HospitalInspections.org

Based on observation, interview and record review the facility failed to properly secure 1 of 44 sampled patient's (Patient 23) antibiotic eye medication in accordance with their policy, making it available to unauthorized staff and visitors.

Findings:

1. On 7/7/10 at approximately 9:50 a.m., during an observation of medication administration, RN 4 was observed to administer neomycin-bacitracin-polymixin eye ointment (also known as Neosporin, a prescription antibiotic ointment) to Patient 23's right eye, then return the multi-use tube to the manufacturer's box supplied by the pharmacy and place it on top of one of the bedside stands adjacent to Patient 23's bed.

Review of Patient 23's clinical record revealed that he was a 68 year-old admitted to the facility on 6/27/10 with diagnoses including Alzheimer's dementia, bacteremia (bacterial infection in the blood); clostridium difficule (C. difficile) colitis (an intestinal bacterial infection characterized by frequent diarrhea episodes) and right eye conjunctivitis (bacterial infection).

Review of Patient 23's Physician Orders included an order (dated 7/1/10) for C. difficile contact precautions (gowning of staff, handwashing and other precautions to prevent the spread of infection to others); and an order (dated 6/28/10) for Neosporin eye ointment to Patient 23's right eye 3 times daily.

Review of Patient 23's 7/6/10 and 7/7/10 computer-generated Medication Administration Record (MARs) revealed, adjacent to the neomycin-bacitracin-polymixin eye ointment order, a handwritten notation indicating "at bedside."

During an interview on 7/7/10 at 2:40 p.m. RN 4 confirmed that she had placed Patient 23's supply of prescription antibiotic eye ointment on the bedside stand adjacent to his bed after she administered the medication at 9:50 a.m. She explained that, since Patient 23 had an order for contact precautions, nursing staff had decided to leave the ointment in his room (instead of taking it back to the locked medication room where the other patient's multi-use medications were stored in bins). RN 4 acknowledged that, by leaving Resident 23's prescription antibiotic eye ointment on top of the bedside stand in his room, it was available to non-licensed staff and family members. When asked facility policy regarding personnel having access to medication, RN 4 stated "licensed nursing staff and pharmacy staff."

Review of the facility policy Administration, Storage and Security of Pharmaceuticals (revised 1/10) indicated under item II.A.1, Storage and Security: "All drugs will be stored in lockable containers, carts, dispensing machines, or specific medication storage areas." Under item II.A.5, the policy indicated: "Medications shall be accessible only to responsible personnel designated by the hospital or to the patient when ordered by the bedside."

During an interview on 7/7/10 at approximately 2:45 p.m. Nurse Manager (NM) acknowledged that only licensed nursing staff and pharmacy staff are authorized to have access to medication throughout the hospital. NM indicated that there is currently no locked area for medication storage in any patient rooms.

During an interview on 7/8/10 at 12:30 p.m. the Director of Pharmacy acknowledged that only licensed nursing staff and pharmacy staff are authorized to have access to medication throughout the hospital.

Based on observation, interview and record review the facility failed to implement their policy regarding expired medications when:
1. Three expired medications in the pharmacy were not sequestered and were available to be dispensed.
2. One vial of expired NPH insulin in the medical-surgical unit medication room was not removed from stock and discarded and was available for use.

Findings:

1. On 7/6/10 at 11:15 a.m. an inspection of the inpatient hospital pharmacy revealed, on a shelf designated for injectable products, a vial of Chloroprocaine 400 mg/20 mL (an injectable local anesthetic used in surgical procedures) in its original manufacturer packaging. Affixed to the lower left corner of the box was a round yellow sticker with a handwritten date of 6/10. Closer inspection of the box and enclosed vial revealed the Chloroprocaine had expired in June 2010 (six days prior to the date of inspection).

During an interview at 11:20 a.m., Pharmacist 1 (Pharm 1) confirmed that the vial of Chloroprocaine had expired at the end of June. Pharm 1 explained that a designated pharmacist inspects the pharmacy monthly for expired medications. Pharm 1 further explained that a sticker is affixed to the product with the month of expiration in advance of the month of expiration; the product is then sequestered prior to expiration. Referring to the expired Chloroprocaine, Pharm 1 indicated that the pharmacist responsible for inspection of the pharmacy "must have overlooked this."

