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21644 STATE RD 7

BOCA RATON, FL 33428

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on medical record review and interview the facility failed to administer medications in accordance to accepted standards of practice, facility failed to verify that drug and dosage are correct and that medications are administered as ordered for 5 of 12 sampled patients (Patients #1, #2, #3, #4 and #11).


The findings include:


1) Review of Patient # 2's clinical record was conducted on 08/09/11. Patient # 2 was admitted to the hospital on 06/16/11 with diagnosis of Transient Ischemic Attack (TIA).
Admitting Physician Orders dated 06/16/11 documented as follows: " Admit to telemetry floor for diagnosis of Transient Ischemic Attack....See medication reconciliation sheet."

Review of the Medication Reconciliation Form dated 06/16/11 documented the home medications as follows: Oxycodone HCL 30 mg every four hours, six times per day. The action on admission documented as to continue the medication. Zulpidermitrate 10 mg daily. The action on admission documented as to continue the medication.

Review of the Medication Administration Record dated 06/16/11 and 06/17/11 failed to document the administration of drug "Zulpidermitate 10 mg daily. " The record revealed Patient # 2 received three doses of Oxycontin 30 mg on 06/17/11 at 0130, 0600 and 1300. Patient refused the dose scheduled at 1000.

Further review of the record failed to provide an explanation why the medication "Zulpidermitate" was not carried thru to the medication administration record, clarified or discontinued.

Interview with the Patient Advocate was conducted on 08/09/11 at 1453. The advocate stated the wife filed a grievance related to the patient ' s medications. The Advocate stated the wife claimed the patient received oxycontin instead of Oxycodone. The Advocate presented a response letter to the grievance dated 07/08/11. In addition the Advocate stated the patient ' s wife was upset because she claimed to have filed a grievance on line, but she never received that original grievance The letter documented: "You were administered the sustained release form of the medication, Oxycodone, instead of the immediate release from that was ordered. Hospital staff involved have been made aware and steps have been taken to help prevent this from occurring in the future".


Phone interview with the Registered Nurse (RN # 1) assigned to care for Patient # 2 on 06/17/11 was conducted on 08/09/11 at 1624. RN # 1 stated Patient # 2 had no complaints of feeling sick. The Nurse stated she realized there was a mistake with the medications, when she was discharging the patient home. The RN stated as she went over the medications the patient stated he does not take Oxycontin. The RN stated she contacted the pharmacy and obtained further clarification. The RN stated the medication was changed to Oxycodone 30 mg. The nurse stated she has given one dose of Oxycontin earlier that day and she advised the patient to take the next dose 12 hours later.

Interview with the Director of Pharmacy and the Compliance and Privacy Officer was conducted on 08/10/11 at 0811. The Director stated he is not familiar with drug "zulpidermitate." He stated he could not explain why the medication was not carried thru as listed on the reconciliation sheet. The Director stated the process to obtain drugs that are not part of the hospital formulary is to contact the physician for a possible substitution, if the physician does not want a substitute, the hospital would obtain the prescribed medications. The Director added if the physician decides to hold or discontinue a medication an order would be written. The Director stated the other option is to have the family bring their own medication. The Director stated that would be noted on the Medication Administration Record as "patient's own medication".
The Director was asked if he was familiar with the incident related to the use of Oxycontin instead of Oxycodone. The Director stated he was made aware of the incident when the grievance was filed. The Director stated the pharmacist on duty transcribed Oxycontin 30 mg every 4 hours instead of Oxycodone 30 mg every 4 hours. The Director added as soon as the nurse made the pharmacist aware a correction was made and the order for Oxycontin was stopped. The Director stated he did not complete an incident report for this event. He stated he has spoken to the pharmacist on duty and advised her to be careful when selecting drugs with similar names.
The Director stated the pharmacy computer system is able to flag abnormalities but he was not sure if that happens on this incident or if the pharmacist had overridden the flag. As a corrective action the pharmacist stated he added the description of sustained release to the drug for additional identification. The pharmacist stated he would consider the incident a medication error but if he had to choose between errors he would pick this one, extended release vs. immediate release of a drug. In his professional opinion he considered this incident a low level error. The Director stated medication errors are tracked thru the Esrm system.

Interview with the Director of Telemetry was conducted on 08/10/11 at 1030. The director stated she was made aware of the error when the spouse filed a grievance. The Director stated the nurses received educational counseling and in addition, she brought the incident during the staff meeting so all another nurses can learned from it.

