Morris Hospital & Healthcare Centers

“PHARMACIST RESPONSIBILITIES CFR(s): 482.25(a)(1) [§482.25 Condition of Participation: Pharmaceutical Services The hospital.... must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision.... §482.25(a)(1) - A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. This Standard is not met as evidenced by: 40079 Based on document review and interview, it was determined that for 1 of 10 patients’ (Pt. #1) clinical records reviewed for medication reconciliation, the hospital failed to ensure that the process for verification and reconciliation was followed as required. Findings include: 1. The hospital’s policy titled, “Medication Reconciliation” (effective 07/23/24) was reviewed and required, “This process entails verification, clarification and reconciliation of medication orders through the generation of current home medications lists. Inpatients ... shall have all home medication orders reconciled by the physician within 24 hours of arrival to the unit. Admission Guidelines: 1. Upon admission, the pharmacist, pharmacy technician, or registered nurse (RN) shall obtain a list of home medications. Sources of information may include but are not limited to: a. Patient; b. Family ... d. Hospital records of previous admissions; e. Patient’s physician office records; f. Patient’s Pharmacy ... 3. Upon admission, the pharmacist, pharmacy technician, or RN shall: a. Update the medication list; b. Add last dose taken times ... 5. The pharmacist shall review the final home medication list. 6. The physician will reconcile all the patient’s medications and determine which medications are to be ordered, discontinued, or held during their current hospitalization ...” 2. The hospital’s “Job Description for Pharmacist” (revised 02/26/2021) was reviewed and required, “Pharmacist Job Relationship: Responsible To: Pharmacy Supervisor, Pharmacy Manager. Description of Position: A person who is responsible for order entry, drug utilization ... preparing and dispensing medications, verification of medications ... communication with nursing/physicians.” 3. The hospital provided a document titled “Medication Reconciliation” (revised 05/18/25) that was reviewed and required, “ ... Notify the patient’s practitioner of any changes in the patient’s medication regimen that you found during the reconciliation process. Include any medications that you added or removed as well as any dosage or route changes.” 4. The clinical record for Pt. #1 was reviewed on 05/02/2026. Pt. #1 presented to the hospital’s Emergency Department (ED) on 03/06/2026 and admitted to inpatient unit. The clinical record included the following: -Emergency Department Note, 03/06/2026 at 6:09 PM, “(Pt. #1’s Parent) at bedside providing independent history. (Pt. #1) presents to the emergency department with (parent), notes (Pt. #1) has had cough congestion, runny nose for the past several days, worse on the day of being seen ... “ -Home Medications Reconciliation Report (E #2/Pharmacist) dated 03/06/2026 at 22:18 (10:18 PM), “Pharmacy Review-Admission. Information Collected by/Medications Entered by/Confirmed by/Medication Reconciliation Status Completed by (Name of Pharmacist/E #2) Reviewed Home Medications with parents. Active Medications: clobazam (long-acting adjunct medication to treat seizures) 2.5 mg/mL (milligram/milliliter) oral suspension 5 mg PO (by mouth) Q12H (every 12 hours) for seizures ...” Audit for trail for clobazam indicated that the medications were verified by E #2 on 03/06/2026 at 6:15 PM and 10:13 PM. However, (E #2) entered the medication as “Clobazam 3.5mg/1.4mL Q12H.” -Physician’s order (MD #1), 03/07/2026, 10:57 AM, “Clobazam suspension 3.5 mg (1.4 mL) PO Q12H (SCH/scheduled) Start Date 03/07/26 - 1800 (6:00 PM) Non-formulary Medication (Home Med/Patient Own Medication)” The medication order trail indicated that on 03/07/26 at 10:57 AM the medication was verified by (MD #1). -Medication Administration Record (MAR) dated 03/07/2026 at 6:00 AM to 03/12/2026 at 12:00 PM, was reviewed and indicated that Pt. #1 was administered Clobazam 3.5mg/1.4 mL every 12 hours, as ordered. The MAR indicated that the medication was given at on time. 5. The Incident Summary Report dated 03/22/2026 was reviewed and included the following, “Encounter Data; Start Date 03/07/2026 at 10:17 PM, Location: Emergency Department; Type: Med (medication)-wrong dose. Significance: no harm: Event reached patient/Outcome: No adverse outcome ... (Parent for Pt. #1) called post discharge because noted the patient’s home pharmacy bottle had a label on it still from the hospital and the dosing was not correct. 