Bringing transparency to federal inspections
Tag No.: A0115
The Condition of Participation: Patient Rights was out of compliance.
Findings included:
Based on record review and interviews, the Hospital failed to ensure three Patients (#1, 2, and 5) were cared for in a safe environment out of a total sample of 11 patients. Patient #1, who was assessed to be at high risk of self-harm and ordered a constant one-to-one observation due to safety concerns, obtained a razor without staff's approval or knowledge and on 8/14/24 and 9/8/24, deeply cut his/her arm, requiring a transfer to an Acute Care Hospital for sutures for repair of a laceration. Patient #2 was not adequately medically monitored and incorrectly was ordered to be administered two daily doses of Kayexalate (a medication used to lower potassium levels) for a total of 7 days and required a transfer an acute care hospital when he/she was discovered to have hypokalemia (low potassium levels which can cause the risk of cardiac arrhythmias, muscle paralysis, and psychological symptoms) with a critically low potassium of 1.7. Patient #5 was not safely monitored, eloped off a locked unit and assaulted facility staff.
Cross Reference:
482.13(c)(2): Care in a Safe Setting (A0144)
Tag No.: A0144
Based on record review and interviews, the Hospital failed to ensure three Patients (#1, 2, and 5) were cared for in a safe environment out of a total sample of 11 patients. Patient #1, who was assessed to be at high risk of self-harm and ordered a constant one-to-one observation due to safety concerns, obtained a razor without staff's approval or knowledge and on 8/14/24 and 9/8/24, deeply cut his/her arm, requiring a transfer to an Acute Care Hospital for sutures for repair of a laceration. Patient #2 was not adequately medically monitored and incorrectly was ordered to be administered two daily doses of Kayexalate (a medication used to lower potassium levels) for a total of 7 days and required a transfer an acute care hospital when he/she was discovered to have hypokalemia (low potassium levels which can cause the risk of cardiac arrhythmias, muscle paralysis, and psychological symptoms) with a critically low potassium of 1.7. Patient #5 was not safely monitored, eloped off a locked unit and assaulted facility staff.
Findings include:
Review of the Hospital's Policy titled, Serious Incident/Adverse Event Reporting, dated 7/1/22, indicated the purpose was to ensure incidents that affect the health and safety of patient were reported to the appropriate internal and external authorities in a timely manner. The Policy indicated that all serious incidents would have a Root Cause Analysis meeting.
Review of the Hospital's Policy titled, Root Cause Analysis: Intensive Assessment, effective date 4/1/23, indicated the purpose was to understand how and why an sentinel event (a safety event not related to the natural course of the patient's illness or underlining condition) occurred and to develop and implement a corrective action plan prevent the same or similar event from reoccurring.
1. Review of the Hospital's Policy titled, Suicide Prevention Protocol, undated, indicated the Hospital would provide evidence-based screening, assessment, and risk mitigation interventions to mitigate suicide risk. The Policy indicated Hospital leadership would provide a safe environment conductive to quality patient care by creating a climate of continuous quality assurance and performance improvement that would lead to better patient care and outcomes.
Review of the Hospital's Policy titled, Patient Observation Guidelines, effective date June 1992, indicated the purpose was to ensure the safety and wellbeing of patients admitted the Hospital. The Policy defined a constant one-to-one observation as requiring an assigned staff member to be within arm's length of the patient at all times and within a field of vision.
Review of the Hospital's Policy titled, Sharps/Contraband Items, effective date October 2003, indicated that the purpose was to ensure safe and therapeutic milieu by providing a locked, secured place for sharps and/or other contraband items.
Patient #1 was admitted in July 2024 for psychiatric treatment on a secured (locked) unit and diagnosis included Post Traumatic Stress Disorder, Major Depressive Disorder, Bipolar Disorder, Borderline Personality Disorder, and Chronic Suicidality.
Review of Patient #1's Individual Psychotherapy Note, dated 8/14/24 at 3:34 P.M., indicated that Patient #1 was on one-to-one observation and a reduction of items that could be used for self-harm. The Note indicated Patient #1 had three significant self-harm (cutting) events in July 2024 and required sutures [at an Acute Care Hospital]. The Note indicated Patient #1 reported current conflict with a family member and frustration over not having access to personal belongings at the Hospital.