Review of the Omnicell report dated 06/16/11 and 06/17/11 revealed Patient # 2 received three doses of Oxycontin 30 mg.

Interview with The Director of Nursing was conducted on 08/10/11 at 9:50 AM. The Director stated the reconciliation sheets are initiated in the emergency department. She stated the nurse has the ability to type in the drug and to select the drug from a drop down menu. The Director stated if a drug is not in the formulary, the pharmacy would print the drug on the medication administration record, and it would appear as not in formulary. " Patient own medication or something similar". The Director stated the nurse is responsible for doing 12 or 24 hour checks and to go over every medication on the reconciliation sheet. If the nurse finds any discrepancies she is to contact the pharmacy and to obtain clarification. The Director stated if she was that nurse she would document the interaction with the pharmacy on the nurses notes. The DON added if the nurse gets clarification from the physician she would expect documentation on the physician order sheets.


2) Review of Patient # 3's clinical record was conducted on 08/10/11. Patient # 3 was admitted to the facility on 7/9/11 with diagnosis of Transient Ischemic Attack.
Medication Reconciliation Form dated 07/09/11 documented Ambien 10 mg nightly. Review of the Medication Administration Record (MAR) revealed the medication was not initialed or circled by the nurse on 07/09/11. The MAR documented Ambien 10 mg PRN and then the PRN was scratched off. Interview with the Director of Telemetry was conducted on 08/10/11 at 1115. The Director stated she researched Patient # 3's medications. The Director stated Ambien 10 mg was not given after researching thru the pharmacy reports. The Director stated the patient had another drug named Trazadone at bedtime, and he probably refused the Ambien. The Director was not able to locate any documentation to support why the drug was not given as ordered.


3) Review of Patient # 4's clinical record was conducted on 08/10/11. Patient # 4 was admitted to the facility on 07/05/11 with diagnosis of L2 fracture. Medication Reconciliation Form dated 07/07/11 documented Amlodipine Besylate 2.5 mg with action to continue upon admission. Review of the Medication Administration Records dated 07/05/11 thru 07/11/11 failed to document the medication was given. Further review of the clinical record failed to provide a physician order to discontinue the drug or documentation to support the omission of the drug ordered.
Review of the Adult Services Flowsheet dated 07/05/11-07/06/11 documented Patient # 4's blood pressure as follows: At 1200 132/67. At 1600 149/69. At 2400 165/76 and at 0400 169/75.
Review of the Adult Services Flowsheet dated 07/07/11-07/08/11 documented Patient # 4's blood pressure as follows: At 0800 156/69. At 2000 153/71.
Review of the Adult Services Flowsheet dated 07/08/11-07/09/11 documented Patient # 4's blood pressure as follows: At 0800 149/76. At 2000 145/80.
Review of the Adult Services Flowsheet dated 07/09/11-07/10/11 documented Patient # 4's blood pressure as follows: At 1200 144/70 and at 0400 178/106. (The nurse documented patient having a panic attack). The following blood pressure reading on 07/10/111 at 0800 was 123/67 and at 12 noon the blood pressure was documented as 136/69.

Interview with The Director of Nursing (DON) was conducted on 08/10/11 at 1548. The DON was asked to review Patient # 4's clinical record and to explain the discrepancy related to the Amlodipine 2.5 mg. The DON reviewed the record and stated the patient was supposed to get the medication. She could not locate any documentation related to the omission or the discontinuation of the drug. The DON verbalized the nurse is responsible for doing 12 or 24 hour checks and to go over every medication on the reconciliation sheet.



4) Review of Patient # 11's clinical record was conducted on 08/10/11. Patient # 11 was admitted to the facility on 08/04/11 with diagnosis of chest pain, dizziness and arrhythmia.
Physician Order dated 08/04/11 documented Prilosec 20 mg daily. Physician Order dated 08/05/11 documented Prilosec 20 mg daily.
Review of the Medication Administration Record (MAR) dated 08/05/11 documented Patient # 11 received Prilosec 20 mg at 0900. The nurse documented another dose of Prilosec 20 mg was given at 2100.
Interview with the Director of Telemetry was conducted on 08/10/11 at 1115. The Director was asked to verify if patient # 11 received two doses of Prilosec on 08/05/11. The Director stated she attempted to contact the nurse on duty. The Director stated she was not able to find any documentation on the record to validate that additional dose. The Director stated she was not able to explain the duplicate administration.