3.5mg (1.4ml) q (every) 12 hours entered on home med [medication] list 09/2025 and reviewed on admission. External history has correct dose of 5mg (2ml). (Parent) notes the patient has never been on 3.5 mg (1.4ml). This dose was continued and administered from home medication supply from 3/9 through discharge on 3/12 ... Med Error Stage in process; Action Plan/Pharmacist Comments: Med communication discussed with individuals involved. Error upon admission medication reconciliation. Clobazam entered as 3.5mg upon admission and should have been 5mg.” 6. The hospital provided emails dated 04/02/2026 and 04/06/2026, from the Supervisor of Pharmacy (E #7) addressed to the two Pharmacists (E #2 and E#6) who did the medication reconciliation. The emails included the following: “An RDE (event reporting system) was entered for (Pt. #1). The parent stated clobazam was brought in from home and the rx (prescription) label said to give 2mL every 12 hours. Upon admission the clobazam was entered as 1.4mL every 12 hours. Can you provide any input regarding this RDE? Response from (E #2) I do remember this patient and (E #2) checked the doses with the parents more than once before (E #2) entered them into the system. I don’t remember any of the liquid meds being even mL amounts such as 2mL. They did not have the bottles with them when I did the history, so I went from what they told me and again, I remember double checking all 3 liquids with the parents before I left the ED. The bottles were brought in the next day after I left so I am not sure whether or not they were checked against what I entered ... Response from (E #6), Yes, I remember this well. Upon verifying the home medication, I did notice the dose and bottle did not match so I went to (Pt. #1’s) chart and saw that the med reconciliation was completed by a pharmacist (E #2) and it stated they spoke to the parents. I also noticed a note from January that said ‘clobazam overdose’. Both of these leads me (E #6) to believe it was possible that the dose was lower than what was filled by the outpatient pharmacy if they were titrating (Pt. #1’s) dose.” 7. An interview was conducted with the Pharmacist (E #2) 5/04/2026 at 9:15 AM. E #2 stated that when conducting a medication reconciliation, the pharmacist will use the external medicine history that is incorporated which shows the most current medications that were filled by the patient’s external pharmacy. The list of home medications is reviewed with the patient or guardian to ensure the profile is current and accurate. If the patient/caregiver has a medication list we can use it and go over each medication to confirm their current dose, frequency, and list time taken. If the patient is unsure of the dose, we ask to speak to someone that can confirm the medication and dose, or we ask them to bring medication bottles from home. E #2 stated that they can call the external pharmacy to confirm medications if the patient is unable to verify. For (Pt. #1) the parents were present during the admission and initially they could not agree on the dose of clobazam, (E #2) went over list of medications at least three times due to their uncertainty of the actual dose. E #2 stated that the parents agreed with the list of home medications that E #2 presented but does not recall the actual doses reviewed with them. E #2 stated that for pediatric patients the medications are verified twice before being dispensed. In this case the 2nd verification by the pharmacist (E #6) questioned the home dose once the parent brought in their home medication which was different than what was ordered. (E #6) reviewed information from initial pharmacy verification done by (E #2) and reviewed the medicine history from a previous admission in January 2026, which indicated that during a previous admission the dose had been decreased to 1.4 mL due to high levels of the medication and went with the decision to use the medication dose of 1.4 mL that was prescribed on previous admission. 8. An interview was conducted with the Pharmacist (E #6) on 05/04/2026 at 10:10 AM. E #6 stated that for medication reconciliation pharmacy has 24 hours to contact the patient or their caregiver to complete a medication reconciliation to get the most current and accurate medication name, dose, route, last time taken and their pharmacy information. We can use an external pharmacy list, previous admission discharge med list, or combination of all the above. E #6 stated that when E #6 was doing a second reconciliation, (Pt. #1’s) parent had brought the medication bottles from home because they were non-formulary, one of the medications (clobazam) had a different dose on the bottle that did not match with the inpatient orders. E #6 looked at (Pt. #1’s) chart to compare the external med history to see if it matched what was entered for inpatient medications, E #6 saw that pharmacist (E #2) had done a medication reconciliation with the parents the night before while in the ED. E #6 reviewed the visit history and there was a previous admission with a progress note from January that indicated due to blood work showing high levels of clobazam the dose was decreased to 3.5mg bid (twice a day) and (Pt. #1) was discharged/transferred to another hospital on this dose. This information made sense that dose would be different than what the home medication showed. E #6 stated that E #6 did not contact the physician to discuss the dose discrepancy and did not call the parent to verify the dose.”

