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Based on medical record reviews, review of hospital policies, review of hospital documentation/timeline of events and interviews, the pharmacy failed to have a comprehensive hospital-wide system in place to ensure the safe use of medications in regards to retrieval of potentially contaminated medication products and lacked a tracking mechanism to identify patients who received the potentially contaminated medication products. The finding includes:


1. Review of a hospital contract dated 6/1/12 identified that Vendor #1 would prepare and supply the hospital with multiple compounded medications that included intravenous (IV) magnesium sulfate (MgSO4) 2 gm in 50 ml of Dextrose 5% (D5W).


2. Patient #13 had a diagnosis of Myelodysplastic syndrome and was being treated at the hospital's oncology outpatient facility. A physician's order dated 3/13/13 directed to administer Magnesium Sulfate (MgSo4) 2 gms in 50 ml of D5W IV (intravenously) over 1 hour.


3. Review of multiple hospital e-mails dated 3/13/13 indicated that RN #1 (employed at the outpatient oncology facility) notified the pharmacy department on 3/13/13 shortly after 11:00 AM that a bag of Vendor #1's IV Mg SO4 was found to have floating particulate inside the bag. Pharmacist #1 retrieved the IV Mg SO4 from RN #1 and identified and retrieved an additional three bags of IV MgSO4 that had a purple or white precipitate from the unit's automated medication dispensing system. Pharmacist #1 then notified Pharmacist #2 (out-patient oncology pharmacist). Additional e-mails dated 3/13/13 at 11:46 AM identified that Pharmacist #2 communicated to Pharmacist #3 (Pharmacy Manager) and Pharmacist #4 that they retrieved 4 IV Mg SO4 bags contained "unknown jellyfish-like matter" and all of the IV bags had the same lot number (Lot #1) from Vendor #1.


4. Review of an e-mail from Pharmacist #3 dated 3/13/13 at 12:13 PM identified that he/she was concerned with what the floating particulate was and if other IV MgSO4 lot numbers could be affected. Despite Pharmacist #3's concerns with Vendor #1's products, interview with the Pharmacy Director on 3/15/13 at approximately 1:30 PM identified that it was not until 3/13/13 at 5:00 PM (6 hours after the first potentially contaminated IV Mg SO4 was discovered) for General Hospital building #1 and not until 10:30PM for General Hospital building #2 (11.5 hours) that all IV MgSO4 was secured and sequestered.
The hospital failed to ensure that all Vendor #1's IV Mg SO4 was removed timely from patient use, which placed all hospital patients (bed capacity of approximately 890) at risk of receiving Vendor #1's potentially contaminated IV MgSO4 during this timeframe.
At this time, although immediate notification was expected, messaging to alert nursing management/leadership and/or physicians of the potentially contaminated IV Mg SO4 had not been done.
Although IV MgSO4 was pulled from the patient units, consideration was not given regarding risk or potential contamination at this time for other Vendor #1 supplied medication products, which included a formulary of approximately 39 formulations across both campuses



5. Further interview with the Pharmacy Director identified that it was not until 10:30 PM (11.5 hours after the first potentially contaminated IV Mg SO4 was discovered) that all Vendor #1's IV MgSO4 was pulled from General Hospital building #2.

The hospital failed to ensure that all Vendor #1's IV Mg SO4 was removed from patient use, which placed all hospital patients (bed capacity of approximately 520) at risk of receiving potentially contaminated IV MgSO4 during this timeframe.


