The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ERLANGER MEDICAL CENTER 975 E 3RD ST CHATTANOOGA, TN 37403 Sept. 26, 2011
VIOLATION: PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES Tag No: A0122
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, review of facility documentation, review of facility policy, and interview, the facility failed to follow hospital policy to address grievances for one patient (#9) of nine patients reviewed.

The findings included:

Medical record review of the History and Physical, dated as dictated and transcribed on July 1, 2001, revealed Patient #9 was admitted to the facility's Trauma Intensive Care Unit (TICU) on July 1, 2011, with diagnoses that include [DIAGNOSES REDACTED].2 (normal 98.6), Pulse 151 (normal 80), Blood Pressure 162/116 (normal 120/80), and Respirations 22 (normal 18). Continued review revealed the patient had [DIAGNOSES REDACTED] Concussion to the frontal and occipital areas. Continued review revealed the plan for treatment was DT (Delirium Tremors) protocol, Rehydration, and Neurology consult.

Medical record review of the Physician's orders revealed the following: July 1, 2011, at 5:20 a.m. - Keppra (medication to treat seizures) 500 mg (milligrams) IV (intravenous) Q (every) 12 hours X (times) 7 days.

Medical record review of the Neurology consult dated as dictated and transcribed on July 1, 2011, revealed Reason for Consultation: Seizure Disorder. Continued review revealed history of heavy alcohol abuse. Brought to the emergency department with decreased level of consciousness. Spouse reports having heard patient fall twice in their room earlier today. The first fall found patient fine while second fall, half an hour later, the patient was acting very confused and a few minutes later started to have jerking on the right side upper extremity, which lasted many minutes. The spouse called Emergency Medical Services and in route to the hospital the patient had a witnessed generalized tonic-clonic seizure. Continued review revealed the spouse reported the patient consumed almost a gallon of whiskey on a daily basis. Continued review revealed the Computerized Tomography (CT) scan of the head showed significant left frontotemporal traumatic intracranial hemorrhage with subdural, subarachnoid, and intraparenchymal component.

Continued review of the Neurology consult dated July 1, 2011 revealed the patient was intubated, fully sedated, was without fever, blood pressure 162/116, and pulse was 145. Continued review of the Data Review (section of the Neurology consult) revealed traumatic intracranial hemorrhage on the right occipital area and bleed mainly on the left frontotemporal area. Continued review revealed the Impression of Traumatic Intracranial Hemorrhage and Post-traumatic Seizure Disorder. Continued review of the Neurological consult revealed the Treatment Plan was noted as maintain the patient on 1000 mg (milligrams) of Keppra (medication used to treat seizures) twice daily.

Medical record review of the Physician's orders revealed the following: July 1, 2011, at 4:26 p.m. - change Keppra to 1 G (gram) IV BID (twice daily).

Medical record review of the Progress Note written by the Neurologist, dated July 4, 2011, no time noted, revealed "...on Keppra 1 G BID. Need to continue and can switch to oral when extubated..."

Medical record review of the Physician's Order, dated July 5, 2011, at 9:30 a.m. - Change Keppra to 1000 mg PO (by mouth) Q 12 Hours; July 6, 2011, at 4:45 p.m. - Give next dose of Keppra 1G IV instead of PO, patient just extubated (given as a verbal order by Resident - Medical Doctor further specializing education).

Medical record review of a Physician's order, dated July 6, 2011, at 5:30 p.m., revealed "...Give Keppra...IV until swallow study..."

Medical record review revealed the patient was transferred from the TICU to the Trauma medical floor on July 7, 2011. Review of the Physician's Transfer Order Sheet (for medications), dated July 7, 2011, at 12:55 p.m., revealed there was no order for Keppra or any other medication to treat seizures.

Medical record review of the Discharge Order Sheet, dated July 12, 2011, at 4:50 p.m., revealed the patient was not on Keppra or other seizure medication. The patient was being discharged to a rehabilitation facility.

Medical record review of the Discharge Summary, dated as dictated and transcribed on August 4, 2011, revealed "...Date of discharge July 12, 2011...Admitting Diagnosis: Convulsions...Primary Diagnosis: Cerebral Laceration/contusion. No open intracranial wounds. Unconsciousness, unspecified duration...was admitted to TICU...placed on DT protocol...neurosurgery and neurology consult requested...was rehydrated...history of alcohol abuse with blood alcohol level negative on admission ...was intubated and able to be extubated...had been stable for transfer out of the unit on July 7th...had an episode of tachycardia and fell and was found on the floor by the nurse on the 9th. Workup implemented was negative...During the hospital stay was followed by Neurosurgery and Neurology...was continued on current medical management. Neurosurgery signed off on the 8th...He had no further seizure activity noted...was becoming more alert but was still agitated...approved for acute rehab and was transferred on the 12th..."

Medical record review of document, History and Physical, dated as dictated and transcribed on July 13, 2011, from the Rehabilitation Hospital accepting the patient in transfer, revealed "...was found down after having a seizure...found to have significant intra cranial hemorrhage...intubated to protect airway...remained intubated for several days...treated (by Neurologist) for one week with Keppra for seizure prophylaxis...remains somewhat confused...seizure prophylaxis has been discontinued...Plan:...will be kept on the monitored unit and have seizure precautions but no seizure prophylaxis has been ordered..."

Medical record review of the History and Physical done at Erlanger Medical Center, dated as dictated and transcribed on July 23, 2011, revealed "...transferred from (named Rehabilitation Hospital) where (patient) was undergoing rehab for post-traumatic subdural hematoma and an ICH (Intra Cranial Hemorrhage) for persistent seizure/new onset seizure activity...in baseline state of health, until on the morning of admission was noted to have at least 30 minutes of seizure activity. Prior to the seizure, the patient had an elevated temperature, but no other reported symptoms. The symptoms were reported as sudden...currently has symptoms, which are severe...vital signs temperature 100.9, pulse 145, respirations 41, blood pressure 160/126...post ictal/unresponsive...alcohol not detected. Urine drug screen negative...Impression: [DIAGNOSES REDACTED]/seizure disorder...Plan:..Start on Keppra IV....Aggressive supportive care. Pancultures (blood and urine cultures). Empiric antibiotics...Plan to consult Neurology if re-seizes on present medication..."