“PHARMACY: REPORTING ADVERSE EVENTS CFR(s): 482.25(b)(6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’ s quality assessment and performance improvement program. This Standard is not met as evidenced by: 40079 Based on document review and interview, it was determined that for 1 of 3 (Pt. #1) medication error reports reviewed, the hospital failed to ensure that the process for managing a report of a medication error was followed as required. Findings include: 1. The hospital’s policy titled, “Medication Error Reporting” (effective 8/28/25) was reviewed and required, “A. Types of medication errors include, but are not limited to: 1. Wrong dose, route, or time ... 3. Report the medication error or adverse drug reaction by submitting a report into the remote data entry (RDE-event reporting system) on the hospital internet ... 4. Investigation breakdowns in processes that contributed to the medication error. C. Appropriate documentation and follow-up shall occur by the department director/manager/supervisor ... E. Summary data and trend analysis shall be performed by the Director of Pharmacy ... F. Summary of medication error data and discussion shall be presented to the Pharmacy and therapeutics committee ...” 2. The clinical record for Pt. #1 was reviewed on 05/02/2026. Pt. #1 presented to the hospital’s Emergency Department (ED) on 03/06/2026 and admitted to inpatient unit. The clinical record included the following: -Emergency Department Note, 03/06/2026 at 6:09 PM, “(Pt. #1’s parent) at bedside providing independent history. (Pt. #1) presents to the emergency department with (parent), notes (Pt. #1) has had cough congestion, runny nose for the past several days, worse on the day of being seen ... decreased appetite and decreased fluid intake and very fussy ...” -Home Medications Reconciliation Report (E #2/Pharmacist) dated 03/06/2026 at 22:18 (10:18 PM), “Pharmacy Review-Admission. Information Collected by/Medications Entered by/Confirmed by/Medication Reconciliation Status Completed by (Name of Pharmacist E #2) Reviewed Home Medications with parents. Active Medications: clobazam (long-acting adjunct mediation to treat seizures) 2.5mg/mL (milligrams/milliliter) oral suspension 5mg PO (by mouth) Q12H (every 12 hours) for seizures.” Audit for trail for clobazam indicated that the medications were verified by E #2 on 03/06/2026 at 6:15 PM and 10:13 PM. However, (E #2) entered clobazam 3.5mg/1.4mL every 12 hours. -Physician’s order (MD #1), 03/07/2026, 10:57 AM, “Clobazam suspension 3.5 mg (1.4 mL) PO Q12H (SCH/scheduled) Start Date 03/07/26 - 1800 (6:00 PM) Non-formulary Medication (Home Med/Patient Own Medication)” The medication order trail indicated that on 03/07/26 at 10:57 AM the medication was verified by (MD #1). -Medication Administration Record (MAR) dated 03/07/2026 at 6:00 AM to 03/12/2026 at 12:00 PM, was reviewed and indicated that Pt. #1 was administered Clobazam 3.5mg/1.4 mL every 12 hours, as ordered. The MAR indicated that the medication was given on time. See incident summary dated 4/01/2026. -Discharge Instructions/Patient Signature Page, 03/12/2026 at 12:24 PM, “The above-named patient (Pt. #1) and/or guardian has received the following: Follow-ups ... Prescriptions ... Home Medication List (including new medications prescribed) ... These are your current medications to keep taking at home. Clobazam 3.5 mg (1.4mL) oral every 12 hours, last taken 3/12/26 at 6:27 AM ...” The discharge instructions are signed by (Pt. #1’s) mother and the pharmacist (E#9). 3. Incident Summary Report dated 03/22/2026 was reviewed and included the following, “Encounter Data; Start Date 03/07/2026 at 10:17 PM, Location: Emergency Department; Type: Med [medication]-wrong dose. Significance: no harm: Event reached patient/Outcome: No adverse outcome ... (Parent for Pt. #1) called post discharge because noted the patient’s home pharmacy bottle had a label on it still from the hospital and the dosing was not correct. 3.5mg (1.4ml) q (every) 12 hours entered on home med list 09/2025 and reviewed on admission. External history has correct dose of 5mg (2ml). (Parent) notes the patient has never been on 3.5 mg (1.4ml). This dose was continued and administered form home medication supply from 3/9 through discharge on 3/12 ... Med Error Stage in process; Action Plan/Pharmacist Comments: Med communication discussed with individuals involved. Error upon admission medication reconciliation. Clobazam entered as 3.5mg upon admission and should have been 5mg.” 4. Incident Summary Report dated 04/01/2026 was reviewed and included the following: Encounter Date: 03/13/2026; Location: 2-East Med/Surgical Unit; Type: Med-dose delay; Significance: No harm: Event reached patient ... Received call from (Pt. #1’s parent) who stated that patient had timed medications for seizures and while (Pt. #1) was with us we did not give medications on time. They also turned them into pharmacy since they brought them from home and found out that they were only dispensing 1.4 ml of medicine instead of the 2.0 ml that was supposed to be. (Parent) states spoke with pharmacy and (name of pharmacy technician) ... but they did not have an answer on why they were dispensing the wrong amount ... 