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Based on observations, staff interviews and record review conducted throughout the days of survey the Governing Body failed to assure an effective quality assessment and performance improvement program. The Governing Body failed to assure that hospital staff communicated relevant information and conducted a thorough quality review and analysis of an adverse event that resulted in a patient requiring emergency treatment.

Refer to tags: A-263, A-267, A-276, A-287

Based on staff interview and record review, the hospital failed to identify a significant quality deficient practice and implement changes that would lead to improvement following an incident involving a patient's potential access to illicit drugs . (Patient #3) Findings include:

Per interview on 6/7/12 at 4:45 the Senior Director of Quality and Regulatory Services confirmed the circumstances and events surrounding Patient #3 ' s emergent transfer to the ED of an acute care hospital on 5/20/12 should have been identified as a Critical Incident requiring a report and a complete review for patient safety concerns and quality improvement. The symptoms of excessive drowsiness, decreased responsiveness, with a oxygen saturation of 84% (normal oxygen level is > 95%) and a drop in blood pressure treated successfully in the ED with Narcan, created the suspicion Patient #3, while hospitalized and medicated for Alcohol detoxification., had possibly obtained access to opioids while attending a public AA meeting.

Per interview on 6/5/11 at 10:15 AM, the Director of Quality confirmed all Code Blue documentation is audited to ensure documentation is complete and procedures were followed. When Patient #3 was experiencing changes in their vital signs and level of consciousness, a Code Blue was called, staff from other units responded to the medical emergency and the patient was transferred to the ED of an acute care hospital for further evaluation and treatment. Patient #3's medical record was initially reviewed by the Director of Quality due to the Code Blue event. However, the Director further confirmed, that at the time of Patient #3 ' s record review pertinent medical information was missing from the record. Although an attempt had been made, by the Quality Department, to obtain the medical record from the ED where treatment had occurred, as of the date of survey that information had still not been obtained, delaying the process for thorough analysis of the event by the facility. At the surveyor's request the ED record was obtained and revealed the ED provider's " Clinical Impression " which stated on 5/20/12: " Reversal of lethargy and hypoxia secondary to narcotic use " . A progress note states " Pt. (patient) placed - opioid titration reversal with 0.1 mg. per min. At 0.3 mg, s/he was able to breath > 10 and awakened .... " .)

As a result of staff not submitting a Critical Incident Report and the lack of communication from Tyler I staff, the Senior Director of Quality and Regulatory Services was not aware of the termination of AA meetings for patients on Tyler I. Per Discharge Summary finalized on 5/29/12 the attending physician states regarding prognosis for Patient #3 " ...it is likely that s/he found some opiate at the AA meeting that s/he attended and used that while s/he was here. " Even though the attending physician and the Medical Director for Tyler 1 had an awareness of Patient #3's clinical case, there was a failure to inform the hospital's Medical Director. It was not until 6/5/12, at the time of survey, the Medical Director was appraised of the circumstances. An opportunity to conduct a Peer review of the case based on the impressions of Patient #3 ' s clinical condition and outcomes also did not occur.

Per Patient Safety Plan (last revised on 04/2009) "The Department Directors and clinical managers are responsible for the prevention, monitoring , identification, investigation, correction and reporting of incidents and adverse events within their area of responsibility"
The nurse manager stated on the morning of 6/6/12 that s/he had not reviewed Patient #3's clinical record to ensure all documentation was complete and policies followed especially as it relates to the potential opiate ingestion/overdose of Patient #3 while under the care of staff on Tyler I. The nurse manager did not obtain written statements from staff who had attended the AA meeting on 5/18/12 with Patient #3 or were present at the time of the Code Blue incident on 5/20/12 as required per Sentinel Event and Critical Incident Management and Communication (last revised 02/2012).

