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Tag No.: A0491
Based on observation and staff interview conducted on July 26, 2017, it was determined that the facility failed to ensure that only pharmacists or pharmacy-supervised personnel label drugs.
Findings include:
1. During an observation in the medication room on 5 North, it was noted that pharmacy labels were partially affixed to the outerwrap of Magnesium Sulfate 2 gram Intravenous solution bags.
2. Upon interview, Staff #6 stated the nurse would remove the pharmacy label from the outerwrap and place it on the inside bag just prior to administration.
a. Pharmacy labels are affixed to containers prior to being dispensed from the pharmacy. The label includes patient information but also the initials of the pharmacist who dispensed and verified the medication.
b. Once this process is completed, the label cannot be removed by a nurse and placed onto a different container since he/she is not under the supervision of the pharmacist.
3. This finding was confirmed by Staff #6.
Tag No.: A0494
Based on observation, staff interview, and document review conducted on July 26, 2017, it was determined that the facility failed to ensure the accountability of Controlled Dangerous Substances (CDS).
Findings include:
Reference #1: Facility policy titled "Controlled Drugs: Non-Automated and Automated Dispensing Units" states, "... D. Administration: ... 2. Controlled substances are removed for one patient at a time, and administered immediately. ...G. Wasting: ...7. A second nurse then enters his/her code as the witness to the waste and observes the waste."
Reference #2: Facility policy titled "Procedure for Medication Administration and Returning of Non-Controlled Substances" states, "...Controlled substances are removed for one patient at a time, and administered immediately."
1. Review of the Narcotic Transaction Record for Patient #1 revealed the following discrepancies when compared with Medical Record #1:
a. On 7/22/17, two (2) vials of Fentanyl 100 mcg were taken out of the Omnicell, a drug dispensing device. Medical Record #1 indicated that one (1) vial of Fentanyl 100 mcg was administered to Patient #1. There was no record of a return transaction for the remaining one vial of Fentanyl 100 mcg at the time of the transaction. It was recorded that one vial of Fentanyl 100 mcg was returned three days later, on 7/25/17.
i. Upon interview, Staff #8 stated that he/she had no one to witness his/her return transaction on 7/22/17, so she/he kept it in his/her locker and returned it on his/her next working day, which was three days later.
b. Review of the Anesthesia Record for Patient #1 indicated that, on 7/22/17, one (1) mg of Hydromorphone was administered. The Narcotic Transaction Record for Patient #1 indicated that, on 7/22/17, one (1) Hydromorphone 1 mg (milligram)/ 1 ml (milliliter) syringe was taken out of the Omnicell and the Narcotic Waste Transaction Record indicated that 1 mg of Hydromorphone 0.5 mg/ 0.5 ml syringe was wasted for Patient #1. If one (1) syringe of Hydromorphone 1 mg/ 1 ml was taken out and administered for Patient #1, there should not have been any waste. The records do not reconcile.
i. Upon interview, Staff #8 stated that he/she thought that she/he had removed one syringe of Hydromorphone 2 mg/ 1 ml, instead of Hydromorphone 1 mg/ 1 ml. He/she stated that he/she documented the administration of 1 mg (0.5 ml) of Hydromorphone when in fact he/she had administered 0.5 mg. This error resulted in the wastage documented as 1 mg instead of 0.5 mg. The quantity of fluid wasted was 0.5 ml.
2. Review of the Narcotic Transaction Record for Patient #2 revealed the following:
a. Patient #2 had an order for Morphine 5 mg (milligram). Staff #5 stated that Morphine is not available as a 5 mg syringe so, Morphine 4 mg and Morphine 2 mg would be used to administer 5 mg and 1 mg of Morphine from the Morphine 2 mg syringe would be wasted immediately.
i. On 7/24/17 at 7:28 PM, one (1) syringe of Morphine 4 mg/1 ml and one (1) syringe of Morphine 2 mg/1 ml were recorded as removed from the Omnicell, a drug dispensing device. There was no evidence of wastage of the remaining Morphine 1 mg.
ii. On 7/24/17 at 10:38 PM, one (1) syringe of Morphine 4 mg/1 ml and one (1) syringe of Morphine 2 mg/1 ml were recorded as removed from the Omnicell. There was no evidence of wastage of the remaining Morphine 1 mg.
iii. On 7/25/17 at 8:12 PM, one (1) syringe of Morphine 4 mg/1 ml and one (1) syringe of Morphine 2 mg/1 ml were recorded as removed from the Omnicell. There was no evidence of wastage of the remaining Morphine 1 mg.
b. The following are documented as wastage of Morphine 1 mg from July 24, 2017 to July 25, 2017:
i. On 7/25/17 at 3:08 AM: The wastage of Morphine 1 mg was recorded.
ii. On 7/25/17 at 3:08 AM: The wastage of Morphine 1 mg was recorded.
iii. On 7/25/17 at 3:09 AM: The wastage of Morphine 1 mg was recorded.
iv. On 7/25/17 at 11:01 PM: The wastage of Morphine 1 mg was recorded.
v. If the administration of Morphine 5 mg was recorded three, separate times (July 24, 2017 at 7:38 PM, 10:38 PM and July 25, 2017 at 8:12 PM), then the wastage of Morphine 1 mg should be recorded as three, separate times instead of four. The records do not reconcile.
c. Upon interview, Staff #6 stated that there was an emergency in the unit on the evening shift on 7/24/17, which delayed the narcotic wastage. Staff #6 confirmed that the witnessing nurse did not observe the actual wastage.
3. Review of the Narcotic Medication Transaction Report for February 4, 2017 to February 5, 2017, for Staff #10 revealed the following:
a. On 2/4/17 at 8:58 PM, one (1) Hydromorphone 1 mg/1 ml was removed from the Omnicell for Patient #9. The administration time was 11:06 PM, 128 minutes later.
b. On 2/5/17 at 7:53 PM, one (1) Morphine 2 mg/1 ml was was removed from the Omnicell for Patient #10. The administration time was 12:01 PM, 248 minutes later.
c. On 2/5/17 at 9:00 PM, one (1) Hydromorphone 2 mg/1 ml was removed from the Omnicell for Patient #11. The administration time was 10:19 PM, 79 minutes later.
d. On 2/5/17 at 9:00 PM, one Zolpidem 5 mg was removed from the Omnicell for Patient #11. The administration time was 11:19 PM, 139 minutes later.
e. Upon interview, Staff #2 confirmed that the practice of removing controlled dangerous substances prior to the time of administration was not in compliance with the policy referenced above.
4. The above findings were confirmed by Staff #2, Staff #4 and Staff #6.
Tag No.: A0500
Based on observation, staff interview, and document review conducted on July 26, 2017, it was determined that the facility failed to ensure that medications are stored in accordance with manufacturer's recommendations.
Findings include:
Reference: The manufacturer's package insert for Symbicort inhaler states, "The inhaler should be discarded when the labeled number of inhalations have been used or within 3 months after removal from the foil pouch."
1. During an observation in the Pharmacy Department, Symbicort inhalers were found, out of the manufacturer's original packaging, without any indication of when the inhalers had been removed from the original packaging. The beyond use date could not be determined.
2. Upon interview, Staff # 6 stated that Symbicort inhalers were cleaned and disinfected by the Respiratory Department for reuse on multiple patients, if the canister was not empty.
3. Staff #7 was not aware of the beyond use date for a Symbicort inhaler removed from the foil pouch.
4. The above findings were confirmed by Staff #6 and Staff #7.