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Based on review of reports, and staff interviews it was determined the facility failed to take actions aimed at performance improvement and, after implementing those actions, the facility failed to measure its success and track performance to ensure that improvements are sustained affecting 1 of 5 sampled patients (#1).

The findings include:

Review of patient #1 ' s clinical record revealed the patient was admitted to the facility on 05/11/10. The admitting diagnosis was Deep Vein Thrombosis (DVT) of the left lower extremity also known as a clot. Review of the history and physical record dated 05/11/10 revealed the admitting physician's plan was to start the patient on anticoagulation (blood thinning) medications, such as, Lovenox, Coumadin and intravenous (IV) Heparin. The patient was seen by vascular, surgery and hematology physicians and coagulation laboratory tests were performed to monitor the patient's blood for evidence of clotting such as, Prothrombin Time (PT), Partial Thromboplastin Time (PTT) and International Normalized Ratio (INR). On 05/15/10 the patient's coagulation labs were found to be within acceptable range. The patient was discharged from the facility with prescriptions to continue two of the blood thinning medications (Lovenox and Coumadin).

Review of the discharge summary dated 05/18/10 revealed that upon discharge the patient went to the pharmacy to fill his/her prescription. While in the pharmacy, the patient felt as if he/she will " pass out." The patient was brought back to the emergency room (ER) and readmitted to the facility. The summary documents the reason the patient may have experienced the feelings described, was that the patient had a "Vasovagal" episode as result of lying in bed for a while. The patient was restarted on a Heparin drip on return to the facility.

A review of the facility grievance log revealed that a grievance was filed by the patient, related to the administration of an expired bag of IV Heparin solution to him/her while hospitalized on 05/16/10. The clinical record review revealed no documentation related to the allegation.

During an interview conducted with the risk manager on 08/18/10 at 4:35 PM, to determine whether the allegation was investigated and the results of the investigation, the risk manager confirmed the event did occur on 05/16/10. The risk manager stated that a root cause analysis was performed by the facility and a meeting was held with the pharmacy director, the unit director, the charge nurse on the unit and the patient liaison. The RN was called at this time, and although she did not provide information regarding the specific date on which the medication expired, she confirmed that the patient was administered the expired IV Heparin solution. The risk manager stated that upon investigation and review of the Accudose machine data, it was confirmed that a bag of IV Heparin solution was scanned out to the patient at 8:15 PM on 05/16/10. At 5:00 AM on 05/17/10 the IV Heparin was completed and a new bag of IV Heparin was scanned out to the patient at 5:49 AM. It was confirmed the patient received the expired bag of Heparin solution for more than 8 hours. The risk manager stated that after discovering the incident had occurred, the floor stock of IV Heparin was checked, but no additional expired IV Heparin solution bags were found. In addition, the risk manager's investigation revealed that the floor stock on the unit was last checked on March 29th 2010, at which time, 3 expired IV Heparin solution bags were removed.

The risk manager explained and demonstrated the pre-mixed IV Heparin solution bag has 2 labels. The upper right hand corner of the bag is labeled with an expiration date. On the front of the bag, there is a white label noting the following specific information: " Heparin 25,000 units added to 500 mls Dextrose 5% Inj (Injection). Caution: High Risk medication. Note Concentration and Volume. Use as directed. Store at Room Temperature. Exp (Expired) ?/?/? " Since the actual IV Heparin solution bag was not available the risk manager was asked whether the investigation revealed the specific date the IV Heparin bag had expired. The risk manager reported the RN had discarded the expired IV Heparin bag, and when questioned, stated, she was unable to remember the expiration date. The risk manager further stated that neither the RN nor the pharmacy technician paid specific attention to the white medication label on the pre-mixed IV Heparin bag and therefore the error was made. The risk manager was asked what has the facility done to ensure that medications are administered safely by license staff, or that the likelihood of a similar situation occurring is minimal, especially since the facility continues to use the same type of IV Heparin bags. The risk manager was unable to specify actions such as facility wide training of license nursing staff, had been implemented since the incident was confirmed.

