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Based on document review and interview, it was determined that for 1 of 3 (Pt #1) clinical records of patients who received lithium (mood stabilizer) medication, the Hospital failed to ensure that the patient's medications were properly reconciled and the recommended follow-up was ordered at discharge, per bylaws.

Findings include:

1. The "Medical Staff Rules and Regulations" (dated 5/2024), was reviewed, and included, " ...A physician member of the Medical Staff shall be responsible for the medical care and treatment of each patient in the Hospital ...General Conduct of Care: 3. All previous orders are to be reconciled on admission, discharge and change in level of care ...The attending Medical Staff member is primarily responsible for requesting consultation when indicated and for calling a qualified consultant ..."

2. The Hospital's policy titled, "Medication Reconciliation" (dated 10/4/2022), was reviewed and required, " ...Reconciliation of Home Medications: Upon entry into the organization, nurse or nurse/provider will obtain a complete medication history as possible from the patient/designated patient representative and or transferring facility. The medication history should begin at the point of entry for the patient including the emergency room or any other outpatient area. The nurse shall make every effort to correctly document the name, dose, frequency, route and time of last dose (if known) for each medication ...A provider, preferably the attending provider, will review and reconcile all home medications in the EMR ...Reconciliation of Medications for Inpatient Discharge: The provider must reconcile the current/active medications and the home list ...After reconciliation, nurse provides the patient/and or the family with discharge medications list ...Patient is instructed to take the reconciled medication list to the follow-up visit with the primary care provider ..."

3. The Medical Staff Bylaws: Governance and Organizational Manual (6/25/2020), was reviewed and required, " ...Responsibilities of Medical Staff ...While utilizing clinical privileges, comply with applicable provisions of the Medical Staff Bylaws ...and Hospital policies ...and all applicable Federal and State laws ..."

4. The clinical record for Pt #1 was reviewed on 6/9/2025. Pt #1 presented to the ED (emergency department) on 11/21/2024 from home, due to a fall. Pt #1 was admitted to the Medical/Surgical PCU unit on 11/21/2024. Pt #1 was discharged to a skilled nursing facility on 12/1/2024.

-ED physician note (dated 11/21/2024 at 2:20 PM), included, " ...[Pt #1] with a history of bipolar disorder [mental illness] and hypertension, presenting after a fall ...Despite the patient's unreliable history, an x-ray was performed, revealing a left intertrochanteric [hip] fracture ...The decision to admit the patient was supported by the on-call hospitalist [MD #3], due to the need for surgical intervention and the patient's complex medical history. The patient's bipolar disorder and hypertension were considered in the decision-making process ..."

-Pt #1's home medications were reconciled on admission (11/21/2024), by the registered nurse (E #8) The home medications list included lithium 300 mg daily and 600 mg at night (900 mg per day).

-The physician orders from 11/21/2024-12/1/2024 (PCU unit), were reviewed. The orders from the Hospitalist (MD #3) included:
- Lithium 300 mg (milligrams) BID (twice a day), oral (order date11/21/2024 at 6:11 PM). Pt #1's inpatient medication orders did not include the 600 mg nightly dose, as indicated on the home medication reconciliation list.

-The Hospitalist note, (dated 11/22/2024 at 12:01 PM), documented by the Hospitalist (MD #3), included, "[Pt #1] with a history of schizophrenia [serious mental illness] presenting to the emergency department due to a possible left femoral neck fracture secondary to mechanical fall ...Behavior Health/Psych: Normal mood and affect ...On lithium, Zyprexa and Lexapro [psychotropic medications] ...Active medications: Lithium carbonate 300 mg BID PO [oral] last administered on 11/22/24 at 8:40 [AM] ..."

- Orders by MD #3 (dated 11/22/2024 at 12:12 PM) included Lithium level.

-The Medication Administration Record (MAR) was reviewed from 11/21/2024-12/1/2024 and included documentation that Pt #1 received lithium 300 mg twice a day, as ordered.