Medical record review of the Neurology consult, dated as dictated on July 24, 2011 and transcribed on July 25, 2011, revealed "...Apparently had a fever...had a protracted seizure lasting at least 30 minutes...apparently this was witnessed...admitted ...Anticonvulsants were started, which (patient) was not taking prior to this event...Past Medical History:...posttraumatic seizure...white blood count 11.3 (normal range 4.5 - 10.5)...Impression:...Protracted partial seizure with apparent secondary generalization...(patient) has numerous reasons to have a seizure, including recent intracranial hemorrhage, urinary tract infection, fever...has been stable since starting Keppra 1000 mg IV BID...Plan: Continue Keppra 1000 mg IV BID, increase to 1500 mg IV BID only if new seizures...Seizure Precaution..."

Medical record review of the Discharge Summary, dated as dictated and transcribed August 2, 2011, revealed "...admitted to ICU with aggressive, supportive care as well as IV Ativan (used if needed to treat breakthrough seizures not controlled by routine anticonvulsant) and Keppra...Neurology services obtained...EEG (electroencephogram - measures brain's electrical activity) was not indicated as it was felt the seizures were secondary to recent traumatic subdural hematoma with ICH...once stable (patient) was transferred out of the ICU to the medical floor...weaned from Keppra and placed on Dilantin (anticonvulsant), as this was a better choice, per Neurology, as (patient) was noted to seize again on Keppra...transfer to (named Rehab Hospital) to complete inpatient rehab..."

Review of facility documents, dated July 26, 2011, at 5:00 p.m., revealed the patient's spouse called and reported the facility transferred the patient to (named rehab hospital) and the patient's Keppra was not ordered and wanting to know who was responsible for ordering the medication as the patient had a seizure at (named rehab hospital) and had to be transferred back to the hospital. Continued review of the facility follow-up documentation, dated July 27, 2011, at 4:30 p.m., revealed " 7/1 -7/12 (July 1 - 12, 2011) admission reviewed. It appears that the Keppra was ordered PO at the same time the patient was getting extubated. The extubation was a little delayed and the oral dose was changed to IV for one dose on 7/6/11 (July 6, 2011) but never got restarted back after (the patient) could take PO. (the patient) had a couple more seizures after extubation but none of the MD's (medical doctors) mentioned the antiseizure medication or lack of in the progress notes. Neuro Surg (neurosurgery) signed off. The patient was discharged to (named rehab hospital) with no orders for the medication. readmitted on July 23, 2011. Going to ask the neurologist if Keppra was warranted during initial admission for TBI (traumatic brain injury) s/p (status post) fall..." Continued review revealed the spouse called on August 4 , 2011, at 12:20 p.m., (2 days after the patient was readmitted and 2 days after the initial call) "wondering why no one had contacted (the spouse)...was informed the on August 4, 2011 at 12:20 p.m., PR (peer review - physician review) was the action plan..."

Review of facility documents revealed the facility sent the spouse a letter, dated August 8, 2011 (13 days after the spouse initially contacted the facility with the complaint) indicating the receipt and disposition of the spouses complaint.

Review of the facility's policy Customer Relations, number 8316.009, dated as revised July 2011, revealed "...process for prompt response to, and resolution of, patient/family complains ...Grievance - is a written or verbal complaint...by a patient or the patient's representative, regarding the patient's care...Whenever a patient or patient's representative requests...requests a response ...the complaint is a grievance and all the requirements apply...All post-discharge complaints...the Customer Response Department will send an acknowledgement letter to the complainant within 7 days of receiving the complaint...The most involved department managers will be responsible for investigating the issues and responding to the complainant within 14 days either phone, email or letter...For physician-related issues, the Clinical Quality Improvement Department Director will send an acknowledgement/closure letter to the complainant within 7 days ...post-discharge complaint that meets the definition of a grievance must be reviewed, investigated, and resolved within a reasonable amount of time..."

Interview with the Clinical Quality Improvement Nurse and Clinical Outcomes Coordinator in the office of the Emergency Manager, on September 22, 2011, at 10:20 a.m., confirmed the complaint was not fully investigated to include the identification of the cause of the medication error and was sent for peer review only. Continued interview confirmed the grievance policy to acknowledge the complaint was not filed in the 7 days per the facility policy.

Interview with the Director of Nursing Quality in the office of the Director of Quality on September 22, 2001, at 1:30 p.m., confirmed the facility policy was not followed related to acknowledgement of complaint within 7 days. Continued interview confirmed the facility investigation was not thorough regarding investigating the cause of the medication error.

C/O # TN

.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, facility policy review, and interview, the facility failed to ensure a medication error and adverse patient event was fully analyzed to determine the cause for one patient (#9) with a significant medication error of nine medical records reviewed.

The findings included:

Medical record review of the History and Physical, dated as dictated and transcribed on July 1, 2001, revealed Patient #9 was admitted to the facility's Trauma Intensive Care Unit (TICU) on July 1, 2011, with diagnoses that include [DIAGNOSES REDACTED].2 (normal 98.6), Pulse 151 (normal 80), Blood Pressure 162/116 (normal 120/80), and Respirations 22 (normal 18). Continued review revealed the patient had [DIAGNOSES REDACTED] Concussion to the frontal and occipital areas. Continued review revealed the plan for treatment was DT (Delirium Tremors) protocol, Rehydration, and Neurology consult.

