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115 LINCOLN STREET

FRAMINGHAM, MA 01701

QAPI

Tag No.: A0263

Based on record review and interview, the Hospital failed to identify opportunities for improvement and changes that will lead to improvement through data collected for 3 Patients (#1, #3 and #7) out of a total sample of 14 Patients; Patients #1 and #3 experienced a delayed ICU (Intensive Care Unit) transfer and clinically decompensated. Patient #7 experienced a delayed CVU (Cardiovascular Unit) transfer and clinically decompensated.

Refer to Tag 0283.

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on record review and interview, the Hospital failed to identify opportunities for improvement and changes that will lead to improvement through data collected for 3 Patients (#1, #3 and #7) out of a total sample of 14 Patients; Patients #1 and #3 experienced a delayed ICU (Intensive Care Unit) transfer and clinically decompensated. Patient #7 experienced a delayed CVU (Cardiovascular Unit) transfer and clinically decompensated.

Findings include:

The Hospital policy titled "Event Reporting", dated 8/30/18, indicated the following:
-Reportable event means an event that is not consistent with the routine operation of the Hospital or the routine care of a patient or patients. The potential for accident, injury, illness, or property damage referred to as a near miss is sufficient for an event to be considered a Reportable Event.
-Any Hospital Staff who witnesses, discovers, or has direct involvement in and /or knowledge of a reportable event must complete an event report.
-Hospital Staff Members must complete and submit an Event Report as soon as possible.
-Each Department Director/Manager/Supervisor is responsible for reviewing events that occur in their area, assigning severity, documenting the results of the review, and assigning or completing follow-up through the Hospital's Patient Safety Reporting System (PSRS) within 7 calendar days of event notice.
-The Hospital's Patient Safety Officer is responsible for initiating investigation and follow-up as soon as possible after an Event Report is submitted. Investigation and follow-up by the Patient Safety Officer will be completed within twenty-one business days of the time the event is submitted and review, categorization, and final investigation as appropriate for all Event Reports.

The Hospital's Quality and Performance Improvement Plan, effective February 2020, indicated the following:
-The aim of the Quality and Performance Improvement Program is to provide a systematic, collaborative, organization-wide approach to planning, measuring, assessing, and improving performance.
-Staff are empowered to identify and report any known or potential problems and whenever possible, to recommend solutions.
-Staff shall participate in quality/process improvement and patient safety activities.
-Leadership is responsible for communicating feedback and learning from performance improvement activities throughout the Hospital.
-Take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success and track performance to ensure that improvements are sustained.
-Occurrence reporting is a mechanism to allow early intervention to ensure patient safety and trending of important data for preventative purposes.
-The objective of this mechanism is to improve the management of patient care and treatment by assuring that appropriate and immediate intervention occurs for the patient's safety and plans are developed and implemented to prevent recurrences.

1. Patient #1 presented to the Hospital Emergency Department on 1/7/23 and was admitted to the Hospital telemetry unit with weakness and shortness of breath and diagnoses of Congestive Heart Failure (CHF) and atrial fibrillation.

Review of Patient #1's medical record indicated Patient #1 presented to the Hospital Emergency Department with a productive cough with sputum production. The Patient was in acute distress and possible experiencing a CHF exacerbation. Patient #1 required 4 L (Liters) of oxygen to maintain his/her oxygen saturations and was administered intravenous (IV) Lasix (diuretic medication) for fluid overload. Patient #1 was evaluated by cardiology on 1/8/23 at 8:55 A.M.; cardiology recommended IV diuresis, keep the Patient NPO (Nothing by mouth) status for a possible cardioversion (a procedure using quick, low-energy shocks to restore a regular heart rhythm), and pulmonary consult for possible thoracentesis (a procedure to drain fluid from the space around the lungs). On 1/9/23 at 7:12 A.M., Patient #1 was clinically deteriorating, likely requiring BIPAP (bilevel positive airway pressure) with a higher level of care in the CVU/ICU; Patient #1 was presenting with increasing weakness, worsening mental status, and shortness of breath. On 1/9/23 at 9:32 A.M., the Pulmonologist evaluated Patient #1; the Pulmonologist's documentation indicated Patient #1 had worsening hypoxemia (low blood oxygen levels) with hypercarbia (increased blood carbon dioxide (CO2) levels) On 1/9/23 at 9:48 A.M. Patient #1 was evaluated by the Cardiologist who recommended the Patient be transferred to CVU/ICU level of care for close monitoring. On 1/9/23 at 12:22 P.M., the Pulmonologist documented there was no CVU bed available for initiation of Patient #1's BIPAP; Patient #1's blood oxygen levels had decreased from 83% at 2:45 A.M. to 71% at this time. Patient #1 arrived to the ICU/CVU on 1/9/23 at 1:48 P.M. Patient #1 was evaluated by the Critical Care Physician on 1/10/23 at 6:22 A.M.; the Critical Care Physician's documentation indicated the Patient was transferred to the CVU/ICU initially on 1/9/23 for BIPAP, however, ended up being intubated, sedated, and mechanically ventilated and due to desaturation of his/her oxygen levels.