-The laboratory results from 11/21/2024-12/1/2024, were reviewed. The lithium level was drawn on 11/22/2024 as ordered. The lithium level was 0.5 (reference range 0.5-1.2). Pt #1's clinical record did not include any subsequent lithium levels after 11/22/2024.

-The Discharge Summary (dated 12/1/2024 at 9:35 AM), documented by the Hospitalist Medical Director (MD #5), included, " ...Discharge diagnosis: Left femoral [thigh bone] neck fracture secondary to mechanical fall ...History of schizophrenia: On lithium Zyprexa and Lexapro [psychotropic medications] ...Patient medically stable for discharge to next level of care pending DON [director of nursing] screening ...Finally discharged to SNF [skilled nursing facility] ...Behavior Health/Psych: Mood normal ...calm and cooperative ..."

-Discharge instructions (dated 12/1/2024) included referrals for follow-up. The referrals included a referral for a psychiatry consult. However, there was no designated time frame for the consult. The instructions indicated that a medication change was made to reflect that the Lithium dose of 600 mg nightly was added back to Pt #1's home medications. However, the discharge instructions lacked instructions or an order for follow-up labs, following the increase of the lithium dose on the day of discharge.

-Pt #1's home medications were reconciled again at discharge (on 12/1/2024) by the discharging Hospitalist (MD #5). Lithium 300 mg daily (AM dose) remained on the home medication list. In addition to the Lithium 300 mg, the Lithium 600 mg nightly dose (from admission home medication list) was added back to the home medication list. Pt #1 had not received the 600 mg dose nightly, during the hospital course (11/21/2024-12/1/2024).

-On 12/6/2024, Pt #1 presented to the ED for a 2nd encounter (5 days after the 12/1/2024 discharge). Pt #1 discharged back to the skilled nursing facility on 12/12/2024.

-The ED provider note on 12/6/2024 at 6:06 PM, included, "[Pt #1] with a past medical history significant for schizophrenia was brought to the Emergency Department by ambulance. The patient presents with altered mental status, having stopped talking yesterday ... [Pt #1] has a recent admission at this facility just over two weeks ago for a hip fracture ...I [MD #6] discussed the Emergency Department work-up and plan of care with the patient's [family member], who is the Power of Attorney (POA). [POA] reported discrepancies in the patient's lithium dosage at the nursing facility, noting that the patient was taking 300 mg in the morning and 600 mg at nighttime, contrary to the hospital records which showed a dosage of 300 mg twice daily ...The patient's medication history, as reported by [POA], revealed a discrepancy in the lithium dosing at the nursing facility, which likely contributed to the elevated lithium levels. This information was crucial in understanding the etiology of the toxicity ...The decision to admit the patient for inpatient care was based on the need for close monitoring and potential further interventions to manage the lithium toxicity and AKI [ acute kidney injury] ...Lithium level 2.5 [high] ..."

-The H & P (dated 12/7/2024 at 6:37 PM), indicated that there was moderate lithium toxicity. The plan was to administer intravenous fluids and daily lithium levels. Lithium was held on admission.

-Pt #1's laboratory results from 12/6/2024-12/12/2024, were reviewed and included frequent lithium level draws. The results included:
- (2.5/high) on 12/6/24; (2.2/high) on 12/7/24; (1.5/high) on 12/8/24; (1.0/within range) on 12/9/24; and (0.6/within range) 12/10/24.

-Discharge Summary (for 2nd encounter), dated 12/12/24 at 12:26 PM, included, " ...Reason for hospitalization: Lithium toxicity causing acute toxic and metabolic encephalopathy [brain dysfunction resulting in change in mental status]. Hospital course. Family met with hospice and signed consents on 12/11 ...Psychiatry is following. Lithium toxicity treated and resolved ...Condition/Disposition: Declining but comfortable. Disposition at discharge SNF on hospice ..."