Review of the Department of Public Health Care Facility Reporting System (HCFRS) Report, dated 8/21/24, indicated that Patient #1, who was assessed to be at high risk of self-harm and ordered a constant one-to-one observation by his/her physician due to safety concerns, obtained razor without staff 's approval or knowledge and on 8/14/24 at approximately 10:20 P.M., a Nurse (not assigned the one-to-one observation) saw Patient #1 had deeply cut (approximately seven centimeters in length) his/her arm with a razor, requiring a transfer to an Acute Care Hospital for multilayer sutures. The Report indicated the Hospital's investigation and root cause analysis found staff followed all policies and procedures and Patient #1's adverse event on 8/14/24 was not preventable; therefore, a system wide corrective action plan was not developed and/or implemented to prevent a like occurrence in the future.
Although the Hospital determined the event was not preventable, a review the Hospital's Internal Investigation, Patient #1's medical records, and Hospital policies during the Survey, determined that Patient #1's self-harm event on 8/14/24 was preventable and the Hospital failed to provide Patient #1 with a safe environment. The Hospital failed to ensure staff followed their Sharps Policy when Patient #1 was able to unsafely obtain and razor; additionally, the Hospital failed to ensure staff implemented their Patient Observation Policy when Patient #1 was able to harm him/herself without the one-to-one Observer noticing or intervening on Patient s self-harm event on 8/14/24.
Further review of the Hospital's Internal Investigation indicated there was no documentation to support the Hospital completed a thorough investigation or review of Patient #1's self-harm event on 8/14/24 to include developing and implementing a systemwide corrective action plan to prevent further potential of similar adverse events.
Review of the Department of Public Health Care Facility Reporting System (HCFRS), dated 9/13/24, indicated that Patient #1, who was assessed to be at high risk of self-harm and ordered a constant one-to-one observation by his/her physician due to safety concerns, obtained razor without staff 's approval or knowledge and on 9/8/24 at approximately 9:20 P.M., a Nurse (not assigned the one-to-one observation) saw Patient #1 cut his/her arm approximately 20 centimeters in length and was bleeding profusely, requiring a transfer to an Acute Care Hospital for sutures. The Report indicated Hospital's investigation and root cause analysis determined staff followed all policies and procedures, and Patient #1's adverse event on 9/8/24 was likely preventable with the following corrective action plan recommendations: Obtain new metal detectors, training on use of the metal detectors, correctional style razors, staff training on searches, and review and train staff on performing one-to-one observation, and review applicable policies and clarify and limit the scope of each policy to ease understanding.
Although the Hospital determined at the time of the event staff followed all policies, a review the Hospital's Internal Investigation, Patient #1's medical records, and Hospital policies during the Survey, determined that Patient #1's event on 8/14/24 was preventable Hospital failed to provide Patient #1 with a safe environment. The Hospital failed to ensure staff followed their Sharps Policy when Patient #1 was able to unsafely obtain a razor; additionally, the Hospital failed to ensure staff implemented their Patient Observation Policy when Patient #1 was able to harm him/herself without the one-to-one Observer noticing or intervening on Patient's self-harm event on 9/8/24.
During an interview with Psychiatrist #2, he said he recalled working at the time of Patient #1's event 9/8/24. Psychiatrist #2 said Patient #1 reported being able to cut themselves by using a laptop to shield the one-to-one observers view. Psychiatrist #2 said a one-to-one observer should be within arms reach and able to see the patient's hands and face. Psychiatrist #2 said he has concerns about the event on 9/8/24 as the one-to-one observer did not see Patient #1 beginning to self-harm and intervening during the event.
During an interview with the Chief Quality Officer and the Quality and Safety Lead Nurse on 11/20/24 at 7:50 A.M. and throughout the Survey, indicated the Quality and Safety Department are responsible for the adverse event root cause analysis process and the interdisciplinary treatment team recommends corrective action plan interventions. They said that corrective action plans interventions would be implemented and monitored by the Assistant Director of Nursing with the assistance of unit specific leadership and/or the Education Department, as needed. They said the Quality Department does not have details on whether the corrective action plans for Patient #1's events on 8/14/24 and 9/8/24 were implemented or not.
During an interview with the Assistant Director of Nursing on 11/21/24 at 10:34 A.M., he said there was no documentation to support the Hospital implemented system wide corrective actions in response to Patient #1's self-harm events on 8/14/24 or 9/8/24.