A category F (moderate harm level) incident report dated 1/10/23 for Patient #1 indicated on 1/9/23 at 10:00 A.M., the Patient required an increased level of care and the Cardiologist advised an ICU transfer for Patient #1. The incident report further indicated there was a multi-hour delay in Patient #1's transfer to the ICU resulting in his/her intubation directly caused by the ICU staffing shortages; Patient harm and failure to salvage caused by unsafe Hospital staffing. The incident report indicated this incident was referred to the Director Clinical Quality Improvement. The report failed to indicate any follow up action, comments, or disposition.

Review of the Hospital ICU/Critical Care schedule for 1/9 indicated 3 Registered Nurses (RN) were scheduled for the 7:00 A.M. - 7:00 P.M. shift.

Review of the ICU Daily Census Overview for 1/9/23 indicated the ICU had a total of 12 beds for patient care and 5 out of 12 beds on the ICU were open.

Review of the Hospital ICU Nursing Unit Census dated 1/9/23 indicated the final census for the ICU on 1/9/23 was 9 including Patient #1.

During an interview with the Director of Emergency Services on 3/6/23 at 11:40 A.M., she said patients cannot be transferred to the ICU if there are not enough nurses to meet the state mandated 1:2 RN to patient ratio. She said patients on the ICU can be triaged for a lower level of care and patients who no longer require ICU level of care can be transferred off the unit to allow for ICU admissions. She said patients can be intubated on other units but need to transfer to the ICU for ventilator support.

During an interview with RN #1 on 3/7/23 at 10:40 A.M., she said there have been delays in patient transfers to the ICU; she said sometimes it takes days to transfer a patient requiring ICU level of care to the ICU due to available staffing in the ICU. She said these delays in patient transfers to the ICU have cause patient conditions to decline by the time the transfer to the ICU is completed. She said she is unaware of any responses to incident reports filed in the Hospital for staffing issues.

During an interview with RN #2 on 3/7/23 at 11:04 A.M., she said there are times when beds are open for patients in the ICU, however, patients requiring ICU care cannot transfer to the ICU due to the ICU not having enough staff.

During an interview with RN #3 on 3/7/23 at 11:52 A.M., she said patients requiring transfer to the ICU for increased levels of care frequently have delayed transfers due to the ICU staffing. She said incident reports filed on staffing concerns within the Hospital do not receive follow-up, and often managers do not seem aware of the reports filed.

The Hospital failed to produce any investigation, follow-up action, or any documentation as of 3/6/23 regarding the incident report for Patient #1 filed on 1/10/23 alleging Hospital staffing directly affected the care of the Patient.


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2. Patient #3 was admitted to the hospital on 1/6/23 with diagnoses including syncope and STEMI (ST elevated myocardial infarction).

Review of Patient #3's History and Physical exam note dated 1/6/23 indicated Patient #3 was found to have an inferior wall STEMI upon arrival to the Emergency Department (ED) and that he/she had been sent to the Cath Lab (a specialized area in the hospital where doctors perform tests and advanced cardiac procedures to diagnose and treat cardiovascular disease) after arrival to the hospital for revascularization (a procedure that can restore blood flow in blocked arteries or veins) and that he/she opted to be a full code for now and was being transferred to the Intensive Care Unit (ICU). Review of a Critical Care Progress note dated 1/8/23 indicated an addendum dated 1/9/23 at 3:06 P.M. that Patient #3 had been transferred from the ICU to a telemetry unit that day (a unit where a patient is under constant electronic monitoring).

Review of Patient #3's Discharge/ Transfer Summary dated 1/10/23 indicated on 1/9/23 the patient was moved to the floors for further management, however during the evening the patient was transferred back to the ICU in the setting of worsening hypotension (low blood pressure) that required vasopressors (drugs that induce vasoconstriction and elevate mean arterial pressure). Despite two vasopressors at maximum amount, patient's clinical condition continued to deteriorate. Following worsening bradycardia (low heart rate), patient passed at 4:39 A.M.