Medical record review of the Physician's orders revealed the following: July 1, 2011, at 5:20 a.m. - Keppra (medication to treat seizures) 500 mg (milligrams) IV (intravenous) Q (every) 12 hours X (times) 7 days.

Medical record review of the Neurology consult dated as dictated and transcribed on July 1, 2011, revealed Reason for Consultation: Seizure Disorder. Continued review revealed history of heavy alcohol abuse. Brought to the emergency department with decreased level of consciousness. Spouse reports having heard patient fall twice in their room earlier today. The first fall found patient fine while second fall, half an hour later, the patient was acting very confused and a few minutes later started to have jerking on the right side upper extremity, which lasted many minutes. The spouse called Emergency Medical Services and in route to the hospital the patient had a witnessed generalized tonic-clonic seizure. Continued review revealed the spouse reported the patient consumed almost a gallon of whiskey on a daily basis. Continued review revealed the Computerized Tomography (CT) scan of the head showed significant left frontotemporal traumatic intracranial hemorrhage with subdural, subarachnoid, and intraparenchymal component. Continued review revealed the patient was intubated, fully sedated, was without fever, blood pressure 162/116, and pulse was 145. Continued review of a Neurology Data Review (a section of the Neurological Consult) revealed a traumatic intracranial hemorrhage on the right occipital area and bleed mainly on the left frontotemporal area. Continued review of the Neurological consult revealed the Impression of Traumatic Intracranial Hemorrhage and Post-traumatic Seizure Disorder. Continued review revealed the Treatment Plan was noted as maintain the patient on 1000 mg (milligrams) of Keppra (medication used to treat seizures) twice daily.

Medical record review of the Physician's orders revealed the following: July 1, 2011, at 4:26 p.m. - change Keppra to 1 G (gram) IV BID (twice daily).

Medical record review of the Progress Note written by the Neurologist, dated July 4, 2011, no time noted, revealed "...on Keppra 1 G BID. Need to continue and can switch to oral when extubated..."

Medical record review of the Physician's Order, dated July 5, 2011, at 9:30 a.m. - Change Keppra to 1000 mg PO (by mouth) Q 12 Hours; July 6, 2011, at 4:45 p.m. - Give next dose of Keppra 1G IV instead of PO, patient just extubated (given as a verbal order by Resident - Medical Doctor further specializing education).

Medical record review revealed the patient was transferred from the TICU to the Trauma medical floor on July 7, 2011. Review of the Physician's Transfer Order Sheet (for medications), dated July 7, 2011, at 12:55 p.m., revealed no order for Keppra or any other medication to treat seizures.

Medical record review of the Trauma Services Progress Note, dated July 8, 2011, at 5:10 a.m., revealed "...Issues/Plan of the day: Intracranial Hemorrhage/Subdural Hematoma - stable on repeat CT scan (Keppra X 1 week)..."

Medical record review of the Trauma Services Progress Note Critical Care (written by a Trauma Intern - medical student) dated July 9, 2011, at 9:25 p.m., revealed "...episode of fall (found on floor by nurse); episode of increased heart rate between 170 to 180 (beats per minute); currently on telemetry (off unit monitoring of cardiac activity)...episode of fall questionable mechanical or cardiac..."

Medical record review of the Trauma Services Progress Note, dated July 10, 2011, no time noted, revealed "Events over the past 24 hours: Fall - last night...B/P (blood pressure) 140/71, HR (heart rate) 78, rhythm regular...Issues/Plan of the Day: S/P (status post) fall with SDH (subdural hematoma), episodes of intermittent tachycardia (?? cause), continue same plan"

Medical record review of the Trauma Services Progress Note written by the Attending Physician, dated July 11, 2011, at 7:00 a.m., revealed "...Some questionable persistent (alcohol) withdrawal..."

Medical record review of the Discharge Order Sheet, dated July 12, 2011, at 4:50 p.m., revealed the patient was not on Keppra or other seizure medication. The patient was being discharged to a rehabilitation facility.

Medical record review of the Discharge Summary, dated as dictated and transcribed on August 4, 2011, revealed "...Date of discharge July 12, 2011...Admitting Diagnosis: Convulsions...Primary Diagnosis: Cerebral Laceration/contusion. No open intracranial wounds. Unconsciousness, unspecified duration...was admitted to TICU...placed on DT protocol...neurosurgery and neurology consult requested...was rehydrated...history of alcohol abuse with blood alcohol level negative on admission ...was intubated and able to be extubated...had been stable for transfer out of the unit on July 7th...had an episode of tachycardia and fell and was found on the floor by the nurse on the 9th. Workup implemented was negative...During the hospital stay was followed by Neurosurgery and Neurology...was continued on current medical management. Neurosurgery signed off on the 8th...was becoming more alert but was still agitated...approved for acute rehab and was transferred on the 12th..."

Medical record review of the History and Physical, dated as dictated and transcribed on July 13, 2011, document from the Rehabilitation Hospital accepting the patient in transfer, revealed "...was found down after having a seizure...found to have significant intra cranial hemorrhage...intubated to protect airway...remained intubated for several days...treated (by Neurologist) for one week with Keppra for seizure prophylaxis...remains somewhat confused...seizure prophylaxis has been discontinued...Plan:...will be kept on the monitored unit and have seizure precautions but no seizure prophylaxis has been ordered..."

Medical record review of the History and Physical done at Erlanger Medical Center, dated as dictated and transcribed on July 23, 2011, revealed "...transferred from (named Rehabilitation Hospital) where (patient) was undergoing rehab for post-traumatic subdural hematoma and an ICH (Intra Cranial Hemorrhage) for persistent seizure/new onset seizure activity...in baseline state of health, until on the morning of admission was noted to have at least 30 minutes of seizure activity. Prior to the seizure, the patient had an elevated temperature, but no other reported symptoms. The symptoms were reported as sudden...currently has symptoms, which are severe...vital signs temperature 100.9, pulse 145, respirations 41, blood pressure 160/126...post ictal/unresponsive...alcohol not detected. Urine drug screen negative...Impression: [DIAGNOSES REDACTED]/seizure disorder...Plan:..Start on Keppra IV....Aggressive supportive care. Pancultures (blood and urine cultures). Empiric antibiotics...Plan to consult Neurology if re-seizes on present medication..."