5. On 6/10/2025 at 10:05 AM, an interview was conducted with the Hospitalist Medical Director (MD #5). MD #5 stated that MD #5 was the discharge physician of Pt #1. MD #5 stated that Pt #1 was discharged to a skilled nursing facility. MD #5 reviewed Pt #1's clinical record and acknowledged that Pt #1 was receiving a lower lithium dose while inpatient (ordered by MD #3). MD #5 stated that MD #5 cannot speak to the reasoning why Pt #1's lithium dose was lowered while inpatient. MD #5 stated that while the patient is in the hospital, there would be a baseline lithium level checked and then a repeat if the patient is displaying signs and symptoms of toxicity with the dosage decrease, or if there is an increase in the dosage. MD #5 stated that the physician does the medication reconciliation at discharge. MD #5 stated that the medication reconciliation includes the review of the patient's home medications and inpatient medications. MD #5 stated that when preparing to discharge Pt #1, MD #5 reviewed Pt #1's medication reconciliation in the computer and discharged Pt #1 based on the home medications that were in the computer versus the inpatient medications. MD #5 stated that both inpatient and home medications should be reviewed when reconciling at discharge. MD #5 stated that with a lithium dose change, there should be follow-up with the psychiatrist after discharge, to see if there needs to be a dose adjustment. MD #5 stated the information of the follow-up date, should be communicated at discharge.

6. On 6/10/2025 at 12:05 PM, a phone interview was conducted with the Hospitalist (MD #3). MD #3 stated that MD #3 was Pt #1's admitting Hospitalist. MD #3 stated that Pt #1 presented to the Hospital after a fall at home. MD #3 stated that Pt #1 had a psychiatric history of schizophrenia and bipolar disorder. MD # stated that Pt #1 was not a good historian due to being developmentally delayed. MD #3 stated that Pt #1 was on lithium at home. MD #3 stated that the medication reconciliation in Pt #1's chart showed that Pt #1 was getting a lithium dose of 300 mg daily and 600 mg at night (900 mg). MD #3 stated that MD #3 changed Pt #1's lithium dose to 300 mg twice a day (total 600 mg) instead the 900 mg to "err on the side of caution." MD #3 stated that MD #3 would rather put the patient on a lower dose than a higher dose. MD #3 stated that generally though, the Hospitalist does not change psychotropic medication doses when a patient is admitted. MD #3 stated that psych (physician) should be consulted for dose changes or recommendations. MD #3 stated that the psychiatrist was not consulted for Pt #1. MD #3 stated that a lithium toxicology level was drawn on Pt #1 on that morning after Pt #1 was admitted (11/22/2024). MD #3 stated that Pt #1's lithium levels were normal. MD #3 stated that there was only one lithium level that was checked on Pt #1 (11/21/24-12/1/24). MD #3 stated that at some point during Pt #1's hospital course, Pt #1's medications must have been verified and this could be why Pt #1's medication dose was changed back at discharge. MD #3 stated that when a patient is admitted, the medication reconciliation is in the computer after the RN, or the MD enters it. MD #3 stated that a patient's medications should be verified if the patient is not sent with actual paperwork that lists current medications. MD #3 stated that best practice when adjusting lithium levels, is to get a repeat toxicology level within 3-5 days and to always follow-up with a provider. MD #3 stated that if a patient is discharged after a dose adjustment, there should be instructions as to when to follow-up and when repeat levels should be drawn. MD #3 stated that MD #3 would put in an order at discharge for the repeat labs.