41143
2. Review of the Hospital policy titled, "Medication Reconciliation", dated June 16, 2020, indicated the following:
-Every medication from the pre-admission medication list will be documented on the admission medication reconciliation order sheet. All medication must be reconciled withing 24 hours of admission.
-Any discrepancy between the patient's pre-admission medications and the medications and the medications documented on the admission medication reconciliation order sheet must be resolved immediately.
-When a patient returns to the Hospital from a visit to an outside facility the nurse will review the paperwork for medication reconciliation that documents the medications that the patient received. The clinician will reconcile the medication summary that the patient was transferred out with, the list of current medications, and the medications that will be ordered at the Hospital.
Review of the Hospital policy titled, "Admission Assessment", dated August 1993, indicated the following:
-The Registered Nurse (RN) will fax the physician admission order to the pharmacy, acknowledge the entry in the eMAR, and compare the eMAR orders to the physician's admission order sheets.
Review of the Hospital policy titled, "Processing New and Renewal Orders", dated June 2024, indicated the following:
-For all new orders a pharmacist shall review the prescriber's original order, or a direct
copy and conduct a prospective drug utilization review before the initial dose is dispensed.
Patient #2 was admitted to the Hospital's psychiatric service on 6/20/24 following an acute care hospitalization for pneumonia, hyperkalemia (high potassium levels), and an acute kidney injury.
Review of Patient #2's medical record indicated the Patient was discharged from the acute care hospital with recommendations for the Patient to be administered 40mg of furosemide (a loop diuretic medication which can also lower potassium) by mouth daily and for 30 g (grams) of sodium polystyrene (kayexalate) by mouth twice daily for 2 doses only. Patient #2's potassium level obtained on 6/19 at the acute care hospital was 4.0 and within normal limits. Patient #2's admission medication reconciliation order sheet completed by Psychiatrist #1 on 6/20/24 indicated sodium polystyrene 30 gram by mouth twice daily was ordered for Patient #2 for an indication of hyperkalemia with no stop date on the order; the admission medication reconciliation order sheet was also signed by RN #1 on 6/20/24 and signed by another RN on 6/21/24 as verified during 24-hour order checks. Patient #2's blood chemistry was obtained on 6/21/24 at 7:10 A.M. and his/her potassium level was 4.1 and within normal range. Psychiatrist #3 performed a History and Physical assessment on Patient #2 on 6/21/24 at 8:54 A.M. and the assessment indicated Patient #2 has a history of hyperkalemia but failed to indicate review of the Patient's blood chemistry of 4.1 on 6/21/24. Patient #2's history and physical assessment also indicated medicine will complete a medical problem list for Patient #2. On 6/27/24, Patient #2 refused breakfast and lunch, was refusing fluids, and was found to have a critically low potassium level of 1.7; Patient #2 was transferred to an acute care hospital emergency department for hypokalemia.
Further review of Patient #2's medical record failed to indicate any progress notes from a medical service provider from 6/20/27 until Patient #2's transfer out of the Hospital on 6/27/24. Patient #2's medical record failed to indicate any acknowledgement of the blood chemistry lab with a normal potassium level performed on 6/21/24 for Patient #2 despite being actively treated with kayexalate with an indication for hyperkalemia.
During an interview with the Pharmacy Quality Assurance and Medication Safety Manager on 11/18/24 at 3:00 P.M., she said she participated in the Root Cause Analysis (RCA) for the review of Patient #2's hypokalemia from June 2024. She said Patient #2 was ordered for kayexalate 30g twice daily by mouth without a stop date. She said all patient admission medication orders are received by fax via paper form to the pharmacy. She said every medication ordered must be reviewed and verified by a pharmacist, however, was unable to explain the criteria for drug utilization review. She said upon verification and review of admission orders by a pharmacist, the pharmacist will then enter the medication orders into the Electronic Medical Record (EMR) for administration. She said she was not sure if the pharmacist reviewed Patient #2's laboratory data, which indicated a normal potassium level and not hyperkalemia, from the acute care hospital prior to verifying the kayexalate for an indication of hyperkalemia. She said the drug references utilized by the pharmacy staff indicated the dosage of the kayexalate order was appropriate, however, the duration was not specified in the drug references. She said the pharmacy has implemented a hard stop of 72 hours for kayexalate orders in the EMR, but it was not implemented for any other medications.
