mg of Seroquel and unknown sleeping pills.

vii. A review of Patient #20's record and EMTALA log for 3/10/24 revealed the patient returned to the facility at 12:10 p.m. after receiving medical treatment at an outside facility.

The screening assessment form was completed at 12:38 p.m. The note on the screening assessment form read, that the patient was previously at the facility on Thursday and overdosed in the intake bathroom.

b. A review of the patient safety event report log revealed there was not a report entered for Patient #20's event. This was in contrast to the Incident Report Protocol and Patient Safety Events policy which read, that incident reports were to be filled out for any patient safety incident. The incident report should have been filled out as soon as practicable after the incident had occurred.

c. A review of the quality committee meeting minutes from 4/25/24 revealed there was no mention of Patient #20's event. This was in contrast to the Risk Management Plan policy which read, that incident reports should have been entered into the database for trend analysis as the Quality Improvement Committee identified risks and adverse events through incident reporting and assessed and implemented corrective actions.

d. Interviews with staff revealed they were unaware of this event and that the event should have been reported.

i. On 7/9/24 at 4:16 p.m., an interview was conducted with registered nurse (RN) #1. RN #1 stated any staff could enter an incident report when an event occurred. RN #1 stated it was important for the event to be entered so it could be reviewed and to prevent a similar event from happening again.

ii. On 7/10/24 at 11:40 a.m., an interview was conducted with the director of nursing (DON) #2. DON #2 stated observations of patients were to be completed whenever a patient was at the facility. DON #2 stated the observations started in the front lobby and intake area. DON #2 stated it was important for observations to be done to ensure patient safety.

DON #2 explained if an event occurred that caused patient harm, an incident report was to be filed. DON #2 stated once an incident report was entered, it would be investigated to identify concerns.

On 7/11/24 at 1:30 p.m., additional documentation regarding the patient safety event for Patient #20 was requested from DON #2. DON #2 stated she was unaware a safety event had occurred with Patient #20.

iii. On 7/15/24 at 11:44 a.m., an interview was conducted with the director of quality, risk, and compliance (Director) #3. Director #3 stated an incident report was to be filed whenever an event occurred that was outside of the normal day-to-day activities. Director #3 stated events such as a drug overdose were supposed to be followed up on immediately.

At 1:04 p.m., a second interview was conducted with Director #3 in which Patient #20 was discussed. Director #3 stated they were unaware of the event that occurred regarding Patient #20. Director #3 reviewed facility documents and confirmed an incident report was not filed regarding Patient #20's drug overdose incident. Director #3 stated it was important for events to be reported for opportunities to be identified and to prevent further patient harm.

2. The facility failed to ensure preventative measures were implemented after patient safety concerns were identified and failed to re-evaluate measures for success when implemented.

a. A review of Patient #25's medical record revealed they arrived at the facility on 6/8/24 at 2:16 p.m. for treatment of a suicide attempt by a drug overdose. The patient observation sheet revealed checks on the patient were started at 2:19 p.m. and were to be conducted on the patient every 15 minutes. Further review of the observation sheet revealed the 15-minute observations did not start until 4:30 p.m., over two hours after the patient arrived at the facility.

A review of a patient safety event for Patient #25 revealed they had eloped from the intake area at 3:35 p.m. The report read the patient had held down the push bar of the door to elope from the hallway. The patient walked out of the door and was followed by staff. The police department was called and the patient was later returned to the facility at 4:30 p.m.

The follow-up for the patient safety event read the patient was placed on elopement precautions once they returned to the facility, however, there was no mention in the safety report that the facility identified the lack of 15-minute observations and implemented measures to ensure continued lapses in 15-minute observations were not recurring at the facility.

b. On 7/1/24 at 1:00 p.m., Patient #12 presented to the facility for alcohol detox. On the Safety Assessment form, Patient #12 marked they felt unsafe and concerned.

A review of the patient observation sheet revealed one 15 minute check of the patient was completed at 1:00 p.m. There was only one 15 minute check performed until the patient left the facility at 3:29 p.m., two and a half hours after the patient presented to the facility.

Similar findings of the lack of every 15-minute observations were found in Patients #2, #3, #4, #17, #19, and #25 intake medical records.

c. The facility's risk assessment last reviewed by the facility on 6/6/24, revealed the push bar doors had been identified as an elopement risk in 2022. The mitigation measure put in place for the identified risk was for assessment staff to monitor the area and patients.

The mitigation measures were in contrast to the medical record review which revealed 12 patients were not consistently monitored while in the intake area.

Additionally, the facility's risk assessment and mitigation measures were in contrast to the facility risk assessment policy which read, the team members would evaluate the risk to determine if current mitigation strategies were in place that sufficiently mitigate the risk. The facility was unable to provide evidence the mitigation measures sufficiently mitigated the risk.

d. On 7/15/24 at 4:12 p.m., an interview was conducted with DON #2. DON #2 stated intake staff had not consistently performed close observation rounds. DON #2 stated to mitigate this, they implemented real-time compliance audits to ensure continuous patient observations were performed. DON #2 stated since March of 2024, two real-time compliance audits were performed in the intake area which had not identified gaps in compliance. They further stated they were not aware patients in the intake area were not continuously monitored until the survey was conducted.