6. Review of the hospital timeline identified that on 3/13/13, at 12:00PM, all Lot 1 bags of IV MgSO4 had been retrieved and sequestered (one hour subsequent to identification). The decision at this time was made to pull all lots of IV MgSO4 prepared and supplied by Vendor #1.
Although the hospital and pharmacy department reported that all Vendor #1's IV MgSO4 were gathered and sequestered in the pharmacy department on 3/13/13, the bags were not examined until the evening of 3/14/13. This untimely inspection for further potential contaminants revealed a fifth potentially contaminated bag of IV MgSO4 identified as being from Lot #2, 27 hours and 50 minutes after the first affected IV Mg SO4 was discovered. The retrieval process was such that the hospital and pharmacy department were unable to determine which patient care unit the fifth potentially contaminated bag of IV MgSO4 originated from. It was noted that while the first potentially contaminated lot was identified in an outpatient area, the potentially contaminated IV MgSO4 now extended to the inpatient areas, and messaging to alert nursing management and/or physicians of the potentially contaminated IV Mg SO4 had not been done. Review of the hospital timeline identified that although a fifth potentially contaminated bag of MgSO4 was identified the evening of 3/14/13, the Director of Pharmacy was not notified until the morning of 3/15/13.


8. Review of hospital and pharmacy documentation including a timeline of events (provided by the hospital) and review of patient medical records identified that Patient #1 and Patients #3 through #21 were receiving out-patient oncology services and were immunocompromised (stem cell transplant/solid tumor). All 20 patients received 1 or more doses of IV MgSO4 between 2/20/13 and 3/13/13.
However, the hospital failed to have a mechanism or system in place to identify which patients received Vendor #1's potentially contaminated IV MgSO4 from Lot #1.


9. Interview with Pharmacist #4 on 3/18/13 at 12:05 PM identified that he/she spoke with ID Specialist #1 on 3/13/13 regarding Vendor #1's contaminated IV MgSO4. ID Specialist #1 directed that microbial testing be conducted in the hospital's laboratory for each of the retained IV MgSO4 bags (one contained purple and one contained white particulate). Although the need for laboratory testing was identified, Pharmacist #4 identified that despite phone messages to the laboratory, the IV MgSO4 bags were not tested on 3/13/13 as directed.
The hospital failed to initiate testing of the potentially contaminated IV MgSO4 fluid for greater than 22 hours from the time of discovery on 3/13/13 at 11:00 AM until testing began on 3/14/13 at approximately 9:30 AM. In a written file statement dated 3/21/13, provided by the hospital authored by the Director of Microbiology, s/he expressed "great faith in the personnel on the evening shift to perform excellent clinical microbiology for patient care, but I am much more comfortable with the personnel of the day shift in handling non-traditional specimens that require special procedures." During an interview with the Assistant Microbiology Coordinator on 3/15/2013, s/he stated that around 4:00PM on 3/13/13 Pharmacist #4 spoke to him/her and indicated that there was no urgency to test the specimen and it could wait until the morning of 3/13/13.



10. Preliminary laboratory testing of Vendor #1's IV MgSO4 on 3/14/13 was presumptive for mold/fungus.


11. Review of hospital documentation including the timeline of events and/or policy review identified that the hospital failed to have processes/policies in place to direct the actions of laboratory and other hospital staff when a contaminated medication and/or biological product defect was identified, to include timely notification to hospital administration, medical and nursing staff, and other appropriate agencies, and/or removal of potentially contaminated products from patient use.


12. Hospital and pharmacy documentation including a timeline of events (requested by the Department) dated 3/13/13 through 3/21/13 and interview with the Director of Accreditation, Safety and Regulatory Affairs on 3/18/13 at 9:47 AM identified that on 3/16/13 at or around 9:00 AM, the hospital identified that approximately 825 patients received IV MgSO4 between 2/20/13 and 3/13/13, and the hospital did not know which patients received Vendor #1's potentially contaminated IV MgSO4 from Lot #2.
Hospital and pharmacy department documentation further identified that although the fifth potentially contaminated bag of IV MgSO4 was found on the evening of 3/14/14, the pharmacy department did not begin formulation of a list of patients who may have received the potentially contaminated IV MgSO4 from Lot #2 until 9:00 AM on 3/16/13. Of the potentially affected patients, seven were pediatric patients (Patients # 22 through #28) who were treated in the out-patient oncology center for diagnoses that included but not limited to leukemia and idiopathic anemia.