04/02/2026, Please review, was this a seizure medication on our time critical med list? Answer: This medication is for seizures but not on our formulary so will not be listed on the critical time policy. 04/06/2026, Home medication list showed 5 mg however, provider ordered 3.5mg during hospitalization-unsure if this was his intention or error. Patient received 10 doses of medication while here and all but one were administered within appropriate time-frame, one was 9 minutes overdue. Discussed with individuals involved.” 5. The hospital provided emails dated 04/02/2026 and 04/06/2026, from the Supervisor of Pharmacy (E #7) addressed to the two Pharmacists (E #2 and E#6) who did the medication reconciliation. The emails included the following: “An RDE was entered for (Pt. #1). The parent stated clobazam was brought in from home and the rx (prescription) label said to give 2mL every 12 hours. Upon admission the clobazam was entered as 1.4mL every 12 hours. Can you provide any input regarding this RDE? Response from (E #2) I do remember this patient and (E #2) checked the doses with the parents more than once before (E #2) entered them into the system. I don’t remember any of the liquid meds being even mL amounts such as 2mL. They did not have the bottles with them when I did the history, so I went from what they told me and again, I remember double checking all 3 liquids with the parents before I left the ED. The bottles were brought in the next day after I left so I am not sure whether or not they were checked against what I entered ... Response from (E #6), Yes, I remember this well. Upon verifying the home medication, I did notice the dose and bottle did not match so I went to (Pt. #1’s) chart and saw that the med reconciliation was completed by a pharmacist (E #2) and it stated they spoke to the parents. I also noticed a note from January that said ‘clobazam overdose’. Both of these leads me (E #6) to believe it was possible that the dose was lower than what was filled by the outpatient pharmacy if they were titrating (Pt. #1’s) dose.” 6. An interview was conducted with the Pharmacist (E #6) on 05/04/2026 at 10:10 AM... E #6 stated that about a month ago their supervisor asked if (E #6) recalled (Pt. #1) and had questions about the medication dose and what had occurred. E #6 explained to (E #7/Pharmacy Supervisor) that E #6 saw a discrepancy in home dose, and E #6 did not contact the physician or (Pt. #1’s) parent to verify the dose, E #6 made the decision to go off the chart history and first pharmacy reconciliation. E #6 is not aware of any further investigation regarding this medication error. 7. Interviews were conducted with the Pharmacy Supervisor (E #7) and the Director of Pharmacy (E #3) on 05/04/2026 at 12:45 PM. E #7 stated that all RDE related to medication errors or adverse events are reviewed by (E #7). E #7 recalls reviewing (Pt. #1’s) RDE and discussing this incident with the staff involved (E #2 and E #6). E #7 stated that E #7 reviewed (Pt. #1’s) chart to see if there were any issues or potential errors and to see who completed the medication reconciliations. In this case the admission was done by the overnight pharmacist (E #2) and a second reconciliation was done the next morning by (E #6). E #7 stated that E #7 trusts that the pharmacist did their job, and the summation of the investigation was that they had correct dose, E #7 did not see that anything was done incorrectly aside from some miscommunication. E #7 stated that while (Pt. #1) was inpatient, they were seizure free. E #7 did not contact the parent or the ordering physician to confirm what the actual dose should have been or what dose (Pt. #1) is currently taking. E #7 stated that another pharmacy staff spoke with (Pt. #1’s) parent, however they are unsure what was discussed. E #3 stated that E #3 was not involved in the investigation of this incident, since it was handled by (E #7). E #3 stated that since Pt #1’s incident, the pharmacists and technicians have been reeducated and reminded during huddles about importance of appropriate verification of medication reconciliation and following the process for investigating medication events/errors, E#3 stated that the pharmacy will also contact Pt. #1’s attending physician and follow the process for reporting and resolving medication error. E #3 added that there has not been any similar incident since Pt. #1 and will continue to monitor and audit medication reconciliation conducted by the pharmacists and technicians.”