A Category I (catastrophic harm) incident report with an event date of 1/9/23 for Patient #3 indicated Patient #3 with complicated IMI developed shock physiology on Monday 1/9. There was a multi-hour delay in transferring the patient to the ICU due to staffing shortages. The patient died 1/10. The chain of events that led to failed salvage of cardiogenic shock includes unsafe staffing in the ICU/CVU (cardiovascular unit). The report further indicated a comment by Nurse Manager #1 that the events were discussed with the nursing supervisor and the incident would be sent to risk management with a referral reason of delay in higher level of care with adverse outcome.

Review of hospital provided patient transfer audit indicated Patient #3 was transferred from the ICU to the 5th floor on 1/9/23 at 11:34 A.M. and a request to transfer Patient #3 from the 5th floor back to the ICU was made on 1/9/23 at 3:06 P.M. (3 hours and 32 minutes after he/she was transferred to the 5th floor). The audit further indicated Patient #3 was not transferred back to the ICU until 1/9/23 at 8:25 P.M. (5 hours and 19 minutes after the request was made).

During an interview on 3/2/23 at 2:17 P.M., Nurse Manager #1 and the Director of Emergency Services said staff generally need orders to transfer to a higher level of care and ICU staff will assess a patient before accepting the patient to the unit. Nurse Manager #1 reviewed the incident report and said she could not remember anything about the incident.

During an interview on 3/6/23 at 8:35 A.M., the Director of Clinical Quality Improvement said that the ICU and CVU (cardiovascular unit) were combined in December 2022 due to staffing issues and that the physical CVU unit was closed and all patients went to the ICU. She said the CVU was the stepdown unit of the ICU. She said the CVU/ICU remained combined from December 2022 into January 2023.

During an interview on 3/6/23 at 2:18 P.M., the Director of Clinical Quality Improvement said she had not yet reviewed the incident report from January for Patient #3 and there had been no follow up or action taken yet for it. The Director of Clinical Quality said that ideally transfer requests will take place within an hour and acknowledged more than 5 hours had elapsed between when staff had requested Patient #3 be transferred back to the ICU and when the transfer occurred. She was unable to say why there was a delay in the transfer.

The Hospital failed to produce any investigation, follow-up action, or any documentation as of 3/6/23 regarding the incident report for Patient #3 filed on 1/10/23 alleging Hospital staffing directly affected the care of the Patient.

3. Patient #7 presented to the Emergency Department on 1/6/23 with altered mental status, shortness of breath and chest pain and subsequently admitted to the hospital on 1/6/23 with diagnoses including cardiomyopathy, atrial fibrillation.

Review of Patient #7's medical record indicated he/she presented to the ED on 1/6/23 with dyspnea (difficulty breathing) and was coughing up blood-tinged thick white sputum and had new leg edema (swelling).

Further review of Patient #7's medical record indicated a cardiology initial consultation note dated 1/6/23: Patient is at high risk for clinical deterioration from withdrawal, possible infection, and/or worsening cardiac function with a history of requiring inotropic support (drugs that help heart muscles beat with more or less power) on several hospitalizations. For each of his/her last 4 hospitalizations he/she has ended up in the intensive care unit with either cardiac arrest or developing the need for inotropic therapy. Given his/her poor physiologic reserve and the likelihood of clinical worsening over the course of his/her hospital stay I think it would be reasonable to admit him/her primarily to the current combined ICU/CVU and considering transitioning to the general telemetry floor if he/she does better than expected. Review of a cardiology addendum to this note dated 1/7/23 at 1:52 P.M. indicated the Patient would ideally best be served on a medical floor in the CVU. Recommendations discussed with hospitalist.

Review of the ED provider chart summary indicated the following:
- An entry on 1/6/23 at 4:43 P.M.: Patient #7 has a history of alcohol use causing nonischemic cardiomyopathy (decreased heart function) and that he/she tends to get cardiac symptoms when he/she has alcohol withdrawal. Cardiology saw Patient #3 and given his/her history suggests placement in the CVU. Because currently CVU is in the ICU, calling the intensivist and they can decide with the hospitalist where to place.
-An entry on 1/6/23 at 5:33 P.M.: ICU team is requesting the ED physician speak to the hospitalist because the Patient will not be physically leaving the department given no beds in the ICU or CVU. Since CVU would normally be managed by the hospitalist anyway, they would like this to happen in the ED.
-An entry on 1/6/23 at 5:56 P.M.: Ultimate disposition pending discussion between ICU team and floor team as we do not have CVU level of care available at this time and there are 2 ICU boarders in the ER already. Discussed with hospitalist who also discussed with ICU physician at this time with the current status will admit to telemetry all parties are understanding and in agreement with this plan of care.

