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Based on record review, staff interviews and review of facility provided adverse patient event internal investigation and action plan documentation, the facility failed to implement actions and mechanisms to prevent potential reoccurrence. Record reviews revealed 1 of 3 sampled patients (Patient #2) failed to have medication reconciliation with the medication list provided by the patient's transferring facility performed accurately. This failure resulted in Patient 2 failing to receive 2 of his/her normal seizure control medications and an incorrect (lower) dose of a third seizure control medication for 2.5 days, causing the patient to have additional seizures and an increased length of stay. After discovery of the error on 2/9/13, by a physician, the facility failed to incorporate education to all inpatient areas to ensure the safety of all patients. The hospital implemented changes on the 4th floor where the error occurred related to nursing and made changes in the pharmacy. However, the facility did not perform quality assurance data collection to ensure the plan implemented to prevent medication reconciliation errors was effective. After conferring with the Centers for Medicare and Medicaid Services (CMS) at 3:10 PM on 4/2/13 it was determined that Immediate Jeopardy (IJ) conditions existed at the hospital since the discovery of the error on 2/9/13. On 4/2/13 the facility had a total of 10 current inpatients who required medication reconciliation with the transferring facility medication records. All 10 of these patients were at potential risk of failing to receive required medications representing a serious and immediate threat to patient safety. The hospital administrator was notified on 4/2/13 at 4:00 PM that IJ conditions were found in the facility. The cumulative effect of the facility failure to ensure the action plans were implemented in all inpatient areas and failure to perform data collection to ensure the plans were effective at reducing the reconciliation medication errors led to a determination the Condition of Participation: Quality Assessment and Performance Improvement Program was not met. See A 0283 and A 0286 for additional information.

Based on record review, staff interviews and review of facility provided adverse patient event internal investigation and action plan documentation, the facility failed to implement actions and mechanisms to prevent potential reoccurrence. Record reviews revealed 1 of 3 sampled patients (Patient #2) failed to have medication reconciliation with the medication list provided by the patient's transferring facility performed accurately. This failure resulted in Patient 2 failing to receive 2 of his/her normal seizure control medications and an incorrect (lower) dose of a third seizure control medication for 2.5 days, causing the patient to have additional seizures and an increased length of stay. After discovery of the error on 2/9/13, by a physician, the facility failed to incorporate education to all inpatient areas to ensure the safety of all patients. The hospital implemented changes on the 4 th floor where the error occurred for nursing and changes in the pharmacy. However, the facility did not perform quality assurance data collection to ensure the plan implemented to prevent medication reconciliation errors was effective. On 4/2/13, after conferring with Centers for Medicare and Medicaid Services (CMS) at 3:10 PM it was determined that Immediate Jeopardy (IJ) conditions existed at the hospital since the discovery of the error on 2/9/13. On 4/2/13 the facility had a total of 10 current inpatients who required medication reconciliation with the transferring facility records. All 10 of these patients were at potential risk of failing to receive required medications representing a serious and immediate threat to patient safety. The hospital administrator was notified on 4/2/13 at 4:00 PM that IJ conditions were found in the facility. The facility census was 75. The total sample was 3. Findings are:

