HospitalInspections.org

26458

Based on observation and interview the hospital failed to ensure that outdated, mislabeled, or otherwise unusable drugs are not available for patient use by having 7 of 7 vials of insulin available for patient use either expired or no date of first puncture documented on the vial. This has the potential to affect all diabetic patients in the hospital. Findings:

BHU - Behavioral Health Unit

In an observation of the medication refrigerator located on the Behavioral Health Unit (BHU) on 09/30/10 at 11:50 a.m. there were 3 vials of insulin available for patient use. There was one vial of Lantus Insulin with no documented date of first puncture on the medication vial, there was one vial of Humulin 70/30 insulin with no documented date of first puncture on the medication vial and there was one vial of Humulin R insulin with a documented date of first puncture of 08/01/10.

In an observation/interview on 09/30/10 at 11:50 with SF3DON she confirmed the above findings at the time of the findings. SF3DON confirmed that the date of first puncture of the two unmarked vials could not be determined, making them unusable. SF3 further confirmed that, per hospital policy, the vial of Humulin R would have expired 28 days after first puncture, therefore it was also an expired medication.

Acute Unit

In an observation of the medication refrigerator located on the acute patient area on 09/30/10 at 12:10 p.m. there were 4 vials of insulin available for patient use. There was one vial of Lantus Insulin with a documented date of first puncture of 08/07 on the medication vial, there was one vial of Humulin 70/30 insulin with a documented date of first puncture of 06/19 on the medication vial, there was one vial of Humulin R insulin with no documented date of first puncture and a vial of Humulin N insulin with a documented date of first puncture of 08/03.

In an observation/interview with SF5RpH and SF2DON on 09/30/10 at 12:10 p.m. both confirmed the above findings. Both stated that all four of the vials of insulin available for patient were expired medications. SF5RpH stated that the hospital policy requires monthly checks for expired insulin by the Pharmacist. SF5RpH could offer no explanation of how the expired medications were still available for patient use.

Review of a hospital policy, titled Labeling and Medication Orders, policy number 38.1, approved by Administration on 08/24/10, reads in part: "....13. All multiple dose vials will bear initials and date of first use. Vial will be discarded after 28 days. Exception is the medication Lantus which will be discarded after 28 days."

Based on observation and interview the hospital failed to ensure that the pharmacist and nursing services promoted safe medication use by failing to ensure the policy for labeling multi-dose vials was followed resulting in the administration of expired medication to 4 of 9 sampled patients. (#F6, #F7, #F8, #F9). Findings:


BHU - Behavioral Health Unit

In an observation of the medication refrigerator located on the Behavioral Health Unit (BHU) on 09/30/10 at 11:50 a.m. there were 3 vials of insulin available for patient use. There was one vial of Lantus Insulin with no documented date of first puncture on the medication vial, there was one vial of Humulin 70/30 insulin with no documented date of first puncture on the medication vial and there was one vial of Humulin R insulin with a documented date of first puncture of 08/01/10.

Review of the medical record of patient #F9 revealed that he was administered Humulin R insulin per the physician's sliding scale orders on 09/24/10 (7 units), 09/25/10 (5 units), 09/26/10 (5 units) and 09/27/10 (10 units).

In an observation/interview on 09/30/10 at 11:50 with SF3DON and she confirmed the above findings at the time of the findings. SF3DON confirmed that the vial of Humulin R would have expired 28 days after first puncture (documented as 08/01/10) ,therefore it was an expired medication. SF3DON further stated that since the only vial of Humulin R available for patient use had expired on 08/29/10, the medication administered to patient #F9 was expired and should have not been available for patient use.


Acute Unit

In an observation of the medication refrigerator located on the acute patient area on 09/30/10 at 12:10 p.m. there were 4 vials of insulin available for patient use. There was one vial of Lantus Insulin with a documented date of first puncture of 08/07 on the medication vial, there was one vial of Humulin 70/30 insulin with a documented date of first puncture of 06/19 on the medication vial, there was one vial of Humulin R insulin with no documented date of first puncture and a vial of Humulin N insulin with a documented date of first puncture of 08/03.

