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Based on record review and interview it was determined the facility failed to maintain an effective and ongoing quality assessment and performance improvement program. Facility staff failed to administer physician ordered anti-seizure medication to a patient from 11/03/12 to 11/06/12. On 11/05/12 the patient experienced seizure activity. The Unit Manager who was responsible for conveying concerns to the Quality Assessment committee failed to notify the Quality Assurance personnel to ensure the concerns with medication administration were addressed. As a result of the failure to monitor medication administration thru the Quality Assessment and Performance Improvement (QAPI) process the facility continued to have patients who were not receiving physician ordered medications due to the medication being unavailable.

The findings include:

On 11/02/12 the facility admitted Patient #11 with a diagnosis of Atypical Pneumonia. Review of the medical record revealed the patient had a physician's order to receive Zonisamide (an anti-seizure medication) 300 milligrams (mg) each day. Facility nursing staff failed to obtain/administer the medication from 11/03/12 to 11/06/12. The patient suffered seizure activity on 11/05/12.

Interview with the Patient Safety Officer (PSO) revealed it was the Unit Manager's responsibility to inform the QAPI program of any identified quality concerns. The PSO had not been notified of the concerns with Patient #11 until 12/06/12.

Interviews with the Unit Manager and Quality Assurance personnel revealed the incident had not been brought to the QAPI program. As a result of the Unit Manager's failure to inform the QAPI program of the missed medications Patient #2 and Patient #7 were not receiving physician ordered medications as current in-patients. According to interview with the Unit Manager, it was her responsibility to inform the QAPI program of patient care concerns and she normally would have informed the QAPI program of the issue but had failed to do so.

(Refer to A0266)

Based on interview and record review it was determined the facility failed to ensure an effective and ongoing quality assessment and performance improvement program. Facility administrative nursing staff were aware of a problem with patient's not receiving physician ordered medications in November 2012; however, staff failed to convey this concern to the facility's quality assessment personnel to ensure problems with unavailable medicatioins were identified and addressed through the Quality Assurance and Performance Improvement (QAPI) program.

The findings include:

Medical record review revealed Patient #11 was admitted to the facility on 11/02/12 with a diagnosis of Atypical Pneumonia. The patient had a physician's order dated 11/02/12 to receive Zonisamide (an anti-seizure medication) 300 milligrams (mg) daily at 9:00 AM. Nursing staff failed to obtain and/or administer the medication from 11/03/12 to 11/06/12. The patient suffered a seizure on 11/05/12. Two (2) additional patients were identified on 12/06/12 who had not received physician ordered medications (Patient #2 and Patient #7) due to the medication being unavailable.

Interview with the facility Patient Safety Officer (PSO) and assistant to Quality Accreditation Director on 12/07/12, at 1:15 PM, revealed the PSO was unaware of the concerns related to Patient #11 until 12/06/12. According to the PSO, the Quality Accreditations Director would receive a listing of complaints thru e-mail. The PSO stated it was the responsibility of the supervisor to address the issues in the Quality Assessment review and to bring any identified quality concerns to the QAPI program. The PSO stated the facility's electronic program would alert the nursing supervisor if a medication error had been entered, however, nursing staff would be required to independently enter the error. The PSO further stated the system would not trigger a medication error if nursing staff entered "not given" on the Medication Administration Record.

Interview on 12/07/12, at 1:20 PM, with the Unit Manager revealed she did not notify the Quality Assurance personnel of the errors related to Patient #11. The Unit Manager stated she did complete an incident report and forwarded that report to the facility Risk Manager but not to the Quality Assurance personnel. According to the Unit Manager, she investigated the concern related to Patient #11 and dealt with the problem as a patient complaint and not a quality assurance issue. The Unit Manager continued that she noted the errors involved different nursing staff on different days and normally that would have been referred to the Quality Assurance personnel but she failed to notify the Quality Assurance staff of the concern. The Unit Manager continued that it was her responsibility to inform the QAPI program of the identified concerns so the problem could be monitored in the programs chart audits. The Unit Manager stated if nursing staff documented a medication was "not given-not available" it was not seen as a medication error. The Unit Manager confirmed she was unaware medications were presently being omitted for current patients. The Unit Manager stated she realized the nursing staff failure to administer/obtain the non-formulary medications and failure to notify the pharmacist and physician was a process issue but failed to inform the QAPI program of the issue.