13. Although hospital staff were aware of the potentially contaminated IV MgSO4 on 3/13/13 at 11:00 AM, interview with Legal Officer #1 on 3/18/13 at 12:35 PM identified that Legal Officer #1 was not notified by pharmacy staff of Vendor #1's potentially contaminated IV MgSO4 until midday on 3/14/13, after the laboratory's preliminary findings of fungus. Following notification of the preliminary laboratory results, Legal Officer #1 arranged for an administrative meeting that convened on 3/14/13 at 3:00 PM. Additionally, the Director of Drug Control and the Department of Public Health were not notified until 3/14/13 at approximately 4:00PM (28 hours after identification).


14. Hospital documentation including the timeline of events dated 3/21/13 indicated that the pharmacy department and/or hospital administration failed to notify nursing leadership and/or nursing staff of Vendor #1's potentially contaminated IV MgSO4 until 3/15/13 at 11:00 AM (2 days after the hospital recall). In addition, nursing staff were not requested to check stock medications in all patient care areas to ensure that there were no IV MgSO4 from Vendor #1 available for patient use (prior to 3/15/13 at 11:00 AM).

15. While the expectation is that notification would be made immediately, according to hospital and pharmacy department documentation including the timeline of events dated from 3/13/13 to 3/21/13 the pharmacy department failed to ensure that physicians working in the cancer center were notified that their patients may have received potentially contaminated IV MgSO4 until 3/14/2013 between 7:00 PM and 11:00 PM (approximately 20 hours after the first potentially contaminated IV MgSO4 was identified).
Although the potentially affected pediatric patients were identified on 3/15/13, the pharmacy failed to notify the Chief of Pediatrics until 3/16/13 that their patients may have received potentially contaminated IV MgSO4, and the hospital's medical staff was not notified of the potentially contaminated IV MgSO4 until 3/18/13 via e-mail (4 days after the fungal contamination was identified).
Additionally, the hospital failed to alert primary care physicians that their patients may have received potentially contaminated IV MgSO4 until 3/21/13 (7 days after the fungal contamination was identified).


16. In addition to the failure to notify medical staff that their patients may have received Vendor #1's potentially contaminated IV MgSO4, the hospital failed to initiate formal notification to patients who may have received Vendor #1's IV MgSO4 until 3/20/13 (6 days after the fungal contamination was identified).


17. According to hospital and pharmacy department documentation including the timeline of events dated from 3/13/13 to 3/21/13, on 3/13/13, the Pharmacy Director failed to secure/sequester all of the potentially contaminated IV MgSO4, but rather retrieved the initial lot of 3/13/13 at 12:00PM, not giving consideration to other MgSO4 that was in circulation for patient use until verbal direction was provided by the Assistant Director of Pharmacy. All IV MgSO4 product was sequestered 11.5 hours after identifying the initial potential contamination.

Pharmacist #3 contacted Vendor #1 via e-mail on 3/13/13 at 12:13 PM alerting the vendor of the potentially contaminated IV MgSO4. Interview with Pharmacist #3 on 3/15/13 at 1:20 PM identified that Vendor #1 came to the hospital and picked up all but 2 (used for testing on 3/14/13) of the retrieved bags of IV MgSO4 on 3/13/13 at approximately 2:30 PM, although a large number of IV MgSO4 remained in circulation as all product was not retrieved immediately.

18. Final laboratory results dated 3/16/13 and 3/19/13 identified that the IV MgSO4 from Vendor #1 was contaminated with Hamigera and Aspergillis.


19. Interview with the Chief Medical Officer on 3/18/13 at 9:30 AM noted that a patient who received Vendor #1's contaminated IV MgSO4 may show symptoms of elevated temperature, rashes and/or visual changes. While the hospital was tracking two (2) potentially affected patients, it was identified that it may take up to six (6) months for signs and symptoms of fungemia to present.


