F 0760
Ensure that residents are free from significant medication errors.
Level of Harm - Actual harm
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** THE
FOLLOWING DEFICIENCY REPRESENTS AN INCIDENT OF PAST NON-COMPLIANCE THAT WAS
SUBSEQUENTLY CORRECTED PRIOR TO THIS SURVEY.
Residents Affected - Few
Based on record review, manufacturer medication information, and interview the facility failed to ensure
Resident #69 was free from significant medication error.
Actual harm occurred on 07/29/24 when Resident #69 required evaluation and treatment in the emergency
room due to a significant medication error of the resident's Topiramate (anti-epileptic/seizure medication).
The resident had been administered, per the nurse practitioner, greater than three times the recommended
dose of the medication (ordered 100 mg twice a day and received 625 mg twice a day) from 07/24/24 until
07/29/24 when the error was discovered. This affected one resident (#69) of five residents reviewed for
medication administration.
Findings include:
Review of Resident #69's admission orders provided by the family per the Director of Nursing (DON)
revealed a hospital After Visit Summary report dated 09/25/23. The report indicated the resident was
ordered Topiramate 25 milligrams (mg)/milliliter (ml) solution, four ml by mouth two times a day for seizures
(100 mg of Topiramate twice daily).
Review of Resident #69's admission Notice form dated 07/24/24 at 5:00 P.M. revealed the resident was a
respite stay from home and was admitted with spastic cerebral palsy with epilepsy.
Review of Resident #69's medical record revealed the resident was admitted on [DATE] and discharged on
07/30/24 with diagnoses including epilepsy, gastrostomy status and scoliosis.
Review of Resident #69's Discharge Minimum Data Set (MDS) 3.0 assessment dated [DATE] revealed the
resident was rarely/never understood.
Review of Resident #69's physician orders revealed an order dated 07/24/24 (discontinued 07/29/24) for
Topiramate oral solution 25 mg/ml give 25 ml via percutaneous endoscopic gastrostomy (PEG) tube (tube
inserted through the abdominal wall and into the stomach for nutrition, fluids and medications to be
delivered directly into the stomach) two times a day to prevent seizures (625 mg of Topiramate twice daily).
Review of Resident #69's Physician/Nurse Practitioner (NP) Progress Note dated 07/27/24 at 12:04 P.M.
authored by NP #889 revealed Resident #69 had severe developmental delay and was not alert and
oriented. The resident was nonverbal and could not make his needs known. The resident appeared
(continued on next page)
Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that other
safeguards provide sufficient protection to the patients. (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days following the
date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following the date
these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued program participation.
LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER
REPRESENTATIVE'S SIGNATURE
TITLE
(X6) DATE
FORM CMS-2567 (02/99)
Previous Versions Obsolete
Facility ID:
If continuation sheet
Page 1 of 4
Event ID:
365753
Printed: 05/15/2026
Form Approved OMB
No. 0938-0391
Department of Health & Human Services
Centers for Medicare & Medicaid Services
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION
365753
B. Wing
A. Building
(X3) DATE SURVEY
COMPLETED
09/16/2024
NAME OF PROVIDER OR SUPPLIER
STREET ADDRESS, CITY, STATE, ZIP CODE
Royal Oak Nursing & Rehab Ctr
6973 Pearl Rd
Middleburg Heights, OH 44130
For information on the nursing home's plan to correct this deficiency, please contact the nursing home or the state survey agency.
(X4) ID PREFIX TAG
SUMMARY STATEMENT OF DEFICIENCIES
(Each deficiency must be preceded by full regulatory or LSC identifying information)
F 0760
comfortable. The resident's past medial history (PMH) included seizures, scoliosis, PEG tube, asthma, and
unspecified lack of expected normal physiological development in childhood.
Level of Harm - Actual harm
Residents Affected - Few
Review of Resident #69's medication administration records (MARS) and treatment administration records
(TARS) revealed the Topiramate 25 ml via the PEG tube twice daily due at rise and bedtime were
administered at bedtime on 07/24/24, rise and bedtime on 07/25/24, rise and bedtime on 07/26/24, rise and
bedtime on 07/27/24, rise and bedtime on 07/28/24 and rise on 07/29/24 for a total of 10 doses.
Review of Resident #69's progress note dated 07/29/24 at 5:01 P.M. authored by the DON revealed the
resident was sent to the emergency department (ED) for evaluation due to a mediation error regarding the
Topiramate seizure medication. Several attempts were made to contact the resident's mother with the
phone going to voicemail.