During the interview conducted with the risk manager, the Chief Nursing Nursing Officer (CNO) was present. The CNO stated that the RN involved was terminated due to an unrelated incident and that plans are to report the RN to the Department of Health -Division of Licensure. Further inquiry regarding the second incident involving the same RN revealed the incident had to do with a second medication error involving a different patient. The CNO agreed that no interdisciplinary facility wide interventions were put in place to minimize re-occurrence.

An interview was conducted with the pharmacy director on 08/19/10 at 1:35 PM, to determine exactly when did the pre-mixed IV Heparin solution expire and how did the pharmacist miss the expired medication. The pharmacy director stated the pre-mixed IV Heparin solution was shipped to the facility (box of 24) on 01/27/10, and would have expired 3 months after it was prepared, approximately 04/22/10. The director stated that 3 more shipments of the pre-mixed IV Heparin solution were received before 05/16/10 and that no additional IV Heparin bags were found to have stored beyond their expiration dates. The director further stated that upon investigation of the incident, the pharmacy technician acknowledged placing the expired medication in the Accudose machine. The technician admitted to paying attention to the expiration date on the upper right hand corner of the IV Heparin solution bag, instead of the white medication label on the front of the bag of solution. The director provided minutes from a department Continuous Quality Improvement meeting held with staff on 07/23/10, in which inventory management and checking of expiration dates were discussed. The director also stated the medication storage bins were relocated so that the IV Heparin solution bags are more visible and the pharmacy technician has since resigned from the facility.

The facility's Policy, "Medication Administration/Orders" specifies at #5, "the pharmacy monitors medication expiration dates as part of the dispensing process and as part of the monthly floor inspection. It is the nurse's responsibility to also check the expiration date prior to administering any medication." The nurse failed to perform this task. The pharmacy technician failed to monitor for and detect the expired medication when the medication was dispensed and during the stocking of the medication.

The facility failed to take corrective actions aimed at performance improvement as it relates to safe administration of medications by both nursing and pharmacy staff and, after implementing those actions, the facility failed to measure it's success and track performance to ensure that improvements are sustained.

Based on record review and interviews a registered nurse (RN) and pharmacy technician failed to administer drugs in accordance with Federal and State regulations, and facility policy and procedure for 1 of 5 sampled patients (#1).

The Findings Include:

Review of patient #1's clinical record revealed the patient was admitted to the facility on 05/11/10. The admitting diagnosis was Deep Vein Thrombosis (DVT) of the left lower extremity also known as a clot. Review of the history and physical record dated 05/11/10 revealed the admitting physician's plan was to start the patient on anticoagulation (blood thinning) medications, such as, Lovenox, Coumadin and intravenous (IV) Heparin. The patient seen by vascular, surgery and hematology physicians and coagulation laboratory tests were performed to monitor the patient's blood for evidence of clotting such as, Prothrombin Time (PT), Partial thromboplastin Time (PTT) and International Normalized Ratio (INR). On 05/15/10 the patient's coagulation labs were found to be within acceptable range. The patient was discharged from the facility with prescriptions to continue two of the blood thinning medications (Lovenox and Coumadin).

Review of the discharge summary dated 05/18/10 revealed that upon discharge the patient went to the pharmacy to fill his/her prescription. While in the pharmacy, the patient felt as if he/she will "pass out." The patient was brought back to the emergency room (ER) and readmitted to the facility summary documents the reason the patient may have experienced the feeling described, was that the patient had a "Vasovagal" episode as result of lying in bed for awhile. The patient was restarted on a Heparin drip on return to the facility.

A review of the facility grievance log revealed that a grievance was filed by the patient, related to the administration of an expired bag of IV Heparin solution to him/her while hospitalized on 05/16/10. The clinical record review revealed no documentation related to the allegation.