7. On 6/11/2025 at 9:20 AM, an interview was conducted with a Psychiatrist (MD #8). MD #8 stated that the Hospitalist can call the psychiatrist for consultation at their discretion. MD #8 stated that some Hospitalist may not feel comfortable adjusting or prescribing some of the mood stabilizing psychotropic medications (example Lithium) due to risk of toxicity. MD #8 stated that if they are not comfortable, this when they would reach out to us (psychiatry). MD #8 stated that psychiatry can also be consulted when a patient has acute psychiatric needs or with dose changes of psychotropic medications. MD #8 stated that any time there is a change in the lithium dose, there should be a specified time frame on when to draw a toxicity level. MD #8 stated that the recommended time frame for redrawing the lithium level after a dose change would be one week. MD #8 stated that if the patient is still in-house, then they could draw it then. MD #8 stated that if the dose was changed at discharge, the doctor should put in the order for the lab draw that specifies the time frame when the level should be checked.

Based on document review and interview, it was determined that for 1 of 6 patients' (Pt. #2) clinical records reviewed for patient care, the hospital failed to ensure reporting and following process for managing medication error was completed.

1. On 6/9/2025, the clinical record for Pt. #2 was reviewed. On 4/15/2025, Pt. #2 was admitted to the hospital's comprehensive rehabilitation unit due to deconditioning and weakness. On 4/21/2025, MD #4 documented that apparently, Pt. #2 was receiving crushed version of valproic acid extended release (seizure medication), which should not be given crushed.

2. . On 6/10/2025, the hospital's policy titled, 'Adverse Drug reaction (ADR) and Medication Error Management Policy" (7/2024) was reviewed and included, "Purpose ... to identify, report, respond to, and monitor actual and potential ... medication errors ... Policy ... D. A report on the medication will be documented in the Event Reporting System (ERS). E. Medication events will be reviewed, investigated, and analyzed by designated pharmacy personnel... C. Review of... Medication Errors: 1. Internal... medication errors are reviewed by the pharmacy department, patient safety, as well as any responsible parties (manager/director of department)... Findings from event reviews and corrections to severity of nature classification will be documented in the ERS. 3. The pharmacy department will review and analyze the data over time for significant trends... D... 1. Information regarding significant events should be shared with appropriate hospital staff to educate healthcare [providers on medication safety and ways to prevent future occurrence of similar medication events..."

3. On 6/10/2025 at approximately 12:57 PM, an interview was conducted with MD #4 (Internal Medicine). MD #4 stated, "I know (Pt. #2) for many years. The father was the caregiver. The father said that nurses were giving the valproic medication crushed. When the father said that I informed the charge nurse (E #2/Rehab Registered Nurse)."

4. On 6/10/2025 at approximately 10:00 AM, E #14 (Director of Patient Quality and Patient Safety) verified that there was no incident or follow-up report filed for Pt. #2.

5. On 6/10/2025 at approximately 1:12 PM, an interview was conducted with E #10 (Manager, Pharmacy). When showed MD #4's progress notes on 4/21/2025 at 9:01 PM, E #10 stated that there was a report of apparent medication error. E #10 stated that when this happens, an incident report should be completed. E #10 stated that the nurse manager would then follow-up, and pharmacy will also get notification of the incident. E #10 stated, "Afterwards, the safety committee will discuss, investigate, and identify potential breakdown in the process, e.g., prescribing, transcribing, dispensing, or administering of the medication. A plan will then be developed to address the problem, which could be reeducation of nurses, involvement of information technology, or enhancing awareness by posting memos or signs. E #10 also stated that adverse events and medication errors are tracked and discussed in the safety committee for quality improvement purposes. E #10 stated that E #10 did not receive an incident report regarding Pt. #2.

6. On 6/11/2025 at 10:01 AM, an interview was conducted with E #12 (Chief Nursing Officer/CNO). When a concern for medication error is identified, E #12 stated that an incident report is made and the nurse manager in charge of the unit follows-up. The incident report will then be forwarded to the safety committee to discuss, investigate and develop a correction plan. E #12 stated that the incident report is also forwarded to E #12 for review. When shown MD #4's documentation of apparent medication error on Pt. #2, E #12 stated, "An incident report should have been written. I was not aware of that." E #12 stated that nurses are expected to follow policies concerning patient care. E #12 stated that a correction plan will be developed to address the problem.