21. An FDA (Food and Drug Administration) document dated 3/18/13 identified that Vendor #1 issued a voluntary nationwide recall of all products/medications prepared by this pharmacy (including IV MgSO4) due to contamination of fungus. The recall identified that "giving a patient a contaminated injectable drug could result in a life-threatening infection."

Based on medical record reviews, review of hospital policies, review of hospital documentation and interviews with hospital staff, the pharmacy failed to ensure that unusable drugs were not available for patient use when potentially contaminated medication products were identified, placing approximately 825 patients who received IV Mg SO4 at risk for receiving the potentially contaminated medication. The findings include:


1. Review of a hospital contract dated 6/1/12 identified that Vendor #1 would prepare and supply the hospital with multiple compounded medications that included intravenous (IV) magnesium sulfate (Mags) 2 gm in 50 ml of Dextrose 5% (D5W).


2. Review of multiple hospital e-mails dated 3/13/13 indicated that RN #1 (employed at the outpatient oncology facility) notified the pharmacy department on 3/13/13 shortly after 11:00 AM that a bag of Vendor #1's IV Mg SO4 was found to have floating particulate inside the bag. Pharmacist #1 retrieved the IV Mg SO4 from RN #1, and identified and retrieved an additional three bags of IV Mags that had a purple or white precipitate from the unit's automated medication dispensing system. Pharmacist #1 then notified Pharmacist #2 (out-patient oncology pharmacist). Additional e-mails dated 3/13/13 at 11:46 AM identified that Pharmacist #2 communicated to Pharmacist #3 (Pharmacy Manager) and Pharmacist #4 that they retrieved 4 IV Mg SO4 bags contained "unknown jellyfish-like matter" and all of the IV bags had the same lot number (Lot #1) from Vendor #1.


3. Review of an e-mail from Pharmacist #3 dated 3/13/13 at 12:13 PM identified that he/she was concerned with what the floating particulate was and if other IV Mags lot numbers could be affected. Despite Pharmacist #3's concerns with Vendor #1's products, interview with the Pharmacy Director on 3/15/13 at approximately 1:30 PM identified that it was not until 3/13/13 at 5:00 PM (6 hours after the first potentially contaminated IV Mg SO4 was discovered) for General Hospital building #1 and not until 10:30PM for General Hospital building #2 (11.5 hours) that all IV Mags was secured and sequestered. The hospital failed to ensure that all Vendor #1's IV Mg SO4 was removed timely from patient use, which placed all hospital patients (bed capacity of approximately 890) at risk of receiving Vendor #1's potentially contaminated IV Mags during this timeframe.
Although IV Mags was pulled from the patient units, consideration was not given regarding risk or potential contamination at this time for other Vendor #1 supplied medication products, which included a formulary of approximately 39 formulations across both campuses.


4. Further interview with the Pharmacy Director identified that it was not until 10:30 PM (11.5 hours after the first affected IV Mg SO4 was discovered) that all Vendor #1's IV Mags was pulled from General Hospital building #2. The hospital failed to ensure that all Vendor #1's IV Mg SO4 was removed from patient use, which placed all hospital patients (bed capacity of approximately 520) at risk of receiving potentially contaminated IV Mags during this timeframe.


5. Review of the hospital timeline identified that on 3/13/13, at 12:00PM, all Lot 1 bags (27 bags of a 50 bags lot size) of IV Mags had been retrieved and sequestered, (one hour subsequent to identification). The decision at this time was made to pull all lots of IV Mags prepared and supplied by Vendor #1. Although the hospital and pharmacy department reported that all Vendor #1's IV Mags were gathered and sequestered in the pharmacy department on 3/13/13, the bags were not examined until the evening of 3/14/13. This untimely inspection for further potential contaminants revealed a fifth potentially contaminated bag of IV Mags identified as being from Lot #2, 27 hours and 50 minutes after the first affected IV Mg SO4 was discovered. The retrieval process was such that the hospital and pharmacy department were unable to determine which patient care unit the fifth potentially contaminated bag of IV Mags originated from. It was noted that while the first potentially contaminated lot was identified in an outpatient area, the potentially contaminated IV Mags now extended to the inpatient areas.