Based on interview, medical record review, and review of facility policy/procedure it was determined the facility failed to ensure drugs were administered by nursing staff in accordance with the orders of the practitioner responsible for the patient's care. The facility admitted Patient #11 on 11/02/12 with an admitting diagnosis of Atypical Pneumonia. Upon admission Patient #11 had a physician's order to receive Zonisamide (an anti-seizure medication) 300 milligrams (mg) once daily. Nursing staff failed to administer the ordered medication from 11/03/12 to 11/05/12 and the patient suffered seizure activity as documented by the physician on 11/05/12. Although staff were aware they were to contact the patient's physician and the facility pharmacist if an ordered medication was not available, three (3) different staff on three (3) consecutive days failed to notify the physician or pharmacist the medication was not available for the patient. Additionally, two (2) patients (Patient #2 and Patient #7) in the facility at the time of the investigation had physician ordered medications that were not available. Nursing staff had not notified the patients' physician or the facility pharmacist. Based on the findings, Immediate Jeopardy was identified on 12/06/12, and the facility was out of compliance with the Condition of Participation at 42 CFR 482.23 Nursing Services (A0385) and the associated Standard Preparation and Administration of Drugs (A0405).

The findings include:

Patient #11 was admitted to the facility on 11/02/12 with a diagnosis of Atypical Pneumonia. The patient had a physician's order to receive Zonisamide (an anti-seizure medication) 300 milligrams (mg) once a day at 9:00 AM. According to the medication administration record (MAR) for Patient #11, the patient had not received the drug since admission. The medication had been documented as given on 11/04/12; however, the Registered Nurse (RN) confirmed during interview that she had not administered the medication and had documented the administration in error. On 11/05/12 the physician had documented the patient had suffered a seizure due to not receiving the anti-seizure medication and interviews with a RN and the patient's family member confirmed the patient had suffered a seizure.

Interviews with the nursing staff caring for Patient #11 from 11/03/12 to 11/06/12 revealed the staff had failed to obtain and administer the ordered medication and had failed to notify the patient's physician and/or the facility pharmacist that the medication was unavailable. Although the Unit Manager was made aware on 12/06/12 that nursing staff had failed to obtain and/or administer an ordered medication for Patient #11 the Unit Manager failed to provide education and monitoring to ensure patient's received medications as ordered.

On 12/06/12 two (2) additional patients had not received physician ordered medications. Patient #2 was admitted to the facility on 12/04/12 with a physician order to receive EEMT HS 0.625 mg (a hormone replacement drug) daily, however, the patient had not received the medication from admission to the date of the survey 12/06/12. Patient #7 had been admitted to the facility on 12/04/12 with a physician order to receive Effient (used for the reduction of thrombotic cardiovascular events) 10 mg daily but as of 12/06/12 the patient had not received the medication. Nursing staff had failed to notify the patients physician and/or the facility pharmacist until 12/06/12.

(Refer to A0405)

Based on interview, record review and review of facility policy/procedure it was determined the facility failed to ensure medication was administered in accordance with physician orders for three (3) of twelve (12) sampled patients (Patient #2, #7 and #11). The facility admitted Patient #11 on 11/02/12 with a diagnosis of Atypical Pneumonia. The patient had a physician's order dated 11/02/12 to receive Zonisamide (an anti-seizure medication) 300 milligrams (mg) once daily. Facility staff failed to notify the patient's physician or the facility pharmacist that the medication was unavailable and staff failed to obtain and/or administer the medication from 11/03/12 until 11/06/12. Patient #11 suffered a seizure on 11/05/12. Additionally, Patient #2 was admitted to the facility on 12/04/12 with a physician order to receive EEMT HS 0.625 mg (a hormone replacement drug) daily, however, the patient had not received the medication from admission to the date of the survey 12/06/12. Patient #7 had been admitted to the facility on 12/04/12 with a physician order to receive Effient 10 mg daily but as of 12/06/12 the patient had not received the medication (Effient is indicated to reduce the rate of thrombotic {clot formation} cardiovascular events in patients with acute coronary syndrome).


The findings include:

1. Review of the facility policy/procedure "Formulary-Non-Formulary Drugs (Prescribing and Procuring)" dated as revised October 2011, revealed a pharmacist would review requests for non-formulary drugs. Further review of the policy/procedure revealed if a prescriber ordered drugs that were not listed in the formulary, the pharmacy would review formulary alternatives with the prescriber. If an alternative drug was not acceptable, the pharmacy would obtain the non-formulary drug from another hospital, community pharmacy, patient's own medication, or other approved source.