It was further confirmed by the Senior Director of Quality and Regulatory Services there was a failure by staff to identify how the events surrounding Patient #3 impacted patient safety on all the patient treatment units. As a result, patients from other units continued to attend the AA public meetings on and after 5/18/12. Due to the lack of prompt reporting of events related to Patient #3, and the incomplete Quality Assessment review of all pertinent information delayed the hospital's opportunity to initiate changes that would lead to improvement.

Based on staff interview and record review, the hospital's Quality Assessment and Performance Improvement failed to track and analyze an adverse patient event thereby creating a delay in appropriate response to assure patient safety. Findings include:

The Quality Assessment/Performance Improvement program failed to track and analyze the causes surrounding a patient adverse event related to the possible substance ingestion/overdose. Per record review, on 5/20/12 at approximately 9:30 AM Patient #3 was transferred to the hospital with symptoms of excessive drowsiness, decreased responsiveness, with a oxygen saturation of 84% (normal oxygen level is > 95%) and a drop in blood pressure. At 11:30 AM the hospital Emergency Department (ED) notified Nurse #1 that Patient #3 became awake and responsive after the administration of intravenous Narcan (an opioid antagonist used to reverse the effects of opioids including respiratory depression, sedation and low blood pressure).

Per interview on 6/5/11 at 10:15 AM Senior Director of Quality and Regulatory Services confirmed all Code Blue documentation is audited to ensure documentation is complete and procedures were followed. When Patient #3 was experiencing changes in their vital signs and level of consciousness, a Code Blue was called and staff from other units responded to the medical emergency. This record was initially reviewed by the Director of Quality due to the Code Blue event. However, the Director further confirmed, that at the time of Patient #3 ' s record review pertinent medical information was missing from the record. Although an attempt had been made, by the Quality Department, to obtain the medical record from the ED where treatment had occurred, as of the date of survey that information had still not been obtained. This delay prevented the the Director from tracking and conducting a thorough analysis of the event. At the surveyor's request the ED record was obtained on 6/6/12 and revealed the ED provider's " Clinical Impression " which stated on 5/20/12: " Reversal of lethargy and hypoxia secondary to narcotic use " . A progress note states " Pt. (patient) placed - opioid titration reversal with 0.1 mg. per min. At 0.3 mg, s/he was able to breath > 10 and awakened .... " .)

As a result of not having obtained all necessary information for analysis, the hospital's Medical Director had not been informed of the potential circumstances surrounding Patient #3's adverse event. On 6/7/12, at the time of survey, the Medical Director was first appraised of the circumstances related to the Code Blue, the possible ingestion of opiates and the patient's response to Narcan while receiving treatment in the Emergency Department. A peer review analysis of causes and responses of the events surrounding Patient #3's medical treatment on Tyler I had not been conducted as of 6/7/12.

Based on staff interview and record review, the hospital failed to identify a significant quality deficient practice and implement changes that would lead to improvement following an incident involving a patient's potential access to illicit drugs . (Patient #3) Findings include:

Per interview on 6/7/12 at 4:45 the Senior Director of Quality and Regulatory Services confirmed the circumstances and events surrounding Patient #3 ' s emergent transfer to the ED of an acute care hospital on 5/20/12 should have been identified as a Critical Incident requiring a report and a complete review for patient safety concerns and quality improvement. The symptoms of excessive drowsiness, decreased responsiveness, with a oxygen saturation of 84% (normal oxygen level is > 95%) and a drop in blood pressure treated successfully in the ED with Narcan, created the suspicion Patient #3, while hospitalized and medicated for Alcohol detoxification., had possibly obtained access to opioids while attending a public AA meeting.