Review of Patient #7's medical progress note dated 1/8/23 indicated: Patient remained boarded in ED as he/she is pending CVU bed.
Patient appears confused and anxious concerning for early alcohol withdrawal. Patient denies shortness of breath, chest pain or abdominal pain.

Review of Patient #7's Service transfer summary dated 1/8/23 indicated he/she was being transferred to the ICU for cardiogenic shock. Further review of Patient #7's medical record indicated on 1/9/23 he/she was being transferred to another hospital for advanced heart failure treatment.

A Category F (moderate harm) incident report with an event date of 1/6/23 indicated the Patient presented to the ER and cardiology advised ICU admission given repeated history of shock physiology with chronic low output state. No ICU beds, patient clinically deteriorates and requires transfer to another hospital for advanced heart failure shock salvage. The patient is never sent to the ICU due to unsafe hospital ICU/ CVU staffing. Delays in care and salvage are a direct result of unsafe staffing. The report status was listed as pending and failed to indicate any follow up action, comments or disposition.

During an interview on 3/6/23 at 3:00 P.M., the Director of Clinical Quality Improvement said there was a period of time when the combined ICU/CVU was tight on staff and there were no beds for triage, meaning there were no patients that could be triaged to a lower level of care to free up beds at a higher level of care. The Director of Clinical Quality Improvement said she was unfamiliar with this Patient's case and the incident report had not yet been looked at and if it had been looked at, she might have answers. She said that the documentation that there were no beds available could have meant there were no physical beds available or there was not enough staff.

The Hospital failed to produce any investigation, follow-up action, or any documentation as of 3/6/23 regarding the incident report for Patient #7 filed on 1/10/23 alleging Hospital staffing directly affected the care of the Patient.

NURSING SERVICES

Tag No.: A0385

1. The Hospital failed to ensure adequate numbers of licensed registered nurses were staffed in the Intensive Care Unit (ICU) to provide nursing care to all patients requiring an ICU level of care with no greater than a 1 Registered Nurse (RN) to 2 patient ratio for 6 Patients (#1, #4, #9, #10, #11, and #14) out of a total sample of 14 Patients. 2. Based on record review and interview, the Hospital failed to ensure licensed nursing staff assessed for self-harm according to the Hospital's policies and procedures for 1 Patients (#6), who was able to take a syringe with medication from a Registered Nurse (RN) and stab his/her own neck, out of a total sample of 14 Patients. 3. Based on record review and interview the Hospital failed to ensure intravenous (IV) Midazolam (a medication used for sedation) was administered as ordered by a physician responsible for the care of one Patient (#8) out of a total sample of 14 Patients.

Refer to tags 0392, 0398, 0405.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

The Hospital failed to ensure adequate numbers of licensed registered nurses were staffed in the Intensive Care Unit (ICU) to provide nursing care to all patients requiring an ICU level of care with no greater than a 1 Registered Nurse (RN) to 2 patient ratio for 6 Patients (#1, #4, #9, #10, #11, and #14) out of a total sample of 14 Patients.

Findings include:

Review of Massachusetts Health Policy Commission 958 CMR 8.00 indicated the following:
(1) In all ICUs, the Patient Assignment for each Staff Nurse shall be one or two ICU Patients depending on the stability of the ICU Patient as assessed pursuant to 958 CMR 8.05.
(2) The maximum Patient Assignment for each Staff Nurse may not exceed two ICU Patients.

The Hospital policy titled "Event Reporting", dated 8/30/18, indicated the following:
-Reportable event means an event that is not consistent with the routine operation of the Hospital or the routine care of a patient or patients. The potential for accident, injury, illness, or property damage referred to as a near miss is sufficient for an event to be considered a Reportable Event.
-Any Hospital Staff who witnesses, discovers, or has direct involvement in and /or knowledge of a reportable event must complete an event report.
-Hospital Staff Members must complete and submit an Event Report as soon as possible.
-Each Department Director/Manager/Supervisor is responsible for reviewing events that occur in their area, assigning severity, documenting the results of the review, and assigning or completing follow-up through the Hospital's Patient Safety Reporting System (PSRS) within 7 calendar days of event notice.
-The Hospital's Patient Safety Officer is responsible for initiating investigation and follow-up as soon as possible after an Event Report is submitted. Investigation and follow-up by the Patient Safety Officer will be completed within twenty-one business days of the time the event is submitted and review, categorization, and final investigation as appropriate for all Event Reports.

