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Based on interview and record review, following an adverse event, the facility failed to fully analyze the causes and fully implement preventative measures to prevent reoccurrence. The facility failed to:

1. Identify a critical system failure regarding knowledge and communication of current professional literature concerning medication safety issues.

2. Evaluate potential risks regarding other patient care devices: multidose medication devices and multi-use patient care equipment.

3. Include all relevant team members in the Root Cause Analysis (RCA) process.

Findings include:

TX # 00189724

Record review of intake # 00189724, (facility-reported incident}, dated 01-14-14, revealed on 10-25-13 a facility nurse manager (Staff ID # 5) discovered that a staff nurse had been using a single patient insulin pen on multiple patients; thereby risking cross contamination of blood borne pathogens. The Chief Nursing Officer (CNO/ ID # 2) was immediately notified and he sent an email to all nursing managers informing them of the incident. He directed the nurse managers to remind their staff this was " strictly a prohibited practice. " The investigation was begun immediately and included the CNO interviewing all staff nurses regarding their understanding of the use of insulin pens.

1.

Record review on 01-17-14 of facility RCA, undated, failed to reveal the identification of critical " information management " breakdown related to the misuse of insulin pens.

Under RCA section labeled " Information Management Issues, " the facility documented that the Joint Commission (JC) coordinator sent " Sentinel Event Alerts " to all staff. There was no other issue listed under this section.

The facility failed to assess the process related to availability and dissemination of current literature related to medication safety and risks.

Interview on 01-17-14 at 2:30 p.m. with CNO / ID #2, he stated after the facility became aware of the misuse of the insulin pens, they began conducting research. The CNO went on to say the research showed this same issue had occurred at other facilities; until time of research they were unaware.

Continued record review on 01-16-14 of facility investigation revealed research compiled after the occurrences. Facility research included a 2009 Food and Drug Administration (FDA) Alert that cautioned sharing of insulin pens possibly transmitting of bloodborne diseases. In addition, facility research included information distributed in 2012 from Centers for Disease Control (CDC) and Centers for Medicare and Medicaid (CMS) both alerting to issues with misuse of insulin pens.

Review of FDA Alert dated March 19, 2009 read: " ... (based upon exposure of 2,000+ patients at two healthcare facilities): " ... The FDA reminds healthcare providers, healthcare facilities ... that each insulin pen (and each insulin pen cartridge) is designed for single-patient use only and is never to be shared among patients. Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user ... "

Interview in 01-17-14 at 9:30 a.m. with Quality Director ID # 4, she stated the process for disseminating medication safety information was not discussed as part of the RCA, but would be considered as they moved forward.

*[Please see related information under A-0495 citation " Pharmacist Responsibilities. " ]

2.

Continued review of facility RCA, undated, failed to reveal the identification of other pen-like medication devices or other point of care devices that may place patients at risk of transmission of bloodborne pathogens.

Interview on 01-17-14 at 1:10 p.m. with Chief Operating Officer (COO) ID # 1 he stated he " informally asked " the pharmacy and laboratory directors to review their processes and protocols for other possible devices. He went on to say they would conduct further review as they moved forward.

Interview on 01-17-14 at 2:20 p.m. with Laboratory Director /ID # 21, he stated the facility used the following multi-patient use devices: glucometers (all nursing units), I-STAT machines (in the Operating Rooms (OR), Emergency room(ER), and imaging departments) ; Hemochron machines(Cath lab, OR, ER, and ICU).

The Laboratory Director/ID # 21 went on to say he was in the process of revising the competencies, which were required upon hire and annually thereafter. He acknowledged the glucometers, ISTAT, and Hemochron machines were all point-of-care / multi-patient use devices. He said the machines must be cleaned appropriately between patient use for infection control purposes.

3.

Interview in 01-17-14 at 9:30 a.m. with Quality Director / Staff ID # 4 she stated the COO /Staff ID # 1 and CNO /Staff ID # 2 were coordinating the investigation, along with the Pharmacist ID # 8. The Quality Director /ID # 4 said she documented actions taken on the RCA form. She acknowledged the Infection Control Practitioner, ID # 20 was not actively involved in the RCA.

Interview on 01-17-14 at 3: 35 p.m. with Infection Control Practitioner, ID # 20 she stated she had been in her position for one and one-half years. She said she was aware of the misuse of insulin pen incident but did not participate in the RCA or other aspects of the investigation or improvement plan.