Per interview on 6/5/11 at 10:15 AM, the Director of Quality confirmed all Code Blue documentation is audited to ensure documentation is complete and procedures were followed. When Patient #3 was experiencing changes in their vital signs and level of consciousness, a Code Blue was called, staff from other units responded to the medical emergency and the patient was transferred to the ED of an acute care hospital for further evaluation and treatment. Patient #3's medical record was initially reviewed by the Director of Quality due to the Code Blue event. However, the Director further confirmed, that at the time of Patient #3 ' s record review pertinent medical information was missing from the record. Although an attempt had been made, by the Quality Department, to obtain the medical record from the ED where treatment had occurred, as of the date of survey that information had still not been obtained, delaying the process for thorough analysis of the event by the facility. At the surveyor's request the ED record was obtained and revealed the ED provider's " Clinical Impression " which stated on 5/20/12: " Reversal of lethargy and hypoxia secondary to narcotic use " . A progress note states " Pt. (patient) placed - opioid titration reversal with 0.1 mg. per min. At 0.3 mg, s/he was able to breath > 10 and awakened .... " .)

As a result of staff not submitting a Critical Incident Report and the lack of communication from Tyler I staff, the Senior Director of Quality and Regulatory Services was not aware of the termination of AA meetings for patients on Tyler I. Per Discharge Summary finalized on 5/29/12 the attending physician states regarding prognosis for Patient #3 " ...it is likely that s/he found some opiate at the AA meeting that s/he attended and used that while s/he was here. " Even though the attending physician and the Medical Director for Tyler 1 had an awareness of Patient #3's clinical case, there was a failure to inform the hospital's Medical Director. It was not until 6/5/12, at the time of survey, the Medical Director was appraised of the circumstances. An opportunity to conduct a Peer review of the case based on the impressions of Patient #3 ' s clinical condition and outcomes also did not occur.

Per Patient Safety Plan (last revised on 04/2009) "The Department Directors and clinical managers are responsible for the prevention, monitoring , identification, investigation, correction and reporting of incidents and adverse events within their area of responsibility"
The nurse manager stated on the morning of 6/6/12 that s/he had not reviewed Patient #3's clinical record to ensure all documentation was complete and policies followed especially as it relates to the potential opiate ingestion/overdose of Patient #3 while under the care of staff on Tyler I. The nurse manager did not obtain written statements from staff who had attended the AA meeting on 5/18/12 with Patient #3 or were present at the time of the Code Blue incident on 5/20/12 as required per Sentinel Event and Critical Incident Management and Communication (last revised 02/2012).

It was further confirmed by the Senior Director of Quality and Regulatory Services there was a failure by staff to identify how the events surrounding Patient #3 impacted patient safety on all the patient treatment units. As a result, patients from other units continued to attend the AA public meetings on and after 5/18/12. Due to the lack of prompt reporting of events related to Patient #3, and the incomplete Quality Assessment review of all pertinent information delayed the hospital's opportunity to initiate changes that would lead to improvement.

Based on staff interview and record review, after being involved in an adverse patient event, hospital staff failed to complete an incident report, as per hospital policy, to ensure such events are investigated, measured, analyzed and monitored for patient safety and quality of care for 1 applicable patient. (Patient #3) Findings include:

Per record review, on 5/20/12 at approximately 9:30 AM Patient #3 was transferred to the ED (Emergency Department) of an acute care hospital with symptoms of excessive drowsiness, decreased responsiveness, with a oxygen saturation of 84% (normal oxygen level is > 95%) and a drop in blood pressure. At 11:30 AM the hospital ED notified Nurse #1 that Patient #3 became awake and responsive after the administration of intravenous Narcan (an opioid antagonist used to reverse the effects of opioids including respiratory depression, sedation and low blood pressure). Although the hospital has a process for reporting substance ingestion/overdose per Sentinel Event and Critical Incident Management and Communication (last revised 02/2012), by completing an Incident/Occurrence report, Nurse #1 failed to follow policy by not submitting an Incident Report. Nurse #1 also failed to follow hospital procedure on 5/20/12 by not reporting immediately the incident of a possible patient ingestion of opioids to the House Nursing Supervisor.

Per review, Patient #3 was a voluntary admission to the hospital on 5/16/12 for treatment of his/her alcohol dependence. Past medical history includes previous dependence of opioids, however upon admission no opioids were detected via laboratory results. During the course of treatment, Patient #3 received Librium (sedative/ hypnotic/benzodiazepine) as per the Alcohol Withdrawal Assessment Guidelines. On 5/18/12 the treatment team assessed Patient #3 to be safe for increased activities on Tyler 1 and within the hospital. On the evening of 5/18/12 Patient #3 attended a public wide Alcohol Anonymous (AA) meeting held in the hospital cafeteria.