Review of the medical records of patients #F6, #F7 and #F8 revealed the following:

Patient #F6's MAR (medication administration record) revealed documentation that the patient was administered one dose of Lantus 30 units subcutaneously at 9:00 p.m. on 09/28/10, one dose of Humulin R insulin 10 units subcutaneously at 2120 (9:20 p.m.) on 09/28/10, one dose of Humulin R insulin 4 units subcutaneously at 06:30 a.m. on 09/29/10, one dose of Humulin R insulin 6 units subcutaneously at 11:00 a.m. on 09/29/10, one dose of Humulin R insulin 6 units subcutaneously at 2100 (9:00 p.m.) on 09/29/10, and one dose of Lantus 30 units subcutaneously at 9:00 p.m. on 09/29/10.

Patient #F7's MAR (medication administration record) revealed documentation that the patient was administered one dose of Humulin R insulin 4 units subcutaneously at 11:00 a.m. on 09/29/10.

Patient #F8's MAR (medication administration record) revealed documentation that the patient was administered one dose of Novolog 70/30 42 units subcutaneously at 8:00 a.m. on 09/28/10, 09/29/10, and 09/30/10 and one dose of Novolog 70/30 42 units subcutaneously at 5:00 p.m. on 09/28/10 and 09/29/10.

In an interview on 09/30/10 at 12:15 a.m. with SF4LPN she confirmed that she had administered the 09/30/10 8:00 a.m. dose of Novolog 70/30 to patient #F8 and failed to check the expiration date prior to administering the medication.

In an observation/interview with SF5RpH and SF2DON on 09/30/10 at 12:10 p.m. both confirmed the above findings. Both stated that all four of the vials of insulin available for patient were expired medications. SF5RpH stated that the hospital policy requires monthly checks for expired insulin by the Pharmacist. SF5RpH could offer no explanation of how the expired medications were still available for patient use.

During the same interview SF5RpH further confirmed that since the expired medications were not discovered there were no Medication Variance Forms filled out and the physician responsible for the care of the patient was not notified.

Review of a hospital policy, titled Labeling and Medication Orders, policy number 38.1, approved by Administration on 08/24/10, reads in part: "....13. All multiple dose vials will bear initials and date of first use. Vial will be discarded after 28 days. Exception is the medication Lantus which will be discarded after 28 days."

Review of a hospital policy titled "Adverse Drug Events", effective August 24, 2010, department Pharmacy and Nursing, policy number 5.2, approved August 24, 2010, and presented as current hospital policy reads in part: "....Policy: All Adverse Drug Events (Medication Variance, Potential Adverse Drug Event (PADE), Medication Errors, and Adverse Drug Reactions) shall be reported...."

26458

Based on observation and interview the hospital failed to 1) ensure that outdated, mislabeled, or otherwise unusable drugs are not available for patient use by having 7 of 7 vials of insulin available for patient use either expired or no date of first puncture documented on the vial and 2) ensure that drugs and biologicals must be prepared and administered in accordance with accepted standards of practice and hospital policy by administering outdated, mislabeled, or otherwise unusable drugs to 4 of 9 sampled patients. (#F6, #F7, #F8, #F9) This has the potential to affect all diabetic patients in the hospital. Findings:

1)

BHU - Behavioral Health Unit

In an observation of the medication refrigerator located on the Behavioral Health Unit (BHU) on 09/30/10 at 11:50 a.m. there were 3 vials of insulin available for patient use. There was one vial of Lantus Insulin with no documented date of first puncture on the medication vial, there was one vial of Humulin 70/30 insulin with no documented date of first puncture on the medication vial and there was one vial of Humulin R insulin with a documented date of first puncture of 08/01/10.

In an observation/interview on 09/30/10 at 11:50 with SF3DON and she confirmed the above findings at the time of the findings. SF3DON confirmed that the date of first puncture of the two unmarked vials could not be determined, making them unusable. SF3 further confirmed that ,per hospital policy, the vial of Humulin R would have expired 28 days after first puncture, therefore it was also an expired medication.

Acute Unit

In an observation of the medication refrigerator located on the acute patient area on 09/30/10 at 12:10 p.m. there were 4 vials of insulin available for patient use. There was one vial of Lantus Insulin with a documented date of first puncture of 08/07 on the medication vial, there was one vial of Humulin 70/30 insulin with a documented date of first puncture of 06/19 on the medication vial, there was one vial of Humulin R insulin with no documented date of first puncture and a vial of Humulin N insulin with a documented date of first puncture of 08/03.