5) Review of Patient # 1's clinical record was conducted on 08/09/11. Patient # 1 was admitted to the facility on 06/18/11 to the Intensive Care Unit (ICU), with diagnosis of Community Acquired Pneumonia and Chronic Obstructive Pulmonary Disease (COPD) Exacerbation.
Review of the Physician Order dated 06/21/11 documented change Doribax (antibiotic) 500 mg intravenously to every 8 hours. Review of the Medication Administration Record (MAR) dated 06/21/11 documented Doribax 500 mg was administered at 0900. The MAR noted the change and a new entry was written Doribax 500 mg intravenously every 8 hours. The next scheduled time for administration was documented as 1800 and 0200. The 1800 was initialed as given. The 0200 dose was not initialed or circled.
Review of the MAR dated 06/22/11 documented the Doribax 500 mg intravenous antibiotic was administered at 0900 and at 2200. Review of the MAR dated 06/23/11 thru 06/26/11 documented Doribax 500 mg intravenously was administered every 12 hours at 0900 and 2200.
Interview with the Director of the Intensive Care Unit was conducted on 08/10/11 at 1315. The Director stated that the physician order dated 06/21/11 was never scanned to the pharmacy and that is why the subsequent administration records noted the antibiotic was to be given every 12 hours instead of 8. In addition the Director stated the error occurred during the transfer to the telemetry unit. The Director stated she was going to gather more details by reviewing the pharmacy computerized system. The Director returned at approximately 1500 and she stated she was not able to determine if the dose scheduled on 06/22/11 at 0200 was given. In addition she verbalized the patient was scheduled for a transfer a few days prior, but due to bed availability the transferred did not occur until 06/22/11. The Director stated the medication reconciliation sheet documented the antibiotic as every 12 hours, and this information was from 06/20/11. The Director stated the nurses are supposed to reconcile medications for the day of transfer and verify the reconciliation sheet during chart checks. The Director acknowledged the medication was never changed to the ordered 8 hour frequency.

Review of the Physician Orders titled "Subcutaneous Insulin Orders" dated 06/23/11 revealed an order to discontinue all previous insulin regimens, give bedtime snack, do not cover blood glucose at 3 AM, medium subcutaneous supplemental insulin algorithms or sliding scale, give insulin NPH 8 units with each dose of Medrol 8 mg scheduled every morning and contact physician with blood glucose tonight.

Review of the Medication Administration Record dated 06/23/11 revealed an entry to discontinue insulin NPH 8 units with Medrol dose as per physician. The entry was dated 06/23/11 at 2200.

Further review of the record failed to document a Physician Orders to discontinue the insulin NPH 8 units with Medrol dose.

Review of the Medication Administration Record dated 06/24/11 revealed insulin NPH 8 units with Medrol dose discontinued by physician. The record documented the insulin was not given.

Review of the Physician Orders titled "Subcutaneous Insulin Orders" dated 06/24/11 at 1520 revealed an order to discontinue all previous insulin regimens, give bedtime snack; do not cover blood glucose at 3 AM, low subcutaneous supplemental insulin algorithms or sliding scale.

Review of the Medication Administration Record dated 06/24/11 revealed the subcutaneous supplemental insulin algorithm or sliding scale was not updated as per the physician order dated 06/24/11.

Review of the Medication Administration Record dated 06/25/11 and 06/26/11 revealed insulin NPH 8 units with Medrol dose was administered each day at 0900. The record also revealed the subcutaneous supplemental insulin algorithm or sliding scale was not updated as per the physician order dated 06/24/11.

Patient # 1 received 3 units of insulin on 06/24/11 at 1830 for blood sugar of 200-249. The physician order dated 06/24/11 documented the patient was ordered to receive 2 units of insulin for blood sugar of 200-249.
Patient # 1 received 5 units of insulin on 06/25/11 at 1200 for blood sugar of 250-299. The physician order dated 06/24/11 documented the patient was ordered to receive 3 units of insulin for blood sugar of 250-299.

Phone interview with the Hospital Compliance and Privacy Officer was conducted on 08/11/11 at approximately 2 PM. The Officer was asked to explain the discrepancy related to the insulin orders dated 06/24/11. The Officer requested sometime to research the record. The Officer returned the call on 08/12/11 at 1220 and she acknowledged the MAR was not updated as per the physician orders.