6. Preliminary laboratory testing of Vendor #1's IV Mags on 3/14/13 was presumptive for mold/fungus.



7. Hospital documentation including the timeline of events dated 3/21/13 indicated that the pharmacy department and/or hospital administration failed to notify nursing leadership and/or nursing staff of Vender #1's contaminated IV Mags until 3/15/13 at 11:00 AM (2 days after the hospital recall). In addition, nursing staff were not requested to check stock medications in all patient care areas to ensure that there were no IV Mags from Vendor #1 available for patient use (prior to 3/15/13 at 11:00 AM).


8. Final laboratory results dated 3/16/13 and 3/19/13 identified that the IV Mags from Vendor #1 was contaminated with Hamigera and Aspergillis.


9. An FDA (Food and Drug Administration) document dated 3/18/13 identified that Vendor #1 issued a voluntary nationwide recall of all products/medications prepared by this pharmacy (including IV Mags) due to contamination of fungus. The recall identified that "giving a patient a contaminated injectable drug could result in a life-threatening infection."

10. Review of hospital documentation including the timeline of events and/or policy review identified that the hospital failed to have processes/policies in place to direct the actions of the pharmacy and/or other hospital staff when a contaminated medication and/or biological product defect was identified, to include notification to hospital administration, medical and nursing staff, and other appropriate agencies and/or processes to remove potentially contaminated medications from patient use

Based on medical record reviews, review of hospital policies, review of hospital documentation/timeline of events and interviews, the pharmacy failed to notify physicians timely when a potentially contaminated medication product was noted that had the potential to harm patients and/or failed to develop and/or implement a clear and concise policy that addressed types of medication events that must be reported to the physician. The finding includes:


1. Review of a hospital contract dated 6/1/12 identified that Vendor #1 would prepare and supply the hospital with multiple compounded medications that included intravenous (IV) magnesium sulfate (Mags) 2 gm in 50 ml of Dextrose 5% (D5W).


2. Patient #13 had a diagnosis of Myelodysplastic syndrome and was being treated at the hospital's oncology outpatient facility. A physician's order dated 3/13/13 directed to administer Magnesium Sulfate (MgSo4) 2 gms in 50 ml of D5W IV (intravenously) over 1 hour.


3. Review of multiple hospital e-mails dated 3/13/13 indicated that RN #1 (employed at the outpatient oncology facility) notified the pharmacy department on 3/13/13 shortly after 11:00 AM that a bag of Vendor #1's IV Mg SO4 was found to have floating particulate inside the bag. Pharmacist #1 retrieved the IV Mg SO4 from RN #1 and identified and retrieved an additional three bags of IV Mags that had a purple or white precipitate from the unit's automated medication dispensing system. Pharmacist #1 then notified Pharmacist #2 (out-patient oncology pharmacist). Additional e-mails dated 3/13/13 at 11:46 AM identified that Pharmacist #2 communicated to Pharmacist #3 (Pharmacy Manager) and Pharmacist #4 that they retrieved 4 IV Mg SO4 bags contained "unknown jellyfish-like matter" and all of the IV bags had the same lot number (Lot #1) from Vendor #1.


4. Review of an e-mail from Pharmacist #3 dated 3/13/13 at 12:13 PM identified that he/she was concerned with what the floating particulate was and if other IV Mags lot numbers could be affected. Despite Pharmacist #3's concerns with Vendor #1's products, interview with the Pharmacy Director on 3/15/13 at approximately 1:30 PM identified that it was not until 3/13/13 at 5:00 PM (6 hours after the first potentially contaminated IV Mg SO4 was discovered) for General Hospital building #1 and not until 10:30PM for General Hospital building #2 (11.5 hours) that all IV Mags was secured and sequestered.
The hospital failed to ensure that all Vendor #1's IV Mg SO4 was removed timely from patient use, which placed all hospital patients (bed capacity of approximately 890) at risk of receiving Vendor #1's potentially contaminated IV Mags during this timeframe. At this time, although immediate notification was expected, messaging to alert nursing management/leadership and/or physicians of the potentially contaminated IV Mg SO4 had not been done. Although IV Mags was pulled from the patient units, consideration was not given regarding risk or potential contamination at this time for other Vendor #1 supplied medication products, which included a formulary of approximately 39 formulations across both campuses.