Review of the Hospital Staffing Concern incident report dated 1/17/23 indicated on 1/17/23 at 2:00 A.M. 3 RNs were working in the ICU at that time with 6 ICU patients. A Patient (#9) was intubated at 2:00 A.M. and brought to the ICU from the CVU (step down unit). This required a RN to leave the floor for a long time for the intubation. Once Patient #9 arrived to the ICU, the charge RN had 3 patients to care for in the ICU, with 7 Patients total on the ICU for 3 RNs. The Patient developed an acute neurological change and required a STAT head CT (computed tomography) exam, and a RN had to leave the ICU to accompany the Patient to the CT exam. The CT exam showed critical results for the Patient; the Patient required 1:1 nursing care despite only 3 RNs staffed in the ICU for 7 Patients. The incident report failed to indicate any follow up action, comments, or disposition.

Review of the Hospital Staffing Concern incident report dated 1/17/23 indicated on 1/17/23 at 7:00 A.M. the ICU had 7 Patients with 3 RNs working. One RN was required to care for 3 patients (#9, #10, and #14), all of which were intubated and mechanically ventilated. One RN (#6) had to leave the ICU to bring a Patient (#1) to obtain a CT exam and left 2 RNs to care for 6 ICU Patients. The incident report failed to indicate any follow up action, comments, or disposition.

Review of the ICU Daily Census Overview for 1/17/23 indicated 7 Patients were present in the ICU on the overnight into the morning of 1/17/23 and 7 Patients were present in the ICU at the start of the 7:00 A.M. to 7:00 P.M. shift. RN #1 was assigned to 3 Patients (#9, #10, and #14) from 7:00 A.M. until 3:00 P.M. (8 hours), when another RN took over the care of Patient #9. Review of the Nursing Unit Census for the ICU for 1/17/23 indicated 7 Patients were on the ICU.

Review of the employee schedule for the ICU for 1/17/23 indicated 3 RNs were scheduled to work from 7:00 A.M. until 7:00 P.M., with a fourth RN starting work at 3:00 P.M.

Review of the ICU Daily Census Overview for 1/19/23 indicated 6 Patients were present on the ICU at the start of the 7:00 A.M. to 3:00 P.M. shift. RN #4 was assigned to 3 Patients (#1, #10, and #11) and RN #3 was on 1:1 care with Patient #9. RN #1 took over the care of Patient #1 from RN #4 later in the shift. Review of the Nursing Unit Census for the ICU for 1/19/23 indicated 6 Patients were on the ICU including Patient #9 who required 1:1 RN care.

Review of the employee schedule for the ICU for 1/19/23 indicated 3 RNs were scheduled to work from 7:00 A.M. until 7:00 P.M., with a fourth RN (#1) starting work at 3:00 P.M.

During an interview with the Director Clinical Quality Improvement on 3/2/23 at 2:00 P.M., she said any follow up to an incident would be indicated on the incident reports. If there is no follow-up documentation on an incident report, the incident has not been followed-up on.

During an interview with RN #1 on 3/7/23 at 10:40 P.M., she said RN staffing in the ICU has been difficult. She said several staff have left employment at the Hospital and the ICU infrequently receives help from traveler RNs. She said the Travel RNs often have trouble adjusting to the ICU. She said RNs working in the Hospital ICU have been going over the mandated 1 RN to 2 Patient ratio. She said on 1/17/23 she was responsible for the care of 3 Patients in the ICU from 7:00 A.M. to 3:00 P.M, one of whom (Patient #9) required 1:1 RN care based on the ICU acuity tool. She said there have been delays in patient transfers to the ICU; she said sometimes it takes days to transfer a patient requiring ICU level of care to the ICU due to available staffing in the ICU. She said these delays in patient transfers to the ICU have cause patient conditions to decline by the time the transfer to the ICU is completed. She said she is unaware of any responses to incident reports filed in the Hospital for staffing issues.

During an interview with RN #2 on 3/7/23 at 11:04 A.M., she said there are times when beds are open for patients in the ICU, however, patients requiring ICU care cannot transfer to the ICU due to the ICU not having enough staff. She said ICU RN staffing has been difficult; she said she has brought her concerns to leadership before regarding loss of retention of the Hospital RN staff, but nothing is ever done to help with staff retention. She said there have been times when she has taken a third patient on her assignment in the ICU while working as the charge RN as well.

