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Tag No.: C0276
Based on observations, interviews, and record reviews, it was determined, although the facility had policies and procedures related to expired drugs, the policies and procedures were not followed, resulting in medications being stored in areas that were available for patient use.
Findings include:
A review of the Pharmacy policy related to the "Functions" of the Pharmacist revealed that pharmacy personnel should conduct at least monthly inspections of all areas where medications were prepared, dispensed, administered, or stored. A record of all such inspections would be maintained. All drugs in the hospital would be checked on a monthly basis by the pharmacist or his designee to ensure drugs were not out of date or for some other reason should not be used. In the event such drugs were present, the drugs were to be removed immediately from the shelves. Review of the policy and procedure "Out of date Drugs" revealed that all out-dated drugs would be discarded and re-ordered.
Observations during a tour of the facility revealed the following:
In Emergency Room (ER) #1 in the locked cabinet, there were four ampules of Pediatric Sodium Bicarbonate 10 milliequivalents that expired on 08/01/10. Additionally, in ER #1 was the thrombolytic box that had three heparin flushes that expired on 07/26/10 and Phenergan 25 milligrams (mg) per milliliter (ml) that expired November 2009. In the Myocardial Infarction box were four tablets of Plavix 75 mg that expired on 07/03/10. On the crash cart, there were two bags of Dobutamine 500 mg that expired on 08/01/10. In the Pediatric crash cart, there was one 10 ml vial of Calcium Gluconate 100 mg per ml that expired July 2010, two vials of 8.4% Sodium Bicarbonate that expired 08/01/10, and one 100 ml bag of 0.9% Sodium Chloride that expired in October 2009.
In ER #3 in the locked cabinet, there was one Nitroglycerin pump-spray that expired in November 2009.
In the crash cart, that was used for the care of the inpatients, were two 250 ml bags of Dobutamine 500 mg that expired 08/01/10, one 5% Dextrose Injection 1000 ml that expired in January 2010, three 10 ml vials of Calcium Gluconate 10% that expired in July 2010, and one Benadryl 50 mg per ml vial that expired in January 2010.
In the Gastrointestinal (GI) Clinic, there was one 1000 ml bag of 5% Dextrose that expired in January 2010.
Stored in the medication dispensing system was a plastic container labeled "EMS Box #0." The following medications were stored in the container: two Morphine Sulfate 10 mg/ml injectables that expired in 02/01/10 and two Valium 5 mg/ml injectables that expired on 10/01/09.
An interview with the Emergency Department Nurse Manager on 08/10/10 at 11:00 AM, revealed the Pharmacist was responsible for checking the medications monthly throughout the facility and removing any medications that were expired. She stated the Pharmacist initialed a check sheet after checking the medications.
A review of the medication check sheets revealed none of the medications had been checked in August 2010 except for the medication in the GI Clinic. A review of the medications sheet for January 2010 through July 2010, revealed the Pharmacist documented he checked for expired medications.
An interview with the Pharmacist, on 08/10/10 at 4:30 PM, revealed he had not checked the medications for August 2010. He should have pulled the medications that were going to expire on August 1, 2010 in July 2010, but he did not notice they were going to expire the first day of August. He stated he did not actually look at the medications when he made his monthly check. He used his check sheet, that had all of the expirations dates listed on the check sheet, to check for expiring medications. He was not sure why some of the dates on his check sheet were not correct.
Interviews with the Administrator and the Chief Nursing Officer, on 08/10/10 at 4:50 PM, revealed the Pharmacist should have been looking at the medications rather than the check sheet to ensure all medications were not expired or were not unusable.