Review of the Facility Policy and Procedure titled " Medication Reconciliation" revealed the following: Purpose: Patients are at a higher risk for medication errors during transition in care across settings services, providers or level of care. The development, reconciliation and commutation of an accurate allergy and medication list throughout the continuum of care is essential in the reduction of transition related medication errors.
Policy: All medications (including prescription, non-prescription herbals, vitamins and nutriceuticals) will be reconciled upon an initial patient encounter, upon transition in care setting and upon discharge or transfer. The patient should be an integral participant in the medication reconciliation process and has requested assistance from another person (e.g., family member, significant other, surrogate decision maker), the authorized person is then involved in the medication reconciliation process. This involvement should occur at all interfaces of care, and on admission to and discharge from the facility.
Procedure: The nurse will obtain and document a complete list of current patient's allergies and medications on the medication reconciliation form.
The physician indicates on the medication reconciliation order form if the medication is to be continue, discontinue or change on admission.
Scan the reconciliation order form to pharmacy.
Pharmacy will process the physician orders, clarify with the physician as needed and reconcile allergies noted on the form.
Daily reconciliation will take place using the chart check process and will include the Transfer Medication Summary Form.

Review of the Facility Policy and Procedure titled "Medication Errors" revealed the following:
The purpose of the policy is to define a medication error and ensure occurrences are documented.
Policy: all actual or potential errors identified will be documented through the hospital's risk management system.
Procedure: a medication error can be defined as, but not limited to any of the following: A drug different from that prescribed, the incorrect dosage of a prescribed drug, mediation administered at the wrong time, failure to administer a medication, and others.


Review of the Facility Policy and Procedure titled "Administration and Documentation of Medications" revealed the following:
Purpose: To set guidelines for the administration of medications.
Policy: All medications should be reordered after surgery and upon transfer to a different level of care.
Procedure: When a physician wishes a patient to continue medications they were taking at home, he/she will write orders for the specific mediations. If the physician writes an order to continue the same medications as the patient takes at home without specifying the medication, the nurse will query the patient as to the medications taken at home, call the physician and confirm that these medications are to be given and transcribe as a telephone order.
Processing/transcribing orders: The original copy will be scanned to the pharmacy or faxed if the scanning system is unavailable or transported in the event of power failure. The nurse will transcribe the physician order to include: start date and date to be discontinued, name of medication, route, dosage and frequency of administration.
Medication Administration Record: The new MAR shall be checked against the expired MAR and shall reflect the signature of the verifying nurse. As the nurse administers each medication he/she will note the following: enter time given, initials, first initial and last name at the bottom of the MAR and shift worked and injection site used if applicable.

Review of the Facility Policy and Procedure titled "Avoiding Look Alike/Sound Alike Medication Errors" revealed the following:
Purpose: To provide an organization wide drug safety policy to prevent Look Alike/Sound Alike Medication Errors as recommended by the National Coordinating Counsel of Medication Error Reporting and Prevention, JCAHO and the Institute for Safe Medication Practices.
Policy: Medications identified to have a potential to cause a Look alike/Sound alike error will be evaluated in an ongoing fashion.
When such a medication is identified, an alert message will be crated in the pharmacy computer system to alert nurses, pharmacist and their health care professional to the potential error. The nursing alert message will print on the MAR and the pharmacy message will be available at the time of the order entry.
Pharmacists will use a double check system during order entry.
All hospital staff is encouraged to report actual as well as potential errors.
Focus medications included Oxycontin/Oxycodone.

PHARMACY: REPORTING ADVERSE EVENTS

Tag No.: A0508

Based on medical record review and interview the facility failed to report a medication error to the attending physician and to the hospital-wide quality assurance program for 1 of 12 sampled patients (Partient #2).

The findings include:

Review of Patient # 2's clinical record was conducted on 08/09/11. Patient # 2 was admitted to the hospital on 06/16/11 with diagnosis of Transient Ischemic Attack (TIA).
Admitting Physician Orders dated 06/16/11 documented as follows: " Admit to telemetry floor for diagnosis of Transient Ischemic Attack. Neurological consult, MRI/MRA of the brain, Aspirin 325 mg daily, Zocor 20 mg daily, Physical Therapy evaluation and treatment and see medication reconciliation sheet. "

Review of the Medication Reconciliation Form dated 06/16/11 documented the home medications as follows: Oxycodone HCL 30 mg every four hours, six times per day. The action on admission documented as to continue the medication.