During an interview with RN #3 on 3/7/23 at 11:52 A.M., she said patients requiring transfer to the ICU for increased levels of care frequently have delayed transfers due to the ICU staffing. She said she was the charge nurse on 1/19/23. She said she was caring for Patient #9, who required 1:1 RN care as he/she was an organ donor, and another RN was over the 1 RN to 2 Patient ratio that shift until a nurse came in to take a Patient from her in the afternoon. She said there were two codes called that day, requiring one nurse to leave the ICU for nearly an hour and leaving two RNs over the ratio for ICU care. She said traveler RNs do pick up shifts, but they are oriented for four hours on the ICU. She said the charge RNs often have full assignments but have no relief in duties as the charge RN. She said incident reports filed on staffing concerns within the Hospital do not receive follow-up, and often managers do not seem aware of the reports filed.

During an interview with RN #4 on 3/7/23 at 2:00 P.M., she said the Hospital has been losing veteran RN staff. She said she does not feel the Hospital Leadership has done anything to retain its own staff. She said she worked in the ICU on the 7:00 A.M. to 7:00 P.M. shift on 1/19/23 and she had 3 Patients in her care for at least 3 hours until another RN came in.

During an interview with RN #6 on 3/8/23 at 1:01 P.M., she said the ICU is down to 8 RNs from 34 RNs. She said the Hospital has not done anything to retain its veteran staff. She said the Hospital lacks a resource nurse and the expectation was ICU RNs would respond to rapid responses or code crimsons (patient hemorrhage). She said the staffing for RNs in the ICU has been a challenge. She said she worked on 1/17/23 during the 7:00 A.M. to 7:00 P.M. shift. She said she and RN #1 had to transport a Patient to radiology for a CT exam. She said while her and RN #1 were off the unit, 1 RN was left on the unit with 6 Patients. She said she filed the incident report on 1/17/23 because of the unsafe staffing in the ICU, however, has not heard anything from Hospital Leadership regarding this report or concerns.

The Hospital failed to ensure adequate numbers of licensed registered nurses were staffed in the Intensive Care Unit (ICU) to provide nursing care to all patients requiring an ICU level of care with no greater than a 1 RN to 2 patient ratio. Further, the Hospital failed to investigate and implement any follow-up action regarding the incident reports regarding staffing on 1/17/23, nor provide an acuity tool for the ICU.

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on record review and interview, the Hospital failed to ensure licensed nursing staff assessed for self-harm according to the Hospital's policies and procedures for 1 Patients (#6), who was able to take a syringe with medication from a Registered Nurse (RN) and stab his/her own neck, out of a total sample of 14 Patients.

Findings include:

The Hospital policy titled "Suicide Risk Assessment", undated, indicated the following:
-The purpose of this policy is to describe the process for assessing for risk and developing a plan of care for patients thirteen years of age or older with suicidal/self-harm/harm to others ideation.
-Psychosocial Factors: history of suicide attempt, history of deliberate self-harm, comorbid alcohol and other substance abuse disorders, current or past psychiatric disorders.
-At a minimum all patients aged thirteen years or older entering the Emergency Department for care will be screened.
-The screening is performed as soon as the patient's condition permits.
-All patients, thirteen years of age and older are screened 24 hours from admission and daily thereafter for ongoing self-harm risk as part of the patient's daily psychosocial nursing assessment.
-The registered nurse documents observed behavior and notifies the attending physician if the patient exhibits:
1. Relief seeking behavior (demanding narcotics, requesting IV (intravenous) meds only, hiding syringes)
2. Hopelessness
3. Impulsivity
4. Outbursts
5. Paranoid or psychotic type behaviors.
-Nursing department directors/managers are responsible to:
1. Ensure that all individuals adhere to the requirements of this policy.
2. Implement and ensure procedures are followed at the hospital.
3. Report to the Chief Nursing Officer (CNO) any instance of non-compliance with this policy.

The Hospital policy titled "Event Reporting", dated 8/30/18, indicated the following:
-Reportable event means an event that is not consistent with the routine operation of the Hospital or the routine care of a patient or patients. The potential for accident, injury, illness, or property damage referred to as a near miss is sufficient for an event to be considered a Reportable Event.
-Any Hospital Staff who witnesses, discovers, or has direct involvement in and /or knowledge of a reportable event must complete an event report.
-Hospital Staff Members must complete and submit an Event Report as soon as possible.
-Each Department Director/Manager/Supervisor is responsible for reviewing events that occur in their area, assigning severity, documenting the results of the review, and assigning or completing follow-up through the Hospital's Patient Safety Reporting System (PSRS) within 7 calendar days of event notice.
-The Hospital's Patient Safety Officer is responsible for initiating investigation and follow-up as soon as possible after an Event Report is submitted. Investigation and follow-up by the Patient Safety Officer will be completed within twenty-one business days of the time the event is submitted and review, categorization, and final investigation as appropriate for all Event Reports.