Medical record review of the Neurology consult, dated as dictated on July 24, 2011 and transcribed on July 25, 2011, revealed "...Apparently had a fever...had a protracted seizure lasting at least 30 minutes...apparently this was witnessed...admitted ...Anticonvulsants were started, which (patient) was not taking prior to this event...Past Medical History:...posttraumatic seizure...white blood count 11.3 (normal range 4.5 - 10.5)...Impression:...Protracted partial seizure with apparent secondary generalization...(patient) has numerous reasons to have a seizure, including recent intracranial hemorrhage, urinary tract infection, fever...has been stable since starting Keppra 1000 mg IV BID...Plan: Continue Keppra 1000 mg IV BID, increase to 1500 mg IV BID only if new seizures...Seizure Precaution..."

Medical record review of the Discharge Summary, dated as dictated and transcribed August 2, 2011, revealed "...admitted to ICU with aggressive, supportive care as well as IV Ativan (used if needed to treat breakthrough seizures not controlled by routine anticonvulsant) and Keppra...Neurology services obtained...EEG (electroencephogram - measures brain's electrical activity) was not indicated as it was felt the seizures were secondary to recent traumatic subdural hematoma with ICH...once stable (patient) was transferred out of the ICU to the medical floor...weaned from Keppra and placed on Dilantin (anticonvulsant), as this was a better choice, per Neurology, as (patient) was noted to seize again on Keppra...transfer to (named Rehab Hospital) to complete inpatient rehab..."

Review of facility documents, dated July 26, 2011, at 5:00 p.m., revealed the patient's spouse called and reported the facility transferred the patient to (named rehab hospital) and the patient's Keppra was not ordered...wanting to know who was responsible for ordering the medication as the patient had a seizure at (named rehab hospital) and had to be transferred back to the hospital. Continued review of the facility follow-up, dated July 27, 2011, at 4:30 p.m., revealed " 7/1 -7/12 (July 1 - 12, 2011) admission reviewed. It appears that the Keppra was ordered PO (by mouth) at the same time the patient was getting extubated. The extubation was a little delayed and the oral dose was changed to IV for one dose on 7/6/11 (July 6, 2011) but never got restarted back after (the patient) could take PO. (the patient) had a couple more seizures after extubation but none of the MD's (medical doctors) mentioned the antiseizure medication or lack of in the progress notes. Neuro Surg (neurosurgery) signed off...the patient was discharged to (named rehab hospital) with no orders for the medication. readmitted on July 23, 2011, going to ask the neurologist if Keppra was warranted during initial admission for TBI (traumatic brain injury) s/p (status post) fall..." Continued review revealed the spouse called back on August 4, 2011 (8 days after initial contact) wondering why no one had contacted (spouse)...was informed the on August 4, 2011 at 12:20 p.m., PR (peer review - physician review) was the action plan..."

Review of facility's Rules and Regulations of the Medical Staff, no number, dated as revised November 2008, revealed " ...Resident Supervision will consist of three levels: general, direct and personal. General supervision means that the care or procedure is conducted under the faculty member's overall direction and control but the faculty member's presence is not required at the time of care. Direct supervision requires that the faculty member must be in the unit or clinic and immediately available to furnish assistance and direction. Personal supervision means that the faculty member must be in attendance in the room during the procedure ...The Chairman of the Department to whom the resident is assigned and/or the resident's Program Director is responsible for the supervision of the resident ...All patients receiving care ...are assigned to a member of the hospital's Medical Staff, designated as that patient's attending physician ...The attending physician will be expected to see the patient and/or review the management plan within 24 hours and at appropriate intervals during the patient's hospitalization ..."

Review of the facility's policy Verbal and Telephone Orders, number PC - 094, dated as revised February 2008, revealed " ...Verbal order: an order accepted by authorized or licensed personnel (i.e. pharmacist, nurse) in an emergency situation from a physician when the physician is present. Telephone order: an order from a physician or his/her designee accepting accepted by an authorized or licensed personnel when the patient's condition does not require the physician's presence in making a medical assessment...The prescribing physician must sign all verbal orders within forty-eight (48) hours...If the verbal order or telephone order involves the change (or clarification of) a previously written order, the authorized or licensed personnel shall: Transcribe order clarification...Transcribe the order to discontinue the previous order written by the physician. Transcribe the correct order as given by the physician..."

Interview with the Pharmacy Director, Pharmacy Chief of Operations, Nursing Quality Director, Clinical Quality Improvement Nurse, and Clinical Outcomes Coordinator, in the office of the Emergency Manager, on September 22, 2011, at 10:20 a.m., revealed the Pharmacy Director confirmed the order of July 6, 2011, for Keppra was indicating a onetime order and not a discontinue order yet the pharmacist reviewing and filling the order discontinued the Keppra by mouth twice daily. Continued interview revealed when pharmacy discontinued a medication, a safety measure in place to prevent the discontinuation of medication required the nurse to verify on the computer the medication had been discontinued. Continued interview revealed no additional medications could be administered until the nurse verified the medication had been discontinued. Continued interview revealed the facility did not have a policy to "hold" medications; only to discontinue and restart. Continued interview confirmed the order as written required clarification prior to filling and the order was not clarified. Interview with the Clinical Quality Improvement Nurse and Clinical Outcomes Coordinator, revealed the orders are checked at the end of each shift by the nurse on duty as a safety measure to prevent medication errors. Continued interview revealed the nurse signed off on the end of shift order check without identifying the discontinuation of Keppra as an error. Interview with the Clinical Outcomes coordinator confirmed the incident was not fully investigated to include the identification of the cause of the medication error and was sent for peer review only.