Review of the medical record of Patient #11 revealed the facility had admitted the patient from a Long Term Care facility on 11/02/12 with a diagnosis of Atypical Pneumonia. Review of the physician's orders for Patient #11 dated 11/02/12 revealed the patient was to receive Zonisamide 300 mg once daily. Review of the Medication Administration Record (MAR) for Patient #11 from 11/03/12 until 11/06/12 revealed on 11/03/12 Registered Nurse (RN) #1 documented the 9:00 AM scheduled dose of Zonisamide as "not given patient to bring in". On 11/04/12 staff had documented the patient had received the medication at 9:00 AM, however; during an interview with Registered Nurse #1 it was revealed the nurse documented the medication as given but the medication had not been given and was not available. On 11/05/12 staff had documented the scheduled 9:00 AM dose of Zonisamide was not given and the patient had been educated to bring the medication to the facility. Further review of the MAR revealed the Zonisamide was documented as "Patient's own med -please notify pharmacy if patient does not bring in".

Review of the physician's progress notes dated 11/06/12 revealed the physician had documented the patient had a questionable seizure event the previous day with shaking in her leg and twitching. The physician continued that the patient had received a dose of Ativan for the seizure activity. According to the progress note the patient had been receiving Zonisamide at the Long Term Care facility for partial seizure but had not received the medication since admission. Further review of the physician's progress notes revealed the patient's family member "picked up" the medication from a retail pharmacy as it was not available on formulary in the hospital.

Interview on 12/06/12, at 2:00 PM, with Registered Nurse (RN) #3 revealed she had been responsible for the care of Patient #11 on 11/03/12. According to RN #3 she did not administer the Zonisamide to Patient #11 as the medication was not available. RN #3 confirmed she did not contact the patient's physician or the facility pharmacist. The RN stated normally during the week she would contact the pharmacist if the medication was not available but as 11/03/12 was the weekend she just documented the medication was not available. RN #3 stated she was not sure what the medication was for or what the consequences were for the patient if it was not given.

Interview on 12/06/12, at 3:05 PM, with RN #1 revealed she had been responsible for the care of Patient #11 on 11/04/12. According to RN #1, the patient's medication was a non-formulary medication and was not available. RN #1 confirmed she had documented the medication as administered when in fact she had not given the medication to Patient #11. The RN stated staff were required to notify the facility pharmacist when a medication was not available and the patient did not bring the medication from home. RN #1 revealed during the interview she was unaware the patient was receiving Zonisamide to prevent seizures. RN #1 confirmed she did not notify the facility pharmacist as required and did not notify the patient's physician.

An interview was conducted on 12/06/12, at 2:50 PM with RN #4. The RN revealed she had been the Charge Nurse on 11/04/12 and worked again on 11/06/12. According to RN #4 it was the primary nurse's responsibility for ensuring patient medications were available and given. RN #4 stated she was not made aware on 11/04/12 that the patient's medication was not available and had not been given. According to RN #4, on 11/06/12 Patient #11's primary nurse informed her the patient had not been receiving the Zonisamide.

Interview with RN #2 on 12/06/12, at 2:07 PM, revealed she had been responsible for the care of Patient #11 on 11/05/12. RN #2 confirmed she was aware on 11/05/12 that Patient #11 had not been receiving the Zonisamide as ordered. According to the RN the Zonisamide was a non-formulary drug and was not available at the facility. RN #2 stated staff routinely request patient's and/or patient family members to bring non-formulary medications from home and staff dispense the medications while the patient remains in the hospital. RN #2 confirmed staff were to notify the facility pharmacist if an ordered medication was not available and she had not notified the pharmacist and did not administer the medication on 11/05/12. The RN stated she did make the physician aware the patient had not received the medication during the physician's rounds. RN #2 further stated the patient was also receiving Kepra which was an anti-seizure medication and she "assumed" the patient would be okay without the Zonisamide.

An interview was conducted with RN #5 on 12/06/12, at 3:40 PM. During the interview RN #5 confirmed she had worked the 7:00 PM to 7:00 AM shift on 11/05/12. According to RN #5, during shift report RN #2 left report to check a patient and when she returned she informed RN #5 that Patient #11 had suffered a seizure. RN #5 stated after she finished with the shift report she began checking the medical record of Patient #11 and found the patient had not received the Zonisamide since admission. RN #5 notified the on-call pharmacist and the on-call Advanced Practice Registered Nurse (APRN) responsible for Patient #11. According to RN #5, staff were unable to obtain the medication that evening but she made the on-coming shift aware they needed to obtain the medication the next morning.

Interview with Licensed Practical Nurse (LPN) #1 on 12/06/12, at 3:25 PM, revealed she had been responsible for the care of Patient #11 on 11/06/12. LPN #1 stated she became aware that morning during shift report that the patient had not received the ordered Zonisamide since admission. LPN #1 confirmed she notified the facility pharmacist and the medication was administered that day. According to LPN #1, she was aware the patient required the medication to prevent seizure activity. The LPN stated it was the responsibility of the primary nurse caring for the patient to inform the pharmacist and physician that a non-formulary medication was not available.