Record review of facility policy titled " Event Reporting, " review date 07/13, read: " ...The Framework (RCA) will focus on systems and processes, not on individual performance. During the development of the framework document, the 2 Why ' s will be asked ...the goal is to determine if there are opportunities for a process re-design to improve patient safety and efficiency.. " (JC Comprehensive Accreditation Manual of Hospitals (January 2013)

Based on interview and record review, the facility pharmacist failed to supervise and coordinate all activities of the pharmacy services. The pharmacist failed to evaluate and disseminate current medication safety information regarding misuse of insulin pens.

Findings include:

TX # 00189724

Record review of facility-reported incident, dated 01-14-14, revealed on 10-25-13 a facility nurse manager (Staff ID # 5) discovered that a staff nurse had been using a single patient insulin pen on multiple patients; thereby risking cross contamination of blood borne pathogens. The Chief Nursing Officer (CNO/ ID # 2) was immediately notified an investigation was begun. The CNO began interviewing all staff nurses regarding their understanding of the use of insulin pens.

Interview on 01-17-14 at 2:30 p.m. with CNO / ID #2, he stated after the facility became aware of the misuse of the insulin pens, they began doing research. The CNO went on to say the research showed this same issue had occurred at other facilities; until time of research they were unaware.

Continued record review on 01-16-14 of facility investigation revealed research compiled after the occurrences. Facility research included a 2009 Food and Drug Administration (FDA) Alert that cautioned sharing of insulin pens possibly transmitting of bloodborne diseases. In addition, facility research included information distributed in 2012 from Centers for Disease Control (CDC) and Centers for Medicare and Medicaid (CMS) alerting to issues with misuse if insulin pens.

Telephone interview on 01-24-14 at 3:30 p.m. with facility Director of Pharmacy/ID # 22 he reported he had been in his position at the facility since October 2009. He went on to say the insulin pens had been used at the facility since January 2009.

Pharmacy Director ID # 22 reported he had access to multiple sources and publications regarding medication safety. He subscribed to the ' American Society of Health-System Pharmacists (ASHP) Journal ' , ' Hospital Pharmacy Times, ' Food & Drug Administration (FDA) Alerts, Institute for Safe Medication Practices (ISMP) Newsletter and other publications.

When asked if he was aware of the FDA Alert 2009 and various ISMP Medication Safety Alerts of 2009 & 2013 regarding insulin pen misuse, Pharmacy Director ID # 22 acknowledged " that information did not come his way. "

He went onto say the hospital formulary included 4,000 medications and many issues were monitored including: look-alike sound alike drugs, high alert medications, adverse drug reactions (ADR) and others.

Record review on 01-16-14 of FDA Alert dated March 19, 2009 read: " ... (based upon exposure of 2,000+ patients at two healthcare facilities): " ... The FDA reminds healthcare providers, healthcare facilities ... that each insulin pen (and each insulin pen cartridge) is designed for single-patient use only and is never to be shared among patients. Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user ... "

Record review on 01-16-14 of ISMP " Medication Safety Alerts " revealed:

ISMP Alert dated February12, 2009: discussion of misuse of insulin pens at a U.S. Army Hospital, exposure of 2,114 paints. " Facilities using insulin pens should act immediately and provide education and continuous monitoring where an individual pen might be reused for another patient ... don ' t assume that everyone knows not to do this. In one report, a nurse told us that rather than waiting for pharmacy to dispense a patient ' s pen, nurses at her hospital often borrowed a pen from another patient, put in a new disposable needle and injected insulin into the second patient using the first patient ' s pen ... "

ISMP Alert dated January 24, 2013: reported insulin pen used on multiple patients at a NY hospital, exposure of more than 700 patients to HIV, Hepatitis B, Hepatitis C.

ISMP Alert dated February 7, 2013: " As a result of persistent ongoing safety issues, the ISMP is calling for hospitals to closely reexamine their policies regarding insulin pen devices, and consider transitioning away from insulin pens for routine inpatient use... "

Interview on 01-17-14 at 1:10 p.m. with Chief Operating Officer (COO) ID # 1 he stated he provided direct oversight of Pharmacy Services. He went on to say that he questioned the pharmacist after the insulin pen occurrence regarding medication alerts and information regarding the insulin pens. He acknowledged this was a process the facility would address as they moved forward.