5. Preliminary laboratory testing of Vendor #1's IV Mags on 3/14/13 was presumptive for mold/fungus.


6. Review of hospital documentation including the timeline of events and/or policy review identified that the hospital failed to have processes/policies in place to direct the actions of laboratory and other hospital staff when a contaminated medication and/or biological product defect was identified, to include timely notification to hospital administration, medical and nursing staff, and other appropriate agencies, and/or removal of potentially contaminated products from patient use.


7. Hospital and pharmacy documentation including a timeline of events (requested by the Department) dated 3/13/13 through 3/21/13 and interview with the Director of Accreditation, Safety and Regulatory Affairs on 3/18/13 at 9:47 AM identified that on 3/16/13 at or around 9:00 AM, the hospital identified that approximately 825 patients received IV Mags between 2/20/13 and 3/13/13, and the hospital did not know which patients received Vendor #1's potentially contaminated IV Mags from Lot #2. Hospital and pharmacy department documentation further identified that although the fifth potentially contaminated bag of IV Mags was found on the evening of 3/14/14, the pharmacy department did not begin formulation of a list of patients who may have received the potentially contaminated IV Mags from Lot #2 until 9:00 AM on 3/16/13. Of the potentially affected patients, seven were pediatric patients (Patients # 22 through #28) who were treated in the out-patient oncology center for diagnoses that included but not limited to leukemia and idiopathic anemia.

8. Although hospital staff were aware of the potentially contaminated IV Mags on 3/13/13 at 11:00 AM, interview with Legal Officer #1 on 3/18/13 at 12:35 PM identified that Legal Officer #1 was not notified by pharmacy staff of Vendor #1's potentially contaminated IV Mags until midday on 3/14/13, after the laboratory's preliminary findings of fungus. Following notification of the preliminary laboratory results, Legal Officer #1 arranged for an administrative meeting that convened on 3/14/13 at 3:00 PM. Additionally, the Director of Drug Control and the Department of Public Health were not notified until 3/14/13 at approximately 4:00PM (28 hours after identification)

9. While the expectation is that notification would be made immediately, according to hospital and pharmacy department documentation including the timeline of events dated from 3/13/13 to 3/21/13 the pharmacy department failed ensure that physicians working in the cancer center were notified that their patients may have received potentially contaminated IV Mags until 3/14/2013 between 7:00 PM and 11:00 PM (approximately 20 hours after the first potentially contaminated IV Mags was identified). Although the potentially affected pediatric patients were identified on 3/15/13, the pharmacy failed to notify the Chief of Pediatrics until 3/16/13 that their patients may have received potentially contaminated IV Mags, and the hospital's medical staff was not notified of the potentially contaminated IV Mags until 3/18/13 via e-mail (4 days after the fungal contamination was identified). The hospital failed to alert primary care physicians that their patients may have received potentially contaminated IV Mags until 3/21/13 (7 days after the fungal contamination was identified).

10. Final laboratory results dated 3/16/13 and 3/19/13 identified that the IV Mags from Vendor #1 was contaminated with Hamigera and Aspergillis.

11. An FDA (Food and Drug Administration) document dated 3/18/13 identified that Vendor #1 issued a voluntary nationwide recall of all products/medications prepared by this pharmacy (including IV Mags) due to contamination of fungus. The recall identified that "giving a patient a contaminated injectable drug could result in a life-threatening infection."