Interview with the TICU Manager, TICU Assistant Manager, TICU Director, Nursing Quality Director, the Register Nurse (RN #1) in charge of the patient's care when the medication error occurred, the Resident who wrote the order of July 6th leading to the medication error, and the Medical Director of Trauma Services, in the office of the TICU Assistant Manager, on September 22, 2011, at 11:10 a.m., revealed RN #1 confirmed the pharmacy discontinuation of the medication, Keppra, which had been discontinued by the pharmacist on July 6, had been verified and signed off in error by RN #1 on the end of the shift chart check. Continued interview confirmed the order was to give one dose IV, which did not indicate the medication was to be discontinued. Interview with the Director of TICU and the Assistant Manager of TICU revealed the verification of discontinued medications was a safety measure to prevent medication errors. Continued interview revealed the verification required the nurse to scroll to the end of the pharmacy discontinuation verification to view the entire order. Continued interview confirmed the medication had been verified as discontinued without justification by RN #1. Interview with the TICU Manager revealed the Rounds Report Updates were generated and available to all physicians and treatment staff for all Trauma Services patients. Continued interview revealed the Rounds Report Updates listed the patient's current medications. Continued interview revealed the medication Keppra would not have been listed on the report on July 7, 2011 after it had been discontinued in the computer Medication Administration Record by pharmacy and verified by nursing as discontinued on July 6, 2011. Interview with the Medical Director of Trauma Services confirmed the Rounds Report was intended to be utilized to review medications for accuracy and the safety measures to prevent medication errors failed for quality improvement, pharmacy, nursing. Continued interview revealed the physicians were to utilize the Rounds Report to verify the medications daily.

Interview with the Director of Nursing Quality in the office of the Director of Quality on September 22, 2001, at 1:30 p.m., confirmed the system's measures to prevent medication errors failed in quality improvement, pharmacy, nursing, and on the physician level. Continued interview confirmed the facility investigation was not thorough regarding investigating the cause of the medication error.

C/O # TN

.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review and intreview, the faciltiy failed to ensure a seizure medication was given as ordered for one patient (#9) of nine patients reviewed.

The findings included:

Medical record review of the History and Physical, dated as dictated and transcribed July 1, 2001, revealed Patient #9 was admitted to the facility's Trauma Intensive Care Unit (TICU) on July 1, 2011, with diagnoses that include [DIAGNOSES REDACTED].2 (normal 98.6), Pulse 151 (normal 80), Blood Pressure 162/116 (normal 120/80), and Respirations 22 (normal 18). Continued review revealed the patient had [DIAGNOSES REDACTED] Concussion to the frontal and occipital areas. Continued review revealed the Treatment Plan for treatment was DT (Delirium Tremors) protocol, Rehydration, and Neurology consult.

Medical record review of the Neurology consult dated as dictated and transcribed July 1, 2011, revealed reason for consultation seizure disorder. Continued review revealed history of heavy alcohol abuse and prior prolonged hospitalization for pneumonia. Brought to the emergency department with decreased level of consciousness. Spouse reports having heard patient fall twice in their room earlier today. The first fall found patient fine while second fall, half an hour later, the patient was acting very confused and a few minutes later started to have jerking on the right side upper extremity, which lasted many minutes. The spouse called Emergency Medical Services and in route to the hospital the patient had a witnessed generalized tonic-clonic seizure. Continued review revealed the spouse reported the patient consumed almost a gallon of whiskey on a daily basis. Continued review revealed the Computerized Tomography (CT) scan of the head showed significant left frontotemporal traumatic intracranial hemorrhage with subdural, subarachnoid, and intraparenchymal component. Continued review revealed the patient was intubated, fully sedated, was without fever, blood pressure 162/116, and pulse was 145. Continued review of the Neurological Data Review (a section of the Neurological consult) revealed a traumatic intracranial hemorrhage on the right occipital area and bleed mainly on the left frontotemporal area. Continued review revealed the Impression of Traumatic Intracranial Hemorrhage and Post-traumatic Seizure Disorder. Continued review of the Neurological Consult revealed the Treatment Plan was noted as maintain the patient on 1000 mg (milligrams) of Keppra (medication used to treat seizures) twice daily.

Medical record review of the Physician's orders revealed the following: July 1, 2011, at 4:26 p.m. - change Keppra to 1 G (gram) IV BID (twice daily).

Medical record review of the Progress Note written by the Neurologist, dated July 4, 2011, no time noted, revealed "...on Keppra 1 G BID. Need to continue and can switch to oral when extubated..."

Medical record review of the Physician's Order revealed the following: July 5, 2011, at 9:30 a.m. - Change Keppra to 1000 mg PO (by mouth) Q 12 Hours; July 6, 2011, at 4:45 p.m. - Give next dose of Keppra 1G IV instead of PO, patient just extubated (given as a verbal order by Resident - Medical Doctor further specializing education) and order noted as authenticated on July 19, 2011, at 1:44 p.m.; and July 6, at 5:30 p.m. - Give Keppra IV until swallow study.

Medical record review revealed the patient was transferred from the TICU to the Trauma medical floor on July 7, 2011. Review of the Physician's Transfer Order Sheet (for medications), dated July 7, 2011, at 12:55 p.m., revealed there was no order for Keppra or any other medication to treat seizures.

Medical record review of the Discharge Order Sheet, dated July 12, 2011, at 4:50 p.m., revealed the patient was not on Keppra or other seizure medication. The patient was discharged to a rehabilitation facility.