On 7/6/10 at 11:26 a.m. further inspection of the inpatient hospital pharmacy revealed, on a shelf designated for antibiotic suspensions, a manufacturer's white plastic bottle containing Augmentin ES 600 mg/5 mL 75 mL (when reconstituted) powder for oral suspension (an antibiotic). Affixed above the manufacturer's label was a round yellow sticker with a handwritten date of 6/10. Closer inspection of the manufacturer's label revealed the Augmentin ES 600 mg/5 mL powder for oral suspension revealed an expiration date of June 2010 (six days prior to the date of inspection).

At 11:28 a.m., on a shelf designated for external medications, two boxes containing tubes (19.8 grams each) of Tucks anti-itch ointment each revealed a round yellow sticker (affixed to the end of the box) with a handwritten date of 6/10. Closer inspection of the two boxes and enclosed tubes revealed the Tucks anti-itch ointment had expired in June 2010 (six days prior to the date of inspection).

During an interview at 11:30 a.m. Pharm 1 confirmed that the bottle of Augmentin ES 600 mg/5 mL powder for oral suspension and two tubes of Tucks anti-itch ointment had expired at the end of June 2010.

Review of the facility policy Pharmacy Inspections (revised 2/09) indicated under item B: "Inspections shall be completed every 30 days and shall be documented on the Offsite Clinic Medication Inspection sheet (Attachment 1), the Inpatient Pharmacy Area Monthly Inspection sheet (Attachment II) or the Patient Care Area Medication sheet (Attachment III)." Under item E7, the policy indicated: "Drugs shall not be kept in stock within two months of the expiration date on the label and no contaminated or deteriorated drugs shall be available for use (see policy and procedure ADMINISTRATION, STORAGE AND SECURITY OF PHARMACEUTICALS."

During an interview on 7/6/10 at 2:10 p.m. the Director of Pharmacy (DOP) confirmed that the pharmacist responsible for inspection of the pharmacy did review the pharmacy in June 2010. When asked for written verification of the pharmacist's June 2010 inspection (the Inpatient Pharmacy Area Monthly Inspection sheet), the DOP was unable to provide the form summarizing the pharmacy area inspection. The DOP indicated that the Inpatient Pharmacy Area Monthly Inspection sheet had not been completed in several months.

2. On 7/7/10 at 9:35 a.m. an inspection of the medical surgical unit medication room (accompanied by Registered Nurse(RN) 3) revealed a plastic container affixed to the wall with individualized compartments containing multi-dose vials of various types of insulin for injection; all had the metal cap removed (indicating the contents of the vials had been accessed through the rubber stopper); all had auxiliary labels affixed to the vials indicating date of first use or expiration. One of the individualized compartments contained a multi-dose vial of Novolin-N U-100 insulin (NPH, a long-acting insulin indicated for diabetes), original quantity 10 mL. The auxiliary label affixed to the vial indicated that the date of first use was 5/15/10 (53 days prior to the date of the inspection). When asked regarding the facility policy for expiration dating of multi-dose vials of insulin, RN 3 indicated that the vials were "good 30 days only," and confirmed that the Novolin-N vial of insulin (which indicated the date of first use was 5/15/10) was expired. RN 3 indicated that Novolin-N insulin is not used frequently, and the expired vial of insulin would have been discovered the next time a dose was administered by licensed nurses.

Review of the facility policy Administration, Storage and Security of Pharmaceuticals, revised 1/10, indicated under item C, Product Dating and Expiration: "Ongoing checks for expired medications will be conducted by nursing and pharmacy services." Under item II.C.1.d., Multi-Dose Vials, the policy indicated: "Discard when empty, when suspected or visible contamination occurs, or expiration date (28 days from the date opened) or the manufacturer's expiration date, whichever is shortest."

During an interview on 7/7/10 at 12:10 p.m. the DOP indicated that the expiration date of multi-dose vials had "always been" 28 days, not 30 days as indicated by RN 3. The DOP indicated that it is the responsibility of licensed nursing staff to monitor for expiration dating on open multi-dose vials (on the nursing units), and that the monthly surveillance by the pharmacist only includes vials that are intact (not open) in medication storage areas outside of the pharmacy. The DOP acknowledged that the multi-dose vial of Novolin-N insulin observed in the medical surgical unit medication room that morning (that had a date of first use indicating 5/15/10, 53 days prior to the date of the inspection) was expired and available for use.