Patient #6 presented to the Hospital Emergency Department on 12/14/22 following a witnessed seizure and was admitted to the telemetry unit with diagnoses including polysubstance abuse and alcohol withdrawal.

Review of Patient #6's medical record indicated Patient #6 presented to the Emergency Department after experiencing alcohol withdrawal syndromes, lost consciousness, fell to the floor, and had convulsions. Patient #6 endorsed his/her last drink was 4 days prior, and he/she drinks half a gallon of whiskey per day. Patient #6 was admitted to telemetry for alcohol withdrawal and medication management. On 12/16/22 at 8:50 P.M., a RN was about to administer intramuscular (IM) Ativan (benzodiazepine medication) 2 mg (milligrams) when Patient #6 asked the RN to administer the medication into the Patient's vein. The RN declined to inject the medication directly into Patient #6's vein; Patient #6 requested to inject the medication into his/her vein him/herself. Patient #6 made this request a few more times, then snatched the syringe from the RN and stuck the needle of the syringe into the right side of his/her neck. A rapid response was called after the event, and Patient #6 was evaluated by a physician. Patient #6 had mild swelling to the right side of his/her neck after the incident without bleeding. Further review of Patient #6's medical record failed to indicate any assessment for self-harm risk was conducted for Patient #6 in the Emergency Department, nor were any assessments for self-harm conducted after the Patient's admission to the telemetry unit until 12/17/22 following the event on 12/16/22.

Review of the Hospital incident report dated 12/17/22 indicated on 12/16/22 at 8:50 P.M. indicated Patient #6 stabbed him/herself in his/her neck with the needle from a syringe containing Ativan. The report further indicated Patient #6 drank the Ativan from the syringe when denied the plunger to the syringe that the RN had maintained control of. The incident report failed to indicate any follow up action, comments, or disposition.

During an interview with the Director Clinical Quality Improvement on 3/2/23 at 2:00 P.M., she said any follow up to an incident would be indicated on the incident reports. If there is no follow-up documentation on an incident report, the incident has not been followed-up on.

During an interview with the Nurse Manager #1 on 3/2/23 at 2:19 P.M., she said she could not recall the incident with Patient #6 on 12/16/22, nor any investigation or follow-up to this event. She said when a staff member enters an incident report into the incident reporting system, she receives an email alert. She said she will review incident report submitted by staff on her unit and will enter her response to an incident by updating the incident report. She also said incident reports can be referred to other managers, directors, or departments through the incident reporting system.

The Hospital failed to ensure nursing staff assessed Patient #6 for self-harm prior to an incident in which the Patient stabbed him/herself in the neck and subsequently failed to ensure the incident was investigated following identification of the event.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on record review and interview the Hospital failed to ensure intravenous (IV) Midazolam (a medication used for sedation) was administered as ordered by a physician responsible for the care of one Patient (#8) out of a total sample of 14 Patients.

Findings include:

The Hospital policy titled "Timely Administration of Scheduled Medications", dated August 2019, indicated the following:
-Drugs and biologicals must be administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care, and accepted standards of practice.
-Audit medical record sample to determine if medication administration conformed to a practitioner's order. Correct medication administration as follows: right patient, right dose, right route, right timing, valid provider order.

The Hospital policy titled "Event Reporting", dated 8/30/18, indicated the following:
-Reportable event means an event that is not consistent with the routine operation of the Hospital or the routine care of a patient or patients. The potential for accident, injury, illness, or property damage referred to as a near miss is sufficient for an event to be considered a Reportable Event.
-Any Hospital Staff who witnesses, discovers, or has direct involvement in and /or knowledge of a reportable event must complete an event report.
-Hospital Staff Members must complete and submit an Event Report as soon as possible.
-Each Department Director/Manager/Supervisor is responsible for reviewing events that occur in their area, assigning severity, documenting the results of the review, and assigning or completing follow-up through the Hospital's Patient Safety Reporting System (PSRS) within 7 calendar days of event notice.
-The Hospital's Patient Safety Officer is responsible for initiating investigation and follow-up as soon as possible after an Event Report is submitted. Investigation and follow-up by the Patient Safety Officer will be completed within twenty-one business days of the time the event is submitted and review, categorization, and final investigation as appropriate for all Event Reports.