Medical record review of the History and Physical done at Erlanger Medical Center, dated as dictated and transcribed on July 23, 2011, revealed "...transferred from (named Rehabilitation Hospital) where (patient) was undergoing rehab for post-traumatic subdural hematoma and an ICH (Intra Cranial Hemorrhage) for persistent seizure/new onset seizure activity...in baseline state of health, until on the morning of admission was noted to have at least 30 minutes of seizure activity. Prior to the seizure, the patient had an elevated temperature, but no other reported symptoms. The symptoms were reported as sudden...currently has symptoms, which are severe...vital signs temperature 100.9, pulse 145, respirations 41, blood pressure 160/126...post ictal/unresponsive...alcohol not detected. Urine drug screen negative...Impression: [DIAGNOSES REDACTED]/seizure disorder...Plan:..Start on Keppra IV....Aggressive supportive care. Pancultures (blood and urine cultures). Empiric antibiotics...Plan to consult Neurology if re-seizes on present medication..."

Medical record review of the Neurology consult, dated as dictated on July 24, 2011 and transcribed on July 25, 2011, revealed "...Apparently had a fever...had a protracted seizure lasting at least 30 minutes...apparently this was witnessed...admitted ...Anticonvulsants were started, which (patient) was not taking prior to this event...Past Medical History:...posttraumatic seizure...white blood count 11.3 (normal range 4.5 - 10.5)...Impression:...Protracted partial seizure with apparent secondary generalization...(patient) has numerous reasons to have a seizure, including recent intracranial hemorrhage, urinary tract infection, fever...has been stable since starting Keppra 1000 mg IV BID...Plan: Continue Keppra 1000 mg IV BID, increase to 1500 mg IV BID only if new seizures...Seizure Precaution..."

Review of the facility's policy Verbal and Telephone Orders, number PC - 094, dated as revised February 2008, revealed " ...Verbal order: an order accepted by authorized or licensed personnel (i.e. pharmacist, nurse) in an emergency situation from a physician when the physician is present. Telephone order: an order from a physician or his/her designee accepting accepted by an authorized or licensed personnel when the patient's condition does not require the physician's presence in making a medical assessment...The prescribing physician must sign all verbal orders within forty-eight (48) hours...If the verbal order or telephone order involves the change (or clarification of) a previously written order, the authorized or licensed personnel shall: Transcribe order clarification...Transcribe the order to discontinue the previous order written by the physician. Transcribe the correct order as given by the physician..."

Interview with the Pharmacy Director, Pharmacy Chief of Operations, Nursing Quality Director, Clinical Quality Improvement Nurse, and Clinical Outcomes Coordinator, in the office of the Emergency Manager, on September 22, 2011, at 10:20 a.m., revealed the Pharmacy Director confirmed the order of July 6, 2011, for Keppra was indicating a onetime order and not a discontinue order yet the pharmacist reviewing and filling the order discontinued the Keppra by mouth twice daily. Continued interview revealed when pharmacy discontinued a medication, a safety measure in place to prevent the discontinuation of medication required the nurse to verify on the computer the medication had been discontinued. Continued interview revealed additional medications could not be administered until the nurse verified the medication had been discontinued. Continued interview revealed the facility did not have a policy to "hold" medications; only to discontinue and restart. Continued interview confirmed the order as written required clarification prior to filling and the order was not clarified. Interview with the Clinical Quality Improvement Nurse and Clinical Outcomes Coordinator, revealed the orders are checked at the end of each shift by the nurse on duty as a safety measure to prevent medication errors. Continued interview revealed the nurse signed off on the end of shift order check without identifying the discontinuation of Keppra.

Interview with the TICU Manager, TICU Assistant Manager, TICU Director, Nursing Quality Director, the Register Nurse (RN #1) in charge of the patient's care when the medication error occurred, the Resident who wrote the order of July 6th leading to the medication error, and the Medical Director of Trauma Services, in the office of the TICU Assistant Manager, on September 22, 2011, at 11:10 a.m., revealed RN #1 confirmed the end of shift chart check verification for the discontinuation of the medication, Keppra, which had been discontinued by the pharmacist on July 6, had been signed off by RN #1. Continued interview confirmed the order was to give one dose IV, which did not indicate the medication was to be discontinued. Interview with the Director of TICU and the Assistant Manager of TICU revealed the verification of discontinued medications was a safety measure to prevent medication errors. Continued interview revealed the verification required the nurse to scroll to the end of the pharmacy discontinuation verification to view the entire order. Continued interview confirmed the medication had been verified as discontinued without justification by RN #1. Interview with the Medical Director of Trauma Services confirmed the safety measures to prevent medication errors failed for nursing.

Interview with the Director of Nursing Quality in the office of the Director of Quality on September 22, 2001, at 1:30 p.m., confirmed the system measures to prevent medication errors failed in nursing.

C/O # TN

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VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, facility policy review, and interview, the facility failed to ensure medications were distributed according to acceptable facility protocol for one patient (#9) of nine patients reviewed.

The findings included:

Medical record review of the History and Physical, dated as dictated and transcribed July 1, 2001, revealed Patient #9 was admitted to the facility's Trauma Intensive Care Unit (TICU) on July 1, 2011, with diagnoses that include [DIAGNOSES REDACTED].2 (normal 98.6), Pulse 151 (normal 80), Blood Pressure 162/116 (normal 120/80), and Respirations 22 (normal 18). Continued review revealed the patient had [DIAGNOSES REDACTED] Concussion to the frontal and occipital areas. Continued review revealed the plan for treatment was DT (Delirium Tremors) protocol, Rehydration, and Neurology consult.