A. Record review of Patient 2's medical record found the patient was admitted through the emergency room on 2/6/13 with multiple seizures to the 4 East nursing unit. The patient resided in a group home prior to admission. The patient has a history of epilepsy, mental retardation, and is non verbal related to autism. The group home provided the facility at admission with the patient's written medication list and dosages. The home medication list included medications for control of seizures. The Registered Nurse (RN) on admission transcribed the seizure medications into the facility computer system incorrectly which was then signed off as physician orders by the nurse practitioner and sent to pharmacy. The patient received the wrong maintenance dosages for the anti seizure medications until discovered by the patient's consulting neurologist on 2/9/13 at 10:10 AM. The patient had multiple generalized seizures requiring immediate medication interventions from admission through 2/9/13. Review of the documentation of the medication list provided by the group home and the Admission Medication Orders/Physician Orders entered on 2/7/13 with the Medication Administration Record (MAR) revealed errors with incorrect dosages being less than the group home for the following anti seizure medications:
? Lamotrigine, group home dose 400 mg (milligram) AM and PM and 200 mg at noon. Dose miscopied by nursing into Medtracker (computer medication management system) , as 4 mg every 12 hours and 200 mg at noon. The Pharmacist put in an electronic "RN Note" on the MAR 2/7/13 stating "Med [medication] clarification needed for Lamotrigine 4 mg, this does not come in 4 mg tabs or 2 mg tabs, comes in 5 mg, 25 mg, 100 200." The note remained on the MAR from 2/7 - 2/9/13 (2 1/2 days) during which time Lamotrigine was not administered. The medication was started when the consulting neurologist discovered the error and wrote a new order on 2/9/13 at 10:10 AM with a 400 mg stat (give immediately) dose ordered.
? Keppra, group home dose 1500 mg AM and PM and 1000 mg at noon. Dose miscopied and administered to the patient 200 mg BID (twice daily) and 1000 mg at noon, a much lower dose (1400 mg instead of the 4,000 mg the patient needed) from 2/7 -2/9/13..
? Banzel 1200 mg AM and PM and 800 mg at noon was the dose at the group home. The medication was not obtained or administered to the patient for 2 1/2 days until a stat dose of 1,200 mg was ordered by the neurologist on 2/9/13 at 10:10 AM. The Pharmacist put in an electronic "RN Note" that appeared on the MAR on 2/7/13 stating "Non Formulary [an agreed upon list by the medical staff of medications kept on hand in pharmacy] Med : Please have MD [Medical Doctor] fill out non-form [formulary] med request form to continue this order. Can pt [patient] supply own med.]." The note remained on the MAR from 2/7/13 - 2/9/13 without any action taken by pharmacy or nursing staff to obtain the drug or clarify the order with the medical practitioner. The error was found on 2/9/13 when the neurologist wrote a new order and pharmacy obtained the medication and the patient received the first dose in 2 1/2 days.
Record review of the Neurologist Progress Notes dated 2/9/13 at 10:10 AM states the patient "is still having frequent milder seizures." The progress notes further state "Prior to admit he was on banzel - not getting in hospital due to non formulary status." The progress note states that the dosages the patient was receiving for the Keppra and Lamotrigine were incorrect. Orders included correct dosages for the seizure control medications. Neurologist notes on 2/10/13 at 10 AM state "doing better today [symbol for no] more seizures." The patient discharged back to the group home on 2/14/13.

B. Record review of the facility provided internal investigation of the adverse event related to Patient 2 revealed the initial investigation was conducted on 2/13/13. The facility document titled "Case Summary Patient Safety Program" was reviewed related to Patient 2. On 2/9/13 the facility identified that communication of the event and review of non formulary medication and RN notes processes were discussed with all nursing Team Leads to relay to all RN staff. Pharmacy was also alerted to the event and all current processes were reviewed. On 2/11/13 Information clarifying the current processes for medication clarification and non-formulary processes was sent to all pharmacists. Information was disseminated to all RN's via RN rounds with an emphasis on addressing RN notes as soon as possible. On 3/8/13 a Root Cause Analysis was completed related to Patient 2 and an action plan developed.,

C. Interview with RN A, the 4 th floor Operations Director (OD), on 4/2/13 at 10:40 AM revealed the OD was informed of the error related to Patient 2 on 2/9/13 by the neurologist. The OD began the investigation of the medication error. The OD reviewed the patient's record and the Medtracker information. The OD found that each shift (from 2/7 -2/9/13 when the error was discovered) clicked "addressed" on the RN notes related to the medication clarification on the electronic MAR and that caused the note to go away until the next day. Multiple nurses failed to address the medication clarification issue. The OD alerted RN B from Patient Safety/Risk Management of the issues. The OD on 2/9/13 told the Team Leads to "remind the staff not to hit "addressed/noted" unless the medication was in hand and available to give. All incidents related to medication reconciliation and cases of non formulary medication issues were to be included in the shift Team Huddles by the off going Team Lead with the on coming staff RN's and NA (Nurse Aides)." RN A stated he/she "has not been monitoring" to ensure staff are doing this and has not been attending any Team Huddles. The OD stated the patient's physician "felt the seizures were associated with this incident of not having meds available." The manager confirmed this was a "serious event and should have done audits to ensure the plan was working." The OD did education with staff related to medication reconciliation and that if staff did not know a medication to look it up. Staff were unfamiliar with the Banzel medication. The OD also implemented nurse leader rounding to include caregivers so that any changes the caregiver sees can be addressed. The OD also implemented a change on 4 th floor that 2 nurses must review and sign off on the Medtracker reconciliation of medications. Education was only done on 4 East and West and not hospital wide for inpatient areas who perform medication reconciliation on admission. The facility failed to incorporate data collection to ensure these changes were made and that they were effective.