During an interview conducted with the risk manager on 08/18/10 at 4:35 PM, to determine whether the allegation was investigated and the results of the investigation, the risk manager confirmed the event did occur on 05/16/10. The risk manager stated that a root cause analysis was performed by the facility and a meeting was held with the pharmacy director, the unit director, the charge nurse on the unit and the patient liaison. The RN was called at this time, and although she did not provide information regarding the specific date on which the medication expired, she confirmed that the patient was administered the expired IV Heparin solution. The risk manager stated that upon investigation and review of the Accudose machine data, it was confirmed that a bag of IV Heparin solution was scanned out to the patient at 8:15 PM on 05/16/10. At 5:00 AM on 05/17/10 the IV Heparin was completed and a new bag of IV Heparin was scanned out to the patient at 5:49 AM. It was confirmed the patient received the expired bag of Heparin solution for more than 8 hours.

The risk manager explained and demonstrated the pre-mixed IV Heparin solution bag has 2 labels. The upper right hand corner of the bag is labeled with an expiration date. On the front of the bag, there is a white label noting the following specific information: "Heparin 25,000 units added to 500mls Dextrose 5% Inj (Injection). Caution: High Risk medication. Note Concentration and Volume. Use as directed. Store at Room Temperature. Exp (Expired) ?/?/? " Since the actual IV Heparin solution bag was not available the risk manager was asked whether the investigation revealed the specific date the IV Heparin bag had expired. The risk manager reported the RN had discarded the expired IV Heparin bag, and when questioned, stated, she was unable to remember the expiration date risk manager further stated that neither the RN nor the pharmacy technician paid specific attention to the white medication label on the pre-mixed IV Heparin bag and therefore the error was made.

During the interview conducted with the risk manager, the Chief Nursing Officer (CNO) was present. The CNO agreed the RN did not follow policy when she failed to ensure the medication had not expired before administering it.

An interview was conducted with the pharmacy director on 08/19/10 at 1:35 PM, to determine exactly when did the pre-mixed IV Heparin solution expire and how did the pharmacist miss the expired medication. The pharmacy director stated the pre-mixed IV Heparin solution was shipped to the facility (box of 24) on 01/27/10, and would have expired 3 months after it was prepared, approximately 04/22/10. The director further stated that upon investigation of the incident, the pharmacy technician acknowledged placing the expired medication in the Accudose machine. The pharmacy technician admitted to paying attention to the expiration date on the upper right hand corner of the IV Heparin solution bag, instead of the white medication label on the front of the bag of solution.

The facility's Policy, "Medication Administration/Orders" specifies at #5, "the pharmacy monitors medication expiration dates as part of the dispensing process and as part of the monthly floor inspection. It is the nurse's responsibility to also check the expiration date prior to administering any medication." The nurse failed to perform this task which lead to a medication error and the potential for patient #1 to develop more clots and/or delay the patient ' s healing process and ultimate discharge. The pharmacy technician failed to monitor for and detect the expired medication when the medication was dispensed and during the stocking of the medication.

Based on observation and interview the facility failed to keep drugs and biologicals in a locked and secure area unaccessible to unauthorized persons.

The Findings Include:

An observational tour was conducted on of 3 Central Medical/Surgical Telemetry unit at approximately 10:25 AM, accompanied by the Chief Nursing Officer (CNO) and the Administrative Director of Quality Management. Intravenous (IV) solution bags, saline flush syringes, needles and numerous other supplies such as, a linen cart filled with linens, oxygen tanks and laboratory supplies were observed to be stored in the medication room. Upon entering the medication room and while in the medication room, a materials management supply technician was in the room ensuring the central supply carts were fully stocked, a Certified Nursing Assistant entered the room to obtain linens and a transporter entered the medication room. The staff had access to the combination lock and were not accompanied by license staff while in the room.

During an interview conducted with the CNO at approximately 10:25 AM, the CNO confirmed that unlicensed staff enters the medication room on 3 Central, but stated, that medications are locked in the Accudose machine and cannot be accessed by unlicensed personnel.