Medical record review of the Neurology consult dated as dictated and transcribed July 1, 2011, revealed Reason for Consultation: Seizure Disorder. Continued review revealed history of heavy alcohol abuse and prior prolonged hospitalization for pneumonia. Brought to the emergency department with decreased level of consciousness. Spouse reports having heard patient fall twice in their room earlier today. The first fall found patient fine while second fall, half an hour later, the patient was acting very confused and a few minutes later started to have jerking on the right side upper extremity, which lasted many minutes. The spouse called Emergency Medical Services and in route to the hospital the patient had a witnessed generalized tonic-clonic seizure. Continued review revealed the spouse reported the patient consumed almost a gallon of whiskey on a daily basis. Continued review revealed the Computerized Tomography (CT) scan of the head showed significant left frontotemporal traumatic intracranial hemorrhage with subdural, subarachnoid, and intraparenchymal component. Continued review revealed the patient was intubated, fully sedated, was without fever, blood pressure 162/116, and pulse was 145. Continued review of a Neurological Data Review (a section of the Neurological Consult) revealed a traumatic intracranial hemorrhage on the right occipital area and bleed mainly on the left frontotemporal area. Continued review revealed the Impression of Traumatic Intracranial Hemorrhage and Post-traumatic Seizure Disorder. Continued review of the Neurological Consult revealed the Treatment Plan was noted as maintain the patient on 1000 mg (milligrams) of Keppra (medication used to treat seizures) twice daily.

Medical record review of the Physician's orders revealed the following: July 1, 2011, at 5:20 a.m. - Keppra 500 mg IV (intravenous) Q (every) 12 hours X (times) 7 days; July 1, 2011, at 4:26 p.m. - change Keppra to 1 G (gram) IV BID (twice daily).

Medical record review of the Progress Note written by the Neurologist, dated July 4, 2011, no time noted, revealed "...on Keppra 1 G BID. Need to continue and can switch to oral when extubated..."

Medical record review of the Physician's Order, dated July 5, 2011, at 9:30 a.m. - Change Keppra to 1000 mg PO (by mouth) Q 12 Hours; July 6, 2011, at 4:45 p.m. - Give next dose of Keppra 1G IV instead of PO, patient just extubated (given as a verbal order by Resident - a Medical Doctor further specializing education); and July 6, 2011, at 5:30 p.m. - Keppra IV until swallow study.

Medical record review revealed the patient was transferred from the TICU to the Trauma medical floor on July 7, 2011. Review of the Physician's Transfer Order Sheet (for medications), dated July 7, 2011, at 12:55 p.m., revealed there was no order for Keppra or any other medication to treat seizures.

Medical record review of the Discharge Order Sheet, dated July 12, 2011, at 4:50 p.m., revealed the patient was not discharged on Keppra or other seizure medication. The patient was discharged to a rehabilitation facility.

Review of the facility's policy Verbal and Telephone Orders, number PC - 094, dated as revised February 2008, revealed "...Verbal order: an order accepted by authorized or licensed personnel (i.e. pharmacist, nurse) in an emergency situation from a physician when the physician is present. Telephone order: an order from a physician or his/her designee accepted by an authorized or licensed personnel when the patient's condition does not require the physician's presence in making a medical assessment...If the verbal order or telephone order involves the change (or clarification of) a previously written order, the authorized or licensed personnel shall: Transcribe order clarification...Transcribe the order to discontinue the previous order written by the physician. Transcribe the correct order as given by the physician..."

Interview with the Pharmacy Director, Pharmacy Chief of Operations, Nursing Quality Director, Clinical Quality Improvement Nurse, and Clinical Outcomes Coordinator, in the office of the Emergency Manager, on September 22, 2011, at 10:20 a.m., revealed the Pharmacy Director confirmed the order of July 6, 2011, for Keppra was indicating a onetime order and not a discontinue order yet the pharmacist reviewing and filling the order discontinued the Keppra by mouth twice daily. Continued interview revealed the facility did not have a policy to "hold" medications; only to discontinue and restart. Continued interview confirmed the order as written required clarification prior to filling, which the pharmacist did not accomplish causing the medication to be discontinued in error without a physician's order.

Interview with the Director of Nursing Quality in the office of the Director of Quality on September 22, 2001, at 1:30 p.m., confirmed the system measures to prevent medication errors failed in pharmacy.

C/O # TN

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VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, facility policy review, and interview, the facility failed to ensure a medication error was investigated and reported according to acceptable facility protocol for one patient (#9) of nine patients reviewed.

The findings included:

Medical record review of the History and Physical, dated as dictated and transcribed July 1, 2001, revealed Patient #9 was admitted to the facility's Trauma Intensive Care Unit (TICU) on July 1, 2011, with diagnoses that include [DIAGNOSES REDACTED].2 (normal 98.6), Pulse 151 (normal 80), Blood Pressure 162/116 (normal 120/80), and Respirations 22 (normal 18). Continued review revealed the patient had [DIAGNOSES REDACTED] Concussion to the frontal and occipital areas. Continued review revealed the plan for treatment was DT (Delirium Tremors) protocol, Rehydration, and Neurology consult.

Medical record review of the Neurology consult dated as dictated and transcribed July 1, 2011, revealed Reason for consultation seizure disorder. Continued review revealed history of heavy alcohol abuse and prior prolonged hospitalization for pneumonia. Brought to the emergency department with decreased level of consciousness. Spouse reports having heard patient fall twice in their room earlier today. The first fall found patient fine while second fall, half an hour later, the patient was acting very confused and a few minutes later started to have jerking on the right side upper extremity, which lasted many minutes. The spouse called Emergency Medical Services and in route to the hospital the patient had a witnessed generalized tonic-clonic seizure. Continued review revealed the spouse reported the patient consumed almost a gallon of whiskey on a daily basis. Continued review revealed the Computerized Tomography (CT) scan of the head showed significant left frontotemporal traumatic intracranial hemorrhage with subdural, subarachnoid, and intraparenchymal component. Continued review revealed the patient was intubated, fully sedated, was afebrile, blood pressure 162/116, and pulse was 145. Continued review of a Neurological Data Review (a section of the Neurological Consult) revealed a traumatic intracranial hemorrhage on the right occipital area and bleed mainly on the left frontotemporal area. Continued review revealed the Impression of Traumatic Intracranial Hemorrhage and Post-traumatic Seizure Disorder. Continued review of the Neurological Consult revealed the Treatment Plan was noted as maintain the patient on 1000 mg (milligrams) of Keppra (medication used to treat seizures) twice daily.