D. Interview with the Director of Nursing 4/1/13 at 3:00 PM revealed "nursing is not doing any quality review to ensure Medtracker with home medication reconciliation is being done correctly." Inpatient hospital units include 4th floor with Medical Surgical and Oncology, 3 rd floor with Intensive and Post intensive units, and 2nd floor with Maternity services and Neonatal ICU.

E. Interview with the Operations Director of Pharmacy on 4/1/13 at 2:45 PM confirmed non formulary medication orders are being addressed by pharmacy and a daily audit found uncompleted orders are being clarified and addressed in pharmacy. Interview with the Operations Director of the Pharmacy on 4/2/13 at 12:40 PM confirmed that "currently our pharmacy staff are not comparing patient's original home medication list with information imputed by RN's into the Medtracker system as was identified as a need in the Root Cause Analysis."

Based on record review, staff interviews and review of facility provided adverse patient event internal investigation and action plan documentation, the facility failed to implement preventative actions and mechanisms that included feedback and learning throughout the hospital to prevent potential reoccurrence. Record reviews revealed 1 of 3 sampled patients (Patient #2) failed to have medication reconciliation with the medication list provided by the patient's transferring facility performed accurately. This failure resulted in Patient 2 failing to receive their normal seizure control medications for 2.5 days causing the patient to have additional seizures and an increased length of stay. After discovery of the error on 2/9/13, by a physician, the facility failed to incorporate education to all inpatient areas to ensure the safety of patients. The hospital implemented changes on the 4 th floor where the error occurred for nursing and in the pharmacy. However, the facility did not perform quality assurance data collection/feedback to ensure the plan implemented to address this adverse event was effective. On 4/2/13, after conferring with Centers for Medicare and Medicaid Services (CMS) at 3:10 PM it was determined that Immediate Jeopardy (IJ) conditions existed at the hospital since discovery of the error on 2/9/13. On 4/2/13 the facility had a total of 10 current inpatients who required medication reconciliation with the transferring nursing facility records. All 10 of these patients were at potential risk of failing to receive required medications representing a serious and immediate threat to patient safety. The hospital administrator was notified on 4/2/13 at 4:00 PM that IJ conditions were found in the facility. The facility census was 75. The total sample was 3. Findings are:

A. Record review of Patient 2's medical record found the patient was admitted through the emergency room on 2/6/13 with multiple seizures to the 4 East nursing unit. The patient resided in a group home prior to admission. The patient has a history of epilepsy, mental retardation, and is non verbal related to autism. The group home provided the facility at admission with the patient's written medication list and dosages. The home medication list included medications for control of seizures. The Registered Nurse (RN) on admission transcribed the seizure medications into the facility computer system incorrectly which was then signed off as physician orders by the nurse practitioner and sent to pharmacy. The patient received the wrong maintenance dosages for the anti seizure medications until discovered by the patient's consulting neurologist on 2/9/13 at 10:10 AM. The patient had multiple generalized seizures requiring immediate medication interventions from admission through 2/9/13. Review of the documentation of the medication list provided by the group home and the Admission Medication Orders/Physician Orders entered on 2/7/13 with the Medication Administration Record (MAR) revealed errors with incorrect dosages being less than the group home for the following anti seizure medications:
? Lamotrigine, group home dose 400 mg (milligram) AM and PM and 200 mg at noon. Dose miscopied by nursing into Medtracker (computer medication management system) , as 4 mg every 12 hours and 200 mg at noon. The Pharmacist put in an electronic "RN Note" on the MAR 2/7/13 stating "Med [medication] clarification needed for Lamotrigine 4 mg, this does not come in 4 mg tabs or 2 mg tabs, comes in 5 mg, 25 mg, 100 200." The note remained on the MAR from 2/7 - 2/9/13 (2 1/2 days) during which time Lamotrigine was not administered. The medication was started when the consulting neurologist discovered the error and wrote a new order on 2/9/13 at 10:10 AM with a 400 mg stat (give immediately) dose ordered.
? Keppra, group home dose 1500 mg AM and PM and 1000 mg at noon. Dose miscopied and administered to the patient 200 mg BID (twice daily) and 1000 mg at noon, a much lower dose (1400 mg instead of the 4,000 mg the patient needed) from 2/7 -2/9/13..
? Banzel 1200 mg AM and PM and 800 mg at noon was the dose at the group home. The medication was not obtained or administered to the patient for 2 1/2 days until a stat dose of 1,200 mg was ordered by the neurologist on 2/9/13 at 10:10 AM. The Pharmacist put in an electronic "RN Note" that appeared on the MAR on 2/7/13 stating "Non Formulary [an agreed upon list by the medical staff of medications kept on hand in pharmacy] Med : Please have MD [Medical Doctor] fill out non-form [formulary] med request form to continue this order. Can pt [patient] supply own med.]." The note remained on the MAR from 2/7/13 - 2/9/13 without any action taken by pharmacy or nursing staff to obtain the drug or clarify the order with the medical practitioner. The error was found on 2/9/13 when the neurologist wrote a new order and pharmacy obtained the medication and the patient received the first dose in 2 1/2 days.
Record review of the Neurologist Progress Notes dated 2/9/13 at 10:10 AM states the patient "is still having frequent milder seizures." The progress notes further state "Prior to admit he was on banzel - not getting in hospital due to non formulary status." The progress note states that the dosages the patient was receiving for the Keppra and Lamotrigine were incorrect. Orders included correct dosages for the seizure control medications. Neurologist notes on 2/10/13 at 10 AM state "doing better today [symbol for no] more seizures." The patient discharged back to the group home on 2/14/13.

