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Tag No.: A0500
Based on observation, interview and review of the manufacturer's drug information sheet regarding Propofol, the facility failed to follow the manufacturer's guidelines. The facility used single patient use vials for multiple patients.
The findings include:
Review of the manufacturer's drug information sheet for the drug Propofol, revealed the drug was supplied in single patient infusion vials of 20 milliliters (ml), 50 ml and 100 ml. Propofol Injectable Emulsion is a single use parental product.
Observation of the anesthesia cart, in Room One in the Endoscopy Suite, on 08/23/11 at 2:55 PM, revealed two (2), ten (10) cubic centimeters (cc) syringes, unlabeled, filled with a white colored substance. A spiked 50 ml vial of Propofol was found in the same drawer.
Interview with Certified Registered Nurse Anesthetist (CRNA) #1, on 08/23/11 at 3:00 PM, revealed she was not the person who prepared the syringes. She stated the syringe contained Propofol because Propofol was the only anesthesia drug that was white in color. She stated the Propofol vials were used for multiple patients because the drug was expensive and there was a shortage of the drug. CRNA #1 stated pharmacy also used the single patient use vials as multiple patient dose vials.
Interview with Pharmacist #1, on 08/23/11 at 4:35 PM, revealed Propofol vials were used as multiple patient dose vials.
Interview with Pharmacist #2, on 08/24/11 at 10:30 AM, revealed the Propofol vials were used as multiple patient dose vials. She stated the syringes were prepared by the pharmacist under a hood, using sterile technique. Pharmacist #2 stated she did not feel comfortable to have anesthesia prepare syringes of Propofol. She acknowledged the vials were labeled for single patient use. However, there was a shortage of Propofol and she revealed using the single use vials as multiple patient dose vials was acceptable.
Interview with the Director of Pharmacy, on 08/22/11, at 4:35 PM, revealed the pharmacy used the single patient use Propofol vials as multiple patient dose vials. He admitted the Propofol vials were labeled as single patient use.
Tag No.: A0505
Based on observation, interview, review of the manufacturer's drug information sheet on the drug Propofol, and review of the facility's policy on labeling of medications, the facility failed to label two syringes in the anesthesia cart.
The findings include:
Review of the Pharmacy's policy on labeling medications, dated 2002, revealed all medications should be properly labeled as to the drug, strength, and any precautionary statements. Perishable drugs should clearly indicate the expiration date on the label. The label should conform with all federal, state, and local laws and regulations.
Review of the manufacturer's drug information sheet on Propofol, revealed syringes should be labeled with the appropriate information to include the date and time the vial was opened. Administration should commence promptly and be completed within twelve (12) hours after the vials were opened.
Observation of the anesthesia cart, in Room One in the Endoscopy Suite, on 08/23/11 at 2:55 PM, revealed two (2) ten (10) cubic centimeters (cc) syringes, unlabeled, filled with a white colored substance.
Interview with Certified Registered Nurse Anesthetist (CRNA) #1, on 08/23/11 at 3:00 PM, revealed she had not prepared the syringes. She stated the syringes contained Propofol because of the color of the substance in the syringe. CRNA #1 stated she would not label Propofol syringes because it was the only anesthesia drug which was white in color.
Interview with Pharmacist #1, on 08/23/11 at 4:35 PM, revealed the syringes should be labeled with the name of the drug, the dose, who prepared the medication and the expiration date.
Interview with the Director of Anesthesia, on 08/24/11 at 10:40 AM, revealed all medication syringes should be properly labeled.