Medical record review of the Physician's orders revealed the following: July 1, 2011, at 5:20 a.m. - Keppra 500 mg IV (intravenous) Q (every) 12 hours X (times) 7 days; July 1, 2011, at 4:26 p.m. - change Keppra to 1 G (gram) IV BID (twice daily).

Medical record review of the Progress Note written by the Neurologist, dated July 4, 2011, no time noted, revealed "...on Keppra 1 G BID. Need to continue and can switch to oral when extubated..."

Medical record review of the Physician's Order, dated July 5, 2011, at 9:30 a.m. - Change Keppra to 1000 mg PO (by mouth) Q 12 Hours; July 6, 2011, at 4:45 p.m. - Give next dose of Keppra 1G IV instead of PO, patient just extubated (given as a verbal order by Resident - a Medical Doctor further specializing education); and July 6, 2011, at 5:30 p.m., Give Keppra IV until swallow study.

Medical record review revealed the patient was transferred from the TICU to the Trauma medical floor on July 7, 2011. Review of the Physician's Transfer Order Sheet (for medications), dated July 7, 2011, at 12:55 p.m., revealed no order for Keppra or any other medication to treat seizures.

Medical record review of the Discharge Order Sheet, dated July 12, 2011, at 4:50 p.m., revealed the patient was not discharged on Keppra or other seizure medication. The patient was discharged to a rehabilitation facility.

Review of the facility's policy Verbal and Telephone Orders, number PC - 094, dated as revised February 2008, revealed "...Verbal order: an order accepted by authorized or licensed personnel (i.e. pharmacist, nurse) in an emergency situation from a physician when the physician is present. Telephone order: an order from a physician or his/her designee accepted by an authorized or licensed personnel when the patient's condition does not require the physician's presence in making a medical assessment...If the verbal order or telephone order involves the change (or clarification of) a previously written order, the authorized or licensed personnel shall: Transcribe order clarification...Transcribe the order to discontinue the previous order written by the physician. Transcribe the correct order as given by the physician..."

Interview with the Pharmacy Director, Pharmacy Chief of Operations, Nursing Quality Director, Clinical Quality Improvement Nurse, and Clinical Outcomes Coordinator, in the office of the Emergency Manager, on September 22, 2011, at 10:20 a.m., revealed the Pharmacy Director confirmed the order of July 6, 2011, for Keppra was indicating a onetime order and not a discontinue order yet the pharmacist reviewing and filling the order discontinued the Keppra by mouth twice daily. Continued interview revealed the facility did not have a policy to "hold" medications; only to discontinue and restart. Continued interview confirmed the medication error had not been detected, investigated, or reported.

Interview with the Director of Nursing Quality in the office of the Director of Quality on September 22, 2001, at 1:30 p.m., confirmed the medication error had not been detected, investigated, or reported by pharmacy

C/O # TN
VIOLATION: VERBAL ORDERS AUTHENTICATED BASED ON LAW Tag No: A0457
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, facility policy review, and interview, the facility failed to ensure verbal orders were authenticated by the physician within fourty-eight hours of the order for one patient (#9) of nine patients reviewed.

The findings included:

Medical record review of the History and Physical, dated as dictated and transcribed July 1, 2001, revealed Patient #9 was admitted to the facility's Trauma Intensive Care Unit (TICU) on July 1, 2011, with diagnoses that include [DIAGNOSES REDACTED].2 (normal 98.6), Pulse 151 (normal 80), Blood Pressure 162/116 (normal 120/80), and Respirations 22 (normal 18). Continued review revealed the patient had [DIAGNOSES REDACTED] Concussion to the frontal and occipital areas. Continued review revealed the plan for treatment was DT (Delirium Tremors) protocol, Rehydration, and Neurology consult.

Medical record review of the Physician's orders revealed the following: July 1, 2011, at 5:20 a.m. - Keppra (medication for seizures) 500 mg (milligrams) IV (intravenous) Q (every) 12 hours X (times) 7 days; July 1, 2011, at 4:26 p.m. - change Keppra to 1 G (gram) IV BID (twice daily).

Medical record review of the Progress Note written by the Neurologist, dated July 4, 2011, no time noted, revealed "...on Keppra 1 G BID. Need to continue and can switch to oral when extubated..."

Medical record review of the Physician's Verbal Order, dated July 6, 2011, at 4:45 p.m. - Give next dose of Keppra 1G IV instead of PO (by mouth), patient just extubated (given as a verbal order by Resident - Medical Doctor further specializing education) and order noted as authenticated on July 19, 2011, at 1:44 p.m. (13 days after the verbal order was given)

Review of the facility's policy Verbal and Telephone Orders, number PC - 094, dated as revised February 2008, revealed "...Verbal order: an order accepted by authorized or licensed personnel (i.e. pharmacist, nurse) in an emergency situation from a physician when the physician is present. Telephone order: an order from a physician or his/her designee accepting accepted by an authorized or licensed personnel when the patient's condition does not require the physician's presence in making a medical assessment...The prescribing physician must sign all verbal orders within forty-eight (48) hours...If the verbal order or telephone order involves the change (or clarification of) a previously written order, the authorized or licensed personnel shall: Transcribe order clarification...Transcribe the order to discontinue the previous order written by the physician. Transcribe the correct order as given by the physician..."

Interview with the Director of Nursing Quality in the office of the Director of Quality on September 22, 2001, at 1:30 p.m., confirmed the facility policy for verbal orders was not followed regarding physician authentication of the order within 48 hours.

C/O # TN

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