B. Record review of the facility provided internal investigation of the adverse event related to Patient 2 revealed the initial investigation was conducted on 2/13/13. The facility document titled "Case Summary Patient Safety Program" was reviewed related to Patient 2. On 2/9/13 the facility identified that communication of the event and review of non formulary medication and RN notes processes were discussed with all nursing Team Leads to relay to all RN staff. Pharmacy was also alerted to the event and all current processes were reviewed. On 2/11/13 Information clarifying the current processes for medication clarification and non-formulary processes was sent to all pharmacists. Information was disseminated to all RN's via RN rounds with an emphasis on addressing RN notes as soon as possible. On 3/8/13 a Root Cause Analysis was completed related to Patient 2 and an action plan developed.,

C. Interview with RN A, the 4 th floor Operations Director (OD), on 4/2/13 at 10:40 AM revealed the OD was informed of the error related to Patient 2 on 2/9/13 by the neurologist. The OD began the investigation of the medication error. The OD reviewed the patient's record and the Medtracker information. The OD found that each shift (from 2/7 -2/9/13 when the error was discovered) clicked "addressed" on the RN notes related to the medication clarification on the electronic MAR and that caused the note to go away until the next day. Multiple nurses failed to address the medication clarification issue. The OD alerted RN B from Patient Safety/Risk Management of the issues. The OD on 2/9/13 told the Team Leads to "remind the staff not to hit "addressed/noted" unless the medication was in hand and available to give. All incidents related to medication reconciliation and cases of non formulary medication issues were to be included in the shift Team Huddles by the off going Team Lead with the on coming staff RN's and NA (Nurse Aides)." RN A stated he/she "has not been monitoring" to ensure staff are doing this and has not been attending any Team Huddles. The OD stated the patient's physician "felt the seizures were associated with this incident of not having meds available." The manager confirmed this was a "serious event and should have done audits to ensure the plan was working." The OD did education with staff related to medication reconciliation and that if staff did not know a medication to look it up. Staff were unfamiliar with the Banzel medication. The OD also implemented nurse leader rounding to include caregivers so that any changes the caregiver sees can be addressed. The OD also implemented a change on 4 th floor that 2 nurses must review and sign off on the Medtracker reconciliation of medications. Education was only done on 4 East and West and not hospital wide for inpatient areas who perform medication reconciliation on admission. The facility failed to incorporate data collection to ensure these changes were made and that they were effective.

D. Interview with the Director of Nursing 4/1/13 at 3:00 PM revealed "nursing is not doing any quality review to ensure Medtracker with home medication reconciliation is being done correctly." Inpatient hospital units include 4th floor with Medical Surgical and Oncology, 3 rd floor with Intensive and Post intensive units, and 2nd floor with Maternity services and Neonatal ICU.

E. Interview with the Operations Director of Pharmacy on 4/1/13 at 2:45 PM confirmed non formulary medication orders are being addressed by pharmacy and a daily audit found uncompleted orders are being clarified and addressed in pharmacy. Interview with the Operations Director of the Pharmacy on 4/2/13 at 12:40 PM confirmed that "currently our pharmacy staff are not comparing patient's original home medication list with information imputed by RN's into the Medtracker system as was identified as a need in the Root Cause Analysis."