Interview with the Patient Advocate was conducted on 08/09/11 at 1453. The advocate stated the wife filed a grievance related to the patient's medications. The Advocate stated the wife claimed the patient received oxycontin instead of Oxycodone. The advocate stated she forwarded the grievance to the director of the unit for follow up. The Advocate stated the grievance was filed on 06/21/11 and the investigation was completed and they acknowledged the error. The Advocate presented a response letter to the grievance dated 07/08/11. The letter documented: "You were administered the sustained release form of the medication, Oxycodone, instead of the immediate release from that was ordered. Hospital staff involved have been made aware and steps have been taken to help prevent this from occurring in the future".

Phone interview with the Registered Nurse (RN # 1) assigned to care for the patent on 06/17/11 was conducted on 08/09/11 at 1624. The RN stated the patient had no complaints of feeling sick during her shift. The RN stated she realized there was a mistake with the medications, when she was discharging the patient home. The RN stated as she went over the medications with the patient, he stated he does not take Oxycontin. The RN stated she contacted the pharmacy and obtained further clarification. The RN stated the medication was changed to Oxycodone 30 mg. The nurse stated she has given one dose of Oxycontin earlier that day and she advised the patient to take the next dose 12 hours later.

Interview with the Director of Pharmacy and the Compliance and Privacy Officer was conducted on 08/10/11 at 0811. The Director was asked if he was familiar with the incident related to the use of oxycontin instead of Oxycodone. The Director stated he was made aware of the incident when the grievance was filed. The Director stated the pharmacist on duty transcribed oxycontin 30 mg every 4 hours instead of Oxycodone 30 mg every 4 hours. The Director added as soon as the nurse made the pharmacist aware of the incident, a correction was made and the order for oxycontin was stopped. The Director stated he did not complete an incident report for this event. He stated he has spoken to the pharmacist on duty and advise her to be careful when selecting drugs with similar names.
The Director stated the pharmacy computer system is able to flag abnormalities but he was not sure if that happens on this incident or if the pharmacist had overridden the flag. As a corrective action the pharmacist stated he added the description of sustained release to the drug for additional identification. The pharmacist stated he would consider the incident a medication error but if he had to choose between errors he would choose this one, use of extended release vs. immediate release of a drug. In his professional opinion he considered this incident a low level error. The Director stated medication errors are tracked thru the Esrm system, but he acknowledged this incident was not reported by the pharmacy. The Compliance/Privacy officer confirmed there was no incident report on file for this incident.

Review of the Medication Administration Record dated 06/17/11 revealed the warning to medication Oxycontin "Sustained Release Form- Not for PRN use " . Was already in place at the time of the incident. Review of the Nurses Notes dated 06/16/11 thru 06/17/11 failed to document the physician was notified of the incident.

Interview with the Director of Telemetry was conducted on 08/10/11 at 1030. The director stated she was made aware of the error when the spouse filed a grievance. The Director stated she takes grievances very seriously and she had spoken to the nurses involved. The Director stated the nurses received educational counseling and in addition, she brought the incident up during the staff meeting so all nurses can learn from it. The Director stated the incident was not reported in the Esrm system (incident report system). The Director stated she did not have any documentation to support the physician was notified of the incident.

Review of the Facility Policy and Procedure titled "Medication Errors" revealed the following:
The purpose of the policy is to define a medication error and ensure occurrences are documented.
Policy: All actual or potential errors identified will be documented through the hospital's risk management system.
Procedure: a medication error can be defined as, but not limited to any of the following: A drug different from that prescribed, the incorrect dosage of a prescribed drug, mediation administered at the wrong time, failure to administer a medication, and others.


Review of the Facility Policy and Procedure titled "Avoiding Look Alike/Sound Alike Medication Errors" revealed the following:
Purpose: To provide an organization wide drug safety policy to prevent Look Alike/Sound Alike Medication Errors as recommended by the National Coordinating Counsel of Medication Error Reporting and Prevention, JCAHO and the Institute for Safe Medication Practices.
Policy: Medications identified to have a potential to cause a Look alike/Sound alike error will be evaluated in an ongoing fashion.
When such a medication is identified, an alert message will be crated in the pharmacy computer system to alert nurses, pharmacist and their health care professional to the potential error. The nursing alert message will print on the MAR and the pharmacy message will be available at the time of the order entry.
Pharmacists will use a double check system during order entry.
All hospital staff is encouraged to report actual as well as potential errors.
Focus medications included Oxycontin/Oxycodone.