Review of Resident #69's After Visit Summary form dated 07/29/24 revealed the resident's reason for visit
was drug overdose and the diagnosis was poisoning by mixed antiepileptics accidental initial encounter.
Review of Resident #69's physician orders revealed an order dated 07/29/24 for Topiramate oral solution 25
mg/ml give four ml via PEG tube two times a day to prevent seizures (100 mg twice daily).
Review of Resident #69's physician orders revealed a new order dated 07/30/24 to hold the Topiramate for
four doses then resume Topiramate 25 mg/ml four ml per PEG tube twice daily.
Review of Resident #69's progress noted dated 07/30/24 at 1:50 A.M. authored by Licensed Practical
Nurse (LPN) #802 revealed the resident returned from the hospital via an ambulance and on a stretcher.
The aunt was notified and the pharmacy stated they would send the new order for the Topiramate seizure
mediation in the night's medication tote.
Review of Resident #69's progress note dated 07/30/24 at 2:16 P.M. authored by LPN #838 revealed a
phone call was received from the NP inquiring on the status of the resident. A new order was received to
hold the Topiramate times four doses then resume at 25 mg/ml give 4 ml per PEG tube twice daily.
Review of Resident #69's progress note dated 07/30/24 at 10:30 P.M. authored by Registered Nurse (RN)
#833 revealed the resident was discharged (home) and a copy of the paperwork was provided to the
mother per request.
Interview on 09/12/24 at 8:21 A.M. with LPN #821 revealed Resident #69 was an evening admission and
she accidentally mixed up the Topiramate order. When questioned, she stated Resident #69's Topiramate
seizure medication was put in the electronic health record (EHR) as the wrong dose and another nurse
caught the error.
Interview on 09/12/24 at 9:28 A.M. with the DON confirmed the significant medication error was identified
on 07/29/24. The DON stated Resident #69's physician order for the Topiramate seizure medication was put
in wrong during the admission process on 07/24/24 and the error was corrected on 07/29/24. The resident
was assessed immediately following discovery of the significant medication error on 07/29/24 with no
adverse outcome including increased seizure activity, convulsions and a change in the resident's vital
signs. The NP was notified who sent the resident to the hospital following
(continued on next page)
FORM CMS-2567 (02/99)
Previous Versions Obsolete
Event ID:
Facility ID:
365753
If continuation sheet
Page 2 of 4
Printed: 05/15/2026
Form Approved OMB
No. 0938-0391
Department of Health & Human Services
Centers for Medicare & Medicaid Services
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION
365753
B. Wing
A. Building
(X3) DATE SURVEY
COMPLETED
09/16/2024
NAME OF PROVIDER OR SUPPLIER
STREET ADDRESS, CITY, STATE, ZIP CODE
Royal Oak Nursing & Rehab Ctr
6973 Pearl Rd
Middleburg Heights, OH 44130
For information on the nursing home's plan to correct this deficiency, please contact the nursing home or the state survey agency.
(X4) ID PREFIX TAG
SUMMARY STATEMENT OF DEFICIENCIES
(Each deficiency must be preceded by full regulatory or LSC identifying information)
F 0760
Level of Harm - Actual harm
Residents Affected - Few
discovery of the significant medication error and the resident's family members were notified of the
significant medication error. The DON stated all other residents were then assessed for significant
medication errors. LPN #821 was immediately provided education on significant medication errors and
putting in orders for new admissions during the admission process. All other nurses were educated on
significant medication errors and putting in orders during the admission process. The DON stated audits for
new admissions were completed daily five times a week to ensure significant medication errors did not
occur again.
Telephone interview on 09/12/24 at 12:39 P.M. with NP #889 indicated she was made aware of Resident
#69's accidental overdose of Topiramate seizure medication. She confirmed the maximum dosage of the
medication was 400 mg per day and the resident received greater than three times the recommended
dosage on the dates noted above. NP #889 stated she had assessed Resident #69 in person on 07/27/24
and denied the resident had a change in condition because of the overdose of the seizure medication
including changes in the resident's vital signs, changes in mentation and increased seizure activity but the
resident was sent to the hospital for monitoring because he had received such a high dose. The NP
confirmed she ordered Topiramate 25 mg/ml four ml twice per day and the facility put in 25 mg/4 ml 25 ml
twice per day in error. NP #889 stated she believed the resident tolerated the overdose because he had
been on the medication for an extended length of time, but the outcome could have been different with a far
more severe outcome including death. NP #889 confirmed she did not catch the inaccurate dose of
Topiramate in the resident's EHR during her visit on 07/27/24 but immediately addressed the overdose on
07/29/24 when she was called by the facility staff.