Interview 12/06/12, at 3:15 PM, with the APRN responsible for Patient #11 during the weekend of 11/03/12 to 11/05/12 revealed staff had not informed her the patient had not received the Zonisamide since admission. According to the APRN, Patient #11 required the Zonisamide to prevent seizures. The APRN stated if she had been informed the medication was not available she would have instructed staff to notify the pharmacy to obtain the medication.

Interview with the facility Director of Pharmacy on 12/06/12, at 2:40 PM, revealed when a patient has an order for a non-formulary medication staff would request the patient and/or family bring the home medication into the facility and staff would dispense the medication. The Director of Pharmacy continued that all newly ordered medications were reviewed by a pharmacist and if the ordered medication is a non-formulary medication, the medication is flagged on the MAR to indicate nursing staff were to notify the physician and the pharmicist if the medication was not available. The Director of Pharmacy stated it was nursing staff responsibility to inform the pharmacy if medication could not be obtained from the family and the pharmacy would obtain the medication for the patient. According to the Director of Pharmacy, nursing staff did not notify the pharmacist until Sunday evening 11/05/12 that the medication was not available. The Director of Pharmacy stated if nursing staff document the medication was not given it would not "flag" the pharmacist. The Director of Pharmacy confirmed that the pharmacy would have obtained the medication from a retail pharmacy if nursing staff had notified the pharmacy that the medication was unavailable.

An interview was conducted on 12/06/12, at 4:10 PM with the Unit Manager for the third floor nursing unit. The Unit Manager stated she was made aware on 11/06/12 that the patient had not received the ordered anti-seizure medication since admission. The Unit Manager confirmed staff were required to notify the pharmacist and herself that the medication was not available. Staff had failed to notify the pharmacy and the Unit Manager. According to the Unit Manager, she reviewed the medical record and determined the problem encompassed more than one staff member. The Unit Manager informed the staff at their monthly November staff meeting of the concerns identified with Patient #11. The Unit Manager stated she dealt with the concern as a complaint and felt the concern had been resolved. The Unit Manager was unaware the patient had suffered a seizure in the facility.

2. Review of the medical record of Patient #2 revealed the patient had been admitted to the facility on 12/04/12 with a diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease and probable Pneumonia. Review of the MAR for Patient #2 revealed a physician's order dated 12/04/12 for EEMT HS 0.625 mg to be administered once daily at 9:00 AM. The following statement was documented on the MAR; "If patient does not have, please inform MD". Further review of the MAR from 12/04/12 to 12/06/12 revealed no evidence staff had administered the medication on 12/05/12 or notified the physician the medication was not available. Further review of the medical record revealed the physician had not been notified until 12/06/12 at 11:12 AM that the medication was unavailable.

3. Review of the medical record of Patient #7 revealed the patient had been admitted to the facility on 12/04/12 with diagnoses of Chest Pain, Rule Out Myocardial Infarction and Pneumonia. Further review of the medical record revealed a physician's order for Effient 10 mg daily at 9:00 AM (Effient is indicated to reduce the rate of thrombotic {clot formation} cardiovascular events in patients with acute coronary syndrome).

Review of the MAR for Patient #7 revealed the patient had not received the medication since admission and the physician had not been notified until 12/06/12 at 11:05 AM.

Interview with RN #2 on 12/06/12, at 10:05 AM, revealed the RN was responsible for patient care on 12/06/12. According to RN #2, staff were to request patients to bring non-formulary medications from home. If the medications were not available staff were to notify the pharmacy and the physician. RN #2 confirmed she had not notified any physician that day that medications were not available related to Patient #2 and Patient #7.

Interview with RN #6 on 12/06/12, at 2:25 PM, revealed the RN was functioning as the charge nurse on 12/06/12. According to RN #6, if medications were not on the hospital's formulary staff were required to ask the patient and/or family to bring the medication from home. If the medications can not be obtained from the patient or family the physician would be notified and the physician would substitute another medication or discontinue the medication. RN #6 stated staff had requested upon admission for Patient #2 and Patient #7 and or family members bring medications from home for the non-formulary medications ordered. RN #6 stated she had notified the physician's for Patient #2 and Patient #7 on 12/06/12 that the patients had non-formulary medications that were not available.

Interview with the Unit Manager on 12/06/12, at 4:10 PM, revealed the Unit Manager was unaware Patient #2 and Patient #7 had not received physician ordered medication. According to the Unit Manager staff should have notified the pharmacy that the medication was not available from home.