During an interview with the Chief Medical Officer on 11/19/24 at 9:00 A.M., he said he reviewed Patient #2's case and participated in the RCA. He said Patient #2 discharged from the acute care hospital on 6/20/24 with an order for kayexalate 30g for only two doses, however, it was ordered indefinitely. He said two issues with the Hospital's medication reconciliation process exist, the EMR is poor for ordering and the physicians are not questioning medication orders. He said the medical provider responsible for a patient's care is responsible for reviewing any lab results for a patient and should acknowledge the lab results in the patient's medical record. He said going forward all medically complex psychiatric patients admitted to the Hospital must have a medical consult on admission. He said Patient #2's hypokalemic event was avoidable, and the pharmacy did not catch the problem with the duration of the kayexalate order for Patient #2 on review. He said all kayexalate orders now drop off after 72 hours as a hard stop; he said he is still going to meet with the pharmacy team next month to review other medication which should require hard stops when ordered for patients.
During an interview with Psychiatrist #3 on 11/19/24 at 11:00 A.M., he said he readmitted Patient #2 from the acute care hospital. He said patients will come from acute care hospitals with a printed medication list and admission orders for the Hospital will be copied from that list. He said he ordered labs to be drawn on Patient #2 when he admitted the Patient and notified the medical Doctor on Call (DOC) for follow up. He said he considered ordering serial potassium levels to be obtained on Patient #2 but did not want to overstep the medical service. He was unable to speak to a process of all medically complex patients having medical consults when admitted to the Hospital.
During an interview with Psychiatric Nurse Practitioner (NP) #1 on 11/19/24 at 12:10 P.M., she said the psychiatric service performs the readmissions for patients being admitted to the psychiatric units. She said the psychiatric service reviews the patients' psychiatric medications during their inpatient stay. She said the medical service reviews laboratory data for patients in the inpatient psychiatric units. She said discussions have occurred on placing medical consultation orders/requests on medically complex psychiatric patients, but that function was just added to the Hospital EMR, and discussions are still ongoing of when this order needs to be placed.
During an interview with RN #1 on 11/19/24 at 2:20 P.M., she said during a patient's admission, two RNs will verify the admission medication reconciliation order sheet and the orders entered in the patient's EMR match. She did not remember the details of Patient #2's inpatient hospitalization in June 2024. She did not recall any changes made around medication reconciliation or Hospital policy since June 2024.
The Hospital failed to ensure Patient #2 was medically monitored and the Patient subsequently experienced critically low potassium/hypokalemia and required a transfer to an acute care hospital for care.
43882
3. Review of Facility policy titled, "Privileges and Passes" review date 5/2024 included the following:
- Restrict to Unit (RTU) must stay on the unit unless otherwise specified.
- Secure Supervised (Secure Fresh Air) provides a secure area with a specialized procedure in order to provide outdoor access/fresh air that is available for patients who are otherwise unable to go outside of locked areas.
Review of Patient #5 ' s medical record indicated Patient #5 was admitted to the Facility on 9/13/24. Patient #5 had a physician order for 15-minute checks from 9/13/24 to 9/20/24. An admission order sheet dated 9/13/24 indicated an order to Restrict to Unit with Secure Fresh Air only.
Review of a Nursing Note dated 10/10/24 indicated Patient #5 attempted to leave the unit prior to Secure Fresh Airtime at 9:00 A.M. and was redirected. Patient #5 was then unable to be found during checks and a Code Grey was initiated at 9:09 A.M. and 9:17 A.M. Patient #5 physically assaulted two staff members while they were trying to secure the basement and then Patient #5 eloped from the building. Patient #5 was found by police at 10:07 A.M. off Hospital property.
Review of the Root Cause Analysis post event staff members identified that Patient #5 was likely able to exit the unit as someone was either entering or exiting.
During an interview with the Quality and Safety Lead Nurse on 11/19/24 at 11:09 A.M., he said a Root Cause Analysis meeting took place regarding the event on 10/10/24 but he was unsure if any corrective actions were put into place following Patient #5 ' s elopement.
During an interview with Assistant Director of Nursing on 11/20/24 at 10:34 A.M., he said staff is educated on the appropriate way, according to Hospital procedures, to make sure doors on locked units were closed completely. He said no official staff education was completed after Patient #5 eloped from the Facility.
The hospital failed to ensure Patient #5 safety was maintained allowing the patient to elope from the secured (locked) unit, physically assault two staff members and then eloped the building and off Hospital property