In an observation/interview with SF5RpH and SF2DON on 09/30/10 at 12:10 p.m. both confirmed the above findings. Both stated that all four of the vials of insulin available for patient were expired medications. SF5RpH stated that the hospital policy requires monthly checks for expired insulin by the Pharmacist. SF5RpH could offer no explanation of how the expired medications were still available for patient use.

Review of a hospital policy, titled Labeling and Medication Orders, policy number 38.1, approved by Administration on 08/24/10, reads in part: "....13. All multiple dose vials will bear initials and date of first use. Vial will be discarded after 28 days. Exception is the medication Lantus which will be discarded after 28 days."

2) BHU - Behavioral Health Unit

In an observation of the medication refrigerator located on the Behavioral Health Unit (BHU) on 09/30/10 at 11:50 a.m. there were 3 vials of insulin available for patient use. There was one vial of Lantus Insulin with no documented date of first puncture on the medication vial, there was one vial of Humulin 70/30 insulin with no documented date of first puncture on the medication vial and there was one vial of Humulin R insulin with a documented date of first puncture of 08/01/10.

Review of the medical record of patient #F9 revealed that he was administered Humulin R insulin per the physician's sliding scale orders on 09/24/10 (7 units), 09/25/10 (5 units), 09/26/10 (5 units) and 09/27/10 (10 units).

In an observation/interview on 09/30/10 at 11:50 with SF3DON and she confirmed the above findings at the time of the findings. SF3DON confirmed that the date of first puncture of the two unmarked vials could not be determined, making them unusable. SF3DON further confirmed that, per hospital policy, the vial of Humulin R would have expired 28 days after first puncture, therefore it was also an expired medication. SF3DON further stated that since the only vial of Humulin R available for patient use had expired on 08/29/10, the medication administered to patient #F9 was expired and should have not been available for patient use.


Acute Unit

In an observation of the medication refrigerator located on the acute patient area on 09/30/10 at 12:10 p.m. there were 4 vials of insulin available for patient use. There was one vial of Lantus Insulin with a documented date of first puncture of 08/07 on the medication vial, there was one vial of Humulin 70/30 insulin with a documented date of first puncture of 06/19 on the medication vial, there was one vial of Humulin R insulin with no documented date of first puncture and a vial of Humulin N insulin with a documented date of first puncture of 08/03.

Review of the medical records of patients #F6, #F7 and #F8 revealed the following:

Patient #F6's MAR (medication administration record) revealed documentation that the patient was administered one dose of Lantus 30 units subcutaneously at 9:00 p.m. on 09/28/10, one dose of Humulin R insulin 10 units subcutaneously at 2120 (9:20 p.m.) on 09/28/10, one dose of Humulin R insulin 4 units subcutaneously at 06:30 a.m. on 09/29/10, one dose of Humulin R insulin 6 units subcutaneously at 11:00 a.m. on 09/29/10, one dose of Humulin R insulin 6 units subcutaneously at 2100 (9:00 p.m.) on 09/29/10, and one dose of Lantus 30 units subcutaneously at 9:00 p.m. on 09/29/10.

Patient #F7's MAR (medication administration record) revealed documentation that the patient was administered one dose of Humulin R insulin 4 units subcutaneously at 11:00 a.m. on 09/29/10.

Patient #F8's MAR (medication administration record) revealed documentation that the patient was administered one dose of Novolog 70/30 42 units subcutaneously at 8:00 a.m. on 09/28/10, 09/29/10, and 09/30/10 and one dose of Novolog 70/30 42 units subcutaneously at 5:00 p.m. on 09/28/10 and 09/29/10.

In an interview on 09/30/10 at 12:15 a.m. with SF4LPN she confirmed that she had administered the 09/30/10 8:00 a.m. dose of Novolog 70/30 to patient #F8 and failed to check the expiration date prior to administering the medication.

In an observation/interview with SF5RpH and SF2DON on 09/30/10 at 12:10 p.m. both confirmed the above findings. Both stated that all four of the vials of insulin available for patient were expired medications. SF5RpH stated that the hospital policy requires monthly checks for expired insulin by the Pharmacist. SF5RpH could offer no explanation of how the expired medications were still available for patient use.

Review of a hospital policy, titled Labeling and Medication Orders, policy number 38.1, approved by Administration on 08/24/10, reads in part: "....13. All multiple dose vials will bear initials and date of first use. Vial will be discarded after 28 days. Exception is the medication Lantus which will be discarded after 28 days."