After being appraised of the incident on 5/20/12 involving Patient #3, the Tyler I unit nurse manager, the medical director for Tyler I and the social worker met on 5/21/12 and made a decision to stop patients from that unit from attending the community public AA meetings. This decision was made on the premise Patient #3 may have obtained an opioid substance from a member of the public on 5/18/12 while attending the AA meeting. Although other units within the hospital allow patients to attend the AA community meetings, staff from Tyler I failed to alert the other units of the potential access of drug contraband from public attendees at the AA meeting. Per interview on 6/6/12 at 9:45 AM, the Tyler I unit manager confirmed " I should have passed it on " .

As a result of not completing an Incident/Occurrence report by Nurse #1 and failure of the Nurse Manager to notify senior management, to include the Medical Director, the interim Director of Nursing and the Chief of Operations of the decision to prohibit patients from Tyler 1 from attending the public AA meetings, the full spectrum of Patient #3's critical incident was not sufficiently investigated to assess the situation and determine what immediate interventions were required.

Per interview on 6/5/12 at 3:55 PM, the Senior Director of Quality and Regulatory Services, confirmed s/he was unaware of the suspicion of drug contraband at the AA meeting on 5/18/12 and Tyler #1 ' s decision to close access to AA meetings for patients. The Director further confirmed on 6/7/12 at 4:45 PM the events surrounding Patient #3 ' s emergent transfer to the ED and immediate response to Narcan should have been identified as a Critical Incident requiring a report and a complete review for patient safety concerns and quality improvement.

Based on staff interview and record review, after being involved in an adverse patient event, hospital staff failed to complete an incident report, as per hospital policy, to ensure such events are investigated, measured, analyzed and monitored for patient safety and quality of care for 1 applicable patient. (Patient #3) Findings include:

Per record review, on 5/20/12 at approximately 9:30 AM Patient #3 was transferred to the ED (Emergency Department) of an acute care hospital with symptoms of excessive drowsiness, decreased responsiveness, with a oxygen saturation of 84% (normal oxygen level is > 95%) and a drop in blood pressure. At 11:30 AM the hospital ED notified Nurse #1 that Patient #3 became awake and responsive after the administration of intravenous Narcan (an opioid antagonist used to reverse the effects of opioids including respiratory depression, sedation and low blood pressure). Although the hospital has a process for reporting substance ingestion/overdose per Sentinel Event and Critical Incident Management and Communication (last revised 02/2012), by completing an Incident/Occurrence report, Nurse #1 failed to follow policy by not submitting an Incident Report. Nurse #1 also failed to follow hospital procedure on 5/20/12 by not reporting immediately the incident of a possible patient ingestion of opioids to the House Nursing Supervisor.

Per review, Patient #3 was a voluntary admission to the hospital on 5/16/12 for treatment of his/her alcohol dependence. Past medical history includes previous dependence of opioids, however upon admission no opioids were detected via laboratory results. During the course of treatment, Patient #3 received Librium (sedative/ hypnotic/benzodiazepine) as per the Alcohol Withdrawal Assessment Guidelines. On 5/18/12 the treatment team assessed Patient #3 to be safe for increased activities on Tyler 1 and within the hospital. On the evening of 5/18/12 Patient #3 attended a public wide Alcohol Anonymous (AA) meeting held in the hospital cafeteria.

After being appraised of the incident on 5/20/12 involving Patient #3, the Tyler I unit nurse manager, the medical director for Tyler I and the social worker met on 5/21/12 and made a decision to stop patients from that unit from attending the community public AA meetings. This decision was made on the premise Patient #3 may have obtained an opioid substance from a member of the public on 5/18/12 while attending the AA meeting. Although other units within the hospital allow patients to attend the AA community meetings, staff from Tyler I failed to alert the other units of the potential access of drug contraband from public attendees at the AA meeting. Per interview on 6/6/12 at 9:45 AM, the Tyler I unit manager confirmed " I should have passed it on " .