Patient #8 was admitted to the Hospital on 11/13/22 with shortness of breath, pneumonia, and urinary tract infection.

Review of Patient #8's medical record indicated Patient #8 presented to the Hospital Emergency Department with a complaint of constant shortness of breath, cough, and nasal congestion. The Patient was placed on 2L (Liters) of oxygen, administered a dose of Ceftriaxone (an antibiotic medication), and admitted to the Hospital. Patient #8's condition was complicated by ARDS (Acute Respiratory Distress Syndrome) and he/she required transfer to the ICU (Intensive Care Unit) on 11/15/22; Patient #8 was intubated and sedated secondary to acute respiratory failure. A Physician entered an order in Patient #8's Electronic Medical Record (EMR) on 12/7/22 for Midazolam 50mg/50ml bag continuous IV infusion. On 12/17/22 at approximately 3:15 A.M., the Registered Nurse (RN #5) caring for Patient #8 observed the IV pump was programmed with the wrong concentration of Midazolam to infuse 50mg/100ml instead of the ordered 50mg/50ml resulting in the Patient receiving double the intended amount; RN #5 documented it appeared the error started between 10:00 A.M., and 12:00 P.M. on 12/16/22, and the Patient was over breathing on the vent. The Physician documented on 12/17/22 at 7:28 A.M. Patient #8 had two overnight episodes of desaturating to 83% oxygen and 89% oxygen.

Review of the dispense log for Patient #8's Midazolam 50mg/50ml bags in December 2022 indicated between 9:01 A.M. on 12/16/22 and 3:32 A.M. on 12/17/22, 3 RNs had collectively dispensed 10 bags of Midazolam 50mg/ml; Further, Patient #8's Administration History Detail indicated 10 corresponding doses of Midazolam 50mg/50ml were administered at the times those bags were dispensed by 3 different RNs.

Review of the Hospital Med-Administering Error incident report dated 12/17/22 indicated on 12/17/22 at 3:15 A.M. RN #5 observed Patient #8 was receiving double the intended dose of Midazolam as the IV pump was programmed with the wrong concentration. RN #5 believed the medication error started between 10:00 A.M. and 12:00 P.M. on 12/16/22. The incident report failed to indicate any follow up action, comments, or disposition.

Review of the Hospital Wrong Quantity/Concentration Quantity incident report dated 12/18/22 indicated on 12/16/22 Patient #8's IV pump malfunctioned and shut off. RN #2 restarted Patient #8's IV pump, but the Pump was programmed with an older concentration of 50mg/100ml instead of the ordered 50mg/50ml. Comments on the incident report indicated RN #2 was distracted while having charge responsibilities and helping a new traveler nurse. The incident report failed to indicate any further follow up or investigation for the medication error.

Review of the Hospital Staffing Issue incident report dated 12/18/22 indicated on 12/16/22 ICU staffing was unsafe; RN #2 was charge on 12/16/22 and was interrupted and pulled of Patient #8's room 9 time by 9:30 A.M., causing a delay in care for the Patient. The report indicated no secretary of aides were available to assist on the ICU that day. Comments on the incident report indicated the ICU is budgeted for a secretary to work 12 hours a day, however, the position as well as positions for aides on the ICU were open at that time. The incident report failed to indicate any further follow up or investigation for the reported unsafe staffing concerns in the ICU.
During an interview with the Director Clinical Quality Improvement on 3/2/23 at 2:00 P.M., she said any follow up to an incident would be indicated on the incident reports. If there is no follow-up documentation on an incident report, the incident has not been followed-up on.

During an interview with RN #2 on 3/7/23 at 11:04 A.M., she said she cared for Patient #8 in December 2022. She said on 12/16/22 she was the charge RN for the ICU on the 7:00 A.M. to 7:00 P.M. shift. She said she was pulled out of Patient #8's room multiple times before 9:00 A.M. She said she was working with a traveler nurse who was not familiar with the Hospital ICU. She said another nurse needed to go home sick and she was attempting to cover that nurse's shift. She said there was no follow up after she reported the event; she reached out to the Hospital's pharmacy after the incident to inform the pharmacist regarding the pre-programmed concentrations on the IV pumps. She said she is not aware of any follow-up action regarding this incident.

The Hospital failed to ensure intravenous (IV) Midazolam was administered as ordered by a physician and failed to investigate a medication error which occurred during two separate shifts on the ICU and under the care of three different RNs.