Review of the manufacturer directions for Topiramate dated 10/2012 revealed the medication was used for
epilepsy with the recommended dose of 400 mg/day in two divided doses. Further review revealed
overdoses of Topiramate had been reported. Signs and symptoms included convulsions, drowsiness,
speech disturbance, blurred vision,, mentation impaired, lethargy, abnormal coordination, stupor,
hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not
severe in most cases, but deaths had been reported after poly/drug overdoses involving Topiramate. In
acute Topiramate overdose, if the ingestion was recent, the stomach should be emptied immediately by
lavage or by induction of emesis. Treatment should be appropriately supportive. Hemodialysis was an
effective means of removing Topiramate from the body.
The deficient practice was corrected on 07/30/24 when the facility implemented the following corrective
actions:
•
On 07/29/24 at approximately 3:00 P.M., Resident #69 was immediately assessed following discovery of the
significant medication error and subsequent overdose of the Topiramate anti-seizure medication.
•
On 07/29/24 at approximately 3:08 P.M., the DON notified NP #889 of Resident #69's Topiramate significant
medication error.
•
On 07/29/24 at 3:45 P.M., NP #889 and LPN #822 sent Resident #69 to the hospital for further
(continued on next page)
FORM CMS-2567 (02/99)
Previous Versions Obsolete
Event ID:
Facility ID:
365753
If continuation sheet
Page 3 of 4
Printed: 05/15/2026
Form Approved OMB
No. 0938-0391
Department of Health & Human Services
Centers for Medicare & Medicaid Services
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION
365753
B. Wing
A. Building
(X3) DATE SURVEY
COMPLETED
09/16/2024
NAME OF PROVIDER OR SUPPLIER
STREET ADDRESS, CITY, STATE, ZIP CODE
Royal Oak Nursing & Rehab Ctr
6973 Pearl Rd
Middleburg Heights, OH 44130
For information on the nursing home's plan to correct this deficiency, please contact the nursing home or the state survey agency.
(X4) ID PREFIX TAG
SUMMARY STATEMENT OF DEFICIENCIES
(Each deficiency must be preceded by full regulatory or LSC identifying information)
F 0760
evaluation.
Level of Harm - Actual harm
•
Residents Affected - Few
On 07/29/24 at approximately 5:01 P.M., the DON notified Resident #69's family members of the
Topiramate significant medication error.
•
On 07/29/24 at approximately 5:00 P.M., the DON provided education to LPN #821 regarding the admission
Order Procedure policy (revised 11/2016), Admission/readmission Chart Review Process policy (revised
03/01/22) and Medication Errors inservice.
•
On 07/29/24 at approximately 6:00 P.M., the DON completed a whole house audit on resident medications
to determine if any other residents had medication errors. No outcomes were identified.
•
On 07/29/24 at 6:00 P.M., the DON implemented a new 24-Hour Admission/Re-Admit Chart Review form to
be completed by all nurses which states once the follow-up had been completed, the audit form would be
maintained in a binder for review by the regional nurse.
•
From 07/29/24 at 4:20 P.M. to 07/30/24 at 8:25 A.M., the DON provided inservice education to LPN #822
regarding the 24-Hour Admission/Re-Admit Chart Review form to be completed by all nurses. The DON
also provided inservice education to an additional 15 LPNs including LPNs #801, #804, #812, #814, #820,
#838, #844, #861, #870, #872, #873, #892, #893, #894, #895 and 3 RN's including RNs #833, #841 and
#875 on on the admission Order policy, Admission/readmission Chart Review Process policy and
Medication Errors Inservice as well as the new 24-Hour Admission/Re-Admit Chart Review form.
•
Beginning 07/30/24, the DON initiated daily audits five times per week (Monday through Friday) of the
24-Hour Admission/Re-Admit Chart Review form to ensure accuracy of medication administration orders.
This deficiency represents non-compliance investigated under Complaint Number OH00156422.
FORM CMS-2567 (02/99)
Previous Versions Obsolete
Event ID:
Facility ID:
365753
If continuation sheet
Page 4 of 4