As a result of not completing an Incident/Occurrence report by Nurse #1 and failure of the Nurse Manager to notify senior management, to include the Medical Director, the interim Director of Nursing and the Chief of Operations of the decision to prohibit patients from Tyler 1 from attending the public AA meetings, the full spectrum of Patient #3's critical incident was not sufficiently investigated to assess the situation and determine what immediate interventions were required.

Per interview on 6/5/12 at 3:55 PM, the Senior Director of Quality and Regulatory Services, confirmed s/he was unaware of the suspicion of drug contraband at the AA meeting on 5/18/12 and Tyler #1 ' s decision to close access to AA meetings for patients. The Director further confirmed on 6/7/12 at 4:45 PM the events surrounding Patient #3 ' s emergent transfer to the ED and immediate response to Narcan should have been identified as a Critical Incident requiring a report and a complete review for patient safety concerns and quality improvement.

Based on staff interview and record review, the hospital's Quality Assessment and Performance Improvement failed to track and analyze an adverse patient event thereby creating a delay in appropriate response to assure patient safety. Findings include:

The Quality Assessment/Performance Improvement program failed to track and analyze the causes surrounding a patient adverse event related to the possible substance ingestion/overdose. Per record review, on 5/20/12 at approximately 9:30 AM Patient #3 was transferred to the hospital with symptoms of excessive drowsiness, decreased responsiveness, with a oxygen saturation of 84% (normal oxygen level is > 95%) and a drop in blood pressure. At 11:30 AM the hospital Emergency Department (ED) notified Nurse #1 that Patient #3 became awake and responsive after the administration of intravenous Narcan (an opioid antagonist used to reverse the effects of opioids including respiratory depression, sedation and low blood pressure).

Per interview on 6/5/11 at 10:15 AM Senior Director of Quality and Regulatory Services confirmed all Code Blue documentation is audited to ensure documentation is complete and procedures were followed. When Patient #3 was experiencing changes in their vital signs and level of consciousness, a Code Blue was called and staff from other units responded to the medical emergency. This record was initially reviewed by the Director of Quality due to the Code Blue event. However, the Director further confirmed, that at the time of Patient #3 ' s record review pertinent medical information was missing from the record. Although an attempt had been made, by the Quality Department, to obtain the medical record from the ED where treatment had occurred, as of the date of survey that information had still not been obtained. This delay prevented the the Director from tracking and conducting a thorough analysis of the event. At the surveyor's request the ED record was obtained on 6/6/12 and revealed the ED provider's " Clinical Impression " which stated on 5/20/12: " Reversal of lethargy and hypoxia secondary to narcotic use " . A progress note states " Pt. (patient) placed - opioid titration reversal with 0.1 mg. per min. At 0.3 mg, s/he was able to breath > 10 and awakened .... " .)

As a result of not having obtained all necessary information for analysis, the hospital's Medical Director had not been informed of the potential circumstances surrounding Patient #3's adverse event. On 6/7/12, at the time of survey, the Medical Director was first appraised of the circumstances related to the Code Blue, the possible ingestion of opiates and the patient's response to Narcan while receiving treatment in the Emergency Department. A peer review analysis of causes and responses of the events surrounding Patient #3's medical treatment on Tyler I had not been conducted as of 6/7/12.

Based on survey findings the Condition of Participation for Quality Assessment and Performance Improvement was not met related to a failure to communicate relevant information in accordance with the facility's event reporting policy, and a failure to obtain pertinent medical information during a quality review of the medical record for one patient. These failures led to a delay in the completion of a comprehensive analysis of the cause of an adverse event and failure to identify a potential quality deficient practice.


Refer to: A-0267, A-0276 and A-0287